ATORVASTATIN-20 TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
18-05-2010
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Aktiva substanser:
ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)
Tillgänglig från:
PRO DOC LIMITEE
ATC-kod:
C10AA05
INN (International namn):
ATORVASTATIN
Dos:
20MG
Läkemedelsform:
TABLET
Sammansättning:
ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 20MG
Administreringssätt:
ORAL
Enheter i paketet:
100/500
Receptbelagda typ:
Prescription
Terapiområde:
HMG-COA REDUCTASE INHIBITORS
Produktsammanfattning:
Active ingredient group (AIG) number: 0133055002; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2011-07-27
Produktens egenskaper
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..................................................................................
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