Metrovis 750 mg Tablets for Dogs

Composition

Each tablet contains:

Active substance:

Metronidazole 750 mg.

Excipient(s):

Qualitative composition of excipients and other constituents

Cellulose, microcrystalline

Sodium starch glycolate, type A

Hydroxypropylcellulose

Yeast (dried)

Beef flavour

Magnesium stearate

Beige coloured, round tablets with a cross-shaped break line on one side.

Tablets can be divided into 2 or 4 equal parts.

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Pharmacological properties

4.1 ATCvet code:

QJ01XD01

4.2 Pharmacodynamics

After metronidazole has penetrated the bacteria, the molecule is reduced by the susceptible bacteria (anaerobe). The metabolites that are created have a toxic effect on the bacteria through binding to the bacterial DNA. In general, metronidazole is bactericidal for susceptible bacteria in concentrations equal to or slightly higher than the minimum inhibiting concentration (MIC).

4.3 Pharmacokinetics

Metronidazole is immediately and well absorbed after oral administration. The bioavailability of metronidazole is almost 100%.

In dogs, a Cmax of 79.5 µg/ml is observed following 1 hour after a single oral dose of 62 mg/kg bw. The terminal half-life in the plasma is about 5.3 hours (3.5 to 7.3 hours).

In cats, a Cmax of 93.6 µg/ml is observed following 1.5 hours after a single oral dose of 83 mg/kg bw. The terminal half-life in the plasma is about 6.7 hours (5.2 to 8.3 hours).

Metronidazole penetrates well into the tissues and bodily fluids, such as saliva, milk, vaginal secretions and semen. Metronidazole is primarily metabolised in the liver. Within 24 hours after oral administration, 35-65% of the administered dose (metronidazole and the metabolites thereof) is excreted in the urine.

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Target species

Dogs.

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Indications

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.

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Dosage

Oral use.

The recommended dose is 50 mg metronidazole per kg bodyweight per day, for 5-7 days. The daily dose may be split into two administrations per day (i.e. 25 mg/kg bodyweight twice daily).

To ensure administration of the correct dosage, bodyweight should be determined as accurately as possible. The following table is intended as a guide to dispensing the veterinary medicinal product at the recommended dose rate of either 50 mg per kg bodyweight, administered once daily or, preferably, administered twice daily in 25 mg per kg bodyweight.

= ¼ tablet = ½ tablet = ¾ tablet = 1 tablet

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.

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Contraindications

Do not use in case of hepatic disorders.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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Adverse reactions

Dogs:

Undetermined frequency (cannot be estimated from the available data): Vomiting, Hepatic toxicosis, Neutropenia, Neurological signs

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.

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Warnings

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.

In very rare cases, neurological signs may occur especially after prolonged treatment with metronidazole.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

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.

Personal protective equipment consisting of impervious gloves should be worn when handling the veterinary medicinal product.

To avoid accidental ingestion, particularly by a child, unused tablets and part-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. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands thoroughly after handling the tablets.

Metronidazole may cause hypersensitivity reactions. In case of known hypersensitivity to metronidazole, avoid contact with the veterinary medicinal product.

Special precautions for the protection of the environment:

Not applicable.

3.11 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.

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Use during pregnancy, lactation or lay

Pregnancy:

Studies in laboratory animals have shown inconsistent results with regard to teratogenic/embryotoxic effects of metronidazole. Therefore, the 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.

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Interactions

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.

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Overdose

Adverse events are more likely to occur at doses and treatment durations in excess of the recommended treatment regimen. If neurologic signs occur, treatment should be discontinued, and the patient should be treated symptomatically.

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Special warnings

None.

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Withdrawal period

Not applicable.

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Incompatibilities

Not applicable.

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Immediate packaging

Aluminium - PVC/PE/PVDC blister

Cardboard box of 1, 2, 5, 10, 25 or 50 blisters of 8 tablets

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special storage conditions.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life of divided tablets: 3 days.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 36547/3017 Vm 36547/5017

8 DATE OF FIRST AUTHORISATION

19 August 2019

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

October 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

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Registration holder

Industrial Veterinaria SA

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