Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
ENROFLOXACIN
Laboratorios Karizoo S.A.
QJ01MA90
ENROFLOXACIN
5 Mg/Ml
Oral Solution
POM
Porcine
Enrofloxacin
Antibacterial
Authorised
2009-07-10
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 ________________________________________________________________________________________________________________________ _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 Læs hele dokumentet