Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
SUMATRIPTAN (SUMATRIPTAN SUCCINATE)
STERIMAX INC
N02CC01
SUMATRIPTAN
6MG
SOLUTION
SUMATRIPTAN (SUMATRIPTAN SUCCINATE) 6MG
SUBCUTANEOUS
0.5ML
Prescription
SELECTIVE SEROTONIN AGONISTS
Active ingredient group (AIG) number: 0123238006; AHFS:
APPROVED
2023-01-18
1 PRODUCT MONOGRAPH PR SUMATRIPTAN INJECTION, USP 6 MG/0.5 ML SUMATRIPTAN (AS SUMATRIPTAN SUCCINATE) SUBCUTANEOUS INJECTION AND AUTOINJECTOR 5-HT 1 Receptor Agonist Migraine Therapy SteriMax Inc. Date of Revision: 2770 Portland Drive JAN 13, 2023 Oakville, Ontario L6H 6R4 Control number: 270786 2 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 ......................................................................................................... 10 DRUG INTERACTIONS .......................................................................................................... 13 DOSAGE AND ADMINISTRATION ...................................................................................... 14 OVERDOSAGE ........................................................................................................................ 15 ACTION AND CLINICAL PHARMACOLOGY ..................................................................... 16 STORAGE AND STABILITY .................................................................................................. 17 DOSAGE FORMS, COMPOSITION AND PACKAGING ...................................................... 17 PART II: SCIENTIFIC INFORMATION ............................................................................... 18 PHARMACEUTICAL INFORMATION.................................................................................. 18 CLINICAL TRIALS ................................................................................ Đọc toàn bộ tài liệu