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EPIRUBICIN COPHARMA 2 MG/ML SOLUTION FOR INJECTION/INFUSION

Active substance(s): EPIRUBICIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Epirubicin Copharma 2 mg/ml Solution for Injection/Infusion
Epirubicin hydrochloride
Read all of this leaflet carefully before you are given this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it
on to others. It may harm them, even if their symptoms 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
In this leaflet:
1.
What Epirubicin Copharma is and what it is used for
2.
Before you are given Epirubicin Copharma
3.
How Epirubicin Copharma is given
4.
Possible side effects
5.
How to store Epirubicin Copharma
6.
Further information
1.

WHAT EPIRUBICIN COPHARMA IS AND WHAT IT IS USED FOR

Epirubicin Copharma – the active substance of Epirubicin hydrochloride – belongs to
a group of active substances called anthracyclins. These cytotoxic active substances
are used to treat cancer.
Epirubicin Copharma is used in the treatment of
breast cancer,
advanced ovarian cancer,
stomach cancer,
small cell lung cancer,
superficial cancer of the bladder.
2.

BEFORE YOU ARE GIVEN EPIRUBICIN COPHARMA

You will not be given Epirubicin Copharma:
if you are allergic (hypersensitive) to epirubicin hydrochloride or any of the
other ingredients of Epirubicin Copharma.
if you have a very low level of white blood cells due to previous treatment with
other cytotoxic medicinal products or radiotherapy.
if you have been given the maximum dose of doxorubicin or daunorubicin
(other anthracyclins).
if you have or have previously had heart problems.
if you suffer from a systemic infection.
if you are breast-feeding.
For use in the bladder, you will not be given Epirubicin Copharma:

if you have an infection of the urinary tract

if the tumour has penetrated the bladder wall

if there are problems inserting the catheter into the bladder

if you suffer from an inflamed bladder

if you retain a large volume of urine in the bladder after passing water

if your bladder is contracted.
Special care is needed (check with your doctor):







if your liver or kidneys are not working properly
if you notice a sensation of discomfort close to or at the injection site during the
infusion (possible leakage into the surrounding tissue)
if your numbers of white and red blood cells and platelets are reduced
if you suffer from stomatitis or mucositis (sore lips or mouth ulcers)
if you have previously received radiotherapy of the breast or medication that
might have side effects on your heart

Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Pregnancy and breast-feeding
Epirubicin Copharma – the active ingredient in Epirubicin hydrochloride – may cause
birth defects, so it is important to tell your doctor if you think you are pregnant. Avoid
becoming pregnant while you or your partner is taking Epirubicin Copharma as well
as for 6 months after treatment.
Men who wish to father children in the future should seek advice about freezing
sperm before treatment with Epirubicin Copharma is started.
You must discontinue breast-feeding before and during therapy with Epirubicin
Copharma.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Epirubicin Copharma may cause nausea and vomiting, which can temporarily affect
your ability to drive and use machines.
Important information about some of the ingredients of Epirubicin Copharma
This medicinal product contains 0.154 mmol (or 3.54 mg) of sodium per ml of solution
for injection/infusion. The different package sizes of Epirubicin Copharma contain the
following amounts of sodium:
5 ml vial:
0.77 mmol (or 17.7 mg)
10 ml vial:
1.54 mmol (or 35.4 mg)
25 ml vial:
3.85 mmol (or 88.5 mg)
50 ml vial:
7.70 mmol (or 177.0 mg)
100 ml vial: 15.40 mmol (or 354.0 mg)
To be taken into consideration by patients on a controlled sodium diet.
3.
HOW EPIRUBICIN COPHARMA IS GIVEN
Epirubicin Copharma will only be given to you under supervision of a doctor
specialised in this type of treatment. Before and during treatment with Epirubicin
Copharma, your doctor will check various laboratory parameters (e.g. blood cell
count, blood uric acid level, your liver function) and carefully monitor your heart
function. Monitoring of the heart function will be continued for several weeks following
the end of treatment with Epirubicin Copharma.
The dosage of Epirubicin Copharma depends on the condition you are treated for,
your response to therapy and other medication you are given.
The dose of Epirubicin Copharma is based on your body surface area. This is
calculated from your height and weight.

The usual dosage of Epirubicin Copharma is 60-90 mg per square metre of body
surface area, given by injection over three to five minutes every three weeks.
In the treatment of small cell lung cancer, a higher dose of 120 mg per square metre
of body surface area is given by injection over three to five minutes or as infusion of
up to 30 minutes, every three weeks.
For the treatment of breast cancer your doctor will decide on the dosage and
regimen.
The dosage will be reduced if you have a low level of white blood cells and platelets
in your body, if you have liver or renal problems, or if the medicinal product is used in
combination with other cytotoxic medicinal products.
Epirubicin Copharma can also be given directly into the bladder to treat superficial
bladder cancer or to stop recurrence after bladder surgery to remove the cancer. The
dose will depend upon the type of bladder cancer.
Your general condition will be closely observed before, during and after the treatment
with Epirubicin Copharma.
If you are given more Epirubicin Copharma than you should
As this injection will be given to you by a doctor or nurse it is unlikely that you will be
given too much or that you will miss a dose. However, if you are concerned about
your treatment, please talk to your doctor or nurse.
In case you were given a higher dosage of Epirubicin Copharma than required
especially your heart function and count of blood cells will be closely monitored. The
occurring side effects may be more severe.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Epirubicin Copharma can cause side effects, although not
everybody gets them.
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.
Epirubicin Copharma may cause a red colouration of the urine for one or two days
after administration. This is normal and nothing to worry about.
Frequency:
Very common (more than 1 in 10 patients)
Common (more than 1 in 100 patients, but less than 1 in 10 patients)
Uncommon (more than 1 in 1,000 patients, but less than 1 in 100 patients)
Rare (more than 1 in 10,000 patients, but less than 1 in 1,000 patients)
Very rare (less than 1 in 10,000 patients)
Not known (cannot be estimated from the available data)

Very common  alopecia (hair loss) normally reversible
 lack of beard growth in males

Common

















nausea (feeling sick)
vomiting (being sick)
diarrhoea – may result in dehydration
loss of appetite
abdominal pain (tummy pain)
oesophagitis (inflammation of the gullet)
hyperpigmentation (darkened areas) of the oral mucosa
hot flushes
chemical cystitis (bladder inflammation) sometimes haemorrhagic (with
blood in the urine) following administration into the bladder
mucositis (inflammation of membranes in digestive tract) including
stomatitis (inflammation of linings of the mouth)
redness along the infusion vein
local phlebitis (inflammation of a vein, usually in the legs)
phlebosclerosis (hardening of the walls of the veins)
local pain and tissue death may occur (following accidental injection into
the surrounding tissue)
allergic reactions after being given into the bladder

Uncommon







hyperpigmentation (darkened areas) of skin and nails
skin reddening
thrombophlebitis (inflammation and a blood clot in a vein)
headache
photosensitivity (sensitivity to light) or hypersensitivity (allergic reaction)
to radiotherapy (referred to as the ‘recall phenomenon’)

Rare


















increased transaminase levels (increased levels of some liver enzymes)
ECG-changes (electrocardiogram)
tachycardia and ventricular tachycardia (rapid heart rate)
bradycardia (slow heart rate)
arrhythmias (abnormal heart beats)
AV block and bundle-branch block (specific forms of arrhythmias)
cardiomyopathy (heart muscle disease)
congestive heart disease (heart problems)
dyspnoea (difficulty in breathing)
oedema and pulmonary oedema (accumulation of fluid)
enlargement of the liver
ascites (accumulation of fluid in the abdominal cavity)
pleural effusion (accumulation of fluid between chest wall and lungs)
gallop rhythm (third heart sound)
urticaria (hives)
hyperuricaemia (high levels of uric acid in the blood)

 secondary acute myeloid leukaemia (malignant tumour of blood-forming
tissues) results when given in combination with other anti-cancer
medicinal products
 fever
 chills
 dizziness
 hyperpyrexia (increased body temperature)
 malaise (feeling of discomfort or uneasiness)
 weakness
 anaphylaxis (severe allergic reactions with or without shock including
skin rash, pruritis (itching), fever and chills)
 amenorrhoea (absence of menstrual periods)
 azoospermia (lack of levels of male sperm)
Not known

 myelosuppression (inhibition of blood cell production in the bone
marrow)
 leukopenia (decreased number of white blood cells)
 granulocytopenia and neutropenia (decreased numbers of a specific
form of white blood cells)
 febrile neutropenia (neutropenia accompanied by fever)
 thrombocytopenia (decreased number of platelets)
 anaemia (decrease in red blood cells)
 haemorrhage (bleeding)
 tissue hypoxia (inadequate oxygen supply)
 fever
 infections
 pneumonia (inflammation of the lungs)
 sepsis (systemic infection) and septic shock
 thromboembolic events (blockage of blood vessel by dislodged blood
clot)

5.
HOW TO STORE EPIRUBICIN COPHARMA
Store in a refrigerator (2 °C – 8 °C).
Storage of diluted product: maximum 24 hours at 2-8°C
Keep the vial in outer carton in order to protect from light. Do not freeze.
Keep out of the reach and sight of children.
Do not use Epirubicin Copharma after the expiry date which is stated on the carton
after EXP. The expiry date refers to the last day of that month.
6.

FURTHER INFORMATION

What Epirubicin Copharma contains
The active substance is epirubicin hydrochloride.
The other ingredients are sodium chloride, hydrochloric acid (for ph-adjustment) and
water for injections.
What Epirubicin Copharma looks like and contents of the pack
Epirubicin Copharma is a clear, red solution.
One millilitre of Epirubicin Copharma contains 2 mg of epirubicin hydrochloride. This
medicinal product comes in five different vial sizes:
 Each 5 ml vial of Epirubicin Copharma contains 10 mg of epirubicin hydrochloride

 Each 10 ml vial of Epirubicin Copharma contains 20 mg of epirubicin hydrochloride
 Each 25 ml vial of Epirubicin Copharma contains 50 mg of epirubicin hydrochloride
 Each 50 ml vial of Epirubicin Copharma contains 100 mg of epirubicin
hydrochloride
 Each 100 ml vial of Epirubicin Copharma contains 200 mg of epirubicin
hydrochloride
Not all pack sizes may be marketed.
Marketing authorisation holder:
COPHARMA ApS, Jægersborg Allé 164, DK-2820 Gentofte, Denmark
Manufacturer:
Oncotec Pharma Produktion GmbH Am Pharmapark D-06861 Dessau-Roβlau
Germany
Company responsible for batch release in the EU:
medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstraße 3 D-20354
Hamburg Germany
This medicinal product is authorised in the Member States of the EEA under
the following names:
Denmark
Finland
Norway
United Kingdom

Epirubicin “ Copharma ”
Epirubicin Copharma 2 mg/ml Injektio-/infuusioneste, liuos
Epirubicin Copharma 2 mg/ml Injeksjonsvæske-/infusjonsvæske,
opløsning
Epirubicin Copharma 2 mg/ml Solution for injection/Infusion

This leaflet was last approved in
<-------------------------------------------------------------------------------------------------------------PACKAGE LEAFLET: TCHNICAL PRESCRIBING INFORMATION
Epirubicin Copharma 2 mg/ml Solution for Injection/Infusion
Epirubicin hydrochloride
The following information is intended for medical or healthcare professionals only:
Epirubicin Copharma may be further diluted in Glucose 5% or Sodium Chloride 0.9%
and administered as an intravenous infusion. The infusion solution should be
prepared immediately before use.
The solution contains no preservative and any unused portion of the vial should be
discarded immediately.
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those
mentioned in section 6.6.

In use stability
Epirubicin hydrochloride may be further diluted, under aseptic conditions, in Glucose
5% or Sodium Chloride 0.9% and administered as an intravenous infusion. The
infusion solution is chemically and physically stable, for upto 24 hrs when prepared

under full aseptically controlled conditions in polypropylene syringes and in PVC
infusion bags at 2 to 8ºC.
However from a microbiological point of view, it is recommended that the product
should be used immediately. If not used immediately, in-use storage times and
conditions prior to use are the responsibility of the user and would normally not be
longer than 24 hours at 2 to 8ºC.
Guidelines for the safe handling and disposal of antineoplastic agents
1. If an infusion solution is to be prepared, this should be performed by trained
personnel under aseptic conditions.
2. Preparation of an infusion solution should be performed in a designated aseptic
area.
3. Adequate protective disposable gloves, goggles, gown and mask should be worn.
4. Precautions should be taken to avoid the medicinal product accidentally coming
into contact with the eyes. In the event of contact with the eyes, irrigate with large
amounts of water and/or 0.9% sodium chloride solution. Then seek medical
evaluation by a physician.
5. In case of skin contact, thoroughly wash the affected area with soap and water or
sodium bicarbonate solution. However, do not abrade the skin by using a scrub
brush. Always wash hands after removing gloves.
6. Spillage or leakage should be treated with dilute sodium hypochlorite (1%
available chlorine) solution, preferably by soaking, and then water. All cleaning
materials should be disposed of as detailed below.
7. Pregnant staff should not handle the cytotoxic preparation.
8. Adequate care and precautions should be taken in the disposal of items
(syringes, needles etc) used to reconstitute and/or dilute cytotoxic medicinal
products. Any unused product or waste material should be disposed of in
accordance with local requirements.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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