Land: Canada
Språk: engelsk
Kilde: Health Canada
SUMATRIPTAN (SUMATRIPTAN SUCCINATE)
GLAXOSMITHKLINE INC
N02CC01
SUMATRIPTAN
100MG
TABLET
SUMATRIPTAN (SUMATRIPTAN SUCCINATE) 100MG
ORAL
24
Prescription
SELECTIVE SEROTONIN AGONISTS
Active ingredient group (AIG) number: 0123238001; AHFS:
APPROVED
2001-07-05
_ _ _ _ _IMITREX sumatriptan _ _Page 1 of 63_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR IMITREX DF (sumatriptan succinate tablets USP) 50 mg and 100 mg sumatriptan PR IMITREX (sumatriptan injection, Mfr. Std) 6 mg / 0.5 mL sumatriptan (as sumatriptan succinate) Subcutaneous Injection and Autoinjector PR IMITREX (sumatriptan nasal spray, Mfr. Std) 5 mg and 20 mg sumatriptan (as hemisulphate) 5-HT 1 Receptor Agonist Migraine Therapy GlaxoSmithKline Inc. 100 Milverton Drive Suite 800 Mississauga, Ontario L5R 4H1 Date of Initial Authorization: January 20, 1992 Date of Revision: October 24, 2022 Submission Control Number: 264269 _©_ _ 2022 GSK group of companies or its licensor _ _Trademarks are owned by or licensed to the GSK group of companies _ _ _ _ _ _IMITREX sumatriptan _ _Page 2 of 63_ RECENT MAJOR LABEL CHANGES SECTION DATE 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment 09/2021 7 Warnings and Precautions, Serotonin toxicity / Serotonin Syndrome 09/2021 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED . RECENT MAJOR LABEL CHANGES............................................................................................ 2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS .............................................................................................................. 4 1.1 Pediatrics .......................................................................................................... 4 1.2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION.................................. Les hele dokumentet