ADVICOR TABLET (IMMEDIATE RELEASE)
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
02-11-2010
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Aktiva substanser:
NICOTINIC ACID; LOVASTATIN
Tillgänglig från:
SEPRACOR PHARMACEUTICALS INC
ATC-kod:
C10BA01
INN (International namn):
LOVASTATIN AND NICOTINIC ACID
Dos:
1000MG; 20MG
Läkemedelsform:
TABLET (IMMEDIATE RELEASE)
Sammansättning:
NICOTINIC ACID 1000MG; LOVASTATIN 20MG
Administreringssätt:
ORAL
Enheter i paketet:
90
Receptbelagda typ:
Prescription
Terapiområde:
HMG-COA REDUCTASE INHIBITORS
Produktsammanfattning:
Active ingredient group (AIG) number: 0251302002; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2012-08-02
Produktens egenskaper
PRODUCT MONOGRAPH
PR
ADVICOR
®
extended-release niacin and lovastatin tablets
500/20 mg, 750/20 mg, 1000/20 mg and 1000/40 mg Film-Coated Tablets
Lipid Metabolism Regulator
Manufacturer:
DATE OF REVISION
:
Sepracor Pharmaceuticals, Inc.
OCTOBER 29, 2010
Mississauga, Ontario
Canada
CONTROL NO. 141231
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................ 3
SUMMARY PRODUCT
INFORMATION................................................................................
3
INDICATIONS AND CLINICAL
USE......................................................................................
3
CONTRAINDICATIONS...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
10
DRUG
INTERACTIONS..........................................................................................................
16
DOSAGE AND
ADMINISTRATION......................................................................................
17
OVERDOSAGE
........................................................................................................................
19
ACTION AND CLINICAL
PHARMACOLOGY....................................................................
19
STORAGE AND STABILITY
.................................................................................................
23
DOSAGE FORMS, COMPOSITION AND
PACKAGING..................................................... 23
PART II: SCIENTIFIC INFORMATION
..............................................................................
24
PHARMACEUTICAL INFORMATION
.................................................................................
24
CLINICAL
TRIALS...........................................................................................
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