PRAVASTATIN-10 TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

PRAVASTATIN SODIUM

Saadav alates:

PRO DOC LIMITEE

ATC kood:

C10AA03

INN (Rahvusvaheline Nimetus):

PRAVASTATIN

Annus:

10MG

Ravimvorm:

TABLET

Koostis:

PRAVASTATIN SODIUM 10MG

Manustamisviis:

ORAL

Ühikuid pakis:

100

Retsepti tüüp:

Prescription

Terapeutiline ala:

HMG-COA REDUCTASE INHIBITORS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0122563001; AHFS:

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2001-06-13

Toote omadused

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
.........................................................................................