Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
PRAVASTATIN SODIUM
ACTAVIS PHARMA COMPANY
C10AA03
PRAVASTATIN
20MG
TABLET
PRAVASTATIN SODIUM 20MG
ORAL
30/100/500
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0122563002; AHFS:
CANCELLED POST MARKET
2018-06-26
_ _ _ _ _Page 1 of 44_ PRODUCT MONOGRAPH Pr ACT PRAVASTATIN Pravastatin Sodium 10 mg, 20 mg and 40 mg Tablets USP Lipid Metabolism Regulator Actavis Pharma Company 6733 Mississauga Road, Suite 400 Mississauga, Ontario L5N 6J5 Date of Revision: June 2, 2017 Submission Control No: 205793 _ _ _Page 2 of 44_ 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 ........................................................... 19 STORAGE AND STABILITY ......................................................................................... 21 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 21 PART II: SCIENTIFIC INFORMATION ............................................................................... 23 PHARMACEUTICAL INFORMATION ......................................................................... 23 CLINICAL TRIALS ......................................................................................................... 24 DETAILED PHARMACOLOGY ................................................. Διαβάστε το πλήρες έγγραφο