Land: Canada
Språk: engelsk
Kilde: Health Canada
SALBUTAMOL (SALBUTAMOL SULFATE)
PHARMASCIENCE INC
R03AC02
SALBUTAMOL
1MG
SOLUTION
SALBUTAMOL (SALBUTAMOL SULFATE) 1MG
INHALATION
2.5ML
Prescription
SELECTIVE BETA 2-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0108887007; AHFS:
APPROVED
2010-05-04
PRODUCT MONOGRAPH PR PMS-SALBUTAMOL Salbutamol Sulphate Inhalation Solution, BP 0.05%; 0.1%; 0.2% 0.5 mg/mL; 1 mg/mL; 2 mg/mL BRONCHODILATOR Beta 2 -adrenergic stimulant PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Canada H4P 2T4 Date of Revision: August 10, 2018 www.pharmascience.com Submission Control No: 217525 _ _ _pms-SALBUTAMOL Product Monograph 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 .................................................................................................... 8 DOSAGE AND ADMINISTRATION ................................................................................ 9 OVERDOSAGE ................................................................................................................ 11 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 11 STORAGE AND STABILITY ......................................................................................... 13 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 13 PART II: SCIENTIFIC INFORMATION ............................................................................... 14 PHARMACEUTICAL INFORMATION ......................................................................... 14 CLINICAL TRIALS ........................................................................................... Les hele dokumentet