DOM-ZOLMITRIPTAN ODT TABLET (ORALLY DISINTEGRATING)

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

ZOLMITRIPTAN

Tilgjengelig fra:

DOMINION PHARMACAL

ATC-kode:

N02CC03

INN (International Name):

ZOLMITRIPTAN

Dosering :

2.5MG

Legemiddelform:

TABLET (ORALLY DISINTEGRATING)

Sammensetning:

ZOLMITRIPTAN 2.5MG

Administreringsrute:

ORAL

Enheter i pakken:

6/30

Resept typen:

Prescription

Terapeutisk område:

SELECTIVE SEROTONIN AGONISTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0134381001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2012-07-23

Preparatomtale

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