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Milbemax Chewable Tablets for dogs |
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Treatment of mixed infections by adult cestodes and nematodes of the following species: Cestodes: Dipylidium caninum, Taenia spp., Echinococcus spp., Mesocestoides spp Nematodes: Anclystoma caninum, Toxocara canis, Toxascaris leonina, Trichuris vulpis. Crenosoma vulpis(reduction of the level of infection), Angiostrongylus vasorum (reduction of the level of infection; see specific treatment schedule under Dosage and administration). The product can also be used in the prevention of heartworm disease (Dirofilaria immitis), if concomitant treatment against cestodes is indicated. Milbemax can be used in pregnant and lactating bitches and in breeding animals.
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Presentation
MILBEMAX chewable tablets for small dogs and puppies: Oval shaped, dark brown, chewable tablet, containing milbemycin oxime 2.5 mg and praziquantel 25.0 mg.
MILBEMAX chewable tablets for dogs: Oval shaped, dark brown, chewable tablet, containing milbemycin oxime 12.5 mg and praziquantel 125.0 mg.
Uses
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: Anclystoma caninum, Toxocara canis, Toxascaris leonina, Trichuris vulpis.
Crenosoma vulpis(reduction of the level of infection),
Angiostrongylus vasorum (reduction of the level of infection; see specific treatment schedule under Dosage and administration).
The product can also be used in the prevention of heartworm disease (Dirofilaria immitis), if concomitant treatment against cestodes is indicated.
Milbemax can be used in pregnant and lactating bitches and in breeding animals.
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Dosage and administration
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:
Weight |
MILBEMAX chewable tablets
for small dogs and puppies |
MILBEMAX chewable
tablets for dogs |
1 - 5 kg |
1 tablet |
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5 – 25 kg |
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1 tablet |
> 25 – 50 kg |
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2 tablets |
> 50 – 75 kg |
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3 tablets |
In cases where 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 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.
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Contra-indications, warnings, etc
Do not use either strength of tablet in dogs weighing less than 1 kg. Do not use MILBEMAX Chewable Tablets for Dogs in dogs weighing less than 5 kg.
Do not use in case of hypersensitivity to the active substances or to any of the excipients.
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.
Precautions for use
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 cases where it is known that a dog has been travelling to and from heartworm risk regions, before using MILBEMAX, 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, tapeworm infection is unusual. Treatment of animals less than 4 weeks old with a combination product may therefore not be necessary.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
In very rare occasions, systemic signs (such as lethargy), neurological signs (such as muscle tremors and ataxia) and/or gastrointestinal signs (such as emesis, drooling, diarrhoea and anorexia) have been observed in dogs after administration of MILBEMAX.
The adverse reactions observed following an overdose are the same as those observed at the recommended dose but more pronounced.
Interaction with other medicinal products and other forms of interaction
The concurrent use of the product with selamectin is well tolerated. No interactions were observed when the recommended dose of the macrocyclic lactone selamectin was administered during treatment with the product at the recommended dose. In the abscence 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.
User 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.
Environmental warnings
MILBEMAX chewable tablets should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Pharmaceutical precautions
Do not store above 25°C.
Any unused product or waste materials should be disposed of in accordance with local requirements.
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Legal category
POM-V
Packaging Quantities
Box with 1 blister or strip of 2 tablets
Box with 1 or 12 blisters or strips of 4 tablets
Not all pack sizes may be marketed.
Further information
Milbemycin oxime belongs to the group of macrocyclic lactones. It is active against mites, against larval and adult stages of nematodes as well as against larvae of Dirofilaria immitis.
After oral administration of milbemycin oxime in dogs, peak plasma levels occur at about 2-4 hours, and decline with a half-life of the unmetabolised milbemycin oxime of 1-4 days.
Bioavailability is about 80%.
Praziquantel is an acylated pyrazino-isoquinoline derivative. Praziquantel is active against cestodes and trematodes.
After oral administration of praziquantel in the dog, peak serum levels of parent are rapidly attained (Tmax approximately 0.5-4hours) and decline quickly (T½ approximately 1.5 hours). There is a substantial hepatic first pass effect, with very rapid and almost complete hepatic biotransformation. Plasma binding is about 80%. Excretion is fast and complete (about 90% in 2 days); the principal route of elimination is renal.
MILBEMAX is effective against Dirofilaria imitis, which is endemic in the USA and some parts of continental Europe. The product is also effective against Echinococcus multilocularis which is endemic in some parts of continental Europe and prophylactic treatment is required (UK only) in all pets entering the UK under the PETS scheme or under quarantine conditions.
Marketing authorisation numbers
MILBEMAX chewable tablets for Small Dogs and Puppies
Vm 12501/4170
MILBEMAX chewable tablets for Dogs
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