TEVA-DICLOFENAC SUPPOSITORY

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

DICLOFENAC SODIUM

Prieinama:

TEVA CANADA LIMITED

ATC kodas:

M01AB05

INN (Tarptautinis Pavadinimas):

DICLOFENAC

Dozė:

50MG

Vaisto forma:

SUPPOSITORY

Sudėtis:

DICLOFENAC SODIUM 50MG

Vartojimo būdas:

RECTAL

Vienetai pakuotėje:

30

Recepto tipas:

Prescription

Gydymo sritis:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Produkto santrauka:

Active ingredient group (AIG) number: 0114417002; AHFS:

Autorizacija statusas:

CANCELLED POST MARKET

Leidimo data:

2018-06-15

Prekės savybės

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