SYLVANT POWDER FOR SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
26-01-2021
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Active ingredient:
SILTUXIMAB
Available from:
EUSA PHARMA (UK) LIMITED
ATC code:
L04AC11
INN (International Name):
SILTUXIMAB
Dosage:
100MG
Pharmaceutical form:
POWDER FOR SOLUTION
Composition:
SILTUXIMAB 100MG
Administration route:
INTRAVENOUS
Units in package:
5.2ML
Prescription type:
Prescription
Therapeutic area:
IMMUNOSUPPRESSIVE AGENTS
Product summary:
Active ingredient group (AIG) number: 0156310001; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-12-03
Summary of Product characteristics
_SPC/SYL/CA/1185/01 _
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_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SYLVANT
®
siltuximab for injection
Lyophilized powder for injection, for intravenous infusion
100 mg/vial and 400 mg/vial
Anti-Interleukin-6 monoclonal antibody
EUSA Pharma (UK) Limited
Breakspear Park
Breakspear Way
Hemel Hempstead
HP2 4TZ
United Kingdom
Imported by:
Innomar Strategies Inc.
Oakville, ON L6L 0C4
Submission Control No: 247027
All trademarks used under license
© 2020 EUSA
Date of Initial Approval:
December 3, 2014
Date of Revision:
January 26, 2021
_SPC/SYL/CA/1185/01 _
_ _
_Page 2 of 38_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................
3
ADVERSE REACTIONS
...........................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................
15
DOSAGE AND ADMINISTRATION
.....................................................................................
16
OVERDOSAGE
.......................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 18
STORAGE AND STABILITY
.................................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
20
DO
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