Metrovis 100 mg tablets for dogs and cats

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Metronidazole

MAH:

LIVISTO Int'l, S.L.

ATC_code:

QP51AA01

INN:

Metronidazole

dosage:

100 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:

2019-08-13

SPC

Health Products Regulatory Authority
19 August 2020
CRN009TNZ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Metrovis 100 mg tablets for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains:
​
ACTIVE SUBSTANCE:
​
​
Metronidazole
​
100 mg
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Beige coloured, round tablets 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 _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 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.
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.
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. Howev