Virbac Milpro 2.5mg/25mg film-coated tablets for dogs 0.5-10 kg dewormed, N2

1. NAME OF VETERINARY MEDICINAL PRODUCT Milpro 2.5 mg/25 mg film-coated tablets for puppies and small breed dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: Active ingredient(s): milbemycin oxime 2.5 mg, praziquantel 25 mg; excipient(s). For the full list of excipients, see page 6.1. 3. DOSAGE FORM Film-coated tablet. Oval tablets with the smell of sand or light brown meat, scored on both sides. 4. CLINICAL DATA 4.1. Target animal species Dogs (small breeds) and puppies. 4.2. Indications for use in the specified target species For the treatment of dogs with mixed infections with immature and mature cestodes (tapeworms) and nematodes (roundworms) caused by the following species: cestodes: Echinococcus multilocularis, Dipylidium caninum, Taenia spp.; nematodes: Ancylostoma tubaeforme, Toxocara cati. The veterinary product can also be used for the prevention of dirofilariasis (Dirofilaria immitis) if treatment against cestodes is required at the same time. 4.3. Contraindications Do not use in cats weighing less than 2 kg. Do not use in case of hypersensitivity to the active substances or to any of the excipients. See also page "Special precautions for use". 4.4. Special precautions for use in specific target species In order for the worming programme to be effective, the local epidemiological situation and the conditions in which the dog is kept must be taken into account and it is recommended that specialist advice be sought. Frequent or repeated use of the same class of anthelmintic may result in parasites becoming resistant to it. It is recommended that all animals in the household be treated at the same time. In case of Dipylidium caninum infestation, it should be remembered that treatment against intermediate hosts such as fleas and lice is carried out simultaneously to prevent re-infestation. 4.5. Special precautions for use When treating such dogs, the recommended dosage must be strictly observed. The tolerability of the veterinary product in puppies of the breeds mentioned has not been studied. Clinical signs in Collie dogs are similar to the general signs of overdose in dogs (see also section 4.10). In accordance with good veterinary practice, animals should be weighed before treatment to ensure accurate dosing. When treating dogs with high levels of microfilariae, hypersensitivity-like reactions such as pale mucous membranes, vomiting, tremors, difficulty breathing, or excessive salivation may occasionally occur. These reactions are caused by proteins secreted by dead or dying microfilariae and are not a direct toxic effect of the drug. For this reason, the drug is not recommended for use in dogs with microfilaremia. In areas with an increased risk of heartworm infection, or if the dog is known to have been in such areas, it is recommended to consult a veterinarian before administering the veterinary product to rule out infection with Dirofilaria immitis. If such a diagnosis is positive, the animal should be treated with agents that kill adult parasites before administering the product. Studies have not been conducted in dogs with severe malnutrition or severe renal or hepatic insufficiency. The use of the veterinary product in such animals is not recommended or should be used only after the responsible veterinarian has assessed the benefits and risks of treatment. Children under 4 weeks Tapeworm infection is uncommon in older dogs. Therefore, it is not advisable to treat older animals with this combination of active substances in children under 4 weeks of age. The tablets are flavoured. To avoid accidental ingestion, keep tablets out of the reach of animals. Special precautions for persons using medicinal products for animals Hands should be washed after handling the medicinal product. If a tablet is accidentally swallowed, especially by a child, seek medical advice immediately and show the package leaflet or the label. Do not use this veterinary medicinal product in case of hypersensitivity to the active substance or to any of the excipients. Other precautions Echinococcosis is dangerous to humans. Since echinococcosis is a notifiable disease of the World Organisation for Animal Health (OIE/TEB), specific recommendations corresponding to the competent authority for treatment, follow-up and human safety must be followed. 6. PHARMACEUTICAL INFORMATION 6.1. List of excipients Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, pregelatinised starch, povidone, magnesium stearate, colloidal hydrophobic silicon dioxide. Coating: natural poultry liver flavour, hypromellose, microcrystalline cellulose, macrogol. 6.2. Major non-conformities None. 6.3. Shelf life The shelf life of the veterinary drug, provided that the original packaging is intact, is 3 years. 6.4. Special storage instructions This veterinary drug does not require any special storage conditions. Keep the blister strip in the cardboard box. 6.5. Nature and contents of the container Aluminium/aluminium blister (oriented polyamide/aluminium/polyethylene chloride fused to aluminium film). Pack sizes: 2-tablet carton containing 1 blister with 2 tablets (tablets can be split), 4-tablet carton containing 2 blisters of 2 tablets (tablets can be split), 24-tablet carton containing 12 blisters of 2 tablets (tablets can be split), 48-tablet carton containing 24 blisters of 2 tablets (tablets can be split). Not all pack sizes may be available.