TEVA-ZOLMITRIPTAN OD TABLET (ORALLY DISINTEGRATING)
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
06-04-2020
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ingredients actius:
ZOLMITRIPTAN
Disponible des:
TEVA CANADA LIMITED
Codi ATC:
N02CC03
Designació comuna internacional (DCI):
ZOLMITRIPTAN
Dosis:
2.5MG
formulario farmacéutico:
TABLET (ORALLY DISINTEGRATING)
Composición:
ZOLMITRIPTAN 2.5MG
Vía de administración:
ORAL
Unidades en paquete:
2/6
tipo de receta:
Prescription
Área terapéutica:
SELECTIVE SEROTONIN AGONISTS
Resumen del producto:
Active ingredient group (AIG) number: 0134381001; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2011-06-07
Fitxa tècnica
PRODUCT MONOGRAPH
PR
TEVA-ZOLMITRIPTAN
(zolmitriptan) tablets
2.5 mg
PR
TEVA-ZOLMITRIPTAN OD
(zolmitriptan) orally disintegrating tablets
2.5 mg
Teva Standard
Migraine Therapy
5-HT
1
Receptor Agonist
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No: 237687
Date of Revision:
April 6, 2020
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................
18
DOSAGE AND ADMINISTRATION
.....................................................................................
19
OVERDOSAGE
.......................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 21
STORAGE AND STABILITY
.................................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 24
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.................................................................................
25
CLINICAL TRIALS
...........................................
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