Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BETAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULPHATE
DUOPHARMA (M) SDN. BHD.
BETAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULPHATE
5ml mL
DUOPHARMA (M) SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 BETACIN EYE/EAR DROPS ® Neomycin sulphate / Betamethasone Phosphate (0.5% w/v / 0.1% w/v) WHAT IS IN THE LEAFLET 1. What Betacin is used for 2. How Betacin works 3. Before you use Betacin 4. How to use Betacin 5. While you are using it 6. Side effects 7. Storage and Disposal of Betacin 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT BETACIN IS USED FOR Betacin is a medicine which is used in inflammatory conditions of the eye or ear where there is bacterial infection. HOW BETACIN WORKS Neomycin sulphate is an antibiotic which can help to treat certain types of infections. Betamethasone phosphate reduces inflammation and can help to relieve the symptoms of inflammatory eye or ear problems. BEFORE YOU USE BETACIN - _When you must not use it _ _Pregnancy and lactation _ _ _ No problems have been documented for Betacin use in breast-feeding. Infants born to mothers who have received substantial doses of corticosteroids should be observed for signs of under activity of the adrenal glands. Your doctor/pharmacist may not prescribe it at all if you: • are allergic or sensitive to or have had a reaction to corticosteroids, aminoglycosides • are allergic or sensitive to neomycin or betamethasone or any of the ingredients listed at the end of this leaflet. • have fungal, viral or bacterial infection of the ear or eye Betacin contains sodium metabisulphite that may cause serious allergic type reactions in certain people. Do not use if known to be hypersensitive to bisulphites. Do not use Betacin: • after the expiry date on the pack; • if the packaging shows signs of tampering; • unless advised by your doctor Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it _ Your prescriber may only prescribe this medicine with special care if you: • Have disease which cause thinning of the eye layers • Have family history of increased eye pressure • have had recent eye or n Lue koko asiakirja
PHARMACODYNAMICS PHARMACOKINETICS 0.5% w/v, Betamethasone Sodium Phosphate 0.1% w/v and ROUTE OF ADMINISTRATION: Eye and Ear March 2021 15000 Co-treatment with CYP3A inhibitors, including cobicistat- containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects. 5ml x 12 bottles _Product Registration Holder & Manufacturer:_ _ _ DUOPHARMA Lue koko asiakirja