Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
MONTELUKAST (MONTELUKAST SODIUM)
APOTEX INC
R03DC03
MONTELUKAST
5MG
TABLET (CHEWABLE)
MONTELUKAST (MONTELUKAST SODIUM) 5MG
ORAL
15G/50G
Prescription
LEUKOTRIENE MODIFIERS
Active ingredient group (AIG) number: 0133823001; AHFS:
APPROVED
2019-04-26
Page 1 of 31 PRODUCT MONOGRAPH PR APO-MONTELUKAST montelukast (as montelukast sodium) 4 mg and 5 mg chewable tablets Leukotriene Receptor Antagonist APOTEX INC. DATE OF REVISION: 150 Signet Drive November 2, 2021 Toronto, Ontario M9L 1T9 SUBMISSION CONTROL NO.: 256160 Page 2 of 31 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ............................................................. 3 SUMMARY PRODUCT INFORMATION ................................................................................ 3 INDICATIONS AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS ....................................................................................................... 4 WARNINGS AND PRECAUTIONS ........................................................................................ 4 ADVERSE REACTIONS........................................................................................................ 7 DRUG INTERACTIONS .......................................................................................................10 DOSAGE AND ADMINISTRATION......................................................................................12 OVERDOSAGE ...................................................................................................................13 ACTION AND CLINICAL PHARMACOLOGY.......................................................................13 STORAGE AND STABILITY ................................................................................................17 DOSAGE FORMS, COMPOSITION AND PACKAGING..........................................................17 PART II: SCIENTIFIC INFORMATION.................................................................................18 PHARMACEUTICAL INFORMATION ..................................................................................18 CLINICAL TRIALS..............................................................................................................19 TOX Aqra d-dokument sħiħ