Land: Indonesië
Taal: Indonesisch
Bron: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
FENOTEROL HYDROBROMIDE
BOEHRINGER INGELHEIM INDONESIA - Indonesia
FENOTEROL HYDROBROMIDE
100 MCG/DOSE
AEROSOL
DUS, KANISTER @ 200 DOSIS
BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG - Federal Republic of Germany
2021-04-22
PT. BOEHRINGER INGELHEIM INDONESIA 1. Medical and Regulatoy Affairs Red : CCDS 0237-05 Green : change position 0237-05 11 April 2019 BEROTEC ® METERED AEROSOL COMPOSITION 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 INDICATIONS 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). DOSAGE AND ADMINISTRATION A) ACUTE ASTHMA EPISODES 1 actuation is sufficient for prompt symptom relief in many cases. If breathing has not noticeably improved after 5 minutes, a second actuation may be taken. If an attack has not been relieved by actuations, further actuations may be required. In these cases, patients should consult the doctor or the nearest hospital immediately. B) PROPHYLAXIS OF EXERCISE INDUCED ASTHMA 1 - 2 actuations for each administration, up to a maximum of 8 actuations per day. C) BRONCHIAL ASTHMA AND OTHER CONDITIONS WITH REVERSIBLE AIRWAYS NARROWING If repeated dosing is required, 1 – 2 actuations for each administration, up to a maximum of 8 actuations per day. In children BEROTEC® 100 mcg metered aerosol should only be used on medical advice and under the supervision of an adult. DISETUJUI OLEH BPOM : 21/02/2021 EREG10036412000398 PT. BOEHRINGER INGELHEIM INDONESIA 2. Medical and Regulatoy Affairs Red : CCDS 0237-05 Green : change position INSTRUCTION FOR USE The correct administration of the metered aerosol is essential for successful therapy. DEPRESS THE VALVE TWICE BEFORE THE APPARATUS IS USED FOR THE FIRST TIME. Before each use the foll Lees het volledige document