국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Chloramphenicol
Mercury Pharmaceuticals Ltd
S01AA; S01AA01
Chloramphenicol
0.5 percent weight/volume
Eye drops, solution
Product subject to prescription which may not be renewed (A)
Antibiotics; chloramphenicol
Marketed
1974-12-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Chloromycetin 0.5% w/v Redidrops Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml of the drops contains 5mg of chloramphenicol (0.5%w/v) Excipient with known effect: Phenylmercuric nitrate 0.002% w/v. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Eye drops, solution A clear, colourless, sterile, aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chloramphenicol is a broad spectrum antibiotic for the treatment of bacterial conjunctivitis caused by chloramphenicol susceptible organisms including:_ Escherichia coli, Haemophilus influenzae, Staphylococcus aureus, Streptococcus_ _haemolyticus, Morax-axenfeld,_ Klebsiella/Enterobacter species and others. Chloramphenicol is indicated in both adults and children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and children: The recommended dosage for adults and children is two drops to be applied to the affected eye every 3 hours or more frequently if required. Treatment should be continued for at least 48 hours after the eye appears normal. Elderly (over 65 years): As for adults. Chloramphenicol has been used successfully at normal dosages in elderly patients. The pattern and incidence of adverse effects does not appear to differ from younger adults. Paediatric population Dosage adjustment may be necessary in newborn infants because of reduced systemic elimination due to immature metabolism and the risk of dose-related adverse effects. The maximum duration of treatment is 10-14 days. Method of administration Topical administration to the eye only. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Chloromycetin Redidrops should not be administered to patients with a known personal or family history of blood dyscrasias including aplastic anaemia. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 전체 문서 읽기