Epirubicin 2 mg/ml Solution for Injection

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Epirubicin hydrochloride

可用日期:

Actavis Group hf

ATC代码:

L01DB; L01DB03

INN（国际名称）:

Epirubicin hydrochloride

剂量:

2 milligram(s)/millilitre

药物剂型:

Solution for injection

处方类型:

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

治疗领域:

Anthracyclines and related substances; epirubicin

授权状态:

Marketed

授权日期:

2008-04-18

资料单张

7
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPIRUBICIN 2 MG/ML SOLUTION FOR INJECTION
Epirubicin hydrochloride
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.
-
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 any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Epirubicin is and what it is used for
2.
What you need to know before you use Epirubicin
3.
How to use Epirubicin
4.
Possible side effects
5.
How to store Epirubicin
6.
Contents of the pack and other information
1.
WHAT EPIRUBICIN IS AND WHAT IT IS USED FOR
Epirubicin is an anti-cancer medicine. Treatment with an anti-cancer
medicine is sometimes called
cancer chemotherapy, Epirubicin is part of a group of medicines called
antrhacyclines. These act upon
cells that are actively growing, to slow or stop their growth and
increase the chance that the cells die.
Epirubicin is used to treat a variety of cancers. The way in which it
is used depends upon the type of
cancer that is being treated.
When injected into the bloodstream, Epirubicin is used to treat
cancers of the breast, stomach and
lung as well as advanced ovarian cancer.
When injected into the bladder through a tube, Epirubicin is used to
treat cancers of the bladder wall.
It can also be used after other treatments for prevention of such
cells from growing again.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EPIRUBICIN
DO NOT USE EPIRUBICIN:
-
if you are allergic to epirubicin hydrochloride or any of the other
ingredients of this medicine
(listed in section 6).
-
if you are allergic to other similar drugs (belonging to a group of
drugs called anthracyclines,
which among others include doxorubicin or daunorubicin)
-
if

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epirubicin 2 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of solution for injection contains 2 mg epirubicin
hydrochloride.
One 5 ml vial of Epirubicin 2 mg/ML solution for injection contains 10
mg epirubicin hydrochloride equivalent to 9.35
mg epirubicin.
One 10 ml vial of Epirubicin 2 mg/ml solution for injection contains
20 mg epirubicin hydrochloride equivalent to 18.7
mg epirubicin.
One 25 ml vial of Epirubicin 2 mg/ml solution for injection contains
50 mg epirubicin hydrochloride equivalent to
46.75 mg epirubicin.
One 50 ml vial of Epirubicin 2 mg/ml solution for injection contains
100 mg epirubicin hydrochloride equivalent to
93.5 mg epirubicin.
One 100 ml vial of Epirubicin 2 mg/ml solution for injection contains
200 mg epirubicin hydrochloride equivalent to
187 mg epirubicin.
Excipient with known effect: Contains sodium 3.54 mg/ml (0.154 mmol)
(see section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear red solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Epirubicin is used in the treatment of a range of neoplastic
conditions including:
-
Carcinoma of the breast
-
Advanced ovarian cancer
-
Gastric cancer
-
Small cell lung cancer
When administered intravesically, epirubicin has been shown to be
beneficial in the treatment of:
-
Papillary transitional cell carcinoma of the bladder
-
Carcinoma-in-situ of the bladder
-
Prophylaxis of recurrences of superficial bladder carcinoma following
transurethral resection.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Epirubicin is for intravenous or intravesical use only.
Paediatric population
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