PRAVACHOL TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

PRAVASTATIN SODIUM

Tilgjengelig fra:

BRISTOL-MYERS SQUIBB CANADA

ATC-kode:

C10AA03

INN (International Name):

PRAVASTATIN

Dosering :

80MG

Legemiddelform:

TABLET

Sammensetning:

PRAVASTATIN SODIUM 80MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

HMG-COA REDUCTASE INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0122563004; AHFS:

Autorisasjon status:

CANCELLED PRE MARKET

Autorisasjon dato:

2017-05-25

Preparatomtale

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_Page 1 of 46_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PRAVACHOL
®
pravastatin sodium
10, 20, 40 and 80 mg
Lipid Metabolism Regulator
Bristol-Myers Squibb Canada
Montréal, Canada
®
Registered trademark
of Bristol-Myers Squibb Company
used under licence by Bristol-Myers Squibb Canada
Date of Preparation:
August 16, 1990
DATE OF REVISION:
MARCH 20, 2017
SUBMISSION CONTROL NO: 200020
_ _
_Page 2 of 46_
TABLE OF CONTENTS
PRODUCT MONOGRAPH
.........................................................................................................1
TABLE OF CONTENTS
.................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
..............................................................3
SUMMARY PRODUCT INFORMATION
...........................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................
3
CONTRAINDICATIONS
......................................................................................................
5
WARNINGS AND PRECAUTIONS
.....................................................................................
6
ADVERSE REACTIONS
.....................................................................................................
12
DRUG INTERACTIONS
.....................................................................................................
17
DOSAGE AND ADMINISTRATION
.................................................................................
19
OVERDOSAGE
...................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 20
STORAGE AND STABILITY
.............................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................