SALBUTAMOL HFA METERED-DOSE AEROSOL

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

SALBUTAMOL (SALBUTAMOL SULFATE)

Disponible depuis:

SANIS HEALTH INC

Code ATC:

R03AC02

DCI (Dénomination commune internationale):

SALBUTAMOL

Dosage:

100MCG

forme pharmaceutique:

METERED-DOSE AEROSOL

Composition:

SALBUTAMOL (SALBUTAMOL SULFATE) 100MCG

Mode d'administration:

INHALATION

Unités en paquet:

200 DOSES

Type d'ordonnance:

Prescription

Domaine thérapeutique:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Descriptif du produit:

Active ingredient group (AIG) number: 0108887003; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2014-02-10

Résumé des caractéristiques du produit

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_Page 1 of 24_
PRODUCT MONOGRAPH
PR
SALBUTAMOL HFA
salbutamol sulfate inhalation aerosol
(100 mcg salbutamol/metered dose)
Bronchodilator
(beta
2
-adrenergic agonist)
SANIS HEALTH INC.
1 Presidents Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision:
July 3, 2018
Submission Control No.: 216774
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_Page 2 of 24_
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................14
SPECIAL HANDLING INSTRUCTIONS
.......................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
...................................