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Advocate Spot-on Solution for Dogs & Cats

Advocate Spot-on Solution for Dogs & Cats

  • 40 Small Cats Up To 4kg » Pack Of 3 Pipettes £19.00
  • 40 Small Cats Up To 4kg » Pack Of 6 Pipettes £34.99
  • 40 Small Dogs Up To 4kg » Pack Of 3 Pipettes £19.99
  • 80 Large Cats 4-8kgs » Pack Of 3 Pipettes £19.49
  • 80 Large Cats 4-8kgs » Pack Of 6 Pipettes £35.50
  • 100 Medium Dogs 4-10kg » Pack Of 3 Pipettes £22.00
  • 100 Medium Dogs 4-10kg » Pack Of 6 Pipettes £28.79
  • 250 Large Dogs 10-25kg » Pack Of 3 Pipettes £23.99
  • 250 Large Dogs 10-25kg » Pack Of 6 Pipettes £31.95
  • 400 Extra Large Dogs 25-40kg » Pack Of 3 Pipettes £28.99
  • 400 Extra Large Dogs 25-40kg » Pack Of 6 Pipettes £38.39

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Description

Advocate is a spot-on treatment used to control internal and external parasites affecting dogs, cats and ferrets. The contents of one pipette are applied to the skin on the back of the neck between the parted hair. The area is then left to dry, which might take a few hours. One of the active ingredients, moxidectin, is absorbed through the skin and travels around the body, treating internal parasites such as worms. The other active ingredient, imidacloprid, transfers across the surface of the body, dissolved in the oils on the surface of the skin and hairs. Surface living parasites such as fleas are killed on contact.

Of all the products available, Advocate probably kills the broadest range of parasites affecting dogs, cats and ferrets

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Medication Datasheets

80 Large Cats 4-8kgs » Pack Of 3 Pipettes

Advocate Spot-on Solution

Presentation

Advocate spot-on solution for cats and ferrets is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 10 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E 321 as an antioxidant). Each pipette of the small cat and ferret presentation contains 0.4 ml (40 mg imidacloprid, 4 mg moxidectin), the large cat presentation contains 0.8 ml (80 mg imidacloprid, 8 mg moxidectin).

Advocate spot-on solution for dogs is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 25 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E321 as an antioxidant). Each pipette of the dog presentations contains either 0.4 ml (40 mg imidacloprid, 10 mg moxidectin), 1.0 ml (100 mg imidacloprid, 25 mg moxidectin), 2.5 ml (250 mg imidacloprid, 62.5 mg moxidectin) or 4.0 ml (400 mg imidacloprid, 100 mg moxidectin).

Uses

For use in cats, ferrets and dogs suffering from, or at risk from, mixed parasitic infections:

For cats:

For ferrets: For the treatment and prevention of flea infestation (Ctenocephalides felis) and the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis).

For dogs:

Dosage and administration

Dosage schedule

The recommended minimum doses for cats are 10 mg/kg body weight imidacloprid and 1.0 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for cats.

Dosage schedule for ferrets: one pipette of Advocate spot-on solution for small cats and ferrets (0.4 ml) should be administered per animal. Do not exceed the recommended dose.

The recommended minimum doses for dogs are 10 mg/kg body weight imidacloprid and 2.5 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for dogs.

The treatment schedule for all species should be based on individual veterinary diagnosis and on the local epidemiological situation.

Cats (Refer to Table 1)

Dogs(Refer to Table 2)

Flea treatment and prevention (Cats and Dogs)

One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine Advocate treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.

Flea treatment and prevention (Ferrets)

One treatment prevents future flea infestation for 3 weeks. Under heavy flea pressure it may be necessary to repeat the dose after 2 weeks.

Treatment of ear mite infestation (Otodectes cynotis) (Cats & Dogs)

A single dose of the product should be administered. In dogs, loose debris should be gently removed from the external ear canal at each treatment. For both cats and dogs, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.

Treatment of biting lice (Trichodectes canis) (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis) (Dogs)

A single dose should be administered twice 4 weeks apart.

Treatment of notoedric mange (Notoedres cati) (Cats)

A single dose of the product should be administered.

Treatment of the lungworm Eucoleus aerophilus (syn. Capillaria aerophila) (adults) (Cats)

A single dose of the product should be administered.

Treatment of Eucoleus (syn. Capillaria) boehmi (adults)(Dogs)

The product should be administered monthly for two consecutive months. It is advisable to prevent auto-coprophagia between the two treatments in order to prevent possible reinfection.

Treatment of the eye worm Thelazia callipaeda (adults)(Dogs)

A single dose of the product should be administered.

Treatment of demodicosis (caused by Demodex canis) (Dogs)

The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against Demodex canis and leads to a marked improvement of clinical signs particularly in mild to moderate cases. Especially severe cases may require more prolonged and more frequent treatment. To achieve the best possible response in these severe cases, at the discretion of the veterinarian, Advocate can be applied once a week and for a prolonged time. In all cases it is essential that the treatment should be continued until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment. Alternative treatment should be administered. Seek the advice of your veterinarian.

As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.

Prevention of heartworm disease (D.immitis) (Cats, Ferrets & Dogs) and cutaneous dirofilariosis (D. repens) (Dogs)

Cats, ferrets and dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with Advocate, the advice provided in Contra-Indications and Warnings etc should be considered. For prevention of heartworm disease and cutaneous dirofilariosis, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. immitis and D. repens larvae) are present. The product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with Advocate must be given within 1 month of the last dose of the former medication. In non-endemic areas there should be no risk of animals having heartworm. Therefore they can be treated without special precautions.

Treatment of microfilariae (D. immitis) (Dogs)

Advocate should be administered monthly for two consecutive months.

Treatment of cutaneous dirofilariosis (skin worm) (adult stages of Dirofilaria repens) (Dogs)

Advocate should be administered monthly for six consecutive months.

Reduction of microfilariae (skin worm) (D. repens) (Dogs)

The product should be administered monthly for four consecutive months.

Roundworm and hookworm treatment (Cats)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworms and hookworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.

Roundworm, hookworm and whipworm treatment (Dogs)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective round-, hook- and whipworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes. Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.

Treatment and Prevention of Angiostrongylus vasorum (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

In endemic areas regular four weekly application will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.

Treatment of Crenosoma vulpis (Dogs)

A single dose should be administered

Prevention of Spirocerca lupi (Dogs)

The product should be administered monthly.

Method of administration

For external use only.

Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown. See Figure 1.

Figure 1: Opening a pipette

Cats and Ferrets

Part the fur on the animal's neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. Application at the base of the skull will minimise the opportunity for the animal to lick the product. Apply only to undamaged skin. See Figure 2.

Figure 2: Administration to the Cat or Ferret

For dogs up to 25kg

With the dog in a standing position, part the coat between the shoulder blades until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. See Figure 3.

Figure 3: Administration to dogs up to 25kg

For dogs of more than 25 kg

For easy application the dog should be standing. The entire contents of the pipette should be applied evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail. At each spot, part the coat until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly onto the skin. Do not apply an excessive amount of solution at any one spot, as that could cause some of the product to run down the animal’s side. See Figure 4.

Figure 4: Administration to dogs over 25kg

Use During Pregnancy and Lactation

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the risk-benefit assessment by the responsible veterinarian.

Contra-indications, warnings, etc

Do not use in kittens under 9 weeks of age.

Do not use in puppies under 7 weeks of age.

Treatment of cats or dogs weighing less than 1 kg, and ferrets weighing less than 0.8 kg should be based on a risk-benefit assessment.

Do not use in the cases of hypersensitivity to the active substances or to any of the excipients.

There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a risk-benefit assessment for these animals.

For cats, the corresponding "Advocate spot-on solution for cat" product, which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used.

For ferrets: Do not use Advocate for large cats (0.8ml) or Advocate for dogs (any size), only "Advocate for small cats and ferrets" (0.4 ml) must be used. The product’s efficacy has not been tested in ferrets weighing over 2 kg and therefore the duration of effect might be shorter in these animals.

For dogs, the corresponding "Advocate for dog" product, which contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin, must be used.

Do not use on canaries.

The product tastes bitter. Salivation may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application will minimise licking of the application site.

In case of accidental oral uptake, symptomatic treatment should be administered. There is no known specific antidote. The use of activated charcoal may be beneficial. After accidental oral ingestion (e.g. licking at the site of application) or overdose, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may be observed in very rare cases.

The use of the product may result in transient pruritus in the animal. On rare occasions greasy fur, erythema and vomiting can occur. These signs disappear without further treatment. The product may, in rare cases cause local hypersensitivity reactions. The product may in very rare cases cause at the application site a sensation resulting in transient behavioural changes such as lethargy, agitation, and inappetence.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Care should be taken that the contents of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.

Do not allow recently treated animals to groom each other.

When the product is applied in 3 to 4 separate spots in larger dogs, specific care should be taken to prevent the animal licking the application sites. Oral uptake by Collies, Old English Sheepdogs and related breeds or crossbreeds should be prevented.

During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered. This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the product as described above. In particular, oral uptake by the recipient and/or other animals in close contact should be prevented.

Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals without any adverse effects, but the safety of application at weekly intervals has not been investigated in ivermectin-sensitive Collie dogs. When 40% of the unit dose was given orally, severe neurological signs were observed. Oral administration of 10% of the recommended dose produced no adverse effects.

Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects or undesirable clinical signs. Five times the recommended minimum dose applied at weekly intervals for 17 weeks was investigated in dogs aged over 6 months and tolerated with no evidence of adverse effects or undesirable clinical signs.

Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or undesirable clinical signs.

The product was administered to kittens and puppies at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.

The product was administered to ferrets at 5 times the recommended dose, every 2 weeks for 4 treatments, and there was no evidence of adverse effects or undesirable clinical signs.

It is recommended that cats and ferrets living in, or travelling to areas endemic for heartworm are treated monthly with the product to protect them from heartworm disease. Whilst the accuracy of diagnosis of heartworm infection is limited, it is recommended that attempts be made to check the heartworm status of any cat and ferret aged over 6 months, before beginning prophylactic treatment, as use of the product on cats or ferrets which have adult heartworms may cause serious adverse effects, including death. If adult heartworm infection is diagnosed, the infection should be treated in accordance with current scientific knowledge.

Although experimental overdosage studies have shown that the product may be safely administered to dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis. It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the product. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of Advocate has not been evaluated when administered on the same day as an adulticide.

Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse effects.

The safety of the product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study. Therefore the use in dogs with obvious or severe symptoms of the disease should be based on a careful benefit risk assessment by the treating veterinarian.

Do not use in dogs classified as Class 4 for heartworm disease as the safety of the product has not been evaluated in this animal group.

A field study has shown that in heartworm positive dogs with microfilaraemia there is a risk of severe respiratory signs (coughing, tachypnoea and dyspnoea) that may require prompt veterinary treatment. In the study these reactions were common (seen in 2 of 106 treated dogs). Gastrointestinal signs (vomiting, diarrhoea, inappetence) and lethargy are also common adverse reactions following treatment in such dogs.

Efficacy against adult Dirofilaria repens has not been tested under field conditions.

In certain individual cats Notoedres cati infestation may be severe. In these severe cases concomitant supportive treatment is necessary as treatment with the product alone may not be sufficient to prevent death of the animal.

Imidacloprid is toxic for birds, especially canaries.

No interactions between Advocate and routinely used veterinary medicinal products or medical or surgical procedures have been observed.

Safety of Advocate when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.

Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the product.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.

The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time.

The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

User Safety

Avoid contact with skin, eyes or mouth.

Do not eat, drink or smoke during application.

Wash hands thoroughly after use.

In case of accidental spillage onto skin, wash off immediately with soap and water.

After application do not stroke or groom animals until the application site is dry.

People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In very rare cases the product may cause skin sensitisation or transient skin reactions (for example numbness, irritation or burning/tingling sensation). In very rare cases the product may cause respiratory irritation in sensitive individuals.

If the product accidentally gets into eyes, they should be thoroughly flushed with water.

If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical attention and show the package insert to the physician.

Environmental Safety

Advocate should not be allowed to enter water courses as it has harmful effects on aquatic organisms: moxidectin is highly toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days after treatment.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Pharmaceutical precautions

Do not store above 30°C.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Legal category

Packaging quantities

White polypropylene unit dose pipette with screw cap.

Further information

Pharmacotherapeutic group: therapeutic antiparasitic agent; ATCvet code: QP54AB52.

Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has minimal pharmacological activity in mammals.

Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is a parasiticide which is active against many internal and external parasites. Moxidectin is active against larval stages of Dirofilaria immitis (L1, L3, L4) and Dirofilaria repens (L1, L3). It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion.

The drug has a persistent action and protects dogs for 4 weeks after a single application against re-infection with the following parasites: Dirofilaria immitis, Dirofilaria repens, Angiostrongylus vasorum

After topical administration of the product, imidacloprid is rapidly distributed over the animal’s skin within one day of application. It can be found on the body surface throughout the treatment interval. Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 1 to 2 days after treatment in cats and approximately 4 to 9 days after treatment in dogs. Following absorption from the skin, moxidectin is distributed systemically throughout the body tissues but due to its lipophilicity it is concentrated mainly in the fat. It is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.

The T ½ in dogs is about 28.4 days.

Studies evaluating the pharmacokinetic behaviour of moxidectin after multiple applications have indicated that steady state serum levels are achieved following approximately 4 consecutive monthly treatments in dogs.

Marketing Authorisation Holder (if different from distributor)

Marketing Authorisation Holder

Bayer Animal Health GmbH, D-51368 Leverkusen, Germany

Distributed by

UK: Bayer plc, 400 South Oak Way, Green Park, Reading, Berkshire, RG2 6AD

Ireland: Bayer Ltd, The Atrium, Blackthorn Road, Sandyford Ind Est, Dublin 18

Marketing Authorisation Number

EU/2/03/039/001 - 005EU/2/03/039/007 - 012EU/2/03/039/019, EU/2/03/039/021, EU/2/03/039/023, EU/2/03/039/025, EU/2/03/039/027, EU/2/03/039/029

250 Large Dogs 10-25kg » Pack Of 3 Pipettes

Advocate Spot-on Solution

Presentation

Advocate spot-on solution for cats and ferrets is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 10 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E 321 as an antioxidant). Each pipette of the small cat and ferret presentation contains 0.4 ml (40 mg imidacloprid, 4 mg moxidectin), the large cat presentation contains 0.8 ml (80 mg imidacloprid, 8 mg moxidectin).

Advocate spot-on solution for dogs is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 25 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E321 as an antioxidant). Each pipette of the dog presentations contains either 0.4 ml (40 mg imidacloprid, 10 mg moxidectin), 1.0 ml (100 mg imidacloprid, 25 mg moxidectin), 2.5 ml (250 mg imidacloprid, 62.5 mg moxidectin) or 4.0 ml (400 mg imidacloprid, 100 mg moxidectin).

Uses

For use in cats, ferrets and dogs suffering from, or at risk from, mixed parasitic infections:

For cats:

For ferrets: For the treatment and prevention of flea infestation (Ctenocephalides felis) and the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis).

For dogs:

Dosage and administration

Dosage schedule

The recommended minimum doses for cats are 10 mg/kg body weight imidacloprid and 1.0 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for cats.

Dosage schedule for ferrets: one pipette of Advocate spot-on solution for small cats and ferrets (0.4 ml) should be administered per animal. Do not exceed the recommended dose.

The recommended minimum doses for dogs are 10 mg/kg body weight imidacloprid and 2.5 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for dogs.

The treatment schedule for all species should be based on individual veterinary diagnosis and on the local epidemiological situation.

Cats (Refer to Table 1)

Dogs(Refer to Table 2)

Flea treatment and prevention (Cats and Dogs)

One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine Advocate treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.

Flea treatment and prevention (Ferrets)

One treatment prevents future flea infestation for 3 weeks. Under heavy flea pressure it may be necessary to repeat the dose after 2 weeks.

Treatment of ear mite infestation (Otodectes cynotis) (Cats & Dogs)

A single dose of the product should be administered. In dogs, loose debris should be gently removed from the external ear canal at each treatment. For both cats and dogs, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.

Treatment of biting lice (Trichodectes canis) (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis) (Dogs)

A single dose should be administered twice 4 weeks apart.

Treatment of notoedric mange (Notoedres cati) (Cats)

A single dose of the product should be administered.

Treatment of the lungworm Eucoleus aerophilus (syn. Capillaria aerophila) (adults) (Cats)

A single dose of the product should be administered.

Treatment of Eucoleus (syn. Capillaria) boehmi (adults)(Dogs)

The product should be administered monthly for two consecutive months. It is advisable to prevent auto-coprophagia between the two treatments in order to prevent possible reinfection.

Treatment of the eye worm Thelazia callipaeda (adults)(Dogs)

A single dose of the product should be administered.

Treatment of demodicosis (caused by Demodex canis) (Dogs)

The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against Demodex canis and leads to a marked improvement of clinical signs particularly in mild to moderate cases. Especially severe cases may require more prolonged and more frequent treatment. To achieve the best possible response in these severe cases, at the discretion of the veterinarian, Advocate can be applied once a week and for a prolonged time. In all cases it is essential that the treatment should be continued until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment. Alternative treatment should be administered. Seek the advice of your veterinarian.

As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.

Prevention of heartworm disease (D.immitis) (Cats, Ferrets & Dogs) and cutaneous dirofilariosis (D. repens) (Dogs)

Cats, ferrets and dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with Advocate, the advice provided in Contra-Indications and Warnings etc should be considered. For prevention of heartworm disease and cutaneous dirofilariosis, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. immitis and D. repens larvae) are present. The product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with Advocate must be given within 1 month of the last dose of the former medication. In non-endemic areas there should be no risk of animals having heartworm. Therefore they can be treated without special precautions.

Treatment of microfilariae (D. immitis) (Dogs)

Advocate should be administered monthly for two consecutive months.

Treatment of cutaneous dirofilariosis (skin worm) (adult stages of Dirofilaria repens) (Dogs)

Advocate should be administered monthly for six consecutive months.

Reduction of microfilariae (skin worm) (D. repens) (Dogs)

The product should be administered monthly for four consecutive months.

Roundworm and hookworm treatment (Cats)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworms and hookworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.

Roundworm, hookworm and whipworm treatment (Dogs)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective round-, hook- and whipworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes. Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.

Treatment and Prevention of Angiostrongylus vasorum (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

In endemic areas regular four weekly application will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.

Treatment of Crenosoma vulpis (Dogs)

A single dose should be administered

Prevention of Spirocerca lupi (Dogs)

The product should be administered monthly.

Method of administration

For external use only.

Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown. See Figure 1.

Figure 1: Opening a pipette

Cats and Ferrets

Part the fur on the animal's neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. Application at the base of the skull will minimise the opportunity for the animal to lick the product. Apply only to undamaged skin. See Figure 2.

Figure 2: Administration to the Cat or Ferret

For dogs up to 25kg

With the dog in a standing position, part the coat between the shoulder blades until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. See Figure 3.

Figure 3: Administration to dogs up to 25kg

For dogs of more than 25 kg

For easy application the dog should be standing. The entire contents of the pipette should be applied evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail. At each spot, part the coat until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly onto the skin. Do not apply an excessive amount of solution at any one spot, as that could cause some of the product to run down the animal’s side. See Figure 4.

Figure 4: Administration to dogs over 25kg

Use During Pregnancy and Lactation

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the risk-benefit assessment by the responsible veterinarian.

Contra-indications, warnings, etc

Do not use in kittens under 9 weeks of age.

Do not use in puppies under 7 weeks of age.

Treatment of cats or dogs weighing less than 1 kg, and ferrets weighing less than 0.8 kg should be based on a risk-benefit assessment.

Do not use in the cases of hypersensitivity to the active substances or to any of the excipients.

There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a risk-benefit assessment for these animals.

For cats, the corresponding "Advocate spot-on solution for cat" product, which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used.

For ferrets: Do not use Advocate for large cats (0.8ml) or Advocate for dogs (any size), only "Advocate for small cats and ferrets" (0.4 ml) must be used. The product’s efficacy has not been tested in ferrets weighing over 2 kg and therefore the duration of effect might be shorter in these animals.

For dogs, the corresponding "Advocate for dog" product, which contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin, must be used.

Do not use on canaries.

The product tastes bitter. Salivation may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application will minimise licking of the application site.

In case of accidental oral uptake, symptomatic treatment should be administered. There is no known specific antidote. The use of activated charcoal may be beneficial. After accidental oral ingestion (e.g. licking at the site of application) or overdose, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may be observed in very rare cases.

The use of the product may result in transient pruritus in the animal. On rare occasions greasy fur, erythema and vomiting can occur. These signs disappear without further treatment. The product may, in rare cases cause local hypersensitivity reactions. The product may in very rare cases cause at the application site a sensation resulting in transient behavioural changes such as lethargy, agitation, and inappetence.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Care should be taken that the contents of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.

Do not allow recently treated animals to groom each other.

When the product is applied in 3 to 4 separate spots in larger dogs, specific care should be taken to prevent the animal licking the application sites. Oral uptake by Collies, Old English Sheepdogs and related breeds or crossbreeds should be prevented.

During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered. This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the product as described above. In particular, oral uptake by the recipient and/or other animals in close contact should be prevented.

Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals without any adverse effects, but the safety of application at weekly intervals has not been investigated in ivermectin-sensitive Collie dogs. When 40% of the unit dose was given orally, severe neurological signs were observed. Oral administration of 10% of the recommended dose produced no adverse effects.

Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects or undesirable clinical signs. Five times the recommended minimum dose applied at weekly intervals for 17 weeks was investigated in dogs aged over 6 months and tolerated with no evidence of adverse effects or undesirable clinical signs.

Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or undesirable clinical signs.

The product was administered to kittens and puppies at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.

The product was administered to ferrets at 5 times the recommended dose, every 2 weeks for 4 treatments, and there was no evidence of adverse effects or undesirable clinical signs.

It is recommended that cats and ferrets living in, or travelling to areas endemic for heartworm are treated monthly with the product to protect them from heartworm disease. Whilst the accuracy of diagnosis of heartworm infection is limited, it is recommended that attempts be made to check the heartworm status of any cat and ferret aged over 6 months, before beginning prophylactic treatment, as use of the product on cats or ferrets which have adult heartworms may cause serious adverse effects, including death. If adult heartworm infection is diagnosed, the infection should be treated in accordance with current scientific knowledge.

Although experimental overdosage studies have shown that the product may be safely administered to dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis. It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the product. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of Advocate has not been evaluated when administered on the same day as an adulticide.

Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse effects.

The safety of the product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study. Therefore the use in dogs with obvious or severe symptoms of the disease should be based on a careful benefit risk assessment by the treating veterinarian.

Do not use in dogs classified as Class 4 for heartworm disease as the safety of the product has not been evaluated in this animal group.

A field study has shown that in heartworm positive dogs with microfilaraemia there is a risk of severe respiratory signs (coughing, tachypnoea and dyspnoea) that may require prompt veterinary treatment. In the study these reactions were common (seen in 2 of 106 treated dogs). Gastrointestinal signs (vomiting, diarrhoea, inappetence) and lethargy are also common adverse reactions following treatment in such dogs.

Efficacy against adult Dirofilaria repens has not been tested under field conditions.

In certain individual cats Notoedres cati infestation may be severe. In these severe cases concomitant supportive treatment is necessary as treatment with the product alone may not be sufficient to prevent death of the animal.

Imidacloprid is toxic for birds, especially canaries.

No interactions between Advocate and routinely used veterinary medicinal products or medical or surgical procedures have been observed.

Safety of Advocate when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.

Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the product.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.

The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time.

The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

User Safety

Avoid contact with skin, eyes or mouth.

Do not eat, drink or smoke during application.

Wash hands thoroughly after use.

In case of accidental spillage onto skin, wash off immediately with soap and water.

After application do not stroke or groom animals until the application site is dry.

People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In very rare cases the product may cause skin sensitisation or transient skin reactions (for example numbness, irritation or burning/tingling sensation). In very rare cases the product may cause respiratory irritation in sensitive individuals.

If the product accidentally gets into eyes, they should be thoroughly flushed with water.

If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical attention and show the package insert to the physician.

Environmental Safety

Advocate should not be allowed to enter water courses as it has harmful effects on aquatic organisms: moxidectin is highly toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days after treatment.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Pharmaceutical precautions

Do not store above 30°C.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Legal category

Packaging quantities

White polypropylene unit dose pipette with screw cap.

Further information

Pharmacotherapeutic group: therapeutic antiparasitic agent; ATCvet code: QP54AB52.

Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has minimal pharmacological activity in mammals.

Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is a parasiticide which is active against many internal and external parasites. Moxidectin is active against larval stages of Dirofilaria immitis (L1, L3, L4) and Dirofilaria repens (L1, L3). It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion.

The drug has a persistent action and protects dogs for 4 weeks after a single application against re-infection with the following parasites: Dirofilaria immitis, Dirofilaria repens, Angiostrongylus vasorum

After topical administration of the product, imidacloprid is rapidly distributed over the animal’s skin within one day of application. It can be found on the body surface throughout the treatment interval. Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 1 to 2 days after treatment in cats and approximately 4 to 9 days after treatment in dogs. Following absorption from the skin, moxidectin is distributed systemically throughout the body tissues but due to its lipophilicity it is concentrated mainly in the fat. It is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.

The T ½ in dogs is about 28.4 days.

Studies evaluating the pharmacokinetic behaviour of moxidectin after multiple applications have indicated that steady state serum levels are achieved following approximately 4 consecutive monthly treatments in dogs.

Marketing Authorisation Holder (if different from distributor)

Marketing Authorisation Holder

Bayer Animal Health GmbH, D-51368 Leverkusen, Germany

Distributed by

UK: Bayer plc, 400 South Oak Way, Green Park, Reading, Berkshire, RG2 6AD

Ireland: Bayer Ltd, The Atrium, Blackthorn Road, Sandyford Ind Est, Dublin 18

Marketing Authorisation Number

EU/2/03/039/001 - 005EU/2/03/039/007 - 012EU/2/03/039/019, EU/2/03/039/021, EU/2/03/039/023, EU/2/03/039/025, EU/2/03/039/027, EU/2/03/039/029

100 Medium Dogs 4-10kg » Pack Of 3 Pipettes

Advocate Spot-on Solution

Presentation

Advocate spot-on solution for cats and ferrets is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 10 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E 321 as an antioxidant). Each pipette of the small cat and ferret presentation contains 0.4 ml (40 mg imidacloprid, 4 mg moxidectin), the large cat presentation contains 0.8 ml (80 mg imidacloprid, 8 mg moxidectin).

Advocate spot-on solution for dogs is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 25 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E321 as an antioxidant). Each pipette of the dog presentations contains either 0.4 ml (40 mg imidacloprid, 10 mg moxidectin), 1.0 ml (100 mg imidacloprid, 25 mg moxidectin), 2.5 ml (250 mg imidacloprid, 62.5 mg moxidectin) or 4.0 ml (400 mg imidacloprid, 100 mg moxidectin).

Uses

For use in cats, ferrets and dogs suffering from, or at risk from, mixed parasitic infections:

For cats:

For ferrets: For the treatment and prevention of flea infestation (Ctenocephalides felis) and the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis).

For dogs:

Dosage and administration

Dosage schedule

The recommended minimum doses for cats are 10 mg/kg body weight imidacloprid and 1.0 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for cats.

Dosage schedule for ferrets: one pipette of Advocate spot-on solution for small cats and ferrets (0.4 ml) should be administered per animal. Do not exceed the recommended dose.

The recommended minimum doses for dogs are 10 mg/kg body weight imidacloprid and 2.5 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for dogs.

The treatment schedule for all species should be based on individual veterinary diagnosis and on the local epidemiological situation.

Cats (Refer to Table 1)

Dogs(Refer to Table 2)

Flea treatment and prevention (Cats and Dogs)

One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine Advocate treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.

Flea treatment and prevention (Ferrets)

One treatment prevents future flea infestation for 3 weeks. Under heavy flea pressure it may be necessary to repeat the dose after 2 weeks.

Treatment of ear mite infestation (Otodectes cynotis) (Cats & Dogs)

A single dose of the product should be administered. In dogs, loose debris should be gently removed from the external ear canal at each treatment. For both cats and dogs, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.

Treatment of biting lice (Trichodectes canis) (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis) (Dogs)

A single dose should be administered twice 4 weeks apart.

Treatment of notoedric mange (Notoedres cati) (Cats)

A single dose of the product should be administered.

Treatment of the lungworm Eucoleus aerophilus (syn. Capillaria aerophila) (adults) (Cats)

A single dose of the product should be administered.

Treatment of Eucoleus (syn. Capillaria) boehmi (adults)(Dogs)

The product should be administered monthly for two consecutive months. It is advisable to prevent auto-coprophagia between the two treatments in order to prevent possible reinfection.

Treatment of the eye worm Thelazia callipaeda (adults)(Dogs)

A single dose of the product should be administered.

Treatment of demodicosis (caused by Demodex canis) (Dogs)

The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against Demodex canis and leads to a marked improvement of clinical signs particularly in mild to moderate cases. Especially severe cases may require more prolonged and more frequent treatment. To achieve the best possible response in these severe cases, at the discretion of the veterinarian, Advocate can be applied once a week and for a prolonged time. In all cases it is essential that the treatment should be continued until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment. Alternative treatment should be administered. Seek the advice of your veterinarian.

As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.

Prevention of heartworm disease (D.immitis) (Cats, Ferrets & Dogs) and cutaneous dirofilariosis (D. repens) (Dogs)

Cats, ferrets and dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with Advocate, the advice provided in Contra-Indications and Warnings etc should be considered. For prevention of heartworm disease and cutaneous dirofilariosis, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. immitis and D. repens larvae) are present. The product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with Advocate must be given within 1 month of the last dose of the former medication. In non-endemic areas there should be no risk of animals having heartworm. Therefore they can be treated without special precautions.

Treatment of microfilariae (D. immitis) (Dogs)

Advocate should be administered monthly for two consecutive months.

Treatment of cutaneous dirofilariosis (skin worm) (adult stages of Dirofilaria repens) (Dogs)

Advocate should be administered monthly for six consecutive months.

Reduction of microfilariae (skin worm) (D. repens) (Dogs)

The product should be administered monthly for four consecutive months.

Roundworm and hookworm treatment (Cats)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworms and hookworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.

Roundworm, hookworm and whipworm treatment (Dogs)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective round-, hook- and whipworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes. Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.

Treatment and Prevention of Angiostrongylus vasorum (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

In endemic areas regular four weekly application will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.

Treatment of Crenosoma vulpis (Dogs)

A single dose should be administered

Prevention of Spirocerca lupi (Dogs)

The product should be administered monthly.

Method of administration

For external use only.

Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown. See Figure 1.

Figure 1: Opening a pipette

Cats and Ferrets

Part the fur on the animal's neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. Application at the base of the skull will minimise the opportunity for the animal to lick the product. Apply only to undamaged skin. See Figure 2.

Figure 2: Administration to the Cat or Ferret

For dogs up to 25kg

With the dog in a standing position, part the coat between the shoulder blades until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. See Figure 3.

Figure 3: Administration to dogs up to 25kg

For dogs of more than 25 kg

For easy application the dog should be standing. The entire contents of the pipette should be applied evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail. At each spot, part the coat until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly onto the skin. Do not apply an excessive amount of solution at any one spot, as that could cause some of the product to run down the animal’s side. See Figure 4.

Figure 4: Administration to dogs over 25kg

Use During Pregnancy and Lactation

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the risk-benefit assessment by the responsible veterinarian.

Contra-indications, warnings, etc

Do not use in kittens under 9 weeks of age.

Do not use in puppies under 7 weeks of age.

Treatment of cats or dogs weighing less than 1 kg, and ferrets weighing less than 0.8 kg should be based on a risk-benefit assessment.

Do not use in the cases of hypersensitivity to the active substances or to any of the excipients.

There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a risk-benefit assessment for these animals.

For cats, the corresponding "Advocate spot-on solution for cat" product, which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used.

For ferrets: Do not use Advocate for large cats (0.8ml) or Advocate for dogs (any size), only "Advocate for small cats and ferrets" (0.4 ml) must be used. The product’s efficacy has not been tested in ferrets weighing over 2 kg and therefore the duration of effect might be shorter in these animals.

For dogs, the corresponding "Advocate for dog" product, which contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin, must be used.

Do not use on canaries.

The product tastes bitter. Salivation may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application will minimise licking of the application site.

In case of accidental oral uptake, symptomatic treatment should be administered. There is no known specific antidote. The use of activated charcoal may be beneficial. After accidental oral ingestion (e.g. licking at the site of application) or overdose, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may be observed in very rare cases.

The use of the product may result in transient pruritus in the animal. On rare occasions greasy fur, erythema and vomiting can occur. These signs disappear without further treatment. The product may, in rare cases cause local hypersensitivity reactions. The product may in very rare cases cause at the application site a sensation resulting in transient behavioural changes such as lethargy, agitation, and inappetence.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Care should be taken that the contents of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.

Do not allow recently treated animals to groom each other.

When the product is applied in 3 to 4 separate spots in larger dogs, specific care should be taken to prevent the animal licking the application sites. Oral uptake by Collies, Old English Sheepdogs and related breeds or crossbreeds should be prevented.

During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered. This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the product as described above. In particular, oral uptake by the recipient and/or other animals in close contact should be prevented.

Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals without any adverse effects, but the safety of application at weekly intervals has not been investigated in ivermectin-sensitive Collie dogs. When 40% of the unit dose was given orally, severe neurological signs were observed. Oral administration of 10% of the recommended dose produced no adverse effects.

Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects or undesirable clinical signs. Five times the recommended minimum dose applied at weekly intervals for 17 weeks was investigated in dogs aged over 6 months and tolerated with no evidence of adverse effects or undesirable clinical signs.

Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or undesirable clinical signs.

The product was administered to kittens and puppies at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.

The product was administered to ferrets at 5 times the recommended dose, every 2 weeks for 4 treatments, and there was no evidence of adverse effects or undesirable clinical signs.

It is recommended that cats and ferrets living in, or travelling to areas endemic for heartworm are treated monthly with the product to protect them from heartworm disease. Whilst the accuracy of diagnosis of heartworm infection is limited, it is recommended that attempts be made to check the heartworm status of any cat and ferret aged over 6 months, before beginning prophylactic treatment, as use of the product on cats or ferrets which have adult heartworms may cause serious adverse effects, including death. If adult heartworm infection is diagnosed, the infection should be treated in accordance with current scientific knowledge.

Although experimental overdosage studies have shown that the product may be safely administered to dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis. It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the product. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of Advocate has not been evaluated when administered on the same day as an adulticide.

Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse effects.

The safety of the product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study. Therefore the use in dogs with obvious or severe symptoms of the disease should be based on a careful benefit risk assessment by the treating veterinarian.

Do not use in dogs classified as Class 4 for heartworm disease as the safety of the product has not been evaluated in this animal group.

A field study has shown that in heartworm positive dogs with microfilaraemia there is a risk of severe respiratory signs (coughing, tachypnoea and dyspnoea) that may require prompt veterinary treatment. In the study these reactions were common (seen in 2 of 106 treated dogs). Gastrointestinal signs (vomiting, diarrhoea, inappetence) and lethargy are also common adverse reactions following treatment in such dogs.

Efficacy against adult Dirofilaria repens has not been tested under field conditions.

In certain individual cats Notoedres cati infestation may be severe. In these severe cases concomitant supportive treatment is necessary as treatment with the product alone may not be sufficient to prevent death of the animal.

Imidacloprid is toxic for birds, especially canaries.

No interactions between Advocate and routinely used veterinary medicinal products or medical or surgical procedures have been observed.

Safety of Advocate when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.

Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the product.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.

The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time.

The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

User Safety

Avoid contact with skin, eyes or mouth.

Do not eat, drink or smoke during application.

Wash hands thoroughly after use.

In case of accidental spillage onto skin, wash off immediately with soap and water.

After application do not stroke or groom animals until the application site is dry.

People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In very rare cases the product may cause skin sensitisation or transient skin reactions (for example numbness, irritation or burning/tingling sensation). In very rare cases the product may cause respiratory irritation in sensitive individuals.

If the product accidentally gets into eyes, they should be thoroughly flushed with water.

If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical attention and show the package insert to the physician.

Environmental Safety

Advocate should not be allowed to enter water courses as it has harmful effects on aquatic organisms: moxidectin is highly toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days after treatment.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Pharmaceutical precautions

Do not store above 30°C.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Legal category

Packaging quantities

White polypropylene unit dose pipette with screw cap.

Further information

Pharmacotherapeutic group: therapeutic antiparasitic agent; ATCvet code: QP54AB52.

Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has minimal pharmacological activity in mammals.

Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is a parasiticide which is active against many internal and external parasites. Moxidectin is active against larval stages of Dirofilaria immitis (L1, L3, L4) and Dirofilaria repens (L1, L3). It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion.

The drug has a persistent action and protects dogs for 4 weeks after a single application against re-infection with the following parasites: Dirofilaria immitis, Dirofilaria repens, Angiostrongylus vasorum

After topical administration of the product, imidacloprid is rapidly distributed over the animal’s skin within one day of application. It can be found on the body surface throughout the treatment interval. Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 1 to 2 days after treatment in cats and approximately 4 to 9 days after treatment in dogs. Following absorption from the skin, moxidectin is distributed systemically throughout the body tissues but due to its lipophilicity it is concentrated mainly in the fat. It is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.

The T ½ in dogs is about 28.4 days.

Studies evaluating the pharmacokinetic behaviour of moxidectin after multiple applications have indicated that steady state serum levels are achieved following approximately 4 consecutive monthly treatments in dogs.

Marketing Authorisation Holder (if different from distributor)

Marketing Authorisation Holder

Bayer Animal Health GmbH, D-51368 Leverkusen, Germany

Distributed by

UK: Bayer plc, 400 South Oak Way, Green Park, Reading, Berkshire, RG2 6AD

Ireland: Bayer Ltd, The Atrium, Blackthorn Road, Sandyford Ind Est, Dublin 18

Marketing Authorisation Number

EU/2/03/039/001 - 005EU/2/03/039/007 - 012EU/2/03/039/019, EU/2/03/039/021, EU/2/03/039/023, EU/2/03/039/025, EU/2/03/039/027, EU/2/03/039/029

40 Small Cats Up To 4kg » Pack Of 3 Pipettes

Advocate Spot-on Solution

Presentation

Advocate spot-on solution for cats and ferrets is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 10 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E 321 as an antioxidant). Each pipette of the small cat and ferret presentation contains 0.4 ml (40 mg imidacloprid, 4 mg moxidectin), the large cat presentation contains 0.8 ml (80 mg imidacloprid, 8 mg moxidectin).

Advocate spot-on solution for dogs is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 25 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E321 as an antioxidant). Each pipette of the dog presentations contains either 0.4 ml (40 mg imidacloprid, 10 mg moxidectin), 1.0 ml (100 mg imidacloprid, 25 mg moxidectin), 2.5 ml (250 mg imidacloprid, 62.5 mg moxidectin) or 4.0 ml (400 mg imidacloprid, 100 mg moxidectin).

Uses

For use in cats, ferrets and dogs suffering from, or at risk from, mixed parasitic infections:

For cats:

For ferrets: For the treatment and prevention of flea infestation (Ctenocephalides felis) and the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis).

For dogs:

Dosage and administration

Dosage schedule

The recommended minimum doses for cats are 10 mg/kg body weight imidacloprid and 1.0 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for cats.

Dosage schedule for ferrets: one pipette of Advocate spot-on solution for small cats and ferrets (0.4 ml) should be administered per animal. Do not exceed the recommended dose.

The recommended minimum doses for dogs are 10 mg/kg body weight imidacloprid and 2.5 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for dogs.

The treatment schedule for all species should be based on individual veterinary diagnosis and on the local epidemiological situation.

Cats (Refer to Table 1)

Dogs(Refer to Table 2)

Flea treatment and prevention (Cats and Dogs)

One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine Advocate treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.

Flea treatment and prevention (Ferrets)

One treatment prevents future flea infestation for 3 weeks. Under heavy flea pressure it may be necessary to repeat the dose after 2 weeks.

Treatment of ear mite infestation (Otodectes cynotis) (Cats & Dogs)

A single dose of the product should be administered. In dogs, loose debris should be gently removed from the external ear canal at each treatment. For both cats and dogs, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.

Treatment of biting lice (Trichodectes canis) (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis) (Dogs)

A single dose should be administered twice 4 weeks apart.

Treatment of notoedric mange (Notoedres cati) (Cats)

A single dose of the product should be administered.

Treatment of the lungworm Eucoleus aerophilus (syn. Capillaria aerophila) (adults) (Cats)

A single dose of the product should be administered.

Treatment of Eucoleus (syn. Capillaria) boehmi (adults)(Dogs)

The product should be administered monthly for two consecutive months. It is advisable to prevent auto-coprophagia between the two treatments in order to prevent possible reinfection.

Treatment of the eye worm Thelazia callipaeda (adults)(Dogs)

A single dose of the product should be administered.

Treatment of demodicosis (caused by Demodex canis) (Dogs)

The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against Demodex canis and leads to a marked improvement of clinical signs particularly in mild to moderate cases. Especially severe cases may require more prolonged and more frequent treatment. To achieve the best possible response in these severe cases, at the discretion of the veterinarian, Advocate can be applied once a week and for a prolonged time. In all cases it is essential that the treatment should be continued until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment. Alternative treatment should be administered. Seek the advice of your veterinarian.

As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.

Prevention of heartworm disease (D.immitis) (Cats, Ferrets & Dogs) and cutaneous dirofilariosis (D. repens) (Dogs)

Cats, ferrets and dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with Advocate, the advice provided in Contra-Indications and Warnings etc should be considered. For prevention of heartworm disease and cutaneous dirofilariosis, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. immitis and D. repens larvae) are present. The product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with Advocate must be given within 1 month of the last dose of the former medication. In non-endemic areas there should be no risk of animals having heartworm. Therefore they can be treated without special precautions.

Treatment of microfilariae (D. immitis) (Dogs)

Advocate should be administered monthly for two consecutive months.

Treatment of cutaneous dirofilariosis (skin worm) (adult stages of Dirofilaria repens) (Dogs)

Advocate should be administered monthly for six consecutive months.

Reduction of microfilariae (skin worm) (D. repens) (Dogs)

The product should be administered monthly for four consecutive months.

Roundworm and hookworm treatment (Cats)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworms and hookworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.

Roundworm, hookworm and whipworm treatment (Dogs)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective round-, hook- and whipworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes. Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.

Treatment and Prevention of Angiostrongylus vasorum (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

In endemic areas regular four weekly application will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.

Treatment of Crenosoma vulpis (Dogs)

A single dose should be administered

Prevention of Spirocerca lupi (Dogs)

The product should be administered monthly.

Method of administration

For external use only.

Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown. See Figure 1.

Figure 1: Opening a pipette

Cats and Ferrets

Part the fur on the animal's neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. Application at the base of the skull will minimise the opportunity for the animal to lick the product. Apply only to undamaged skin. See Figure 2.

Figure 2: Administration to the Cat or Ferret

For dogs up to 25kg

With the dog in a standing position, part the coat between the shoulder blades until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. See Figure 3.

Figure 3: Administration to dogs up to 25kg

For dogs of more than 25 kg

For easy application the dog should be standing. The entire contents of the pipette should be applied evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail. At each spot, part the coat until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly onto the skin. Do not apply an excessive amount of solution at any one spot, as that could cause some of the product to run down the animal’s side. See Figure 4.

Figure 4: Administration to dogs over 25kg

Use During Pregnancy and Lactation

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the risk-benefit assessment by the responsible veterinarian.

Contra-indications, warnings, etc

Do not use in kittens under 9 weeks of age.

Do not use in puppies under 7 weeks of age.

Treatment of cats or dogs weighing less than 1 kg, and ferrets weighing less than 0.8 kg should be based on a risk-benefit assessment.

Do not use in the cases of hypersensitivity to the active substances or to any of the excipients.

There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a risk-benefit assessment for these animals.

For cats, the corresponding "Advocate spot-on solution for cat" product, which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used.

For ferrets: Do not use Advocate for large cats (0.8ml) or Advocate for dogs (any size), only "Advocate for small cats and ferrets" (0.4 ml) must be used. The product’s efficacy has not been tested in ferrets weighing over 2 kg and therefore the duration of effect might be shorter in these animals.

For dogs, the corresponding "Advocate for dog" product, which contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin, must be used.

Do not use on canaries.

The product tastes bitter. Salivation may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application will minimise licking of the application site.

In case of accidental oral uptake, symptomatic treatment should be administered. There is no known specific antidote. The use of activated charcoal may be beneficial. After accidental oral ingestion (e.g. licking at the site of application) or overdose, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may be observed in very rare cases.

The use of the product may result in transient pruritus in the animal. On rare occasions greasy fur, erythema and vomiting can occur. These signs disappear without further treatment. The product may, in rare cases cause local hypersensitivity reactions. The product may in very rare cases cause at the application site a sensation resulting in transient behavioural changes such as lethargy, agitation, and inappetence.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Care should be taken that the contents of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.

Do not allow recently treated animals to groom each other.

When the product is applied in 3 to 4 separate spots in larger dogs, specific care should be taken to prevent the animal licking the application sites. Oral uptake by Collies, Old English Sheepdogs and related breeds or crossbreeds should be prevented.

During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered. This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the product as described above. In particular, oral uptake by the recipient and/or other animals in close contact should be prevented.

Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals without any adverse effects, but the safety of application at weekly intervals has not been investigated in ivermectin-sensitive Collie dogs. When 40% of the unit dose was given orally, severe neurological signs were observed. Oral administration of 10% of the recommended dose produced no adverse effects.

Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects or undesirable clinical signs. Five times the recommended minimum dose applied at weekly intervals for 17 weeks was investigated in dogs aged over 6 months and tolerated with no evidence of adverse effects or undesirable clinical signs.

Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or undesirable clinical signs.

The product was administered to kittens and puppies at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.

The product was administered to ferrets at 5 times the recommended dose, every 2 weeks for 4 treatments, and there was no evidence of adverse effects or undesirable clinical signs.

It is recommended that cats and ferrets living in, or travelling to areas endemic for heartworm are treated monthly with the product to protect them from heartworm disease. Whilst the accuracy of diagnosis of heartworm infection is limited, it is recommended that attempts be made to check the heartworm status of any cat and ferret aged over 6 months, before beginning prophylactic treatment, as use of the product on cats or ferrets which have adult heartworms may cause serious adverse effects, including death. If adult heartworm infection is diagnosed, the infection should be treated in accordance with current scientific knowledge.

Although experimental overdosage studies have shown that the product may be safely administered to dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis. It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the product. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of Advocate has not been evaluated when administered on the same day as an adulticide.

Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse effects.

The safety of the product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study. Therefore the use in dogs with obvious or severe symptoms of the disease should be based on a careful benefit risk assessment by the treating veterinarian.

Do not use in dogs classified as Class 4 for heartworm disease as the safety of the product has not been evaluated in this animal group.

A field study has shown that in heartworm positive dogs with microfilaraemia there is a risk of severe respiratory signs (coughing, tachypnoea and dyspnoea) that may require prompt veterinary treatment. In the study these reactions were common (seen in 2 of 106 treated dogs). Gastrointestinal signs (vomiting, diarrhoea, inappetence) and lethargy are also common adverse reactions following treatment in such dogs.

Efficacy against adult Dirofilaria repens has not been tested under field conditions.

In certain individual cats Notoedres cati infestation may be severe. In these severe cases concomitant supportive treatment is necessary as treatment with the product alone may not be sufficient to prevent death of the animal.

Imidacloprid is toxic for birds, especially canaries.

No interactions between Advocate and routinely used veterinary medicinal products or medical or surgical procedures have been observed.

Safety of Advocate when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.

Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the product.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.

The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time.

The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

User Safety

Avoid contact with skin, eyes or mouth.

Do not eat, drink or smoke during application.

Wash hands thoroughly after use.

In case of accidental spillage onto skin, wash off immediately with soap and water.

After application do not stroke or groom animals until the application site is dry.

People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In very rare cases the product may cause skin sensitisation or transient skin reactions (for example numbness, irritation or burning/tingling sensation). In very rare cases the product may cause respiratory irritation in sensitive individuals.

If the product accidentally gets into eyes, they should be thoroughly flushed with water.

If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical attention and show the package insert to the physician.

Environmental Safety

Advocate should not be allowed to enter water courses as it has harmful effects on aquatic organisms: moxidectin is highly toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days after treatment.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Pharmaceutical precautions

Do not store above 30°C.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Legal category

Packaging quantities

White polypropylene unit dose pipette with screw cap.

Further information

Pharmacotherapeutic group: therapeutic antiparasitic agent; ATCvet code: QP54AB52.

Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has minimal pharmacological activity in mammals.

Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is a parasiticide which is active against many internal and external parasites. Moxidectin is active against larval stages of Dirofilaria immitis (L1, L3, L4) and Dirofilaria repens (L1, L3). It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion.

The drug has a persistent action and protects dogs for 4 weeks after a single application against re-infection with the following parasites: Dirofilaria immitis, Dirofilaria repens, Angiostrongylus vasorum

After topical administration of the product, imidacloprid is rapidly distributed over the animal’s skin within one day of application. It can be found on the body surface throughout the treatment interval. Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 1 to 2 days after treatment in cats and approximately 4 to 9 days after treatment in dogs. Following absorption from the skin, moxidectin is distributed systemically throughout the body tissues but due to its lipophilicity it is concentrated mainly in the fat. It is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.

The T ½ in dogs is about 28.4 days.

Studies evaluating the pharmacokinetic behaviour of moxidectin after multiple applications have indicated that steady state serum levels are achieved following approximately 4 consecutive monthly treatments in dogs.

Marketing Authorisation Holder (if different from distributor)

Marketing Authorisation Holder

Bayer Animal Health GmbH, D-51368 Leverkusen, Germany

Distributed by

UK: Bayer plc, 400 South Oak Way, Green Park, Reading, Berkshire, RG2 6AD

Ireland: Bayer Ltd, The Atrium, Blackthorn Road, Sandyford Ind Est, Dublin 18

Marketing Authorisation Number

EU/2/03/039/001 - 005EU/2/03/039/007 - 012EU/2/03/039/019, EU/2/03/039/021, EU/2/03/039/023, EU/2/03/039/025, EU/2/03/039/027, EU/2/03/039/029

400 Extra Large Dogs 25-40kg » Pack Of 3 Pipettes

Advocate Spot-on Solution

Presentation

Advocate spot-on solution for cats and ferrets is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 10 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E 321 as an antioxidant). Each pipette of the small cat and ferret presentation contains 0.4 ml (40 mg imidacloprid, 4 mg moxidectin), the large cat presentation contains 0.8 ml (80 mg imidacloprid, 8 mg moxidectin).

Advocate spot-on solution for dogs is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 25 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E321 as an antioxidant). Each pipette of the dog presentations contains either 0.4 ml (40 mg imidacloprid, 10 mg moxidectin), 1.0 ml (100 mg imidacloprid, 25 mg moxidectin), 2.5 ml (250 mg imidacloprid, 62.5 mg moxidectin) or 4.0 ml (400 mg imidacloprid, 100 mg moxidectin).

Uses

For use in cats, ferrets and dogs suffering from, or at risk from, mixed parasitic infections:

For cats:

For ferrets: For the treatment and prevention of flea infestation (Ctenocephalides felis) and the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis).

For dogs:

Dosage and administration

Dosage schedule

The recommended minimum doses for cats are 10 mg/kg body weight imidacloprid and 1.0 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for cats.

Dosage schedule for ferrets: one pipette of Advocate spot-on solution for small cats and ferrets (0.4 ml) should be administered per animal. Do not exceed the recommended dose.

The recommended minimum doses for dogs are 10 mg/kg body weight imidacloprid and 2.5 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for dogs.

The treatment schedule for all species should be based on individual veterinary diagnosis and on the local epidemiological situation.

Cats (Refer to Table 1)

Dogs(Refer to Table 2)

Flea treatment and prevention (Cats and Dogs)

One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine Advocate treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.

Flea treatment and prevention (Ferrets)

One treatment prevents future flea infestation for 3 weeks. Under heavy flea pressure it may be necessary to repeat the dose after 2 weeks.

Treatment of ear mite infestation (Otodectes cynotis) (Cats & Dogs)

A single dose of the product should be administered. In dogs, loose debris should be gently removed from the external ear canal at each treatment. For both cats and dogs, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.

Treatment of biting lice (Trichodectes canis) (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis) (Dogs)

A single dose should be administered twice 4 weeks apart.

Treatment of notoedric mange (Notoedres cati) (Cats)

A single dose of the product should be administered.

Treatment of the lungworm Eucoleus aerophilus (syn. Capillaria aerophila) (adults) (Cats)

A single dose of the product should be administered.

Treatment of Eucoleus (syn. Capillaria) boehmi (adults)(Dogs)

The product should be administered monthly for two consecutive months. It is advisable to prevent auto-coprophagia between the two treatments in order to prevent possible reinfection.

Treatment of the eye worm Thelazia callipaeda (adults)(Dogs)

A single dose of the product should be administered.

Treatment of demodicosis (caused by Demodex canis) (Dogs)

The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against Demodex canis and leads to a marked improvement of clinical signs particularly in mild to moderate cases. Especially severe cases may require more prolonged and more frequent treatment. To achieve the best possible response in these severe cases, at the discretion of the veterinarian, Advocate can be applied once a week and for a prolonged time. In all cases it is essential that the treatment should be continued until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment. Alternative treatment should be administered. Seek the advice of your veterinarian.

As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.

Prevention of heartworm disease (D.immitis) (Cats, Ferrets & Dogs) and cutaneous dirofilariosis (D. repens) (Dogs)

Cats, ferrets and dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with Advocate, the advice provided in Contra-Indications and Warnings etc should be considered. For prevention of heartworm disease and cutaneous dirofilariosis, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. immitis and D. repens larvae) are present. The product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with Advocate must be given within 1 month of the last dose of the former medication. In non-endemic areas there should be no risk of animals having heartworm. Therefore they can be treated without special precautions.

Treatment of microfilariae (D. immitis) (Dogs)

Advocate should be administered monthly for two consecutive months.

Treatment of cutaneous dirofilariosis (skin worm) (adult stages of Dirofilaria repens) (Dogs)

Advocate should be administered monthly for six consecutive months.

Reduction of microfilariae (skin worm) (D. repens) (Dogs)

The product should be administered monthly for four consecutive months.

Roundworm and hookworm treatment (Cats)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworms and hookworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.

Roundworm, hookworm and whipworm treatment (Dogs)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective round-, hook- and whipworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes. Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.

Treatment and Prevention of Angiostrongylus vasorum (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

In endemic areas regular four weekly application will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.

Treatment of Crenosoma vulpis (Dogs)

A single dose should be administered

Prevention of Spirocerca lupi (Dogs)

The product should be administered monthly.

Method of administration

For external use only.

Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown. See Figure 1.

Figure 1: Opening a pipette

Cats and Ferrets

Part the fur on the animal's neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. Application at the base of the skull will minimise the opportunity for the animal to lick the product. Apply only to undamaged skin. See Figure 2.

Figure 2: Administration to the Cat or Ferret

For dogs up to 25kg

With the dog in a standing position, part the coat between the shoulder blades until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. See Figure 3.

Figure 3: Administration to dogs up to 25kg

For dogs of more than 25 kg

For easy application the dog should be standing. The entire contents of the pipette should be applied evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail. At each spot, part the coat until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly onto the skin. Do not apply an excessive amount of solution at any one spot, as that could cause some of the product to run down the animal’s side. See Figure 4.

Figure 4: Administration to dogs over 25kg

Use During Pregnancy and Lactation

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the risk-benefit assessment by the responsible veterinarian.

Contra-indications, warnings, etc

Do not use in kittens under 9 weeks of age.

Do not use in puppies under 7 weeks of age.

Treatment of cats or dogs weighing less than 1 kg, and ferrets weighing less than 0.8 kg should be based on a risk-benefit assessment.

Do not use in the cases of hypersensitivity to the active substances or to any of the excipients.

There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a risk-benefit assessment for these animals.

For cats, the corresponding "Advocate spot-on solution for cat" product, which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used.

For ferrets: Do not use Advocate for large cats (0.8ml) or Advocate for dogs (any size), only "Advocate for small cats and ferrets" (0.4 ml) must be used. The product’s efficacy has not been tested in ferrets weighing over 2 kg and therefore the duration of effect might be shorter in these animals.

For dogs, the corresponding "Advocate for dog" product, which contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin, must be used.

Do not use on canaries.

The product tastes bitter. Salivation may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application will minimise licking of the application site.

In case of accidental oral uptake, symptomatic treatment should be administered. There is no known specific antidote. The use of activated charcoal may be beneficial. After accidental oral ingestion (e.g. licking at the site of application) or overdose, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may be observed in very rare cases.

The use of the product may result in transient pruritus in the animal. On rare occasions greasy fur, erythema and vomiting can occur. These signs disappear without further treatment. The product may, in rare cases cause local hypersensitivity reactions. The product may in very rare cases cause at the application site a sensation resulting in transient behavioural changes such as lethargy, agitation, and inappetence.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Care should be taken that the contents of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.

Do not allow recently treated animals to groom each other.

When the product is applied in 3 to 4 separate spots in larger dogs, specific care should be taken to prevent the animal licking the application sites. Oral uptake by Collies, Old English Sheepdogs and related breeds or crossbreeds should be prevented.

During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered. This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the product as described above. In particular, oral uptake by the recipient and/or other animals in close contact should be prevented.

Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals without any adverse effects, but the safety of application at weekly intervals has not been investigated in ivermectin-sensitive Collie dogs. When 40% of the unit dose was given orally, severe neurological signs were observed. Oral administration of 10% of the recommended dose produced no adverse effects.

Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects or undesirable clinical signs. Five times the recommended minimum dose applied at weekly intervals for 17 weeks was investigated in dogs aged over 6 months and tolerated with no evidence of adverse effects or undesirable clinical signs.

Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or undesirable clinical signs.

The product was administered to kittens and puppies at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.

The product was administered to ferrets at 5 times the recommended dose, every 2 weeks for 4 treatments, and there was no evidence of adverse effects or undesirable clinical signs.

It is recommended that cats and ferrets living in, or travelling to areas endemic for heartworm are treated monthly with the product to protect them from heartworm disease. Whilst the accuracy of diagnosis of heartworm infection is limited, it is recommended that attempts be made to check the heartworm status of any cat and ferret aged over 6 months, before beginning prophylactic treatment, as use of the product on cats or ferrets which have adult heartworms may cause serious adverse effects, including death. If adult heartworm infection is diagnosed, the infection should be treated in accordance with current scientific knowledge.

Although experimental overdosage studies have shown that the product may be safely administered to dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis. It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the product. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of Advocate has not been evaluated when administered on the same day as an adulticide.

Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse effects.

The safety of the product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study. Therefore the use in dogs with obvious or severe symptoms of the disease should be based on a careful benefit risk assessment by the treating veterinarian.

Do not use in dogs classified as Class 4 for heartworm disease as the safety of the product has not been evaluated in this animal group.

A field study has shown that in heartworm positive dogs with microfilaraemia there is a risk of severe respiratory signs (coughing, tachypnoea and dyspnoea) that may require prompt veterinary treatment. In the study these reactions were common (seen in 2 of 106 treated dogs). Gastrointestinal signs (vomiting, diarrhoea, inappetence) and lethargy are also common adverse reactions following treatment in such dogs.

Efficacy against adult Dirofilaria repens has not been tested under field conditions.

In certain individual cats Notoedres cati infestation may be severe. In these severe cases concomitant supportive treatment is necessary as treatment with the product alone may not be sufficient to prevent death of the animal.

Imidacloprid is toxic for birds, especially canaries.

No interactions between Advocate and routinely used veterinary medicinal products or medical or surgical procedures have been observed.

Safety of Advocate when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.

Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the product.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.

The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time.

The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

User Safety

Avoid contact with skin, eyes or mouth.

Do not eat, drink or smoke during application.

Wash hands thoroughly after use.

In case of accidental spillage onto skin, wash off immediately with soap and water.

After application do not stroke or groom animals until the application site is dry.

People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In very rare cases the product may cause skin sensitisation or transient skin reactions (for example numbness, irritation or burning/tingling sensation). In very rare cases the product may cause respiratory irritation in sensitive individuals.

If the product accidentally gets into eyes, they should be thoroughly flushed with water.

If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical attention and show the package insert to the physician.

Environmental Safety

Advocate should not be allowed to enter water courses as it has harmful effects on aquatic organisms: moxidectin is highly toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days after treatment.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Pharmaceutical precautions

Do not store above 30°C.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Legal category

Packaging quantities

White polypropylene unit dose pipette with screw cap.

Further information

Pharmacotherapeutic group: therapeutic antiparasitic agent; ATCvet code: QP54AB52.

Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has minimal pharmacological activity in mammals.

Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is a parasiticide which is active against many internal and external parasites. Moxidectin is active against larval stages of Dirofilaria immitis (L1, L3, L4) and Dirofilaria repens (L1, L3). It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion.

The drug has a persistent action and protects dogs for 4 weeks after a single application against re-infection with the following parasites: Dirofilaria immitis, Dirofilaria repens, Angiostrongylus vasorum

After topical administration of the product, imidacloprid is rapidly distributed over the animal’s skin within one day of application. It can be found on the body surface throughout the treatment interval. Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 1 to 2 days after treatment in cats and approximately 4 to 9 days after treatment in dogs. Following absorption from the skin, moxidectin is distributed systemically throughout the body tissues but due to its lipophilicity it is concentrated mainly in the fat. It is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.

The T ½ in dogs is about 28.4 days.

Studies evaluating the pharmacokinetic behaviour of moxidectin after multiple applications have indicated that steady state serum levels are achieved following approximately 4 consecutive monthly treatments in dogs.

Marketing Authorisation Holder (if different from distributor)

Marketing Authorisation Holder

Bayer Animal Health GmbH, D-51368 Leverkusen, Germany

Distributed by

UK: Bayer plc, 400 South Oak Way, Green Park, Reading, Berkshire, RG2 6AD

Ireland: Bayer Ltd, The Atrium, Blackthorn Road, Sandyford Ind Est, Dublin 18

Marketing Authorisation Number

EU/2/03/039/001 - 005EU/2/03/039/007 - 012EU/2/03/039/019, EU/2/03/039/021, EU/2/03/039/023, EU/2/03/039/025, EU/2/03/039/027, EU/2/03/039/029

40 Small Dogs Up To 4kg » Pack Of 3 Pipettes

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Advocate 40 mg + 4 mg spot-on solution for small cats and ferrets
Advocate 80 mg + 8 mg spot-on solution for large cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substances:

Advocate for cats contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin.

Each unit dose (pipette) contains:

Unit dose Imidacloprid Moxidectin
Advocate for small cats ( 4 kg) and ferrets 0.4 ml 40 mg 4 mg
Advocate for large cats (> 48 kg) 0.8 ml 80 mg 8 mg

Excipients:

Benzyl alcohol
Butylhydroxytoluene 1 mg/ml (E 321; as antioxidant).

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Spot-on solution.
Clear yellow to brownish solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cats, ferrets

4.2 Indications for use, specifying the target species

For cats suffering from, or at risk from, mixed parasitic infections:
the treatment and prevention of flea infestation (Ctenocephalides felis),
the treatment of ear mite infestation (Otodectes cynotis),
the treatment of notoedric mange (Notoedres cati),
the treatment of the lungworm Eucoleus aerophilus (syn. Capillaria aerophila) (adults),
the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis),
the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and
adults of Toxocara cati and Ancylostoma tubaeforme).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

For ferrets suffering from, or at risk from, mixed parasitic infections:
the treatment and prevention of flea infestation (Ctenocephalides felis),
the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis).

4.3 Contraindications

Do not use in kittens under 9 weeks of age.

Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

For ferrets: Do not use Advocate for large cats (0.8 ml) or Advocate for dogs (any size).

For dogs, the corresponding "Advocate for dog" product, which contains 100 mg/ml imidacloprid and
25 mg/ml moxidectin, must be used.

Do not use on canaries.

4.4 Special warnings for each target species

Please refer to section 4.5.

The product's efficacy has not been tested in ferrets weighing over 2 kg and therefore the duration of
effect might be shorter in these animals.

Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely
to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the
animal in water after treatment may reduce the efficacy of the product.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated
use of an anthelmintic of that class. Therefore, the use of this product should be based on the
assessment of each individual case and on local epidemiological information about the current
susceptibility of the target species in order to limit the possibility of a future selection for resistance.

The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of
infection, where prevention applies) at the same time (see also sections 4.2 and 4.9).

4.5 Special precautions for use

Special precautions for use in animals

The treatment of cats weighing less than 1 kg and ferrets weighing less than 0.8 kg should be based on
a benefit-risk assessment.

There is limited experience on the use of the product in sick and debilitated animals, thus the product
should only be used based on a benefit-risk assessment for these animals.

Care should be taken that the content of the pipette or the applied dose does not come into contact with
the eyes or mouth of the recipient and/or other animals. Do not allow recently treated animals to
groom each other. Oral uptake by Collie or Old English Sheep dogs and related breeds or crossbreeds
should be prevented.

It is recommended that cats and ferrets living in, or travelling to areas endemic for heartworm are
treated monthly with the product to protect them from heartworm disease.

Whilst the accuracy of diagnosis of heartworm infection is limited, it is recommended that attempts be
made to check the heartworm status of any cat and ferret aged over 6 months, before beginning
prophylactic treatment, as use of the product on cats or ferrets which have adult heartworms may
cause serious adverse effects, including death. If adult heartworm infection is diagnosed, the infection
should be treated in accordance with current scientific knowledge.

In certain individual cats Notoedres cati infestation may be severe. In these severe cases concomitant
supportive treatment is necessary as treatment with the product alone may not be sufficient to prevent
death of the animal.

Imidacloprid is toxic for birds, especially canaries.

Special precautions to be taken by the person administering the veterinary medicinal product to
animals

Avoid contact with skin, eyes or mouth.
Do not eat, drink or smoke during application.
Wash hands thoroughly after use.
After application do not stroke or groom animals until the application site is dry.
In case of accidental spillage onto skin, wash off immediately with soap and water.
People with known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer
the product with caution. In very rare cases the product may cause skin sensitisation or transient skin
reactions (for example numbness, irritation or burning/tingling sensation).
In very rare cases the product may cause respiratory irritation in sensitive individuals.
If the product accidentally gets into eyes, they should be thoroughly flushed with water.
If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical advice
immediately and show the package leaflet or the label to the physician.

The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and
finished surfaces. Allow the application site to dry before permitting contact with such materials.

4.6 Adverse reactions (frequency and seriousness)

Use of the product may result in transient pruritus in cats. On rare occasions greasy fur, erythema and
vomiting can occur. These signs disappear without further treatment. The product may, in rare cases,
cause local hypersensitivity reactions. If the animal licks the application site after treatment,
neurological signs (most of which are transient) may be observed in very rare cases (see section 4.10).

The product tastes bitter. Salivation may occasionally occur if the animal licks the application site
immediately after treatment. This is not a sign of intoxication and disappears within some minutes
without treatment. Correct application will minimise licking of the application site.

The product may in very rare cases cause at the application site a sensation resulting in transient
behavioural changes such as lethargy, agitation, and inappetence.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any
evidence of teratogenic, foetotoxic or maternotoxic effects.
Use only accordingly to the benefit-risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered.

No interactions between Advocate and routinely used veterinary medicinal products or medical or
surgical procedures have been observed.

4.9 Amounts to be administered and administration route

Dosage schedule for cats:

The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 1.0 mg/kg bodyweight
moxidectin, equivalent to 0.1 ml/kg bodyweight Advocate for cats.

The treatment schedule should be based on individual veterinary diagnosis and on the local
epidemiological situation.

Weight of cat Pipette size to be used Volume Imidacloprid Moxidectin
[kg] [ml] [mg/kg bw] [mg/kg bw]
4 kg Advocate for small cats 0.4 minimum of 10 minimum of 1

48 kg Advocate for large cats 0.8 1020 12
8 kg the appropriate combination of pipettes

Flea treatment and prevention (Ctenocephalides felis)

One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may
emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions.
Therefore, it may be necessary to combine Advocate treatment with environmental treatments aimed
at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the
household flea population. The product should be administered at monthly intervals when used as part
of a treatment strategy for flea allergy dermatitis.

Treatment of ear mite infestation (Otodectes cynotis)

A single dose of the product should be administered. A further veterinary examination 30 days after
treatment is recommended as some animals may require a second treatment. Do not apply directly to
the ear canal.

Treatment of notoedric mange (Notoedres cati)

A single dose of the product should be administered.

Treatment of the lungworm Eucoleus aerophilus (syn. Capillaria aerophila) (adults)

A single dose of the product should be administered.

Heartworm prevention (Dirofilaria immitis)

Cats in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected
with adult heartworms. Therefore prior to treatment with Advocate, the advice provided in section 4.5
should be considered.

For prevention of heartworm disease, the product must be applied at regular monthly intervals during
the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm
larvae) are present. The product may be administered throughout the year or at least 1 month before
the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until
1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that
the same day or date be used each month. When replacing another heartworm preventative product in
a heartworm prevention programme, the first treatment with Advocate must be given within 1 month
of the last dose of the former medication.

In non-endemic areas there should be no risk of cats having heartworm. Therefore they can be treated
without special precautions.

Roundworm and hookworm treatment (Toxocara cati and Ancylostoma tubaeforme)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection
caused by the respective roundworms and hookworms. In areas non-endemic for heartworm, the
product can be used as part of a seasonal prevention programme against fleas and gastrointestinal
nematodes.

Dosage schedule for ferrets:

One pipette of Advocate spot-on solution for Small Cats (0.4 ml) should be administered per animal.
Do not exceed the recommended dose.
The treatment schedule should be based on the local epidemiological situation.

Flea treatment and prevention (Ctenocephalides felis)

One treatment prevents future flea infestation for 3 weeks. Under heavy flea pressure it may be
necessary to repeat administration after 2 weeks.

Heartworm prevention (Dirofilaria immitis)

Ferrets in areas endemic for heartworm, or those which have travelled to endemic areas, may be
infected with adult heartworms. Therefore prior to treatment with Advocate, the advice provided in
section 4.5 should be considered.

For prevention of heartworm disease, the product must be applied at regular monthly intervals during
the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm
larvae) are present. The product may be administered throughout the year or at least 1 month before
the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until
1 month after the last exposure to mosquitoes.
In non-endemic areas there should be no risk of ferrets having heartworm. Therefore they can be
treated without special precautions.

Method of administration

For external use only.

Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull
off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown.

Part the fur on the animal's neck at the base of the skull until the skin is visible. Place the tip of the
pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the
skin. Application at the base of the skull will minimise the opportunity for the animal to lick the
product. Apply only to undamaged skin.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or
undesirable clinical signs.
The product was administered to kittens at up to 5 times the recommended dose, every 2 weeks for 6
treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and
transient rapid respiration were observed.
After accidental oral ingestion or overdose, neurological signs (most of which are transient) such as
ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal
respiration, salivation and vomiting may occur in very rare cases.

The product was administered to ferrets at 5 times the recommended dose, every 2 weeks for 4
treatments, and there was no evidence of adverse effects or undesirable clinical signs.

In case of accidental oral uptake, symptomatic treatment should be administered. There is no known
specific antidote. The use of activated charcoal may be beneficial.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antiparasitic products, insecticides and repellents, macrocyclic lactones,
milbemycins.
ATCvet code: QP54AB52.

5.1 Pharmacodynamic properties

Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an
ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more
accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea

stages and adult fleas. Flea larvae in the pet's surroundings are killed after contact with a pet treated
with the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the
post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of
cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the
interaction with mammalian nicotinergic receptors and the postulated poor penetration through the
blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has
minimal pharmacological activity in mammals.

Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the
milbemycin family. It is a parasiticide which is active against many internal and external parasites.
Moxidectin is active against larval stages (L3, L4) of Dirofilaria immitis. It is also active against
gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels.
This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions
and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites,
followed by their death and/or expulsion.

5.2 Pharmacokinetic particulars

After topical administration of the product, imidacloprid is rapidly distributed over the animal's skin
within one day of application. It can be found on the body surface throughout the treatment interval.
Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 1
to 2 days after treatment in cats. Following absorption from the skin, moxidectin is distributed
systemically and is slowly eliminated from the plasma as manifested by detectable moxidectin
concentrations in plasma throughout the treatment interval of one month.

Environmental properties

See section 6.6.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzyl alcohol
Butylhydroxytoluene
Propylene carbonate

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

6.4 Special precautions for storage

Do not store above 30 C.

6.5 Nature and composition of immediate packaging

Container material White polypropylene unit dose pipette with screw cap.

Pack sizes 0.4 ml and 0.8 ml per pipette.
Blister pack containing 1, 2, 3, 4, 6, 9, 12, 21 or 42 unit dose pipettes.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products

Advocate should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Bayer Animal Health GmbH
51368 Leverkusen
GERMANY

  1. MARKETING AUTHORISATION NUMBER(S)

EU/2/03/039/001-004, EU/2/03/039/013-014, EU/2/03/039/019-022, EU/2/03/039/031-038

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 02/04/2003.
Date of last renewal: 14/01/2013.

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (http://www.ema.europa.eu/).

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Advocate 40 mg + 10 mg spot-on solution for small dogs
Advocate 100 mg + 25 mg spot-on solution for medium dogs
Advocate 250 mg + 62.5 mg spot-on solution for large dogs
Advocate 400 mg + 100 mg spot-on solution for extra-large dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substances:

Advocate for dogs contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin.

Each unit dose (pipette) contains:

Unit dose Imidacloprid Moxidectin
Advocate for small dogs ( 4 kg) 0.4 ml 40 mg 10 mg
Advocate for medium dogs (> 410 kg) 1.0 ml 100 mg 25 mg
Advocate for large dogs (> 1025 kg) 2.5 ml 250 mg 62.5 mg
Advocate for extra-large dogs (> 2540 kg) 4.0 ml 400 mg 100 mg

Excipients:

Benzyl alcohol
Butylhydroxytoluene 1 mg/ml (E 321; as antioxidant).

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Spot-on solution.
Clear yellow to brownish solution.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

For dogs suffering from, or at risk from, mixed parasitic infections:
the treatment and prevention of flea infestation (Ctenocephalides felis),
the treatment of biting lice (Trichodectes canis),
the treatment of ear mite infestation (Otodectes cynotis), sarcoptic mange (caused by Sarcoptes
scabiei var. canis), demodicosis (caused by Demodex canis),
the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis),
the treatment of circulating microfilariae (Dirofilaria immitis),
the treatment of cutaneous dirofilariosis (adult stages of Dirofilaria repens)
the prevention of cutaneous dirofilariosis (L3 larvae of Dirofilaria repens),
the reduction of circulating microfilariae (Dirofilaria repens),

the prevention of angiostrongylosis (L4 larvae and immature adults of Angiostrongylus
vasorum),
the treatment of Angiostrongylus vasorum and Crenosoma vulpis,
the prevention of spirocercosis (Spirocerca lupi),
the treatment of Eucoleus (syn. Capillaria) boehmi (adults),
the treatment of the eye worm Thelazia callipaeda (adults),
the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and
adults of Toxocara canis, Ancylostoma caninum and Uncinaria stenocephala, adults of
Toxascaris leonina and Trichuris vulpis).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

4.3 Contraindications

Do not use in puppies under 7 weeks of age.

Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

Do not use in dogs classified as Class 4 for heartworm disease as the safety of the product has not been
evaluated in this animal group.

For cats, the corresponding "Advocate for cats" product (0.4 or 0.8 ml), which contains 100 mg/ml
imidacloprid and 10 mg/ml moxidectin, must be used.

For ferrets: Do not use Advocate for dogs. Only "Advocate for small cats and ferrets" (0.4 ml) must be
used.

Do not use on canaries.

4.4 Special warnings for each target species

Please refer to section 4.5.

Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely
to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the
animal in water after treatment may reduce the efficacy of the product.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated
use of an anthelmintic of that class. Therefore, the use of this product should be based on the
assessment of each individual case and on local epidemiological information about the current
susceptibility of the target species in order to limit the possibility of a future selection for resistance.

The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of
infection, where prevention applies) at the same time (see also sections 4.2 and 4.9).

Efficacy against adult Dirofilaria repens has not been tested under field conditions.

4.5 Special precautions for use

Special precautions for use in animals

The treatment of animals weighing less than 1 kg should be based on a benefit-risk assessment.

There is limited experience on the use of the product in sick and debilitated animals, thus the product
should only be used based on a benefit-risk assessment for these animals.

Care should be taken that the contents of the pipette or the applied dose does not come into contact
with the eyes or mouth of the recipient and/or other animals. Do not allow recently treated animals to

groom each other. When the product is applied in 3 to 4 separate spots (see section 4.9), specific care
should be taken to prevent the animal licking the application sites.

This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with
Collie or Old English Sheep dogs and related breeds or crossbreeds, to correctly administer the
product as described under section 4.9; in particular, oral uptake by the recipient and/or other animals
in close contact should be prevented.

Advocate should not enter water courses as it has harmful effects on aquatic organisms: moxidectin is
highly toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days
after treatment.

The safety of the product has only been evaluated in dogs classified as either Class 1 or 2 for
heartworm disease in laboratory studies and in a few Class 3 dogs in a field study. Therefore the use in
dogs with obvious or severe symptoms of the disease should be based on a careful benefit-risk
assessment by the treating veterinarian.

Although experimental overdosage studies have shown that the product may be safely administered to
dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis. It is
therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm,
should be tested for existing adult heartworm infection before being treated with the product. At the
discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult
heartworms. The safety of Advocate has not been evaluated when administered on the same day as an
adulticide.

Imidacloprid is toxic for birds, especially canaries.

Special precautions to be taken by the person administering the veterinary medicinal product to
animals

Avoid contact with skin, eyes or mouth.
Do not eat, drink or smoke during application.
Wash hands thoroughly after use.

After application do not stroke or groom animals until the application site is dry.
In case of accidental spillage onto skin, wash off immediately with soap and water.
People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer
the product with caution. In very rare cases the product may cause skin sensitisation or transient skin
reactions (for example numbness, irritation or burning/tingling sensation).
In very rare cases the product may cause respiratory irritation in sensitive individuals.
If the product accidentally gets into eyes, they should be thoroughly flushed with water.
If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical advice
immediately and show the package leaflet or label to the physician.

The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and
finished surfaces. Allow the application site to dry before permitting contact with such materials.

4.6 Adverse reactions (frequency and seriousness)

Use of the product may result in transient pruritus in dogs. On rare occasions greasy hair, erythema
and vomiting can occur. These signs disappear without further treatment. The product may, in rare
cases, cause local hypersensitivity reactions. If the animal licks the application site after treatment,
neurological signs (most of which are transient) may be observed in very rare cases (see section 4.10).

The product tastes bitter. Salivation may occasionally occur if the animal licks the application site
immediately after treatment. This is not a sign of intoxication and disappears within some minutes
without treatment. Correct application will minimise licking of the application sites.

The product may in very rare cases cause at the application site a sensation resulting in transient
behavioural changes such as lethargy, agitation, and inappetence.

A field study has shown that in heartworm positive dogs with microfilaraemia there is a risk of severe
respiratory signs (coughing, tachypnea and dyspnea) that may require prompt veterinary treatment. In
the study these reactions were common (seen in 2 of 106 treated dogs). Gastrointestinal signs
(vomiting, diarrhoea, inappetence) and lethargy are also common adverse reactions following
treatment in such dogs.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any
evidence of teratogenic, foetotoxic or maternotoxic effects.
Use only accordingly to the benefit-risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered.

No interactions between Advocate and routinely used veterinary medicinal products or medical or
surgical procedures have been observed.

Safety of Advocate when administered on the same day as an adulticide to remove adult heartworms
has not been evaluated.

4.9 Amounts to be administered and administration route

Dosage schedule:

The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 2.5 mg/kg bodyweight
moxidectin, equivalent to 0.1 ml/kg bodyweight Advocate for dogs.

The treatment schedule should be based on individual veterinary diagnosis and on the local
epidemiological situation.

Weight of dog Pipette size to be used Volume Imidacloprid Moxidectin
[kg] [ml] [mg/kg bw] [mg/kg bw]
4 kg Advocate for small dogs 0.4 minimum of 10 minimum of 2.5

410 kg Advocate for medium dogs 1.0 1025 2.56.25
1025 kg Advocate for large dogs 2.5 1025 2.56.25
2540 kg Advocate for extra-large dogs 4.0 1016 2.54
40 kg the appropriate combination of pipettes

Flea treatment and prevention (Ctenocephalides felis)

One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may
emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions.
Therefore, it may be necessary to combine Advocate treatment with environmental treatments aimed

at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the
household flea population. The product should be administered at monthly intervals when used as part
of a treatment strategy for flea allergy dermatitis.

Treatment of biting lice (Trichodectes canis)

A single dose should be administered. A further veterinary examination 30 days after treatment is
recommended as some animals may require a second treatment.

Treatment of ear mite infestation (Otodectes cynotis)

A single dose of the product should be administered. Loose debris should be gently removed from the
external ear canal at each treatment. A further veterinary examination 30 days after treatment is
recommended as some animals may require a second treatment. Do not apply directly to the ear canal.

Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis)

A single dose should be administered twice 4 weeks apart.

Treatment of demodicosis (caused by Demodex canis)

The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against Demodex
canis and leads to a marked improvement of clinical signs particularly in mild to moderate cases.
Especially severe cases may require more prolonged and more frequent treatment. To achieve the best
possible response in these severe cases, at the discretion of the veterinarian, Advocate can be applied
once a week and for a prolonged time. In all cases it is essential that the treatment should be continued
until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be
stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment.
Alternative treatment should be administered. Seek the advice of your veterinarian.

As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying
disease appropriately.

Prevention of heartworm disease (D. immitis) and cutaneous dirofilariosis (skinworm) (D. repens)

Dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected
with adult heartworms. Therefore prior to treatment with Advocate, the advice provided in section 4.5
should be considered.

For prevention of heartworm disease and cutaneous dirofilariosis, the product must be applied at
regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which
carry and transmit D. immitis and D. repens larvae) are present. The product may be administered
throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment
should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To
establish a treatment routine, it is recommended that the same day or date be used each month. When
replacing another heartworm preventative product in a heartworm prevention programme, the first
treatment with Advocate must be given within 1 month of the last dose of the former medication.

In non-endemic areas there should be no risk of dogs having heartworm. Therefore they can be treated
without special precautions.

Treatment of microfilariae (D. immitis)

Advocate should be administered monthly for two consecutive months.

Treatment of cutaneous dirofilariosis (skin worm) (adult stages of Dirofilaria repens)

Advocate should be administered monthly for six consecutive months.

Reduction of microfilariae (skin worm) (D. repens)

The product should be administered monthly for four consecutive months.

Treatment and prevention of Angiostrongylus vasorum

A single dose should be administered. A further veterinary examination 30 days after treatment is
recommended as some animals may require a second treatment.
In endemic areas regular monthly applications will prevent angiostrongylosis and patent infection with
Angiostrongylus vasorum.

Treatment of Crenosoma vulpis

A single dose should be administered.

Prevention of spirocercosis (Spirocerca lupi)

The product should be administered monthly.

Treatment of Eucoleus (syn. Capillaria) boehmi (adults)

The product should be administered monthly for two consecutive months. It is advisable to prevent
auto-coprophagia between the two treatments in order to prevent possible reinfection.

Treatment of the eye worm Thelazia callipaeda (adults)

A single dose of the product should be administered.

Roundworm, hookworm and whipworm treatment (Toxocara canis, Ancylostoma caninum, Uncinaria
stenocephala, Toxascaris leonina and Trichuris vulpis).

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection
caused by the respective round-, hook- and whipworms. In areas non-endemic for heartworm, the
product can be used as part of a seasonal prevention programme against fleas and gastrointestinal
nematodes.

Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria
stenocephala.

Method of administration

For external use only.

Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull
off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown.

For dogs up to 25 kg:

With the dog in a standing position, part the coat between the shoulder blades until the skin is visible.
Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the
pipette firmly several times to empty its contents directly onto the skin.

For dogs of more than 25 kg:
For easy application the dog should be standing. The entire contents of the pipette should be applied
evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail. At
each spot, part the coat until the skin is visible. Wherever possible apply to undamaged skin. Place the
tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly
onto the skin. Do not apply an excessive amount of solution at any one spot, as that could cause some
of the product to run down the animal's side.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects
or undesirable clinical signs. Five times the recommended minimum dose applied at weekly intervals
for 17 weeks was investigated in dogs aged over 6 months and tolerated with no evidence of adverse
effects or undesirable clinical signs.
The product was administered to puppies at up to 5 times the recommended dose, every 2 weeks for 6
treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and
transient rapid respiration were observed.
After accidental oral ingestion or overdose, neurological signs (most of which are transient) such as
ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal
respiration, salivation and vomiting may occur in very rare cases.
Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly
intervals without any adverse effects, but the safety of application at weekly intervals has not been
investigated in ivermectin-sensitive Collie dogs. When 40% of the unit dose was given orally, severe
neurological signs were observed. Oral administration of 10% of the recommended dose produced no
adverse effects.
Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for
3 treatments, without any adverse effects.

In case of accidental oral uptake, symptomatic treatment should be administered. There is no known
specific antidote. The use of activated charcoal may be beneficial.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antiparasitic products, insecticides and repellents, macrocyclic lactones,
milbemycins.
ATCvet code: QP54AB52.

5.1 Pharmacodynamic properties

Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an
ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more
accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea
stages and adult fleas. Flea larvae in the pet's surroundings are killed after contact with a pet treated
with the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the
post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of
cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the
interaction with mammalian nicotinergic receptors and the postulated poor penetration through the
blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has
minimal pharmacological activity in mammals.

Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the
milbemycin family. It is a parasiticide which is active against many internal and external parasites.
Moxidectin is active against larval stages of Dirofilaria immitis (L1, L3, L4) and Dirofilaria repens
(L1, L3). It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and
glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic
junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid
paralysis of affected parasites, followed by their death and/or expulsion.
The drug has a persistent action and protects dogs for 4 weeks after a single application against re-
infection with the following parasites: Dirofilaria immitis, Dirofilaria repens, Angiostrongylus
vasorum.

5.2 Pharmacokinetic particulars

After topical administration of the product, imidacloprid is rapidly distributed over the animal's skin
within one day of application. It can be found on the body surface throughout the treatment interval.
Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 4
to 9 days after treatment in dogs. Following absorption from the skin, moxidectin is distributed
systemically throughout the body tissues but due to its lipophilicity it is concentrated mainly in the fat.
It is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in
plasma throughout the treatment interval of one month.
The T in dogs is about 28.4 days.
Studies evaluating the pharmacokinetic behaviour of moxidectin after multiple applications have
indicated that steady state serum levels are achieved following approximately 4 consecutive monthly
treatments in dogs.

Environmental properties

See sections 4.5 and 6.6.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzyl alcohol
Butylhydroxytoluene
Propylene carbonate

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

6.4 Special precautions for storage

Do not store above 30 C.

6.5 Nature and composition of immediate packaging

Container material White polypropylene unit dose pipette with screw cap.

Pack sizes 0.4 ml, 1.0 ml, 2.5 ml and 4.0 ml per pipette.
Blister pack containing 1, 2, 3, 4, 6, 9, 12, 21 or 42 unit dose pipettes.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
product should be disposed of in accordance with local requirements.
Advocate should not enter water courses as this may be dangerous for fish and other aquatic organisms.

7. MARKETING AUTHORISATION HOLDER

Bayer Animal Health GmbH
51368 Leverkusen
GERMANY

  1. MARKETING AUTHORISATION NUMBER(S)

EU/2/03/039/005-012, EU/2/03/039/015-018, EU/2/03/039/023-030, EU/2/03/039/039-054

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 02/04/2003.
Date of last renewal: 14/01/2013.

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (http://www.ema.europa.eu/).

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

40 Small Cats Up To 4kg » Pack Of 6 Pipettes

Advocate Spot-on Solution

Presentation

Advocate spot-on solution for cats and ferrets is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 10 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E 321 as an antioxidant). Each pipette of the small cat and ferret presentation contains 0.4 ml (40 mg imidacloprid, 4 mg moxidectin), the large cat presentation contains 0.8 ml (80 mg imidacloprid, 8 mg moxidectin).

Advocate spot-on solution for dogs is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 25 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E321 as an antioxidant). Each pipette of the dog presentations contains either 0.4 ml (40 mg imidacloprid, 10 mg moxidectin), 1.0 ml (100 mg imidacloprid, 25 mg moxidectin), 2.5 ml (250 mg imidacloprid, 62.5 mg moxidectin) or 4.0 ml (400 mg imidacloprid, 100 mg moxidectin).

Uses

For use in cats, ferrets and dogs suffering from, or at risk from, mixed parasitic infections:

For cats:

For ferrets: For the treatment and prevention of flea infestation (Ctenocephalides felis) and the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis).

For dogs:

Dosage and administration

Dosage schedule

The recommended minimum doses for cats are 10 mg/kg body weight imidacloprid and 1.0 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for cats.

Dosage schedule for ferrets: one pipette of Advocate spot-on solution for small cats and ferrets (0.4 ml) should be administered per animal. Do not exceed the recommended dose.

The recommended minimum doses for dogs are 10 mg/kg body weight imidacloprid and 2.5 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for dogs.

The treatment schedule for all species should be based on individual veterinary diagnosis and on the local epidemiological situation.

Cats (Refer to Table 1)

Dogs(Refer to Table 2)

Flea treatment and prevention (Cats and Dogs)

One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine Advocate treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.

Flea treatment and prevention (Ferrets)

One treatment prevents future flea infestation for 3 weeks. Under heavy flea pressure it may be necessary to repeat the dose after 2 weeks.

Treatment of ear mite infestation (Otodectes cynotis) (Cats & Dogs)

A single dose of the product should be administered. In dogs, loose debris should be gently removed from the external ear canal at each treatment. For both cats and dogs, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.

Treatment of biting lice (Trichodectes canis) (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis) (Dogs)

A single dose should be administered twice 4 weeks apart.

Treatment of notoedric mange (Notoedres cati) (Cats)

A single dose of the product should be administered.

Treatment of the lungworm Eucoleus aerophilus (syn. Capillaria aerophila) (adults) (Cats)

A single dose of the product should be administered.

Treatment of Eucoleus (syn. Capillaria) boehmi (adults)(Dogs)

The product should be administered monthly for two consecutive months. It is advisable to prevent auto-coprophagia between the two treatments in order to prevent possible reinfection.

Treatment of the eye worm Thelazia callipaeda (adults)(Dogs)

A single dose of the product should be administered.

Treatment of demodicosis (caused by Demodex canis) (Dogs)

The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against Demodex canis and leads to a marked improvement of clinical signs particularly in mild to moderate cases. Especially severe cases may require more prolonged and more frequent treatment. To achieve the best possible response in these severe cases, at the discretion of the veterinarian, Advocate can be applied once a week and for a prolonged time. In all cases it is essential that the treatment should be continued until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment. Alternative treatment should be administered. Seek the advice of your veterinarian.

As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.

Prevention of heartworm disease (D.immitis) (Cats, Ferrets & Dogs) and cutaneous dirofilariosis (D. repens) (Dogs)

Cats, ferrets and dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with Advocate, the advice provided in Contra-Indications and Warnings etc should be considered. For prevention of heartworm disease and cutaneous dirofilariosis, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. immitis and D. repens larvae) are present. The product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with Advocate must be given within 1 month of the last dose of the former medication. In non-endemic areas there should be no risk of animals having heartworm. Therefore they can be treated without special precautions.

Treatment of microfilariae (D. immitis) (Dogs)

Advocate should be administered monthly for two consecutive months.

Treatment of cutaneous dirofilariosis (skin worm) (adult stages of Dirofilaria repens) (Dogs)

Advocate should be administered monthly for six consecutive months.

Reduction of microfilariae (skin worm) (D. repens) (Dogs)

The product should be administered monthly for four consecutive months.

Roundworm and hookworm treatment (Cats)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworms and hookworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.

Roundworm, hookworm and whipworm treatment (Dogs)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective round-, hook- and whipworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes. Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.

Treatment and Prevention of Angiostrongylus vasorum (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

In endemic areas regular four weekly application will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.

Treatment of Crenosoma vulpis (Dogs)

A single dose should be administered

Prevention of Spirocerca lupi (Dogs)

The product should be administered monthly.

Method of administration

For external use only.

Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown. See Figure 1.

Figure 1: Opening a pipette

Cats and Ferrets

Part the fur on the animal's neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. Application at the base of the skull will minimise the opportunity for the animal to lick the product. Apply only to undamaged skin. See Figure 2.

Figure 2: Administration to the Cat or Ferret

For dogs up to 25kg

With the dog in a standing position, part the coat between the shoulder blades until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. See Figure 3.

Figure 3: Administration to dogs up to 25kg

For dogs of more than 25 kg

For easy application the dog should be standing. The entire contents of the pipette should be applied evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail. At each spot, part the coat until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly onto the skin. Do not apply an excessive amount of solution at any one spot, as that could cause some of the product to run down the animal’s side. See Figure 4.

Figure 4: Administration to dogs over 25kg

Use During Pregnancy and Lactation

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the risk-benefit assessment by the responsible veterinarian.

Contra-indications, warnings, etc

Do not use in kittens under 9 weeks of age.

Do not use in puppies under 7 weeks of age.

Treatment of cats or dogs weighing less than 1 kg, and ferrets weighing less than 0.8 kg should be based on a risk-benefit assessment.

Do not use in the cases of hypersensitivity to the active substances or to any of the excipients.

There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a risk-benefit assessment for these animals.

For cats, the corresponding "Advocate spot-on solution for cat" product, which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used.

For ferrets: Do not use Advocate for large cats (0.8ml) or Advocate for dogs (any size), only "Advocate for small cats and ferrets" (0.4 ml) must be used. The product’s efficacy has not been tested in ferrets weighing over 2 kg and therefore the duration of effect might be shorter in these animals.

For dogs, the corresponding "Advocate for dog" product, which contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin, must be used.

Do not use on canaries.

The product tastes bitter. Salivation may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application will minimise licking of the application site.

In case of accidental oral uptake, symptomatic treatment should be administered. There is no known specific antidote. The use of activated charcoal may be beneficial. After accidental oral ingestion (e.g. licking at the site of application) or overdose, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may be observed in very rare cases.

The use of the product may result in transient pruritus in the animal. On rare occasions greasy fur, erythema and vomiting can occur. These signs disappear without further treatment. The product may, in rare cases cause local hypersensitivity reactions. The product may in very rare cases cause at the application site a sensation resulting in transient behavioural changes such as lethargy, agitation, and inappetence.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Care should be taken that the contents of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.

Do not allow recently treated animals to groom each other.

When the product is applied in 3 to 4 separate spots in larger dogs, specific care should be taken to prevent the animal licking the application sites. Oral uptake by Collies, Old English Sheepdogs and related breeds or crossbreeds should be prevented.

During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered. This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the product as described above. In particular, oral uptake by the recipient and/or other animals in close contact should be prevented.

Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals without any adverse effects, but the safety of application at weekly intervals has not been investigated in ivermectin-sensitive Collie dogs. When 40% of the unit dose was given orally, severe neurological signs were observed. Oral administration of 10% of the recommended dose produced no adverse effects.

Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects or undesirable clinical signs. Five times the recommended minimum dose applied at weekly intervals for 17 weeks was investigated in dogs aged over 6 months and tolerated with no evidence of adverse effects or undesirable clinical signs.

Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or undesirable clinical signs.

The product was administered to kittens and puppies at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.

The product was administered to ferrets at 5 times the recommended dose, every 2 weeks for 4 treatments, and there was no evidence of adverse effects or undesirable clinical signs.

It is recommended that cats and ferrets living in, or travelling to areas endemic for heartworm are treated monthly with the product to protect them from heartworm disease. Whilst the accuracy of diagnosis of heartworm infection is limited, it is recommended that attempts be made to check the heartworm status of any cat and ferret aged over 6 months, before beginning prophylactic treatment, as use of the product on cats or ferrets which have adult heartworms may cause serious adverse effects, including death. If adult heartworm infection is diagnosed, the infection should be treated in accordance with current scientific knowledge.

Although experimental overdosage studies have shown that the product may be safely administered to dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis. It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the product. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of Advocate has not been evaluated when administered on the same day as an adulticide.

Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse effects.

The safety of the product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study. Therefore the use in dogs with obvious or severe symptoms of the disease should be based on a careful benefit risk assessment by the treating veterinarian.

Do not use in dogs classified as Class 4 for heartworm disease as the safety of the product has not been evaluated in this animal group.

A field study has shown that in heartworm positive dogs with microfilaraemia there is a risk of severe respiratory signs (coughing, tachypnoea and dyspnoea) that may require prompt veterinary treatment. In the study these reactions were common (seen in 2 of 106 treated dogs). Gastrointestinal signs (vomiting, diarrhoea, inappetence) and lethargy are also common adverse reactions following treatment in such dogs.

Efficacy against adult Dirofilaria repens has not been tested under field conditions.

In certain individual cats Notoedres cati infestation may be severe. In these severe cases concomitant supportive treatment is necessary as treatment with the product alone may not be sufficient to prevent death of the animal.

Imidacloprid is toxic for birds, especially canaries.

No interactions between Advocate and routinely used veterinary medicinal products or medical or surgical procedures have been observed.

Safety of Advocate when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.

Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the product.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.

The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time.

The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

User Safety

Avoid contact with skin, eyes or mouth.

Do not eat, drink or smoke during application.

Wash hands thoroughly after use.

In case of accidental spillage onto skin, wash off immediately with soap and water.

After application do not stroke or groom animals until the application site is dry.

People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In very rare cases the product may cause skin sensitisation or transient skin reactions (for example numbness, irritation or burning/tingling sensation). In very rare cases the product may cause respiratory irritation in sensitive individuals.

If the product accidentally gets into eyes, they should be thoroughly flushed with water.

If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical attention and show the package insert to the physician.

Environmental Safety

Advocate should not be allowed to enter water courses as it has harmful effects on aquatic organisms: moxidectin is highly toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days after treatment.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Pharmaceutical precautions

Do not store above 30°C.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Legal category

Packaging quantities

White polypropylene unit dose pipette with screw cap.

Further information

Pharmacotherapeutic group: therapeutic antiparasitic agent; ATCvet code: QP54AB52.

Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has minimal pharmacological activity in mammals.

Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is a parasiticide which is active against many internal and external parasites. Moxidectin is active against larval stages of Dirofilaria immitis (L1, L3, L4) and Dirofilaria repens (L1, L3). It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion.

The drug has a persistent action and protects dogs for 4 weeks after a single application against re-infection with the following parasites: Dirofilaria immitis, Dirofilaria repens, Angiostrongylus vasorum

After topical administration of the product, imidacloprid is rapidly distributed over the animal’s skin within one day of application. It can be found on the body surface throughout the treatment interval. Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 1 to 2 days after treatment in cats and approximately 4 to 9 days after treatment in dogs. Following absorption from the skin, moxidectin is distributed systemically throughout the body tissues but due to its lipophilicity it is concentrated mainly in the fat. It is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.

The T ½ in dogs is about 28.4 days.

Studies evaluating the pharmacokinetic behaviour of moxidectin after multiple applications have indicated that steady state serum levels are achieved following approximately 4 consecutive monthly treatments in dogs.

Marketing Authorisation Holder (if different from distributor)

Marketing Authorisation Holder

Bayer Animal Health GmbH, D-51368 Leverkusen, Germany

Distributed by

UK: Bayer plc, 400 South Oak Way, Green Park, Reading, Berkshire, RG2 6AD

Ireland: Bayer Ltd, The Atrium, Blackthorn Road, Sandyford Ind Est, Dublin 18

Marketing Authorisation Number

EU/2/03/039/001 - 005EU/2/03/039/007 - 012EU/2/03/039/019, EU/2/03/039/021, EU/2/03/039/023, EU/2/03/039/025, EU/2/03/039/027, EU/2/03/039/029

100 Medium Dogs 4-10kg » Pack Of 6 Pipettes

Advocate Spot-on Solution

Presentation

Advocate spot-on solution for cats and ferrets is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 10 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E 321 as an antioxidant). Each pipette of the small cat and ferret presentation contains 0.4 ml (40 mg imidacloprid, 4 mg moxidectin), the large cat presentation contains 0.8 ml (80 mg imidacloprid, 8 mg moxidectin).

Advocate spot-on solution for dogs is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 25 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E321 as an antioxidant). Each pipette of the dog presentations contains either 0.4 ml (40 mg imidacloprid, 10 mg moxidectin), 1.0 ml (100 mg imidacloprid, 25 mg moxidectin), 2.5 ml (250 mg imidacloprid, 62.5 mg moxidectin) or 4.0 ml (400 mg imidacloprid, 100 mg moxidectin).

Uses

For use in cats, ferrets and dogs suffering from, or at risk from, mixed parasitic infections:

For cats:

For ferrets: For the treatment and prevention of flea infestation (Ctenocephalides felis) and the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis).

For dogs:

Dosage and administration

Dosage schedule

The recommended minimum doses for cats are 10 mg/kg body weight imidacloprid and 1.0 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for cats.

Dosage schedule for ferrets: one pipette of Advocate spot-on solution for small cats and ferrets (0.4 ml) should be administered per animal. Do not exceed the recommended dose.

The recommended minimum doses for dogs are 10 mg/kg body weight imidacloprid and 2.5 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for dogs.

The treatment schedule for all species should be based on individual veterinary diagnosis and on the local epidemiological situation.

Cats (Refer to Table 1)

Dogs(Refer to Table 2)

Flea treatment and prevention (Cats and Dogs)

One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine Advocate treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.

Flea treatment and prevention (Ferrets)

One treatment prevents future flea infestation for 3 weeks. Under heavy flea pressure it may be necessary to repeat the dose after 2 weeks.

Treatment of ear mite infestation (Otodectes cynotis) (Cats & Dogs)

A single dose of the product should be administered. In dogs, loose debris should be gently removed from the external ear canal at each treatment. For both cats and dogs, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.

Treatment of biting lice (Trichodectes canis) (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis) (Dogs)

A single dose should be administered twice 4 weeks apart.

Treatment of notoedric mange (Notoedres cati) (Cats)

A single dose of the product should be administered.

Treatment of the lungworm Eucoleus aerophilus (syn. Capillaria aerophila) (adults) (Cats)

A single dose of the product should be administered.

Treatment of Eucoleus (syn. Capillaria) boehmi (adults)(Dogs)

The product should be administered monthly for two consecutive months. It is advisable to prevent auto-coprophagia between the two treatments in order to prevent possible reinfection.

Treatment of the eye worm Thelazia callipaeda (adults)(Dogs)

A single dose of the product should be administered.

Treatment of demodicosis (caused by Demodex canis) (Dogs)

The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against Demodex canis and leads to a marked improvement of clinical signs particularly in mild to moderate cases. Especially severe cases may require more prolonged and more frequent treatment. To achieve the best possible response in these severe cases, at the discretion of the veterinarian, Advocate can be applied once a week and for a prolonged time. In all cases it is essential that the treatment should be continued until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment. Alternative treatment should be administered. Seek the advice of your veterinarian.

As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.

Prevention of heartworm disease (D.immitis) (Cats, Ferrets & Dogs) and cutaneous dirofilariosis (D. repens) (Dogs)

Cats, ferrets and dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with Advocate, the advice provided in Contra-Indications and Warnings etc should be considered. For prevention of heartworm disease and cutaneous dirofilariosis, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. immitis and D. repens larvae) are present. The product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with Advocate must be given within 1 month of the last dose of the former medication. In non-endemic areas there should be no risk of animals having heartworm. Therefore they can be treated without special precautions.

Treatment of microfilariae (D. immitis) (Dogs)

Advocate should be administered monthly for two consecutive months.

Treatment of cutaneous dirofilariosis (skin worm) (adult stages of Dirofilaria repens) (Dogs)

Advocate should be administered monthly for six consecutive months.

Reduction of microfilariae (skin worm) (D. repens) (Dogs)

The product should be administered monthly for four consecutive months.

Roundworm and hookworm treatment (Cats)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworms and hookworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.

Roundworm, hookworm and whipworm treatment (Dogs)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective round-, hook- and whipworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes. Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.

Treatment and Prevention of Angiostrongylus vasorum (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

In endemic areas regular four weekly application will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.

Treatment of Crenosoma vulpis (Dogs)

A single dose should be administered

Prevention of Spirocerca lupi (Dogs)

The product should be administered monthly.

Method of administration

For external use only.

Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown. See Figure 1.

Figure 1: Opening a pipette

Cats and Ferrets

Part the fur on the animal's neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. Application at the base of the skull will minimise the opportunity for the animal to lick the product. Apply only to undamaged skin. See Figure 2.

Figure 2: Administration to the Cat or Ferret

For dogs up to 25kg

With the dog in a standing position, part the coat between the shoulder blades until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. See Figure 3.

Figure 3: Administration to dogs up to 25kg

For dogs of more than 25 kg

For easy application the dog should be standing. The entire contents of the pipette should be applied evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail. At each spot, part the coat until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly onto the skin. Do not apply an excessive amount of solution at any one spot, as that could cause some of the product to run down the animal’s side. See Figure 4.

Figure 4: Administration to dogs over 25kg

Use During Pregnancy and Lactation

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the risk-benefit assessment by the responsible veterinarian.

Contra-indications, warnings, etc

Do not use in kittens under 9 weeks of age.

Do not use in puppies under 7 weeks of age.

Treatment of cats or dogs weighing less than 1 kg, and ferrets weighing less than 0.8 kg should be based on a risk-benefit assessment.

Do not use in the cases of hypersensitivity to the active substances or to any of the excipients.

There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a risk-benefit assessment for these animals.

For cats, the corresponding "Advocate spot-on solution for cat" product, which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used.

For ferrets: Do not use Advocate for large cats (0.8ml) or Advocate for dogs (any size), only "Advocate for small cats and ferrets" (0.4 ml) must be used. The product’s efficacy has not been tested in ferrets weighing over 2 kg and therefore the duration of effect might be shorter in these animals.

For dogs, the corresponding "Advocate for dog" product, which contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin, must be used.

Do not use on canaries.

The product tastes bitter. Salivation may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application will minimise licking of the application site.

In case of accidental oral uptake, symptomatic treatment should be administered. There is no known specific antidote. The use of activated charcoal may be beneficial. After accidental oral ingestion (e.g. licking at the site of application) or overdose, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may be observed in very rare cases.

The use of the product may result in transient pruritus in the animal. On rare occasions greasy fur, erythema and vomiting can occur. These signs disappear without further treatment. The product may, in rare cases cause local hypersensitivity reactions. The product may in very rare cases cause at the application site a sensation resulting in transient behavioural changes such as lethargy, agitation, and inappetence.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Care should be taken that the contents of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.

Do not allow recently treated animals to groom each other.

When the product is applied in 3 to 4 separate spots in larger dogs, specific care should be taken to prevent the animal licking the application sites. Oral uptake by Collies, Old English Sheepdogs and related breeds or crossbreeds should be prevented.

During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered. This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the product as described above. In particular, oral uptake by the recipient and/or other animals in close contact should be prevented.

Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals without any adverse effects, but the safety of application at weekly intervals has not been investigated in ivermectin-sensitive Collie dogs. When 40% of the unit dose was given orally, severe neurological signs were observed. Oral administration of 10% of the recommended dose produced no adverse effects.

Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects or undesirable clinical signs. Five times the recommended minimum dose applied at weekly intervals for 17 weeks was investigated in dogs aged over 6 months and tolerated with no evidence of adverse effects or undesirable clinical signs.

Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or undesirable clinical signs.

The product was administered to kittens and puppies at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.

The product was administered to ferrets at 5 times the recommended dose, every 2 weeks for 4 treatments, and there was no evidence of adverse effects or undesirable clinical signs.

It is recommended that cats and ferrets living in, or travelling to areas endemic for heartworm are treated monthly with the product to protect them from heartworm disease. Whilst the accuracy of diagnosis of heartworm infection is limited, it is recommended that attempts be made to check the heartworm status of any cat and ferret aged over 6 months, before beginning prophylactic treatment, as use of the product on cats or ferrets which have adult heartworms may cause serious adverse effects, including death. If adult heartworm infection is diagnosed, the infection should be treated in accordance with current scientific knowledge.

Although experimental overdosage studies have shown that the product may be safely administered to dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis. It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the product. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of Advocate has not been evaluated when administered on the same day as an adulticide.

Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse effects.

The safety of the product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study. Therefore the use in dogs with obvious or severe symptoms of the disease should be based on a careful benefit risk assessment by the treating veterinarian.

Do not use in dogs classified as Class 4 for heartworm disease as the safety of the product has not been evaluated in this animal group.

A field study has shown that in heartworm positive dogs with microfilaraemia there is a risk of severe respiratory signs (coughing, tachypnoea and dyspnoea) that may require prompt veterinary treatment. In the study these reactions were common (seen in 2 of 106 treated dogs). Gastrointestinal signs (vomiting, diarrhoea, inappetence) and lethargy are also common adverse reactions following treatment in such dogs.

Efficacy against adult Dirofilaria repens has not been tested under field conditions.

In certain individual cats Notoedres cati infestation may be severe. In these severe cases concomitant supportive treatment is necessary as treatment with the product alone may not be sufficient to prevent death of the animal.

Imidacloprid is toxic for birds, especially canaries.

No interactions between Advocate and routinely used veterinary medicinal products or medical or surgical procedures have been observed.

Safety of Advocate when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.

Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the product.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.

The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time.

The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

User Safety

Avoid contact with skin, eyes or mouth.

Do not eat, drink or smoke during application.

Wash hands thoroughly after use.

In case of accidental spillage onto skin, wash off immediately with soap and water.

After application do not stroke or groom animals until the application site is dry.

People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In very rare cases the product may cause skin sensitisation or transient skin reactions (for example numbness, irritation or burning/tingling sensation). In very rare cases the product may cause respiratory irritation in sensitive individuals.

If the product accidentally gets into eyes, they should be thoroughly flushed with water.

If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical attention and show the package insert to the physician.

Environmental Safety

Advocate should not be allowed to enter water courses as it has harmful effects on aquatic organisms: moxidectin is highly toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days after treatment.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Pharmaceutical precautions

Do not store above 30°C.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Legal category

Packaging quantities

White polypropylene unit dose pipette with screw cap.

Further information

Pharmacotherapeutic group: therapeutic antiparasitic agent; ATCvet code: QP54AB52.

Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has minimal pharmacological activity in mammals.

Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is a parasiticide which is active against many internal and external parasites. Moxidectin is active against larval stages of Dirofilaria immitis (L1, L3, L4) and Dirofilaria repens (L1, L3). It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion.

The drug has a persistent action and protects dogs for 4 weeks after a single application against re-infection with the following parasites: Dirofilaria immitis, Dirofilaria repens, Angiostrongylus vasorum

After topical administration of the product, imidacloprid is rapidly distributed over the animal’s skin within one day of application. It can be found on the body surface throughout the treatment interval. Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 1 to 2 days after treatment in cats and approximately 4 to 9 days after treatment in dogs. Following absorption from the skin, moxidectin is distributed systemically throughout the body tissues but due to its lipophilicity it is concentrated mainly in the fat. It is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.

The T ½ in dogs is about 28.4 days.

Studies evaluating the pharmacokinetic behaviour of moxidectin after multiple applications have indicated that steady state serum levels are achieved following approximately 4 consecutive monthly treatments in dogs.

Marketing Authorisation Holder (if different from distributor)

Marketing Authorisation Holder

Bayer Animal Health GmbH, D-51368 Leverkusen, Germany

Distributed by

UK: Bayer plc, 400 South Oak Way, Green Park, Reading, Berkshire, RG2 6AD

Ireland: Bayer Ltd, The Atrium, Blackthorn Road, Sandyford Ind Est, Dublin 18

Marketing Authorisation Number

EU/2/03/039/001 - 005EU/2/03/039/007 - 012EU/2/03/039/019, EU/2/03/039/021, EU/2/03/039/023, EU/2/03/039/025, EU/2/03/039/027, EU/2/03/039/029

80 Large Cats 4-8kgs » Pack Of 6 Pipettes

Advocate Spot-on Solution

Presentation

Advocate spot-on solution for cats and ferrets is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 10 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E 321 as an antioxidant). Each pipette of the small cat and ferret presentation contains 0.4 ml (40 mg imidacloprid, 4 mg moxidectin), the large cat presentation contains 0.8 ml (80 mg imidacloprid, 8 mg moxidectin).

Advocate spot-on solution for dogs is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 25 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E321 as an antioxidant). Each pipette of the dog presentations contains either 0.4 ml (40 mg imidacloprid, 10 mg moxidectin), 1.0 ml (100 mg imidacloprid, 25 mg moxidectin), 2.5 ml (250 mg imidacloprid, 62.5 mg moxidectin) or 4.0 ml (400 mg imidacloprid, 100 mg moxidectin).

Uses

For use in cats, ferrets and dogs suffering from, or at risk from, mixed parasitic infections:

For cats:

For ferrets: For the treatment and prevention of flea infestation (Ctenocephalides felis) and the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis).

For dogs:

Dosage and administration

Dosage schedule

The recommended minimum doses for cats are 10 mg/kg body weight imidacloprid and 1.0 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for cats.

Dosage schedule for ferrets: one pipette of Advocate spot-on solution for small cats and ferrets (0.4 ml) should be administered per animal. Do not exceed the recommended dose.

The recommended minimum doses for dogs are 10 mg/kg body weight imidacloprid and 2.5 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for dogs.

The treatment schedule for all species should be based on individual veterinary diagnosis and on the local epidemiological situation.

Cats (Refer to Table 1)

Dogs(Refer to Table 2)

Flea treatment and prevention (Cats and Dogs)

One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine Advocate treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.

Flea treatment and prevention (Ferrets)

One treatment prevents future flea infestation for 3 weeks. Under heavy flea pressure it may be necessary to repeat the dose after 2 weeks.

Treatment of ear mite infestation (Otodectes cynotis) (Cats & Dogs)

A single dose of the product should be administered. In dogs, loose debris should be gently removed from the external ear canal at each treatment. For both cats and dogs, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.

Treatment of biting lice (Trichodectes canis) (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis) (Dogs)

A single dose should be administered twice 4 weeks apart.

Treatment of notoedric mange (Notoedres cati) (Cats)

A single dose of the product should be administered.

Treatment of the lungworm Eucoleus aerophilus (syn. Capillaria aerophila) (adults) (Cats)

A single dose of the product should be administered.

Treatment of Eucoleus (syn. Capillaria) boehmi (adults)(Dogs)

The product should be administered monthly for two consecutive months. It is advisable to prevent auto-coprophagia between the two treatments in order to prevent possible reinfection.

Treatment of the eye worm Thelazia callipaeda (adults)(Dogs)

A single dose of the product should be administered.

Treatment of demodicosis (caused by Demodex canis) (Dogs)

The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against Demodex canis and leads to a marked improvement of clinical signs particularly in mild to moderate cases. Especially severe cases may require more prolonged and more frequent treatment. To achieve the best possible response in these severe cases, at the discretion of the veterinarian, Advocate can be applied once a week and for a prolonged time. In all cases it is essential that the treatment should be continued until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment. Alternative treatment should be administered. Seek the advice of your veterinarian.

As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.

Prevention of heartworm disease (D.immitis) (Cats, Ferrets & Dogs) and cutaneous dirofilariosis (D. repens) (Dogs)

Cats, ferrets and dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with Advocate, the advice provided in Contra-Indications and Warnings etc should be considered. For prevention of heartworm disease and cutaneous dirofilariosis, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. immitis and D. repens larvae) are present. The product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with Advocate must be given within 1 month of the last dose of the former medication. In non-endemic areas there should be no risk of animals having heartworm. Therefore they can be treated without special precautions.

Treatment of microfilariae (D. immitis) (Dogs)

Advocate should be administered monthly for two consecutive months.

Treatment of cutaneous dirofilariosis (skin worm) (adult stages of Dirofilaria repens) (Dogs)

Advocate should be administered monthly for six consecutive months.

Reduction of microfilariae (skin worm) (D. repens) (Dogs)

The product should be administered monthly for four consecutive months.

Roundworm and hookworm treatment (Cats)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworms and hookworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.

Roundworm, hookworm and whipworm treatment (Dogs)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective round-, hook- and whipworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes. Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.

Treatment and Prevention of Angiostrongylus vasorum (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

In endemic areas regular four weekly application will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.

Treatment of Crenosoma vulpis (Dogs)

A single dose should be administered

Prevention of Spirocerca lupi (Dogs)

The product should be administered monthly.

Method of administration

For external use only.

Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown. See Figure 1.

Figure 1: Opening a pipette

Cats and Ferrets

Part the fur on the animal's neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. Application at the base of the skull will minimise the opportunity for the animal to lick the product. Apply only to undamaged skin. See Figure 2.

Figure 2: Administration to the Cat or Ferret

For dogs up to 25kg

With the dog in a standing position, part the coat between the shoulder blades until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. See Figure 3.

Figure 3: Administration to dogs up to 25kg

For dogs of more than 25 kg

For easy application the dog should be standing. The entire contents of the pipette should be applied evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail. At each spot, part the coat until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly onto the skin. Do not apply an excessive amount of solution at any one spot, as that could cause some of the product to run down the animal’s side. See Figure 4.

Figure 4: Administration to dogs over 25kg

Use During Pregnancy and Lactation

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the risk-benefit assessment by the responsible veterinarian.

Contra-indications, warnings, etc

Do not use in kittens under 9 weeks of age.

Do not use in puppies under 7 weeks of age.

Treatment of cats or dogs weighing less than 1 kg, and ferrets weighing less than 0.8 kg should be based on a risk-benefit assessment.

Do not use in the cases of hypersensitivity to the active substances or to any of the excipients.

There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a risk-benefit assessment for these animals.

For cats, the corresponding "Advocate spot-on solution for cat" product, which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used.

For ferrets: Do not use Advocate for large cats (0.8ml) or Advocate for dogs (any size), only "Advocate for small cats and ferrets" (0.4 ml) must be used. The product’s efficacy has not been tested in ferrets weighing over 2 kg and therefore the duration of effect might be shorter in these animals.

For dogs, the corresponding "Advocate for dog" product, which contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin, must be used.

Do not use on canaries.

The product tastes bitter. Salivation may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application will minimise licking of the application site.

In case of accidental oral uptake, symptomatic treatment should be administered. There is no known specific antidote. The use of activated charcoal may be beneficial. After accidental oral ingestion (e.g. licking at the site of application) or overdose, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may be observed in very rare cases.

The use of the product may result in transient pruritus in the animal. On rare occasions greasy fur, erythema and vomiting can occur. These signs disappear without further treatment. The product may, in rare cases cause local hypersensitivity reactions. The product may in very rare cases cause at the application site a sensation resulting in transient behavioural changes such as lethargy, agitation, and inappetence.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Care should be taken that the contents of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.

Do not allow recently treated animals to groom each other.

When the product is applied in 3 to 4 separate spots in larger dogs, specific care should be taken to prevent the animal licking the application sites. Oral uptake by Collies, Old English Sheepdogs and related breeds or crossbreeds should be prevented.

During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered. This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the product as described above. In particular, oral uptake by the recipient and/or other animals in close contact should be prevented.

Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals without any adverse effects, but the safety of application at weekly intervals has not been investigated in ivermectin-sensitive Collie dogs. When 40% of the unit dose was given orally, severe neurological signs were observed. Oral administration of 10% of the recommended dose produced no adverse effects.

Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects or undesirable clinical signs. Five times the recommended minimum dose applied at weekly intervals for 17 weeks was investigated in dogs aged over 6 months and tolerated with no evidence of adverse effects or undesirable clinical signs.

Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or undesirable clinical signs.

The product was administered to kittens and puppies at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.

The product was administered to ferrets at 5 times the recommended dose, every 2 weeks for 4 treatments, and there was no evidence of adverse effects or undesirable clinical signs.

It is recommended that cats and ferrets living in, or travelling to areas endemic for heartworm are treated monthly with the product to protect them from heartworm disease. Whilst the accuracy of diagnosis of heartworm infection is limited, it is recommended that attempts be made to check the heartworm status of any cat and ferret aged over 6 months, before beginning prophylactic treatment, as use of the product on cats or ferrets which have adult heartworms may cause serious adverse effects, including death. If adult heartworm infection is diagnosed, the infection should be treated in accordance with current scientific knowledge.

Although experimental overdosage studies have shown that the product may be safely administered to dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis. It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the product. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of Advocate has not been evaluated when administered on the same day as an adulticide.

Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse effects.

The safety of the product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study. Therefore the use in dogs with obvious or severe symptoms of the disease should be based on a careful benefit risk assessment by the treating veterinarian.

Do not use in dogs classified as Class 4 for heartworm disease as the safety of the product has not been evaluated in this animal group.

A field study has shown that in heartworm positive dogs with microfilaraemia there is a risk of severe respiratory signs (coughing, tachypnoea and dyspnoea) that may require prompt veterinary treatment. In the study these reactions were common (seen in 2 of 106 treated dogs). Gastrointestinal signs (vomiting, diarrhoea, inappetence) and lethargy are also common adverse reactions following treatment in such dogs.

Efficacy against adult Dirofilaria repens has not been tested under field conditions.

In certain individual cats Notoedres cati infestation may be severe. In these severe cases concomitant supportive treatment is necessary as treatment with the product alone may not be sufficient to prevent death of the animal.

Imidacloprid is toxic for birds, especially canaries.

No interactions between Advocate and routinely used veterinary medicinal products or medical or surgical procedures have been observed.

Safety of Advocate when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.

Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the product.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.

The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time.

The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

User Safety

Avoid contact with skin, eyes or mouth.

Do not eat, drink or smoke during application.

Wash hands thoroughly after use.

In case of accidental spillage onto skin, wash off immediately with soap and water.

After application do not stroke or groom animals until the application site is dry.

People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In very rare cases the product may cause skin sensitisation or transient skin reactions (for example numbness, irritation or burning/tingling sensation). In very rare cases the product may cause respiratory irritation in sensitive individuals.

If the product accidentally gets into eyes, they should be thoroughly flushed with water.

If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical attention and show the package insert to the physician.

Environmental Safety

Advocate should not be allowed to enter water courses as it has harmful effects on aquatic organisms: moxidectin is highly toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days after treatment.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Pharmaceutical precautions

Do not store above 30°C.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Legal category

Packaging quantities

White polypropylene unit dose pipette with screw cap.

Further information

Pharmacotherapeutic group: therapeutic antiparasitic agent; ATCvet code: QP54AB52.

Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has minimal pharmacological activity in mammals.

Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is a parasiticide which is active against many internal and external parasites. Moxidectin is active against larval stages of Dirofilaria immitis (L1, L3, L4) and Dirofilaria repens (L1, L3). It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion.

The drug has a persistent action and protects dogs for 4 weeks after a single application against re-infection with the following parasites: Dirofilaria immitis, Dirofilaria repens, Angiostrongylus vasorum

After topical administration of the product, imidacloprid is rapidly distributed over the animal’s skin within one day of application. It can be found on the body surface throughout the treatment interval. Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 1 to 2 days after treatment in cats and approximately 4 to 9 days after treatment in dogs. Following absorption from the skin, moxidectin is distributed systemically throughout the body tissues but due to its lipophilicity it is concentrated mainly in the fat. It is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.

The T ½ in dogs is about 28.4 days.

Studies evaluating the pharmacokinetic behaviour of moxidectin after multiple applications have indicated that steady state serum levels are achieved following approximately 4 consecutive monthly treatments in dogs.

Marketing Authorisation Holder (if different from distributor)

Marketing Authorisation Holder

Bayer Animal Health GmbH, D-51368 Leverkusen, Germany

Distributed by

UK: Bayer plc, 400 South Oak Way, Green Park, Reading, Berkshire, RG2 6AD

Ireland: Bayer Ltd, The Atrium, Blackthorn Road, Sandyford Ind Est, Dublin 18

Marketing Authorisation Number

EU/2/03/039/001 - 005EU/2/03/039/007 - 012EU/2/03/039/019, EU/2/03/039/021, EU/2/03/039/023, EU/2/03/039/025, EU/2/03/039/027, EU/2/03/039/029

250 Large Dogs 10-25kg » Pack Of 6 Pipettes

Advocate Spot-on Solution

Presentation

Advocate spot-on solution for cats and ferrets is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 10 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E 321 as an antioxidant). Each pipette of the small cat and ferret presentation contains 0.4 ml (40 mg imidacloprid, 4 mg moxidectin), the large cat presentation contains 0.8 ml (80 mg imidacloprid, 8 mg moxidectin).

Advocate spot-on solution for dogs is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 25 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E321 as an antioxidant). Each pipette of the dog presentations contains either 0.4 ml (40 mg imidacloprid, 10 mg moxidectin), 1.0 ml (100 mg imidacloprid, 25 mg moxidectin), 2.5 ml (250 mg imidacloprid, 62.5 mg moxidectin) or 4.0 ml (400 mg imidacloprid, 100 mg moxidectin).

Uses

For use in cats, ferrets and dogs suffering from, or at risk from, mixed parasitic infections:

For cats:

For ferrets: For the treatment and prevention of flea infestation (Ctenocephalides felis) and the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis).

For dogs:

Dosage and administration

Dosage schedule

The recommended minimum doses for cats are 10 mg/kg body weight imidacloprid and 1.0 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for cats.

Dosage schedule for ferrets: one pipette of Advocate spot-on solution for small cats and ferrets (0.4 ml) should be administered per animal. Do not exceed the recommended dose.

The recommended minimum doses for dogs are 10 mg/kg body weight imidacloprid and 2.5 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for dogs.

The treatment schedule for all species should be based on individual veterinary diagnosis and on the local epidemiological situation.

Cats (Refer to Table 1)

Dogs(Refer to Table 2)

Flea treatment and prevention (Cats and Dogs)

One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine Advocate treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.

Flea treatment and prevention (Ferrets)

One treatment prevents future flea infestation for 3 weeks. Under heavy flea pressure it may be necessary to repeat the dose after 2 weeks.

Treatment of ear mite infestation (Otodectes cynotis) (Cats & Dogs)

A single dose of the product should be administered. In dogs, loose debris should be gently removed from the external ear canal at each treatment. For both cats and dogs, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.

Treatment of biting lice (Trichodectes canis) (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis) (Dogs)

A single dose should be administered twice 4 weeks apart.

Treatment of notoedric mange (Notoedres cati) (Cats)

A single dose of the product should be administered.

Treatment of the lungworm Eucoleus aerophilus (syn. Capillaria aerophila) (adults) (Cats)

A single dose of the product should be administered.

Treatment of Eucoleus (syn. Capillaria) boehmi (adults)(Dogs)

The product should be administered monthly for two consecutive months. It is advisable to prevent auto-coprophagia between the two treatments in order to prevent possible reinfection.

Treatment of the eye worm Thelazia callipaeda (adults)(Dogs)

A single dose of the product should be administered.

Treatment of demodicosis (caused by Demodex canis) (Dogs)

The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against Demodex canis and leads to a marked improvement of clinical signs particularly in mild to moderate cases. Especially severe cases may require more prolonged and more frequent treatment. To achieve the best possible response in these severe cases, at the discretion of the veterinarian, Advocate can be applied once a week and for a prolonged time. In all cases it is essential that the treatment should be continued until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment. Alternative treatment should be administered. Seek the advice of your veterinarian.

As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.

Prevention of heartworm disease (D.immitis) (Cats, Ferrets & Dogs) and cutaneous dirofilariosis (D. repens) (Dogs)

Cats, ferrets and dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with Advocate, the advice provided in Contra-Indications and Warnings etc should be considered. For prevention of heartworm disease and cutaneous dirofilariosis, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. immitis and D. repens larvae) are present. The product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with Advocate must be given within 1 month of the last dose of the former medication. In non-endemic areas there should be no risk of animals having heartworm. Therefore they can be treated without special precautions.

Treatment of microfilariae (D. immitis) (Dogs)

Advocate should be administered monthly for two consecutive months.

Treatment of cutaneous dirofilariosis (skin worm) (adult stages of Dirofilaria repens) (Dogs)

Advocate should be administered monthly for six consecutive months.

Reduction of microfilariae (skin worm) (D. repens) (Dogs)

The product should be administered monthly for four consecutive months.

Roundworm and hookworm treatment (Cats)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworms and hookworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.

Roundworm, hookworm and whipworm treatment (Dogs)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective round-, hook- and whipworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes. Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.

Treatment and Prevention of Angiostrongylus vasorum (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

In endemic areas regular four weekly application will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.

Treatment of Crenosoma vulpis (Dogs)

A single dose should be administered

Prevention of Spirocerca lupi (Dogs)

The product should be administered monthly.

Method of administration

For external use only.

Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown. See Figure 1.

Figure 1: Opening a pipette

Cats and Ferrets

Part the fur on the animal's neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. Application at the base of the skull will minimise the opportunity for the animal to lick the product. Apply only to undamaged skin. See Figure 2.

Figure 2: Administration to the Cat or Ferret

For dogs up to 25kg

With the dog in a standing position, part the coat between the shoulder blades until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. See Figure 3.

Figure 3: Administration to dogs up to 25kg

For dogs of more than 25 kg

For easy application the dog should be standing. The entire contents of the pipette should be applied evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail. At each spot, part the coat until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly onto the skin. Do not apply an excessive amount of solution at any one spot, as that could cause some of the product to run down the animal’s side. See Figure 4.

Figure 4: Administration to dogs over 25kg

Use During Pregnancy and Lactation

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the risk-benefit assessment by the responsible veterinarian.

Contra-indications, warnings, etc

Do not use in kittens under 9 weeks of age.

Do not use in puppies under 7 weeks of age.

Treatment of cats or dogs weighing less than 1 kg, and ferrets weighing less than 0.8 kg should be based on a risk-benefit assessment.

Do not use in the cases of hypersensitivity to the active substances or to any of the excipients.

There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a risk-benefit assessment for these animals.

For cats, the corresponding "Advocate spot-on solution for cat" product, which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used.

For ferrets: Do not use Advocate for large cats (0.8ml) or Advocate for dogs (any size), only "Advocate for small cats and ferrets" (0.4 ml) must be used. The product’s efficacy has not been tested in ferrets weighing over 2 kg and therefore the duration of effect might be shorter in these animals.

For dogs, the corresponding "Advocate for dog" product, which contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin, must be used.

Do not use on canaries.

The product tastes bitter. Salivation may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application will minimise licking of the application site.

In case of accidental oral uptake, symptomatic treatment should be administered. There is no known specific antidote. The use of activated charcoal may be beneficial. After accidental oral ingestion (e.g. licking at the site of application) or overdose, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may be observed in very rare cases.

The use of the product may result in transient pruritus in the animal. On rare occasions greasy fur, erythema and vomiting can occur. These signs disappear without further treatment. The product may, in rare cases cause local hypersensitivity reactions. The product may in very rare cases cause at the application site a sensation resulting in transient behavioural changes such as lethargy, agitation, and inappetence.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Care should be taken that the contents of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.

Do not allow recently treated animals to groom each other.

When the product is applied in 3 to 4 separate spots in larger dogs, specific care should be taken to prevent the animal licking the application sites. Oral uptake by Collies, Old English Sheepdogs and related breeds or crossbreeds should be prevented.

During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered. This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the product as described above. In particular, oral uptake by the recipient and/or other animals in close contact should be prevented.

Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals without any adverse effects, but the safety of application at weekly intervals has not been investigated in ivermectin-sensitive Collie dogs. When 40% of the unit dose was given orally, severe neurological signs were observed. Oral administration of 10% of the recommended dose produced no adverse effects.

Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects or undesirable clinical signs. Five times the recommended minimum dose applied at weekly intervals for 17 weeks was investigated in dogs aged over 6 months and tolerated with no evidence of adverse effects or undesirable clinical signs.

Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or undesirable clinical signs.

The product was administered to kittens and puppies at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.

The product was administered to ferrets at 5 times the recommended dose, every 2 weeks for 4 treatments, and there was no evidence of adverse effects or undesirable clinical signs.

It is recommended that cats and ferrets living in, or travelling to areas endemic for heartworm are treated monthly with the product to protect them from heartworm disease. Whilst the accuracy of diagnosis of heartworm infection is limited, it is recommended that attempts be made to check the heartworm status of any cat and ferret aged over 6 months, before beginning prophylactic treatment, as use of the product on cats or ferrets which have adult heartworms may cause serious adverse effects, including death. If adult heartworm infection is diagnosed, the infection should be treated in accordance with current scientific knowledge.

Although experimental overdosage studies have shown that the product may be safely administered to dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis. It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the product. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of Advocate has not been evaluated when administered on the same day as an adulticide.

Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse effects.

The safety of the product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study. Therefore the use in dogs with obvious or severe symptoms of the disease should be based on a careful benefit risk assessment by the treating veterinarian.

Do not use in dogs classified as Class 4 for heartworm disease as the safety of the product has not been evaluated in this animal group.

A field study has shown that in heartworm positive dogs with microfilaraemia there is a risk of severe respiratory signs (coughing, tachypnoea and dyspnoea) that may require prompt veterinary treatment. In the study these reactions were common (seen in 2 of 106 treated dogs). Gastrointestinal signs (vomiting, diarrhoea, inappetence) and lethargy are also common adverse reactions following treatment in such dogs.

Efficacy against adult Dirofilaria repens has not been tested under field conditions.

In certain individual cats Notoedres cati infestation may be severe. In these severe cases concomitant supportive treatment is necessary as treatment with the product alone may not be sufficient to prevent death of the animal.

Imidacloprid is toxic for birds, especially canaries.

No interactions between Advocate and routinely used veterinary medicinal products or medical or surgical procedures have been observed.

Safety of Advocate when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.

Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the product.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.

The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time.

The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

User Safety

Avoid contact with skin, eyes or mouth.

Do not eat, drink or smoke during application.

Wash hands thoroughly after use.

In case of accidental spillage onto skin, wash off immediately with soap and water.

After application do not stroke or groom animals until the application site is dry.

People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In very rare cases the product may cause skin sensitisation or transient skin reactions (for example numbness, irritation or burning/tingling sensation). In very rare cases the product may cause respiratory irritation in sensitive individuals.

If the product accidentally gets into eyes, they should be thoroughly flushed with water.

If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical attention and show the package insert to the physician.

Environmental Safety

Advocate should not be allowed to enter water courses as it has harmful effects on aquatic organisms: moxidectin is highly toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days after treatment.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Pharmaceutical precautions

Do not store above 30°C.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Legal category

Packaging quantities

White polypropylene unit dose pipette with screw cap.

Further information

Pharmacotherapeutic group: therapeutic antiparasitic agent; ATCvet code: QP54AB52.

Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has minimal pharmacological activity in mammals.

Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is a parasiticide which is active against many internal and external parasites. Moxidectin is active against larval stages of Dirofilaria immitis (L1, L3, L4) and Dirofilaria repens (L1, L3). It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion.

The drug has a persistent action and protects dogs for 4 weeks after a single application against re-infection with the following parasites: Dirofilaria immitis, Dirofilaria repens, Angiostrongylus vasorum

After topical administration of the product, imidacloprid is rapidly distributed over the animal’s skin within one day of application. It can be found on the body surface throughout the treatment interval. Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 1 to 2 days after treatment in cats and approximately 4 to 9 days after treatment in dogs. Following absorption from the skin, moxidectin is distributed systemically throughout the body tissues but due to its lipophilicity it is concentrated mainly in the fat. It is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.

The T ½ in dogs is about 28.4 days.

Studies evaluating the pharmacokinetic behaviour of moxidectin after multiple applications have indicated that steady state serum levels are achieved following approximately 4 consecutive monthly treatments in dogs.

Marketing Authorisation Holder (if different from distributor)

Marketing Authorisation Holder

Bayer Animal Health GmbH, D-51368 Leverkusen, Germany

Distributed by

UK: Bayer plc, 400 South Oak Way, Green Park, Reading, Berkshire, RG2 6AD

Ireland: Bayer Ltd, The Atrium, Blackthorn Road, Sandyford Ind Est, Dublin 18

Marketing Authorisation Number

EU/2/03/039/001 - 005EU/2/03/039/007 - 012EU/2/03/039/019, EU/2/03/039/021, EU/2/03/039/023, EU/2/03/039/025, EU/2/03/039/027, EU/2/03/039/029

400 Extra Large Dogs 25-40kg » Pack Of 6 Pipettes

Advocate Spot-on Solution

Presentation

Advocate spot-on solution for cats and ferrets is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 10 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E 321 as an antioxidant). Each pipette of the small cat and ferret presentation contains 0.4 ml (40 mg imidacloprid, 4 mg moxidectin), the large cat presentation contains 0.8 ml (80 mg imidacloprid, 8 mg moxidectin).

Advocate spot-on solution for dogs is a clear yellow to brownish solution containing 100 mg/ml imidacloprid and 25 mg/ml moxidectin with benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E321 as an antioxidant). Each pipette of the dog presentations contains either 0.4 ml (40 mg imidacloprid, 10 mg moxidectin), 1.0 ml (100 mg imidacloprid, 25 mg moxidectin), 2.5 ml (250 mg imidacloprid, 62.5 mg moxidectin) or 4.0 ml (400 mg imidacloprid, 100 mg moxidectin).

Uses

For use in cats, ferrets and dogs suffering from, or at risk from, mixed parasitic infections:

For cats:

For ferrets: For the treatment and prevention of flea infestation (Ctenocephalides felis) and the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis).

For dogs:

Dosage and administration

Dosage schedule

The recommended minimum doses for cats are 10 mg/kg body weight imidacloprid and 1.0 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for cats.

Dosage schedule for ferrets: one pipette of Advocate spot-on solution for small cats and ferrets (0.4 ml) should be administered per animal. Do not exceed the recommended dose.

The recommended minimum doses for dogs are 10 mg/kg body weight imidacloprid and 2.5 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for dogs.

The treatment schedule for all species should be based on individual veterinary diagnosis and on the local epidemiological situation.

Cats (Refer to Table 1)

Dogs(Refer to Table 2)

Flea treatment and prevention (Cats and Dogs)

One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine Advocate treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.

Flea treatment and prevention (Ferrets)

One treatment prevents future flea infestation for 3 weeks. Under heavy flea pressure it may be necessary to repeat the dose after 2 weeks.

Treatment of ear mite infestation (Otodectes cynotis) (Cats & Dogs)

A single dose of the product should be administered. In dogs, loose debris should be gently removed from the external ear canal at each treatment. For both cats and dogs, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.

Treatment of biting lice (Trichodectes canis) (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis) (Dogs)

A single dose should be administered twice 4 weeks apart.

Treatment of notoedric mange (Notoedres cati) (Cats)

A single dose of the product should be administered.

Treatment of the lungworm Eucoleus aerophilus (syn. Capillaria aerophila) (adults) (Cats)

A single dose of the product should be administered.

Treatment of Eucoleus (syn. Capillaria) boehmi (adults)(Dogs)

The product should be administered monthly for two consecutive months. It is advisable to prevent auto-coprophagia between the two treatments in order to prevent possible reinfection.

Treatment of the eye worm Thelazia callipaeda (adults)(Dogs)

A single dose of the product should be administered.

Treatment of demodicosis (caused by Demodex canis) (Dogs)

The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against Demodex canis and leads to a marked improvement of clinical signs particularly in mild to moderate cases. Especially severe cases may require more prolonged and more frequent treatment. To achieve the best possible response in these severe cases, at the discretion of the veterinarian, Advocate can be applied once a week and for a prolonged time. In all cases it is essential that the treatment should be continued until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment. Alternative treatment should be administered. Seek the advice of your veterinarian.

As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.

Prevention of heartworm disease (D.immitis) (Cats, Ferrets & Dogs) and cutaneous dirofilariosis (D. repens) (Dogs)

Cats, ferrets and dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with Advocate, the advice provided in Contra-Indications and Warnings etc should be considered. For prevention of heartworm disease and cutaneous dirofilariosis, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. immitis and D. repens larvae) are present. The product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with Advocate must be given within 1 month of the last dose of the former medication. In non-endemic areas there should be no risk of animals having heartworm. Therefore they can be treated without special precautions.

Treatment of microfilariae (D. immitis) (Dogs)

Advocate should be administered monthly for two consecutive months.

Treatment of cutaneous dirofilariosis (skin worm) (adult stages of Dirofilaria repens) (Dogs)

Advocate should be administered monthly for six consecutive months.

Reduction of microfilariae (skin worm) (D. repens) (Dogs)

The product should be administered monthly for four consecutive months.

Roundworm and hookworm treatment (Cats)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworms and hookworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.

Roundworm, hookworm and whipworm treatment (Dogs)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective round-, hook- and whipworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes. Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.

Treatment and Prevention of Angiostrongylus vasorum (Dogs)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

In endemic areas regular four weekly application will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.

Treatment of Crenosoma vulpis (Dogs)

A single dose should be administered

Prevention of Spirocerca lupi (Dogs)

The product should be administered monthly.

Method of administration

For external use only.

Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown. See Figure 1.

Figure 1: Opening a pipette

Cats and Ferrets

Part the fur on the animal's neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. Application at the base of the skull will minimise the opportunity for the animal to lick the product. Apply only to undamaged skin. See Figure 2.

Figure 2: Administration to the Cat or Ferret

For dogs up to 25kg

With the dog in a standing position, part the coat between the shoulder blades until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. See Figure 3.

Figure 3: Administration to dogs up to 25kg

For dogs of more than 25 kg

For easy application the dog should be standing. The entire contents of the pipette should be applied evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail. At each spot, part the coat until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly onto the skin. Do not apply an excessive amount of solution at any one spot, as that could cause some of the product to run down the animal’s side. See Figure 4.

Figure 4: Administration to dogs over 25kg

Use During Pregnancy and Lactation

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the risk-benefit assessment by the responsible veterinarian.

Contra-indications, warnings, etc

Do not use in kittens under 9 weeks of age.

Do not use in puppies under 7 weeks of age.

Treatment of cats or dogs weighing less than 1 kg, and ferrets weighing less than 0.8 kg should be based on a risk-benefit assessment.

Do not use in the cases of hypersensitivity to the active substances or to any of the excipients.

There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a risk-benefit assessment for these animals.

For cats, the corresponding "Advocate spot-on solution for cat" product, which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used.

For ferrets: Do not use Advocate for large cats (0.8ml) or Advocate for dogs (any size), only "Advocate for small cats and ferrets" (0.4 ml) must be used. The product’s efficacy has not been tested in ferrets weighing over 2 kg and therefore the duration of effect might be shorter in these animals.

For dogs, the corresponding "Advocate for dog" product, which contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin, must be used.

Do not use on canaries.

The product tastes bitter. Salivation may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application will minimise licking of the application site.

In case of accidental oral uptake, symptomatic treatment should be administered. There is no known specific antidote. The use of activated charcoal may be beneficial. After accidental oral ingestion (e.g. licking at the site of application) or overdose, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may be observed in very rare cases.

The use of the product may result in transient pruritus in the animal. On rare occasions greasy fur, erythema and vomiting can occur. These signs disappear without further treatment. The product may, in rare cases cause local hypersensitivity reactions. The product may in very rare cases cause at the application site a sensation resulting in transient behavioural changes such as lethargy, agitation, and inappetence.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Care should be taken that the contents of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.

Do not allow recently treated animals to groom each other.

When the product is applied in 3 to 4 separate spots in larger dogs, specific care should be taken to prevent the animal licking the application sites. Oral uptake by Collies, Old English Sheepdogs and related breeds or crossbreeds should be prevented.

During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered. This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the product as described above. In particular, oral uptake by the recipient and/or other animals in close contact should be prevented.

Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals without any adverse effects, but the safety of application at weekly intervals has not been investigated in ivermectin-sensitive Collie dogs. When 40% of the unit dose was given orally, severe neurological signs were observed. Oral administration of 10% of the recommended dose produced no adverse effects.

Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects or undesirable clinical signs. Five times the recommended minimum dose applied at weekly intervals for 17 weeks was investigated in dogs aged over 6 months and tolerated with no evidence of adverse effects or undesirable clinical signs.

Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or undesirable clinical signs.

The product was administered to kittens and puppies at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.

The product was administered to ferrets at 5 times the recommended dose, every 2 weeks for 4 treatments, and there was no evidence of adverse effects or undesirable clinical signs.

It is recommended that cats and ferrets living in, or travelling to areas endemic for heartworm are treated monthly with the product to protect them from heartworm disease. Whilst the accuracy of diagnosis of heartworm infection is limited, it is recommended that attempts be made to check the heartworm status of any cat and ferret aged over 6 months, before beginning prophylactic treatment, as use of the product on cats or ferrets which have adult heartworms may cause serious adverse effects, including death. If adult heartworm infection is diagnosed, the infection should be treated in accordance with current scientific knowledge.

Although experimental overdosage studies have shown that the product may be safely administered to dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis. It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the product. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of Advocate has not been evaluated when administered on the same day as an adulticide.

Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse effects.

The safety of the product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study. Therefore the use in dogs with obvious or severe symptoms of the disease should be based on a careful benefit risk assessment by the treating veterinarian.

Do not use in dogs classified as Class 4 for heartworm disease as the safety of the product has not been evaluated in this animal group.

A field study has shown that in heartworm positive dogs with microfilaraemia there is a risk of severe respiratory signs (coughing, tachypnoea and dyspnoea) that may require prompt veterinary treatment. In the study these reactions were common (seen in 2 of 106 treated dogs). Gastrointestinal signs (vomiting, diarrhoea, inappetence) and lethargy are also common adverse reactions following treatment in such dogs.

Efficacy against adult Dirofilaria repens has not been tested under field conditions.

In certain individual cats Notoedres cati infestation may be severe. In these severe cases concomitant supportive treatment is necessary as treatment with the product alone may not be sufficient to prevent death of the animal.

Imidacloprid is toxic for birds, especially canaries.

No interactions between Advocate and routinely used veterinary medicinal products or medical or surgical procedures have been observed.

Safety of Advocate when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.

Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the product.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.

The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time.

The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

User Safety

Avoid contact with skin, eyes or mouth.

Do not eat, drink or smoke during application.

Wash hands thoroughly after use.

In case of accidental spillage onto skin, wash off immediately with soap and water.

After application do not stroke or groom animals until the application site is dry.

People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In very rare cases the product may cause skin sensitisation or transient skin reactions (for example numbness, irritation or burning/tingling sensation). In very rare cases the product may cause respiratory irritation in sensitive individuals.

If the product accidentally gets into eyes, they should be thoroughly flushed with water.

If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical attention and show the package insert to the physician.

Environmental Safety

Advocate should not be allowed to enter water courses as it has harmful effects on aquatic organisms: moxidectin is highly toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days after treatment.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Pharmaceutical precautions

Do not store above 30°C.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Legal category

Packaging quantities

White polypropylene unit dose pipette with screw cap.

Further information

Pharmacotherapeutic group: therapeutic antiparasitic agent; ATCvet code: QP54AB52.

Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has minimal pharmacological activity in mammals.

Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is a parasiticide which is active against many internal and external parasites. Moxidectin is active against larval stages of Dirofilaria immitis (L1, L3, L4) and Dirofilaria repens (L1, L3). It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion.

The drug has a persistent action and protects dogs for 4 weeks after a single application against re-infection with the following parasites: Dirofilaria immitis, Dirofilaria repens, Angiostrongylus vasorum

After topical administration of the product, imidacloprid is rapidly distributed over the animal’s skin within one day of application. It can be found on the body surface throughout the treatment interval. Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 1 to 2 days after treatment in cats and approximately 4 to 9 days after treatment in dogs. Following absorption from the skin, moxidectin is distributed systemically throughout the body tissues but due to its lipophilicity it is concentrated mainly in the fat. It is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.

The T ½ in dogs is about 28.4 days.

Studies evaluating the pharmacokinetic behaviour of moxidectin after multiple applications have indicated that steady state serum levels are achieved following approximately 4 consecutive monthly treatments in dogs.

Marketing Authorisation Holder (if different from distributor)

Marketing Authorisation Holder

Bayer Animal Health GmbH, D-51368 Leverkusen, Germany

Distributed by

UK: Bayer plc, 400 South Oak Way, Green Park, Reading, Berkshire, RG2 6AD

Ireland: Bayer Ltd, The Atrium, Blackthorn Road, Sandyford Ind Est, Dublin 18

Marketing Authorisation Number

EU/2/03/039/001 - 005EU/2/03/039/007 - 012EU/2/03/039/019, EU/2/03/039/021, EU/2/03/039/023, EU/2/03/039/025, EU/2/03/039/027, EU/2/03/039/029

Delivery Information

How quickly do you deliver?

Under almost all products on our website is an Estimated dispatch time, check this for a delivery prediction specific to the item you are looking to purchase. These badges are updated live based on the stock levels we have and also those of our suppliers - so are usually very accurate, but cannot be guaranteed. In more general terms, we aim to dispatch all orders within 1 working day of receiving payment (and a prescription if required). If we cannot do so within 3 working days we will contact you by email.

What do you charge for delivery?

For UK delivery, we charge the following:

Order Total Weight Delivery
£0-£28.99 Under 2kg £2.99
2kg+ £4.99
£29-£38.99 Under 2kg Free
2kg+ £4.99
£39+ Under 2kg Free
2kg+ Free

Prices quoted are for delivery to all parts of mainland UK except certain Scottish postcodes (where the price is higher for items sent by courier. Delivery of food abroad (including Channel Islands, N. Ireland and other islands around the UK) is charged at a higher price and free delivery is not available. Temperature controlled products, such as Insulin, are also not always subject to the standard and/or free delivery options.

For full information on our delivery charges, including prices on heavy deliveries to Scotland and abroad, see our delivery information page.

We can deliver most items to all around the world, but prices do vary. The majority of light weight orders (less than 1.5kg) can be delivered for a flat rate of £10. For an accurate estimate of the delivery charge, please put the items you require in your basket and use the "Estimate Delivery" system on the shopping basket page (you only need to enter your country and postal/zip code) for a quick quote. For deliveries to the USA you may need to go to the checkout page and enter your full address to get a quote (as some services need your state in order to quote too). For more information on international deliveries, please see our delivery information page.

Delivery of aerosols

Due to restrictions aerosols can't be sent by Royal Mail. We appreciate your understanding.

Delivery of temperature controlled items

Some products, such as insulin and frozen food, need to be delivered in insulated packaging to prevent them from getting too warm (or too cold) during transit from us to you. Purchasing any of these items in your order will result in a £1.99 charge being added to the total to cover the high cost of the insulated packaging materials. You only pay the £1.99 once per order, regardless of how many temperature controlled items you purchase in that order.

How do I cancel or return an order?

Please call us as soon as possible if you need to amend or cancel an order on 01582 842096. If your order has been processed for dispatch we will be unable to cancel or amend the order. You will however be able to return your product for a full refund*.

To return an item, you must contact us by phone or email to arrange this BEFORE posting any product back to us. We will explain the process at this stage for you.

*For full details on returns, see our terms and conditions page.

Reviews (199)

Q & A

Below are some recent questions we've received regarding Advocate Spot-on Solution for Dogs & Cats, including answers from our team.

12 February 2018 at 6:38pm

Prescription

Marie

Can I purchase advocate without a prescription please

  • Veterinary Advisor

No, I'm afraid not. You must have a prescription from your vet to purchase Advocate. Once you have a prescription we would be very happy to supply you with it.

15 November 2017 at 1:06am

Safe to use on Shetland Sheepdog or Collie ?

Suki Man

  • VioVet customer since 2017
  • From: Kowloon, Hong Kong

Is it Safe to use on Shetland Sheepdog or Collie ?
My baby is a 11 years old female Shetland sheep dog

  • Veterinary Advisor

This product contains Moxidectin, a Macrocyclic Lactone, in the same class as Ivermectin. Advocate was tested on Ivermectin sensitive collies at 5 times the recommended dose with no adverse effects so it is unlikely to cause a problem for your dog. However it is important that she doesn't lick it. Please see blurb from the data sheet below:

"When the product is applied in 3 to 4 separate spots in larger dogs, specific care should be taken to prevent the animal licking the application sites. Oral uptake by Collies, Old English Sheepdogs and related breeds or crossbreeds should be prevented.

During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered. This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the product as described above. In particular, oral uptake by the recipient and/or other animals in close contact should be prevented.

Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals without any adverse effects, but the safety of application at weekly intervals has not been investigated in ivermectin-sensitive Collie dogs. When 40% of the unit dose was given orally, severe neurological signs were observed. Oral administration of 10% of the recommended dose produced no adverse effects."

3 October 2016 at 8:58pm

Advocate used but still got a couple of fleas

Lyndsay Luciano

  • VioVet customer since 2015
  • From: Isle of Wight, United Kingdom

I use advocate on my spaniel every month but gave just noticed a couple of fleas on her . Her last treatment was Wednesday and Friday I noticed fleas on her Sunday what do you suggest thanks

  • Veterinary Advisor

Advocate is generally very good and should be effective if you have applied it properly. What you might have is a problem with fleas in the house. Fleas can reside in the environment and jump onto your dog. The advocate should kill the fleas once they are on your dog but not instantly hence why you have seen a few on your dog. You should use a flea spray such as Virbac Indorex to treat the house- carpets, furniture, bedding, curtains etc.

26 March 2016 at 9:00pm

Can you get a tablet instead of advocatt spot on

Anita

My dog Hates me putting the advocart
On his neck. Is there a tablet that covers the same lung worm ect?
We do also worm him as normal with the tablet for that .

  • Non-Executive Director

There is a tablet which acts against the same type of lungworm (Angiostrongylus vasorum) but it is best given more frequently and needs to be prescribed by your vet. You could ask your vet about possibly using Milbemax as an alternative to Advocate, but for most dogs it is not a sensible alternative. For your dog it might make sense though.

27 September 2015 at 2:29am

Lungworm

bigi

Is it really necessary to apply advocate to my puppy every month. I am worried about over medicating him as I take my mini pinscher abroad with me three times a year and have to give him a tablet for worms each time so I can bring him back to the UK. He is a very happy and lively dog but quite skinny for my liking. I hope that's not due to all the poison I am forced to give him. Please advise urgently. Thank you.

  • Non-Executive Director

If you travel abroad with your puppy, he is almost certainly at much greater risk if he is not treated with these things, than if he is treated. I understand your concerns about forcing "chemicals" upon him, but they are very thoroughly tested products and have been demonstrated to have no adverse effects when used as recommended. Dogs which are not treated are known to suffer a whole host of adverse effects from various parasites which are controlled very effectively by what you are using. (The tablets is for tapeworms which is just about the only worm not treated by Advocate, so they are good to be used together.) I think you are right to question giving these treatments and it does go against the grain somewhat. However I am sure that on average, treated dogs do significantly better than none treated dogs. On balance, your puppy is better off on treatment. Being underweight can be caused by so many different things, it is very unlikely to have anything to do with parasite treatments.

4 July 2015 at 12:37pm

I don't have a prescription for advocat

Jackie

Why do I need a prescription for flea and worker?

  • Non-Executive Director

If we are posting medication to an address in the UK, we have to follow relevant UK law. For reasons we are not involved in, some medicines are legally classed as POM-V which means a veterinary prescription is needed. We will always aim to follow the law. Please note that some other flea and worm treatments do not need a prescription, though at the moment Advocate seems to be an exceptionally effective and safe product. If in the fullness of time it is proven to be this safe, then its legal classification might be relaxed and it might then be available without prescription. Obviously we would like that very much, but it is not our decision. Usually this only happens after a new product has been used widely for a few years to allow time for a full assessment to be made. Advocate is still newer than many of the other products.

23 June 2015 at 11:21am

Ticks?

Jan

My springer/cocker seems to be very subject to ticks at the moment. Is this effective on ticks? I can't see any specific mention of it.
Thanks.

  • Non-Executive Director

Advocate is not effective against ticks. (It is a great product and very effective against most parasites, but not against ticks or tapeworms.) There are a number of other treatments for ticks. You can use Frontline Spot-on or a Scalibor collar (the latter probably more effective, both are non-prescription). There are a number of prescription products for ticks, your vet would have to advise you on these. I would suggest the collar to use along with Advocate.

6 April 2015 at 5:04pm

Puppy

Rachel Stokes

  • VioVet customer since 2014
  • From: Essex, United Kingdom

Hi what can I use to treat a 6 week old puppy that has mites

  • Non-Executive Director

The safest thing to do is to wait until the puppy is 7 weeks of age, then treat with Advocate. If the mite problem is too bad for that and the diagnosis is definite then your vet might direct you to use Advocate at 6 weeks of age, or try a different product such as Stronghold (which can be used from 6 weeks of age anyway).

7 February 2015 at 10:26am

Advocate wormer

kay

Can you tell me how long it takes to kill and pass worms after Advocate spot on treatment for my dog.

  • Non-Executive Director

I would expect most worms to be killed within 24 hours. However most of them will be digested, rather than expelled, so you would not expect to see any passed in a recognisable state. (Some old fashioned wormers worked partly through getting the entire gut contents to pass out very quickly, worms and all. This made them obvious to see, but is not actually as good for the dog or cat.)

25 January 2015 at 8:30pm

Advocate and worming

Leanne Scarr

  • VioVet customer since 2012
  • From: East Riding of Yorkshire, United Kingdom

Hi if I give my cat advocate do I need an additional wormer? Of so for which type of worms- my puppy has had advocate at vets and they advised she needs a tapeworm ing tablet at 12 weeks. I use fibrospot and dronal at the moment

  • Non-Executive Director

Advocate covers all worms apart from tapeworms. It also covers for fleas, so you do not need the Fiprospot if you continue with Advocate. Drontal does cover for tapeworms as well as most other worms. If you want a treatment just for tapeworms then Droncit is the one I would recommend (a tablet or spot-on is available).