TEVA-DICLOFENAC SUPPOSITORY

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

DICLOFENAC SODIUM

Saadav alates:

TEVA CANADA LIMITED

ATC kood:

M01AB05

INN (Rahvusvaheline Nimetus):

DICLOFENAC

Annus:

100MG

Ravimvorm:

SUPPOSITORY

Koostis:

DICLOFENAC SODIUM 100MG

Manustamisviis:

RECTAL

Ühikuid pakis:

30

Retsepti tüüp:

Prescription

Terapeutiline ala:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0114417001; AHFS:

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2018-06-15

Toote omadused

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
.......................................................................