NU-SALBUTAMOL PLASTIC AMPULES 1 MG/ML SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

SALBUTAMOL (SALBUTAMOL SULFATE)

Διαθέσιμο από:

NU-PHARM INC

Φαρμακολογική κατηγορία (ATC):

R03AC02

INN (Διεθνής Όνομα):

SALBUTAMOL

Δοσολογία:

1MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

SALBUTAMOL (SALBUTAMOL SULFATE) 1MG

Οδός χορήγησης:

INHALATION

Μονάδες σε πακέτο:

2.5ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0108887007; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2012-09-04

Αρχείο Π.Χ.Π.

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