Contraindications
Milprazon CHEWABLE 2.5 mg/25 mg film-coated Tablets for Small Dogs and Puppies Weighing At Least 0.5 kg. Do not use in puppies of less than 2 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.
Milprazon CHEWABLE 12.5 mg/125 mg film-coated Tablets for Dogs Weighing At Least 5 kg. 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.
Special warnings for use in animals: 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 programe 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.
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 veterinary medicinal product. No studies have been performed with severely debilitated dogs or individuals with seriously compromised kidney or liver function. The veterinary medicinal 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 veterinary medicinal 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.
Other precautions: Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable disease to the World Organisation for Animal Health (WOAH), specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.
User safety: Accidental ingestion of a tablet by a child may be harmful. In order to prevent children from accessing the product, tablets should be administered and stored out of sight and reach of children. Wash hands after use. Part tablets should be returned to the open blister pocket and inserted into the outer carton. 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 physician.
Adverse reactions: On very rare occasions, hypersensitivity reaction, systemic disorders (such as lethargy), neurological disorders (such as muscle tremors and ataxia) and/or digestive tract disorders (such as emesis, diarrhoea, anorexia and drooling) have been observed in dogs after administration of the combination of milbemycin oxime and praziquantel.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative, or the national competent authority via the national reporting system. See the package leaflet for contact details.
Overdose: No other signs than those observed at the recommended dose have been observed
Interactions 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.
Major incompatiblities: Not applicable