Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
CHLORAMPHENICOL
Bausch & Lomb UK Limited
S01AA01
CHLORAMPHENICOL
0.5 Per Cent
Eye Drops Solution
Product subject to prescription which may not be renewed (A)
chloramphenicol
Marketed
1977-04-01
MINIMS ® CHLORAMPHENICOL 0.5% EYE DROPS, SOLUTION CHLORAMPHENICOL IN THIS LEAFLET: 1. What Minims ® Chloramphenicol eye drops are and what they are used for 2. Before you use your eye drops 3. How to use your eye drops 4. Possible side effects 5. How to store your eye drops 6. Further information 1. WHAT MINIMS ® CHLORAMPHENICOL EYE DROPS ARE AND WHAT ARE THEY USED FOR Minims ® Chloramphenicol contains an antibiotic. It is used to treat infections of your eyes. Sometimes parts of the outer surface of the eye, such as the cornea (the transparent membrane covering the surface of the eye) or the conjunctiva (the lining of the inside of the eyelids and part of the eye), may become infected with bacteria. These eye drops can be used to treat this infection and are effective against many different types of bacteria. If the eye infection is very severe, your doctor may give you antibiotic tablets as well as this antibiotic eye drops. This medicine is indicated for children, adults and the elderly. 2. BEFORE YOU USE YOUR EYE DROPS DO NOT USE THESE DROPS IF • you are allergic to the active substance (chloramphenicol) or any of the ingredients (refer to the end of this leaflet). TAKE SPECIAL CARE If you use these eye drops over a long period of time they could possibly become less effective or produce allergic reactions. In order to prevent this, make sure that you stop using this medicine as soon as your doctor tells you to. DO YOU USE ANY OF THESE MEDICINES? Chymotrypsin (solution used during cataract surgery) may not work properly when used at the same time as Minims ® Chloramphenicol. If you are pregnant, may be pregnant, or are breastfeeding tell your doctor or eye specialist, he/she may decide to use these drops or to prescribe you an alternative. CONTACT LENSES Your doctor will ask you to remove your contact lenses prior to the administration of the drops. Do not wear your contact lenses throughout the entire treatment course. DRIVING AND USING MACHINES As with all eye drops, your vision may be blurred after Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Minims Chloramphenicol 0.5% Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Chloramphenicol 0.5% w/v. _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Clear, colourless, sterile single use eye drops solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chloramphenicol is indicated for the topical treatment of infections due to micro-organisms sensitive to the anti- infective. Chloramphenicol is indicated in adults and children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults (including the Elderly) One to two drops applied topically to each affected eye up to six times daily or more frequently if required. (Severe infections may require one to two drops every fifteen to twenty minutes initially, reducing the frequency of instillation gradually as the infection is controlled). Paediatric population As for adults however 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. 4.3 CONTRAINDICATIONS Use in patients with a history of hypersensitivity or toxicity to chloramphenicol or any other component of the preparation. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In severe infections topical use of chloramphenicol should be supplemented with appropriate systemic treatment. Aplastic anaemia has, very rarely, followed topical use of chloramphenicol eye drops and, whilst this hazard is an uncommon one, it should be borne in mind when the benefits of the use of chloramphenicol are assessed. Prolonged use should be avoided as it may increase the likelihood of sensitisation and the emergence of resistant organisms. Chloramphenicol should be reserved for use only in infections for which it is specifically indicated. Contact lenses should be removed during the period of treatment. 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 ___ __ Läs hela dokumentet