KARIFLOX 5 MG/ML ORAL SOLUTION FOR PIGLETS

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

ENROFLOXACIN

Commercializzato da:

Laboratorios Karizoo S.A.

Codice ATC:

QJ01MA90

INN (Nome Internazionale):

ENROFLOXACIN

Dosaggio:

5 Mg/Ml

Forma farmaceutica:

Oral Solution

Tipo di ricetta:

POM

Gruppo terapeutico:

Porcine

Area terapeutica:

Enrofloxacin

Indicazioni terapeutiche:

Antibacterial

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2009-07-10

Scheda tecnica

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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 01/08/2014_
_CRN 7015916_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not use for prophylaxis.
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.
Whe