Country: Կանադա
language: անգլերեն
source: Health Canada
PRAVASTATIN SODIUM
DOMINION PHARMACAL
C10AA03
PRAVASTATIN
20MG
TABLET
PRAVASTATIN SODIUM 20MG
ORAL
100/500
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0122563002; AHFS:
APPROVED
2004-05-03
PRODUCT MONOGRAPH PR DOM-PRAVASTATIN Pravastatin Sodium Tablets, House Standard 10 mg, 20 mg and 40 mg Lipid Metabolism Regulator DOMINION PHARMACAL 6111 Royalmount Ave., Suite 100 Montréal, Québec H4P 2T4 Date of Revision: June 7, 2017 Submission Control No.: 205830 _ _ _Dom-PRAVASTATIN Product Monograph _ _Page 2 of 41_ 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 ................................................................................................. 10 DRUG INTERACTIONS .................................................................................................. 14 DOSAGE AND ADMINISTRATION .............................................................................. 16 OVERDOSAGE ................................................................................................................ 17 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 18 STORAGE AND STABILITY ......................................................................................... 20 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 20 PART II: SCIENTIFIC INFORMATION ............................................................................... 21 PHARMACEUTICAL INFORMATION ......................................................................... 21 CLINICAL TRIALS .......................................................................................................... 22 DETAILED PHARMACOLOGY ..................... read_full_document