ETOPOSIDE

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

ETOPOSIDE

제공처:

Accord Healthcare Limited

ATC 코드:

L01CB01

INN (국제 이름):

ETOPOSIDE

복용량:

20 Mg/Ml

약제 형태:

Concentrate for Soln for Inf

처방전 유형:

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

치료 영역:

etoposide

승인 상태:

Marketed

승인 날짜:

2014-07-25

환자 정보 전단

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

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Etoposide 20mg/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 100 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 Accord 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 Accord 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/m2 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
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