Riik: Kanada
keel: inglise
Allikas: Health Canada
SALBUTAMOL (SALBUTAMOL SULFATE)
GLAXOSMITHKLINE INC
R03AC02
SALBUTAMOL
100MCG
METERED-DOSE AEROSOL
SALBUTAMOL (SALBUTAMOL SULFATE) 100MCG
INHALATION
200 DOSES
Prescription
SELECTIVE BETA 2-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0108887003; AHFS:
APPROVED
2001-08-14
_Page 1 of 24_ PRODUCT MONOGRAPH PR VENTOLIN HFA salbutamol pressurised inhalation, suspension Mfr. Std. 100 mcg salbutamol (as salbutamol sulfate) / metered dose Bronchodilator (beta 2 -adrenergic agonist) GlaxoSmithKline Inc. 7333 Mississauga Road Mississauga, Ontario L5N 6L4 www.gsk.ca Date of Revision: March 16, 2021 Submission Control No.: 244377 © 2021 GSK group of companies or its licensor. Trademarks are owned by or licensed to the GSK group of companies. _ _ _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 ................................................................................................ 9 DOSAGE AND ADMINISTRATION ........................................................................... 10 OVERDOSAGE ............................................................................................................ 12 ACTION AND CLINICAL PHARMACOLOGY .......................................................... 12 STORAGE AND STABILITY ...................................................................................... 14 SPECIAL HANDLING INSTRUCTIONS .................................................................... 14 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................... 14 PART II: SCIENTIFIC INFORMATION ............................................................................ 15 PHARMACEUTICAL INFORMATION................ Lugege kogu dokumenti