VENTOLIN RESPIRATOR SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

SALBUTAMOL (SALBUTAMOL SULFATE)

Tilgængelig fra:

GLAXOSMITHKLINE INC

ATC-kode:

R03AC02

INN (International Name):

SALBUTAMOL

Dosering:

5MG

Lægemiddelform:

SOLUTION

Sammensætning:

SALBUTAMOL (SALBUTAMOL SULFATE) 5MG

Indgivelsesvej:

INHALATION

Enheder i pakken:

10 ML X 1, 10

Recept type:

Prescription

Terapeutisk område:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Produkt oversigt:

Active ingredient group (AIG) number: 0108887006; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2001-07-26

Produktets egenskaber

_VENTOLIN Respirator Solution, salbutamol sulfate solution _
_Page 1 of 27_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VENTOLIN RESPIRATOR SOLUTION
salbutamol sulfate solution
Solution, 5 mg/mL salbutamol (as sulfate), for Oral Inhalation
Bronchodilator
(beta
2
-adrenergic agonist)
GlaxoSmithKline Inc.
100 Milverton Drive, Suite 800
Mississauga, ON
L5R 4H1
Canada
Date of Initial Authorization:
December 1, 1998
Date of Revision:
September 29, 2023
Submission Control Number: 273936
©2023_ GSK group of companies or its licensor _
_Trademarks are owned by or licensed to the GSK group of companies_
_ _
_VENTOLIN Respirator Solution, salbutamol sulfate solution _
_Page 2 of 27_
RECENT MAJOR LABEL CHANGES
Not applicable
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics
.................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
4
DOSAGE AND ADMINISTRATION
..................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
...................................