PRZ-ROSUVASTATIN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ROSUVASTATIN (ROSUVASTATIN CALCIUM)

Boleh didapati daripada:

PHARMARIS CANADA INC

Kod ATC:

C10AA07

INN (Nama Antarabangsa):

ROSUVASTATIN

Dos:

40MG

Borang farmaseutikal:

TABLET

Komposisi:

ROSUVASTATIN (ROSUVASTATIN CALCIUM) 40MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

15G/50G

Jenis preskripsi:

Prescription

Kawasan terapeutik:

HMG-COA REDUCTASE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0148963003; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2020-09-25

Ciri produk

Page 1 of 43
PRODUCT MONOGRAPH
PR
PRZ-ROSUVASTATIN
Rosuvastatin Calcium Tablets, USP
Tablets: 5 mg, 10 mg, 20 mg and 40 mg of rosuvastatin (as rosuvastatin
calcium)
Lipid Metabolism Regulator
Pharmaris Canada Inc.
8310-130 Street, Suite 102,
Surrey, British Columbia
Canada V3W 8J9
DATE OF PREPARATION: September 23,
2020
CONTROL NO: 234091
Page 2 of 43
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
................................................................. 3
INDICATIONS AND CLINICAL
USE.......................................................................
3
CONTRAINDICATIONS
............................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................
5
ADVERSE REACTIONS
..........................................................................................
10
DRUG INTERACTIONS
...........................................................................................
14
DOSAGE AND ADMINISTRATION
.......................................................................
21
OVERDOSAGE
.........................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
..................................................... 23
STORAGE AND STABILITY
..................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................... 26
PART II: SCIENTIFIC INFORMATION
.............................................................................
27
PHARMACEUTICAL INFORMATION
.................................................................. 27
CLINICAL
TRIALS...................................................................................................
28
DETAILED PHARMACOLOGY
..............................................................................
31
TOXICO