Krajina: Južná Afrika
Jazyk: angličtina
Zdroj: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
ORPIC 2 mg/mL IV (intravenous infusion) SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ORPIC 2 mg/mL IV (intravenous infusion) COMPOSITION: Each 50 mL vial contains: 127 mg Ciprofloxacin Lactate equivalent to 100 mg Ciprofloxacin Each 100 mL vial contains: 254 mg Ciprofloxacin Lactate equivalent to 200 mg Ciprofloxacin Each 200 mL vial contains: 508 mg Ciprofloxacin Lactate equivalent to 400 mg Ciprofloxacin PHARMACOLOGICAL CLASSIFICATION: A 20.1.1. Broad and medium spectrum antibiotics. PHARMACOLOGICAL ACTION: Ciprofloxacin is a synthetic fluoroquinolone antibiotic. It is bactericidal and acts by inhibiting the A subunit of DNA- gyrase which is essential in the reproduction of bacterial DNA. Pharmacokinetics: After oral administration, ciprofloxacin plasma levels are dose-related and peak at 0,5-2 hours. The absolute bioavailability is approximately 70%. Protein binding is 40%. Forty to fifty percent is excreted in urine as unchanged ciprofloxacin. Approximately 15% of a single dose is eliminated as metabolites. Elimination is primarily renal and mainly during the first 12 hours after dosing. Renal clearance is approximately 300 mL/ minute. The elimination half-life of unchanged ciprofloxacin is 3-5 hours. The elimination kinetics is linear. Micro-organisms resistant to ciprofloxacin: Enterococcus faecium; Norcardia asteroids; Ureaplasma urealyticum; Peptostreptococcus species; Peptococcus species; Bacteroides; Treponema pallidum. INDICATIONS: ORPIC 2 mg/mL IV is indicated for the treatment of the following infections, when caused by susceptible organisms: Lower Respiratory Tract Infections caused by: Enterobacter cloacae, Escherichia coli, Haemophilus parainfluenzae, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa. Urinary tract infections caused by: Citrobacter diversus, Citro Prečítajte si celý dokument