国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
ENROFLOXACIN
Bayer Limited
QJ01MA90
ENROFLOXACIN
25 Mg/Ml
Oral Suspension
POM
Feline
Enrofloxacin
Antibacterial
Authorised
2011-08-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Baytril flavour 25 mg/ml oral suspension for cat 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of the product contains: ACTIVE SUBSTANCE: Enrofloxacin 25 mg EXCIPIENTS: Ascorbic acid (E300) 0.2 mg Sorbic acid (E200) 2 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral suspension White to yellow-white suspension 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cat 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of single or mixed bacterial infections of the respiratory, alimentary and urinary tract, skin or wounds caused by the following enrofloxacin-sensitive Gram-negative and Gram-positive bacteria: Staphylococci, _E. coli, Haemophilus _spp. and _Pasteurella _spp_._ 4.3 CONTRAINDICATIONS Do not use in Animals with existing impairment of cartilage growth. Animals with a known history of seizures_, _since enrofloxacin may cause CNS stimulation. Animals with known hypersensitivity to fluoroquinolones or any of the excipients. For use in pregnant animals see section 4.7 and for interactions with other medicinal products see section 4.8 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 27/05/2016_ _CRN 7022033_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not use in cases of known resistance to quinolones because of near-total cross-resistance with these compounds and complete cross-resistance with other fluoroquinolones. In animals where product administration is associated with excessive salivation or where difficulty administering the required dose is experienced, administration should be discontinued and an alternative therapy used. 4.5 SPECIAL PRECAUTIONS 完全なドキュメントを読む