APO-PRAVASTATIN TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
17-07-2020
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Werkstoffen:
PRAVASTATIN SODIUM
Beschikbaar vanaf:
APOTEX INC
ATC-code:
C10AA03
INN (Algemene Internationale Benaming):
PRAVASTATIN
Dosering:
40MG
farmaceutische vorm:
TABLET
Samenstelling:
PRAVASTATIN SODIUM 40MG
Toedieningsweg:
ORAL
Eenheden in pakket:
30/100
Prescription-type:
Prescription
Therapeutisch gebied:
HMG-COA REDUCTASE INHIBITORS
Product samenvatting:
Active ingredient group (AIG) number: 0122563003; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2001-02-27
Productkenmerken
Page 1 of 40
PRODUCT MONOGRAPH
Pr
APO-PRAVASTATIN
PRAVASTATIN SODIUM TABLETS USP
10 MG, 20 MG AND 40 MG
LIPID METABOLISM REGULATOR
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
JULY 17, 2020
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 240816
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
........................................................................................
5
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
......
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