Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULPHATE
PFIZER (MALAYSIA) SDN. BHD.
OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULPHATE
3.5 gm
PT PFIZER (INDONESIA)
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ TERRAMYCIN ® EYE OINTMENT Oxytetracycline/Polymyxin B (5 mg / 10,000 units per gram) 1 WHAT IS IN THIS LEAFLET 1. What TERRAMYCIN is used for 2. How TERRAMYCIN works 3. Before you use TERRAMYCIN 4. How to use TERRAMYCIN 5. While you are using it 6. Side effects 7. Storage and Disposal of TERRAMYCIN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT TERRAMYCIN IS USED FOR TERRAMYCIN is used in the treatment of superficial eye infections. HOW TERRAMYCIN WORKS TERRAMYCIN contains two different antibiotics, oxytetracycline and polymyxin B. Oxytetracycline belongs to a group of medicines called tetracycline antibiotics. The combination of oxytetracycline and polymyxin B works by killing or stopping the growth of bacteria causing your infection. BEFORE YOU USE TERRAMYCIN - _When you must not use it_ DO NOT use TERRAMYCIN if you have ever had an allergic reaction to oxytetracycline, polymyxin B or any of the other the ingredients of the ointment. _Pregnancy and lactation_ The safety of topical (applied to body surfaces) tetracyclines has not been established in pregnant women. You should use topical tetracyclines only after discussing the potential benefits to you and the potential risks to your unborn child with your doctor. It is not known whether topically applied tetracyclines are distributed into breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the medicine to the mother. Ask your doctor or pharmacist for advice before using this medicine. - _Before you start to use it_ Check with your doctor before you use this medicine. - _Taking other medicines_ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. There are no known intera Đọc toàn bộ tài liệu
Pfizer Confidential 1 1. NAME OF THE MEDICINAL PRODUCT TERRAMYCIN w/Polymyxin B 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ophthalmic Ointment with Polymyxin B contains 0.5% oxytetracycline and 10,000 units of Polymyxin B per gram of sterile petrolatum base. A 1% solution in water is acidic (pH about 2.5). Its potency is reduced in solutions more acidic than pH 2 and it is rapidly destroyed by alkali hydroxides. Oxytetracycline is chemically designated as 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a- octahydro-3,5,6,10,12,12a-hexahydroxy-6-methyl-1,11-dioxo-2-naphthacenacarboxamide and has a molecular formula of C 22 H 24 N 2 O 9 . The molecular weight of oxytetracycline hydrochloride is 496.90. It is an odorless, bitter, yellow crystalline powder soluble in water. It forms a cloudy or turbid solution in water due to liberation of oxytetracycline base. Polymyxin B Sulfate is a white or buff-coloured, hygroscopic powder, odorless or with a slight odor. It is very soluble in water with a 2% solution producing a pH of 5 to 7. 3. PHARMACEUTICAL FORM Oxytetracycline Ophthalmic Ointment with Polymyxin B 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oxytetracycline with Polymyxin B Ophthalmic preparations are indicated in the treatment of superficial ocular infections involving the conjunctiva and/or cornea due to susceptible microorganisms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oxytetracycline with Polymyxin B ophthalmic preparations are administered as a small quantity (approximately 1 cm) of the ointment. The preparation should be instilled or applied into the conjunctival sac of the lower lid 4 to 6 times daily until the infection is cleared and healing is complete. This may take from one day to several weeks depending on the nature and severity of the infection. In blepharitis, scales and crusts should be removed before applying medication. For prophylaxis, the same procedure is followed on the day before the operation and subsequently for several days following it. Pfizer Confidential 2 The patient should be Đọc toàn bộ tài liệu