PRAVASTATIN-10 TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
02-03-2021
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Aktiv bestanddel:
PRAVASTATIN SODIUM
Tilgængelig fra:
PRO DOC LIMITEE
ATC-kode:
C10AA03
INN (International Name):
PRAVASTATIN
Dosering:
10MG
Lægemiddelform:
TABLET
Sammensætning:
PRAVASTATIN SODIUM 10MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100
Recept type:
Prescription
Terapeutisk område:
HMG-COA REDUCTASE INHIBITORS
Produkt oversigt:
Active ingredient group (AIG) number: 0122563001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2001-06-13
Produktets egenskaber
Page 1 of 41
PRODUCT MONOGRAPH
Pr
PRAVASTATIN
– 10
Pr
PRAVASTATIN
– 20
Pr
PRAVASTATIN
– 40
PRAVASTATIN SODIUM TABLETS USP
10 MG, 20 MG AND 40 MG
LIPID METABOLISM REGULATOR
PRO DOC LTÉE
DATE OF REVISION:
2925, boul. Industriel
March 2, 2021
Laval, Quebec
H7L 3W9
CONTROL NUMBER: 249000
Page 2 of 41
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
.........................................................................................
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