Land: Canada
Taal: Engels
Bron: Health Canada
ZOLMITRIPTAN
SANIS HEALTH INC
N02CC03
ZOLMITRIPTAN
2.5MG
TABLET
ZOLMITRIPTAN 2.5MG
ORAL
6
Prescription
SELECTIVE SEROTONIN AGONISTS
Active ingredient group (AIG) number: 0134381001; AHFS:
APPROVED
2015-07-31
_ _ _ZOLMITRIPTAN and ZOLMITRIPTAN ODT _ _Page 1 of 44_ PRODUCT MONOGRAPH PR ZOLMITRIPTAN Zolmitriptan 2.5 mg Tablet PR ZOLMITRIPTAN ODT Zolmitriptan 2.5 mg Orally Disintegrating Tablet 5-HT 1 Receptor Agonist MIGRAINE THERAPY Date of Revision: August 21, 2020 Submission Control No.: 242166 L6Y 5S5 Brampton, Ontario 1 President’s Choice Circle Sanis Health Inc. _ _ _ZOLMITRIPTAN and ZOLMITRIPTAN ODT _ _Page 2 of 44_ 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 ................................................................................................. 17 DOSAGE AND ADMINISTRATION ............................................................................. 19 OVERDOSAGE ............................................................................................................... 20 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 21 STORAGE AND STABILITY ......................................................................................... 23 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 23 PART II: SCIENTIFIC INFORMATION .............................................................................. 25 PHARMACEUTICAL INFORMATION ......................................................................... 25 CLINICAL TRIALS .................................................................. Lees het volledige document