ETOPOSIDE 20 Mg/Ml Concentrate for Soln for Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ETOPOSIDE

Available from:

Cipla (EU) Limited

ATC code:

L01CB01

INN (International Name):

ETOPOSIDE

Dosage:

20 Mg/Ml

Pharmaceutical form:

Concentrate for Soln for Inf

Administration route:

slow intravenous infusion

Units in package:

Pack sizes: 1 vial or 10 vials

Prescription type:

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

Manufactured by:

Cipla (EU) Limited

Therapeutic area:

Podophyllotoxin derivatives

Therapeutic indications:

It is indicated in adults for the management of: resistant non-seminomatous testicular tumours in combination with other chemotherapeutic agents; small cell lung cancer, in combination with other chemotherapeutic agents; acute monoblastic leukaemia (AML M5) and acute myelomonoblastic leukaemia (AML M4) when standard induction therapy has failed (in combination with other chemotherapeutic agents).

Authorization status:

Authorised

Authorization date:

2015-06-26

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 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 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 Etoposide will be given
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 your medicine is ‘Etoposide 20 mg/ml concentrate for
solution for infusion’ but in the rest of the leaflet it will be
called ‘etoposide’. This 
medicine contains the active substance etoposide. Etoposide belongs to
a type of drugs known as podophyllotoxin derivatives. Etoposide works
by 
interfering with the production of new DNA, which is needed to make
more cells. Therefore, when etoposide is taken up by the cancer
cells, it stops 
the growth of new cancer cells.
This medicine is used in adults to treat variety of cancers. It can be
used alone or in combination with other anti-cancer medicines to
treat:
•  small-cell lung cancer.
•  acute monoblastic & acute myelomonoblastic leukaemia (cancer of
the blood-forming tissues of bone marrow).
•  Resistant non-seminomatous testicular tumours (cancer of
testis).

2.  WHAT YOU NEED TO KNOW BEFORE YOU USE ETOPOSIDE
DO NOT USE ETOPOSIDE
•  If you are allergic to etoposide, podophyllotoxines or
 podophyllotoxine-derivatives or any other ingredients of this
medicine (listed in section 6) 
•  If your liver is not working properly 
•  If your bone marrow does not produce enough blood cells
•  If you

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 concentrate for solution for infusion contains 20 mg etoposide
One 5 ml vial contains 100 mg of etoposide.
Excipients with known effects:
Benzyl alcohol: 30mg/ml
Ethanol: 30.5%v/v
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear colourless to pale yellow sterile non-aqueous solution
pH : 3.00-4.00
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Etoposide is indicated in adults for the management of:
resistant non-seminomatous testicular tumours in combination with other chemotherapeutic agents
small cell lung cancer, in combination with other chemotherapeutic agents
acute monoblastic leukaemia (AML M5) and acute myelomonoblastic leukaemia (AML M4) when standard
induction therapy has failed (in combination with other chemotherapeutic agents).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Etoposide should only be administered under strict observation by a doctor specialised in oncology, preferable in
institutions specialised in such therapies.
Etoposide is intended for slow intravenous infusion. Etoposide should not be administered as a rapid intravenous
injection.
Posology
_Adults_
The recommended dose of etoposide is 60-120 mg/m
2
i. v. per day for 5 subsequent days. As etoposide causes
myelosuppression, the course of treatment must not be repeated more often than in intervals of 10 to 20 days. For non-
haematological indications courses may not be repeated more frequently than at 21 days intervals. Repeated courses of
treatment with etoposide infusion must not be given before the blood picture has been controlled for signs of
HEALTH PRODUCTS REGULATORY