Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Metronidazole
CP-Pharma Handelsgesellschaft mbH
QP51AA01
Metronidazole
250 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
metronidazole
Authorised
2021-05-14
Health Products Regulatory Authority 14 May 2021 CRN009N5Z Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Metrotab vet. Flavoured 250 mg tablets for dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Metronidazole 250 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Off-white to light brown with brown spots, round and convex flavoured tablet with a cross-shaped break line on one side. The 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 known cases 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. Especially after prolonged treatment with metronidazole neurological signs could occur. As tablets are flavoured, store tablets out of reach of the animals in order to avoid accidental ingestion. Health Products Regulatory Authority 14 May 2021 CRN009N5Z Page 2 of 5 Special precautions to be taken by the person administering the veterinary medicinal product to Read the complete document