Metrotab vet. Flavoured 250 mg tablets for dogs and cats

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Metronidazole

Dostupno od:

CP-Pharma Handelsgesellschaft mbH

ATC koda:

QP51AA01

INN (International ime):

Metronidazole

Doziranje:

250 mg/tablet

Farmaceutski oblik:

Tablet

Tip recepta:

POM: Prescription Only Medicine as defined in relevant national legislation

Područje terapije:

metronidazole

Status autorizacije:

Authorised

Datum autorizacije:

2021-05-14

Svojstava lijeka

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 250 mg tablets for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:​
​
​
Metronidazole
​
250 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 and cats.
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