Etoposide 20mg/ml Concentrate for Solution for Infusion

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Etoposide

Tilgængelig fra:

Accord Healthcare Ireland Ltd.

ATC-kode:

L01CB; L01CB01

INN (International Name):

Etoposide

Dosering:

20 milligram(s)/millilitre

Lægemiddelform:

Concentrate for solution for infusion

Terapeutisk område:

Podophyllotoxin derivatives; etoposide

Autorisation status:

Marketed

Autorisation dato:

2014-07-25

Indlægsseddel

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 taking 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 pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of
illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Etoposide Injection is and what it is used for.
2. What you need to know before you are given Etoposide Injection.
3. How you will be given Etoposide Injection.
4. Possible side effects.
5. How to store Etoposide Injection.
6. Contents of the pack and other information.
1. WHAT ETOPOSIDE INJECTION IS AND WHAT IT IS USED FOR
This medicine contains the active substance etoposide. This medicine
belongs to the group of medicines called
cytostatics which are used in the treatment of cancer.
Etoposide Injection 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 Injection 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 Injection is
best discussed with your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ETOPOSIDE INJECTION
DO NOT TAKE ETOPOSIDE INJECTION
•
if you are allergic to etoposide or any other ingredients of this
medicine (listed

Produktets egenskaber

Health Products Regulatory Authority
13 March 2024
CRN00F6C4
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Etoposide 20 mg /ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 20 mg Etoposide.
Each 5 ml vial contains 100 mg of Etoposide. Each 10 ml vial contains
200 mg of Etoposide.
Each 12.5 ml vial contains 250 mg of Etoposide. Each 20 ml vial
contains 400 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, anhydrous: 240.64 mg/ml
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for Solution for infusion.
The product is a clear, colourless to pale yellow solution, which is
practically free from particles.
pH: 3.0 - 4.0.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TESTICULAR CANCER
Etoposide injection 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 injection is indicated in combination with other approved
chemotherapeutic agents for the treatment of small-cell
lung cancer in adults.
HODGKIN'S LYMPHOMA
Etoposide injection 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 injection 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 injection 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 injection is indicated for first line and second line
therapy in combination with other approved chemotherapeutic
agents for the treatment of high ri