Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: 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
2010-02-26
Health Products Regulatory Authority 19 July 2018 CRN000YNC Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Unisol 100 mg/ml Oral Solution for use in drinking water for chickens and turkeys. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Enrofloxacin.......................................................... 100.0 mg EXCIPIENTS: Benzyl Alcohol (E 1519)......................................... 14.0 mg F or a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral 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._ TURKEYS _Mycoplasma gallisepticum,_ _Mycoplasma synoviae,_ _Pasteurella multocida._ Enrofloxacin should be used where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the active substance of choice. Health Products Regulatory Authority 19 July 2018 CRN000YNC Page 2 of 6 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 cases of known 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 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 stirred. Before use, header tanks should be inspected at regular intervals for Soma hati kamili