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 presentations 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 the treatment and prevention of flea infestation (Ctenocephalides felis), treatment of ear mite infestation (Otodectes cynotis), prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis) and 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: 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: For the treatment and prevention of flea infestation (Ctenocephalides felis), treatment of biting lice (Trichodectes canis), treatment of ear mite infestation (Otodectes cynotis), sarcoptic mange (caused by Sarcoptes scabiei var. canis), demodicosis (caused by Demodex canis), prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis) and angiostrongylosis (L4 larvae and immature adults of Angiostrongylus vasorum), treatment of Angiostrongylus vasorum and Crenosoma vulpis and 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).

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 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 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.

Heartworm prevention (Cats, Ferrets & 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, 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 animals having heartworm. Therefore they can be treated without special precautions.

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

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.

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.

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.

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.

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 case 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.

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 minimize 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 (i.e. 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.

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.

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 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.

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

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

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.

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 surface waters 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 product or waste materials derived from such veterinary medicinal products 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

POM-V

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 (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.

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 and is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.

Marketing Authorisation Holder (if different from distributor)

Marketing Authorisation Holder

Bayer Animal Health GmbH, D-51368 Leverkusen, Germany

Distributed by

UK: Bayer plc, Animal Health Division, Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA

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

Marketing authorisation number

GTIN (Global Trade Item No)

Advocate Spot-on solution for Small Cats and Ferrets (3 Pack)

04007221016878

Advocate Spot-on solution for Small Cats and Ferrets (6 Pack)

04007221020691

Advocate Spot-on solution for Large Cats (3 Pack)

04007221016885

Advocate Spot-on solution for Large Cats (6 Pack)

04007221020684

Advocate Spot-on solution for Small Dogs (3 Pack)

04007221016892

Advocate Spot-on solution for Medium Dogs (3 Pack)

04007221016908

Advocate Spot-on solution for Medium Dogs (6 Pack)

04007221020677

Advocate Spot-on solution for Large Dogs (3 Pack)

04007221016915

Advocate Spot-on solution for Large Dogs (6 Pack)

04007221020660

Advocate Spot-on solution for Extra-large Dogs (3 Pack)

04007221016922

Advocate Spot-on solution for Extra-large Dogs (6 Pack)

04007221020653