Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
ENROFLOXACIN
Krka, d.d., Novo mesto
QJ01MA90
ENROFLOXACIN
100 Mg/Ml
Infus/Pdr/Oral Soln
POM
Fowl - Chicken, Fowl - Turkey
Enrofloxacin
Antibacterial
Authorised
2013-06-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Enrofloxacin Krka 100 mg/ml oral solution for chickens and turkeys. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of oral solution contains: ACTIVE SUBSTANCE: Enrofloxacin 100 mg EXCIPIENTS: Benzyl alcohol 14 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution. Clear, yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chicken and Turkey. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of infections caused by the following bacteria susceptible to enrofloxacin: Chickens _Mycoplasma gallisepticum,_ _Mycoplasma synoviae,_ _Avibacterium paragallinarum,_ _Pasteurella multocida,_ _Escherichia coli._ Turkey _Mycoplasma gallisepticum,_ _Mycoplasma synoviae,_ _Pasteurella multocida,_ _Escherichia coli._ HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 11/05/2015_ _CRN 7020381_ _page number: 1_ 4.3 CONTRAINDICATIONS Do not use for prophylaxis. Do not use when resistance / cross-resistance to (fluoro)quinolones is known to occur in the flock intended for treatment. Do not use in case of hypersensitivity to the active substance, other (fluoro)quinolones or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Treatment of _Mycoplasma _spp. infections may not eradicate the organism. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS 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. Whenever possible, fluoroquinoones should only be u Soma hati kamili