Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
PRAVASTATIN SODIUM
SIVEM PHARMACEUTICALS ULC
C10AA03
PRAVASTATIN
20MG
TABLET
PRAVASTATIN SODIUM 20MG
ORAL
15G/50G
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0122563002; AHFS:
APPROVED
2022-09-21
_PRAVASTATIN Product Monograph_ Page 1 of 40 PRODUCT MONOGRAPH Pr PRAVASTATIN pravastatin sodium tablets USP 10 mg, 20 mg and 40 mg Lipid Metabolism Regulator SIVEM PHARMACEUTICALS ULC 4705 Dobrin Street Saint-Laurent, Quebec, Canada H4R 2P7 www.sivem.ca CONTROL NUMBER: 280722 DATE OF PREPARATION: JUL 23, 2012 DATE OF REVISION NOV 27, 2023 _PRAVASTATIN Product Monograph_ Page 2 of 40 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 ..................................................................................................16 DOSAGE AND ADMINISTRATION ..............................................................................18 OVERDOSAGE ................................................................................................................19 ACTION AND CLINICAL PHARMACOLOGY ............................................................19 STORAGE AND STABILITY ..........................................................................................22 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................22 PART II: SCIENTIFIC INFORMATION .............................................................................. 23 PHARMACEUTICAL INFORMATION .........................................................................23 CLINICAL TRIALS ........................................................................................................ Baca dokumen lengkapnya