Etoposide 20mg/ml concentrate for solution for infusion concentrate for solution for infusion

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

etoposide

Доступна с:

Accord Healthcare Limited

код АТС:

L01CB01

ИНН (Международная Имя):

etoposide

дозировка:

20mg/ml

Фармацевтическая форма:

concentrate for solution for infusion

Штук в упаковке:

5ml glass vial

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2018-02-27

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

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 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 treatment with etoposide infusion must not be
given before the
blood
picture
has
been
controlled
for
signs
of
mye