ETOPOSIDE INJECTION USP SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

ETOPOSIDE

Pieejams no:

SANDOZ CANADA INCORPORATED

ATĶ kods:

L01CB01

SNN (starptautisko nepatentēto nosaukumu):

ETOPOSIDE

Deva:

20MG

Zāļu forma:

SOLUTION

Kompozīcija:

ETOPOSIDE 20MG

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

5/10/25/50ML

Receptes veids:

Prescription

Ārstniecības joma:

ANTINEOPLASTIC AGENTS

Produktu pārskats:

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

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2023-07-28

Produkta apraksts

_Etoposide Injection USP _
_Page 1 of 26 _
PRODUCT MONOGRAPH
PR
ETOPOSIDE INJECTION USP
(Etoposide)
20 mg/mL
(100 mg/5 mL, 200 mg/10 mL, 500 mg/25 mL, 1 g/50 mL)
Antineoplastic Agent
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Date of Revision:
May 21, 2015
Submission Control No: 184066
_Etoposide Injection USP _
_Page 2 of 26 _
PRODUCT MONOGRAPH
PR ETOPOSIDE INJECTION USP
20 mg/mL
(100 mg/5 mL, 200 mg/10 mL, 500 mg/25 mL, 1 g/50 mL)
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
CAUTION: ETOPOSIDE IS A POTENT DRUG AND SHOULD BE USED ONLY
BY QUALIFIED PHYSICIANS EXPERIENCED WITH CANCER CHEMO-
THERAPEUTIC DRUGS (SEE WARNINGS AND PRECAUTIONS). 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 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