Etoposide 20 mg/ml concentrate for solution for infusion

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Etoposide

Tilgængelig fra:

Fresenius Kabi Oncology Plc

ATC-kode:

L01CB; L01CB01

INN (International Name):

Etoposide

Dosering:

20 milligram(s)/millilitre

Lægemiddelform:

Concentrate for solution for infusion

Recept type:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Podophyllotoxin derivatives; etoposide

Autorisation status:

Marketed

Autorisation dato:

2014-05-16

Indlægsseddel

ETOPOSIDE - PACK INSERT - IRELAND+UK
(Travesh Sharma)
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- Pack Insert - Ireland+UK.indd
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V002
FONT SIZE: TIMES NEW ROMAN 10 PT.
DATE: 15 JANUARY 2019 10:20 AM VERSION: 08
FINAL PACKAGING SITE: BORDON
MFG. SITE: BADDI-2
DIMENSION: 592 X 300 MM
FOLDING SIZE: 60 X 33 MM
(OUTLINE OF FOLDING SIZE FOR INDICATION PURPOSE ONLY, IT
SHOULD BE REMOVED BEFORE FINAL PRINTING.)
Form No.: SOP/PDD/014-02 Rev. 00
THE FOLLOWING INFORMATION
IS INTENDED FOR HEALTHCARE
PROFESSIONALS ONLY:
Cytotoxic agent
INSTRUCTIONS ON HOW TO DILUTE, STORE
AND DISPOSE OF ETOPOSIDE
DILUTION
Etoposide 20 mg/ml concentrate for
solution for infusion must be diluted
immediately prior to use with either
50 mg/ ml (5%) dextrose in water,
or 9 mg/ ml (0.9%) sodium chloride
solution to give a final concentration
of 0.2 mg/ml to 0.4 mg/ml. At higher
concentrations precipitation of
etoposide may occur.
Etoposide is administered by slow
intravenous infusion (usually over a
30 to 60 minute period). Etoposide
SHOULD NOT BE GIVEN
BY RAPID INTRAVENOUS
INJECTION.
STORAGE OF THE PREPARED SOLUTION
After dilution
Chemical and physical in-use
stability of the solution diluted to a
concentration of 0.2 mg/ml or
0.4 mg/ml has been demonstrated up
to 24 hours at 15°C to 25°C.
From a microbiological point of view,
the diluted product should be used
immediately. If not used immediately,
in-use storage times and conditions
prior to use are the responsibility
of the user and would normally not
be longer than 12 hours at 15°C to
25°C, unless dilution has taken place
in controlled and validated aseptic
conditions.
HANDLING AND DISPOSAL
The normal procedures for proper
handling and disposal of anti-cancer
medicinal products should be adopted:
•
Staff should be trained to
reconstitute the medicinal product.
•
Pregnant staff should be excluded
from working with this medicinal
product.
•
Staff handling this medicinal
product during dilution should
wear protective clothing including
mask, gogg

Produktets egenskaber

Health Products Regulatory Authority
05 July 2019
CRN008HJG
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Etoposide 20 mg/ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml concentrate for solution for infusion contains 20 mg of
etoposide.
Each 5 ml vial contains 100 mg of etoposide.
Each 10 ml vial contains 200 mg of etoposide.
Each 25 ml vial contains 500 mg of etoposide.
Each 50 ml vial contains 1000 mg of etoposide.
Excipients with known effect:
Benzyl alcohol 30 mg/ml
Ethanol: 241.4 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear, light yellow to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TESTICULAR CANCER
Etoposide is indicated in combination with other approved
chemotherapeutic agents for the treatment of first line, recurrent or
refractory testicular cancer in adults.
SMALL CELL LUNG CANCER
Etoposide is indicated in combination with other approved
chemotherapeutic agents for the treatment of small-cell lung
cancer in adults
HODGKIN'S LYMPHOMA
Etoposide is indicated in combination with other approved
chemotherapeutic agents for the treatment of Hodgkin's lymphoma
in adult and paediatric patients
NON-HODGKIN'S LYMPHOMA
Etoposide is indicated in combination with other approved
chemotherapeutic agents for the treatment of non-Hodgkin's
lymphoma in adult and paediatric patients.
ACUTE MYELOID LEUKAEMIA
Etoposide is indicated in combination with other approved
chemotherapeutic agents for the treatment of acute myeloid
leukaemia in adult and paediatric patients.
GESTATIONAL TROPHOBLASTIC NEOPLASIA
Etoposide is indicated for first line and second line therapy in
combination with other approved chemotherapeutic agents for
the treatment of high risk gestational trophoblastic neoplasia in
adults.
OVARIAN CANCER
Etoposide is indicated in combination with other approved
chemotherapeutic agents for the treatment of non-epithelial
ovarian