TEVA-DICLOFENAC SUPPOSITORY

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

DICLOFENAC SODIUM

Disponible desde:

TEVA CANADA LIMITED

Código ATC:

M01AB05

Designación común internacional (DCI):

DICLOFENAC

Dosis:

50MG

formulario farmacéutico:

SUPPOSITORY

Composición:

DICLOFENAC SODIUM 50MG

Vía de administración:

RECTAL

Unidades en paquete:

30

tipo de receta:

Prescription

Área terapéutica:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Resumen del producto:

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

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2018-06-15

Ficha técnica

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