Land: Canada
Språk: engelsk
Kilde: Health Canada
SUMATRIPTAN (SUMATRIPTAN SUCCINATE)
PHARMASCIENCE INC
N02CC01
SUMATRIPTAN
50MG
TABLET
SUMATRIPTAN (SUMATRIPTAN SUCCINATE) 50MG
ORAL
6/30
Prescription
SELECTIVE SEROTONIN AGONISTS
Active ingredient group (AIG) number: 0123238002; AHFS:
APPROVED
2005-08-24
_pms-SUMATRIPTAN Product Monograph _ _Page 1 of 41 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PMS-SUMATRIPTAN Sumatriptan Tablets Tablets, 25 mg, 50 mg and 100 mg sumatriptan (as sumatriptan succinate), Oral USP 5-HT 1 Receptor Agonist Migraine Therapy PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Québec H4P 2T4 www.pharmascience.com Submission Control Number: 259228 Date of Initial Authorization: AUG 24, 2005 Date of Revision: MAY 11, 2022 _ _ _ _ _pms-SUMATRIPTAN Product Monograph _ _Page 2 of 41 _ RECENT MAJOR LABEL CHANGES 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment 05/2022 7 Warnings and Precautions, Serotonin toxicity / Serotonin Syndrome 05/2022 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES............................................................................................. 2 TABLE OF CONTENTS ............................................................................................................... 2 1 INDICATIONS ..................................................................................................................... 4 1.1 Pediatrics ............................................................................................................... 4 1.2 Geriatrics................................................................................................................ 4 2 CONTRAINDICATIONS........................................................................................................ 4 4 DOSAGE AND ADMINISTRATION ....................................................................................... 5 4.1 Dosing Considerations ............................................................................................ 5 4.2 Recommended Dose and Dosage Adjustment ......................................................... 6 4.4 Administration............................................................ Les hele dokumentet