TEVA-DICLOFENAC SUPPOSITORY
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
22-08-2016
Noen dokumenter for dette produktet er ikke tilgjengelig for øyeblikket, du kan sende en forespørsel til kundeservicen vår, og vi vil varsle deg så snart vi kan få dem.
Send forespørsel.
Send forespørsel.
Aktiv ingrediens:
DICLOFENAC SODIUM
Tilgjengelig fra:
TEVA CANADA LIMITED
ATC-kode:
M01AB05
INN (International Name):
DICLOFENAC
Dosering :
100MG
Legemiddelform:
SUPPOSITORY
Sammensetning:
DICLOFENAC SODIUM 100MG
Administreringsrute:
RECTAL
Enheter i pakken:
30
Resept typen:
Prescription
Terapeutisk område:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0114417001; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2018-06-15
Preparatomtale
Page 1 of 45
PRODUCT MONOGRAPH
Pr
TEVA-DICLOFENAC EC
Pr
TEVA-DICLOFENAC SR
Pr
TEVA-DICLOFENAC
(diclofenac sodium)
25 mg and 50 mg Enteric Coated Tablets, USP
75 mg and 100 mg Slow Release Tablets, Teva Standard
50 mg and 100 mg Suppositories, Teva Standard
Nonsteroidal Anti-Inflammatory Drug (NSAID)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Revision:
August 15, 2016
Control no. 197101
Page 2 of 45
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................. 3
SUMMARY PRODUCT INFORMATION
...........................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................
4
CONTRAINDICATIONS
......................................................................................................
5
WARNINGS AND PRECAUTIONS
.....................................................................................
6
ADVERSE REACTIONS
....................................................................................................
16
DRUG INTERACTIONS
.....................................................................................................
18
DOSAGE AND ADMINISTRATION
.................................................................................
22
OVERDOSAGE
...................................................................................................................
24
ACTION AND CLINICAL
PHARMACOLOGY................................................................
24
STORAGE AND STABILITY
.............................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 27
PART II: SCIENTIFIC INFORMATION
...................................................................................
28
PHARMACEUTICAL INFORMATION
.......................................................................
Les hele dokumentet
