DUOVENT UDVS NEBULISER SOLUTION

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Fenoterol hydrobromide; Ipratropium bromide monohydrate 0.52mg/4ml eqv. to Ipratropium bromide anhydrous

Available from:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

ATC code:

R03AK03

Dosage:

1.25 mg/4 ml

Pharmaceutical form:

SOLUTION

Composition:

Fenoterol hydrobromide 1.25 mg/4 ml; Ipratropium bromide monohydrate 0.52mg/4ml eqv. to Ipratropium bromide anhydrous 0.5 mg/4 ml

Administration route:

NASAL

Prescription type:

Prescription Only

Manufactured by:

Laboratoire Unither

Authorization status:

ACTIVE

Authorization date:

1994-11-15

Patient Information leaflet

0279‐ 02 
20140417  
DUOVENT
®

ABCD

COMPOSITION 
DUOVENT
® 
solution for inhalation in unit dose vials (UDVs) 
1 unit dose vial (= 4 ml solution for inhalation) contains 
(8r)-3
-hydroxy-8-isopropyl-1H,5H-tropanium bromide ()-tropate
monohydrate 

(= ipratropium bromide) corresponding to 500 mcg ipratropium
bromide anhydrous  

0.520mg 
1-(3,5-dihydroxy-phenyl)-2-[[1-(4-hydroxy-benzyl)-ethyl]-amino]-ethanol
hydrobromide  
(= fenoterol hydrobromide) 
                                  1.250mg 
Excipients: 
sodium chloride, hydrochlorid acid, water purified 

DESCRIPTION 
DUOVENT
® 
solution for inhalation in unit dose vials (UDVs) 
Clear, colourless or almost
colourless liquid, free from suspended particles and
filled into polyethylene unit dose vials   

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.  

DUOVENT
® 
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 
preclinical studies, it inhibits vagally mediated reflexes
by antagonising the action of acetylcholine, the transmitter 
agent released from the vagus nerve. Anticholinergics prevent the
increase in intracellular concentration of Ca++ 
which is caused by interaction of acetylcholine with the
muscarinic receptor on bronchial smooth muscle Ca++ 
release is mediated by the second messenger
system consisting of IP3 (inositol triphosphate) and DAG 
(diacylglycero

Summary of Product characteristics

COMBIVENT
ABCD
1.
NAME OF THE MEDICINAL PRODUCT
COMBIVENT® nebuliser solution in unit dose vials
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 unit-dose vial (2.5 mL) nebuliser solution contains:
(8r) -3α-hydroxy-8-isopropyl-1αH,5αH-tropanium bromide (+)-tropate
monohydrate
(= ipratropium bromide) corresponding to 500 mcg ipratropium bromide
anhydrous
522mcg
Di[(RS)-2-tert-butylamino-1-(4-hydroxy-3-hydroxymethyl-phenyl)
ethanol] sulphate
(= salbutamol sulphate) corresponding to 2500 mcg salbutamol base
3013mcg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nebuliser solution.
Clear, colourless or almost colourless liquid, free from suspended
particles, filled into polyethylene unit
dose vials.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
COMBIVENT® nebuliser solution in unit dose vials are indicated for
the management of reversible
bronchospasm associated with obstructive airway diseases in patients
who require more than a single
bronchodilator.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
SPECIAL POPULATIONS
Patients with hepatic or renal impairment
COMBIVENT® has not been studied in patients with hepatic or renal
insufficiency. It should be used
with caution in those patient populations.
Paediatric population
Because of insufficient information in children COMBIVENT® is not
indicated for paediatric patients.
Patients should be advised to consult a physician or the nearest
hospital immediately in the case of
acute or rapidly worsening dyspnoea if additional inhalations of
COMBIVENT® do not produce an
adequate improvement.
If higher than recommended doses of COMBIVENT® are required to
control symptoms, the patient's
therapy plan should be reviewed.
In asthma, concomitant anti-inflammatory therapy should be considered.
The following doses of COMBIVENT® are recommended for adults
(including elderly patients):
COMBIVENT® nebuliser solution in unit dose vials (UDVs)
COMBIVENT® nebuliser solution in unit dose vials may be administered
from a suitable nebuliser or an
intermitte