Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Enrofloxacin
Krka, d.d., Novo mesto
QJ01MA90
Enrofloxacin
100 milligram(s)/millilitre
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
Chickens, Turkeys
enrofloxacin
Antibacterial
Authorised
2013-06-14
Health Products Regulatory Authority 03 July 2018 CRN000YPH Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Enrofloxacin Krka 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 EXCIPIENTS: Benzyl alcohol 14 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution. Clear, yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chicken and Turkey. 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 03 July 2018 CRN000YPH Page 2 of 7 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 case of 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 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 classes of antimicrobials. Whenever possible, fluoroquinolones should only be used based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance. Since en Aqra d-dokument sħiħ