Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TOBRAMYCIN
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
TOBRAMYCIN
5ml mL
Alcon-Couvreur NV
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ TOBREX OPHTHALMIC SOLUTION _ _ Tobramycin (3mg/ml) 1 WHAT IS IN THIS LEAFLET 1. What TOBREX is used for 2. How TOBREX works 3. Before you use TOBREX 4. How to use TOBREX 5. While you are using TOBREX 6. Side effects of TOBREX 7. Storage and Disposal of TOBREX 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT TOBREX IS USED FOR Tobrex is a topical antibiotic indicated in the treatment of bacterial infections of the eye. HOW TOBREX WORKS Tobramycin works by stopping the growth of bacteria. BEFORE YOU USE TOBREX _- When you must not use it _ Do not use Tobrex if you are allergic to tobramycin or any of the other ingredients of this medicine. _Pregnancy and breast-feeding _ Tobrex should be used during pregnancy only if clearly needed. If you are pregnant, you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Tobrex is not recommended during breastfeeding. _ _ _- Before you start to use it _ A preservative in Tobrex (benzalkonium chloride) may cause eye irritation and is also known to discolour soft contact lenses. Wearing contact lenses is not recommended during treatment of an eye infection. If you are allowed to wear contact lenses you should remove them before using this product and wait at least 15 minutes before putting your lenses back in. _- Taking other medicines_ Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. If you are using other antibiotic treatment with Tobrex, ask your doctor for advice. _ _ Tobrex Ophthalmic Ointment may be used in conjunction with Tobrex Ophthalmic Solution. HOW TO USE TOBREX _- How much to use _ For mild and moderate infections, 1-2 drops instilled in the conjunctival sac with regular intervals with 4 hours between individual instillations for 7 days. _- When to use it _ Use as directed by your doctor or pharmacist. _- How long to use it _ Continue using Baca dokumen lengkap
Novartis Page 2 Malaysian Package Insert 22-Mar-2019 Tobrex ® 1 NAME OF THE MEDICINAL PRODUCT TOBREX ® (tobramycin 0.3%) Ophthalmic Solution 0.3% 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active: tobramycin 0.3% (3 mg/mL) Preservative: benzalkonium chloride 0.01% (0.1 mg/mL) Excipients: See section 6.1 3 PHARMACEUTICAL FORM Eye drops, solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TOBREX ® Ophthalmic Solution is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX ® Ophthalmic Solution. Clinical studies have shown tobramycin to be safe and effective for use in children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND CHILDREN OLDER THAN 1 YEAR: • For mild and moderate infections, 1 to 2 drops instilled in the conjunctival sac with regular intervals with 4 hours between individual instillations for 7 days. Novartis Page 3 Malaysian Package Insert 22-Mar-2019 Tobrex ® • For severe infections, 2 drops instilled every hour. After the condition has improved, dosage can be reduced. PEDIATRIC POPULATION • Safety and effectiveness in pediatric patients below the age of 2 months has not been established. GERIATRIC USE • No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients. RENAL IMPAIRMENT • The safety and efficacy of Tobrex Eye Drops in patients with renal impairment have not been established. HEPATIC IMPAIRMENT • The safety and efficacy of Tobrex Eye Drops in patients with hepatic impairment have not been established. METHOD OF ADMINISTRATION • For ocular use only. • Keep the bottle tightly closed when not in use. After cap is removed, if tamper evident snap collar is loose, remove before using product. _ _ • Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic ab Baca dokumen lengkap