Metrobactin 500 mg Tablets for Dogs and Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Metronidazole

Available from:

Le Vet Beheer B.V.

ATC code:

QP51AA01

INN (International Name):

Metronidazole

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2015-12-18

Summary of Product characteristics

Revised: April 2022
AN: 02906/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Metrobactin 500 mg tablets for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains:
ACTIVE SUBSTANCE:
Metronidazole
500 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
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.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE 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.) susceptible to
metronidazole.
4.3
CONTRAINDICATIONS
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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: April 2022
AN: 02906/2021
Page 2 of 5
4.5
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 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
has
confirmed
mutagenic
and
genotoxic
properties
in
laboratory
animal