البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
ENROFLOXACIN
Krka, d.d., Novo mesto
QJ01MA90
ENROFLOXACIN
100 Mg/Ml
Oral Solution
POM
Fowl - Chicken, Fowl - Turkey
Enrofloxacin
Antibacterial
Authorised
2008-06-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Enrox 100 mg/ml oral solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Oral solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens (broilers, broiler breeders, replacement chickens), 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._ TURKEYS _Mycoplasma gallisepticum,_ _Mycoplasma synoviae,_ _Pasteurella multocida,_ _Escherichia coli._ 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 poultry producing eggs for human consumption. Do not use in aquatic poultry. Do not use in infections caused by _Streptococcus _spp., because of only marginal susceptibility to enrofloxacin. ACTIVE SUBSTANCE 1 ml of oral solution contains: Enrofloxacin 100 mg. EXCIPIENTS Benzyl alcohol 14 mg. For the full list of excipients, see section 6.1 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 02/04/2015_ _CRN 7020279_ _page number: 1_ 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 c اقرأ الوثيقة كاملة