Country: Kanada
Tungumál: enska
Heimild: Health Canada
SALBUTAMOL (SALBUTAMOL SULFATE)
GLAXOSMITHKLINE INC
R03AC02
SALBUTAMOL
200MCG
POWDER
SALBUTAMOL (SALBUTAMOL SULFATE) 200MCG
INHALATION
60 DOSES
Prescription
SELECTIVE BETA 2-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0108887005; AHFS:
APPROVED
2001-07-26
_ _ _ _ _ _ _ _ _Page 1 of 24_ PRODUCT MONOGRAPH PR VENTOLIN DISKUS salbutamol sulfate dry powder for inhalation 200 mcg salbutamol/blister Bronchodilator (beta 2 -adrenergic agonist) GlaxoSmithKline Inc. 7333 Mississauga Road Mississauga, Ontario L5N 6L4 Date of Revision: November 17, 2017 Submission Control No: 207155 © 2017 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 ................................................................................................................11 ACTION AND CLINICAL PHARMACOLOGY ............................................................11 STORAGE AND STABILITY ..........................................................................................12 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................13 PART II: SCIENTIFIC INFORMATION ...............................................................................14 PHARMACEUTICAL INFORMATION ..........................................................................14 CLINICAL TRIALS .................. Lestu allt skjalið