Country: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)
TEVA CANADA LIMITED
L04AE01
FINGOLIMOD
0.5MG
CAPSULE
FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5MG
ORAL
30/90
Prescription
Immunomodulatory Agents
Active ingredient group (AIG) number: 0152886001; AHFS:
APPROVED
2019-03-11
_Teva-Fingolimod Page 1 of 66 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TEVA-FINGOLIMOD Fingolimod Capsules Capsule, 0.5 mg Fingolimod (as fingolimod hydrochloride), Oral Sphingosine 1-phosphate receptor modulator Teva Canada Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 Date of Initial Authorization: March 11, 2019 Date of Revision: April 20, 2022 Submission Control Number: 259158 _Teva-Fingolimod Page 2 of 66 _ RECENT MAJOR LABEL CHANGES 2 Contraindications 02/2020 4 Dosage and Administration 04/2022 7 Warnings and Precautions 04/2022 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 ........................................................................................... 5 4.1 Dosing Considerations ......................................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ...................................................................... 7 4.4 Administration .................................................... সম্পূর্ণ নথি পড়ুন