Metrotab vet. Flavoured 1000 mg tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Metronidazole

Available from:

CP-Pharma Handelsgesellschaft mbH

ATC code:

QP51AA01

INN (International Name):

Metronidazole

Dosage:

1000 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

metronidazole

Authorization status:

Authorised

Authorization date:

2021-05-14

Summary of Product characteristics

Health Products Regulatory Authority
14 May 2021
CRN009N5Z
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Metrotab vet. Flavoured 1000 mg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:​
​
​
Metronidazole
​
1000 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Off-white to light brown with brown spots, round and convex flavoured
tablet with a cross-shaped break line on one side.
The tablets can be divided into 2 or 4 equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
4.3 CONTRAINDICATIONS
Do not use in cases of hepatic disorders.
Do not use in known cases of hypersensitivity to the active substance
or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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.
Especially after prolonged treatment with metronidazole neurological
signs could occur.
As tablets are flavoured, store tablets out of reach of the animals in
order to avoid accidental ingestion.
Health Products Regulatory Authority
14 May 2021
CRN009N5Z
Page 2 of 5
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Metroni