SALBUTAMOL INHALATION SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

SALBUTAMOL (SALBUTAMOL SULFATE)

MAH:

IVAX PHARMACEUTICALS INCORPORATED

ATC_code:

R03AC02

INN:

SALBUTAMOL

dosage:

2MG

pharmaceutical_form:

SOLUTION

composition:

SALBUTAMOL (SALBUTAMOL SULFATE) 2MG

administration_route:

INHALATION

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0108887001; AHFS:

authorization_status:

CANCELLED PRE MARKET

authorization_date:

2018-07-24

SPC

PRODUCT MONOGRAPH
SALBUTAMOL INHALATION SOLUTION
(salbutamol sulphate respirator solution)
1 mg salbutamol/mL (2.5 mg/2.5 mL) in unit dose nebules
2 mg salbutamol/mL (5 mg/2.5 mL) in unit dose nebules
BRONCHODILATOR
(beta
2
-adrenergic stimulant)
MANUFACTURER:
IVAX PHARMACEUTICALS INC DATE OF PREPARATION: 05 JUNE, 2001
4400 BISCAYNE BLVD.,
MIAMI, FLORIDA, USA DATE OF REVISION: 26 FEBRUARY, 2004
33137
CONTROL # 089878
DISTRIBUTED BY:
IVAX PHARMACEUTICALS CANADA INC.
1 PLACE VILLE-MARIE, SUITE 3900
MONTREAL, QUEBEC, CANADA
H3B 4M7
2
PRODUCT MONOGRAPH
SALBUTAMOL INHALATION SOLUTION
(salbutamol sulphate respirator solution)
1 mg salbutamol/mL (2.5 mg/2.5 mL) in unit dose nebules
2 mg salbutamol/mL (5 mg/2.5 mL) in unit dose nebules
BRONCHODILATOR
(beta
2
-adrenergic stimulant)
CLINICAL PHARMACOLOGY
Salbutamol produces bronchodilation through stimulation of beta
2
-adrenergic receptors in
bronchial smooth muscle, thereby causing relaxation of bronchial
muscle fibres. This action
is manifested by an improvement in pulmonary function as demonstrated
by spirometric
measurements.
A measurable decrease in airway resistance is typically observed 5 to
15 minutes after
inhalation of salbutamol. The maximum improvement in pulmonary
function usually occurs
60 to 90 minutes after salbutamol treatment, and significant
bronchodilator activity has been
observed to persist for 3 to 6 hours.
INDICATIONS AND CLINICAL USE
SALBUTAMOL INHALATION SOLUTION (salbutamol sulphate respirator
solution) is
indicated for the treatment of severe bronchospasm associated with
exacerbations of chronic
bronchitis and bronchial asthma. They can be used by "wet"
nebulization. When
administered through a nebulizer, salbutamol respirator solutions
should be used with
compressed air or oxygen.
3
CONTRAINDICATIONS
Salbutamol is contraindicated in patients with a hypersensitivity to
any of the ingredients and
in patients with tachyarrythmias.
WARNINGS
USE OF ANTI-INFLAMMATORY
AGENTS:
In accordance with the present practice for
asthma treatment, concomitant a