BEROTEC N METERED DOSE INHALER 100 mcg/puff

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

FENOTEROL HBr

Available from:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

ATC code:

R03AC04

Dosage:

100 mcg/puff

Pharmaceutical form:

AEROSOL, SPRAY

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

Prescription Only

Manufactured by:

BOEHRINGER INGELHEIM PHARMA GMBH & CO KG

Authorization date:

2001-10-29

Patient Information leaflet

Proposed Package Insert – Final Text 
0237-03 
20120907 
BEROTEC

 N 100 MCG/PUFF  METERED DOSE INHALER

Abcd

COMPOSITION 
BEROTEC
®
 100MCG METERED AEROSOL; HFA 
1 metered dose (puff) 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 
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.  
Trials with a  treatment duration of up to three
months involving adult asthmatics and COPD patients, and 
asthmatic children, in which the HFA formulation and the
CFC formulation have been compared have shown 
the two formulations to be therapeutically equivalent.  
Fenoterol hydrobromide is a direct acting sympathomimetic agent, selectively stimulating beta
2
-receptors in the 
therapeutic dose rang