Država: Kanada
Jezik: engleski
Izvor: Health Canada
DIMETHYL FUMARATE
TEVA CANADA LIMITED
L04AX07
DIMETHYL FUMARATE
120MG
CAPSULE (DELAYED RELEASE)
DIMETHYL FUMARATE 120MG
ORAL
100
Prescription
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Active ingredient group (AIG) number: 0154210001; AHFS:
APPROVED
2021-10-04
_Teva-Dimethyl Fumarate _ _Page 1 of 39_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr TEVA-DIMETHYL FUMARATE Dimethyl Fumarate Delayed-Release Capsules Delayed-Release Capsules, 120 mg and 240 mg, Oral Antineoplastic and Immunomodulating Agents Teva Canada Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 Date of Initial Authorization: October 30, 2019 Date of Revision: July 29, 2022 Submission Control No: 261462 _Teva-Dimethyl Fumarate _ _Page 2 of 39_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS 07/2022 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 .......................................................................................4 4.1 Dosing Considerations..................................................................................... 4 4.2 Recommended Dose and Dosage Adjustment..................................................... 5 4.4 Administration ............................................................................................... 5 4.5 Missed Dose ................................................................ Pročitajte cijeli dokument