Dogs

Treatment of infections of the gastrointestinal tract 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.

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.

None

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.

Metronidazole has confirmed mutagenic and genotoxic properties in laboratory animals as well as in humans. Metronidazole is a confirmed carcinogen in laboratory animals and thus may have carcinogenic effects in humans as well. However, there is inadequate evidence in humans for the carcinogenicity of metronidazole.

The veterinary medicinal product can cause skin sensitisation. In case of known hypersensitivity to metronidazole or other nitroimidazole derivatives or one of the components of the veterinary medicinal product, avoid contact with the veterinary medicinal product.

Avoid 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.

Wash hands after use.

In case of skin contact, wash thoroughly the affected area.

Metronidazole may cause adverse (neurological) effects.

Avoid accidental ingestion.

Do not drink, eat or smoke when administering the veterinary medicinal product. Close the bottle immediately after use to avoid the child gaining access to the contents. Do not leave a syringe containing suspension in the sight or reach of children. In order to prevent children from getting access to used syringes, keep the syringes in the original packaging after use.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Avoid the access of children to the dog’s medicated food. In order to prevent children from getting access to the dog’s medicated food, pour it over a part of the feed and wait until the animal has completely consumed the medicated feed, then administer the rest of the feed. Give the treatment out of the sight and reach of children. Any uneaten medicated food must be removed immediately and the bowl washed thoroughly; wear gloves and wash hands when handling the veterinary medicinal product and cleaning the contaminated food bowl.

Dogs:

*Especially after prolonged treatment with metronidazole.

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.

Studies in laboratory animals have shown inconsistent results with regard to teratogenic/embryotoxic effects of metronidazole. Therefore, the use of this veterinary medicinal product is not recommended during pregnancy.

Metronidazole is excreted in milk and the use is therefore not recommended during lactation.

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.

Oral use.

The recommended dose is 50 mg metronidazole per kg bodyweight per day (i.e. 0.4 mL per kg bodyweight), preferably given in two equally divided doses (i.e. 25 mg equivalent to 0.2 mL per kg bodyweight twice daily) for 5-7 days.

To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing and overdosing. The dosage table is intended as a guide to dispensing the product at the volume corresponding to either 25 mg/kg for administration twice daily or 50 mg/kg for administration once daily.

Examples of bodyweight (kg)	Volume to administer twice daily for 25mg/kg	Volume to administer once daily for 50mg/kg
1		0.4ml
2	0.4ml	0.8ml
3	0.6ml	1.2ml
4	0.8ml	1.6ml
5	1.0ml	2.0ml
10	2.0ml	4.0ml
15	3.0ml	6.0ml
20	4.0ml	8.0ml
25	5.0ml	10.0ml
30	6.0ml	12.0ml
35	7.0ml	14.0ml
40	8.0ml	16.0ml

For doses requiring more than two filled syringes, the dosing should be twice daily in order to minimize counting and dosing errors.

The oral suspension is delivered through the package described below:

Administer the product by pouring it over a part of the feed or by direct administration into the animal's mouth. Wear impervious gloves when handling the product and/or administering the product into the animal's mouth.

When administered over the feed, wait until the animal has completely consumed the medicated feed, then administer the rest of the feed.

Administer the product by pouring it over a part of the feed or by direct administration into the animal's mouth. Wear impervious gloves when handling the product and/or administering the product into the animal's mouth.

When administered over the feed, wait until the animal has completely consumed the medicated feed, then administer the rest of the feed.

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.

Not applicable