Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Chloramphenicol
Martindale 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
Not marketed
2001-01-26
PACKAGE LEAFLET CHLORAMPHENICOL 1.0% W/W EYE OINTMENT CHLORAMPHENICOL READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Chloramphenicol Eye Ointment is and what it is used for 2. What you need to know before you use Chloramphenicol Eye Ointment 3. How to use Chloramphenicol Eye Ointment 4. Possible side effects 5. How to store Chloramphenicol Eye Ointment 6. Contents of the pack and other information 1. WHAT CHLORAMPHENICOL EYE OINTMENT IS AND WHAT IT IS USED FOR Chloramphenicol belongs to a group of medicines called antibiotics. An antibiotic is a medicine which is used for the treatment of a variety of infections caused by bacteria. Chloramphenicol Eye Ointment are used in both adults and children for the treatment of a wide range of eye infections caused by bacteria. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CHLORAMPHENICOL EYE OINTMENT DO NOT USE THE OINTMENT IF: • You are allergic to Chloramphenicol or any of the other ingredients of this medicine listed in section 6 • You or a member of your family has had problems with their blood or bone marrow. These problems can include a severe reduction in red blood cells or lower than normal blood count. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Chloramphenicol Eye Ointment if: • you have visual disturbances • you have severe pain in the eye • you are sensitive to light • your eye is inflamed and you have a rash on the scalp or face • your eye looks cloudy • your black or coloured part of the eye look Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Chloramphenicol 0.5% w/v Eye Drops. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml of the drops contains 5mg of chloramphenicol (0.5%w/v) Excipients with known effect Contains Phenylmercuric Nitrate 0.02mg/ml (0.002% w/v). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. Clear 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, including the elderly and children One or two drops applied to each affected eye up to 6 times daily or more frequently if required. 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 Eye Drops for topical administration 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 a known personal or family history of blood dyscrasias including aplastic anaemia. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Chloramphenicol is absorbed systemically from the eye and toxicity has been reported following chronic exposure. Bone marrow hypoplasia, including aplastic anaemia and death, has been reported following topical use of chloramphenicol. Whilst the hazard is a rare one, it should be borne in mind when assessing the benefits expected 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Baca dokumen lengkap