MINT-ZOLMITRIPTAN TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
18-12-2020
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Aktiv bestanddel:
ZOLMITRIPTAN
Tilgængelig fra:
MINT PHARMACEUTICALS INC
ATC-kode:
N02CC03
INN (International Name):
ZOLMITRIPTAN
Dosering:
2.5MG
Lægemiddelform:
TABLET
Sammensætning:
ZOLMITRIPTAN 2.5MG
Indgivelsesvej:
ORAL
Enheder i pakken:
6
Recept type:
Prescription
Terapeutisk område:
SELECTIVE SEROTONIN AGONISTS
Produkt oversigt:
Active ingredient group (AIG) number: 0134381001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2014-03-18
Produktets egenskaber
MINT-ZOLMITRIPTAN Product Monograph
Page 1 of 37
PRODUCT MONOGRAPH
PR
MINT-ZOLMITRIPTAN
Zolmitriptan Tablets
2.5 mg
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario L5T 2M3
www.mintpharmaceuticals.com
Date of Revision: December 18, 2020
Submission Control No.: 242060
MINT-ZOLMITRIPTAN Product Monograph
Page 2 of 37
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
.........................................................................................................11
DRUG INTERACTIONS
.........................................................................................................17
DOSAGE AND ADMINISTRATION
.....................................................................................19
OVERDOSAGE
.......................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
...................................................................20
STORAGE AND STABILITY
.................................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................23
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
.................................................................................24
CLINICAL TRIALS
.............................
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