ELAPRASE SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

IDURSULFASE

Disponibbli minn:

TAKEDA CANADA INC

Kodiċi ATC:

A16AB09

INN (Isem Internazzjonali):

IDURSULFASE

Dożaġġ:

2MG

Għamla farmaċewtika:

SOLUTION

Kompożizzjoni:

IDURSULFASE 2MG

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

3ML

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ENZYMES

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0152221001; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2021-02-11

Karatteristiċi tal-prodott

_ELAPRASE_
_®_
_ Product Monograph _
_Page 1 of 31_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ELAPRASE
®
idursulfase for injection
2 mg/mL concentrate for solution for intravenous infusion
Enzyme Replacement Therapy
Takeda Canada Inc.
22 Adelaide Street West, Suite 3800
Toronto Ontario M5H 4E3
Date of Initial Approval:
June 13, 2007
Date of Revision:
February 11, 2021
Submission Control No: 243289
ELAPRASE
®
and the ELAPRASE Logo
®
are registered trademarks of Shire Human Genetic Therapies,
Inc.
TAKEDA™ and the TAKEDA Logo
®
are trademarks of Takeda Pharmaceutical Company Limited,
used under license.
_ELAPRASE_
_®_
_ Product Monograph _
_Page 2 of 31_
RECENT MAJOR LABEL CHANGES
None.
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 4
1
INDICATIONS
.................................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
...........................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 4
4.3
Administration
........................................................................................................
4
5
OVERDOSAGE
...............................................................................................................
5
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
......................... 6
8
WARNINGS AND PRECAUTIONS
..................................................................