Indications for use, specifying the target species
In dogs: treatment of mixed infections by adult cestodes and nematodes of the following species susceptible to praziquantel and milbemycin oxime:
Angiostrongylus vasorum (Reduction of the level of infection by immature adult (L5) and adult parasite stages) (see specific treatment and prevention disease schedules under “Amounts to be administered and administration route”)
Thelazia callipaeda (see specific treatment schedule under “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 1 kg.
Do not use in cases of hypersensitivity to the active substances or to any of excipients.
See also section "Special precautions for use".
Special warnings for each target species
It is recommended to treat all the animals living in the same household concomitantly.
When infection with the cestode D. caninum has been confirmed, concomitant treatment against intermediate hosts, such as fleas and lice, should be discussed with a veterinarian to prevent re-infection.
The use of the product should follow the implementation of appropriate diagnostic measures towards mixed infections by nematodes and cestodes with consideration of animal history and characteristics (e.g. age, health status), environment (e.g. kennelled dogs, hunting dogs), feeding (e.g. access to raw meat), geographical location and travel. Judgement of the administration of the product in dogs at risk from mixed re-infections or in specific at risk situations (such as zoonotic risks), should be made by the veterinarian responsible.
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 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.
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.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after use.
People with known hypersensitivity to any of the ingredients should avoid contact with the veterinary medicinal product.
In case of accidental ingestion of the tablets, particularly by a child, seek medical advice immediately and show the package leaflet or the label to the physician.
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.
Adverse reactions (frequency and seriousness)
In very rare occasions, hypersensitivity reactions, systemic signs (such as lethargy), neurological signs (such as muscle tremors, ataxia and convulsions) and/or gastrointestinal signs (such as emesis, drooling, diarrhoea and anorexia) have been observed in dogs after administration of the veterinary medicinal product.
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).
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has been established during pregnancy and lactation.
Can be used in pregnant and lactating bitches.
Can be used in breeding animals.
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 product at the recommended dose.
Although not recommended, the concomitant use of the product with a spot on containing moxidectin and imidacloprid at recommended dose rates following a single application was well tolerated in one experimental study by beagle dogs at the age 11 months or older. Transient neurological adverse reactions (poor proprioception, flaccid frontal and hind legs, incoordination, slight tremors and high stepping gait of the hind limbs only) were observed after concurrent administration of both products in another study conducted in puppies aged 8-12 weeks. Such signs were however not observed in this study after giving MILBEMAX alone.
The safety and efficacy of this combination have not been investigated in field studies.
In the absence of further studies, caution should be taken in the case of concurrent use of MILBEMAX and any other macrocyclic lactone. Also, no such studies have been performed with reproducing animals, Collies, related breeds and their crosses.
Amounts to be administered and administration route
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:
Number of Tablet
1 – 5 kg
To ensure a correct dosage, body weight should be determined as accurately as possible to avoid under dosing.
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, milbemcycin 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.
For guidance on dosing intervals reference should be made to ESCCAP Guidelines which currently advise that, administration of the product every four weeks is effective against D. immitis third stage larvae (L3) and L4 which have developed within the previous 30 days and thus prevents disease caused by the adult worms. Administration of the product should begin within one month of first exposure with the last dose given within one month after the end of exposure. Before starting any prophylactic treatment, adult D. immitis (or D. repens) infections must be ruled out by testing for circulating antigen or microfilariae. Heartworm-infected animals should first be treated for adult worms; prophylactic treatment can begin around 4 weeks later.
Overdose (symptoms, emergency procedures, antidotes), if necessary
The adverse reactions observed are the same as those observed at the recommended dose (see “Adverse reactions (frequency and seriousness)”) but more pronounced.