TARO-PRAVASTATIN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

PRAVASTATIN SODIUM

Boleh didapati daripada:

SUN PHARMA CANADA INC

Kod ATC:

C10AA03

INN (Nama Antarabangsa):

PRAVASTATIN

Dos:

40MG

Borang farmaseutikal:

TABLET

Komposisi:

PRAVASTATIN SODIUM 40MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

HMG-COA REDUCTASE INHIBITORS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2022-12-09

Ciri produk

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_TARO-PRAVASTATIN Product Monograph_ Page 1 of 39
PRODUCT MONOGRAPH
Pr
TARO-PRAVASTATIN
Pravastatin Sodium Tablets, USP
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
Sun Pharma Canada Inc.
126
East Drive
Brampton, Ontario
L6T 1C1
Control#
269572
Date of Preparation:
AUG 14, 2020
Date of Revision:
DEC
08, 2022
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_TARO-PRAVASTATIN Product Monograph_ Page 2 of 39
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
...................................................................................
18
STORAGE AND STABILITY
................................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................................
20
PART II: SCIENTIFIC INFORMATION
...................................