DOGS

In dogs: treatment of mixed infections by adult cestodes (tapeworms) and nematodes (roundworms) of the following species:

Cestodes:

Nematodes:

Thelazia callipaeda (see specific treatment schedules under “Amounts to be administered and administration route”,

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”.

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 dogs weighing less than 5 kg

Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

See also point "Special precautions for use"

In order to develop an effective worm control programme local epidemiological information and the living conditions of the dog should be taken into account and therefore it is recommended to seek professional advice.

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. When Dipylidium caninum infection is present, concomitant treatment against intermediate hosts, such as fleas and lice, should be considered to prevent reinfection.

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 also section "Overdose").

As per good veterinary practice, animals should be weighed to ensure accurate dosing.

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, tapeworm infection is unusual. Treatment of animals less than 4 weeks old with a combination product may therefore not be necessary.

The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.

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.

Do not handle this product in case of known hypersensitivity to the active substances or to any of the excipients.

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.

Hypersensitivity reactions, systemic signs (such as lethargy), neurological signs (such as muscle tremors, ataxia and convulsions) and/or gastrointestinal signs (such as emesis, diarrhoea, anorexia and drooling) may be observed, in very rare occasions, in dogs after administration of the veterinary medicinal product.

In a study, this combination of active substances was demonstrated to be well tolerated in breeding bitches, including during pregnancy and lactation. As a specific study with this product has not been performed, use during pregnancy and lactation only according to a benefit/risk assessment by the responsible veterinarian.

The concurrent use of the combination praziquantel/milbemycin oxime with selamectin is well tolerated. No interactions were observed when the recommended dose of the macrocyclic lactone selamectin was administered during treatment with the combination 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.

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.

The tablets are meat flavoured and easy to administer (usually dogs and puppies will accept them voluntarily even without any food).

Depending on the bodyweight of the dog, the practical dosing is as follows:

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 other signs than those observed at the recommended dose have been observed.

See above under adverse reactions

Not applicable