VENTOLIN NEBULES P.F. - 5MG/2.5ML SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SALBUTAMOL (SALBUTAMOL SULFATE)

Available from:

GLAXOSMITHKLINE INC

ATC code:

R03AC02

INN (International Name):

SALBUTAMOL

Dosage:

5MG

Pharmaceutical form:

SOLUTION

Composition:

SALBUTAMOL (SALBUTAMOL SULFATE) 5MG

Administration route:

INHALATION

Units in package:

2.5ML DOSE X 20

Prescription type:

Prescription

Therapeutic area:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2022-07-05

Summary of Product characteristics

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_Page 1 of 33_
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PRODUCT MONOGRAPH
PR
VENTOLIN
RESPIRATOR SOLUTION
salbutamol sulfate solution
5 mg/mL
PR
VENTOLIN NEBULES P.F.
salbutamol sulfate solution
2.5 mg/2.5 mL, 5 mg/2.5 mL ampoules
Bronchodilator
(beta
2
-adrenergic agonist)
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
November 17, 2017
Submission Control No: 207158
© 2017 GSK group of companies or its licensor.
Trademarks are owned by or licensed to the GSK
group of companies.
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_Page 2 of 33_
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
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND STABILITY
..........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
...............................................................................16
PHARMACEUTICAL INFORMATION
.........................................................