Country: Ирска
Језик: Енглески
Извор: 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
2013-09-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Enro-Sleecol 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 EXCIPIENT: Benzyl alcohol 14 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Solution. Clear, yellow 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._ TURKEYS _Mycoplasma gallisepticum,_ _Mycoplasma synoviae,_ _Pasteurella multocida,_ _Escherichia coli._ 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 case of hypersensitivity to the active substance or to any of the excipients. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 15/04/2016_ _CRN 7022042_ _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 Before use, header tanks should be emptied, thoroughly cleaned and then filled with a known volume of clean water before adding the required amount of the product. The resulting mixture should be stirred. Before use, header tanks should be inspected at regular intervals for presence of dus Прочитајте комплетан документ