AVA-PRAVASTATIN TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

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Fachinformation Fachinformation (SPC)
30-03-2011

Wirkstoff:

PRAVASTATIN SODIUM

Verfügbar ab:

AVANSTRA INC

ATC-Code:

C10AA03

INN (Internationale Bezeichnung):

PRAVASTATIN

Dosierung:

40MG

Darreichungsform:

TABLET

Zusammensetzung:

PRAVASTATIN SODIUM 40MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Therapiebereich:

HMG-COA REDUCTASE INHIBITORS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0122563003; AHFS:

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2011-12-12

Fachinformation

                                Page 1 of 42
PRODUCT MONOGRAPH
Pr
AVA-PRAVASTATIN
PRAVASTATIN SODIUM
10, 20 AND 40 MG TABLETS
LIPID METABOLISM REGULATOR
AVANSTRA INC. DATE OF PREPARATION:
10761 – 25TH NE, SUITE 110, BUILDING “B” FEBRUARY 21, 2011
CALGARY, ALBERTA
T2C 3C2
CONTROL NO.: 145177
Page 2 of 42
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.......................................................................................................
10
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
.............................................................................
22
PHARMACEUTICAL
INFORMATION...............................................................................
22
CLINICAL TRIALS
...............................................................................................................
23
DETAILED PHARMACOLOGY
.......
                                
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