PMS-SALBUTAMOL SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SALBUTAMOL (SALBUTAMOL SULFATE)

Available from:

PHARMASCIENCE INC

ATC code:

R03AC02

INN (International Name):

SALBUTAMOL

Dosage:

1MG

Pharmaceutical form:

SOLUTION

Composition:

SALBUTAMOL (SALBUTAMOL SULFATE) 1MG

Administration route:

INHALATION

Units in package:

2.5ML

Prescription type:

Prescription

Therapeutic area:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2010-05-04

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
PMS-SALBUTAMOL
Salbutamol Sulphate Inhalation Solution, BP
0.05%; 0.1%; 0.2%
0.5 mg/mL; 1 mg/mL; 2 mg/mL
BRONCHODILATOR
Beta
2
-adrenergic stimulant
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
Date of Revision:
August 10, 2018
www.pharmascience.com
Submission Control No: 217525
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_pms-SALBUTAMOL Product Monograph Page 2 of 24_
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
....................................................................................................
8
DOSAGE AND ADMINISTRATION
................................................................................
9
OVERDOSAGE
................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 11
STORAGE AND STABILITY
.........................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 13
PART II: SCIENTIFIC INFORMATION
...............................................................................
14
PHARMACEUTICAL INFORMATION
.........................................................................
14
CLINICAL TRIALS
...........................................................................................