Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FENOTEROL HYDROBROMIDE
BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.
FENOTEROL HYDROBROMIDE
10ml mL
BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG
BEROTEC ® N METERED DOSE INHALER Fenoterol hydrobromide (100mcg/puff in 10ml) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What BEROTEC is used for 2. How BEROTEC works 3. Before you use BEROTEC 4. How to use BEROTEC 5. While you are using it 6. Side effects 7. Storage and Disposal of BEROTEC 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT BEROTEC IS USED FOR BEROTEC is used for the: a) treatment of acute asthma attacks b) prevention of exercise-induced asthma c) treatment of asthma and/or other conditions associated with temporary narrowing of the airways such as chronic obstructive bronchitis. Concomitant anti- inflammatory therapy should be considered for people with asthma and steroid responsive chronic obstructive pulmonary disease (COPD) HOW BEROTEC WORKS BEROTEC is a bronchodilator (anti- asthmatic agent / beta 2 -agonist). Fenoterol is an active substance that rapidly dilates the constricted airways in shortness of breath associated with asthma and inflammation. BEFORE YOU USE BEROTEC - _When you must not use it_ _ _ • if you are hypersensitive (allergic) to fenoterol or any of the other ingredients of this medicine (listed in _Product description_ ). • if you suffer from thickened heart muscle that blocks the blood outflow from the heart or with an increased heart rate. _ _ _Children and adolescents _ In children BEROTEC should only be used on medical advice and under the supervision of an adult. _ _ _Pregnancy and lactation _ If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. - _Before you start use it _ Take special care with BEROTEC: • If you have an overactive thyroid gland • If you have an uncontrolled diabetes • If you have a phaeochromocytoma (tumour of the adrenal gland) • If you have a severe blood vessel disease, suffer from a severe underlying disease of the heart (e.g. recent heart at Read the complete document
Proposed Package Insert – Final Text 0237-05 20200323 BEROTEC N 100 MCG/PUFF METERED DOSE INHALER Abcd COMPOSITION BEROTEC ® 100MCG PRESSURISED INHALATION, SOLUTION; HFA 1 metered dose (actuation) contains 1-(3,5-dihydroxy-phenyl)-2-[[1-(4-hydroxy-benzyl)-ethyl]-amino]- ethanol hydrobromide (= fenoterol hydrobromide) 100 mcg propellant: 1,1,1,2-Tetrafluoroethane (HFA 134a) other excipients: citric acid anhydrous, purified water, ethanol absolute DESCRIPTION Clear, colourless liquid, free from suspended particles. INDICATION a) Symptomatic treatment of acute asthma attacks b) Prophylaxis of exercise induced asthma. c) Symptomatic treatment of bronchial asthma and other conditions with reversible airway narrowing e.g. chronic obstructive bronchitis. Concomitant anti-inflammatory therapy should be considered for patients with bronchial asthma and steroid responsive chronic obstructive pulmonary disease (COPD). PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: Adrenergics for inhalative use in obstructive airway diseases, selective beta-2- adrenoreceptor agonists ATC code: R03AC04 BEROTEC ® is an effective bronchodilator for use in acute asthma in other conditions with reversible airway narrowing such as chronic obstructive bronchitis with or without pulmonary emphysema. Following inhalation of fenoterol hydrobromide in obstructive lung diseases, bronchodilatation occurs within a few minutes. The bronchodilator effect lasts 3-5 hours. Mode of Action Fenoterol hydrobromide is a direct acting sympathomimetic agent, selectively stimulating beta 2 -receptors in the therapeutic dose range. The stimulation of beta 1 -receptors comes into effect at a higher dose range. Occupation of beta 2 -receptors activates adenyl cyclase via a stimulatory G s -protein. The increase in cyclic AMP activates protein kinase A which then phosphorylates target proteins in smooth muscle cells. This in turn leads to the phosphorylation of myosin light chain kinase, inhibition of phosphoinositide hydrolysis, and the opening of large- Read the complete document