البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
PRAVASTATIN SODIUM
MANTRA PHARMA INC
C10AA03
PRAVASTATIN
20MG
TABLET
PRAVASTATIN SODIUM 20MG
ORAL
100
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0122563002; AHFS:
CANCELLED PRE MARKET
2018-04-19
Page 1 of 44 PRODUCT MONOGRAPH Pr M-PRAVASTATIN Pravastatin Sodium Tablets, USP 10 mg, 20 mg and 40 mg Lipid Metabolism Regulator Mantra Pharma Inc. Date of Preparation: 4605-B boul. Lapinière, Suite 250 August 15, 2017 Brossard, Quebec J4Z 3T5 Control# 207352 Page 2 of 44 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .............................................................................. 3 SUMMARY PRODUCT INFORMATION ............................................................................................... 3 INDICATIONS AND CLINICAL USE .................................................................................................... 3 CONTRAINDICATIONS .......................................................................................................................... 5 WARNINGS AND PRECAUTIONS ........................................................................................................ 5 ADVERSE REACTIONS ........................................................................................................................ 11 DRUG INTERACTIONS ........................................................................................................................ 15 DOSAGE AND ADMINISTRATION .................................................................................................... 17 OVERDOSAGE ....................................................................................................................................... 18 ACTION AND CLINICAL PHARMACOLOGY ................................................................................... 19 STORAGE AND STABILITY ................................................................................................................ 21 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................................... 21 PART II: SCIENTIFIC INFORMATION ................................................................................................... 23 PHARMACEUTICAL INFORMATION ..... اقرأ الوثيقة كاملة