PRAVASTATIN TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

PRAVASTATIN SODIUM

Beszerezhető a:

SANIS HEALTH INC

ATC-kód:

C10AA03

INN (nemzetközi neve):

PRAVASTATIN

Adagolás:

40MG

Gyógyszerészeti forma:

TABLET

Összetétel:

PRAVASTATIN SODIUM 40MG

Az alkalmazás módja:

ORAL

db csomag:

30/100

Recept típusa:

Prescription

Terápiás terület:

HMG-COA REDUCTASE INHIBITORS

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2010-11-03

Termékjellemzők

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRAVASTATIN
Pravastatin Sodium Tablets
10 mg, 20 mg and 40 mg
Manufacturer’s Standard
Lipid Metabolism Regulator
Sanis Health Inc.
Date of Revision:
1 President’s Choice Circle
November 9, 2020
Brampton, Ontario
L6Y 5S5
SUBMISSION CONTROL NO.: 244865
_ _
2
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
................................................................................
30
TOXICOLOGY
.............