Indications for use, specifying the target species
Treatment of gastrointestinal tractinfections caused by Giardia spp. and Clostridia spp. (i.e. C. perfringens orC. difficile).
Treatment of infections of the urogenitaltract, oral cavity, throat and skin caused by obligate anaerobic bacteria (e.g.Clostridia spp.) susceptible to metronidazole.
Contraindications
Do not use in case of hepatic disorders.
Do not use in case of hypersensitivity tothe active substance or to any of the excipients.
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 onlybe 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 mayoccur especially after prolonged treatment with metronidazole.
Special precautions to be taken by theperson administering the veterinary medicinal product to animals
Metronidazole has confirmed mutagenic andgenotoxic properties in laboratory animals as well as in humans. Metronidazoleis a confirmed carcinogen in laboratory animals and has possible carcinogeniceffects in humans. However, there is inadequate evidence in humans for thecarcinogenicity of metronidazole. Impervious gloves should be worn duringadministration of the product to avoid skin contact with the product.
To avoid accidental ingestion, particularlyby a child, unused part-tablets should be returned to the open blister spaceand inserted back into the carton.
In case of accidental ingestion, seekmedical advice immediately and show the package leaflet or the label to thephysician.Wash hands thoroughly after handling the tablets.
Adverse reactions (frequency andseriousness)
The following adverse reactions may occurafter administration of metronidazole: vomiting, hepatotoxicity, neutropeniaand neurologic signs.
Use during pregnancy and lactation
Studies in laboratory animals have showninconsistent results with regard to teratogenic/embryotoxic effects ofmetronidazole. Therefore, use of this product during pregnancy is notrecommended.Metronidazole is excreted in milk and use during lactation istherefore not recommended.
Interaction with other medicinal productsand other forms of interaction
Metronidazole may have an inhibitory effecton the degradation of other drugs in the liver, such as phenytoin, cyclosporineand warfarin.
Cimetidine may decrease the hepaticmetabolism of metronidazole resulting in increased serum concentration of metronidazole.
Phenobarbital may increase hepaticmetabolism of metronidazole resulting in decreased serum concentration ofmetronidazole.
Amounts to be administered andadministration route
For oral administration.
The recommended dose is 50 mg metronidazoleper kg bodyweight per day, for 5 7 days. The daily dose may be divided equally for twice daily administration(i.e. 25 mg/kg bodyweight twice daily).
To ensure administration of the correctdosage bodyweight should be determined as accurately as possible. The followingtable is intended as a guide to dispensing the product at the recommended doserate of 50 mg per kg bodyweight per day.
To ensure administration of the correctdosage bodyweight should be determined as accurately as possible. The followingtable is intended as a guide to dispensing the product at the recommended doserate of 50 mg per kg bodyweight per day.