RELAFEN TABLETS 750MG

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

NABUMETONE

Dostupno od:

GLAXOSMITHKLINE INC

ATC koda:

M01AX01

INN (International ime):

NABUMETONE

Doziranje:

750MG

Farmaceutski oblik:

TABLET

Sastav:

NABUMETONE 750MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Proizvod sažetak:

Active ingredient group (AIG) number: 0122821002; AHFS:

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2006-02-13

Svojstava lijeka

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_Page 1 of 28_
PRODUCT MONOGRAPH
Pr
RELAFEN
®
nabumetone
500 mg and 750 mg Oral Tablets
Manufacturer’s Standard
Nonsteroidal Anti-Inflammatory Agent
GlaxoSmithKline Inc.
7333 Mississauga Road North
Mississauga, Ontario
L5N 6L4
Date of Preparation:
March 6, 1998
Date of Revision:
October 31, 2005
Submission Control No : 096377
_©_
_2005, GlaxoSmithKline Inc., All Rights Reserved _
_®_
_RELAFEN is a registered trademark, used under license by
GlaxoSmithKline Inc. _
_DCMT/1034/523/2005-10-28/131-pristine-relafen.doc _
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_Page 2 of 28_
Table of Contents
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND
PRECAUTIONS..................................................................................5
ADVERSE
REACTIONS..................................................................................................10
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND
ADMINISTRATION..............................................................................15
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND
STABILITY..........................................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................18
PART II: SCIENTIFIC INFORMATION
...............................................................................19