Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Acetylcysteine
MEDISPEC (M) SDN.BHD
Acetylcysteine
10tablet Tablets
PT Caprifarmindo Laboratories
SANBEACETIN ® 600 Acetylcysteine (600 mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _SANBEACETIN_ _®_ _600 _ is used for 2. How _SANBEACETIN _ _®_ _600 _ works 3. Before you use _SANBEACETI _ _®_ _600 _ 4. How to use _SANBEACETIN_ _®_ _600 _ 5. While you are using it 6. Side effects 7. Storage and Disposal of _SANBEACETIN_ _®_ _600_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _SANBEACETIN_ _®_ _600 _IS USED FOR SANBEACETIN is used for treatment of respiratory affections characterized by a lot of thick and viscous secretions: acute bronchitis, chronic bronchitis (inflammation of the airways that carry air to your lungs) and its exacerbations (worsening); pulmonary emphysema (damages to the air sacs (alveoli) in your lungs), mucoviscidosis (abnormal mucus production in lungs) and bronchieactasis (abnormal widening of airways). HOW _SANBEACETIN_ _®_ _600 _WORKS Acetylcysteine has strong fluidification activity to mucus and pus secretion It acts by reduces inflammation and increase mucosa regeneration speed. BEFORE YOU USE _SANBEACETIN_ _®_ _600 _ _When you must not use it _ • You are allergic to _ _ _SANBEACETIN_ _®_ _600 _ • You are allergic to any of the other ingredients of _ _ _SANBEACETIN _ _®_ _600 _ • You are children below two (2) years of age _ _ If any of the above applies to you, talk to your doctor or pharmacist. _ _ _ _ _Pregnancy and lactation _ Pregnancy category B. Not known whether acetylcysteine is distributed into milk. _ _ Ask your doctor or pharmacist for advice before taking any medicine. _ _ - _Before you start to use it _ 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. - _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. HOW TO USE _SANBEACETIN_ _ Διαβάστε το πλήρες έγγραφο
® SANBEACETIN 600 ACETYLCYSTEINE Effervescent Tablet COMPOSITION Each effervescent tablet contains: Acetylcysteine ………...........................….......……. 600 mg PRODUCT DESCRIPTION ® SANBEACETIN 600 (Acetylcysteine Effervescent Tablet) is a round flat tablet, the colour is white with yellow spot and has orange odour. After dissolved in 200 mL, the solution is rather turbid, colourless and has orange odour with sweet-sour taste. PHARMACODYNAMICS Acetylcysteine has strong fluidification activity to mucus secretion and mucopurulent by depolimerization of mucoprotein acid complex and nucleic acid were as act as viscosity agent from mucoid component, sputum purulenta and others secretions, it acts as anti flogistic and increase mucose regeneration speed. PHARMACOKINETICS _Absorption _ Bioavailability Absorbed following oral administration, with peak plasma concentration achieved within 1 - 2 hours. Absorbed from the pulmonary ephitelium. _Distribution_ Extent: Crosses the placenta following oral or IV administration. Plasma protein binding: 50 - 83%. _Metabolism_ Deacetylated in the liver to cysteine. _Elimination_ Elimination route: Principally (70%) nonrenal. Half - life: 6.25 hours after oral administration. INDICATIONS ® SANBEACETIN 600 (Acetylcysteine Effervescent Tablet) is indicated in the treatment of respiratory affections characterized by thick and viscous hyper- secretions: • acute bronchitis • chronic bronchitis and its exacerbations • pulmonary emphysema • mucoviscidosis • bronchieactasis. RECOMMENDED DOSAGE Adults: ® 1 effervescent tablet of SANBEACETIN 600 a day (preferably in the evening). DIRECTIONS FOR USE Dissolve 1 effervescent tablet into a glass of water (± 200 mL). ROUTE OF ADMINISTRATION Oral. CONTRA-INDICATIONS Patients with hypersensitivity to Acetylcysteine. Contraindicated in children below two (2) years of age. WARNING AND PRECAUTIONS Patient with gastric, should be administered after food. Several animal and human researches showed no teratogenic and dangerou Διαβάστε το πλήρες έγγραφο