ERWINASE POWDER FOR SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ASPARAGINASE

Disponible desde:

JAZZ PHARMACEUTICALS FRANCE SAS

Código ATC:

L01XX02

Designación común internacional (DCI):

ASPARAGINASE

Dosis:

10000UNIT

formulario farmacéutico:

POWDER FOR SOLUTION

Composición:

ASPARAGINASE 10000UNIT

Vía de administración:

INTRAMUSCULAR

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0109328001; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2021-04-09

Ficha técnica

PRODUCT MONOGRAPH
ERWINASE
®
(ERWINIA L-ASPARAGINASE)
FREEZE-DRIED POWDER
FOR INJECTION
FOR IM, SC, OR BOLUS IV USE
THERAPEUTIC CLASSIFICATION: CYTOSTATIC (LOI XX02)
Jazz Pharmaceuticals France SAS
69006 Lyon
France
Control No. 196585
Canadian Distributor:
CGF Pharmatec
3516 Griffith
Montreal, Québec H4T 1A7
Date of Revision: July 20, 2016
Date of Approval: August 30, 2016
PRODUCT MONOGRAPH
ERWINASE
®
(ERWINIA L-ASPARAGINASE)
FREEZE-DRIED POWDER FOR INJECTION
FOR IM, SC, OR BOLUS IV USE
10,000 U/VIAL THERAPEUTIC
CLASSIFICATION: CYTOSTATIC
WARNING
IT IS RECOMMENDED THAT ERWINASE (ERWINIA L-ASPARAGINASE) FOR INJECTION
BE ADMINISTERED TO PATIENTS ONLY IN A HOSPITAL SETTING UNDER THE
SUPERVISION OF A PHYSICIAN WHO IS QUALIFIED BY TRAINING AND EXPERIENCE
TO
ADMINISTER
CANCER
CHEMOTHERAPEUTIC
AGENTS
BECAUSE
OF
THE
POSSIBILITY OF SEVERE REACTIONS, INCLUDING ANAPHYLAXIS AND SUDDEN
DEATH. THE PHYSICIAN MUST BE PREPARED TO TREAT ANAPHYLAXIS AT EACH
ADMINISTRATION OF THE DRUG.
IN THE TREATMENT OF EACH PATIENT THE PHYSICIAN MUST WEIGH CAREFULLY
THE POSSIBILITY OF ACHIEVING THERAPEUTIC BENEFIT VERSUS THE RISK OF
TOXICITY. THE FOLLOWING INFORMATION SHOULD BE THOROUGHLY REVIEWED
BEFORE ADMINISTERING THE RECONSTITUTED PRODUCT.
CLINICAL PHARMACOLOGY
Action
Erwinia L-asparaginase is effective in inducing remission in patients
with acute lymphocytic
leukemia (ALL).
Its oncolytic mode of action is based on a metabolic defect in
asparagine synthesis of the
malignant cells. The leukemic cells have a poorly active asparagine
synthetase (1, 2). They
depend on an exogenous source of the amino acid asparagine for their
protein metabolism
and survival (3). Asparaginase hydrolyzes circulating asparagine
resulting in the starvation and
death of the malignant cells (4). Normal cells that can synthesize
asparagine de novo are not
affected. Wade et al. (5) first discovered certain Erwinia species to
be a commercial source
of the oncolytic enzyme. And, MacLennan et al. (6) showed Erwinia
L-asparaginase to be
serologically (antigenically) dist