BERODUAL SOLUTION

Country: সিঙ্গাপুর

ভাষা: ইংরেজি

সূত্র: HSA (Health Sciences Authority)

সক্রিয় উপাদান:

FENOTEROL HYDROBROMIDE; IPRATROPIUM BROMIDE 0.261 mg/ml EQV IPRATROPIUM BROMIDE ANHYDROUS

থেকে পাওয়া:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

এটিসি কোড:

R03AK03

ডোজ:

0.5 mg/ml

ফার্মাসিউটিকাল ফর্ম:

SOLUTION

রচনা:

FENOTEROL HYDROBROMIDE 0.5 mg/ml; IPRATROPIUM BROMIDE 0.261 mg/ml EQV IPRATROPIUM BROMIDE ANHYDROUS 0.25 mg/ml

প্রশাসন রুট:

RESPIRATORY (INHALATION)

প্রেসক্রিপশন টাইপ:

Prescription Only

Manufactured by:

ISTITUTO DE ANGELI S.R.L.

অনুমোদন অবস্থা:

ACTIVE

অনুমোদন তারিখ:

1989-04-28

তথ্য লিফলেট

Final Clean Copy  
0279‐02 
20140417 
BERODUAL
®

ABCD

COMPOSITION 
BERODUAL
®
 Solution for Inhalation  
1 ml (= 20 drops) solution for inhalation contains: 
(8r)-3
-hydroxy-8-isopropyl-1H,5H-tropanium bromide ()-tropate
monohydrate 
(= ipratropium bromide) corresponding to 250 mcg ipratropium
bromide anhydrous        

0.261mg 
1-(3,5-dihydroxy-phenyl)-2-[[1-(4-hydroxy-benzyl)-ethyl]-amino]-ethanol

hydrobromide (= fenoterol hydrobromide)  

0.500mg  
Excipients: benzalkonium 
chloride, 
disodium edetate dihydrate, sodium chloride, hydrochlorid acid,
water purified 

BERODUAL
® 
N Metered Dose Inhaler 
1 metered dose (puff) contains: 
(8r)-3
-hydroxy-8-isopropyl-1H,5H-tropanium bromide ()-tropate
monohydrate 

(= ipratropium bromide) corresponding to 20
mcg ipratropium bromide anhydrous 

21 mcg 
1-(3,5-dihydroxy-phenyl)-2-[[1-(4-hydroxy-benzyl)-ethyl]-amino]-ethanol
hydrobromide  
(= fenoterol hydrobromide) 
 50 
mcg 
Propellant: 

1,1,1,2-Tetrafluoroethane (HFA 134a) 
Other excipients: citric acid anhydrous, water purified, ethanol
absolute, nitrogen (inert gas) 

DESCRIPTION 
BERODUAL
®
 Solution for Inhalation  
Clear, colourless or almost
colourless liquid, free from suspended particles 

BERODUAL
® 
N Metered Dose Inhaler 
Clear, colourless liquid, free from suspended particles  

PROPERTIES  
Trials with 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.  

BERODUAL
® 
contains two active bronchodilating ingredients: ipratropium
bromide, exhibiting an anticholinergic effect 
and fenoterol hydrobromide a beta-adrenergic agent.  
_ _
Ipratropium bromide is a quate

পণ্য বৈশিষ্ট্য

BERODUAL
®
ABCD
1. NAME OF THE MEDICINAL PRODUCT
BERODUAL Solution for Inhalation
BERODUAL N Metered Dose Inhaler
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
BERODUAL Solution for Inhalation
1 mL (= 20 drops) solution for inhalation contains:
(8r)-3

-hydroxy-8-isopropyl-1

H,5

H-tropanium bromide (

)-tropate monohydrate
(= ipratropium bromide) corresponding to 250 mcg ipratropium bromide
anhydrous
261mcg
1-(3,5-dihydroxy-phenyl)-2-[[1-(4-hydroxy-benzyl)-ethyl]-amino]-ethanol
hydrobromide (= fenoterol hydrobromide) 500mcg
For the full list of excipients, see section 6.1.
BERODUAL
N Metered Dose Inhaler
1 metered dose (puff) contains:
(8r)-3

-hydroxy-8-isopropyl-1

H,5

H-tropanium bromide (

)-tropate monohydrate
21mcg
(= ipratropium bromide) corresponding to 20 mcg ipratropium bromide
anhydrous
1-(3,5-dihydroxy-phenyl)-2-[[1-(4-hydroxy-benzyl)-ethyl]-amino]-ethanol
hydrobromide
(= fenoterol hydrobromide)
50mcg
Propellant: 1,1,1,2-Tetrafluoroethane (HFA 134a)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
BERODUAL Solution for Inhalation
Solution for inhalation
BERODUAL
N Metered Dose Inhaler
Pressurized inhalation solution
3.1 PRODUCT DESCRIPTION
BERODUAL Solution for Inhalation
Clear, colourless or almost colourless liquid, free from suspended
particles
BERODUAL
N Metered Dose Inhaler
Clear, colourless liquid, free from suspended particles
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BERODUAL is a bronchodilator for the prevention and treatment of
symptoms in chronic obstructive airway disorders
with reversible airflow limitation such as bronchial asthma and
especially chronic bronchitis with or without emphysema.
Concomitant anti-inflammatory therapy should be considered for
patients with bronchial asthma and steroid responsive
chronic obstructive pulmonary disease (COPD).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
BERODUAL SOLUTION FOR INHALATION
(1 mL contains 261 mcg ipratropium bromide + 500 mcg fenoterol
hydrobromide)
(20 drops = 1 mL)
Posology
T