KARIFLOX 5 mg/ml oral solution for piglets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enrofloxacin

Available from:

Laboratorios Karizoo S.A.

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Pigs

Therapeutic area:

enrofloxacin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2009-07-10

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
KARIFLOX 5 mg/ml oral solution for piglets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin.........................................................
5.0
mg
EXCIPIENTS:
Benzyl Alcohol (E 1519).................................... 14.0
mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Ready to use aqueous clear, oral solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Piglets.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In piglets (up to 10 kg):
- 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 when resistance/cross-resistance to (fluoro)quinolones is
known to occur.
Do not use in case of known hypersensitivity to the active substance,
other (flouro)quinolones or to any of the
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.
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR