TEVA-FLURBIPROFEN TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
14-07-2015
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ingredients actius:
FLURBIPROFEN
Disponible des:
TEVA CANADA LIMITED
Codi ATC:
M01AE09
Designació comuna internacional (DCI):
FLURBIPROFEN
Dosis:
50MG
formulario farmacéutico:
TABLET
Composición:
FLURBIPROFEN 50MG
Vía de administración:
ORAL
Unidades en paquete:
100/500
tipo de receta:
Prescription
Área terapéutica:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Resumen del producto:
Active ingredient group (AIG) number: 0115998002; AHFS:
Estat d'Autorització:
CANCELLED POST MARKET
Data d'autorització:
2019-08-08
Fitxa tècnica
PRODUCT MONOGRAPH
PR
TEVA-FLURBIPROFEN
(Flurbiprofen tablets BP)
50 mg and 100 mg Tablets
Nonsteroidal anti-inflammatory drug (NSAID)
Teva Canada Limited
Date of Revision:
30 Novopharm Court
July 14, 2015
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Control No.: 184835
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
INDICATIONS AND CLINICAL USE
..........................................................................
3
CONTRAINDICATIONS
................................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
5
ADVERSE REACTIONS
...............................................................................................
16
DRUG INTERACTIONS
...............................................................................................
19
DOSAGE AND ADMINISTRATION
..........................................................................
22
OVERDOSAGE
..............................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 23
STORAGE AND
STABILITY.......................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................... 25
PART II: SCIENTIFIC INFORMATION
..............................................................................
27
PHARMACEUTICAL INFORMATION
.....................................................................
27
CLINICAL TRIALS
.......................................................................................................
28
DETAILED PHARMACOLOGY
.................................................................................
30
TOXICOLOGY
..............................................................................................................
30
REFERENCES
.
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