מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
PRAVASTATIN SODIUM
MINT PHARMACEUTICALS INC
C10AA03
PRAVASTATIN
10MG
TABLET
PRAVASTATIN SODIUM 10MG
ORAL
30/100
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0122563001; AHFS:
APPROVED
2021-02-09
Page 1 of 39 PRODUCT MONOGRAPH Pr MINT-PRAVASTATIN Pravastatin Sodium Tablets, USP 10 mg, 20 mg and 40 mg Lipid Metabolism Regulator Mint Pharmaceuticals Inc., 6575 Davand Drive Mississauga, ON L5T 2M3 Date of Preparation: MAR 08, 2024 Control# 283801 Page 2 of 39 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 ................................................................................................... 22 PHARMACEUTICAL INFORMATION ............... קרא את המסמך השלם