NU-SALBUTAMOL PLASTIC AMPULES 2 MG/ML SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

SALBUTAMOL (SALBUTAMOL SULFATE)

MAH:

NU-PHARM INC

ATC_code:

R03AC02

INN:

SALBUTAMOL

dosage:

2MG

pharmaceutical_form:

SOLUTION

composition:

SALBUTAMOL (SALBUTAMOL SULFATE) 2MG

administration_route:

INHALATION

units_in_package:

2.5ML

prescription_type:

Prescription

therapeutic_area:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

leaflet_short:

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

authorization_status:

CANCELLED POST MARKET

authorization_date:

2012-09-04

SPC

PRODUCT MONOGRAPH
NU-SALBUTAMOL RESPIRATOR SOLUTIONS
(Salbutamol Sulfate Solutions BP)
NU-SALBUTAMOL Respirator Solution 50 mg/10 mL (5 mg/mL Salbutamol)
NU-SALBUTAMOL Plastic Ampules 2.5 mg/2.5 mL (1 mg/mL Salbutamol)
NU-SALBUTAMOL Plastic Ampules 5.0 mg/2.5 mL (2 mg/mL Salbutamol)
Bronchodilator, Β
2
-adrenergic Stimulant
NU PHARM Inc.
50 Mural Street, Units 1 & 2
Richmond Hill, Ontario
DATE OF REVISION:
L4B 1E4
December 16, 2004
Control # 094010
PRODUCT MONOGRAPH
NU-SALBUTAMOL RESPIRATOR SOLUTIONS
(Salbutamol Sulfate Solutions BP)
NU-SALBUTAMOL Respirator Solution 50 mg/10 mL (5 mg/mL Salbutamol)
NU-SALBUTAMOL Plastic Ampules 2.5 mg/2.5 mL (1 mg/mL Salbutamol)
NU-SALBUTAMOL Plastic Ampules 5.0 mg/2.5 mL (2 mg/mL Salbutamol)
THERAPEUTIC CLASSIFICATION
Bronchodilator, β
2
-adrenergic Stimulant
ACTIONS AND 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.
At
therapeutic
doses,
salbutamol
has
little
action
on
the
beta
1
-adrenergic
receptors in cardiac muscle (salbutamol inhalation aerosol and dry
powder formulations).
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
NU-SALBUTAMOL Respirator Solutions (Salbutamol Sulfate Solution BP)
are 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, NU-SALBUTAMOL Respirator Solutions (Salbutamol Sulfate
Solution BP) should be
used with compressed air or oxygen.
- 2 -
CONTRAINDICATIONS
Hypersens