País: Canadá
Língua: inglês
Origem: Health Canada
SALBUTAMOL (SALBUTAMOL SULFATE)
GLAXOSMITHKLINE INC
R03AC02
SALBUTAMOL
5MG
SOLUTION
SALBUTAMOL (SALBUTAMOL SULFATE) 5MG
INHALATION
2.5ML DOSE X 20
Prescription
SELECTIVE BETA 2-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0108887001; AHFS:
CANCELLED POST MARKET
2022-07-05
_ _ _ _ _Page 1 of 33_ _ _ 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. _ _ _ _ _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 ......................................................... Leia o documento completo