APO-PRAVASTATIN TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

PRAVASTATIN SODIUM

Disponibbli minn:

APOTEX INC

Kodiċi ATC:

C10AA03

INN (Isem Internazzjonali):

PRAVASTATIN

Dożaġġ:

20MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

PRAVASTATIN SODIUM 20MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

30/100/500

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

HMG-COA REDUCTASE INHIBITORS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0122563002; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2001-02-27

Karatteristiċi tal-prodott

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
......