ETOPOSIDE INJECTION LIQUID

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ETOPOSIDE

Tersedia dari:

TEVA CANADA LIMITED

Kode ATC:

L01CB01

INN (Nama Internasional):

ETOPOSIDE

Dosis:

20MG

Bentuk farmasi:

LIQUID

Komposisi:

ETOPOSIDE 20MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

5/10/20/25/50ML

Jenis Resep:

Prescription

Area terapi:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2014-04-03

Karakteristik produk

PRODUCT MONOGRAPH
PR
ETOPOSIDE INJECTION
(etoposide injection, Teva standard)
20 mg/mL
ANTINEOPLASTIC AGENT
Teva Canada Limited
Date of Revision:
30 Novopharm Court
April 22, 2016
Toronto, Ontario
Canada, M1B 2K9
Control Number: 188887
2
PRODUCT MONOGRAPH
PR
ETOPOSIDE INJECTION
20 mg/mL
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
CAUTION: ETOPOSIDE INJECTION 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
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.
ACTIONS 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 premitotic phase. Etoposide interferes with the synthesis
of DNA and has a secondary
effect on arresting cells in resting (G
2
) 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.
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% of body weight. The
plasma decay was
biphasic with a beta half-life of 11.5 hours. Urinary recovery was 44%
of which 67% was
unchanged drug. Recovery in feces was variable (1.5 - 16%) over a
three-day period.
In a limited number of children, etoposide administered in a do