Etoposide 100mg/5ml concentrate for solution for infusion vials

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Etoposide

Доступна с:

Accord-UK Ltd

код АТС:

L01CB01

ИНН (Международная Имя):

Etoposide

дозировка:

20mg/1ml

Фармацевтическая форма:

Solution for infusion

Администрация маршрут:

Intravenous

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 08010400; GTIN: 5055565712603

тонкая брошюра

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.

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 side effects, talk to your doctor or 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 Injection is and what it is used for.
2. What you need to know before you use Etoposide Injection.
3. How to use 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. It works by
interfering production cycle of DNA and slow or
stop the growth of cancer cells.
Etoposide Injection is used 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).

testicular tumours (cancer of testis).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ETOPOSIDE INJECTION
DO NOT USE ETOPOSIDE INJECTION

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 are breast-feeding.

if you have a weak immune system and you are being vaccinated against
yellow fever at the same time.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before you use Etoposide
Injection:

if you have a low serum alb

Характеристики продукта

OBJECT 1
ETOPOSIDE 20 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 01-May-2015 | Accord
Healthcare Limited
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
Etoposide Injection 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
Treatment with etoposide should be initiated by or in consultation
with a qualified physician experienced
in cancer chemotherapy.
Etoposide Injection 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