Etoposide 20mg/ml Concentrate for Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Etoposide

Available from:

Actavis Group PTC ehf

ATC code:

L01CB; L01CB01

INN (International Name):

Etoposide

Dosage:

20 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Prescription type:

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

Therapeutic area:

Podophyllotoxin derivatives; etoposide

Authorization status:

Marketed

Authorization date:

2014-07-18

Patient Information leaflet

1
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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist 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 use Etoposide
3.
How to use 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. It contains
the active ingredient etoposide.
Etoposide belongs to a 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 USE ETOPOSIDE
DO NOT USE ETOPOSIDE:
-
if you are allergic to etoposide or any of the other ingredients of
this medicine (listed in
section 6).
-
if you have recently been given a live vaccine, including Yellow fever
vaccine.
-
if you are breast-feeding or planning to breast-feed.
If any of the above affects you, or if you are unsure if

Summary of Product characteristics

Health Products Regulatory Authority
27 February 2019
CRN008L83
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 of concentrate for solution for infusion contains 20 mg of
etoposide.
One vial of 5 ml concentrate for solution for infusion contains 100 mg
of etoposide.
Excipients with known effect:
1 ml of concentrate for solution for infusion contains 158 mg ethanol.
One vial of 5 ml concentrate for solution for infusion contains 790 mg
ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, pale yellow solution, slightly viscous, free from visible
particles.
The pH is between 3,0 and 4,0.
The osmolarity is > 2000 mOsmol/L.
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
Health Product