Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Metronidazole
LIVISTO Int'l, S.L.
QP51AA01
Metronidazole
100 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
metronidazole
Authorised
2019-08-13
Health Products Regulatory Authority 19 August 2020 CRN009TNZ Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Metrovis 100 mg tablets for dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet contains: ACTIVE SUBSTANCE: Metronidazole 100 mg EXCIPIENT(S): For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Beige coloured, round tablets with a cross-shaped break line on one side. Tablets can be divided into 2 or 4 equal parts. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of gastrointestinal tract infections caused by _Giardia_ spp. and _Clostridia _spp. (i.e. _C. perfringens_ or _C. difficile_). Treatment of infections of the urogenital tract, oral cavity, throat, and skin caused by obligate anaerobic bacteria (e.g. _Clostridia_ spp.) susceptible to metronidazole. 4.3 CONTRAINDICATIONS Do not use in case of hepatic disorders. Do not use in case of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Due to the likely variability (time, geographical) in the occurrence of metronidazole resistant bacteria, bacteriological sampling and susceptibility testing are recommended. Whenever possible, the product should only be used based on susceptibility testing. Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used. In very rare cases, neurological signs may occur especially after prolonged treatment with metronidazole. Special precautions to be taken by the person administering the veterinary medicinal product to animals Metronidazole has confirmed mutagenic and genotoxic properties in laboratory animals as well as in humans. Metronidazole is a confirmed carcinogen in laboratory animals and has possible carcinogenic effects in humans. Howev Les hele dokumentet