Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Milbemycin oxime; Praziquantel
Krka, d.d., Novo mesto
QP54AB51
Milbemycin oxime; Praziquantel
4, 10 mg/tablet
Film-coated tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Cats
milbemycin oxime, combinations
Endoparasiticide
Authorised
2015-07-10
Health Products Regulatory Authority 23 August 2021 CRN00C8RG Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Milbactor 4 mg/10 mg film-coated tablets for small cats and kittens weighing at least 0.5 kg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: ACTIVE SUBSTANCES: Milbemycin oxime 4 mg Praziquantel 10 mg EXCIPIENTS: Iron Oxide, yellow (E172) 0.20 mg Titanium dioxide (E171) 0.51 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Brown yellow, oval, biconvex film-coated tablets with score line on one side. The tablets can be divided into halves. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats (small cats and kittens). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In cats: treatment of mixed infections by immature and adult cestodes and nematodes of the following species: - Cestodes: _Dipylidium caninum_ _Taenia _spp. _Echinococcus multilocularis_ - Nematodes: _Ancylostoma tubaeforme_ _Toxocara cati_ Prevention of heartworm disease (_Dirofilaria immitis_) if concomitant treatment against cestodes is indicated. 4.3 CONTRAINDICATIONS Do not use in cats of less than 6 weeks of age and/or weighing less than 0.5 kg. Do not use in known cases of hypersensitivity to the active substances or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES It is recommended to treat all the animals living in the same household concomitantly. In order to develop an effective worm control programme local epidemiological information and the risk of exposure of the cat should be taken into account. Health Products Regulatory Authority 23 August 2021 CRN00C8RG Page 2 of 5 When _D. caninum_ infection is present, concomitant treatment against intermediate hosts, such as fleas and lice, should be considered to prevent re-infection. Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated Olvassa el a teljes dokumentumot