BEROTEC

Country: Ինդոնեզիա

language: ինդոնեզերեն

source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

active_ingredient:

FENOTEROL HYDROBROMIDE

MAH:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN:

FENOTEROL HYDROBROMIDE

dosage:

100 MCG/DOSE

pharmaceutical_form:

AEROSOL

units_in_package:

DUS, KANISTER @ 200 DOSIS

manufactured_by:

BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG - Federal Republic of Germany

authorization_date:

2021-04-22

SPC

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