Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
PRAVASTATIN SODIUM
SANDOZ CANADA INCORPORATED
C10AA03
PRAVASTATIN
20MG
TABLET
PRAVASTATIN SODIUM 20MG
ORAL
100
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0122563002; AHFS:
CANCELLED PRE MARKET
2019-08-01
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION 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: June 2, 2017 Boucherville, QC, Canada J4B 7K8 Control No. 205299 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 ........................................................................ Belgenin tamamını okuyun