ELELYSO POWDER FOR SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

TALIGLUCERASE ALFA

可用日期:

PFIZER CANADA ULC

ATC代码:

A16AB11

INN（国际名称）:

TALIGLUCERASE ALFA

剂量:

200UNIT

药物剂型:

POWDER FOR SOLUTION

组成:

TALIGLUCERASE ALFA 200UNIT

给药途径:

INTRAVENOUS

每包单位数:

5ML

处方类型:

Prescription

治疗领域:

ENZYMES

產品總結:

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

授权状态:

APPROVED

授权日期:

2014-05-29

产品特点

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