Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MILBEMYCIN OXIME PRAZIQUANTEL
Novartis Animal Health UK Ltd
QP54AB51
Coated Tablets
Endoparasiticide
Feline
2009-06-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Milbemax Film-coated tablets for cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Excipients QS one divisable tablet of 132.5 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet Oblong shaped, reddish to reddish brown, artificial beef flavoured tablets with a score on both sides. One side bears the imprint “KK”, the other side “NA”. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats 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 weighing less than 2 kg. Each tablet contains: Active substances: Milbemycin oxime 16 mg Praziquantel 40 mg Excipients: Iron oxide (E172) 0.288 mg IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/05/2011_ _CRN 7010359_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS As per good veterinary practice, animals should be weighed to ensure accurate dosing. 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 cats or individuals with seriously compromised Read the complete document