Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Enrofloxacin
Vetpharma Animal Health, S.L.
QJ01MA90
Enrofloxacin
100 milligram(s)/millilitre
Solution for use in drinking water
POM: Prescription Only Medicine as defined in relevant national legislation
Chickens, Turkeys
enrofloxacin
Antibacterial
Authorised
2010-04-30
Health Products Regulatory Authority 19 July 2018 CRN000YNC Page 1 of 6 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._ TURKEY _Mycoplasma gallisepticum, _ _Mycoplasma synoviae, _ _Pasteurella multocida._ Health Products Regulatory Authority 19 July 2018 CRN000YNC Page 2 of 6 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 substanceor 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 resistant organisms. Resistance has also been reported in _Mycoplasma synoviae _in the EU. 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 product. The resulting mixture should be stirr Les hele dokumentet