Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chloramphenicol
Reckitt Benckiser Healthcare (UK) Ltd
S01AA01
Chloramphenicol
10mg/1gram
Eye ointment
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11030100; GTIN: 5011417566411
December 2019 9-COLOP-36-GB-PV2 December Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Chloramphenicol 1% w/w Eye Ointment Golden Eye Antibiotic 1% w/w Eye Ointment Optrex Bacterial conjunctivitis 1% w/w Eye ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of ointment contains 10 mg Chloramphenicol (1% w/w) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Eye Ointment 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of acute bacterial conjunctivitis in adults and children aged 2 years and over 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Topical administration to the eye only. Adults, children aged 2 years and over and elderly The recommended dose is a small amount of ointment (~ 1cm) to be applied to the affected eye(s). The ointment should be applied either at night if eye drops are used during the day, or 3 to 4 times a day if eye ointment is used alone The pharmacist will advise on the most suitable treatment. Treatment should continue for 5 days even if symptoms improve. 4.3 CONTRAINDICATIONS Hypersensitivity to chloramphenicol or any of the excipients listed in section 6.1. • Patients who have experienced myelosuppression during previous exposure to chloramphenicol. • Patients with a family history of blood dyscrasias. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Chloramphenicol is absorbed systemically from the eye and systemic toxicity has been reported (see section 4.8). In severe bacterial conjunctivitis and in cases where infection is not confined to the conjunctivae, the topical use of chloramphenicol should be supplemented by appropriate systemic treatment. Therefore, the patient should be referred to seek medical advice. The use of topical chloramphenicol may occasionally result in overgrowth of non- susceptible organisms including fungi. If any new infection appears during treatment, the patient should be referred to the doctor. Prolonged or frequent intermittent topical application of chloramphenicol should be avoided since it may increase the likelihood of sens Soma hati kamili