Country: Canada
Language: English
Source: Health Canada
SALBUTAMOL (SALBUTAMOL SULFATE)
PHARMEL INC
R03AC02
SALBUTAMOL
0.5MG
SOLUTION
SALBUTAMOL (SALBUTAMOL SULFATE) 0.5MG
INHALATION
2.5ML POLYNEBS
Prescription
SELECTIVE BETA 2-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0108887009; AHFS:
CANCELLED POST MARKET
2016-10-08
PRODUCT MONOGRAPH PR PHL-SALBUTAMOL RESPIRATOR SOLUTION Salbutamol Sulphate Inhalation Solution 0.05%; 0.1%; 0.2%; 0.5% 0.5 mg/mL; 1 mg/mL; 2 mg/mL; 5 mg/mL BRONCHODILATOR Beta 2 -adrenergic stimulant PHARMEL INC. 6111 Royalmount Ave., Suite 100 Montréal, Canada H4P 2T4 Date of Revision: October 07, 2016 Submission Control No: 198569 _ _ _phl-SALBUTAMOL RESPIRATOR SOLUTION Product Monograph Page 2 of 36_ 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 ................................................................................................................ 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 TRIALS ................................................................... Read the complete document