DOXORUBICIN ACCORD 2 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Doxorubicin Accord 2 mg/ml Concentrate for Solution for Infusion EFG

Doxorubicin 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.
• • If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

Doxorubicin Accord belongs to a group of medicines called anthracyclines. These medicines are also known as anticancer medicines, chemotherapy or 'chemo'. They are used in the treatment of various types of cancer to slow down or stop the growth of cancer cells. Often, a combination of different types of anticancer medicines is used to achieve better results and minimize side effects.

Doxorubicin Accord is used to treat the following types of cancer:

• breast cancer
• cancer of the connective tissue, ligaments, bones, muscles (sarcoma)
• cancer developed in the stomach or in the intestine
• lung cancer
• lymphomas, a cancer that affects the immune system
• leukaemia, a cancer that causes abnormal production of blood cells
• thyroid cancer
• advanced ovarian and endometrial cancer (a cancer of the lining of the uterus or the uterus)
• urinary bladder cancer
• advanced neuroblastoma (a cancer of nerve cells that commonly occurs in children)
• malignant kidney tumour in children (Wilms' tumour)
• myeloma (bone marrow cancer)

2. What you need to know before you use Doxorubicin Accord

Do not use Doxorubicin Accord

• if you are allergic to doxorubicin hydrochloride or any of the other ingredients of this medicine (listed in section 6), anthracenediones or other anthracyclines.
• if you have persistent suppression of your bone marrow's ability to produce blood cells (myelosuppression)
• if you have previously received doxorubicin or other similar chemotherapy medicines such as idarubicin, epirubicin or daunorubicin, as previous treatment with these similar medicines may increase the risk of side effects with Doxorubicin Accord.
• if you have any type of infection.
• if your liver is not working properly.
• if you have had a heart attack.
• if you have any heart function disorder.
• if you have any severe heart rhythm disorder (arrhythmia).
• if you are breast-feeding (see section "Pregnancy, breast-feeding and fertility")

You must not receive the medicine through a catheter (a thin, flexible tube) in the bladder:

• if you are allergic to doxorubicin hydrochloride or any of the other ingredients of this medicine (listed in section 6), anthracenediones or other anthracyclines.
• if you have a tumour that has grown into the bladder wall
• if you have a urinary tract infection
• if you have inflammation of the bladder
• if you have blood in your urine (haematuria)
• if you have problems with the insertion of a catheter
• if you are breast-feeding (see section "Pregnancy, breast-feeding and fertility")

Warnings and precautions

Tell your doctor or pharmacist if you suffer from or have suffered from any of the following medical conditions or diseases:

• low production of blood cells in the bone marrow
• heart problems
• liver disorders
• kidney disorders

You must also inform your doctor:

• if you have ever received doxorubicin or any other similar anticancer medicine (anthracycline) for cancer treatment.
• if you have received radiotherapy in the upper part of your body.
• if you are currently using or have recently used Trastuzumab (a medicine used in the treatment of certain types of cancer). Trastuzumab may remain in your body for up to 7 months. As Trastuzumab may affect the heart, you must not use doxorubicin until 7 months after you have stopped using Trastuzumab. If you use doxorubicin before this time, your heart function will need to be carefully monitored.

Before starting treatment with Doxorubicin Accord and during treatment, your doctor will perform the following tests:

• blood tests
• heart, liver and kidney function tests

During treatment with doxorubicin, it is possible that your bone marrow may not be able to produce enough blood cells and platelets, and your blood count may change; for this reason, blood tests must be performed before and during each treatment. The following symptoms may occur as a result of a lack of blood cells and/or platelets: fever, infections, blood poisoning, bleeding and tissue damage. If you have a fever, you must contact your doctor immediately.

Skin eruption along the vein in which the medicine is administered is not unusual and may be followed by inflammation of the vein (phlebitis). Hardening or thickening of the vein wall may occur, especially if the medicine is administered repeatedly in a thin vein. If the medicine leaks from the blood vessel into the surrounding tissue (extravasation), local pain, severe inflammation of the subcutaneous tissue (cellulitis) and tissue damage may occur. Tell a nurse if you experience a burning sensation during injection: the infusion must be stopped immediately and the needle reinserted in another vein.

Your doctor will carefully monitor your heart function during treatment, as:

• doxorubicin may damage the heart muscle.
• treatment with doxorubicin may lead to heart failure after a certain cumulative dose (addition of single doses).
• the risk of heart muscle damage is greater if you have previously received medicines that may damage the heart or radiotherapy in the upper part of your body.

As a rule, this medicine is not recommended in combination with live attenuated vaccines. Contact with people recently vaccinated against polio should be avoided.

During treatment with doxorubicin, inflammation of the mucous membranes (mainly in the mouth, less frequently in the oesophagus) may occur. This is manifested as pain or burning sensation, skin eruption, ulceration of the superficial mucosa (often on the entire side of the tongue or under the tongue), bleeding and infections. Any mouth inflammation usually appears shortly after administration of the medicine and in severe cases may progress to mucosal ulcers within a few days; however, in most cases, the patient recovers from this side effect by the third week of treatment.

Nausea, vomiting and occasionally diarrhoea may occur. These can be prevented or alleviated with appropriate treatment that your doctor may prescribe for you.

Discolouration of the urine (which is normal and related to the colour of the medicine). You must inform your doctor if this does not stop after a few days or if you think there is blood in your urine. Inform your doctor if you experience these symptoms.

Doxorubicin may cause infertility problems and damage to reproductive cells. Both men and women must use effective contraceptive methods during treatment and for a period after completing treatment with doxorubicin (see the section "Pregnancy, breast-feeding and fertility"). If you wish to become pregnant after treatment with doxorubicin, you must talk to your doctor about genetic counselling and options for preserving fertility before starting treatment.

Skin reactions and hypersensitivity reactions:

• Hair loss and interruption of beard growth may occur. This side effect is usually reversible, with complete hair growth between two and three months after completing treatment.
• Redness, discolouration of the skin and nails and hypersensitivity to sunlight may occur.
• In rare cases, allergic reactions (hypersensitivity) may occur; the signs or symptoms of these reactions may vary from skin eruption and itching (pruritus, urticaria) to fever, chills and anaphylactic shock.

Using Doxorubicin Accord with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

The following medicines may interact with Doxorubicin Accord:

• other cytostatics (anticancer medicines), e.g. trastuzumab, anthracyclines (daunorubicin, epirubicin, idarubicin), cisplatin, cyclophosphamide, cyclosporin, cytarabine, dacarbazine, dactinomycin, fluorouracil, mitomycin C, taxanes (e.g. paclitaxel), mercaptopurine, methotrexate, streptozocin
• cyclosporin: which may enhance the effects of doxorubicin and may cause prolonged bone marrow and blood cell suppression (coma and convulsions have also been described with concomitant administration of cyclosporin and doxorubicin)
• cardioactive medicines (medicines for treating heart diseases), e.g. calcium antagonists, verapamil and digoxin
• cytochrome P-450 inhibitors (medicines that cause the substance cytochrome P-450, which is important for the body's detoxification, to stop working: e.g. cimetidine), cytochrome P-450 inducers (e.g. rifampicin, barbiturates, such as phenobarbital)
• antiepileptic medicines (e.g. carbamazepine, phenytoin, valproate)
• antipsychotics: Clozapine (a medicine used for schizophrenia)
• warfarin (prevents blood clotting)
• antiretroviral medicines (medicines against special forms of viruses)
• chloramphenicol and sulphonamides (medicines against bacteria)
• amphotericin B (medicines used against fungal diseases)
• live vaccines (e.g. polio (poliomyelitis), malaria)
• Some medicines affect the concentration and clinical effect of doxorubicin (e.g. St. John's Wort).
• Paclitaxel: which may enhance the effects of doxorubicin

Note that this may also apply to medicines used recently.

Pregnancy, breast-feeding and fertility

Pregnancy

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

In animal experiments, it has been observed that doxorubicin crosses the placenta and causes damage to the foetus. If you are pregnant, your doctor will only give you doxorubicin if the benefit of treatment outweighs the potential harm to the foetus. Tell your doctor immediately if you are pregnant or think you may be.

Women must not become pregnant during treatment with doxorubicin or for up to 7 months after treatment. Men must take adequate precautions to ensure that their partner does not become pregnant during treatment with doxorubicin or for up to 4 months after treatment.

Breast-feeding

Do not breast-feed while being treated with Doxorubicin Accord and for at least 14 days after the last dose. The medicine may pass into your baby through breast milk and may harm your child.

Fertility

Men should seek advice on the cryopreservation (or cryoconservation) of sperm before treatment, due to the possibility of irreversible infertility as a consequence of treatment with Doxorubicin Accord.

If you are considering becoming a parent after treatment, consult your doctor.

Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines

Due to the frequent occurrence of nausea and vomiting, do not drive or operate machines.

Doxorubicin Accord contains sodium

Patients on low-sodium diets should be aware that this medicine contains 3.5 mg (0.15 mmol) of sodium per ml. The different pack sizes of this medicine contain the following amounts of sodium:

This medicine contains less than 1 mmol of sodium (23 mg) per 5 ml vial, i.e. it is "essentially sodium-free".

This medicine contains 35.42 mg of sodium (a major component of kitchen/table salt) per 10 ml vial. This is equivalent to 1.77% of the maximum recommended daily dietary intake of sodium for an adult.

This medicine contains 88.55 mg of sodium (a major component of kitchen/table salt) per 25 ml vial. This is equivalent to 4.43% of the maximum recommended daily dietary intake of sodium for an adult.

This medicine contains 177.10 mg of sodium (a major component of kitchen/table salt) per 50 ml vial. This is equivalent to 8.85% of the maximum recommended daily dietary intake of sodium for an adult.

This medicine contains 354.20 mg of sodium (a major component of kitchen/table salt) per 100 ml vial. This is equivalent to 17.71% of the maximum recommended daily dietary intake of sodium for an adult.

3. How to use Doxorubicin Accord

Form and administration route

Doxorubicin Accord should only be administered under the supervision of a doctor with experience in cancer treatment.

Your doctor will decide the dose you will receive.

Do not administer the medicine yourself. The medicine will be administered to you as part of an intravenous infusion, in a blood vessel, under the supervision of specialists. You will undergo regular check-ups during and after treatment. If you suffer from superficial cancer of the urinary bladder, you may receive the medicine directly into the bladder (intravesical use).

Posology

Your doctor will decide the dose you will receive.

The dose is usually calculated based on your body surface area. Doses of 60-75 mg per square metre of body surface area are usually administered every 3 weeks when this medicine is used alone. It may be necessary to reduce the dose to 30-60 mg per square metre of body surface area and prolong the treatment interval when administered in combination with other anticancer medicines. Your doctor will tell you the amount you need. If administered weekly, the recommended dose is 15 to 20 mg per square metre of body surface area. Your doctor will tell you the amount you need.

Patients with reduced liver and kidney function

In case of reduced liver or kidney function, the dose must be reduced. Your doctor will tell you the amount you need.

Children/elderly or patients after radiotherapy

It may be necessary to reduce the dose in children and the elderly or if you have received radiotherapy. Your doctor will tell you the amount you need.

Patient with bone marrow suppression

It may be necessary to reduce the dose in patients with bone marrow suppression. Your doctor will tell you the amount you need.

Obese patients

In obese patients, the initial dose may be reduced or the dosing interval prolonged. Your doctor will tell you the amount and frequency you need.

If you use more Doxorubicin Accord than you should

During and after treatment, your doctor or nurse will closely monitor your progress. The symptoms of an overdose are an extension of the possible side effects of Doxorubicin Accord, in particular, changes in the blood, gastrointestinal and heart problems. Heart disorders may occur up to six months after receiving an overdose.

In the event of an overdose, your doctor will take the necessary measures, such as a blood transfusion and/or treatment with antibiotics.

Tell your doctor if you experience any of these symptoms.

If you forget to use a dose of Doxorubicin Accord

Your doctor will decide the duration of your treatment with Doxorubicin Accord. If treatment is interrupted before completing the recommended treatment cycles, the effects of therapy with Doxorubicin Accord may be reduced. Consult your doctor if you wish to interrupt treatment.

If you stop treatment with Doxorubicin Accord

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

4. Possible Adverse Effects

Like all medicines, Doxorubicin Accord can cause adverse effects, although not all people suffer from them.

In certain individuals, this medication may cause a severe allergic reaction (anaphylaxis) that can be life-threatening. Contact a doctor immediately if you notice the sudden onset of breathing difficulties, swelling of the face and throat, and general discomfort (shock).

Doxorubicin severely impairs the immune system's response capacity, so there is a significant risk of infection or infestation that can cause a generalized infection related to the entry of microbes into the blood (septicemia). Contact a doctor immediately in case of high fever because blood poisoning can be fatal.

Other side effects that may occur are as follows:

Very Common:may affect more than 1 in 10 people

• Infection
• Loss of appetite (anorexia)
• Inflammation of the mouth (stomatitis)/inflammation of the mucous membranes (mucositis)
• Diarrhea
• Nausea or vomiting
• Reduction in the number of cells in the blood: red blood cells (anemia), all or some white blood cells (leukopenia, neutropenia), and platelets (thrombocytopenia)
• Redness, swelling, numbness, pain, and tingling in the palms of the hands and feet (palmar-plantar erythrodysesthesia or acral erythema)
• Hair loss on the head and body (alopecia and interruption of beard growth)
• Fever, feeling of weakness (asthenia), chills
• Abnormal ECG (this is an electrical trace of your heart)
• Asymptomatic reductions in left ventricular ejection fraction
• Changes in liver enzyme levels (transaminases)
• Weight gain in patients with early breast cancer
• Damage to the heart muscle (cardiotoxicity)

Common:may affect up to 1 in 10 people

• Inflammation of the conjunctiva, the membrane that covers the front of the eye and the inside of the eyelids (conjunctivitis)
• Changes in heart function, particularly in heart rate (sinus tachycardia), reduction in the amount of blood pumped by the heart throughout the body (congestive heart failure)
• Inflammation of the esophagus (esophagitis)
• Stomach pain
• Rash with itching, rash, discoloration (hyperpigmentation) of the skin and nails
• Blood poisoning
• Redness and swelling may appear at the injection site
• Local side effects when administered in the bladder, such as inflammation of the bladder (chemical cystitis)

Uncommon:may affect up to 1 in 100 people

• Emboli (blood clots in a blood vessel)

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

• Secondary leukemia (blood cancer developed after treatment of another cancer), when doxorubicin is used in combination with other cancer medications that damage DNA
• Tumor lysis syndrome (complications from receiving chemotherapy due to the breakdown products of dying cancer cells that can affect the blood and kidneys)

Frequency Not Known:(frequency cannot be estimated from available data)

• Dehydration
• Increased urea in the blood (hyperuricemia)
• Blood cancer (lymphocytic acute leukemia, acute myeloid leukemia)
• Shock
• Inflammation of the cornea surface (keratitis), increased tear production
• Increased heart rate (tachyarrhythmias), loss of nerve impulses to the heart (atrioventricular block and branch block)
• Inflammation of the veins (phlebitis), complete blockage of a vein (thrombophlebitis), redness, bleeding problems (hemorrhage)
• Irritation or bleeding in the intestines, pain or ulcers in the mouth, which may not appear until 3 to 10 days after treatment, discoloration inside the mouth
• Increased sensitivity of the skin to sunlight
• Inflammation of the large intestine (colitis) and inflammation of the stomach lining
• Itching of the skin and other skin disorders
• Hypersensitivity of irradiated skin (radiation recall reactions)
• Red discoloration of the urine
• Women may also notice that their periods stop (amenorrhea), but their periods should return to normal after stopping the medication. In some cases, premature menopause may occur
• In men, doxorubicin can cause absence or decrease in sperm count (oligospermia, azoospermia), but this may return to normal after stopping the medication
• Feeling of discomfort
• Liver toxicity
• Temporary increase in liver enzymes
• Condition in which the kidney stops functioning (acute renal failure)
• Difficulty breathing due to spasm of the muscles in the respiratory tract (bronchospasm)

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 that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Doxorubicin Accord

• Keep this medication out of sight and reach of children
• Do not use this medication after the expiration date stated on the vial or on the outer packaging after CAD. The expiration date is the last day of the month indicated
• Store in the refrigerator (between 2°C and 8°C). Keep the vial in the outer packaging to protect it from light
• Do not use this medication if you observe that the solution is not transparent, red, and free of particles

• For single use

All materials used for preparation and administration, or those that have come into contact with cisplatin in any way, must be disposed of in accordance with local requirements for cytotoxics

Unopened vials: 18 months

Opened vials: The product must be used immediately after opening the vial

Physical and chemical stability has been demonstrated in 0.9% sodium chloride injection and 5% dextrose injection for a maximum of 28 days at 2-8°C and for a maximum of 7 days at 25°C, if prepared in light-protected glass containers

From a microbiological point of view, the product must be used immediately. If not used immediately, the storage times during use and the conditions prior to use are the responsibility of the user. Normally, they should not exceed 24 hours, and the temperature should be between 2°C and 8°C, unless the dilution has been carried out under controlled and validated aseptic conditions

6. Container Content and Additional Information

Composition of Doxorubicin Accord

The active ingredient is doxorubicin hydrochloride.

Each ml contains 2 mg of doxorubicin hydrochloride.

Each 5 ml vial contains 10 mg of doxorubicin hydrochloride.

Each 10 ml vial contains 20 mg of doxorubicin hydrochloride.

Each 25 ml vial contains 50 mg of doxorubicin hydrochloride.

Each 50 ml vial contains 100 mg of doxorubicin hydrochloride.

Each 100 ml vial contains 200 mg of doxorubicin hydrochloride.

Product Appearance and Container Content

Doxorubicin Accord 2 mg/ml concentrate for solution for infusion EFG is a clear, red solution that is practically free of particles.

Container sizes:

• 1 vial of 5 ml
• 1 vial of 10 ml
• 1 vial of 25 ml
• 1 vial of 50 ml
• 1 vial of 100 ml

Some container sizes may not be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6ª planta

08039 Barcelona

Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,

95-200 Pabianice, Poland

or

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

or

Accord Healthcare single member S.A.

64th Km National Road Athens,

Lamia, Schimatari, 32009,

Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names

Date of Last Revision of this Leaflet: November 2023

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals

Posology and Method of Administration

Doxorubicin injection should only be administered under the supervision of a qualified physician with extensive experience in cytotoxic therapy. Additionally, patients should be carefully and frequently monitored during treatment.

Due to the risk of cardiomyopathy, which is often fatal, it is necessary to evaluate the risks and benefits of each patient before each application.

Doxorubicin is administered intravenously and intravesically and should not be administered orally, subcutaneously, intramuscularly, or intrathecally. Doxorubicin can be administered intravenously as an injection over a few minutes, as a short infusion of up to one hour, or as a continuous infusion of up to 96 hours.

The solution is administered through a uniform flow tube system for intravenous infusion with a 9 mg/ml (0.9%) sodium chloride injectable solution or a 50 mg/ml (5%) dextrose injectable solution over 3-10 minutes. This technique minimizes the risk of thrombophlebitis or perivenous extravasation, which can lead to local cellulitis, blister formation, and severe tissue necrosis. Direct intravenous injection is not recommended due to the risk of extravasation, which can occur even in the presence of adequate blood return by aspiration with a needle.

Intravenous Administration:

The dose of doxorubicin depends on the posology, the patient's general health status, and previous treatment. The dosage regimen of doxorubicin hydrochloride may vary according to the indication (solid tumors or acute leukemia) and according to its use in the specific treatment regimen (as a single agent or in combination with other cytotoxic agents, or as part of multidisciplinary procedures that include a combination of chemotherapy, surgery, radiotherapy, and hormonal treatment).

Monotherapy

The dose is usually calculated based on body surface area (mg/m2). On this basis, a dose of 60-75 mg/m2 of body surface area every three weeks is recommended when doxorubicin is used as a single agent.

Combination Regimen

When doxorubicin is administered in combination with other antitumor agents with overlapping toxicities, such as high-dose IV cyclophosphamide or related anthracycline compounds, such as daunorubicin, idarubicin, and/or epirubicin, the dose of doxorubicin should be reduced to 30-60 mg/m2 every 3-4 weeks.

In patients who cannot receive the full dose (e.g., in cases of immunosuppression, old age), an alternative posology is 15-20 mg/m2 of body surface area per week.

Intravesical Administration:

Doxorubicin can be administered by intravesical instillation in the treatment of superficial urinary bladder carcinoma or in the prophylaxis of tumor recurrence after transurethral resection (TUR) in patients at high risk of recurrence. The recommended dose of doxorubicin for local intravesical treatment of superficial bladder tumors is the instillation of 30-50 mg in 25-50 ml of 9 mg/ml (0.9%) sodium chloride injectable solution. The optimal concentration is approximately 1 mg/ml. In general, the solution should be kept intravesically for 1-2 hours. During this period, the patient should be rotated 90° every 15 minutes. The patient should not drink liquids for 12 hours before treatment to avoid undesirable effects of urine dilution (this should reduce urine production to approximately 50 ml/h). Instillation can be repeated at an interval of 1 week to 1 month, depending on whether the treatment is therapeutic or prophylactic.

Patient with Hepatic Impairment

Since doxorubicin is primarily excreted through the liver and bile, the elimination of the drug may be decreased in patients with hepatic impairment or biliary obstruction, which could lead to severe side effects.

General dose adjustment recommendations in patients with hepatic impairment are based on serum bilirubin concentration:

Doxorubicin is contraindicated in patients with severe hepatic function impairment.

Patient with Renal Impairment

In patients with renal impairment (GFR <10 ml min), only 75% of the planned dose should be administered.< p>

In order to avoid cardiomyopathy, it is recommended that the total cumulative dose of doxorubicin (including related medications, such as daunorubicin) not exceed 450-550 mg/m2 of body surface area. If a patient with concomitant heart disease receives mediastinal and/or cardiac irradiation or previous treatment with alkylating agents, or if the patient is at high risk (hypertension for more than 5 years, previous coronary, valvular, or myocardial lesions, or age over 70 years), the maximum total dose should not exceed 400 mg/m2 of body surface area, and cardiac function should be monitored.

Dose in Children

The dose in children may need to be reduced; consult treatment protocols and specialized literature.

Obese Patients and Patients with Neoplastic Infiltration of Bone Marrow

In the case of obese patients and patients with neoplastic infiltration of bone marrow, it may be considered to administer a reduced initial dose or a prolonged dosing interval.

Incompatibilities

Doxorubicin should not be mixed with heparin, as a precipitate may form, and should not be mixed with 5-fluorouracil, as it may degrade. Prolonged contact with any alkaline pH solution should be avoided, as it may lead to hydrolysis of the drug.

Until detailed information on the compatibility of mixtures is available, doxorubicin should not be mixed with other medications except for 0.9% sodium chloride injection and 5% dextrose injection.

Prepared Infusion Solutions

Physicochemical stability has been demonstrated in 0.9% sodium chloride injection and 5% dextrose injection for up to 28 days at 2-8°C and up to 7 days at 25°C, if prepared in light-protected glass containers.

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user. Normally, storage should not exceed 24 hours, and the temperature should be between 2°C and 8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.

Elimination

Medicinal product residues, as well as all materials used for dilution and administration, should be destroyed according to the standard hospital procedures applicable to cytotoxic agents and in accordance with current legislation on the disposal of hazardous waste.

Any unused medicinal product or waste material should be disposed of in accordance with local provisions for cytotoxic agents.

Shelf Life and Storage

Unopened vials: 18 months.

Opened vials: the product should be used immediately after opening the vial.

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

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