Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Milbemycin oxime; Praziquantel
Krka, d.d., Novo mesto
QP54AB51
Milbemycin oxime; Praziquantel
16, 40 mg/tablet
Chewable tablet
POM: Prescription Only Medicine as defined in relevant national legislation
milbemycin oxime, combinations
Authorised
2018-07-27
PI_Text042367_1 – Updated: Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Milprazon CHEWABLE 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg (BE, BG, CZ, DE, IT, LT, LV, NL, PT, RO, SI, SK, UK (NI)) Milprazon a croquer 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg (FR) Milprazon Sabor 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg (ES) Milprazon Plus 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg (HR, EE, HU, PL) Amcofen 16 mg/40 mg chewable tablets for cats weighing at least 2 kg (IE) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: ACTIVE SUBSTANCES: Milbemycin oxime 16 mg Praziquantel 40 mg EXCIPIENTS: Iron Oxide, yellow (E172) 0.03 mg Iron Oxide, red (E172) 0.12 mg Iron Oxide, black (E172) 0.05 mg Titanium dioxide (E171) 0.21 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Brown, 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 (weighing at least 2 kg). 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_ CONFIDENTIAL PI_Text042367_1 – Updated: Page 2 of 17 _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. 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 t সম্পূর্ণ নথি পড়ুন