מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Milbemycin oxime; Praziquantel
Krka, d.d., Novo mesto
QP54AB51
Milbemycin oxime; Praziquantel
4, 10 mg/tablet
Chewable tablet
POM: Prescription Only Medicine as defined in relevant national legislation
milbemycin oxime, combinations
Authorised
2018-07-27
Health Products Regulatory Authority 15 July 2021 CRN00C9QC Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Milgusto 4 mg/10 mg chewable 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) 0.18 mg Iron Oxide, red (E172) 0.02 mg Titanium dioxide (E171) 0.21 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Brownish orange, 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 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 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, and it is recommended to seek professional (e. g. veterinary) advice. When _D. caninum_ infection is present, concomitant treatment against intermediate hosts, such as fleas and lice, should be considered to prevent re-infection. Health Products Regulatory Authority 15 July 2021 CRN00C9QC Page 2 of 5 Parasite resistance to any particular c קרא את המסמך השלם