Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DEXAMETHASONE; TOBRAMYCIN
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
DEXAMETHASONE; TOBRAMYCIN
5 ml
S.A ALCON COUVREUR N.V.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ TOBRADEX OPHTHALMIC SUSPENSION/OINTMENT _ _ Tobramycin/ Dexamethasone (3mg/ml / 1mg/ml or 3mg/g / 1mg/g) 1 WHAT IS IN THIS LEAFLET 1. What TOBRADEX is used for 2. How TOBRADEX works 3. Before you use TOBRADEX 4. How to use TOBRADEX 5. While you are using TOBRADEX 6. Side effects of TOBRADEX 7. Storage and Disposal of TOBRADEX 8. Product Description 9. Manufacture and Product Registration Holder 10. Date of revision WHAT TOBRADEX IS USED FOR Tobradex is used to treat eye inflammation which is responsive to steroid and to treat or prevent bacterial infection of the eye. HOW TOBRADEX WORKS Tobradex exerts an anti-inflammatory and anti-bacterial action. BEFORE YOU USE TOBRADEX - _When you must not use it _ If you are allergic to dexamethasone, tobramycin or any of the other ingredients of this medicine. _ _ If you think you have: • Herpes simplex keratitis, Smallpox, Chickenpox/Herpes Zoster, or any other viral infection of the eye • Tuberculosis of the eye • Fungal diseases of the eye or an untreated parasitic eye infections _ _ _ _ _ _ _Pregnancy and breast-feeding _ If you are pregnant or might get pregnant, or if you are breast-feeding, talk to your doctor before you use this medicine. Tobradex is not recommended during pregnancy or breastfeeding. _ _ - _Before you start to use it _ Tobradex contains benzalkonium chloride. Wearing contact lenses (hard or soft) is not advisable during treatment of eye inflammation as it may make your condition worse. A preservative in Tobradex (benzalkonium chloride) may cause eye irritation and is also known to discolor soft contact lenses. If your healthcare provider considers that you can use contact lenses, you should remove them before using Tobradex and wait 15 minutes before putting your lenses back in. _[Only applicable _ _for _ _Ophthalmic _ _Suspension _ _(Eye _ _Drops)] _ _ _ - _Taking other medicines _ Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Especia Đọc toàn bộ tài liệu
Novartis Page 2 Malaysian Package Insert 22-Mar-2019 Tobradex ® 1 NAME OF THE MEDICINAL PRODUCT Tobradex (Tobramycin and Dexamethasone) Sterile Ophthalmic Suspension Tobradex (Tobramycin and Dexamethasone) Sterile Ophthalmic Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION [TOBRADEX STERILE OPHTHALMIC SUSPENSION] Active: 1 mL of suspension contains 3 mg of tobramycin and 1 mg of dexamethasone Preservative: benzalkonium chloride (0.01%) Excipients: See section 6.1 [TOBRADEX STERILE OPHTHALMIC OINTMENT] Active: 1 gram ointment contains 3 mg of tobramycin and 1 mg of dexamethasone Preservative: chlorobutanol, anhydrous (0.5%) Excipients: See section 6.1 3 PHARMACEUTICAL FORM Ophthalmic Suspension: white to off-white suspension Ophthalmic Ointment: white to off-white homogeneous ointment 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tobradex Ophthalmic Suspension and Ointment are indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective Novartis Page 3 Malaysian Package Insert 22-Mar-2019 Tobradex ® conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococci, including _S. aureus_ and _S. epidermidis_ (coagulase-positive and coagulase-negative), i Đọc toàn bộ tài liệu