ELELYSO POWDER FOR SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

TALIGLUCERASE ALFA

Fáanlegur frá:

PFIZER CANADA ULC

ATC númer:

A16AB11

INN (Alþjóðlegt nafn):

TALIGLUCERASE ALFA

Skammtar:

200UNIT

Lyfjaform:

POWDER FOR SOLUTION

Samsetning:

TALIGLUCERASE ALFA 200UNIT

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

5ML

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ENZYMES

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2014-05-29

Vara einkenni

_ _
_ _
_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
................................................