Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
PRAVASTATIN SODIUM
AURO PHARMA INC
C10AA03
PRAVASTATIN
10MG
TABLET
PRAVASTATIN SODIUM 10MG
ORAL
30/100/500
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0122563001; AHFS:
APPROVED
2016-11-21
Page 1 of 40 PRODUCT MONOGRAPH PR AURO-PRAVASTATIN Pravastatin Tablets, BP 10 mg, 20 mg and 40 mg of pravastatin sodium Lipid Metabolism Regulator AURO PHARMA INC. 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8 CANADA Date of Revision: August 7, 2020 SUBMISSION CONTROL NO: 239425 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 ..........................…….............. 6 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 ...............................................……………...... 24 DETAILED PHARMACOLOGY ..............................…………….. 30 TOXICOLOGY ...........................…………………………............ 31 REFERENCE…...................................…………………………..... 36 PART III: CONSUMER INFORMATION.....................…………………....... 41 Page 3 of 40 PR AURO-PRAVASTATIN Pravastatin Tablets, BP 10 mg, 20 mg and 40 mg of pravastatin sodium PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION ROUTE OF ADMINISTRATION DOSAGE FORM / STRENGTH ALL NON-MEDICINAL INGREDIENTS Přečtěte si celý dokument