Ország: Kanada
Nyelv: angol
Forrás: Health Canada
FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)
SANDOZ CANADA INCORPORATED
L04AE01
FINGOLIMOD
0.5MG
CAPSULE
FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5MG
ORAL
28
Prescription
Immunomodulatory Agents
Active ingredient group (AIG) number: 0152886001; AHFS:
APPROVED
2019-03-11
_Sandoz Fingolimod _ _Page 1 of 68 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR SANDOZ ® FINGOLIMOD Fingolimod capsules Capsule, 0.5 mg fingolimod (as fingolimod hydrochloride), Oral Sphingosine 1-phosphate receptor modulator Sandoz Canada Inc. 110, Rue de Lauzon Boucherville, Québec, Canada J4B 1E6 Date of Inital Authorization: October 31, 2019 Date of Revision: February 23, 2022 Submission Control No: 256559 _Sandoz Fingolimod _ _Page 2 of 68 _ RECENT MAJOR LABEL CHANGES 2 Contraindications 02/2022 4 Dosage and administration 02/2022 7 Warnings and Precautions 02/2022 TABLE OF CONTENTS 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 .................................................................................. 5 4.1 DOSING CONSIDERATIONS.........................................................................................5 4.2 RECOMMENDED DOSE AND DOSAGE ADJUSTMENT .....................................................7 4.4 ADMINISTRATION ....................................................................................................8 4.5 MISSED DOSE....................................................................................................... Olvassa el a teljes dokumentumot