ELELYSO POWDER FOR SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

TALIGLUCERASE ALFA

Tilgængelig fra:

PFIZER CANADA ULC

ATC-kode:

A16AB11

INN (International Name):

TALIGLUCERASE ALFA

Dosering:

200UNIT

Lægemiddelform:

POWDER FOR SOLUTION

Sammensætning:

TALIGLUCERASE ALFA 200UNIT

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

5ML

Recept type:

Prescription

Terapeutisk område:

ENZYMES

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2014-05-29

Produktets egenskaber

_ _
_ _
_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
............................................................................................................
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
................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
................................................