SANDOZ FINGOLIMOD CAPSULE
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
23-02-2022
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Aktiv ingrediens:
FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)
Tilgjengelig fra:
SANDOZ CANADA INCORPORATED
ATC-kode:
L04AE01
INN (International Name):
FINGOLIMOD
Dosering :
0.5MG
Legemiddelform:
CAPSULE
Sammensetning:
FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5MG
Administreringsrute:
ORAL
Enheter i pakken:
28
Resept typen:
Prescription
Terapeutisk område:
Immunomodulatory Agents
Produkt oppsummering:
Active ingredient group (AIG) number: 0152886001; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2019-03-11
Preparatomtale
_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.......................................................................................................
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