PRAVASTATIN TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

PRAVASTATIN SODIUM

Prieinama:

SANIS HEALTH INC

ATC kodas:

C10AA03

INN (Tarptautinis Pavadinimas):

PRAVASTATIN

Dozė:

40MG

Vaisto forma:

TABLET

Sudėtis:

PRAVASTATIN SODIUM 40MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

30/100

Recepto tipas:

Prescription

Gydymo sritis:

HMG-COA REDUCTASE INHIBITORS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2010-11-03

Prekės savybės

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