国: カナダ
言語: 英語
ソース: Health Canada
SUMATRIPTAN (SUMATRIPTAN SUCCINATE); NAPROXEN SODIUM
ARALEZ PHARMACEUTICALS CANADA INC
N02CC51
SUMATRIPTAN AND NAPROXEN
85MG; 500MG
TABLET
SUMATRIPTAN (SUMATRIPTAN SUCCINATE) 85MG; NAPROXEN SODIUM 500MG
ORAL
15G/50G
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0262035001; AHFS:
APPROVED
2020-02-27
_SUVEXX_ ® _ Product Monograph _ _(sumatriptan/naproxen sodium) tablets _ _ _ _Page 1 of 45_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR SUVEXX ® sumatriptan/naproxen sodium tablets 85 mg sumatriptan (as sumatriptan succinate) / 500 mg naproxen sodium Serotonin (5-HT 1B/1D ) receptor agonist (triptan) / Non-Steroidal Anti-Inflammatory Drug (NSAID) Aralez Pharmaceuticals Canada Inc.* 6733 Mississauga Road, Suite 800 Mississauga, Ontario Canada L5N 6J5 www.miravohealthcare.com Date of Initial Approval: February 26, 2020 Date of Revision: December 20, 2021 Submission Control No: 253456 *Doing business as (d/b/a) Miravo Healthcare _ _ _SUVEXX_ ® _ Product Monograph _ _(sumatriptan/naproxen sodium) tablets _ _ _ _ _ _Page 2 of 45_ TABLE OF CONTENTS TABLE OF CONTENTS....................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................... 4 1 INDICATIONS ........................................................................................................... 4 1.1 Pediatrics .......................................................................................................... 4 1.2 Geriatrics .......................................................................................................... 4 2 CONTRAINDICATIONS ........................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .............................................. 6 4 DOSAGE AND ADMINISTRATION ......................................................................... 7 4.1 General ............................................................................................................. 7 4.2 Dosing Considerations..................................................................................... 7 4.3 Recommended Dose and Dosage Adjustment .............................................. 7 4.4 Administration........................... 完全なドキュメントを読む