البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BUDESONIDE; FORMOTEROL FUMARATE
ASTRAZENECA SDN. BHD.
BUDESONIDE; FORMOTEROL FUMARATE
60 Units; 120 Units
ASTRAZENECA AB
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ SYMBICORT TURBUHALER 80/4.5 MCG/DOSE, 160/4.5 MCG/DOSE Budesonide/formoterol fumarate dihydrate (80/4.5 mcg/dose) Budesonide/formoterol fumarate dihydrate (160/4.5 mcg/dose) _ _ 1 WHAT IS IN THIS LEAFLET 1. What Symbicort Turbuhaler is used for 2. How Symbicort Turbuhaler works 3. Before you use Symbicort Turbuhaler 4. How to use Symbicort Turbuhaler 5. While you are using it 6. Side effects 7. Storage & Disposal of Symbicort Turbuhaler 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial number WHAT SYMBICORT TURBUHALER IS USED FOR Symbicort Turbuhaler is an inhaler that is used to treat asthma in adults, adolescents aged 12-17 years and children aged 6 years and above. It is also used to treat the symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults aged 18 years and older. _ASTHMA _ Symbicort Turbuhaler can be prescribed for asthma in two different ways. - Some people can take Symbicort Turbuhaler when they need it – they use Symbicort Turbuhaler as an anti-inflammatory ”reliever” to treat their symptoms when their asthma gets worse and to help prevent symptoms from happening (eg before exercise or exposure to other triggers such as allergens). - Some people need to take Symbicort Turbuhaler everyday – they use their Symbicort Turbuhaler as a daily maintenance preventer to help maintain control of their asthma symptoms and help prevent asthma attacks. _CHRONIC OBSTRUCTIVE _ _PULMONARY DISEASE (COPD) _ Symbicort Turbuhaler can also be used to treat the symptoms of COPD in adults. COPD is a long-term disease of the airways in the lungs, which is often caused by cigarette smoking. HOW SYMBICORT TURBUHALER WORKS Symbicort Turbuhaler is an inhaler. It contains two different medicines: budesonide and formoterol fumarate dihydrate. • Budesonide belongs to a group of medicines called ‘corticosteroids’. It works by reducing and preventing swelling and inflammation in your lungs. • Formoter اقرأ الوثيقة كاملة
1 SYMBICORT TURBUHALER , 80/4.5 G/INHALATION SYMBICORT TURBUHALER , 160/4.5 G/INHALATION _Budesonide/Formoterol fumarate dihydrate _ _ _ INHALATION POWDER. WHITE POWDER. QUALITATIVE AND QUANTITATIVE COMPOSITION SYMBICORT TURBUHALER 80/4.5 MICROGRAMS/INHALATION Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide 80 micrograms/inhalation and formoterol fumarate dihydrate 4.5 micrograms/inhalation, Each metered dose contains: budesonide 100 micrograms/inhalation and formoterol fumarate dihydrate 6 micrograms/inhalation. Excipient with known effect: Lactose monohydrate 810 micrograms per delivered dose. SYMBICORT TURBUHALER 160/4.5 MICROGRAMS/INHALATION Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide 160 micrograms/inhalation and formoterol fumarate dihydrate 4.5 micrograms/inhalation. Each metered dose contains: budesonide 200 micrograms/inhalation and formoterol fumarate dihydrate 6 micrograms/inhalation. Excipient with known effect: Lactose monohydrate 730 micrograms per delivered dose. CLINICAL PARTICULARS THERAPEUTIC INDICATION ASTHMA Symbicort Turbuhaler is indicated for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations (see Section Posology and Method of Administration). NOTE : Symbicort (80/4.5 micrograms/inhalation) is not appropriate in patients with severe asthma. CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)_ _ Symbicort Turbuhaler is indicated in adults, aged 18 years and older, for the symptomatic 2 treatment of patients with COPD with FEV 1 < 70% predicted normal (post bronchodilator) and an exacerbation history despite regular bronchodilator therapy. POSOLOGY AND METHOD OF ADMINISTRATION Route of administration For inhalation use Posology ASTHMA Symbicort Turbuhaler can be used according to different treatment approaches: A. Symbicort anti-inflammatory reliever therapy (patients with mild disease). B. Symbicort anti-inflammatory reliever plu اقرأ الوثيقة كاملة