国家: 加拿大
语言: 英文
来源: Health Canada
ZOLMITRIPTAN
SEPTA PHARMACEUTICALS INC
N02CC03
ZOLMITRIPTAN
2.5MG
TABLET (ORALLY DISINTEGRATING)
ZOLMITRIPTAN 2.5MG
ORAL
2X3
Prescription
SELECTIVE SEROTONIN AGONISTS
Active ingredient group (AIG) number: 0134381001; AHFS:
APPROVED
2014-08-15
_SEPTA ZOLMITRIPTAN-ODT _ _Page 1 of 32_ PRODUCT MONOGRAPH PR SEPTA ZOLMITRIPTAN-ODT Zolmitriptan Orally Disintegrating Tablets 2.5 mg 5-HT 1 Receptor Agonist MIGRAINE THERAPY Septa Pharmaceuticals, Inc Date of Preparation: 7490 Pacific Circle, # 1, Mississauga ON L5T 2A3 August 7, 2014 Canada SUBMISSION CONTROL NO.: 176170 _SEPTA ZOLMITRIPTAN-ODT _ _Page 2 of 32_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION................................................. 3 SUMMARY PRODUCT INFORMATION..................................................................... 3 INDICATIONS AND CLINICAL USE............................................................................ 3 CONTRAINDICATIONS.................................................................................................. 3 WARNINGS AND PRECAUTIONS................................................................................ 4 ADVERSE REACTIONS.................................................................................................. 10 DRUG INTERACTIONS.................................................................................................. 15 DOSAGE AND ADMINISTRATION.............................................................................. 16 OVERDOSAGE................................................................................................................. 17 ACTION AND CLINICAL PHARMACOLOGY............................................................. 18 STORAGE AND STABILITY.......................................................................................... 20 DOSAGE FORMS, COMPOSITION AND PACKAGING............................................. 20 PART II: SCIENTIFIC INFORMATION......................................................................... 21 PHARMACEUTICAL INFORMATION.......................................................................... 21 CLINICAL TRIALS.......................................................................................................... 21 DETAILED PHARMACOLOGY........... 阅读完整的文件