Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Enrofloxacin
aniMedica GmbH
QJ01MA90
Enrofloxacin
100 milligram(s)/millilitre
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
Chickens, Rabbits, Turkeys
enrofloxacin
Antibacterial
Authorised
2013-06-21
Health Products Regulatory Authority 22 August 2018 CRN008DKX Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Enrotron 100 mg/ml solution for use in drinking waterfor chicken, turkeys and rabbits 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Enrofloxacin 100.0 mg EXCIPIENTS: Benzyl alcohol (E-1519) 14.0 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for use in drinking water. Clear yellowish solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens, turkeys, rabbits 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._ Health Products Regulatory Authority 22 August 2018 CRN008DKX Page 2 of 7 _ _ RABBITS For the treatment of infectious diseases due to _Pasteurella multocida_ and bacterial enteritis due to infection with _E. coli._ 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. 4.3 CONTRAINDICATIONS 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. Do not use for prophylaxis. 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 poor Lire le document complet