Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Enrofloxacin
Ecuphar NV
QJ01MA90
Enrofloxacin
25 milligram(s)/millilitre
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
enrofloxacin
Authorised
2017-05-26
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enrocare 25 mg/ml concentrate for oral solution for pet rabbits, rodents, ornamental birds and reptiles. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Enrofloxacin 25 mg EXCIPIENT: Benzyl Alcohol 14 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for Oral Solution Clear Solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pet rabbits, rodents, ornamental birds and reptiles. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pet rabbits Treatment of infections of the digestive and respiratory tracts caused by enrofloxacin susceptible strains of: _Escherichia coli, Pasteurella multocida and Staphylococcus spp_ . Treatment of skin and wound infections caused by enrofloxacin susceptible strains of _Staphylococcus _ _aureus_ . Rodents, reptiles and ornamental birds Treatment of infections of the digestive and respiratory tracts where clinical experience, if possible, supported by susceptibility testing of the causal organism, indicates enrofloxacin as the substance of choice. 4.3 CONTRAINDICATIONS The product should not be used for prophylaxis. Do not use in cases of confirmed or suspected resistance to quinolones, since a high degree or cross resistance between enrofloxacin and other quinolones exists. Do not use in cases of hypersensitivity to fluoroquinolones or to any of the excipients. Do not use in animals that are epileptic or suffer from seizures since enrofloxacin may cause CNS stimulation. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 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 deviat Lugege kogu dokumenti