FASTURTEC POWDER FOR SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

RASBURICASE

Fáanlegur frá:

SANOFI-AVENTIS CANADA INC

ATC númer:

V03AF07

INN (Alþjóðlegt nafn):

RASBURICASE

Skammtar:

1.5MG

Lyfjaform:

POWDER FOR SOLUTION

Samsetning:

RASBURICASE 1.5MG

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

3VIALS

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ENZYMES

Vörulýsing:

Active ingredient group (AIG) number: 0149668001; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2006-03-21

Vara einkenni

_FASTURTEC (Rasburicase for Injection) _
_Page 1 of 24_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
FASTURTEC®
Rasburicase for Injection
Powder for Injection
Professed
1.5 mg/vial
(1.5 mg/mL/vial)
Uricolytic Agent
ATC Code: V03AF07
sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval, Quebec H7V 0A3
Date of Initial Authorization:
October 29, 2003
Date of Revision:
August 31, 2023
Submission Control Number: 271866
_ _
_FASTURTEC (Rasburicase for Injection) _
_Page 2 of 24_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.3 Reconstitution
07/2023
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
07/2023
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
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.2
Dosing Considerations
..............................................................................................
5
4.3
Reconstitution
...........................................................................................................
5
4.4
Administration
.............................................................