Metrocare Flavour 500 mg Tablets for Dogs and Cats

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

Aktivna sestavina:

Metronidazole

Dostopno od:

Ecuphar NV

Koda artikla:

QP51AA01

INN (mednarodno ime):

Metronidazole

Farmacevtska oblika:

Tablet

Tip zastaranja:

POM-V - Prescription Only Medicine – Veterinarian

Terapevtska skupina:

Cats, Dogs

Terapevtsko območje:

Antimicrobial

Status dovoljenje:

Authorized

Datum dovoljenje:

2019-09-23

Lastnosti izdelka

Issued: September 2019
AN: 02328/2017
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Metrocare Flavour 500 mg tablets for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Metronidazole 500 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white, round and convex 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 _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 cases of hypersensitivity to the active substance or to
any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Issued: September 2019
AN: 02328/2017
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.
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