AVA-DICLOFENAC SR TABLET (EXTENDED-RELEASE)
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
12-10-2012
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ingredients actius:
DICLOFENAC SODIUM
Disponible des:
AVANSTRA INC
Codi ATC:
M01AB05
Designació comuna internacional (DCI):
DICLOFENAC
Dosis:
75MG
formulario farmacéutico:
TABLET (EXTENDED-RELEASE)
Composición:
DICLOFENAC SODIUM 75MG
Vía de administración:
ORAL
Unidades en paquete:
100
tipo de receta:
Prescription
Área terapéutica:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Resumen del producto:
Active ingredient group (AIG) number: 0114417005; AHFS:
Estat d'Autorització:
CANCELLED POST MARKET
Data d'autorització:
2014-08-21
Fitxa tècnica
_Ava-Diclofenac and Ava-Diclofenac SR _
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PRODUCT MONOGRAPH
PR
AVA-DICLOFENAC
PR AVA-DICLOFENAC SR
(diclofenac sodium)
25 mg and 50 mg Enteric-Coated Tablets
75 and 100 mg Slow-Release Tablets
Nonsteroidal Anti-Inflammatory Drug (NSAID)
Date of Revision:
October 12, 2012
Avanstra Inc
10761-25
th
str.NE, Suite 110
Calgary, Alberta, Canada
T3N 0A4
Control no. 158868
_Ava-Diclofenac and Ava-Diclofenac SR _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...................................................................................
3
INDICATIONS AND CLINICAL USE
.........................................................................................
3
CONTRAINDICATIONS
..............................................................................................................
4
WARNINGS AND PRECAUTIONS
.............................................................................................
5
ADVERSE REACTIONS
.............................................................................................................
13
DRUG INTERACTIONS
.............................................................................................................
15
DOSAGE AND ADMINISTRATION
.........................................................................................
18
OVERDOSAGE
...........................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
20
STORAGE AND STABILITY
.....................................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
..
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