País: Regne Unit
Idioma: anglès
Font: VMD (Veterinary Medicines Directorate)
Metronidazole
Ecuphar NV
QP51AA01
Metronidazole
Tablet
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Antimicrobial
Authorized
2019-09-23
Issued: September 2019 AN: 02328/2017 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Metrocare Flavour 500 mg tablets for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Metronidazole 500 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White to off-white, round and convex tablet 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 cases of hepatic disorders. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Issued: September 2019 AN: 02328/2017 Page 2 of 5 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 Llegiu el document complet