Metrobactin 250 mg Tablets for Dogs and Cats

Composition

Each tablet contains:

Active substance:

Metronidazole 250 mg

Excipients:

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Pharmaceutical form

Light brown with brown spots, round and convex flavoured tablet 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 sensitive 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 sensitive bacteria in concentrations equal to or a little higher than the minimum inhibiting concentration (MIC).

Clinically metronidazole does not have any relevant effect on facultative anaerobe, obligate aerobe and microaerophilic bacteria.

4.3 Pharmacokinetics

Metronidazole is immediately and well absorbed after oral administration. After 1 hour a plasma concentration of 10 micrograms/ml was reached with a single dose of 50 mg. The bioavailability of metronidazole is almost 100% and the half life in the plasma is approximately 8-10 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, cats.

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Indications

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.).

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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 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.

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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.

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Adverse reactions

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.

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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. 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.

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, 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 neurological 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, 3, 4, 5, 6, 7, 8, 9, 10, 25 or 50 blisters of 10 tablets. Cardboard box containing 10 boxes, each containing 1 or 10 blisters of 10 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 50406/4016

8 DATE OF FIRST AUTHORISATION

18 December 2015

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

October 2024

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.

Approved 06 February 2025

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Registration holder

Dechra Regulatory B.V.

Handelsweg 25

5531 AE Bladel

The Netherlands

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