Etoposide-Teva 20 mg/ml Concentrate for Solution for Infusion

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Etoposide

Disponible depuis:

Teva Pharma B.V.

Code ATC:

L01CB; L01CB01

DCI (Dénomination commune internationale):

Etoposide

Dosage:

20 milligram(s)/millilitre

forme pharmaceutique:

Concentrate for solution for infusion

Type d'ordonnance:

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

Domaine thérapeutique:

Podophyllotoxin derivatives; etoposide

Statut de autorisation:

Marketed

Date de l'autorisation:

1998-07-27

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
ETOPOSIDE-TEVA 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.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
•
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-TEVA IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ETOPOSIDE-TEVA
3. HOW YOU WILL BE GIVEN ETOPOSIDE-TEVA
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ETOPOSIDE-TEVA
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT ETOPOSIDE-TEVA IS AND WHAT IT IS USED FOR
The name of this medicine is Etoposide-Teva. Etoposide belongs to the
group of medicines called
cytostatics which are used in the treatment of cancer.
Etoposide-Teva 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-Teva 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-Teva is best
discussed with your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ETOPOSIDE-TEVA
DO NOT TAKE ETOPOSIDE-TEVA
-
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, inc

Résumé des caractéristiques du produit

Health Products Regulatory Authority
18 November 2022
CRN00D5TQ
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Etoposide-Teva 20 mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate for solution for infusion contains etoposide 20
mg.
Each 5 ml vial contains 100 mg etoposide.
Each 10 ml vial contains 200 mg etoposide.
Excipient with known effect
Each vial with 5 ml concentrate for solution for infusion contains 1.2
g ethanol.
Each vial with 10 ml concentrate for solution for infusion contains
2.4 g ethanol.
This is equivalent to 241 mg/ml concentrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Sterile, clear, yellowish, slightly viscous concentrate.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TESTICULAR CANCER
Etoposide-Teva 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-Teva is indicated in combination with other approved
chemotherapeutic agents for the treatment of small-cell lung
cancer in adults.
HODGKIN'S LYMPHOMA
Etoposide-Teva 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-Teva 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-Teva 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-Teva 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-Tev