البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
ENROFLOXACIN
Vetpharma Animal Health, S.L.
QJ01MA90
ENROFLOXACIN
100 Mg/Ml
Infus/Pdr/Oral Soln
POM
Fowl - Chicken, Fowl - Turkey
Enrofloxacin
Antibacterial
Authorised
2010-04-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT LANFLOX 100 mg/ml Solution for use in drinking water for Chickens and Turkeys. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Enrofloxacin..................................................... 100 mg EXCIPIENTS: Benzyl Alcohol (E 1519).................................... 14 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for use in drinking water. An aqueous, clear, yellowish solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens and Turkeys. 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 12/09/2014_ _CRN 7018863_ _page number: 1_ 4.3 CONTRAINDICATIONS Do not use in birds producing eggs for human consumption. 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 cases of hypersensitivity to the active substance 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 Since enrofloxacin was first authorised for use in poultry, there has been widespread reduction in susceptibility of _E.coli _to fluoroquinolones and emergence of resist اقرأ الوثيقة كاملة