BERODUAL N METERED DOSE INHALER
Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Summary of Product characteristics
(SPC)
30-03-2020
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Active ingredient:
FENOTEROL HYDROBROMIDE; IPRATROPIUM BROMIDE
Available from:
BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.
INN (International Name):
FENOTEROL HYDROBROMIDE; IPRATROPIUM BROMIDE
Units in package:
10ml mL
Manufactured by:
BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG
Summary of Product characteristics
DELETED:
0279‐ 03
20150618
Date
: 19 March 2020
Country
: Malaysia & Singapore
Drug substance
: Ipratropium + Fenoterol
References
: CCDS 0279-05
Remarks
: Routine CCDS review & updates to sections – Instruction for use,
Driving and Using machines,
Overdose & Pharmacokinetics, Editorial changes
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
261mcg
1-(3,5-dihydroxy-phenyl)-2-[[1-(4-hydroxy-benzyl)-ethyl]-amino]-ethanol
hydrobromide (= fenoterol hydrobromide) 500mcg
Excipients:
benzalkonium chloride, disodium edetate dihydrate, sodium chloride,
hydrochloric 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
21mcg
(= ipratropium bromide) corresponding to 20 mcg ipratropium bromide
anhydrous
1-(3,5-dihydroxy-phenyl)-2-[[1-(4-hydroxy-benzyl)-ethyl]-amino]-ethanol
hydrobromide 50mcg
(= fenoterol hydrobromide)
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
Pharmacotherapeutic group: Adrenergics in combination with
anticholinergics for obstructive airway diseases
ATC code: R03AL01
BERODUAL
contains two active bronchodilating ingredients: ipratropium bromide,
exhibiting an anticholinergic effect
and fenoterol hydrobromide a beta-adrenergic agent.
_ _
Ipratropium bromide is a quaternary ammonium compound with
anticholinergic (parasympatholytic) properties. In non-
clinical studies, it inhibits vagally mediated reflexes by
antagonising the action
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