Target species Dogs 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 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. 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 Special precautions for use. Special warnings for each target species Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Special precautions for use Special precautions for use in animals Studies with milbemycin oxime indicate that the margin of safety in certain dogs of Collie or related breeds is less than in other breeds. In these dogs, the recommended dose should be strictly observed. The tolerance of the product in young puppies from these breeds has not been investigated. Clinical signs in Collies are similar to those seen in the general dog population when overdosed (see in section Overdose). Treatment of dogs with a high number of circulating microfilariae can sometimes lead to the appearance of hypersensitivity reactions, such as pale mucous membranes, vomiting, trembling, laboured breathing or excessive salivation. These reactions are associated with the release of proteins from dead or dying microfilariae and are not a direct toxic effect of the product. The use in dogs suffering from microfilaremia is thus not recommended. In heartworm risk-areas, or in the case it is known that a dog has been travelling to and from heartworm risk regions, before using the product, a veterinary consultation is advised to exclude the presence of any concurrent infestation of Dirofilaria immitis. In the case of a positive diagnosis, adulticidal therapy is indicated before administering the product. Echinococcosis represents a hazard for humans. In case of echinococcosis, specific guidelines on the treatment and follow up and on the safeguard of persons have to be followed. Experts or institutes of parasitology should be consulted. No studies have been performed with severely debilitated dogs or individuals with seriously compromised kidney or liver function. The product is not recommended for such animals or only according to a benefit/risk assessment by the responsible veterinarian. In dogs less than 4 weeks old, tapeworm infection is unusual. Treatment of animals less than 4 weeks old with a combination product may therefore not be necessary. Special precautions to be taken by the person administering the veterinary medicinal product to 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. Part tablets should be returned to the open blister pocket and inserted into the outer carton. Other precautions 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) On very rare occasions, systemic signs (such as lethargy), neurological signs (such as muscle tremors and ataxia) and/or gastrointestinal signs (such as emesis, diarrhoea, anorexia and drooling) have been observed in dogs after administration of the combination of milbemycin oxime and praziquantel. Use during pregnancy, lactation or lay The product may be used in breeding dogs including pregnant and lactating bitches. 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.