BENLYSTA POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

BELIMUMAB

Disponibil de la:

GLAXOSMITHKLINE INC

Codul ATC:

L04AG04

INN (nume internaţional):

BELIMUMAB

Dozare:

400MG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

BELIMUMAB 400MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

20ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

IMMUNOSUPPRESSIVE AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0152941001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2011-07-06

Caracteristicilor produsului

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_BENLYSTA, Belimumab _
_Page 1 of 66_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
BENLYSTA
Belimumab for injection
120 mg in 5 mL vial lyophilized powder for intravenous infusion
400 mg in 20 mL vial lyophilized powder for intravenous infusion
Belimumab injection
200 mg in 1 mL for subcutaneous injection
Selective Immunosuppressant
GlaxoSmithKline Inc.
100 Milverton Drive
Suite 800
Mississauga, Ontario
L5R 4H1
Date of Initial Authorization:
July 06, 2011
Date of Revision:
March 6, 2024
Submission Control Number: 279901
_©_
_2024 GSK group of companies or its licensor _
_Trademarks are owned by or licensed to the GSK group of companies _
_ _
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_BENLYSTA, Belimumab _
_Page 2 of 66_
RECENT MAJOR LABEL CHANGES
SECTION
DATE
7 WARNINGS AND PRECAUTIONS
10/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
05/2023
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
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2
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................. 4
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
............................................................... 5
4.2
Recommended Dose and Dosage Adjustment .......................... 5