ACT PRAVASTATIN TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
06-06-2017
Noen dokumenter for dette produktet er ikke tilgjengelig for øyeblikket, du kan sende en forespørsel til kundeservicen vår, og vi vil varsle deg så snart vi kan få dem.
Send forespørsel.
Send forespørsel.
Aktiv ingrediens:
PRAVASTATIN SODIUM
Tilgjengelig fra:
ACTAVIS PHARMA COMPANY
ATC-kode:
C10AA03
INN (International Name):
PRAVASTATIN
Dosering :
40MG
Legemiddelform:
TABLET
Sammensetning:
PRAVASTATIN SODIUM 40MG
Administreringsrute:
ORAL
Enheter i pakken:
30/100/500
Resept typen:
Prescription
Terapeutisk område:
HMG-COA REDUCTASE INHIBITORS
Produkt oppsummering:
Active ingredient group (AIG) number: 0122563003; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2018-06-26
Preparatomtale
_ _
_ _
_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
.................................................
Les hele dokumentet
