Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
PRAVASTATIN SODIUM
SANDOZ CANADA INCORPORATED
C10AA03
PRAVASTATIN
40MG
TABLET
PRAVASTATIN SODIUM 40MG
ORAL
30/100/250/500
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0122563003; AHFS:
CANCELLED POST MARKET
2017-05-29
PRODUCT MONOGRAPH PR SANDOZ PRAVASTATIN Pravastatin Sodium 10 mg, 20 mg and 40 mg tablets Lipid Metabolism Regulator Sandoz Canada Inc. 145 Jules-Léger Date of Revision: February 16, 2017 Boucherville, QC, Canada J4B 7K8 Control No. 202280 Sandoz Pravastatin 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 ......................................................................................................... 11 DRUG INTERACTIONS .......................................................................................................... 15 DOSAGE AND ADMINISTRATION ...................................................................................... 17 OVERDOSAGE ........................................................................................................................ 18 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 ............................................................................................................ Prečítajte si celý dokument