Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
SALBUTAMOL (SALBUTAMOL SULFATE)
TEVA CANADA LIMITED
R03AC02
SALBUTAMOL
1MG
SOLUTION
SALBUTAMOL (SALBUTAMOL SULFATE) 1MG
INHALATION
20(2.5ML UNIT DOSES)
Prescription
SELECTIVE BETA 2-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0108887007; AHFS:
APPROVED
2012-07-05
PRODUCT MONOGRAPH PR TEVA-SALBUTAMOL STERINEBS TM P.F. Salbutamol Sulphate Solution 1 mg / mL (2.5 mg / 2.5 mL) salbutamol per ampoule 2 mg / mL (5 mg / 2.5 mL) salbutamol per ampoule Bronchodilator (beta 2 -adrenergic agonist) Teva Canada Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 Canada www.tevacanada.com Submission Control No: 254982 Date of Revision:: Dec. 21, 2021 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 DOSAGE FORMS, COMPOSITION AND PACKAGING ...................................................... 14 PART II: SCIENTIFIC INFORMATION ............................................................................... 15 PHARMACEUTICAL INFORMATION.................................................................................. 15 CLINICAL TRIAL Belgenin tamamını okuyun