ATORVASTATIN TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
05-11-2012
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Aktívna zložka:
ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)
Dostupné z:
APOTEX INC
ATC kód:
C10AA05
INN (Medzinárodný Name):
ATORVASTATIN
Dávkovanie:
20MG
Forma lieku:
TABLET
Zloženie:
ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 20MG
Spôsob podávania:
ORAL
Počet v balení:
250ML
Typ predpisu:
Prescription
Terapeutické oblasti:
HMG-COA REDUCTASE INHIBITORS
Prehľad produktov:
Active ingredient group (AIG) number: 0133055002; AHFS:
Stav Autorizácia:
MARKETED
Dátum Autorizácia:
2013-01-07
Súhrn charakteristických
Page 1 of 46
PRODUCT MONOGRAPH
Pr
ATORVASTATIN
(ATORVASTATIN CALCIUM TABLETS)
10 MG, 20 MG, 40 MG AND 80 MG
(ATORVASTATIN AS ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)
LIPID METABOLISM REGULATOR
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
NOVEMBER 5, 2012
TORONTO, ONTARIO
M9L 1T9
SUBMISSION CONTROL NO: 159558
Page 2 of 46
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
......................................................................................................................
9
DRUG INTERACTIONS
.....................................................................................................................
12
DOSAGE AND ADMINISTRATION
.................................................................................................
16
OVERDOSAGE
...................................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................
18
STORAGE AND STABILITY
.............................................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
..........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................ 21
PART II: SCIENTIFIC INFORMATION
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