Land: Canada
Språk: engelsk
Kilde: Health Canada
SALBUTAMOL (SALBUTAMOL SULFATE)
GLAXOSMITHKLINE INC
R03AC02
SALBUTAMOL
5MG
SOLUTION
SALBUTAMOL (SALBUTAMOL SULFATE) 5MG
INHALATION
10 ML X 1, 10
Prescription
SELECTIVE BETA 2-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0108887006; AHFS:
APPROVED
2001-07-26
_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 ................................... Les hele dokumentet