Epirubicin Accord

Package Leaflet: Information for the Patient

Epirubicin Accord, 2 mg/mL, Solution for Injection/Infusion

Epirubicin Hydrochloride

Read All of This Leaflet Carefully Before You Start Using This Medicine.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What Epirubicin Accord is and what it is used for
• 2. What you need to know before you are given Epirubicin Accord
• 3. How Epirubicin Accord is given
• 4. Possible side effects
• 5. How to store Epirubicin Accord
• 6. Contents of the pack and other information

1. What Epirubicin Accord is and what it is used for

Epirubicin Accord is an anti-cancer medicine. Anti-cancer treatment is sometimes called chemotherapy. Epirubicin belongs to a group of substances called anthracyclines. These substances work by interfering with the growth of cancer cells, which are eventually destroyed.

Epirubicin Accord is used to treat different types of cancer, alone or in combination with other medicines. The way the medicine is given depends on the type of cancer being treated.

Epirubicin Accord is used to treat breast, lung, ovarian, and stomach cancer. It can also be given directly into the bladder through a catheter to treat cancer or non-cancerous conditions of the bladder wall. The medicine may be used after other treatments to prevent the return of these conditions.

If there is no improvement or if you feel worse, you should consult your doctor.

2. What you need to know before you are given Epirubicin Accord

When Epirubicin Accord should not be given

• if you are allergic to epirubicin or any of the other ingredients of this medicine (listed in section 6);
• if you are breast-feeding;
• if you have a low blood cell count (which can cause infections, bleeding, or anaemia);
• if you have severe liver disease;
• if you have had a recent heart attack, heart failure, severe heart rhythm disorders, sudden chest pain, or non-inflammatory heart disease;

or any other severe heart disease in the past or if you are currently being treated for this condition.

• if you have been treated before with epirubicin or other anthracyclines (a group of anti-cancer medicines), as previous treatment with these medicines may increase the risk of side effects;
• if you have severe infections.

Epirubicin Accord must not be given directly into the bladder (intravesical administration):

• if you have a urinary tract infection;
• if you have inflammation of the bladder;
• if you have an invasive tumour of the bladder wall;
• if you have problems with catheterisation (your doctor has difficulty inserting the catheter);
• if you have blood in your urine.

Warnings and precautions

Before you are given Epirubicin Accord, tell your doctor, pharmacist, or nurse:

• if you have liver or kidney problems.
• if you have been vaccinated recently.
• if you are elderly, as there is a higher risk of severe side effects affecting the heart. Your heart function will be monitored before and after treatment with epirubicin.
• if you have had heart disease in the past or if you currently have heart disease. You should tell your doctor, as your dose of epirubicin may need to be adjusted. Your doctor will monitor this regularly.
• if you have been treated before with anti-cancer medicines or if you have had radiotherapy, as the risk of side effects affecting the heart is higher. This may affect the dose of epirubicin.
• if you have an infection or bleeding. Epirubicin can affect the bone marrow. The number of white blood cells in your blood may decrease, making you more prone to infections (leukopenia). You may also bleed more easily (thrombocytopenia). These side effects are temporary. The number of white blood cells is usually at its lowest 10-14 days after starting treatment and returns to normal by the 21st day.
• if you currently have a severe infection, such as mouth ulcers, low white blood cell count, low platelet count, or a systemic infection.
• if you are taking or have recently taken trastuzumab (a medicine used to treat certain types of cancer). Trastuzumab can remain in your body for up to 7 months. Because trastuzumab can affect the heart, your doctor should not give you Epirubicin Accord for up to 7 months after you finish taking trastuzumab. If Epirubicin Accord is given before this time, your heart function will be closely monitored.
• if you have had or are going to have radiotherapy to the chest area
• if you are pregnant. There have been reports of heart problems in newborns and unborn babies when epirubicin was used during pregnancy. This will help your doctor decide whether this medicine is suitable for you.

Tell your doctor or nurse if you get any of the following while being treated with Epirubicin Accord (see also section 4 "Possible side effects"):

• heart problems, which can be:
• acute(occurring soon after starting treatment): changes in heart rhythm (arrhythmia) and changes in heart rate. These can usually be detected by an electrocardiogram (ECG) and are not serious enough to stop treatment with this medicine;
• delayed(usually occurring long after starting treatment) The most common symptoms of delayed toxicity are:
• heart failure (when the heart is not able to pump enough blood to meet the body's needs). The most common symptoms are difficulty breathing (dyspnoea), fluid build-up in the lungs (pulmonary oedema), swelling of other parts of the body, especially the feet, ankles, and hands, enlargement of the heart (cardiomegaly) and liver (hepatomegaly), decreased urine production (oliguria), fluid build-up in the abdomen (ascites) and the space between the lungs and chest cavity (pleural effusion), and irregular heart rhythms (arrhythmias). In some cases, heart failure can be severe and life-threatening.
• reduced numbers of white blood cells(leukopenia) or a type of white blood cell called neutrophils (neutropenia), platelets(thrombocytopenia), or red blood cells(anaemia). The number of white blood cells is usually at its lowest 10-14 days after starting treatment and returns to normal by the 21st day. In some cases, the decrease in the number of these blood cells can be severe and can lead to fever, infections of various organs and the blood, shock, bleeding, decreased oxygen supply to the brain, and death.
• a type of blood cancer (secondary leukaemia) that did not exist before treatment with epirubicin started. Leukaemia can appear 1-3 years after the end of epirubicin treatment, and the risk is higher if this medicine is given in high doses or in combination with other anti-cancer medicines or radiotherapy.
• vomiting and inflammation of the mucous membranes of the mouth. In severe cases, ulcers of the mucous membranes can also occur. These changes usually resolve within three weeks of treatment.
• liver problems, as the risk of toxic effects on the whole body may increase. Your doctor will adjust the dose of epirubicin according to your condition;
• inflammation of the veins into which epirubicin has been injected multiple times,
• inflammation and blockage of the veins (thrombophlebitis),
• a burning sensation at the injection site. This may indicate that epirubicin has leaked out of the blood vessel. You should inform your doctor immediately.
• a significant increase in the level of uric acidin the blood;
• inflammation and blood clots in the veins, mainly in the legs, pelvis (deep vein thrombosis) and lungs (pulmonary embolism). In some cases, pulmonary embolism can be life-threatening.

Tell your doctor or nurse if you get any of the following while Epirubicin Accord is being given directly into your bladder (intravesical administration) (see also section 4 "Possible side effects"):

• difficulty urinating (dysuria), frequent urination of small amounts without drinking fluids (urinary frequency), frequent need to urinate at night (nocturia), painful, slow, and interrupted urination, often in drops (stranguria), blood in the urine (haematuria), discomfort in the bladder, necrosis of the inner bladder wall, pressure on the bladder.

During treatment with Epirubicin Accord, your doctor will also regularly check:

• your blood count to ensure it is not too low;
• your heart function to ensure it is normal;
• your liver function to ensure it is normal;
• the level of uric acid in your blood;

During treatment with Epirubicin Accord, you should not have "live" or "attenuated" vaccinations, as they can cause severe or life-threatening infections due to a weakened immune system. However, you can receive vaccines with killed microorganisms or "inactivated" vaccines, although the effect of such vaccination may be reduced.

This medicine can cause irreversible changes that can also affect unborn babies. During treatment with Epirubicin Accord, women of childbearing age should be informed of the need to use effective contraception to prevent pregnancy.

If you wish to have children after treatment, you should consult a specialist.

Before and during treatment with Epirubicin Accord, your doctor will order frequent and regular laboratory tests to assess your health and the effectiveness of this medicine.

Epirubicin Accord and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, including those obtained without a prescription.

• Cimetidine(a medicine used to treat stomach ulcers and heartburn). Cimetidine may increase the effect of Epirubicin Accord.
• Calcium channel blockers(heart medicines).
• Interferon α2b(a medicine used to treat cancer).
• Quinine(a medicine used to treat malaria).
• Antibioticssuch as sulfonamides and chloramphenicol.
• Antiretroviral medicines(medicines used to treat HIV infection).
• Phenytoin(a medicine used to treat epilepsy).
• Painkillers, such as aminopyrine derivatives.
• Dexverapamil(a medicine used to treat certain heart conditions).
• Trastuzumab(a medicine used to treat certain types of cancer). Your doctor should not give you Epirubicin Accord for up to 7 months after you finish taking trastuzumab, if possible. If Epirubicin Accord is given before this time, your heart function will be closely monitored.
• Dexrazoxane(used to prevent chronic cumulative cardiotoxicity caused by epirubicin).
• Do not have "live" vaccinations while taking epirubicin.
• Paclitaxel or docetaxel(medicines used to treat cancer). When paclitaxel is given before epirubicin, it may increase the level of epirubicin in the blood. However, when paclitaxel and docetaxel are given at the same time and after epirubicin, they do not affect its level.
• Antibiotics, such as sulfonamides, and certain diuretics; additive effect of epirubicin on increasing the level of uric acid in the blood.
• Heparin (a medicine that prevents blood clotting); may lead to a loss of effectiveness of both epirubicin and heparin.

Pregnancy, breast-feeding, and fertility

If you are pregnant, breast-feeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

You should avoid becoming pregnant while you or your partner are taking this medicine.

Both men and women of childbearing age should use effective contraception to prevent pregnancy during treatment.

This medicine can cause birth defects, so it is essential to inform your doctor if you think you may be pregnant.

Breast-feeding

Do not breast-feed while being treated with this medicine and for at least 7 days after the last dose.

Fertility

Epirubicin can affect fertility in both men and women.

Men: there is a risk of infertility due to treatment with epirubicin.

Patients should consider storing sperm before treatment. Men treated with epirubicin should be informed not to plan to conceive a child during treatment and for at least 4 months after the end of treatment.

Women: Epirubicin can cause a lack of menstruation or premature menopause in women before menopause. Women treated with epirubicin should be informed not to become pregnant during treatment and for at least 7 months after the end of treatment.

Driving and using machines

There are no special precautions, as long as you feel fully recovered after hospital treatment and have discussed this with your doctor.

Epirubicin Accord contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per mL, which means it is essentially "sodium-free".

3. How Epirubicin Accord is given

If you have been prescribed Epirubicin Accord, the medicine will be given to you by doctors or nurses experienced in the use of chemotherapy.

This medicine is usually given by a doctor or nurse through a drip (infusion) into a vein.

Your doctor will decide on the dose and the number of days you will receive the medicine, depending on your condition.

The dose is calculated based on the type of disease, your height, and weight. Based on your height and weight, your doctor will calculate your body surface area, which will be used to calculate your individual dose.

Epirubicin Accord can also be given directly into the bladder to treat bladder cancer or to prevent its return. The dose depends on the type of bladder cancer.

When the medicine is given directly into the bladder, you will be instructed not to drink any fluids for 12 hours before the procedure to prevent the medicine from being diluted by urine in the bladder.

Although one treatment cycle may sometimes be enough, your doctor usually recommends additional cycles of treatment every 3 or 4 weeks. You may need to undergo several cycles of treatment before the disease is under control and you start to feel better.

Regular medical check-ups during treatment with Epirubicin Accord

During treatment, you will need to have regular checks:

• of your bloodto check for a low blood cell count, which may need treatment;
• of your heart functionto check for heart disease, which can occur even if you have no symptoms. Regular checks are necessary because heart disease can remain undetected for several weeks;
• of your liver functionto check for any adverse effects of the medicine on this organ;
• of the level of uric acidin your blood, as Epirubicin Accord can increase the level of uric acid, leading to a condition called gout (podagra). If the level of uric acid is too high, you may need treatment with other medicines.

What to do if you are given too much Epirubicin Accord

Taking too much of this medicine can increase the risk of side effects, such as mouth ulcers or a decrease in the number of white blood cells (which fight infections) or platelets (which help the blood to clot). In this case, treatment with antibiotics or blood transfusions may be necessary. If you have mouth ulcers, treatment to reduce discomfort can be given.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Epirubicin Accord can cause side effects, although not everybody gets them.

Severe side effects

If you experience any of the following side effects, contact your doctor immediately, as you may need urgent medical attention or hospitalization:

Very common (may affect more than 1 in 10 people)

• a significant decrease in the production of blood cells in the bone marrow (myelosuppression), which can cause:
• a decrease in the number of white blood cells (which fight infections), making you more prone to infections and fever (leukopenia)
• a decrease in the number of platelets (which help the blood to clot), making you more prone to bruising or bleeding (thrombocytopenia)
• a decrease in the number of certain types of white blood cells (granulocytes and neutrophils) (granulocytopenia and neutropenia)
• a decrease in the number of certain types of white blood cells with fever (febrile neutropenia)
• a decrease in the number of red blood cells (anaemia), which can cause fatigue and weakness
• inflammation of the veins

Common (may affect up to 1 in 10 people)

• heart problems (heart failure) (see section 2 "Warnings and precautions"). Heart problems can cause difficulty breathing (dyspnoea), swelling of various parts of the body due to fluid build-up, especially the feet, ankles, and hands, enlargement of the liver (hepatomegaly), presence of fluid in the abdomen (ascites) and the space between the lungs and chest cavity (pleural effusion), and irregular heart rhythms (arrhythmias)
• severe heart rhythm disorders (ventricular arrhythmia)
• certain types of heart rhythm disorders (atrioventricular block, bundle branch block)
• slow heart rate (bradycardia)
• bleeding
• pain or burning sensation in the digestive tract
• ulcers in the digestive tract
• inflammation of the mucous membranes of the digestive tract

Uncommon (may affect up to 1 in 100 people)

• certain types of blood cancer (acute lymphoblastic leukaemia, acute myeloid leukaemia) (see section 2 "Warnings and precautions")
• high fever, chills, general feeling of being unwell, possible feeling of cold hands and feet due to blood infection
• blockage of a vein by a blood clot (thrombosis) that can break loose and travel to the lungs, causing pain and difficulty breathing (pulmonary embolism)
• blockage of an artery (arterial thrombosis)
• swelling and pain in the legs or arms due to inflammation of the blood vessels caused by repeated injections of the medicine (see section 2 "Warnings and precautions") or blockage of the blood vessels by blood clots
• bleeding from the digestive tract

Rare (may affect up to 1 in 1,000 people)

• a life-threatening allergic reaction. Symptoms include sudden signs of allergy, such as rash, itching, or hives on the skin, swelling of the face, lips, tongue, or other parts of the body, difficulty breathing, wheezing, or trouble breathing
• absence of sperm in the semen
• allergic reactions after intravesical administration of epirubicin hydrochloride

Frequency not known (cannot be estimated from the available data)

• a life-threatening condition that occurs when blood pressure is too low due to blood infection (septic shock)
• discomfort in the abdominal area
• septic shock
• lack of oxygen in the tissues
• death of tissue (necrosis) due to leakage of the medicine from the vein into which it was injected. In this case, the administration of Epirubicin Accord should be stopped immediately (see section 2 "Warnings and precautions").

Other side effects

Very common (may affect more than 1 in 10 people)

• infections
• inflammation of the eye with redness and tearing (conjunctivitis)
• inflammation of the transparent part of the eye called the cornea (keratitis)
• hot flushes
• nausea
• vomiting
• inflammation of the mucous membranes of the mouth
• fever
• diarrhoea
• hair loss (alopecia)
• skin changes
• red colour of the urine for 1 to 2 days after administration of Epirubicin Accord
• absence of menstruation
• painful inflammation and ulcers of the mucous membranes of the digestive tract
• general feeling of being unwell
• changes in the activity of certain liver enzymes (transaminases)
• inflammation of the bladder (chemical cystitis) after intravesical administration. Symptoms may include: difficulty urinating (dysuria), frequent urination of small amounts without drinking fluids (urinary frequency), frequent need to urinate at night (nocturia), painful, slow, and interrupted urination, often in drops (stranguria), blood in the urine (haematuria), discomfort in the bladder, necrosis of the inner bladder wall (see section 2 "Warnings and precautions")

Common (may affect up to 1 in 10 people)

• decreased appetite
• loss of body fluids (dehydration)
• decreased amount of blood pumped by the heart to the body through the arteries (left ventricular ejection fraction)
• redness of the skin (flushing)
• inflammation of the mucous membranes of the digestive tract
• rash, itching, skin changes, darker skin and nail pigmentation (hyperpigmentation)
• need to urinate more frequently than usual after intravesical administration of Epirubicin Accord
• chills
• irritation at the injection site
• burning sensation after intravesical administration of Epirubicin Accord

Uncommon (may affect up to 1 in 100 people)

• lung infection (pneumonia)
• hives
• redness of the skin
• feeling of weakness

Rare (may affect up to 1 in 1,000 people)

• increased level of uric acid in the blood (hyperuricaemia)
• abnormalities in the electrocardiogram (ECG) due to heart problems
• dizziness (feeling of emptiness in the head)

Frequency not known (cannot be estimated from the available data)

• damage to the mucous membranes of the mouth, pain and burning sensation of the mucous membranes, bleeding from the mouth, and appearance of dark spots in the mouth
• redness or other skin reactions similar to sunburn after exposure to sunlight or ultraviolet radiation (e.g., in a solarium)
• increased sensitivity of the skin that has been previously exposed to radiotherapy
• pain at the injection site
• inflammation of the connective tissue
• thickening of the walls of the blood vessels (arteriosclerosis)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Side effects can be reported to the national reporting system listed below.

5. How to store Epirubicin Accord

Keep this medicine out of the sight and reach of children.

Do not use Epirubicin Accord after the expiry date stated on the label and carton after EXP.

The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C). Do not freeze.

Store the vial in the outer packaging to protect it from light.

Do not use Epirubicin Accord if you notice any signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

6. Contents of the pack and other information

What Epirubicin Accord contains

The active substance is epirubicin hydrochloride.

Each mL contains 2 mg of epirubicin hydrochloride.

The other ingredients are sodium chloride, hydrochloric acid (to adjust the pH), and water for injections.

What Epirubicin Accord looks like and contents of the pack

Epirubicin Accord is a clear red solution.

Pack sizes:

1 vial of 5 mL (10 mg/5 mL)

1 vial of 10 mL (20 mg/10 mL)

1 vial of 25 mL (50 mg/25 mL)

1 vial of 50 mL (100 mg/50 mL)

1 vial of 100 mL (200 mg/100 mL)

The 5 mL vial is made of type I glass with a 20 mm chlorobutyl rubber stopper and a white flip-off aluminium seal.

The 10 mL vial is made of type I glass with a 20 mm chlorobutyl rubber stopper and a white flip-off aluminium seal.

The 25 mL vial is made of type I glass with a 20 mm chlorobutyl rubber stopper and a white or purple flip-off aluminium seal.

The 50 mL vial is made of type I glass with a 20 mm chlorobutyl rubber stopper and a purple flip-off aluminium seal.

The 100 mL vial is made of type I glass with a 20 mm chlorobutyl rubber stopper and a white or purple flip-off aluminium seal.

Pack size: 1 vial.

Not all pack sizes may be marketed.

Marketing authorisation holder

Accord Healthcare Polska Sp. z o.o.

ul. Taśmowa 7

02-677 Warszawa

Tel: + 48 22 577 28 00

Manufacturer/Importer

Laboratori FUNDACIO DAU

C/ De la letra C, 12-14

Poligono Industrial de la Zona Franca

08040 Barcelona

Spain

Accord Healthcare Polska Sp. z o.o.

ul. Lutomierska 50

95-200 Pabianice

Accord Healthcare Single Member S.A.

64th Km National Road Athens

Lamia, Schimatari, 32009

Greece

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Member State

Marketing authorisation holder

Austria

Epirubicin Hydrochloride Accord

Belgium

Epirubicine Accord Healthcare 2 mg/ml, solution pour injection ou perfusion/oplossing voor injectie of infusie/Lösung zur Injektion oder Infusion

Czech Republic

Epirubicin Accord 2 mg/ml solution for injection or infusion

Denmark

Epirubicin Accord

Estonia

Epirubicin Accord

Spain

Epirubicin Hydrochloride Accord Healthcare

Finland

Epirubicin Accord

Hungary

Epirubicin Accord

Ireland

Epirubicin Hydrochloride 2 mg/ml solution for injection or infusion

Italy

Epirubicina Accord

Lithuania

Epirubicin Accord 2 mg/ml koncentratas injekciniam/infuziniam tirpalui

Latvia

Epirubicin Accord

Netherlands

Epirubicin Hydrochloride Accord 2 mg/ml, oplossing voor injectie

Norway

Epirubicin Accord

Poland

Epirubicin Accord

Portugal

Epirrubicina Accord

Sweden

Epirubicin Accord

Slovakia

Epirubicin Accord

United Kingdom (Northern Ireland)

Epirubicin Hydrochloride 2 mg/ml solution for injection or infusion

Date of last revision of the package leaflet: June 2025

Information intended for healthcare professionals only

Incompatibilities

Epirubicin Accord should not be mixed with other medicines, and it is recommended that it not be administered in the same equipment as heparin due to a reported physical incompatibility.

Instructions for use

Intravenous administration: It is recommended that the product be administered through a running intravenous infusion of 0.9% sodium chloride or 5% glucose. To minimize the risk of thrombophlebitis or extravasation, the infusion time can range from 5 to 10 minutes, depending on the dose and infusion volume. Direct injection is not recommended due to the risk of extravasation, which can occur even with a correctly placed intravenous needle or catheter.

Intravesical administration: Epirubicin Accord should be diluted in sterile water for injections or 0.9% sodium chloride solution immediately before administration. Epirubicin should be administered through a catheter and retained in the bladder for 1-2 hours.

During the instillation, the patient should be asked to change positions to ensure that the bladder mucosa is in contact with the solution. To avoid unnecessary dilution of the solution by urine, the patient should be instructed not to drink fluids for 12 hours before instillation. The patient should be instructed to urinate after the instillation period.

The solution for instillation does not contain preservatives, and any unused solution should be discarded immediately.

Special precautions for disposal

1. Preparation of the infusion solution should be carried out under aseptic conditions by trained personnel.

2. Preparation of the infusion solution should be carried out in a dedicated aseptic area.

3. Personnel should wear appropriate disposable gloves, eye protection, gowns, and masks.

4. Appropriate precautions should be taken to avoid accidental contact of the product with the eyes. In the event of contact with the eyes, they should be flushed with large amounts of water and/or 0.9% sodium chloride solution. Medical attention should be sought.

5. In the event of skin contact with the product, the area should be washed thoroughly with soap and water. However, the skin should not be scrubbed with a brush. After removing gloves, hands should always be washed.

6. Spills or leakage of the product should be cleaned up as soon as possible, preferably by absorption with a solution of sodium hypochlorite (1% available chlorine), followed by water. All materials used in cleaning should be disposed of as described below.

7. Pregnant women should not prepare cytotoxic medicines or handle them.

8. Appropriate precautions should be taken when disposing of materials (syringes, needles, etc.) used in the preparation and administration of cytotoxic medicines. All unused product or waste materials should be disposed of in accordance with local requirements for the disposal of cytotoxic waste.

Shelf life

Product in the original packaging:Store in a refrigerator (2°C - 8°C). Do not freeze.

Store the vial in the outer packaging to protect it from light.

Shelf life after first opening of the container

The vials are for single use only, and any unused product should be discarded after use. From a microbiological point of view, the product should be used immediately after piercing the rubber stopper. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

Shelf life after dilution of the injection solution

Epirubicin Accord can be diluted in 5% glucose or 0.9% sodium chloride solution and administered as an intravenous infusion. From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user. The storage time should not exceed 24 hours at 2°C - 8°C, unless dilution has been made in controlled and validated aseptic conditions.

Disposal of unused product:

Medicines should not be disposed of via wastewater or household waste. All materials used in the preparation and administration of the product, as well as materials that have come into contact with epirubicin, should be disposed of in accordance with local requirements for the disposal of cytotoxic waste.

Further information on Epirubicin Accord, 2 mg/mL, solution for injection/infusion, can be found in the Summary of Product Characteristics (SPC).