Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
MONTELUKAST (MONTELUKAST SODIUM)
RANBAXY PHARMACEUTICALS CANADA INC.
R03DC03
MONTELUKAST
4MG
TABLET (CHEWABLE)
MONTELUKAST (MONTELUKAST SODIUM) 4MG
ORAL
30
Prescription
LEUKOTRIENE MODIFIERS
Active ingredient group (AIG) number: 0133823003; AHFS:
CANCELLED POST MARKET
2022-07-28
1 ` PRODUCT MONOGRAPH PR RAN™-MONTELUKAST Montelukast Chewable Tablets montelukast (as montelukast sodium) 4mg and 5mg Leukotriene Receptor Antagonist Ranbaxy Pharmaceuticals Canada Inc. DATE OF REVISION: 126 East Drive March 21, 2016 Brampton, ON L6T 1C1 Control #: 192448 RAN Trademark owned by Sun Pharmaceutical Industries Ltd. 2 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 ............................................................................................................ 16 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................................... 17 PART II: SCIENTIFIC INFORMATION ........................................................................................... 18 CLINICAL TRIALS .................... Đọc toàn bộ tài liệu