DOM-ZOLMITRIPTAN TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
21-03-2016
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ingredients actius:
ZOLMITRIPTAN
Disponible des:
DOMINION PHARMACAL
Codi ATC:
N02CC03
Designació comuna internacional (DCI):
ZOLMITRIPTAN
Dosis:
2.5MG
formulario farmacéutico:
TABLET
Composición:
ZOLMITRIPTAN 2.5MG
Vía de administración:
ORAL
Unidades en paquete:
6/30
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:
2012-07-23
Fitxa tècnica
PRODUCT MONOGRAPH
PR
DOM-ZOLMITRIPTAN
(ZOLMITRIPTAN FILM-COATED TABLETS)
2.5 MG
PR
DOM-ZOLMITRIPTAN ODT
(ZOLMITRIPTAN ORALLY DISPERSIBLE TABLETS)
2.5 MG
5-HT1 RECEPTOR AGONIST
MIGRAINE THERAPY
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION:
March 21, 2016
SUBMISSION CONTROL NO: 192863
_ _
_Dom-ZOLMITRIPTAN and Dom-ZOLMITRIPTAN ODT Product Monograph _
_Page 2 of 41 _
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
..................................................................................................11
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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