Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
ZOLMITRIPTAN
PHARMASCIENCE INC
N02CC03
ZOLMITRIPTAN
2.5MG
TABLET (ORALLY DISINTEGRATING)
ZOLMITRIPTAN 2.5MG
ORAL
6/30
Prescription
SELECTIVE SEROTONIN AGONISTS
Active ingredient group (AIG) number: 0134381001; AHFS:
APPROVED
2011-06-07
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 .................... Baca dokumen lengkapnya