Ülke: Yunanistan
Dil: İngilizce
Kaynak: HMA (Heads of Medicines Agencies)
cefquinome sulfate 4.5 g
Intervet Deutschland GmbH
QJ01DA91
Powder and solvent for solution for injection
cefquinome
Horses Food
2011-03-11
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT COBACTAN IV IM 4.5% w/v, powder and solvent for solution for injection for horses DK: Cobactan Vet., pulver og solvens til injektionsvæske, opløsning, 45 mg/ml til heste NL: Cobactan 4.5% w/v poeder en solvens voor oplossing voor injectie voor paarden 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial with powder contains: 30 mL-vial: 1.35 g cefquinome (as sulfate) 100 mL-vial 4.5 g cefquinome (as sulfate) 1 mL solvent contains: Preservative: Benzyl alcohol 10 mg (E 1519) Each mL of the reconstituted solution contains: ACTIVE SUBSTANCE: Cefquinome (as sulfate) 45 mg EXCIPIENT: Benzyl alcohol 10 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection White to pale yellowish-white crystalline powder and clear colourless solvent 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horse (adult and foal) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of: - Respiratory diseases in horses caused by _Streptococcus equi _subsp. _zooepidemicus_ - Severe bacterial infections with a high risk of septicaemia in foals in which _Escherichia coli _is involved 4.3 CONTRAINDICATIONS Do not use in animals which are known to be hypersensitive to cephalosporin antibiotics, other β-lactam antibiotics or to any of the excipients. Do not use in poultry (including eggs) due to risk of spread of antimicrobial resistance to humans. 2 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIA Belgenin tamamını okuyun