Страна: Канада
мова: англійська
Джерело: Health Canada
PRAVASTATIN SODIUM
RANBAXY PHARMACEUTICALS CANADA INC.
C10AA03
PRAVASTATIN
40MG
TABLET
PRAVASTATIN SODIUM 40MG
ORAL
100
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0122563003; AHFS:
APPROVED
2009-08-20
_ _ _ _ 1 PRODUCT MONOGRAPH Pr PRAVASTATIN TABLETS (pravastatin sodium) TABLETS, 10, 20, AND 40 MG LIPID METABOLISM REGULATOR Ranbaxy Pharmaceuticals Canada Inc., 2680 Matheson Blvd. East, Suite 200 Mississauga, Ontario L4W 0A5 Date of Preparation: August 17, 2009 CONTROL # 131984 _ _ _ _ 2 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION …………………………….. 3 SUMMARY PRODUCT INFORMATION ………………………………………. 3 INDICATIONS AND CLINICAL USE ……………………………….……… 3 CONTRAINDICATIONS ………………………………………………………… 7 WARNINGS AND PRECAUTIONS …………………………………………….. 8 ADVERSE REACTIONS ……………………………………………………….. 13 DRUG INTERACTIONS ……………………………………………………….. 17 DOSAGE AND ADMINISTRATION …………………………………………… 19 OVERDOSAGE ………………………………………………………………. 21 ACTION AND CLINICAL PHARMACOLOGY ………………………..…….... 21 STORAGE AND STABILITY …………………………………………………… 24 DOSAGE FORMS, COMPOSITION AND PACKAGING ……………….…….. 24 PART II: SCIENTIFIC INFORMATION ……………………………………………… 25 PHARMACEUTICAL INFORMATION ……………………………………..… 25 CLINICAL TRIALS ……………………………………………………………... 25 DETAILED PHARMACOLOGY ………………………………………………… 31 TOXICOLOGY …………………………………………………………......…….. 33 REFERENCES ………………………....………………………………………… 37 PART III: CONSUMER INFORMATION ………………………….………………… 42 _ _ _ _ 3 PRODUCT MONOGRAPH PRAVASTATIN TABLETS (PRAVASTATIN SODIUM) Tablets, 10, 20, and 40 mg PART I: HEALTH PROFESSIONAL INFORMATION SUMMAR Прочитайте повний документ