البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: VMD (Veterinary Medicines Directorate)
Metronidazole
Le Vet Beheer B.V.
QP51AA01
Metronidazole
Tablet
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Antimicrobial
Authorized
2015-12-18
Revised: April 2022 AN: 02906/2021 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Metrobactin 500 mg tablets for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet contains: ACTIVE SUBSTANCE: Metronidazole 500 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Light brown with brown spots, round and convex flavoured 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 _Clostridium_ 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. _Clostridium _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. Revised: April 2022 AN: 02906/2021 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. The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals. Especially after prolonged treatment with metronidazole neurological signs could occur. Special precautions to be taken by the person administering the veterinary medicinal product to animals Metronidazole has confirmed mutagenic and genotoxic properties in laboratory animal اقرأ الوثيقة كاملة