Etoposide 20mg/ml concentrate for solutionn for infusion (5ml vial)
Country: Малта
Језик: Енглески
Извор: Medicines Authority
Информативни летак
(PIL)
17-05-2024
Карактеристике производа
(SPC)
17-05-2024
Активни састојак:
ETOPOSIDE
Доступно од:
Fresenius Kabi Oncology PLC
АТЦ код:
L01CB01
INN (Међународно име):
ETOPOSIDE
Фармацеутски облик:
CONCENTRATE FOR SOLUTION FOR INFUSION
Састав:
ETOPOSIDE 20 mg/ml
Тип рецептора:
POM
Терапеутска област:
ANTINEOPLASTIC AGENTS
Статус ауторизације:
Authorised
Датум одобрења:
2014-03-26
Информативни летак
Page 1 of 7
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 any side effects, talk to
your doctor or nurse. This includes any possible side effects
not
listed in this leaflet.
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’. It contains
the active ingredient etoposide. Etoposide
belongs to a type of drugs known as podophyllotoxin derivatives.
Etoposide is used in adults in the
treatment of small cell lung cancer, testicular cancer and
cancer of
the blood-forming tissues of bone marrow (acute myelomonocytic
and monoblastic leukaemia). It is
often used at the same time as other anti-cancer medicines.
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ETOPOSIDE
DO NOT TAKE ETOPOSIDE
- if you are ALLERGIC to etoposide,
podophyllotoxines or podophyllotoxine-derivatives or any other
ingredients of this medici
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Карактеристике производа
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Etoposide 20 mg/ml concentrate for solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml concentrate for solution for infusion contains 20
mg of etoposide.
Each 5 ml vial contains 100 mg of etoposide.
Each 10 ml vial contains 200 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: 241.4 mg/ml
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear, light yellow to pale yellow solution.
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.
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 day
intervals. Repeated courses of treatment with
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