EPIRUBICIN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

EPIRUBICIN HYDROCHLORIDE

Available from:

Seacross Pharmaceuticals Limited

ATC code:

L01DB03

INN (International Name):

EPIRUBICIN HYDROCHLORIDE

Dosage:

2 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

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

Therapeutic area:

epirubicin

Authorization status:

Not Marketed

Authorization date:

2009-04-03

Patient Information leaflet

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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 or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist. 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 contains the active substance Epirubicin hydrochloride,
referred to as
“epirubicin” throughout this leaflet.
Epirubicin is an anti-cancer medicine. Treatment with an anti-cancer
medicine is sometimes
called cancer chemotherapy.
Epirubicin is used in the treatment of:
•
Cancer of the breast
•
Cancer of the stomach
•
Cancer of the ovaries
•
Cancer of the lung (small cell lung cancer)
•
It is used either alone or in combination with other anti-cancer
medicines
Epirubicin is also used intravesically to treat early (superficial)
urinary bladder cancer and
help prevent recurrence of bladder cancer after surgery.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE EPIRUBICIN
DO NOT USE EPIRUBICIN:
•
if you are allergic (hypersensitive) to epirubicin, similar medicines
(called
anthracyclines or anthracenediones - see below) or any of the other
ingredients of
Product nameEpirubicin Seacross> 2 mg/ml, solution for injection
(listed in section
6)
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•
if you have been treated with high doses of

Summary of Product characteristics

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.
The content of sodium is 3.54mg per ml and per vial is as follows:
5ml vial 17.71mg, 10ml vial 35.42mg, 25ml vial 88.55mg, 50ml vial
177.1mg and 100ml vial 354.2mg
For a 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
Intravesical prophylaxis of recurrences of superficial bladder
carcinoma following transurethral resection
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Epirubicin is for intravenous or intravesical use only.
The safety and efficacy of epirubicin in children has not been
established.
Epirubicin 2 mg/ml Solution for Injection is compatible with both
dextrose 5% and sodium chloride 0.9%.
Please refer to section 6.6 for instructions on the preparation and
handling of the drug product.
INTRAVENOUS ADMINISTRATION
It is advisable to administer epirubicin via the tubing of a
free-running intravenous sodium chloride 0.9% infusion after
checking that the needle is properly placed in the vein. Care should
be taken to avoid extravasation (see section 4.4). In
case of extravasation, administration should be stopped immediately.
_CONVENTIONAL DOSE_
When epirubicin is used as a single agent, the recommended dosage in
adults is 60-90 mg/m² body area. Epirubicin
should be injected intravenously over 3-5 minutes. The dose should be
repeated at 21-day intervals, depending upon the
patient's haematological status and bone marrow functi