NIASPAN FCT TABLET (EXTENDED-RELEASE)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

NICOTINIC ACID

Boleh didapati daripada:

SUNOVION PHARMACEUTICALS CANADA INC

Kod ATC:

C10AD02

INN (Nama Antarabangsa):

NICOTINIC ACID

Dos:

750MG

Borang farmaseutikal:

TABLET (EXTENDED-RELEASE)

Komposisi:

NICOTINIC ACID 750MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

90

Jenis preskripsi:

Prescription

Kawasan terapeutik:

MISCELLANEOUS ANTILIPEMIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0108396016; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2017-05-31

Ciri produk

PRODUCT MONOGRAPH
PR
NIASPAN FCT
®
Extended-Release Niacin
500 mg, 750 mg, 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 23, 2015
SUBMISSION CONTROL NUMBER: 185767
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
....................................................................
14
STORAGE AND STABILITY
.................................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 17
PART II: SCIENTIFIC INFORMATION
..............................................................................
18
PHARMACEUTICAL INFORMATION
.................................................................................
18
CLINICAL
TRIALS............................................................