Eradia 125 mg/ml Oral Suspension for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Metronidazole

Available from:

Virbac

ATC code:

QP51AA01

INN (International Name):

Metronidazole

Pharmaceutical form:

Oral suspension

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2018-04-10

Summary of Product characteristics

Unlimited renewal: August 2022
AN: 01235/2022
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ERADIA 125 mg/mL oral suspension for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains
ACTIVE SUBSTANCE:
Metronidazole
125 mg
EXCIPIENTS:
Butylhydroxytoluene (E321)
0.2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
Flavoured oily suspension with brown visible particles.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections of the gastrointestinal tract caused by
_Giardia_ spp. and
_Clostridium _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. _Clostridium _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.
Unlimited renewal: August 2022
AN: 01235/2022
Page 2 of 8
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.
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 thus may have carcinogenic effects in humans as well.
However, there
is inadequate evidence in humans for the carcinogenicity of
metronidazole.
The produ