NIASPAN FCT TABLET (EXTENDED-RELEASE)
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
18-10-2017
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
NICOTINIC ACID
Fáanlegur frá:
SUNOVION PHARMACEUTICALS CANADA INC
ATC númer:
C10AD02
INN (Alþjóðlegt nafn):
NICOTINIC ACID
Skammtar:
500MG
Lyfjaform:
TABLET (EXTENDED-RELEASE)
Samsetning:
NICOTINIC ACID 500MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
3/90
Gerð lyfseðils:
Prescription
Lækningarsvæði:
MISCELLANEOUS ANTILIPEMIC AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0108396003; AHFS:
Leyfisstaða:
CANCELLED POST MARKET
Leyfisdagur:
2019-07-22
Vara einkenni
PRODUCT MONOGRAPH
PR
NIASPAN FCT
®
Extended-Release Niacin
500 mg and 1000 mg Extended-Release Film Coated Tablets
Lipid Metabolism Regulator
Manufacturer:
Sunovion Pharmaceuticals Canada Inc.
6790 Century Ave., Suite 100
Mississauga, Ontario
Canada
DATE OF REVISION:
October 18, 2017
SUBMISSION CONTROL NUMBER:
208538
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
...........................................................................................................
7
DRUG INTERACTIONS
..........................................................................................................
11
DOSAGE AND ADMINISTRATION
......................................................................................
12
OVERDOSAGE
........................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
15
STORAGE AND STABILITY
.................................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 17
PART II: SCIENTIFIC INFORMATION
..............................................................................
18
PHARMACEUTICAL INFORMATION
.................................................................................
18
CLINICAL
TRIALS.................................................................
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