Etoposide 20 mg/ml concentrate for solution for infusion

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Etoposide

Verfügbar ab:

Fresenius Kabi Deutschland GmbH

ATC-Code:

L01CB; L01CB01

INN (Internationale Bezeichnung):

Etoposide

Dosierung:

20 milligram(s)/millilitre

Darreichungsform:

Concentrate for solution for infusion

Therapiebereich:

Podophyllotoxin derivatives; etoposide

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2014-05-16

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
ETOPOSIDE 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
ETOPOSIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What etoposide is and what it is used for
2.
What you need to know before you are given etoposide
3.
How you will be given etoposide
4.
Possible side effects
5.
How to store etoposide
6.
Contents of the pack and other information
1.
WHAT ETOPOSIDE IS AND WHAT IT IS USED FOR
The name of this medicine is ‘Etoposide 20 mg/ml concentrate for
solution for infusion’ but in the rest
of the leaflet it will be called ‘etoposide’. It contains the
active ingredient etoposide. Etoposide
belongs to the group of medicines called cytostatics which are used in
the treatment of cancer.
Etoposide is used in the treatment of certain types of cancers in
adults:
- testicular cancer
- small cell lung cancer
- cancer of the blood (acute myeloid leukaemia)
- tumour in the lymphatic system (Hodgkin’s lymphoma,
non-Hodgkin’s lymphoma)
- reproductive system cancers (gestational trophoblastic neoplasia and
ovarian cancer)
Etoposide is used in the treatment of certain types of cancers in
children:
- cancer of the blood (acute myeloid leukaemia)
- tumour in the lymphatic system (Hodgkin’s lymphoma,
non-Hodgkin’s lymphoma)
The exact reason why you have been prescribed etoposide is best
discussed with your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ETOPOSIDE
DO NOT TAKE ETOPOSIDE
-
if you are allergic to etoposide or any of the other ingredients of
this medicine (listed in section
6).
-
If you are breast-feeding or planning to breast-feed
-
If you have recently been given a live vaccine, including Yellow fev

Fachinformation

Health Products Regulatory Authority
13 February 2024
CRN00F1YY
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
ovar