Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
ZOLMITRIPTAN
DOMINION PHARMACAL
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
2012-07-23
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 ....................................................................... Baca dokumen lengkap