ELELYSO POWDER FOR SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

TALIGLUCERASE ALFA

Disponible desde:

PFIZER CANADA ULC

Código ATC:

A16AB11

Designación común internacional (DCI):

TALIGLUCERASE ALFA

Dosis:

200UNIT

formulario farmacéutico:

POWDER FOR SOLUTION

Composición:

TALIGLUCERASE ALFA 200UNIT

Vía de administración:

INTRAVENOUS

Unidades en paquete:

5ML

tipo de receta:

Prescription

Área terapéutica:

ENZYMES

Resumen del producto:

Active ingredient group (AIG) number: 0155691001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2014-05-29

Ficha técnica

_ _
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_Elelyso_
_®_
_ (taliglucerase alfa for injection)_
_ _
_Page 1 of 29_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ELELYSO
®
Taliglucerase alfa for injection
(recombinant human glucocerebrosidase analogue)
Powder for Solution, 200 units / vial, Intravenous
Enzyme Replacement Therapy
ATC code: A16AB11
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Qc
H9J 2M5
Date of Initial Authorization:
May 29, 2014
Date of Revision:
March 7, 2023
Submission Control Number: 268539
®
Pfizer Inc.
Pfizer Canada ULC, Licensee
© Pfizer Canada ULC. 2023
_ _
_ _
_ _
_Elelyso_
_®_
_ (taliglucerase alfa for injection)_
_ _
_Page 2 of 29_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
XX/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
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
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
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
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