ERADIA 125 mg/ml oral suspension for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Metronidazole

Available from:

Virbac S.A.

ATC code:

QP51AA01

INN (International Name):

Metronidazole

Dosage:

125 milligram(s)/millilitre

Pharmaceutical form:

Oral suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

metronidazole

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2018-04-13

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:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION IS
ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
Butylhydroxytoluene (E321)
0.2 mg
Aluminium stearate
Stearic acid (E570)
Poultry liver powder
Triglycerides medium chain
Oily suspension with brown visible particles.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs.
3.2
INDICATIONS FOR USE FOR EACH 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.
3.3
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.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Due to the likely variability (time, geographical) in the occurrence
of metronidazole resistant bacteria,
bacteriological sampling and susceptibility testing are recommended.
Whenever possible, the veterinary medicinal 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
carcinoge