Selection of 3 products from
£2.29 to £6.49
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
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".
Tablet. Yellowish-white with brown spots, oval, biconvex tablets scored on one side. The tablets can be divided into equal halves.
Dogs (small dogs and puppies).
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.
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".
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
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.
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.
The product may be used in breeding dogs including pregnant and lactating bitches.
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.
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.
No data available.
Not applicable
Pharmacotherapeutic group: Endectocides, Macrocyclic lactones ATCVet code: QP54AB51
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.
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.
Cellulose, microcrystalline Lactose monohydrate Povidone Croscarmellose sodium Silica, colloidal anhydrous Meat Flavour Yeast powder Magnesium stearate
Not applicable.
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.
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.
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.
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.
KRKA, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia
Vm 01656/4097
18 November 2014.
July 2015.
For animal treatment only. Keep out of the sight and reach of children
Legal category: POM-V
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
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".
Tablet. Yellowish-white with brown spots, round, slightly biconvex tablets.
Dogs (weighing at least 5 kg).
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.
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".
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
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.
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.
The product may be used in breeding dogs including pregnant and lactating bitches.
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.
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.
No data available.
Not applicable
Pharmacotherapeutic group: Endectocides, Macrocyclic lactones ATCVet code: QP54AB51
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.
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.
Cellulose, microcrystalline Lactose monohydrate Povidone Croscarmellose sodium Silica, colloidal anhydrous Meat Flavour Yeast powder Magnesium stearate
Not applicable.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Store in the original package in order to protect from moisture.This veterinary medicinal product does not require any special temperature storage conditions.
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.
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.
KRKA, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia
Vm 01656/4098
18 November 2014.
July 2015.
For animal treatment only. Keep out of the sight and reach of children.
Legal category: POM-V
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
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".
Film-coated tablet. Brown yellow, oval, biconvex film-coated tablets with score line on one side. The tablets can be divided into equal halves.
Cats (small cats and kittens).
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.
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.
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 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.
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.
The veterinary medicinal product can be used in breeding cats including pregnant and lactating queens.
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.
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.
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.
Not applicable
Pharmacotherapeutic group: Endectocides, Macrocyclic lactones, milbemycin combinations ATCVet code: QP54AB51
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.
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.
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)
Not applicable.
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.
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.
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.
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.
KRKA, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia
Vm 01656/4100
6 May 215.
July 2015.
For animal treatment only. Keep out of the sight and reach of children.
Legal category: POM-V
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
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".
Film-coated tablet. Brown red, oval, biconvex film-coated tablets with score line on one side. The tablets can be divided into equal halves.
Cats (weighing at least 2 kg).
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.
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.
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 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.
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.
The veterinary medicinal product can be used in breeding cats including pregnant and lactating queens.
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.
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.
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.
Not applicable
Pharmacotherapeutic group: Endectocides, Macrocyclic lactones, milbemycin combinations ATCVet code: QP54AB51
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.
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.
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)
Not applicable.
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.
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.
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.
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.
KRKA, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia
Vm 01656/4099
18 March 2015.
July 2015.
For animal treatment only. Keep out of the sight and reach of children.
Legal category: POM-V
All prices include VAT where applicable.
SUMMARY OF PRODUCT CHARACTERISTICS
Milquantel 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg
Each film-coated tablet contains: Active substances: Milbemycin oxime 16 mg Praziquantel 40 mg
Excipients: Iron Oxide, red (E172) 0.20 mg Titanium dioxide (E171) 0.51 mg
For the full list of excipients, see section 6.1.
Film-coated tablet. Brown red, oval, biconvex film-coated tablets with score line on one side. The tablets can be divided into equal halves.
4.1 Target species
Cats (weighing at least 2 kg).
4.2 Indications for use, specifying the target species
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.
4.3 Contraindications
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.
4.4 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, and it is recommended to seek professional advice.
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.
4.5 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. As the tablets are flavoured, they should be stored in a safe place out of the reach of animals.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
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. Part tablets should be returned to the open blister pocket and inserted into the outer carton.
Other precautions
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.
4.6 Adverse reactions (frequency and seriousness)
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.
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 veterinary medicinal product can be used in breeding cats including pregnant and lactating queens.
4.8 Interaction with other medicinal products and other forms of interaction
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.
4.9 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 bodyweight of the cat, the practical dosing is as follows:
Weight Film-coated tablets for cats 2 - 4 kg ½ tablet
4 - 8 kg 1 tablet 8 - 12 kg 1½ tablets
The product can be inserted into a programme for prevention of heartworm disease if at the same time treatment against tapeworms is indicated. For the prevention of heartworm disease: the product kills Dirofilaria immitis larvae up to one month after their transmission by mosquitoes.. For regular prevention of heartworm disease the use of a monosubstance is preferred.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of overdose, in addition to signs observed at the recommended dose (see 4.6), drooling may be observed. This sign will usually disappear spontaneously within a day.
4.11 Withdrawal period(s)
Not applicable.
Pharmacotherapeutic group: Endectocides, Macrocyclic lactones, milbemycin, combinations ATCvet code: QP54AB51
5.1 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.
5.2 Pharmacokinetic particulars
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. 6. PHARMACEUTICAL PARTICULARS
6.1 List of 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)
6.2 Major incompatibilities
Not applicable.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years Shelf life for halved tablets after first opening the immediate packaging: 6 months.
6.4. 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.
6.5 Nature and composition of 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 of 4 tablets. 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. The product should not enter water courses as this may be dangerous for fish and other aquatic organisms. 7. MARKETING AUTHORISATION HOLDER
KRKA, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia
Vm 01656/4099
18 March 2015
July 2018
Approved: 31 July 2018
SUMMARY OF PRODUCT CHARACTERISTICS
Milquantel 4 mg/10 mg film-coated tablets for small cats and kittens weighing at least 0.5 kg
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 6.1.
Film-coated tablet. Brown yellow, oval, biconvex film-coated tablets with score line on one side. The tablets can be divided into equal halves.
4.1 Target species
Cats (small cats and kittens).
4.2 Indications for use, specifying the target species
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.
4.3 Contraindications
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.
4.4 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, and it is recommended to seek professional advice.
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.
4.5 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. As the tablets are flavoured, they should be stored in a safe place out of the reach of animals.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
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. Part tablets should be returned to the open blister pocket and inserted into the outer carton.
Other precautions
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.
4.6 Adverse reactions (frequency and seriousness)
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.
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 veterinary medicinal product can be used in breeding cats including pregnant and lactating queens.
4.8 Interaction with other medicinal products and other forms of interaction
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.
4.9 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 bodyweight of the cat, the practical dosing is as follows:
Weight Film-coated tablets for small cats and kittens 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. For the prevention of heartworm disease: the product kills Dirofilaria immitis larvae up to one month after their transmission by mosquitoes. For regular prevention of heartworm disease the use of a monosubstance is preferred.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of overdose, in addition to signs observed at the recommended dose (see 4.6), drooling may be observed. This sign will usually disappear spontaneously within a day.
4.11 Withdrawal period(s)
Not applicable.
Pharmacotherapeutic group: Endectocides, Macrocyclic lactones, milbemycin, combinations ATCvet code: QP54AB51
5.1 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.
5.2 Pharmacokinetic particulars
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. 6. PHARMACEUTICAL PARTICULARS
6.1 List of 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)
6.2 Major incompatibilities
Not applicable.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years Shelf life for halved tablets after first opening the immediate packaging: 3 months.
6.4 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.
6.5 Nature and composition of 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 of 4 tablets. 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. The product should not enter water courses as this may be dangerous for fish and other aquatic organisms. 7. MARKETING AUTHORISATION HOLDER
KRKA, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia
Vm 01656/4100
06 May 2015
July 2018
Approved: 31 July 2018
SUMMARY OF PRODUCT CHARACTERISTICS
Milquantel 2.5 mg/25 mg tablets for small dogs and puppies weighing at least 0.5 kg
Each tablet contains:
Active substances:
Milbemycin oxime 2.5 mg Praziquantel 25.0 mg
Excipients:
For the full list of excipients, see section 6.1.
Tablet. Yellowish-white with brown spots, oval, biconvex tablets scored on one side. The tablets can be divided into equal halves.
4.1 Target species
Dogs (small dogs and puppies).
4.2 Indications for use, specifying the target species
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 4.9 “Amounts to be administered and administration route”).
Thelazia callipaeda (see specific treatment schedule under section 4.9 “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.
4.3 Contraindications
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 4.5 "Special precautions for use".
4.4 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. It is recommended to treat all the animals in the same household concomitantly. In order to develop an effective worm control programme local epidemiological information and the risk of exposure of the dog should be taken into account, and it is recommended to seek professional advice. When D. caninum infection is present, concomitant treatment against intermediate hosts, such as fleas and lice, should be considered to prevent re-infection.
4.5 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.
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.
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.
As the tablets are flavoured, they should be stored in a safe place out of the reach of animals.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
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. Part tablets should be returned to the open blister pocket and inserted into the outer carton.
Other precautions
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.
4.6 Adverse reactions (frequency and seriousness)
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.
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 product may be used in breeding dogs including pregnant and lactating bitches.
4.8 Interaction with other medicinal products and other forms of interaction
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.
4.9 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 bodyweight of the dog, the practical dosing is as follows:
Body weight Tablets 0.5 – 1 kg 1/2 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No data available.
4.11 Withdrawal period(s)
Not applicable.
Pharmacotherapeutic group: Endectocides, Macrocyclic lactones, milbemycin, combinations ATCvet code: QP54AB51
5.1 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.
5.2 Pharmacokinetic particulars
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.
6.1 List of excipients
Cellulose, microcrystalline Lactose monohydrate Povidone Croscarmellose sodium Silica, colloidal anhydrous Meat Flavour Yeast powder Magnesium stearate
6.2 Major incompatibilities
Not applicable.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years Shelf life for halved tablets after first opening the immediate packaging: 6 months.
6.4 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.
6.5 Nature and composition of 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.
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. The product should not enter water courses as this may be dangerous for fish and other aquatic organisms.
KRKA, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia
Vm 01656/4097
18 November 2014
August 2018
Approved: 01 August 2018
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.
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.
Due to restrictions aerosols can't be sent by Royal Mail. We appreciate your understanding.
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.
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.
Below are some recent questions we've received regarding Milquantel Tablets for Dogs & Cats, including answers from our team.
Jean
Does this cover lungworms in dogs?only
We are most concerned about the lungworm Angiostrongylus Vasorum which Milquantel is indeed effective against.
