RYLAZE SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

CRISANTASPASE

Disponível em:

JAZZ PHARMACEUTICALS IRELAND LIMITED

Código ATC:

L01XX02

DCI (Denominação Comum Internacional):

ASPARAGINASE

Dosagem:

10MG

Forma farmacêutica:

SOLUTION

Composição:

CRISANTASPASE 10MG

Via de administração:

INTRAMUSCULAR

Unidades em pacote:

15G/50G

Tipo de prescrição:

Prescription

Resumo do produto:

Active ingredient group (AIG) number: 0164041001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2022-09-02

Características técnicas

_RYLAZE_
_TM_
_ (crisantaspase recombinant) Draft dated 24Aug2022 _
_Page 1 of 25_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
RYLAZE
TM
crisantaspase recombinant
Solution for Intramuscular Injection, 10 mg/0.5 mL (20 mg/mL)
Antineoplastic Agent
Jazz Pharmaceuticals Ireland Limited.
5
th
Floor Waterloo Exchange,
Waterloo Road, Dublin D04 EW57
Imported by:
Jazz Pharmaceuticals Canada Inc.,
4080 Confederation Parkway, Suite 602,
Mississauga, ON L5B 0G1
Date of Initial Authorization:
September 2, 2022
Submission Control Number: 257092
RYLAZE is a trademark of Jazz Pharmaceuticals plc or its subsidiaries.
©2022 Jazz Pharmaceuticals, Inc. All rights reserved.
_RYLAZE_
_TM_
_ _
_(crisantaspase recombinant) _
_Page 2 of 25_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics (1 to < 17 years of
age).............................................................................
4
1.2
Geriatrics (> 65 years of age)
....................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Administration
..........................................................................................................
6
5
OVERDOSAGE
.........................................................................................................