Target species
Dogs, cats.
Indications for use for each 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.).
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.
Special warnings
None.
Special precautions for safe use in the target species
Due to the likely variability (time, geographical) in the occurrence of metronidazole resistant bacteria, bacteriological sampling and susceptibility testing are recommended.
Whenever possible, the veterinary medicinal 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 may cause hypersensitivity reactions. People with known hypersensitivity to metronidazole should avoid contact with the veterinary medicinal product.
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. However, there is inadequate evidence in humans for the carcinogenicity of metronidazole.
Metronidazole may be harmful for the unborn child.
Avoid accidental ingestion and contact with the skin or mucous membranes including hand-to-mouth contact.
To avoid such contact wear impervious gloves when handling the veterinary medicinal product and/or for direct administration into the animal's mouth.
Do not allow treated dogs to lick persons immediately after intake of the medication.
In case of skin contact, wash thoroughly the affected area.
To avoid accidental ingestion, particularly by a child, unused parts of the tablets should be returned to the open blister space, inserted back into the outer packaging and kept in a safe place out of the sight and reach of children. The remaining part should be used at the time of next administration.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands thoroughly after use.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Dogs, cats:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Neurological signs Vomiting Hepatic toxicosis Neutropenia |
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy:
Studies in laboratory animals have shown inconsistent results with regard to teratogenic/embryotoxic effects of metronidazole. Therefore, use of this veterinary medicinal product during pregnancy is not recommended.
Lactation:
Metronidazole is excreted in milk and use during lactation is therefore not recommended.
Interaction with other medicinal products and other forms of interaction
Metronidazole may have an inhibitory effect on the degradation of other drugs in the liver, such as phenytoin, cyclosporine and warfarin.
Cimetidine may decrease the hepatic metabolism of metronidazole resulting in increased serum concentration of metronidazole.
Phenobarbital may increase hepatic metabolism of metronidazole resulting in decreased serum concentration of metronidazole.
Amounts to be administered and administration route
Oral use.
The recommended dose is 50 mg metronidazole per 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 correct dosage bodyweight should be determined as accurately as possible.
Tablets can be divided into 2 or 4 equal parts to ensure accurate dosing. Place the tablet on a flat surface, with its scored side facing up and the convex (rounded) side facing the surface.
Halves: press down with your thumbs on both sides of the tablet.
Quarters: press down with your thumb in the middle of the tablet.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Adverse events are more likely to occur at doses and treatment durations in excess of the recommended treatment regimen. If neurological signs occur, treatment should be discontinued and the patient should be treated symptomatically.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.