Ülke: Yunanistan
Dil: İngilizce
Kaynak: HMA (Heads of Medicines Agencies)
enrofloxacin 150 mg
aniMedica GmbH
QJ01MA90
Tablet
enrofloxacin
Dogs
2011-02-24
ANIMEDICA GMBH Enrotron Flavour 150 mg ENROTRON FLAVOUR 150 MG SMPC DCP-D210 Version: 28.07.2010, JB DE/V/0137/002/DC approved: 1 von 5 _ _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enrotron Flavour 150 mg Tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet contains ACTIVE SUBSTANCE(S): Enrofloxacin 150.0 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White to off-white, round tablet with one breakline and one decorative line. The tablet can be divided into two equal parts. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of bacterial single or combined infections of the respiratory, alimentary or urinary tract, the skin or wounds, caused by Enrofloxacin-sensitive gram-negative and gram –positive bacteria: E. coli, Pasteurella spp., Haemophilus spp. and staphylococci. 4.3 CONTRAINDICATIONS Do not use in young or growing dogs (dogs aged less than 12 months (small breed) or less than 18 months (large breed)) as the product may cause epiphyseal cartilage alterations in growing puppies. Do not use in dogs having seizure disorders, since enrofloxacin may cause CNS stimulation. Do not use in dogs with known hypersensitivity to fluoroquinolones or to any of the excipients of the product. Do not use in case of resistance to quinolones, as there exists almost complete cross resistance to other quinolones and complete cross resistance to other fluoroquinolones. Do not use with tetracyclines, phenicols or macrolides because of potential antagonistic effects. See also section 4.7 4.4 Belgenin tamamını okuyun