Irinotecan Accord

Package Leaflet: Information for the User

Irinotecan Accord 20 mg/ml concentrate for solution for infusion

Generic medicine
The full name of this medicine is “Irinotecan Accord 20 mg/ml concentrate for solution for infusion”, but it will be referred to as “Irinotecan Accord” throughout the rest of this leaflet.
Please read this leaflet carefully before 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 experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Irinotecan Accord belongs to a group of medicines known as cytostatics (anti-cancer drugs). Irinotecan
Accord may be used alone or in combination with a number of other drugs for the treatment of advanced
cancer of the colon and rectum in adults. Irinotecan Accord is an anti-tumour medicine containing the
active substance irinotecan hydrochloride trihydrate. Irinotecan hydrochloride trihydrate interferes with
the growth and spread of cancer cells in the body.

Your doctor may use Irinotecan Accord in combination with 5-fluorouracil/folinic acid (5FU/FA) and
bevacizumab to treat cancer of the large intestine (colon or rectum).

Your doctor may use Irinotecan Accord in combination with capecitabine, with or without bevacizumab,
to treat cancer of the colon and rectum.

Your doctor may use Irinotecan Accord in combination with cetuximab to treat a particular type
of cancer of the large intestine (KRAS wildtype) that expresses a protein called EGFR.

2. What you should know before you are given Irinotecan Accord

You must not be given Irinotecan Accord if

• you are allergic to irinotecan hydrochloride trihydrate or any of the other ingredients of this medicine (listed in section 6)
• you have or have previously had chronic inflammatory bowel disease or intestinal obstruction
• you are breastfeeding
• you have severe liver disease (bilirubin level is 3 times higher than the upper limit of normal range)
• you have severe bone marrow failure
• you are in a poor general state of health (according to international standards), WHO performance status higher than 2
• you are taking St. John’s Wort (Hypericum perforatum), a herbal remedy
• you are about to receive or have recently received live attenuated vaccines (vaccines against yellow fever, varicella, herpes zoster, measles, mumps, rubella, tuberculosis, rotavirus, influenza) and during the 6 months following the end of chemotherapy.

If you are taking Irinotecan Accord in combination with other medicines, please make sure you have also read
the package leaflet of the other medicines regarding additional contraindications.
Warnings and precautions
Particular caution is required in elderly patients.
Since Irinotecan Accord is an anticancer medicine, it will be administered in a special unit and under the
supervision of a doctor experienced in the use of anticancer drugs. The staff of the unit will explain to you what
you need to do to take special measures during and after treatment.
This leaflet will help you remember.
Before treatment with Irinotecan Accord, inform your doctor if any of the following apply to you:
You have liver problems
You have kidney problems
You have asthma
You have previously received radiotherapy
You previously experienced severe diarrhoea or fever after receiving Irinotecan Accord
You have heart problems
You smoke, have high blood pressure or high cholesterol, as these may increase the risk of
heart problems during treatment with Irinotecan Accord
You have received or are due to receive any vaccination
You are taking any other medicine. See the section below “Other medicines and irinotecan”
You have Gilbert’s syndrome, a hereditary condition that may cause elevated bilirubin levels and jaundice
(yellowing of the skin and eyes).

1) The first 24 hours after administration of Irinotecan Accord
During administration of Irinotecan Accord (30–90 minutes) and immediately after administration, you may experience
some of the following symptoms:

• Diarrhoea
• Tearing of the eyes
• Sweating
• Visual disturbances
• Abdominal pain
• Excessive salivation

Acute cholinergic syndrome
This medicine may affect part of your nervous system that controls body secretions,
leading to what is known as cholinergic syndrome. Symptoms may include runny nose, increased salivation, excessive
tearing of the eyes, sweating, hot flushes, abdominal cramps and diarrhoea. Inform your doctor or nurse promptly if you notice any of these symptoms, as there are medicines that can help control them.

2) From the day after treatment with Irinotecan Accord until the next treatment.
During this period, you may experience various symptoms, which may be serious and require immediate treatment
and close monitoring.

Diarrhoea
If diarrhoea begins more than 24 hours after administration of Irinotecan Accord (“delayed diarrhoea”), it may
be serious. It is often observed about 5 days after administration. Diarrhoea must be treated
immediately and closely monitored. If left untreated, it may lead to dehydration and severe electrolyte imbalances, which can be life-threatening. Your doctor will prescribe medicines to help you
prevent or manage this side effect. Make sure you have the medicine available so you have it at home when you need it. Immediately after the first loose stool, proceed as follows:

1. Take any anti-diarrhoeal treatment prescribed by your doctor exactly as instructed. The treatment must not be changed without consulting your doctor. The recommended anti-diarrhoeal treatment is loperamide (4 mg for the first dose, then 2 mg every 2 hours, including during the night). This treatment must be continued for at least 12 hours after the last loose stool. The recommended dose of loperamide must not be taken for more than 48 hours.
2. Immediately drink large amounts of water and rehydrating fluids (e.g. water, soda, carbonated drinks, broth or oral rehydration therapy).
3. Inform your doctor responsible for monitoring your treatment immediately about the onset of diarrhoea. If you cannot reach your doctor, contact the hospital department responsible for treatment with Irinotecan Accord. It is extremely important that they are aware of the onset of diarrhoea.

You must inform your doctor or the responsible treatment department immediately if

• you have nausea, vomiting or fever in addition to diarrhoea
• you still have diarrhoea 48 hours after starting anti-diarrhoeal treatment

Note: do not take anti-diarrhoeal treatments other than those prescribed by your doctor or the fluids described above.
Follow your doctor’s instructions. The anti-diarrhoeal treatment must not be used to prevent further
diarrhoeal episodes, even if you experienced delayed diarrhoea in previous cycles.

Fever
If your body temperature rises above 38°C, it may indicate an infection, especially if you have diarrhoea. If you have a fever (above 38°C), contact your doctor or
the department immediately so they can provide any necessary treatment.

Nausea and vomiting
If you experience nausea and/or vomiting, contact your doctor or the department immediately. Your doctor may give you medicines before treatment to help prevent nausea and vomiting. Your doctor will likely prescribe anti-nausea medicines for you to take home. Keep these medicines available for when you need them.
Contact your doctor if you are unable to take fluids orally due to nausea and vomiting.

Neutropenia
Irinotecan Accord may cause a reduction in the number of certain white blood cells, which play an important
role in fighting infections. This reduction is called neutropenia, is often observed during treatment with Irinotecan Accord and is reversible. Your doctor will arrange regular blood tests to monitor your white blood cells. Neutropenia is serious, must be treated immediately and closely monitored. Make sure to inform your doctor or nurse promptly if you show any signs of infection, such as fever (38°C or higher), chills, pain when urinating, a new cold or presence of sputum. Avoid close contact with people who are ill or have infections. Inform your doctor if you develop signs of infection.
Blood tests
Your doctor will likely perform blood tests before and during treatment to monitor the medicine’s effects on red blood cell counts or blood parameters. Based on test results, you may need medicines to help manage side effects. Your doctor may also need to reduce or delay your next dose of this medicine or even stop it completely. Attend all your appointments with your doctor and undergo blood tests as scheduled.
This medicine may lower platelet counts in the weeks after administration, increasing the risk of bleeding. Talk to your doctor before taking any medicines or supplements that may affect your body’s ability to stop bleeding, such as aspirin or medicines containing aspirin, warfarin or vitamin E. Inform your doctor promptly if you experience unusual bruising or bleeding such as nosebleeds, bleeding gums when brushing your teeth, or black, tarry stools.
Pulmonary disorders
Rarely, patients taking this medicine have experienced serious lung problems. Inform your doctor promptly if you develop a cough or worsening cough, have difficulty breathing and fever. Your doctor may need to discontinue treatment to manage this problem.
This medicine may increase the risk of serious blood clots in the veins of the legs and lungs, which may travel to other parts of the body such as the lungs or brain. Inform your doctor promptly if you notice chest pain, shortness of breath or swelling, pain, redness or warmth in one arm or leg.
Chronic intestinal inflammation and/or intestinal blockage
Contact your doctor if you have abdominal pain and are unable to pass stools, especially if you also have bloating and loss of appetite.
Radiotherapy
If you have recently received pelvic or abdominal radiotherapy, you may be at increased risk of developing bone marrow suppression. Contact your doctor before starting therapy with Irinotecan Accord.
Renal function
Cases of renal dysfunction have been reported.
Cardiac disorders
Inform your doctor if you suffer from or have suffered from heart disease or if you have previously received anticancer medicines. Your doctor will monitor you closely and discuss with you how risk factors (e.g. smoking, high blood pressure and high fat levels) can be reduced.
Vascular disorders
Irinotecan Accord is rarely associated with disturbances in blood flow (blood clots in blood vessels of the legs and lungs), which may rarely occur in patients with multiple risk factors.

Impaired liver function
Before starting treatment with Irinotecan Accord and before each subsequent treatment cycle, liver function must be checked (via blood tests).

Other
This medicine may cause mouth or lip ulcers, often within the first few weeks after starting treatment. This may cause mouth pain, bleeding or even difficulties eating. Your doctor or nurse may suggest ways to reduce this, such as changing how you eat or brush your teeth. If necessary, your doctor may prescribe a medicine to help relieve pain.

For information on contraception, pregnancy, breastfeeding and fertility, refer to the information provided below
in the section Contraception, pregnancy, breastfeeding and fertility.
Inform your doctor or dentist that you are taking this medicine if you are planning any surgical procedure.
If, due to your condition, it is used in combination with other anticancer medicines, make sure you have also read the package leaflet for the other medicine.
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Other medicines and irinotecan
Inform your doctor if you are taking or have recently taken any other medicines, including those without a prescription, such as herbal remedies, vitamin and mineral supplements.

• Medicines used to treat seizures (carbamazepine, phenobarbital, phenytoin and fosphenytoin)
• Medicines used to treat fungal infections (clarithromycin, erythromycin and telithromycin)
• Medicines used to treat bacterial infections (rifampicin and rifabutin)
• Medicines used to treat tuberculosis (rifampicin and rifabutin)
• St. John’s Wort (a herbal dietary supplement)
• Live attenuated vaccines
• Medicines used to treat HIV (indinavir, ritonavir, amprenavir, fosamprenavir, nelfinavir, atazanavir, and others)
• Medicines used to suppress your body’s immune system to prevent transplant rejection (cyclosporine and tacrolimus)
• Medicines used to treat cancer (regorafenib, crizotinib, idelalisib and apalutamide)
• Vitamin K antagonists (common anticoagulants such as Warfarin)
• Medicines used to relax muscles during general anaesthesia and surgery (suxamethonium)
• 5-fluorouracil/folic acid
• Bevacizumab (a blood vessel growth inhibitor)
• Cetuximab (an EGF receptor inhibitor)

Inform your doctor, pharmacist or nurse before using Irinotecan Accord if you are receiving or have
recently received chemotherapy (and radiotherapy).
If you are scheduled for surgery, tell your doctor or anaesthetist that you are being treated with
irinotecan, as it may alter the effect of some medicines used during surgery.
Do not start or stop any medicine while taking Irinotecan Accord without first consulting your doctor.
This medicine may cause severe diarrhoea. Try to avoid laxatives and stool softeners while taking this medicine.
There may be many medicines that interact with Irinotecan Accord. Check with your doctor,
pharmacist or nurse about other medicines, herbs and supplements, and alcohol, which may cause problems
with this medicine.

Contraception, pregnancy, breastfeeding and fertility
Contraception
If you are a woman of childbearing potential, you must use an effective method of contraception during and for 6 months after stopping treatment.
As a man, you must use effective contraception during and for 3 months after stopping treatment.
It is important to consult your doctor about which types of birth control can be used with this medicine.

Pregnancy
This medicine may harm the unborn baby if taken at the time of conception or during pregnancy. Before starting treatment, your doctor will ensure you are not pregnant.
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.

Breastfeeding
Irinotecan and its metabolite have been detected in breast milk. Breastfeeding must be discontinued throughout the duration of treatment with Irinotecan Accord.
Consult your doctor before taking any medicine.

Fertility
Studies have not been conducted; however, this medicine may affect fertility. Before taking this medicine, talk to your doctor about the possible risks with this medicine and options for preserving your ability to have children.

Driving and using machines
In some cases, Irinotecan Accord may cause side effects that affect your ability to drive and use tools or machines. If in doubt, contact your doctor.
During the first 24 hours after administration of Irinotecan Accord, you may experience dizziness or visual disturbances.
In this case, do not drive and do not use tools or machines.

Important information about some excipients in Irinotecan Accord
This medicine contains 45 mg of sorbitol per ml. Sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you (or your child) must not take this medicine. Patients with HFI cannot metabolise fructose, which may cause serious side effects.
You must inform your doctor before taking this medicine if you (or your child) have HFI or if your child can no longer consume sweets or drinks because they cause discomfort, vomiting or side effects such as bloating, stomach cramps or diarrhoea.
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially “sodium-free”.

3. How Irinotecan Accord will be administered to you

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
Irinotecan Accord will be administered to you by healthcare professionals.
Your doctor may recommend a DNA test before your first dose of Irinotecan Accord.
Some people are genetically more likely to experience certain side effects after taking the medicine.
You may be given other medicines to prevent nausea, vomiting, diarrhoea, and other side effects while you are receiving Irinotecan Accord. You may need to continue taking these medicines for at least one day after the injection of Irinotecan Accord.
Inform the healthcare staff if you feel burning, pain, or swelling around the intravenous (IV) needle when Irinotecan Accord is being injected. If the medicine leaks out of the vein, it may cause tissue damage. If you experience pain or notice redness or swelling at the IV injection site while receiving Irinotecan Accord, alert the healthcare professional immediately.
Irinotecan Accord will be given as an intravenous infusion over a period of 30 to 90 minutes.
The dose you receive will depend on your age, body size, and general medical condition. It will also depend on any other cancer treatments you may have received.
Your doctor will calculate your body surface area in square metres (m²).

• If you have previously been treated with 5-fluorouracil, you will normally be treated with Irinotecan Accord alone, starting at a dose of 350 mg/m² every 3 weeks.
• If you have not received prior chemotherapy, you will normally receive 180 mg/m² of Irinotecan Accord every two weeks. This will be followed by folinic acid and 5-fluorouracil.
• If you are treated with irinotecan in combination with cetuximab, you will normally receive the same dose of irinotecan as was administered in the last cycles of your previous irinotecan-containing regimen. Irinotecan Accord must not be administered less than 1 hour before the end of the cetuximab infusion.

Your doctor may adjust these doses depending 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 does happen, you may experience severe blood disorders and diarrhoea. Intensive supportive care must be provided to prevent dehydration caused by diarrhoea and to treat any infectious complications. Contact the doctor administering the medicine to you.
If you miss a dose of Irinotecan Accord
It is extremely important that you receive all scheduled doses. If you miss a dose, contact your doctor immediately.

4. Possible side effects

Like all medicines, Irinotecan Accord can cause side effects, although not everyone gets them.
Your doctor will discuss the side effects with you and explain the risks and benefits of the treatment.
Some of these side effects must be treated immediately.
See also the information in the section "Warnings and precautions".
If you experience any of the side effects listed after receiving the medicine, inform your doctor immediately.
If you are not in hospital, you MUST seek immediate medical attention.

• Allergic reactions. If you have shortness of breath, difficulty breathing, rash or itching (affecting the whole body), contact your doctor or pharmacist immediately.
• Severe allergic reactions (anaphylactic/anaphylactoid reactions) may occur more frequently within minutes after injection of the product: skin rash, including itchy red skin, swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing), and you may experience symptoms of fainting.
• Diarrhoea (see section 2).
• Early diarrhoea: Occurs within 24 hours of taking the medicine, accompanied by symptoms such as runny nose, increased salivation, tearing, flushing, abdominal cramps. (This may occur while the medicine is being administered. If it occurs, notify healthcare personnel promptly. A medicine may be given to stop and/or reduce this early side effect.)
• Delayed diarrhoea: Occurs more than 24 hours after taking the medicine. Since this may lead to dehydration and electrolyte imbalance along with diarrhoea, it is important to stay in contact with healthcare professionals for monitoring and advice regarding medications and dietary changes.

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

• Blood disorders: neutropenia (reduced number of certain white blood cells), thrombocytopenia (reduced number of platelets in the blood), anaemia
• Delayed diarrhoea
• Nausea and vomiting
• Hair loss (hair will regrow after treatment ends)
• In combination therapy, transient increases in certain liver enzymes (ALT, AST, alkaline phosphatase) or bilirubin in serum

Common (may affect up to 1 in 10 people)

• Acute cholinergic syndrome: main symptoms include early diarrhoea and other symptoms such as abdominal pain, red, sore, itchy and watery eyes (conjunctivitis); runny nose (rhinitis); low blood pressure; vasodilation; sweating, chills; a feeling of discomfort and general malaise, dizziness; visual disturbances, constricted pupils; watery eyes and increased salivation, occurring during or within the first 24 hours after infusion of Irinotecan Accord
• Fever, infections (including sepsis)
• Fever associated with a severe reduction in white blood cell count
• Dehydration, commonly associated with diarrhoea and/or vomiting
• Constipation
• Fatigue
• Increased levels of liver enzymes and creatinine in blood

Uncommon (may affect up to 1 in 100 people)

• Allergic reactions. If you have shortness of breath, difficulty breathing, rash or itching (affecting the whole body), contact your doctor or nurse immediately.
• Mild skin reactions; mild reactions at the infusion site
• Breathing difficulties
• Lung disease (interstitial lung disease)
• Intestinal obstruction
• Abdominal pain and inflammation causing diarrhoea (a condition called pseudomembranous colitis)
• Infrequent cases of renal failure, low blood pressure or cardiocirculatory failure have been observed in patients who experienced episodes of dehydration associated with diarrhoea and/or vomiting or sepsis.

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

• Severe allergic reactions (anaphylactic/anaphylactoid reactions) may occur more frequently within minutes after injection of the product: skin rash, including itchy red skin, swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing), and you may experience symptoms of fainting. In this case, inform your doctor immediately.
• Early effects such as muscle twitching or cramps and numbness (paraesthesia).
• Gastrointestinal bleeding and inflammation of the colon, including the appendix.
• Intestinal perforation, anorexia, abdominal pain, inflammation of mucous membranes.
• Inflammation of the pancreas.
• Increased blood pressure during and after administration.
• Decreased levels of potassium and sodium in blood, mostly related to diarrhoea and vomiting.

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

• Transient speech disorders
• Increased levels of certain digestive enzymes that break down sugars and fats.

Not known (frequency cannot be estimated from available data)

• Severe, persistent or bloody diarrhoea (which may be associated with stomach pain or
• fever) caused by bacteria called (Clostridium difficile)
• Blood infection
• Dehydration (caused by diarrhoea and vomiting)
• Dizziness, rapid heartbeat and paleness (a condition called hypovolemia)
• Allergic reaction
• Temporary language disturbances during or immediately after treatment
• Tingling
• High blood pressure (during or after infusion)
• Heart problems*
• Lung disease causing wheezing and shortness of breath (see section 2)
• Hiccups
• Intestinal obstruction
• Enlarged colon
• Intestinal bleeding
• Inflammation of the large intestine
• Abnormal laboratory results
• Intestinal perforation
• Fatty liver disease
• Skin reactions
• Reactions at the site where the medicine was administered
• Low levels of potassium in blood
• Low levels of salt in blood, mostly related to diarrhoea and vomiting
• Muscle cramps
• Kidney problems*
• Low blood pressure*
• Fungal infections
• Viral infections

* Rare cases of these events have been observed in patients who experienced episodes of dehydration
associated with diarrhoea and/or vomiting or blood infections.

If you are receiving Irinotecan Accord in combination with cetuximab, some of the side effects you may experience could also be related to this combination. These side effects may include acne-like skin rash. Therefore, make sure to also read the package leaflet for cetuximab.

If you are receiving Irinotecan Accord in combination with capecitabine, some of the side effects you may experience could also be related to this combination. These side effects may include:
very common blood clots, common allergic reactions, heart attack and fever in patients with low white blood cell count. Therefore, make sure to also read the package leaflet for capecitabine.

If you are receiving Irinotecan Accord in combination with capecitabine and bevacizumab, some of the side effects you may experience could 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 package leaflet for capecitabine and bevacizumab.

If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Irinotecan Accord

Keep this medicine out of the sight and reach of children.
Do not freeze.
For single use only.
This medicine does not require any special storage temperature conditions.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton and vial after "Exp".
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer require. This will help protect the environment.

6. Package contents and other information

What Irinotecan Accord contains:

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

Description of the appearance of Irinotecan Accord and contents of the pack:
Irinotecan Accord 20 mg/ml Concentrate for solution for infusion is a clear, pale yellow solution.
Packs:
2 ml
5 ml
15 ml
25 ml
50 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
Accord Healthcare single member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009,
Greece

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Irinotecan Accord 20 mg/ml concentrate for solution for infusion
The following information is intended for healthcare professionals only:

Instructions for Use - CYTOSTATIC

Handling of Irinotecan Accord
Like other antineoplastic agents, Irinotecan Accord must be handled with care. Dilution must be performed under aseptic conditions by adequately trained personnel in a designated area.
Take appropriate precautions to avoid contact with skin and mucous membranes.
Protective instructions for the preparation of irinotecan infusion solution

1. A biological safety cabinet must be used, and gloves and protective clothing must be worn. If a biological safety cabinet is not available, eye protection and a face mask must be used.
2. Opened containers such as injection vials, infusion bottles, used cannulas, syringes, catheters, tubing, and cytotoxic waste must be considered hazardous waste and must be disposed of in accordance with local regulations for handling of HAZARDOUS WASTE.
3. Follow these instructions in case of spillage:
   • wear protective clothing
   • collect broken glass and place it in the container for HAZARDOUS WASTE
   • thoroughly wash contaminated surfaces with cold water
   • thoroughly dry washed surfaces and dispose of used materials as HAZARDOUS WASTE
4. If Irinotecan Accord comes into contact with the skin, rinse the area with running water and then wash with water and soap. In case of contact with mucous membranes, thoroughly rinse the affected area with water. In case of discomfort, contact a physician.
5. If irinotecan comes into contact with the eyes, rinse thoroughly with water. Immediately contact an ophthalmologist.

Preparation of the infusion solution
Irinotecan concentrate for solution for infusion is intended for intravenous infusion administration only after dilution with the recommended diluents: either a 0.9% sodium chloride infusion solution or a 5% glucose infusion solution. Aseptically withdraw the required amount of irinotecan concentrate solution from the vial using a graduated syringe and inject it into a 250 ml infusion bag or bottle. The infusion must then be thoroughly mixed by manual rotation.
The product must be diluted and used immediately after opening.
The solution of Irinotecan Accord is physically and chemically stable with infusion solutions (0.9% (w/v) sodium chloride solution and 5% (w/v) glucose solution) for up to 28 days when stored in LDPE or PVC containers at 5°C or 25°C and protected from light.
When the solution is exposed to light, physical-chemical stability is indicated for up to 3 days.
From a microbiological standpoint, the diluted solution should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2°C–8°C, unless reconstitution/dilution has been performed under controlled and validated aseptic conditions.
If precipitate is observed in the vials or after reconstitution, the medicinal product must be discarded in accordance with standard procedures for cytotoxic agents.
Irinotecan Accord must not be administered as a bolus or as an intravenous infusion lasting less than 30 minutes or more than 90 minutes.
Disposal:
All materials used in the preparation, administration, or that have come into contact with Irinotecan Accord must be disposed of in accordance with local regulations regarding the handling of cytotoxic drugs.