PRZ-ROSUVASTATIN TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
23-09-2020
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Aktiv ingrediens:
ROSUVASTATIN (ROSUVASTATIN CALCIUM)
Tilgjengelig fra:
PHARMARIS CANADA INC
ATC-kode:
C10AA07
INN (International Name):
ROSUVASTATIN
Dosering :
40MG
Legemiddelform:
TABLET
Sammensetning:
ROSUVASTATIN (ROSUVASTATIN CALCIUM) 40MG
Administreringsrute:
ORAL
Enheter i pakken:
15G/50G
Resept typen:
Prescription
Terapeutisk område:
HMG-COA REDUCTASE INHIBITORS
Produkt oppsummering:
Active ingredient group (AIG) number: 0148963003; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2020-09-25
Preparatomtale
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
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