Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MILBEMYCIN OXIME, PRAZIQUANTEL
Krka, d.d., Novo mesto
QP54AB51
MILBEMYCIN OXIME, PRAZIQUANTEL
12.5 mg/25
Tablets
POM
Canine
Milbemycin, combinations
Endectoparasiticides
Authorised
2015-01-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Milbactor 12.5 mg/125 mg tablets for dogs weighing at least 5 kg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Tablet. Yellowish-white with brown spots, round, slightly biconvex tablets. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs (weighing at least 5 kg). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In dogs: treatment of mixed infections by adult cestodes and nematodes of the following species: - Cestodes: _Dipylidium caninum_ _Taenia _spp. _Echinococcus _spp. _Mesocestoides _spp. - Nematodes: _Ancylostoma caninum_ _Toxocara canis_ _Toxascaris leonina_ _Trichuris vulpis_ _Crenosoma vulpis _(Reduction of the level of infection) _Angiostrongylus vasorum _(Reduction of the level of infection by immature adult (L5) and adult parasite stages; see specific treatment and disease prevention schedules under section 4.9 “Amounts to be administered and administration route”) _Thelazia callipaeda _(see specific treatment schedule under section 4.9 “Amounts to be administered and administration route”) The product can also be used in the prevention of heartworm disease (_Dirofilaria immitis_) if concomitant treatment against cestodes is indicated. Each tablet contains: Active substances Milbemycin Oxime 12.5 mg Praziquantel 125.0 mg Excipients For the full list of excipients, see section 6.1. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 24/11/2016_ _CRN 7025046_ _page number: 1_ 4.3 CONTRAINDICATIONS 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. See also point "Special precautions for use". 4.4 SPECIAL Read the complete document