METROBACTIN 250 MG TABLETS FOR DOGS AND CATS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
13-04-2016
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Active ingredient:
METRONIDAZOLE
Available from:
Le Vet Beheer B.V.
ATC code:
QJ01XD01
INN (International Name):
METRONIDAZOLE
Dosage:
250 mg/tablet
Pharmaceutical form:
Tablets
Prescription type:
POM
Therapeutic group:
Canine, Feline
Therapeutic area:
Metronidazole QP51AA01 Metronidazole
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2015-12-18
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Metrobactin 250 mg tablets for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains:
ACTIVE SUBSTANCE:
Metronidazole
250 mg
EXCIPIENT(S):
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 _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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 23/03/2016_
_CRN 7023084_
_page number: 1_
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
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