TEVA-SALBUTAMOL HFA METERED-DOSE AEROSOL

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

SALBUTAMOL (SALBUTAMOL SULFATE)

Disponible depuis:

TEVA CANADA LIMITED

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: 0108887013; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2009-12-07

Résumé des caractéristiques du produit

_Page 1_
PRODUCT MONOGRAPH
Pr
TEVA-SALBUTAMOL HFA
salbutamol (as salbutamol sulfate)
Inhalation Aerosol
100 mcg salbutamol per actuation
Bronchodilator
(beta
2
-adrenergic agonist)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No: 213098
Date of Revision:
March 20, 2018
_Page 2_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
....................................................................................................
3
WARNINGS AND PRECAUTIONS
..................................................................................
4
ADVERSE REACTIONS
....................................................................................................
7
DRUG INTERACTIONS
..................................................................................................
10
DOSAGE AND ADMINISTRATION
..............................................................................
11
OVERDOSAGE
.................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 13
STORAGE AND STABILITY
..........................................................................................
15
SPECIAL HANDLING INSTRUCTIONS
........................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 15
PART II: SCIENTIFIC INFORMATION
...............................................................................
16
PHARMACEUTICAL INFORMATION
..........................................................................
16
CLINICAL TRIALS
..........................