ETOPOSIDE INJECTION, USP SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

ETOPOSIDE

Disponible des:

STRIDES PHARMA CANADA INC

Codi ATC:

L01CB01

Designació comuna internacional (DCI):

ETOPOSIDE

Dosis:

20MG

formulario farmacéutico:

SOLUTION

Composición:

ETOPOSIDE 20MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

5/10/25/50ML

tipo de receta:

Prescription

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0114567002; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2014-07-09

Fitxa tècnica

1
PRODUCT MONOGRAPH
PR
ETOPOSIDE INJECTION, USP
(ETOPOSIDE 20 MG/ML)
SOLUTION FOR INTRAVENOUS USE
ANTINEOPLASTIC AGENT
Strides Pharma Canada Inc.
1565, Boul. Lionel- Boulet
Varennes, Quebec
Canada, J3X 1P7
Submission Control No.: 241160
Date of Revision:
August 10, 2020
2
PRODUCT MONOGRAPH
PR
ETOPOSIDE INJECTION, USP
ETOPOSIDE 20 MG/ML
SOLUTION FOR INTRAVENOUS USE
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
CAUTION: ETOPOSIDE IS A POTENT DRUG AND SHOULD BE USED ONLY BY
QUALIFIED PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC
DRUGS (SEE WARNINGS AND PRECAUTIONS). SEVERE MYELOSUPPRESSION
WITH RESULTING INFECTION OR BLEEDING MAY OCCUR. BLOOD COUNTS AS
WELL
AS
RENAL
AND
HEPATIC
FUNCTION
TESTS
SHOULD
BE
TAKEN
REGULARLY. DISCONTINUE THE DRUG IF ABNORMAL DEPRESSION OF BONE
MARROW OR ABNORMAL RENAL OR HEPATIC FUNCTION IS SEEN. ETOPOSIDE
INJECTION USP CONTAINS POLYSORBATE 80. IN PREMATURE INFANTS A LIFE
THREATENING
SYNDROME
OF
LIVER
AND
RENAL
FAILURE,
PULMONARY
DETERIORATION,
THROMBOCYTOPENIA
AND
ASCITES
HAS
BEEN
ASSOCIATED
WITH
INJECTABLE
VITAMIN
E
PRODUCT
CONTAINING
POLYSORBATE 80. ETOPOSIDE INJECTION USP CONTAINS BENZYL ALCOHOL.
BENZYL ALCOHOL HAS BEEN ASSOCIATED WITH AN INCREASED INCIDENCE
OF
NEUROLOGICAL
AND
OTHER
COMPLICATIONS
IN
NEWBORN
INFANTS
WHICH ARE SOMETIMES FATAL.
ACTION AND CLINICAL PHARMACOLOGY
Etoposide is a semi-synthetic derivative of podophyllotoxin used in
the treatment of certain
neoplastic diseases.
_In vitro_
, etoposide has cytostatic action, which prevents the cells from
entering mitosis or destroys
them in the pre-mitotic phase. Etoposide interferes with the synthesis
of DNA and has a secondary
effect on arresting cells in resting (G2) phase in experiments with
human lymphoblastic cell lines.
Etoposide has a marked action on human hemopoietic cells causing
leukopenia and
thrombocytopenia. Animal experiments have shown evidence of
teratogenicity.
3
An intravenous dose (259 mg/m
2
) of tritium-labelled etoposide given over one hour in man,
showed the mean volume of distribution to be 32%