Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)
PRO DOC LIMITEE
C10AA05
ATORVASTATIN
80MG
TABLET
ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 80MG
ORAL
30/100
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0133055004; AHFS:
CANCELLED POST MARKET
2011-07-27
Page 1 of 48 PRODUCT MONOGRAPH Pr ATORVASTATIN – 10 Pr ATORVASTATIN – 20 Pr ATORVASTATIN – 40 Pr ATORVASTATIN – 80 (ATORVASTATIN CALCIUM TABLETS) 10 MG, 20 MG, 40 MG AND 80 MG (ATORVASTATIN AS ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) LIPID METABOLISM REGULATOR PRO DOC LTÉE DATE OF PREPARATION: 2925, BOUL. INDUSTRIEL MAY 18, 2010 LAVAL, QUÉBEC H7L 3W9 SUBMISSION CONTROL NO: 137958 Page 2 of 48 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION................................................................3 SUMMARY PRODUCT INFORMATION.................................................................................3 INDICATIONS AND CLINICAL USE.......................................................................................3 CONTRAINDICATIONS .......................................................................................................... 4 WARNINGS AND PRECAUTIONS.........................................................................................5 ADVERSE REACTIONS .......................................................................................................10 DRUG INTERACTIONS........................................................................................................11 DOSAGE AND ADMINISTRATION.......................................................................................15 OVERDOSAGE.....................................................................................................................17 ACTION AND CLINICAL PHARMACOLOGY .......................................................................17 STORAGE AND STABILITY .................................................................................................20 SPECIAL HANDLING INSTRUCTIONS................................................................................20 DOSAGE FORMS, COMPOSITION AND PACKAGING ......................................................20 PART II: SCIENTIFIC INFORMATION.................................................................................. Soma hati kamili