ATROVENT SOLUTION 0.025%

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

IPRATROPIUM BROMIDE

Disponible desde:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Código ATC:

R03BB01

Dosis:

0.25 mg/ml

formulario farmacéutico:

SOLUTION

Composición:

IPRATROPIUM BROMIDE 0.25 mg/ml

Vía de administración:

RESPIRATORY (INHALATION)

tipo de receta:

Prescription Only

Fabricado por:

ISTITUTO DE ANGELI S.R.L. (IDAPH)

Estado de Autorización:

ACTIVE

Fecha de autorización:

1989-05-18

Información para el usuario

Proposed Package Insert – final 
0260‐00 (MY & SG) 
20120130 
ATROVENT
®

ABCD

COMPOSITION 
ATROVENT
®
 N 20 mcg/puff Metered Dose Inhaler 
1 metered dose (puff) contains 21 mcg  
(8r)-3
-hydroxy-8-isopropyl-1H,5H-tropanium bromide ()-tropate  
monohydrate (= ipratropium bromide monohydrate) corresponding to  
20 mcg 
ipratropium bromide anhydrous 
Propellant: 1,1,1,2-Tetrafluoroethane (HFA [hydrofluoralkane] 134a) 
Other excipients: citric acid anhydrous, water purified , ethanol
anhydrous, nitrogen (inert gas) 

ATROVENT
®
 0.025 % Solution for Inhalation 
1 ml (20 drops) solution for inhalation contains 261 mcg 
(8r)-3
-hydroxy-8-isopropyl-1H,5H-tropanium bromide ()-tropate  
monohydrate (= ipratropium bromide monohydrate) corresponding to  
250 mcg  
ipratropium bromide anhydrous 
Excipients: benzalkonium chloride, disodium edetate dihydrate, sodium
chloride, hydrochloric acid, purified water 

DESCRIPTION 
ATROVENT
®
 N 20 mcg/puff Metered Dose Inhaler 
Clear, colourless liquid, free from suspended particles  

ATROVENT
®
 0.025 % Solution for Inhalation 
Clear, colourless or almost colourless liquid, free from suspended
particles 

PROPERTIES  
Atrovent
®
 (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 Atrovent
®
 (ipratropium bromide) is primarily

Ficha técnica

ATROVENT
®
ABCD
1.
NAME OF THE MEDICINAL PRODUCT
ATROVENT
®
N Metered Dose Inhaler 20 mcg/puff
ATROVENT
®
0.025 % Nebuliser Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For ATROVENT
®
N Metered Dose Inhaler 20 mcg/puff
1 metered dose (puff) contains 21 mcg
(8r)-3α-hydroxy-8-isopropyl-1αH,5αH-tropanium bromide (±)-tropate
monohydrate (= ipratropium bromide monohydrate) corresponding to 20mcg
ipratropium bromide anhydrous.
For the full list of excipients, see section 6.1.
For ATROVENT
®
0.025 % Nebuliser Solution
1 mL (20 drops) nebuliser solution contains 261mcg
(8r)-3α-hydroxy-8-isopropyl-1αH,5αH-tropanium bromide
(±)-tropate monohydrate (= ipratropium bromide monohydrate)
corresponding to 250 mcg ipratropium bromide
anhydrous
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
For ATROVENT
®
N Metered Dose Inhaler 20 mcg/puff
Pressurised inhalation solution
For ATROVENT
®
0.025 % Nebuliser Solution
Nebuliser solution
3.1
PRODUCT DESCRIPTION
For ATROVENT
®
N Metered Dose Inhaler 20 mcg/puff
Clear, colourless liquid, free from suspended particles
For ATROVENT
®
0.025 % Nebuliser Solution
Clear, colourless or almost colourless liquid, free from suspended
particles
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For ATROVENT
®
N Metered Dose Inhaler 20 mcg/puff
ATROVENT
®
is indicated as a bronchodilator for maintenance treatment of
bronchospasm associated with
chronic obstructive pulmonary disease, including chronic bronchitis,
emphysema and asthma.
For ATROVENT
®
0.025 % Nebuliser Solution
ATROVENT
®
is indicated as a bronchodilator for maintenance treatment of
bronchospasm associated with
chronic obstructive pulmonary disease, including chronic bronchitis
and emphysema.
ATROVENT
®
is
indicated, when
used concomitantly with inhaled
beta-agonists in the
treatment of
acute
bronchospasm associated with chronic obstructive pulmonary disease
including chronic bronchitis and asthma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage should be adapted to the indivi