Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
POLYMYXIN B SULFATE ; BACITRACIN ZINC
Pliva Pharma Limited
D06AX05
POLYMYXIN B SULFATE ; BACITRACIN ZINC
International Unit
Unknown
Product subject to prescription which may not be renewed (A)
bacitracin
Not Marketed
1977-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER POLYFAX OINTMENT, 10,000 IU POLYMYXIN B SULPHATE + 500 IU BACITRACIN ZINC (polymyxin B sulphate and bacitracin zinc) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. WHAT POLYFAX OINTMENT IS AND WHAT IT IS USED FOR 2. BEFORE YOU USE POLYFAX OINTMENT 3. HOW YOU USE POLYFAX OINTMENT 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE POLYFAX OINTMENT 6. FURTHER INFORMATION 1 WHAT POLYFAX OINTMENT IS AND WHAT IT IS USED FOR Polyfax Ointment is a skin ointment, which contains the active ingredients polymyxin B sulphate and bacitracin zinc. Polymyxin B sulphate and bacitracin zinc are antibacterials. Polyfax Ointment is used to help prevent infection of the skin following: • minor burns • a skin graft being taken • surgery • accidental cuts, scratches or scrapes. Polyfax Ointment is used for the treatment of: • infected accidental wounds • infected burns • infected skin grafts • infected ulcers (on the skin) • infected surgical cut. It is also used to treat infected skin caused by skin diseases such as: • impetigo (itchy skin blisters) • bacterial otitis external (infection of the outer ear) • ecthyma (bacterial infection that affects the deep layers of the skin) • folliculitis (infection of the hair roots) • paronychia (infection of the nail bed) • eczema (skin condition with itching, redness and a burning feeling) • scabies (infestation of the skin caused by a mite). 2 BEFORE YOU USE POLYFAX OINTMENT DO NOT USE POLYFAX OINTMENT IF YOU: • Are allergic (hypersensitive) to polymyxin B sulphate, bacitracin zin Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Polyfax Ointment, 10,000 IU Polymyxin B Sulphate + 500 IU Bacitracin Zinc. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of ointment contains: For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment Off-white translucent ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Polyfax Ointment is indicated in conditions where superficial skin infection is present or likely to occur. These include:- Prophylaxis in minor and/or partial thickness burns, graft donor sites, surgical incisions, accidental cuts, scratches and abrasions. Therapeutic use in primary infected dermatoses, such as impetigo, bacterial otitis externa, ecthyma, folliculitis and paronychia; in secondarily infected dermatoses, such as infected eczema, secondarily infected lesions of infestations (e.g. scabies) and secondary bacterial infection accompanying viral infections. Polyfax Ointment is also indicated in the treatment of infected ulcers, accidental cuts, scratches and abrasions, and superficial skin infections following surgical procedures and burns. The use of Polyfax Ointment does not exclude concomitant systemic therapy with other antibiotics where appropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Following removal of debris, such as pus, crusts, etc., from the affected area, a thin film of the ointment should be applied, two or more times daily as directed by the physician. _Use in Children:_ Polyfax ointment may be used in children with dosages and administration as for adults. _Use in elderly:_ No specific information is available regarding the use of Polyfax Ointment in the elderly, however the maximum dosage should be reduced in cases where a decrease in renal function may exist (_see Special warnings and_ _Precautions for use)._ Polymyxin B Sulphate 10,000 IU/ Bacitracin Zinc 500 IU/ 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Citiți documentul complet