Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Milbemycin oxime; Praziquantel
Krka, d.d., Novo mesto
QP54AB51
Milbemycin oxime; Praziquantel
12.5,125 mg/tablet
Film-coated tablet
POM: Prescription Only Medicine as defined in relevant national legislation
milbemycin oxime, combinations
Authorised
2021-09-17
1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Mektix 12.5 mg/125 mg film-coated tablets for dogs weighing at least 5 kg (ES, IE) Mektix CHEWABLE 12.5 mg/125 mg film-coated tablets for dogs weighing at least 5 kg (AT, BE, CY, DE, FR, GR, HU, IT, LT, LV, NL, PT, RO, UK (NI)) Mektix vet 12.5 mg/125 mg film-coated tablets for dogs weighing at least 5 kg (DK, FI, SE) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: ACTIVE SUBSTANCES: Milbemycin oxime 12.5 mg Praziquantel 125.0 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS Cellulose, microcrystalline Lactose monohydrate Povidone Croscarmellose sodium Silica, colloidal anhydrous Meat Flavour Yeast powder Magnesium stearate Hypromellose Talc Propylene Glycol Liver Flavour Pale yellowish brown, oval, biconvex, mottled, film coated tablets. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Dogs (weighing at least 5 kg). 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES Treatment of mixed infections by adult cestodes and nematodes of the following species: - Cestodes: _Dipylidium caninum _ _Taenia_ spp. 2 _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 3.9 Administration routes and dosage) _Thelazia callipaeda_ (see specific treatment schedule under section 3.9 Administration routes and dosage) The veterinary medicinal product can also be used in the prevention of heartworm disease ( _Dirofilaria _ _immitis_ ) if concomitant treatment against cestodes is indicated. 3.3 CONTRAINDICATIONS Do not use in dogs weighing less than 5 kg. Do not use in cases of hypersensitivity to the active substances or to any of the excipients. See also section 3.5 Special precautions for use. 3.4 SPECIAL WARNINGS Parasite r Прочитать полный документ