PMS-ZOLMITRIPTAN TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
15-04-2020
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Aktiv ingrediens:
ZOLMITRIPTAN
Tilgjengelig fra:
PHARMASCIENCE INC
ATC-kode:
N02CC03
INN (International Name):
ZOLMITRIPTAN
Dosering :
2.5MG
Legemiddelform:
TABLET
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:
2011-06-07
Preparatomtale
PRODUCT MONOGRAPH
PR
PMS-ZOLMITRIPTAN
Zolmitriptan Film-Coated Tablets, House Standard
2.5 mg
PR
PMS-ZOLMITRIPTAN ODT
Zolmitriptan Orally Dispersible Tablets, House Standard
2.5 mg
5-HT1 RECEPTOR AGONIST
MIGRAINE THERAPY
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
April 15, 2020
Submission Control No.: 237071
_ _
_pms-ZOLMITRIPTAN and pms-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
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
CLINICAL TRIALS
....................
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