COLMYC 25 mg/ml ORAL SOLUTION for calves

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Enrofloxacin

Fáanlegur frá:

SP Veterinaria, S.A.

ATC númer:

QJ01MA90

INN (Alþjóðlegt nafn):

Enrofloxacin

Skammtar:

25 milligram(s)/millilitre

Lyfjaform:

Oral solution

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Cattle

Lækningarsvæði:

enrofloxacin

Ábendingar:

Antibacterial

Leyfisstaða:

Authorised

Leyfisdagur:

2010-09-30

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
COLMYC 25 mg/ml ORAL SOLUTION for calves
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Oral solution.
Clear yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Calves.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In calves:
-
treatment of respiratory infections due to_ Pasteurella multocida_
and_ Mannheimia haemolytica_
-
treatment of gastro-intestinal infection due to_ Escherichia coli_.
To be used where clinical experience and/or sensitivity testing
indicates enrofloxacin as the drug of choice.
4.3 CONTRAINDICATIONS
Do not use in cases of confirmed, or suspected, resistance to
quinolones.
Do not
use in cases of
known hypersensitivity to the active substance,
to other
(fluoro)quinolones or
to any of
excipients.
Do not
use in case of disturbances in growth of cartilage and/or during
injury of locomotory system particularly on
functionally loaded joints or due to body weight loaded joints.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin
25.0 mg
EXCIPIENTS:
Benzyl alcohol (E1519)
14.0 mg
For the full list of excipients, see section 6.1.
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4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Do not use for prophylaxis.
Of