Etoposide 20mg/ml Concentrate for solution for Infusion (250mg/12.5ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ETOPOSIDE

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

L01CB01

INN (International Name):

ETOPOSIDE 20 mg

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

ETOPOSIDE 20 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2014-06-10

Patient Information leaflet

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 i

Summary of Product characteristics

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 risk
gestational
trophoblastic neoplasia in adults.
OVARIAN CANCER