COMBIVENT UNIT DOSE VIAL FOR INHALATION

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

IPRATROPIUM BROMIDE MONOHYDRATE 0.52MG/2.5ML EQV. TO IPRATROPIUM BROMIDE ANHYDROUS; SALBUTAMOL SULPHATE 3.01MG/2.5ML EQV. TO SALBUTAMOL

Available from:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

ATC code:

R03AK04

Dosage:

0.5 mg/2.5 ml

Pharmaceutical form:

SOLUTION

Composition:

IPRATROPIUM BROMIDE MONOHYDRATE 0.52MG/2.5ML EQV. TO IPRATROPIUM BROMIDE ANHYDROUS 0.5 mg/2.5 ml; SALBUTAMOL SULPHATE 3.01MG/2.5ML EQV. TO SALBUTAMOL 2.500 mg/2.5 ml

Administration route:

NASAL

Prescription type:

Prescription Only

Manufactured by:

LABORATOIRE UNITHER

Authorization status:

ACTIVE

Authorization date:

1997-11-28

Patient Information leaflet

0204-04  
20130520 
COMBIVENT
®

ABCD

COMPOSITION 
COMBIVENT
® 
solution for inhalation in unit dose vials (UDVs) 
1 unit-dose vial (2.5 ml) solution for inhalation contains: 

(8r)-
3α-hydroxy-8-isopropyl-1αH,5αH-tropanium bromide (+ )-tropate
monohydrate 

(= ipratropium bromide) corresponding to 0.5 mg
ipratropium bromide anhydrous 

 520mcg    
di[(RS)-2-tert-butylamino-1-(4-hydroxy-3-hydroxymethyl-phenyl)ethanol] sulphate 
(= salbutamol sulphate) corresponding to 2.5 mg salbutamol base 
                   3010mcg  
Excipients: 
sodium chloride, hydrochloric acid, purified water 

DESCRIPTION  
Clear, colourless or almost colourless liquid, free
from suspended particles, filled into polyethylene
unit dose vials 

PROPERTIES 
Ipratropium bromide is a quaternary ammonium compound with
anticholinergic (parasympatholytic) properties. In 
preclinical studies, it appears to inhibit vagally mediated reflexes by antagonizing 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 
(diacylglycerol).

The bronchodilation following inhalation of ipratropium bromide is primarily local and site specific to the lung and not 
systemic in nature. 

Salbutamol sulphate is a beta
2
-adrenergic agent which acts on airway smooth muscle resulting in relaxation. 
Salbutamol relaxes all smooth muscle from the trachea to the terminal bronchioles and protects  against all 
bronchoconstrictor challenges. 

COMBIVENT
®
  provides the simultaneous release
of ip

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