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Milquantel Tablets for Dogs & Cats

  • Adult Cat (at least 2kg weight) » Priced per tablet £2.89
  • Adult Dog (at least 5kg weight) » Priced per tablet £2.80
  • Small Dog/Puppy (at least 0.5kg weight) » Priced per tablet £1.49

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Milquantel Tablets for Dogs & Cats can be purchased from VioVet at fantastic prices. With free delivery of most orders over £29 and a wide range of products available, you can buy with confidence from VioVet!

Milquantel 2.5 mg/25 mg tablets for small dogs and puppies weighing at least 0.5 kg

Species: Dogs

Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for dogs Active ingredient: Milbemycin Oxime Product:Milquantel 2.5 mg/25 mg tablets for small dogs and puppies weighing at least 0.5 kg Product index: Milquantel 2.5mg/25 mg tablets for small dogs and puppies weighing at least 0.5 kg

Qualitative and quantitative composition

Each film-coated tablet contains: Active substances: Milbemycin oxime 2.5 mg Praziquante 25 mg Excipients: For the full list of excipients, see section "Pharmaceutical particulars".

Pharmaceutical form

Tablet. Yellowish-white with brown spots, oval, biconvex tablets scored on one side. The tablets can be divided into equal halves.

Clinical particulars

Target species

Dogs (small dogs and puppies).

Indications for use

In dogs: treatment of mixed infections by adult cestodes and nematodes of the following species: - Cestodes: Dipylidium caninum Taenia spp. Echinococcus spp. Mesocestoides spp. - Nematodes: Ancylostoma caninum Toxocara canis Toxascaris leonina Trichuris vulpis Crenosoma vulpis (Reduction of the level of infection) Angiostrongylus vasorum (Reduction of the level of infection by immature adult (L5) and adult parasite stages; see specific treatment and disease prevention schedules under section “Amounts to be administered and administration route”. Thelazia callipaeda (see specific treatment schedule under section “Amounts to be administered and administration route”. The product can also be used in the prevention of heartworm disease (Dirofilaria immitis) if concomitant treatment against cestodes is indicated.

Contra-indications

Do not use in puppies of less than 2 weeks of age and/or weighing less than 0.5 kg. Do not use in case of hypersensitivity to the active substances or to any of the excipients. See also section " Special precautions for use".

Special warnings for each target species

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

Special precautions for use

Special precautions for use in animals Studies with milbemycin oxime indicate that the margin of safety in certain dogs of Collie or related breeds is less than in other breeds. In these dogs, the recommended dose should be strictly observed. The tolerance of the product in young puppies from these breeds has not been investigated. Clinical signs in Collies are similar to those seen in the general dog population when overdosed (see in section "Overdose"). Treatment of dogs with a high number of circulating microfilariae can sometimes lead to the appearance of hypersensitivity reactions, such as pale mucous membranes, vomiting, trembling, laboured breathing or excessive salivation. These reactions are associated with the release of proteins from dead or dying microfilariae and are not a direct toxic effect of the product. The use in dogs suffering from microfilaremia is thus not recommended. In heartworm risk-areas, or in the case it is known that a dog has been travelling to and from heartworm risk regions, before using the product, a veterinary consultation is advised to exclude the presence of any concurrent infestation of Dirofilaria immitis. In the case of a positive diagnosis, adulticidal therapy is indicated before administering the product. Echinococcosis represents a hazard for humans. In case of Echinococcosis, specific guidelines on the treatment and follow up and on the safeguard of persons have to be followed. Experts or institutes of parasitology should be consulted. No studies have been performed with severely debilitated dogs or individuals with seriously compromised kidney or liver function. The product is not recommended for such animals or only according to a benefit/risk assessment by the responsible veterinarian. In dogs less than 4 weeks old, tape worm infection is unusual. Treatment of animals less than 4 weeks old with a combination product may therefore not be necessary. Operator warnings: Wash hands after use. In the event of accidental ingestion of the tablets, particularly by a child, seek medical advice immediately and show the package leaflet or the label to the doctor. Part tablets should be returned to the open blister pocket and inserted into the outer carton.

Adverse reactions

On very rare occasions, systemic signs (such as lethargy), neurological signs (such as muscle tremors and ataxia) and/or gastrointestinal signs (such as emesis, diarrhoea, anorexia and drooling) have been observed in dogs after administration of the combination of milbemycin oxime and praziquantel.

Use during pregnancy, lactation or lay

The product may be used in breeding dogs including pregnant and lactating bitches.

Interactions

No interactions were observed when the recommended dose of the macrocyclic lactone selamectin was administered during treatment with the combination of milbemycin oxime and praziquantel at the recommended dose. In the absence of further studies, caution should be taken in the case of concurrent use of the product and other macrocyclic lactones. Also, no such studies have been performed with reproducing animals.

Amounts to be administered and administration route

Oral use. Dogs should be weighed to ensure accurate dosing. Minimum recommended dose rate: 0.5 mg of milbemycin oxime and 5 mg of praziquantel per kg are given once orally. The product should be administered with or after some food. Depending on the body weight of the dog, the practical dosing is as follows:

Body weight Tablets
0.5 - 1 kg ½ tablet
> 1- 5 kg 1 tablet
> 5 - 10 kg 2 tablets


In cases when heartworm disease prevention is used and at the same time treatment against tapeworm is required, the product can replace the monovalent product for the prevention of heartworm disease. For treatment of Angiostrongylus vasorum infections, milbemycin oxime should be given four times at weekly intervals. It is recommended, where concomitant treatment against cestodes is indicated, to treat once with the product and continue with the monovalent product containing milbemycin oxime alone, for the remaining three weekly treatments. In endemic areas administration of the product every four weeks will prevent angiostrongylosis by reducing immature adult (L5) and adult parasite burden, where concomitant treatment against cestodes is indicated. For the treatment of Thelazia callipaeda, milbemycin oxime should be given in 2 treatments, seven days apart. Where concomitant treatment against cestodes is indicated, the product can replace the monovalent product containing milbemycin oxime alone.

Overdose

No data available.

Withdrawal periods

Not applicable

Pharmacological particulars

Pharmacotherapeutic group: Endectocides, Macrocyclic lactones ATCVet code: QP54AB51

Pharmacodynamic properties

Milbemycin oxime belongs to the group of macrocyclic lactones, isolated from the fermentation of Streptomyces hygroscopicus var. aureolacrimosus. It is active against mites, against larval and adult stages of nematodes as well as against larvae of Dirofilaria immitis. The activity of milbemycin is related to its action on invertebrate neurotransmission: Milbemycin oxime, like avermectins and other milbemycins, increases nematode and insect membrane permeability to chloride ions via glutamate-gated chloride ion channels (related to vertebrate GABAA and glycine receptors). This leads to hyperpolarisation of the neuromuscular membrane and flaccid paralysis and death of the parasite. Praziquantel is an acylated pyrazino-isoquinoline derivative. Praziquantel is active against cestodes and trematodes. It modifies the permeability for calcium (influx of Ca2+) in the membranes of the parasite inducing an imbalance in the membrane structures, leading to membrane depolarisation and almost instantaneous contraction of the musculature (tetany), rapid vacuolization of the syncytial tegument and subsequent tegumental disintegration (blebbing), resulting in easier expulsion from the gastrointestinal tract or death of the parasite.

Pharmacokinetic properties

After oral administration of praziquantel in the dog, after a small amount of food, peak serum levels of parent are rapidly attained (Tmax approximately 0.25-2.5 hours) and decline quickly (t1/2 approximately 1 hour); there is a substantial hepatic first-pass effect, with very rapid and almost complete hepatic biotransformation, principally to monohydroxylated (also some di- and tri-hydroxylated) derivatives, which are mostly glucuronide and/or sulfate conjugated before excretion. Plasma binding is about 80%. Excretion is fast and complete (about 90% in 2 days); the principal route of elimination is renal. After oral administration of milbemycin oxime in dogs, after a small amount of food, peak plasma levels occur at about 0.75-3.5 hours, and decline with a half-life of the unmetabolised milbemycin oxime of 1-4 days. Bioavailability is about 80%. In the rat, metabolism appears to be complete although slow, since unchanged milbemycin oxime has not been found in urine or faeces. Main metabolites in the rat are monohydroxylated derivatives, attributable to hepatic biotransformation. In addition to relatively high liver concentrations, there is some concentration in fat, reflecting its lipophilicity.

Pharmaceutical particulars

Excipients

Cellulose, microcrystalline Lactose monohydrate Povidone Croscarmellose sodium Silica, colloidal anhydrous Meat Flavour Yeast powder Magnesium stearate

Major incompatibilities

Not applicable.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life for halved tablets after first opening the immediate packaging: 6 months.

Special precautions for storage

Store in the original package in order to protect from moisture.This veterinary medicinal product does not require any special temperature storage conditions. Halved tablets should be stored below 25°C in the original blister and be used for the next administration. Keep the blister in the outer carton.

Immediate packaging

Blister packs consisting of cold formed OPA/Al/PVC foil and aluminium foil. Box with 1 blister of 2 tablets. Box with 1 blister of 4 tablets. Box with 12 blisters, each blister contains 4 tablets. Not all pack sizes may be marketed.

Disposal

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

Marketing Authorisation Holder (if different from distributor)

KRKA, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia

Marketing Authorisation Number

Vm 01656/4097

Significant changes

Date of the first authorisation or date of renewal

18 November 2014.

Date of revision of the text

July 2015.

Any other information

For animal treatment only. Keep out of the sight and reach of children

Legal category

Legal category: POM-V

Milquantel 12.5 mg/125 mg tablets for dogs weighing at least 5 kg

Species: Dogs Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for dogs Active ingredient: Milbemycin Oxime Product:Milquantel 12.5 mg/125 mg tablets for dogs weighing at least 5 kg Product index: Milquantel 12.5 mg/125 mg tablets for dogs weighing at least 5 kg

Qualitative and quantitative composition

Each tablet contains: Active substances: Milbemycin oxime 12.5 mg Praziquantel 125.0 mg Excipients: For the full list of excipients, see section "Pharmaceutcal particulars".

Pharmaceutical form

Tablet. Yellowish-white with brown spots, round, slightly biconvex tablets.

Clinical particulars

Target species

Dogs (weighing at least 5 kg).

Indications for use

In dogs: treatment of mixed infections by adult cestodes and nematodes of the following species: - Cestodes: Dipylidium caninum Taenia spp. Echinococcus spp. Mesocestoides spp. - Nematodes: Ancylostoma caninum Toxocara canis Toxascaris leonina Trichuris vulpis Crenosoma vulpis (Reduction of the level of infection) Angiostrongylus vasorum (Reduction of the level of infection by immature adult (L5) and adult parasite stages; see specific treatment and disease prevention schedules under section “Amounts to be administered and administration route”. Thelazia callipaeda (see specific treatment schedule under section “Amounts to be administered and administration route”. The product can also be used in the prevention of heartworm disease (Dirofilaria immitis) if concomitant treatment against cestodes is indicated.

Contra-indications

Do not use in dogs weighing less than 5 kg. Do not use in case of hypersensitivity to the active substances or to any of the excipients. See also section " Special precautions for use".

Special warnings for each target species

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

Special precautions for use

Special precautions for use in animals Studies with milbemycin oxime indicate that the margin of safety in certain dogs of Collie or related breeds is less than in other breeds. In these dogs, the recommended dose should be strictly observed. The tolerance of the product in young puppies from these breeds has not been investigated. Clinical signs in Collies are similar to those seen in the general dog population when overdosed (see in section "Overdose"). Treatment of dogs with a high number of circulating microfilariae can sometimes lead to the appearance of hypersensitivity reactions, such as pale mucous membranes, vomiting, trembling, laboured breathing or excessive salivation. These reactions are associated with the release of proteins from dead or dying microfilariae and are not a direct toxic effect of the product. The use in dogs suffering from microfilaremia is thus not recommended. In heartworm risk-areas, or in the case it is known that a dog has been travelling to and from heartworm risk regions, before using the product, a veterinary consultation is advised to exclude the presence of any concurrent infestation of Dirofilaria immitis. In the case of a positive diagnosis, adulticidal therapy is indicated before administering the product. Echinococcosis represents a hazard for humans. In case of Echinococcosis, specific guidelines on the treatment and follow up and on the safeguard of persons have to be followed. Experts or institutes of parasitology should be consulted. No studies have been performed with severely debilitated dogs or individuals with seriously compromised kidney or liver function. The product is not recommended for such animals or only according to a benefit/risk assessment by the responsible veterinarian. In dogs less than 4 weeks old, tape worm infection is unusual. Treatment of animals less than 4 weeks old with a combination product may therefore not be necessary. Operator warnings: Wash hands after use. In the event of accidental ingestion of the tablets, particularly by a child, seek medical advice immediately and show the package leaflet or the label to the doctor.

Adverse reactions

On very rare occasions, systemic signs (such as lethargy), neurological signs (such as muscle tremors and ataxia) and/or gastrointestinal signs (such as emesis, diarrhoea, anorexia and drooling) have been observed in dogs after administration of the combination of milbemycin oxime and praziquantel.

Use during pregnancy, lactation or lay

The product may be used in breeding dogs including pregnant and lactating bitches.

Interactions

No interactions were observed when the recommended dose of the macrocyclic lactone selamectin was administered during treatment with the combination of milbemycin oxime and praziquantel at the recommended dose. In the absence of further studies, caution should be taken in the case of concurrent use of the product and other macrocyclic lactones. Also, no such studies have been performed with reproducing animals.

Amounts to be administered and administration route

Oral use. Dogs should be weighed to ensure accurate dosing. Minimum recommended dose rate: 0.5 mg of milbemycin oxime and 5 mg of praziquantel per kg are given once orally. The product should be administered with or after some food. Depending on the body weight of the dog, the practical dosing is as follows:

Body weight Tablets
5 - 25 kg 1 tablet
> 25 - 50 kg 2 tablets
> 50 - 75 kg 3 tablets


In cases when heartworm disease prevention is used and at the same time treatment against tapeworm is required, the product can replace the monovalent product for the prevention of heartworm disease. For treatment of Angiostrongylus vasorum infections, milbemycin oxime should be given four times at weekly intervals. It is recommended, where concomitant treatment against cestodes is indicated, to treat once with the product and continue with the monovalent product containing milbemycin oxime alone, for the remaining three weekly treatments. In endemic areas administration of the product every four weeks will prevent angiostrongylosis by reducing immature adult (L5) and adult parasite burden, where concomitant treatment against cestodes is indicated. For the treatment of Thelazia callipaeda, milbemycin oxime should be given in 2 treatments, seven days apart. Where concomitant treatment against cestodes is indicated, the product can replace the monovalent product containing milbemycin oxime alone.

Overdose

No data available.

Withdrawal periods

Not applicable

Pharmacological particulars

Pharmacotherapeutic group: Endectocides, Macrocyclic lactones ATCVet code: QP54AB51

Pharmacodynamic properties

Milbemycin oxime belongs to the group of macrocyclic lactones, isolated from the fermentation of Streptomyces hygroscopicus var. aureolacrimosus. It is active against mites, against larval and adult stages of nematodes as well as against larvae of Dirofilaria immitis. The activity of milbemycin is related to its action on invertebrate neurotransmission: Milbemycin oxime, like avermectins and other milbemycins, increases nematode and insect membrane permeability to chloride ions via glutamate-gated chloride ion channels (related to vertebrate GABAA and glycine receptors). This leads to hyperpolarisation of the neuromuscular membrane and flaccid paralysis and death of the parasite. Praziquantel is an acylated pyrazino-isoquinoline derivative. Praziquantel is active against cestodes and trematodes. It modifies the permeability for calcium (influx of Ca2+) in the membranes of the parasite inducing an imbalance in the membrane structures, leading to membrane depolarisation and almost instantaneous contraction of the musculature (tetany), rapid vacuolization of the syncytial tegument and subsequent tegumental disintegration (blebbing), resulting in easier expulsion from the gastrointestinal tract or death of the parasite.

Pharmacokinetic properties

After oral administration of praziquantel in the dog, after a small amount of food, peak serum levels of parent are rapidly attained (Tmax approximately 0.25-2.5 hours) and decline quickly (t1/2 approximately 1 hour); there is a substantial hepatic first-pass effect, with very rapid and almost complete hepatic biotransformation, principally to monohydroxylated (also some di- and tri-hydroxylated) derivatives, which are mostly glucuronide and/or sulfate conjugated before excretion. Plasma binding is about 80%. Excretion is fast and complete (about 90% in 2 days); the principal route of elimination is renal. After oral administration of milbemycin oxime in dogs, after a small amount of food, peak plasma levels occur at about 0.75-3.5 hours, and decline with a half-life of the unmetabolised milbemycin oxime of 1-4 days. Bioavailability is about 80%. In the rat, metabolism appears to be complete although slow, since unchanged milbemycin oxime has not been found in urine or faeces. Main metabolites in the rat are monohydroxylated derivatives, attributable to hepatic biotransformation. In addition to relatively high liver concentrations, there is some concentration in fat, reflecting its lipophilicity.

Pharmaceutical particulars

Excipients

Cellulose, microcrystalline Lactose monohydrate Povidone Croscarmellose sodium Silica, colloidal anhydrous Meat Flavour Yeast powder Magnesium stearate

Major incompatibilities

Not applicable.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Special precautions for storage

Store in the original package in order to protect from moisture.This veterinary medicinal product does not require any special temperature storage conditions.

Immediate packaging

Blister packs consisting of cold formed OPA/Al/PVC foil and aluminium foil. Box with 1 blister of 2 tablets. Box with 1 blister of 4 tablets. Box with 12 blisters, each blister contains 4 tablets. Not all pack sizes may be marketed.

Disposal

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

Marketing Authorisation Holder (if different from distributor)

KRKA, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia

Marketing Authorisation Number

Vm 01656/4098

Significant changes

Date of the first authorisation or date of renewal

18 November 2014.

Date of revision of the text

July 2015.

Any other information

For animal treatment only. Keep out of the sight and reach of children.

Legal category

Legal category: POM-V

Milquantel 4 mg/10 mg film-coated tablets for small cats and kittens weighing at least 0.5 kg

Species: Cats Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for cats Active ingredient: Milbemycin Oxime Product:Milquantel 4 mg/10 mg film-coated tablets for small cats and kittens weighing at least 0.5 kg Product index: Milquantel 4 mg/10 mg film-coated tablets for small cats and kittens weighing at least 0.5 kg

Qualitative and quantitative composition

Each tablet contains: Active substances: Each film-coated tablet contains: Active substances: Milbemycin oxime 4 mg Praziquantel 10 mg Excipients: Iron Oxide, yellow (E172) 0.20 mg Titanium dioxide (E171) 0.51 mg For the full list of excipients, see section "Pharmaceutical particulars".

Pharmaceutical form

Film-coated tablet. Brown yellow, oval, biconvex film-coated tablets with score line on one side. The tablets can be divided into equal halves.

Clinical particulars

Target species

Cats (small cats and kittens).

Indications for use

In cats: treatment of mixed infections by immature and adult cestodes and nematodes of the following species: - Cestodes: Dipylidium caninum Taenia spp. Echinococcus multilocularis - Nematodes: Ancylostoma tubaeforme Toxocara cati Prevention of heartworm disease (Dirofilaria immitis) if concomitant treatment against cestodes is indicated.

Contra-indications

Do not use in cats of less than 6 weeks of age and/or weighing less than 0.5 kg. Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

Special warnings for each target species

It is recommended to treat all the animals living in the same household concomitantly. In order to develop an effective worm control programme local epidemiological information and the risk of exposure of the cat should be taken into account. When D. caninum infection is present, concomitant treatment against intermediate hosts, such as fleas and lice, should be considered to prevent re-infection. Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

Special precautions for use

Special precautions for use in animals No studies have been performed with severely debilitated cats or individuals with seriously compromised kidney or liver function. The product is not recommended for such animals or only according to a benefit/risk assessment by the responsible veterinarian. Operator warnings: In the event of accidental ingestion of the tablets, particularly by a child, seek medical advice immediately and show the package leaflet or the label to the doctor. Wash hands after use. Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.

Adverse reactions

On very rare occasions, especially in young cats, systemic signs (such as lethargy), neurological signs (such as ataxia and muscle tremors) and/or gastrointestinal signs (such as emesis and diarrhoea) have been observed after administration of the combination milbemycin/praziquantel.

Use during pregnancy, lactation or lay

The veterinary medicinal product can be used in breeding cats including pregnant and lactating queens.

Interactions

The concurrent use of the milbemycin oxime and praziquantel with selamectin is well tolerated. No interactions were observed when the recommended dose of the macrocyclic lactone selamectin was administered during treatment with milbemycin oxime and praziquantel at the recommended dose. In the absence of further studies, caution should be taken in the case of concurrent use of the product and other macrocyclic lactones. Also, no such studies have been performed with reproducing animals.

Amounts to be administered and administration route

Oral use. Animals should be weighed to ensure accurate dosing. Minimum recommended dose rate: 2 mg of milbemycin oxime and 5 mg of praziquantel per kg are given orally as a single dose. The product should be administered with or after some food. Doing so ensures optimum protection against heartworm disease. Depending on the body weight of the cat, the practical dosing is as follows:

Body weight Tablets
0.5 - 1 kg ½ tablet
> 1- 2 kg 1 tablet

The product can be inserted into a programme for prevention of heartworm disease if at the same time treatment against tapeworms is indicated. The product has a duration of heartworm prevention of one month. For regular prevention of heartworm disease the use of a monosubstance is preferred.

Overdose

In case of overdose, in addition to signs observed at the recommended dose (see section "Adverse reactions"), drooling may be observed. This sign will usually disappear spontaneously within a day.

Withdrawal periods

Not applicable

Pharmacological particulars

Pharmacotherapeutic group: Endectocides, Macrocyclic lactones, milbemycin combinations ATCVet code: QP54AB51

Pharmacodynamic properties

Milbemycin oxime belongs to the group of macrocyclic lactones, isolated from the fermentation of Streptomyces hygroscopicus var. aureolacrimosus. It is active against mites, against larval and adult stages of nematodes as well as against larvae of Dirofilaria immitis. The activity of milbemycin is related to its action on invertebrate neurotransmission: Milbemycin oxime, like avermectins and other milbemycins, increases nematode and insect membrane permeability to chloride ions via glutamate-gated chloride ion channels (related to vertebrate GABAA and glycine receptors). This leads to hyperpolarisation of the neuromuscular membrane and flaccid paralysis and death of the parasite. Praziquantel is an acylated pyrazino-isoquinoline derivative. Praziquantel is active against cestodes and trematodes. It modifies the permeability for calcium (influx of Ca2+) in the membranes of the parasite inducing an imbalance in the membrane structures, leading to membrane depolarisation and almost instantaneous contraction of the musculature (tetany), rapid vacuolization of the syncytial tegument and subsequent tegumental disintegration (blebbing), resulting in easier expulsion from the gastrointestinal tract or death of the parasite.

Pharmacokinetic properties

In cats under fed condition, praziquantel reaches peak plasma concentrations within 3 hours after oral administration. The half life of elimination is around 2 hours. After oral administration in cats under fed condition, milbemycin oxime reaches peak plasma concentrations within 5 hours. The half life of elimination is around 43 hours (± 21 hours). In the rat, metabolism appears to be complete although slow, since unchanged milbemycin oxime has not been found in urine or feces. Main metabolites in the rat are monohydroxylated derivatives, attributable to hepatic biotransformation. In addition to relatively high liver concentrations, there is some concentration in fat, reflecting its lipophilicity.

Pharmaceutical particulars

Excipients

Core: Cellulose, microcrystalline Lactose monohydrate Povidone Croscarmellose sodium Silica, colloidal anhydrous Magnesium stearate Coat: Hypromellose Talc Propylene glycol Titanium dioxide (E171) Meat Flavour Yeast powder Iron Oxide, yellow (E172)

Major incompatibilities

Not applicable.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life for halved tablets after first opening the immediate packaging: 3 months.

Special precautions for storage

Store in the original package in order to protect from moisture. Halved tablets should be stored below 25°C in the original blister and be used for the next administration.

Immediate packaging

Blister packs consisting of cold formed OPA/Al/PVC foil and aluminium foil. Box with 1 blister of 2 tablets. Box with 1 blister of 4 tablets. Box with 12 blisters, each blister contains 4 tablets. Not all pack sizes may be marketed.

Disposal

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

Marketing Authorisation Holder (if different from distributor)

KRKA, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia

Marketing Authorisation Number

Vm 01656/4100

Significant changes

Date of the first authorisation or date of renewal

6 May 215.

Date of revision of the text

July 2015.

Any other information

For animal treatment only. Keep out of the sight and reach of children.

Legal category

Legal category: POM-V

Milquantel 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg

Species: Cats Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for cats Active ingredient: Milbemycin Oxime Product:Milquantel 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg Product index: Milquantel 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg

Qualitative and quantitative composition

Each tablet contains: Active substances: Each film-coated tablet contains: Active substances: Milbemycin oxime 16 mg Praziquantel 40 mg Excipients: Iron Oxide, yellow (E172) 0.20 mg Titanium dioxide (E171) 0.51 mg For the full list of excipients, see section "Pharmaceutical particulars".

Pharmaceutical form

Film-coated tablet. Brown red, oval, biconvex film-coated tablets with score line on one side. The tablets can be divided into equal halves.

Clinical particulars

Target species

Cats (weighing at least 2 kg).

Indications for use

In cats: treatment of mixed infections by immature and adult cestodes and nematodes of the following species: - Cestodes: Dipylidium caninum Taenia spp. Echinococcus multilocularis - Nematodes: Ancylostoma tubaeforme Toxocara cati Prevention of heartworm disease (Dirofilaria immitis) if concomitant treatment against cestodes is indicated.

Contra-indications

Do not use in cats weighing less than 2 kg. Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

Special warnings for each target species

It is recommended to treat all the animals living in the same household concomitantly. In order to develop an effective worm control programme local epidemiological information and the living conditions of the cat should be taken into account. When D. caninum infection is present, concomitant treatment against intermediate hosts, such as fleas and lice, should be considered to prevent re-infection Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

Special precautions for use

Special precautions for use in animals No studies have been performed with severely debilitated cats or individuals with seriously compromised kidney or liver function. The product is not recommended for such animals or only according to a benefit/risk assessment by the responsible veterinarian. Operator warnings: In the event of accidental ingestion of the tablets, particularly by a child, seek medical advice immediately and show the package leaflet or the label to the doctor. Wash hands after use. Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.

Adverse reactions

In very rare occasions, especially in young cats, systemic signs (such as lethargy), neurological signs (such as ataxia and muscle tremors) and/or gastrointestinal signs (such as emesis and diarrhoea) have been observed after administration of the combination milbemycin/praziquantel.

Use during pregnancy, lactation or lay

The veterinary medicinal product can be used in breeding cats including pregnant and lactating queens.

Interactions

The concurrent use of the milbemycin oxime and praziquantel with selamectin is well tolerated. No interactions were observed when the recommended dose of the macrocyclic lactone selamectin was administered during treatment with milbemycin oxime and praziquantel at the recommended dose. In the absence of further studies, caution should be taken in the case of concurrent use of the product and other macrocyclic lactones. Also, no such studies have been performed with reproducing animals.

Amounts to be administered and administration route

Animals should be weighed to ensure accurate dosing. Minimum recommended dose rate: 2 mg of milbemycin oxime and 5 mg of praziquantel per kg are given orally as a single dose. The product should be administered with or after some food. Doing so ensures optimum protection against heartworm disease. Depending on the body weight of the cat, the practical dosing is as follows:

Body weight Tablets
2 - 4 kg ½ tablet
> 4- 8 kg 1 tablet
>8 - 12 kg 1½ tablet

The product can be inserted into a programme for prevention of heartworm disease if at the same time treatment against tapeworms is indicated. The product has a duration of heartworm prevention of one month. For regular prevention of heartworm disease the use of a monosubstance is preferred.

Overdose

In case of overdose, in addition to signs observed at the recommended dose (see section "Adverse reactions"), drooling may be observed. This sign will usually disappear spontaneously within a day.

Withdrawal periods

Not applicable

Pharmacological particulars

Pharmacotherapeutic group: Endectocides, Macrocyclic lactones, milbemycin combinations ATCVet code: QP54AB51

Pharmacodynamic properties

Milbemycin oxime belongs to the group of macrocyclic lactones, isolated from the fermentation of Streptomyces hygroscopicus var. aureolacrimosus. It is active against mites, against larval and adult stages of nematodes as well as against larvae of Dirofilaria immitis. The activity of milbemycin is related to its action on invertebrate neurotransmission: Milbemycin oxime, like avermectins and other milbemycins, increases nematode and insect membrane permeability to chloride ions via glutamate-gated chloride ion channels (related to vertebrate GABAA and glycine receptors). This leads to hyperpolarisation of the neuromuscular membrane and flaccid paralysis and death of the parasite. Praziquantel is an acylated pyrazino-isoquinoline derivative. Praziquantel is active against cestodes and trematodes. It modifies the permeability for calcium (influx of Ca2+) in the membranes of the parasite inducing an imbalance in the membrane structures, leading to membrane depolarisation and almost instantaneous contraction of the musculature (tetany), rapid vacuolization of the syncytial tegument and subsequent tegumental disintegration (blebbing), resulting in easier expulsion from the gastrointestinal tract or death of the parasite.

Pharmacokinetic properties

In cats under fed condition, praziquantel reaches peak plasma concentrations within 3 hours after oral administration. The half life of elimination is around 2 hours. After oral administration in cats under fed condition, milbemycin oxime reaches peak plasma concentrations within 5 hours. The half life of elimination is around 43 hours (± 21 hours). In the rat, metabolism appears to be complete although slow, since unchanged milbemycin oxime has not been found in urine or feces. Main metabolites in the rat are monohydroxylated derivatives, attributable to hepatic biotransformation. In addition to relatively high liver concentrations, there is some concentration in fat, reflecting its lipophilicity.

Pharmaceutical particulars

Excipients

Core: Cellulose, microcrystalline Lactose monohydrate Povidone Croscarmellose sodium Silica, colloidal anhydrous Magnesium stearate Coat: Hypromellose Talc Propylene glycol Titanium dioxide (E171) Meat Flavour Yeast powder Iron Oxide, red (E172)

Major incompatibilities

Not applicable.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life for halved tablets after first opening the immediate packaging: 6 months.

Special precautions for storage

Store in the original package in order to protect from moisture. Halved tablets should be stored below 25°C in the original blister and be used for the next administration.

Immediate packaging

Blister packs consisting of cold formed OPA/Al/PVC foil and aluminium foil. Box with 1 blister of 2 tablets. Box with 1 blister of 4 tablets. Box with 12 blisters, each blister contains 4 tablets. Not all pack sizes may be marketed.

Disposal

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

Marketing Authorisation Holder (if different from distributor)

KRKA, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia

Marketing Authorisation Number

Vm 01656/4099

Significant changes

Date of the first authorisation or date of renewal

18 March 2015.

Date of revision of the text

July 2015.

Any other information

For animal treatment only. Keep out of the sight and reach of children.

Legal category

Legal category: POM-V

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Milquantel

4th Sep 2017
Jean

Does this cover lungworms in dogs?only

  • Veterinary Advisor

We are most concerned about the lungworm Angiostrongylus Vasorum which Milquantel is indeed effective against.