Prospect: Information for the user

Irinotecán Accord 20 mg/ml concentrate for infusion EFG

Irinotecán hydrochloride trihydrate

The name of the medicinal product is “Irinotecán Accord 20 mg/ml concentrate for infusion”, but in the rest of the prospectus it will be referred to as “Irinotecan Accord”.

Read this prospectus carefully before starting to use this medicinal product, because it contains important information for you.

- Keep this prospectus, as you may have to read it again.

- If you have any doubts, consult your doctor, pharmacist or nurse.

- If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospectus. See section 4.

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

2. What you need to know before starting to use Irinotecán Accord

3. How to use Irinotecán Accord

4. Possible adverse effects

5. Storage of Irinotecán Accord

6. Contents of the package and additional information

Irinotecán belongs to a group of medications known as cytostatics (anticancer medications). Irinotecán Accord is used for the treatment of advanced colon and rectal cancer in adults, both alone and in combination with other medications.Irinotecán Accordis an anticancer medication that contains the active substance irinotecan hydrochloride trihydrate. Irinotecan hydrochloride trihydrate interferes with the growth and propagation of cancer cells in the body.

Your doctor may use a combination of irinotecan with5-fluorouracil/leucovorin (5-FU/LV)andbevacizumabto treat yourcolorectal cancer (colon or rectum).

Your doctor may use a combination of irinotecan withcapecitabinewith or withoutbevacizumabto treatcolon and rectal cancer.

Your doctor may use a combination of irinotecan withcetuximabto treat a particular type ofcolorectal cancer (wild-type RAS)that expresses a protein calledEGFR.

No use Irinotecán Accord if

- is allergic to irinotecan hydrochloride trihydrate or to any of the other components of this medication (listed in section 6).

- has or has had a chronic inflammatory bowel disease or intestinal obstruction

- is breastfeeding

- has a severe liver disease (bilirubin level is greater than 3 times the upper limit of the normal range)

- has a severe bone marrow deficiency

- has a general poor health status (WHO performance status greater than 2)

- is using the herbal remedy St. John's Wort (Hypericum perforatum)

-If taking or has taken recently live attenuated vaccines (vaccines against yellow fever, chickenpox, herpes zoster, measles, mumps, rubella, tuberculosis, rotavirus, flu) and during the 6 months after stopping chemotherapy.

If receiving Irinotecan Accord in combination with other medications, please also read the prospectus of the other medications regarding additional contraindications.

Warnings and precautions

Special precautions are necessary in elderly patients.

As irinotecan is a cancer medication, it will have to be administered in a special unit and under the supervision of a qualified doctor in the use of cancer medications. The unit staff will explain the precautions you should take during and after treatment. This prospectus will help you remember.

Before starting treatment with Irinotecan Accord, talk to your doctor if any of the following circumstances apply to you:
• You have liver problems
• You have kidney problems
• You have asthma
• You have ever received radiation therapy
• You have had intense diarrhea or fever after being treated with irinotecan previously

• You have heart problems
• You smoke, have high blood pressure or high cholesterol, as this may increase the risk of cardiac problems during irinotecan treatment
• You have been administered or will be administered any vaccine
• You are taking other medications. Please see the section"Other medications and irinotecan"

• If you have Gilbert's syndrome, a hereditary condition that can cause elevated bilirubin levels and jaundice (yellow skin and eyes)

1) The first 24 hours after administration of Irinotecán Accord

During the administration of Irinotecán Accord (30-90 min.) and immediately after administration, you may experience some of the following symptoms:

- Diarrhea

- Runny eyes

- Sweating

- Visual disturbances

- Abdominal pain

- Excessive salivation

Acute cholinergic syndrome

This medication can affect the part of your nervous system that controls bodily secretions, leading to what is known as acute cholinergic syndrome. Symptoms may include nasal secretion, increased saliva, excessive tear production, sweating, flushing, abdominal cramps, and diarrhea. Inform your doctor or nurse immediately if you notice any of these symptoms, as there are medications that can help control them.

2) From the day after treatment with Irinotecán Accord until the next treatment

During this period, you may experience various symptoms that can be severe and require immediate treatment and close monitoring.

Diarrea

If you experience diarrhea after the first 24 hours following irinotecan administration ("late diarrhea"), it may be severe. It often occurs 5 days after administration. Diarrhea should be treated immediately and closely monitored. If not treated, dehydration and severe chemical imbalances can occur, which can put your life at risk. Your doctor will prescribe a medication to help prevent or control this adverse effect.Make sure to have the medication on hand, so you have it at home when you need it.Immediately after the first liquid stool, the following should be done:

1. Take the antidiarrheal medication prescribed by your doctor and follow the instructions given by your doctor exactly. Do not change the treatment without consulting your doctor. The recommended antidiarrheal treatment is loperamide (4 mg for the first dose and then 2 mg every 2 hours, also at night). This treatment should be continued for at least 12 hours after the last liquid stool. The recommended dose of loperamide should not be taken for more than 48 hours.
2. Drink a large amount of water and rehydration liquids immediately (i.e., water, siphon, carbonated beverages, soup, or oral rehydration therapy)
3. Inform your doctor immediately that you are experiencing diarrhea and who is supervising your treatment. If you cannot reach your doctor, contact the hospital unit that is supervising your irinotecan treatment. It is very important that they know that the treatment has caused diarrhea.

You must contact your doctor or the unit supervising your treatment immediately if:

- You experience nausea, vomiting, or fever, as well as diarrhea

- You continue to experience diarrhea 48 hours after starting diarrhea treatment

Nota:Only take the medication for diarrhea prescribed by your doctor and the liquids described above. Follow your doctor's instructions. The antidiarrheal treatmentshould not be used to prevent future episodes of diarrhea, even if you have had late diarrhea in previous cycles.

Fiebre

If your temperature rises above 38°C, it may be a sign of infection, especially if you have also had diarrhea. If your temperature rises (above 38°C), contact your doctor or the Service where you are being treated immediately, so they can administer the necessary treatment.

Náuseas y vómitos

If you experience nausea and/or vomiting, contact your doctor or the hospital unit immediately. It is possible that your doctor will give you medications before your treatment to help prevent nausea and vomiting. It is likely that your doctor will prescribe anti-nausea medications that you can take at home. Have these medications on hand when you need them. Inform your doctor if you cannot take liquids orally due to nausea and vomiting.

Neutropenia

Irinotecan can cause a decrease in the number of your white blood cells (neutropenia), which are important in fighting infections. Neutropenia is often observed during irinotecan treatment and is reversible. Your doctor will need to perform regular blood tests to check these white blood cells. Neutropenia is severe and should be treated immediately and closely monitored. Make sure to inform your doctor or nurse immediately if you have symptoms of an infection, such as fever (38°C or higher), chills, painful urination, new cough, or sputum. Avoid being near people who are sick or have an infection. Inform your doctor if you develop symptoms of an infection.

Blood tests

It is likely that your doctor will analyze your blood before and during treatment to verify if the medication has any effects on blood counts or blood test results. Based on the test results, it may be necessary to prescribe medications to help treat the effects. Your doctor may also need to reduce or delay your next dose of this medication, or even stop treatment altogether. Make sure to keep all your medical appointments and laboratory tests.

This medication can decrease the number of platelets in the weeks following its use, which can increase the risk of bleeding. Talk to your doctor before taking any medication or supplement that may affect your body's ability to stop bleeding, such as aspirin or medications containing aspirin, warfarin, or vitamin E. Inform your doctor immediately if you have unusual bruises or bleeding, such as nasal bleeding, bleeding gums when brushing your teeth, or black, tarry stools.

Pulmonary disorders

Rarely, people taking this medication have severe pulmonary problems. Inform your doctor immediately if you have a new cough or worsening cough, difficulty breathing, and fever. Your doctor may need to suspend treatment to treat this problem.

This medication can increase the risk of developing significant blood clots in the veins of the legs or lungs, which can travel to other parts of the body such as the lungs or brain. Inform your doctor immediately if you notice chest pain, difficulty breathing, or swelling, pain, redness, or heat in an arm or leg.

Chronic inflammatory bowel disease and/or intestinal obstruction

Inform your doctor if you have abdominal pain and cannot move your intestines, especially if you also have swelling and loss of appetite.

Radiation therapy

If you recently received pelvic or abdominal radiation therapy, you may be at higher risk of developing bone marrow suppression. Please talk to your doctor before starting irinotecan treatment.

Renal function

Cases of renal function deterioration have been reported.

Cardiac disorders

Inform your doctor if you have/have had heart disease or if you have received cancer medications previously. Your doctor will closely monitor you and discuss with you how to reduce risk factors (e.g., smoking, high blood pressure, and high fat content).

Vascular disorders

Irinotecan is associated with rare cases of altered blood flow (blood clots in the veins and lungs) and may occur rarely in patients with multiple risk factors.

Insuficiencia hepática

Before starting treatment with Irinotecan and before each cycle, liver function should be monitored (through blood tests).

Others

This medication can cause mouth sores or lip sores, often within the first few weeks after starting treatment. This can cause mouth pain, bleeding, or even eating difficulties. Your doctor or nurse may suggest ways to reduce this, such as changing the way you eat or brush your teeth. If necessary, your doctor may prescribe medications to help soothe the pain.

For information on contraception and lactation, see the information provided below in the section Contraception, pregnancy, lactation, and fertility.

Inform your doctor or dentist that you are being treated with this medication if you are planning to undergo surgery or any other procedure.

If used in combination with other cancer medications for your condition, make sure to also read the prospectuses of the other medications.

If your doctor has informed you that you have an intolerance to some sugars, contact your doctor before taking this medication.

Other medications and irinotecan
Inform your doctor, pharmacist, or nurse before receiving Irinotecan Accord if you are already taking or have recently taken other medications, including those purchased without a prescription. This includes medications based on plants, vitamins, and minerals.

• Medications used to treat epilepsy (carbamazepine, phenobarbital, phenytoin, or fosphenytoin)
• Medications used to treat fungal infections (ketoconazole, itraconazole, voriconazole, and posaconazole)
• Medications used to treat bacterial infections (clarithromycin, erythromycin, and telithromycin)
• Medication used to treat tuberculosis (rifampicin and rifabutin)
• St. John's Wort or hypericum (a dietary herbal supplement)
• Live attenuated vaccines
• Medication used to treat HIV (indinavir, ritonavir, amprenavir, fosamprenavir, nelfinavir, atazanavir, and others)
• Medications used to suppress the immune system to prevent transplant rejection (ciclosporin and tacrolimus)
• Medications used to treat cancer (regorafenib, crizotinib, idelalisib, and apalutamida)
• Anticoagulants used to thin the blood (such as warfarin)
• Medications used to relax muscles used during anesthesia and surgery (suxamethonium)
• 5-fluorouracil/folinic acid
• Bevacizumab (a vascular growth inhibitor)
• Cetuximab (an epidermal growth factor receptor inhibitor)

Inform your doctor, pharmacist, or nurse before receiving Irinotecan Accord if you have recently received chemotherapy (and radiation therapy).

If you need surgery, inform your doctor or anesthesiologist that you are being treated with irinotecan, as it may alter the effect of some medications used during surgery.

Do not start or stop taking medications while being treated with irinotecan without first talking to your doctor.

This medication can cause severe diarrhea. Try to avoid using laxatives and stool softeners while taking this medication.

You may have other medications that interact with irinotecan. Consult your doctor, pharmacist, or nurse about your other medications, herbs, and supplements, and whether alcohol can cause problems with this medication.

Contraception, pregnancy, lactation, and fertility
Contraception

If you are a fertile woman, you should use an effective contraceptive method during and for 6 months after stopping treatment.

As a man, you should use an effective contraceptive method during and for 3 months after completing treatment. It is essential to consult with your doctor about what types of contraceptives can be used with this medication.

Pregnancy

This medication can cause problems with the fetus if taken during conception or during pregnancy. Before starting treatment, your doctor will ensure that you are not pregnant.

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

Lactation

Irinotecan and its metabolite were detected in human milk.

Breastfeeding should be interrupted during irinotecan treatment.
Please ask your doctor before taking any medication.

Fertility

No studies have been conducted, however, this medication may affect fertility. Before using this medication, talk to your doctor about the possible risk with this medication and options to preserve your ability to have children.

Driving and operating machinery

In some cases, irinotecan may cause side effects that affect your ability to drive and use tools and machines. Contact your doctor if you are unsure.

During the first 24 hours after irinotecan administration, you may feel dizzy or have visual disturbances. If this happens, do not drive or use tools or machines.

Important information about some components of Irinotecan Accord
This medication contains 45mg of sorbitol per ml. Sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance (IHF), a rare genetic disease, you should not receive this medication. Patients with IHF cannot break down fructose, which can causesevere adverse effects.

Consult your doctor before receiving this medication if you (or your child) have IHF or cannot take sweet foods or drinks because they cause dizziness, vomiting, or unpleasant effects such as bloating, stomach cramps, or diarrhea.

This medication contains less than 1 mmol (23 mg) of sodium per dose; it is essentially "sodium-free".

Use this medication exactly as your doctor has told you. Consult your doctor if you are unsure.

Irinotecan will be administered by healthcare professionals.

Your doctor may recommend a DNA test before the first dose of irinotecan.

Some people are genetically more prone to certain side effects from this medication.

You may be given other medications to prevent nausea, vomiting, diarrhea, and other side effects while receiving irinotecan. You may need to continue using these medications for at least one day after the irinotecan infusion.

Inform your caregivers if you feel burning, pain, or swelling around the intravenous needle when irinotecan is injected. If the medication leaks from the vein, it may cause damage to the injection site. If you experience pain or notice redness or swelling at the IV injection site while receiving irinotecan, alert your healthcare professional immediately.

This medication will be administered as an infusion into your veins over a period of 30-90 minutes. The amount of infusion to be administered will depend on your age, weight, and overall health status. It will also depend on any other cancer treatment you may have received. Your doctor will calculate your body surface area in square meters (m2).

- If you have been previously treated with 5-fluorouracil, you will usually be treated with irinotecan alone, starting with a dose of 350 mg/m2every 3 weeks.

- If you have not received chemotherapy before, you will usually receive 180 mg/m2of irinotecan every 2 weeks, followed by folinic acid and 5-fluorouracil.

• If you are being treated with irinotecan in combination with cetuximab, you will usually receive the same dose of irinotecan as administered in the last cycles of the previous regimen containing irinotecan. Irinotecan should not be administered less than 1 hour after the end of the cetuximab infusion.

Your doctor will adjust these doses based on your condition and any side effects you may experience.

If you receive more Irinotecan Accord than you should

It is unlikely that you will receive too much Irinotecan Accord. However, if this happens, you may experience severe blood disorders and diarrhea. You should be closely monitored to prevent dehydration due to diarrhea and to treat any infectious complications. You should speak with the doctor administering the medication.

If you forget a dose of Irinotecan Accord

It is very important to receive all scheduled doses. If you forget a dose, contact your doctor immediately.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Your doctor will inform you of the possible side effects and explain the risks and benefits of your treatment. Some of these side effects must be treated immediately.

See also information in the section“Warnings and precautions”

If you experience any of the following side effects after receiving the medicine, inform your doctor immediately. If you are not in the hospital, YOU MUST GO IMMEDIATELY.

• Allergic reactions. If you have asthma, difficulty breathing, swelling, hives, or itching (especially affecting the whole body) contact your doctor or nurse immediately.
• Severe allergic reactions (anaphylactic/anaphylactoid reactions) may occur more frequently within minutes of product administration: skin eruptions including itchy red skin, swelling of hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing) and you may also feel like fainting.
• Diarrhea (see section 2).
• Early diarrhea: occurs within the first 24 hours after receiving this medicine, accompanied by symptoms of nasal discharge, increased salivation, watery eyes, sweating, redness, abdominal cramps. (This may occur while the medicine is being administered. If so, inform your healthcare professional quickly. Medication may be given to stop and/or reduce this early side effect).
• Late diarrhea: occurs more than 24 hours after receiving this medicine. Due to the risk of dehydration and electrolyte imbalances with diarrhea, it is essential to be in contact with healthcare professionals for monitoring, and for advice on medication and dietary modifications.

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

- Blood disorders: neutropenia (decrease in the number of some white blood cells), thrombocytopenia (decrease in the number of platelets in the blood), anemia (decrease in the number of red blood cells in the blood).

- Late diarrhea

- Nausea and vomiting

- Hair loss (hair grows back after completing treatment)

- In combined therapy, a transient increase in levels of some liver enzymes or bilirubin.

Common (may affect up to 1 in 10 people)

- Acute cholinergic syndrome: the main symptoms are early diarrhea and other symptoms such as abdominal pain; redness, itching, stinging, or tearing of the eyes (conjunctivitis); nasal discharge (rhinitis); low blood pressure; vasodilation; sweating, chills; general discomfort, dizziness; visual disturbances, pupil constriction; tearing of the eyes, and increased salivation, which occur within the first 24 hours after irinotecan infusion.

- Fever, infections (including sepsis)

- Fever associated with a severe decrease in the number of some white blood cells

- Dehydration, usually associated with diarrhea and/or vomiting.

- Constipation

- Fatigue

- Increased levels of liver enzymes and creatinine in the blood.

Rare (may affect up to 1 in 100 people)

- Allergic reactions. If you have asthma, difficulty breathing, sweating, swelling, hives, or itching (especially affecting the whole body) contact your doctor or nurse immediately.

- Mild skin reactions; mild reactions at the infusion site.

- Respiratory difficulties

- Pulmonary disease (interstitial lung disease)

- Intestinal obstruction

- Abdominal pain and inflammation, causing diarrhea (a condition known as pseudomembranous colitis)

- Cases of rare renal insufficiency, low blood pressure, or heart or vascular failure have been observed in patients who experienced episodes of dehydration associated with diarrhea and/or vomiting or sepsis.

Very rare (may affect up to 1 in 10,000 people)

- Transient speech disturbances.

- Increased levels of some digestive enzymes that break down sugars and fats.

Unknown (the frequency cannot be estimated from the available data)

• Severe, persistent, or bloody diarrhea (which may be associated with abdominal pain or fever) caused by a bacteria called Clostridium difficile)
• Blood infection
• Dehydration (due to diarrhea and vomiting).
• Dizziness, rapid heart rate, and pale skin (a condition called hypovolemia).
• Allergic reaction
• Temporary speech disturbances during or shortly after treatment.
• Tickling
• High blood pressure (during or after infusion)
• Heart problems*
• Pulmonary disease that causes wheezing and shortness of breath (see section 2)
• Low blood pressure*
• Intestinal blockage
• Enlarged colon
• Intestinal bleeding.
• Colitis
• Abnormal laboratory test results.
• Intestinal perforation; anorexia (loss of appetite); abdominal pain; mucosal inflammation
• Pancreatitis.
• Increased blood pressure during and after administration.
• Decreased levels of potassium and sodium in the blood, mainly related to diarrhea and vomiting.
• Muscle cramps
• Renal problems*
• Low blood pressure*
• Fungal infections
• Viral infections

* Cases of these side effects have been observed in patients who experienced episodes of dehydration associated with diarrhea and/or vomiting, or blood infections.

If you receive irinotecan in combination withcetuximab, some of the side effects you may experience may also be related to this combination. These side effects may include a skin rash similar to acne. Therefore, make sure to also read the cetuximab prospectus.

If you receive irinotecan in combination withcapecitabina, some of the side effects you may experience may also be related to this combination. These side effects may include: very frequently, blood clots, frequently, allergic reactions, heart attacks, and fever in patients with low white blood cell counts. Therefore, make sure to also read the capecitabina prospectus.

If you receive irinotecan in combination withcapecitabinaandbevacizumab,some of the side effects you may experience may also be related to this combination. These side effects include: low white blood cell count, blood clots, high blood pressure, and heart attack. Therefore, make sure to also read the prospectuses for capecitabina and bevacizumab.

If any of the side effects you experience are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not mentioned in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not freeze.

For single use only.

This medication does not require special temperature storage conditions. Store this medication in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition of Irinotecan Accord

• The active ingredient is irinotecan hydrochloride trihydrate
• 1 ml of concentrate contains 20 mg of irinotecan hydrochloride trihydrate equivalent to 17.33 mg of irinotecan
• 1 vial of 2 ml contains 40 mg of irinotecan hydrochloride trihydrate
• 1 vial of 5 ml contains 100 mg of irinotecan hydrochloride trihydrate
• 1 vial of 15 ml contains 300 mg of irinotecan hydrochloride trihydrate
• 1 vial of 25 ml contains 500 mg of irinotecan hydrochloride trihydrate
• 1 vial of 50 ml contains 1000 mg of irinotecan hydrochloride trihydrate
• The other components are sorbitol (E420), lactic acid, sodium hydroxide, hydrochloric acid, and water for injection preparations

Appearance of the product and contents of the package

Irinotecan Accord 20 mg/ml concentrate for solution for infusion is a transparent pale yellow solution

Package sizes:
2 ml
5 ml
15 ml
25 ml

50 ml
Not all package sizes may be marketed

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Responsible manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,

95-200 Pabianice, Poland

This medicinal product is authorized in the following Member States of the EEA:

Last review date of this leaflet:October 2023

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS), (http://www.aemps.gob.es/).

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Irinotecan Accord 20 mg/ml concentrate for solution for infusion EFG

This information is intended solely for healthcare professionals:

Instructions for use – Cytotoxic

Handling of Irinotecan Accord

As with other antineoplastic agents, Irinotecan Accord should be handled with caution. Dilution should be performed in aseptic conditions, by qualified personnel, and in a designated area. Precautions should be taken to avoid contact with the skin and mucous membranes.

Instructions for protection for the preparation of the infusion solution of irinotecan:

1. Use a protective hood, as well as protective gloves and a protective gown. If you do not have a protective hood, use glasses and a mask.

1. Open containers, such as injection vials and infusion bags and cannulas used, syringes, catheters, tubes, and cytostatic waste should be considered hazardous waste and disposed of in accordance with local regulations for the handling of HAZARDOUS WASTE.

1. In case of spill, follow these instructions:

- Wear protective clothing

- Broken glass should be collected and disposed of in a HAZARDOUS WASTE container

- Contaminated surfaces should be washed thoroughly with cold water

- Surfaces washed with water should be completely cleaned and materials used should be disposed of as HAZARDOUS WASTE

1. If irinotecan comes into contact with the skin, wash the affected area with plenty of running water and then wash with soap. If you have any discomfort, contact a doctor.

5. If irinotecan comes into contact with the eyes, wash them thoroughly with plenty of water. Contact an ophthalmologist immediately.

Preparation of the infusion solution

Irinotecan Accord concentrate for infusion solution is only for intravenous infusion after dilution prior to administration in the recommended diluents, sodium chloride 0.9% infusion solution or glucose 5% infusion solution. Aspirate aseptically the required amount of irinotecan concentrate for infusion from the vial with a calibrated syringe and inject into a 250 ml infusion bag or bottle. The infusion solution to be administered should be mixed thoroughly by manual rotation.

After opening, the product should be diluted and used immediately.

The irinotecan solution is physically and chemically stable in sodium chloride 0.9% (v/v) and glucose 5% (v/v) infusion solutions for up to 28 days when stored in low-density polyethylene or PVC containers at 5°C or 25°C and protected from light. When exposed to light, the physical and chemical stability is 3 days.
From a microbiological point of view, the diluted solution should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and should not normally exceed 24 hours between 2 and 8°C, unless the reconstitution/dilution (etc.) has been performed in controlled and validated aseptic conditions.

If any precipitate is observed in the vials or after reconstitution, the product should be discarded in accordance with standard procedures for the disposal of cytotoxic agents.

Irinotecan Accord should not be administered as a bolus intravenous injection or infusion with a duration of less than 30 minutes or more than 90 minutes.

Disposal

All materials used for the preparation, administration, or coming into contact with irinotecan should be disposed of in accordance with local regulations for the handling of cytotoxic compounds.