KARIFLOX 25 mg/ml oral solution for calves

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:

25 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

enrofloxacin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2009-07-10

Summary of Product characteristics

Health Products Regulatory Authority
31 July 2017
CRN000VGP
Page 1 of 6
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
KARIFLOX 25 mg/ml oral solution for calves
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin.......................................................
25.0mg
EXCIPIENTS:
Benzyl Alcohol (E 1519).................................... 14.0mg
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
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 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
Health Products Regulatory Authority
31 July 2017
CRN000VGP
Page 2 of 6
loaded joints.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Do not use for prophylaxis.
During the period of rapid growth, enrofloxacin may affect articular
cartilage.
Official and local antimicrobial policies should be taken into account
when the
product is used.
Fluoroquinolones should be reserved for the treatment of clinical
conditions which
have responded poorly, or are expected to respond poorly, to other
classes of
antimicrobials.
Wherever possible, fluoroquinolones should only be used based on
susceptibility
testing.
Use of the product deviating from instructions given in the SPC may
increase the
prevalence