Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chloramphenicol
J M McGill Ltd
S02AA01
Chloramphenicol
100mg/1ml
Ear drops
Auricular
No Controlled Drug Status
Valid as a prescribable product
BNF: 12010100
5. HOW TO STORE CHLORAMPHENICOL EAR DROPS Keep out of the sight and reach of children. Do not use Chloramphenicol Ear Drops after the expiry date printed on the bottle label. The expiry date refers to the last day of that month. This medicine needs to be stored upright between 2-8°C (in a refrigerator). Protect from light. Do not allow it to freeze. Once you have opened the bottle it should not be used after four weeks. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT CHLORAMPHENICOL EAR DROPS CONTAIN The active ingredient is Chloramphenicol 10% w/v. The other ingredient is Propylene Glycol (90%). WHAT CHLORAMPHENICOL EAR DROPS LOOK LIKE AND CONTENTS OF THE PACK Chloramphenicol Ear Drops are supplied in plastic bottles, each bottle containing 10ml of solution. MARKETING AUTHORISATION HOLDER AND MANUFACTURER Martindale Pharmaceuticals Ltd. Bampton Road, Romford, RM3 8UG, England IF YOU WOULD LIKE ANY MORE INFORMATION, OR WOULD LIKE THE LEAFLET IN A DIFFERENT FORMAT, PLEASE CONTACT MEDICAL INFORMATION AT THE ABOVE ADDRESS. PRODUCT LICENCE NUMBER: PL 00156/0051 This leaflet was last revised in: June 2018 This medicine will be referred to as Chloramphenicol ear drops in the rest of this leaflet. WHAT IS IN THIS LEAFLET 1. What Chloramphenicol Ear Drops are and what they are used for 2. What you need to know before you use Chloramphenicol Ear Drops 3. How to use Chloramphenicol Ear Drops 4. Possible side effects 5. How to store Chloramphenicol Ear Drops 6. Contents of the pack and other information 1. WHAT CHLORAMPHENICOL EAR DROPS ARE AND WHAT THEY ARE 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 Ear Drops are used in the treatment of a wide range of bacterial infections of the Διαβάστε το πλήρες έγγραφο
1 NAME OF THE MEDICINAL PRODUCT Chloramphenicol 10% w/v Ear Drops 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Chloramphenicol 10% w/v Excipient with known effect 1ml contains 0.9g of propylene glycol For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Ear Drops Clear, colourless to pale yellow very slightly viscous liquid 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chloramphenicol is a broad spectrum bacteriostatic antibiotic. It is active against a wide range of Gram-negative and Gram-positive organisms, including _ Salmonella typhi, Haemophilus _ _influenzae, Neisseria meningitidis, Streptococcus pneumoniae and Bacteroides fragilis. _It has antirickettsial and antichlamydial activity. It is indicated for the topical treatment of bacterial infection of the external ear caused by pathogens which are sensitive to it. Chloramphenicol is indicated in adults and children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, Children and the Elderly Apply 3 - 4 drops into the affected ear 2 - 3 times daily for up to 1 week. Following administration of ear drops patients should be advised to lie down with the affected ear uppermost for a minimum of 10 minutes. After this time cotton wool may be inserted into the ear and normal activities resumed. Infants Only use if considered essential by the physician. Method of administration For topical use 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • If the ear drum is perforated. • Myelosuppression during previous exposure to chloramphenicol. • Known personal or family history of blood dyscrasias including aplastic anaemia 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Avoid use for more than 1 week as this may result in sensitivity to chloramphenicol or the emergence of resistant organisms. Where chloramphenicol ear drops are used on a long term or intermittent basis, it may be advisable to perform a routine blood profile before therapy and at appropriate intervals thereafter to d Διαβάστε το πλήρες έγγραφο