Epirubicin Teva 2 mg/ml solution for injection and infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Epirubicina Teva 2 mg/ml concentrate for solution for infusion EFG

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 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.

What is in this leaflet

1. What Epirubicina Teva 2 mg/ml is and what it is used for
2. What you need to know before using Epirubicina Teva 2 mg/ml
3. How to use Epirubicina Teva 2 mg/ml
4. Possible side effects
5. How to store Epirubicina Teva 2 mg/ml
6. Contents of the pack and other information

1. What Epirubicin Teva 2 mg/ml is and what it is used for

Epirubicin belongs to the group of cytostatic agents (medicines used to treat cancer).

Epirubicin prevents cancer cells from growing and ultimately destroys them.

Epirubicin Teva is used in the treatment of:

• breast cancer;
• stomach cancer;
• Epirubicin is also administered intravesically (directly into the bladder) for the treatment of early-stage (superficial) bladder cancer and helps prevent recurrence of bladder cancer after surgery.

Epirubicin is frequently used in combination with other anticancer medicines (polychemotherapy regimens).

2. What you need to know before using Epirubicin Teva 2 mg/ml

Do not use Epirubicin Teva 2 mg/ml

• if you are allergic to epirubicin, to similar medicines (called anthracyclines or anthracenediones, see below), or to any of the other ingredients of this medicine (listed in section 6);
• if you are breastfeeding

Depending on the route of administration, Epirubicin Teva 2 mg/ml must not be administered in the following situations:

Intravenous route (into a vein):

• if you have previously been treated with high doses of other anticancer medicines, including doxorubicin and daunorubicin, which belong to the same group of drugs as Epirubicin Teva 2 mg/ml (called anthracyclines). These medicines have similar adverse effects (including effects on the heart);
• if you have or have had heart problems;
• if you have low blood cell counts;
• if you have severe liver disorder;
• if you have a severe acute infection.

Intravesical route (directly into the bladder):

• if cancer has invaded the wall of the bladder;
• if you have a urinary tract infection;
• if you have pain or inflammation in the bladder;
• if your doctor has difficulty inserting the catheter (tube) into your bladder;
• if there is a large residual volume of urine in your bladder after attempting to empty it;
  • if there is blood in your urine;
  • if you have a contracted bladder.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Epirubicin Teva 2 mg/ml:

• if you are an elderly person or a child, because there is a higher risk of serious adverse effects on the heart. Your cardiac function will be checked before and after treatment with epirubicin.
• if you have had heart problems in the past or currently have such problems. You must inform your doctor. The dose of epirubicin should be adjusted. Your doctor will regularly check whether your heart is functioning properly.
• if you have previously been treated with anticancer medicines (anthracyclines (such as doxorubicin or daunorubicin)), anthracenediones, or trastuzumab, or if you have received radiation therapy to the chest area, due to an increased risk of serious adverse cardiac effects. Inform your doctor, as this will influence the determination of the total dose of epirubicin to be administered.
• if you have kidney or liver problems. This may lead to an increase in adverse effects. Both kidney and liver functions will be monitored regularly, and the dose may be adjusted if necessary.
• if you are planning to have children. Both men and women should use effective contraception during treatment and for 6.5 months (women) or 3.5 months (men) after treatment ends. It is recommended that both seek genetic counseling (see “Pregnancy, breastfeeding and fertility”).
• if you suffer from infections or bleeding. Epirubicin can affect the bone marrow. The number of white blood cells in the blood may decrease, making you more susceptible to infections (leukopenia). Bleeding may occur more easily (thrombocytopenia). These adverse effects are transient. The decrease in white blood cell count is greatest 10–14 days after administration and usually returns to normal 21 days after administration. Your doctor will perform regular blood tests.
• if you have recently received or plan to receive any vaccines.

Take special care during treatment with Epirubicin Teva 2 mg/ml:

• to monitor your blood uric acid levels. Your doctor will check this.
• if blood clots form in your blood vessels (thromboembolism), which may lead to vein inflammation (thrombophlebitis) or blockage of a lung artery (pulmonary embolism).
• if you develop severe inflammation or ulcers in the mouth.
• if you experience a burning sensation at the site of administration. This may indicate that epirubicin has leaked out of the vein. Inform your doctor immediately.

Children and adolescents

The safety and efficacy of epirubicin in children have not been established.

Using Epirubicin Teva 2 mg/ml with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

An interaction means that medicines taken together may affect each other’s action and/or their adverse effects. An interaction may occur when this solution is used together with:

• prior or concomitant administration of other products related to epirubicin (also called anthracyclines; (e.g., anticancer medicines such as mitomycin-C, dacarbazine, dactinomycin, andcyclophosphamide )** ), other medicines that may affect the heart (e.g., anticancer medicines such as 5-fluorouracil, cyclophosphamide, cisplatin, taxanes, trastuzumab ) or calcium channel blockers (used to treat high blood pressure or certain heart conditions); heart damage may increase. In such cases, more intensive monitoring of heart function is required.
• epirubicin may enhance the effects of radiation and even cause serious adverse effects in the irradiated area some time after epirubicin administration.
• paclitaxel and docetaxel (medicines used against certain types of cancer); when paclitaxel is administered before epirubicin or docetaxel is administered immediately after epirubicin, the blood levels of epirubicin increase, which may lead to increased adverse effects.
• dexverapamil (a medicine used to treat certain heart conditions); if used together with epirubicin, it may have negative effects on the bone marrow.
• interferon alfa-2b (a medicine used against certain types of cancer and lymphomas and in certain forms of hepatitis).
• quinine (a medicine used to treat malaria and leg cramps); may increase the distribution rate of epirubicin in the body, which may negatively affect red blood cells.
• dexrazoxane (a medicine sometimes used with doxorubicin to reduce the risk of heart problems); the duration of epirubicin in the body may decrease, which may reduce the effectiveness of epirubicin.
• cimetidine (a medicine used to treat stomach ulcers); increases the amount of epirubicin in the blood, which may lead to increased adverse effects.
• prior or concomitant treatment with other medicines that may affect the bone marrow (e.g., other anticancermedicines, sulfonamides and chloramphenicol***(antibiotics), phenytoin(antiepileptic),amidopyrine derivatives(analgesics)*,medicines against certain viruses ) ; blood cell formation may be affected.
• medicines that cause heart failure.
• medicines that affect liver function; the hepatic metabolism of epirubicin may be altered, which may reduce the effectiveness of epirubicin or increase adverse effects.
• live or live attenuated vaccines; there is a risk of developing a fatal disease, so this combination is not recommended.

Using Epirubicin Teva 2 mg/ml with food and drinks

Do not drink anything for the 12 hours before administration if epirubicin is administered into the bladder.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy and fertility

Epirubicin may harm the unborn baby if used during pregnancy. Animal studies have shown that epirubicin is harmful to the fetus and may cause malformations.

It is very important that you inform your doctor if you are pregnant or become pregnant during treatment. Epirubicin hydrochloride 2 mg/ml should not be used during pregnancy unless your doctor considers immediate treatment with epirubicin absolutely necessary.

If you become pregnant during treatment with epirubicin, genetic counseling is recommended. Some reports in pregnant women have linked epirubicin to heart problems in newborns and fetuses, including fetal death.

Women of childbearing potential must use effective contraception during treatment and for at least 6.5 months after the last dose. Men receiving epirubicin treatment must use effective contraception during treatment and for at least 3.5 months after the last dose.

Treatment with epirubicin may cause infertility. Both men and women should seek advice on fertility preservation before treatment.

Epirubicin may cause absence of menstruation or premature menopause in premenopausal women.

Breastfeeding

It is unknown whether epirubicin is excreted in breast milk. You must stop breastfeeding during treatment with Epirubicin Teva 2 mg/ml and for at least 7 days after the last dose.

Driving and using machines

Driving and operating machinery are not recommended, as many patients experience nausea or vomiting during treatment.

Epirubicin Teva 2 mg/ml contains sodium

This medicine contains 18 mg of sodium (the main component of cooking/table salt) in each 5 ml vial. This corresponds to 0.9% of the maximum daily recommended sodium intake for an adult.

This medicine contains 35 mg of sodium (the main component of cooking/table salt) in each 10 ml vial. This corresponds to 1.8% of the maximum daily recommended sodium intake for an adult.

This medicine contains 89 mg of sodium (the main component of cooking/table salt) in each 25 ml vial. This corresponds to 4.4% of the maximum daily recommended sodium intake for an adult.

This medicine contains 266 mg of sodium (the main component of cooking/table salt) in each 75 ml vial. This corresponds to 13.3% of the maximum daily recommended sodium intake for an adult.

This medicine contains 354 mg of sodium (the main component of cooking/table salt) in each 100 ml vial. This corresponds to 17.7% of the maximum daily recommended sodium intake for an adult.

3. How to use Epirubicin Teva 2 mg/ml

Epirubicin Teva 2 mg/ml must only be administered under the supervision of a physician experienced in the use of this type of treatment. Consult your doctor or pharmacist if you have any questions.

Your doctor will perform blood tests while you are receiving epirubicin treatment. These are carried out to monitor the drug's effects. Your doctor will also perform tests to check heart function. Blood tests and heart monitoring will be performed before and during treatment with epirubicin.

The dose administered will depend on the type of cancer you have, your general health, your age, liver function, and other medications you may be taking.

Administration into the vein (intravenous administration)

The dose is determined based on your general health status and any prior treatments, taking into account your height and body weight. The dose is expressed in milligrams per square meter of body surface area.

This medicine is administered either as an intravenous injection over 3–5 minutes or as an intravenous infusion lasting up to 30 minutes.

When epirubicin hydrochloride is administered alone, i.e. without other anticancer drugs, the recommended dose is 60–90 mg/m² of body surface area. This dose may be given as a single dose or divided over 2–3 consecutive days. This regimen is repeated every 21 days. When used in combination with other anticancer drugs, doses are reduced.

Administration is performed via a catheter or by infusion using a saline or glucose (sugar) solution.

Higher doses are used for the treatment of breast cancer (100–120 mg/m² of body surface area).

Administration into the bladder (intravesical administration)

The medicine may be administered directly into the bladder (for the treatment of bladder cancer) via a catheter. If this method is used, you must not drink any fluids during the 12 hours prior to treatment to avoid excessive dilution of the medicine by urine.

After administration, the drug solution should remain in the bladder for 1–2 hours. Occasionally, you may need to change position to ensure the medicine reaches all parts of the bladder.

When urinating after administration of the medicine, take care to avoid contact of urine with the skin. If contact occurs, wash the affected area thoroughly with soap and water, but do not rub.

If you use more Epirubicin Teva 2 mg/ml than you should

This medicine will be administered in the hospital, so the risk of overdose is unlikely. However, an overdose may affect your heart, reduce blood cell counts, and cause gastrointestinal toxic effects (mainly mucositis). You may develop mouth sores. If you think you have been given too much Epirubicin Teva 2 mg/ml, contact your doctor immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at (91) 562 04 20.

If you forget to use Epirubicin Teva 2 mg/ml

This medicine will be administered in the hospital, so the risk of missing a dose is unlikely.

Consult your doctor if you have any questions.

If you stop using Epirubicin Teva 2 mg/ml

Consult your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

It can be expected that more than 10% of treated patients may develop adverse effects. The most frequent adverse effects are decreased production of blood cells (myelosuppression), gastrointestinal adverse effects, loss of appetite (anorexia), hair loss (alopecia), and infection.

The following adverse effects may occur, among others:

Very common: may affect more than 1 in 10 people

• Infection
• Inflammation of the eye (conjunctivitis or keratitis)
• Decreased production of blood cells (bone marrow suppression; resulting in reduced white blood cells, red blood cells, and platelets), leading to increased susceptibility to infections and fever, anemia, bruising, and bleeding when injured
• Hot flushes, redness along the vein (phlebitis)
• Nausea and vomiting (often occur within the first 24 hours (in almost all patients)), inflammation of the mucous membrane of the mouth (stomatitis), inflammation of the mucous membrane (mucositis; may occur 5 to 10 days after starting treatment), diarrhea which may lead to dehydration
• Hair loss (alopecia, in 60-90% of treated cases. This includes poor beard growth in men. Hair loss is dose-dependent and reversible in most cases)
• Skin damage
• Red discoloration of urine for 1 or 2 days after administration
• Absence of menstruation (amenorrhea)
• General malaise, fever
• Changes in levels of certain enzymes (transaminases)
• Inflammation of the bladder (cystitis), sometimes with bleeding, after direct administration into the bladder

Common: may affect up to 1 in 10 people

• Loss of appetite (anorexia), dehydration
• Reduced heart function resulting in blood congestion (congestive heart failure), heart failure (dyspnea, fluid accumulation throughout the body (edema), liver enlargement, fluid accumulation in the abdominal cavity (ascites), fluid accumulation in the lungs (pulmonary edema), pleural effusions, abnormal heart rhythm (gallop rhythm)), increased heart rate originating from the lower chambers of the heart (ventricular tachycardia), slow heart rate (bradycardia), cessation of impulse transmission in the heart (AV block, bundle branch block)
• Decreased fraction of blood pumped from a ventricle with each heartbeat (reduced ejection fraction)
• Bleeding (hemorrhage), skin redness (flushing)
• Inflammation of the mucous membrane of the esophagus (esophagitis), abdominal pain, erosion and ulcers in the gastrointestinal tract
• Skin rash, intense itching (pruritus), skin disorders
• Increased pigmentation (hyperpigmentation) of the skin and nails
• Redness at the infusion site, chills
• Local reactions such as burning sensation and frequent urgency to urinate have been observed after administration into the bladder

Uncommon: may affect up to 1 in 100 people

• Blood poisoning (sepsis), lung infection (pneumonia)
• Certain forms of blood cancer (acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML))
• Vascular inflammation with blood clot formation, often felt as a painful area with a firm core and surrounding red skin (thrombophlebitis)
• Blood clot formation (embolism, arterial embolism), including blood clots in the lungs (pulmonary embolism, isolated cases with fatal outcome)
• Bleeding in the gastrointestinal tract
• Skin rash with small bumps (urticaria), skin redness (erythema)
• Feeling of weakness (asthenia)

Rare: may affect up to 1 in 1,000 people

• Immediate, severe allergic reaction (anaphylactic/anaphylactoid reaction) with or without shock, including skin rash and itching, fever and chills
• Increased level of uric acid in the blood (hyperuricemia)
• Dizziness
• Cardiotoxicity (e.g., ECG abnormalities, arrhythmias, heart muscle disease (cardiomyopathy))
• Absence of sperm in semen (azoospermia)
• Fever (extremely high)

Not known: frequency cannot be estimated from available data

• Blood poisoning and shock (septic shock) as a result of decreased production of blood cells (myelosuppression)
• Bleeding, tissue hypoxia
• Certain nerve disorders (peripheral neuropathy), headache
• Shock
• Abdominal discomfort, erosion of oral mucous membrane, mouth ulceration, mouth pain, burning sensation in the mucous membrane, mouth bleeding (oral hemorrhage), discoloration of the oral cavity (oral pigmentation)
• Sensitivity to light (photosensitivity) or allergic reaction upon radiation exposure (radiation recall reaction)
• Increased amount of protein in urine (proteinuria) in patients treated with high doses
• Local pain, severe inflammation of the cellular tissue (cellulitis), tissue death (tissue necrosis), thickening or hardening of the vein walls (phlebosclerosis) after accidental injection outside the vein

Intravesical route (into the bladder): Serious systemic adverse reactions as well as allergic reactions are rare when Epirubicin Teva 2 mg/ml is administered into the bladder.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Epirubicin Teva 2 mg/ml

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label/carton after EXP. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C).

Refrigerated storage and transport.

Do not freeze.

After first opening, the medicine should be used immediately.

The chemical and physical stability is as follows:

Viaflo Bag (non-PVC)	Refrigerator 2–8 °C	Room temperature 15–25 °C, normal light
Sodium chloride 0.9% for injection	28 days	14 days
Glucose 5% for injection	28 days	28 days
Polypropylene Syringe	Refrigerator 2–8 °C	Room temperature 15–25 °C, normal light
Sodium chloride 0.9% for injection	28 days	14 days
Water for injection preparations	28 days	7 days
Undiluted	28 days	14 days

From a microbiological standpoint, the medicine should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2-8°C.

Storage of the injection solution under cold conditions may result in the formation of a gel-like product. This gel-like product will gradually change from slightly viscous to a mobile solution within 2 hours and up to a maximum of 4 hours at controlled room temperature (15-25°C).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Epirubicin Teva 2 mg/ml

• The active substance is epirubicin hydrochloride; 1 ml of solution contains 2 mg of epirubicin hydrochloride.

• The other components are sodium chloride, hydrochloric acid and water for injection.

Appearance of the product and contents of the container

Epirubicin Teva 2 mg/ml is a medicine presented as a red, transparent injectable and infusion solution. It is marketed in glass injection vials containing 5 ml (10 mg), 10 ml (20 mg), 25 ml (50 mg), 75 ml (150 mg) or 100 ml (200 mg) of injectable and infusion solution.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Holder

Teva Pharma S.L.U.
C/ Anabel Segura, 11. Edificio Albatros B, 1ª planta
Alcobendas, 28108 Madrid (Spain)

Manufacturer

Pharmachemie B.V.
Swensweg 5
P.O. Box 552
2003 RN Haarlem, The Netherlands

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

Belgium: EPIRUBICINE TEVA 2 mg/ml
Denmark: Epirubicin Teva solution for injection or infusion
France: EPIRUBICINE TEVA CLASSICS 2 mg/ml, solution injectable ou pour perfusion
Germany: Epi Teva 2 mg/ml Injektionslösung oder Infusionslösung
Greece: Epirubicin HCL / PCH, ευ?σιμο δι?λυμα ? δι?λυμα για ?γχυση 2 mg/ml
Hungary: Epirubicin- Teva 2 mg/ml oldatos injekció vagy infúzió
Italy: Epirubicina Teva 2 mg/ml soluzione iniettabile o per infusione
Luxembourg: EPIRUBICINE TEVA 2 mg/ml
The Netherlands: Epirubicine HCL Pharmachemie 2 mg/ml oplossing voor injectie of intraveneuze infusie
Norway: Epirubicina Teva 2 mg/ml injeksjons/infusjonsvæke, oppløsning
Portugal: Epirrubicina Teva Solução injectável ou para perfusão
Slovenia: Epirubicin Teva 2 mg/ml, raztopina za injiciranje ali infundiranje
Spain: Epirubicina Teva 2 mg/ml solución inyectable y para perfusión EFG
Sweden: Epirubicin Teva 2 mg/ml injektions/infusionsvätska, lösning
United Kingdom (Northern Ireland): Epirubicin 2 mg/ml solution for injection or infusion

Date of the most recent revision of this leaflet: November 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es

This information is intended for healthcare professionals only:

GUIDE FOR THE PREPARATION FOR USE OF EPIRUBICIN TEVA 2 MG/ML, INJECTION OR INFUSION SOLUTION

It is important to read the entire content of this procedure before preparing either Epirubicin Teva 2 mg/ml injection solution or infusion solution.

1. FORMULATION

Epirubicin Teva 2 mg/ml injectable and infusion solution

Excipients:

Sodium chloride
Hydrochloric acid, for pH adjustment
Water for injection

2. SPECIAL STORAGE PRECAUTIONS

Store in a refrigerator (2°C–8°C)
Keep refrigerated during storage and transport
Do not freeze

The physical and chemical stability is as follows:

Viaflo Bag (non-PVC)	Refrigerator 2–8 °C	Room temperature 15–25 °C, normal light
0.9% Injectable NaCl	28 days	14 days
5% Injectable Glucose	28 days	28 days
Polypropylene Syringe	Refrigerator 2–8 °C	Room temperature 15–25 °C, normal light
0.9% Injectable NaCl	28 days	14 days
Water for Injectable Preparations	28 days	7 days
Undiluted	28 days	14 days

From a microbiological standpoint, the medicinal product should be used immediately; storage times and conditions prior to use are the responsibility of the user and must not exceed 24 hours at 2-8°C.

Storage of the injectable solution under cold conditions may result in the formation of a gelatinous product. This gelatinous product will transform from slightly viscous to a mobile solution within 2 hours and up to a maximum of 4 hours at room temperature (15–25°C).

1. NATURE AND CONTENTS OF THE CONTAINER

Epirubicin Teva 2 mg/ml is marketed in colorless type I glass vials with bromobutyl rubber stoppers, aluminum seals, and snap-caps, containing 5 ml, 10 ml, 25 ml, 75 ml, and 100 ml, respectively, of injectable and infusion solution.

Each package contains a single vial.

Only certain pack sizes may be commercially available.

1. INCOMPATIBILITIES

Prolonged contact with alkaline solutions should be avoided, as this may lead to hydrolysis. Epirubicin Teva 2 mg/ml must not be mixed with heparin due to the risk of possible precipitation.

This medicinal product must not be mixed with other medicinal products except with 0.9% sodium chloride, 5% glucose, or sterile water.

1. INSTRUCTIONS FOR USE

If an infusion solution needs to be prepared, it must be prepared by trained personnel under aseptic conditions.

Preparation of an infusion solution must be carried out in a designated aseptic area.

Personnel handling Epirubicin Teva 2 mg/ml must wear protective gloves, safety goggles, and a face mask.

Epirubicin Teva 2 mg/ml contains no preservatives and is intended for single use only. After use, any unused medicinal product must be disposed of in accordance with local regulations for cytotoxic agents. See below “Disposal”.

Spills or leaks of the medicinal product must be neutralized using a 1% sodium hypochlorite solution or simply with a phosphate buffer agent (pH > 8) until the solution is decolorized. All cleaning materials must be handled as described under “Disposal”.

Pregnant women must avoid contact with cytotoxic agents.

Excreta and vomit must be handled with care.

A damaged vial must be handled with the same precautions and considered as contaminated material. Contaminated material must be stored in specially labeled containers designated for such waste. See “Waste Disposal”.

1. PREPARATION OF THE SOLUTION

Epirubicin may only be administered intravenously or intravesically.

6.1 Preparation for intravenous administration

Epirubicin Teva 2 mg/ml may be diluted with 0.9% sodium chloride or 5% glucose and administered intravenously. The solution must be prepared immediately before use.

It is recommended that the red-colored solution, which must be clear and transparent, be administered via an intravenous infusion line using a continuous flow of 0.9% saline or 5% glucose solution over a period of up to 30 minutes (depending on dose and infusion volume). The cannula must be correctly positioned in the vein. This method reduces the risk of thrombosis or extravasation, which could lead to severe cellulitis and necrosis. In case of extravasation, administration must be stopped immediately. Injections into small veins or repeated injections into the same vein may lead to venous sclerosis.

In high-dose treatment, epirubicin may be administered as an intravenous bolus over 3–5 minutes or as an infusion over up to 30 minutes.

6.2 Preparation for intravesical administration

For intravesical administration, Epirubicin Teva 2 mg/ml must be diluted in 0.9% sodium chloride or sterile water. The dilution concentration should be 0.6–1.6 mg/ml.

Dilution table for vesical instillation solutions

Required dose of epirubicin hydrochloride	Volume of epirubicin hydrochloride 2 mg/ml for injection	Volume of sterile diluent for injection or 0.9% sterile saline solution	Total volume for intravesical instillation
30 mg	15 ml	35 ml	50 ml
50 mg	25 ml	25 ml	50 ml
80 mg	40 ml	10 ml	50 ml

1. DISPOSAL

Disposal of unused medication and all materials that have come into contact with it must be carried out in accordance with local regulations.