Leaflet: information for the user

Oxaliplatino Accord 5 mg/ml concentrate for solution for infusion EFG

Read the entire leaflet carefully before starting to use the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• If you experience any side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

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

3. How to use Oxaliplatino Accord

4. Possible side effects

5. Storage of Oxaliplatino Accord

6. Contents of the pack and additional information

Oxaliplatino Accord contains the active ingredient oxaliplatino.

Oxaliplatino is used to treat colorectal cancer (stage III colon cancer after complete resection of the primary tumor, metastatic colon and rectal cancer). Oxaliplatino is used in combination with other anticancer medications called 5-fluorouracilo and folinic acid.

Oxaliplatino must be dissolved in a solution before it can be injected into a vein.

Oxaliplatino is an antineoplastic or antitumor medication and contains platinum.

No use Oxaliplatino Accord

• if you are allergic to oxaliplatino or any of the other components of Oxaliplatino Accord.
• if you are breastfeeding.
• if you already have a reduction in blood cell count.
• if you already experience numbness or tingling in your fingers or toes and have difficulty performing delicate tasks, such as buttoning your clothes.
• if you have severe kidney problems.

Advertencias y precauciones

Consult your doctor or pharmacist before starting to use Oxaliplatino Accord.Oxaliplatino Accord

• if you have ever had an allergic reaction to medications containing platinum, such as carboplatino or cisplatino. Allergic reactions can occur during the infusion of any platinum.

• if you have moderate or mild kidney problems.
• if you have any liver problems or abnormal liver function test results during treatment.
• If you have or have had cardiac abnormalities such as an abnormal electrical signal called prolonged QT interval, irregular heartbeat, or a family history of cardiac problems.
• if you have been administered or are planned to be administered any vaccine. During treatment with oxaliplatino, you should not be vaccinated with live or live attenuated vaccines, such as the yellow fever vaccine.

If any of the following happens to you at any time, inform your doctor immediately. Your doctor may need to treat you for these events and may need to reduce the dose of Oxaliplatino Accord, or delay or interrupt treatment with Oxaliplatino Accord.

• if you have an unpleasant sensation in your throat, particularly when swallowing, and feel like you are out of breath, during treatment.
• if you have nerve problems in your hands or feet, such as numbness and tingling, or a decrease in sensation in your hands or feet.
• if you have headaches, mental function alterations, seizures, and abnormal vision, from blurry vision to loss of vision.
• if you do not feel well (nausea and vomiting).
• if you have severe diarrhea.
• if you have pain in your lips or ulcers in your mouth (mucositis/stomatitis).
• if you have diarrhea or a decrease in white blood cells or platelets. Your doctor may need to reduce the dose of Oxaliplatino Accord or postpone your treatment with Oxaliplatino Accord.
• if you have unexplained respiratory symptoms such as coughing, or difficulty breathing. Your doctor may stop your treatment with Oxaliplatino Accord.
• if you develop extreme fatigue, shortness of breath, or kidney problems that cause you to urinate little or not at all (symptoms of acute renal failure).
• if you have a fever (temperature equal to or greater than 38°C), or chills, which may be signs of infection. You may be at risk of developing a blood infection.
• if you have a fever > 38°C. Your doctor may determine if you also have a decrease in white blood cells.
• if you unexpectedly experience bleeding or a bruise (disseminated intravascular coagulation). These may be signs of blood clots throughout the small blood vessels of your body.
• if you are dizzy (loss of consciousness) or have an irregular heartbeat while taking Oxaliplatino Accord. This may be a sign of a severe cardiac disorder.
• if you develop muscle pain and swelling, along with weakness, fever, and reddish-brown urine. These may be signs of muscle damage (rhabdomyolysis) and may lead to kidney problems or other complications.
• if you have abdominal pain, nausea, vomiting with blood or vomiting like coffee grounds, dark stools that may be signs of intestinal ulcer (gastrointestinal ulcer with potential hemorrhage or perforation).
• if you have abdominal pain (at the navel level), diarrhea with blood, nausea, and/or vomiting that may be caused by a decrease in blood flow to the walls of your intestine (intestinal ischemia).

Niños y adolescentes

Oxaliplatino should not be used in children and adolescents under 18 years of age.

Uso de otros medicamentos

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

-5-fluorouracilo (cancer medication)

-Eritromicina (an antibiotic)

-Salicilatos (pain relief medications)

-Granisetron, (medication to prevent vomiting)

-Paclitaxel, (cancer medication)

-Valproato sódico, (epilepsy medication)

Embarazo y lactancia y fertilidad

Embarazo

• We recommend that you do not become pregnant during treatment with oxaliplatino and use effective contraception. Female patients should adopt appropriate contraceptive measures during treatment and continue them for 4 months after treatment is completed.
• If you are pregnant or planning to become pregnant, it is very important that you talk to your doctor before receiving any treatment.
• If you become pregnant during treatment, inform your doctor immediately.

Lactancia

• You should not breastfeed your child while on treatment with oxaliplatino.

Fertilidad

• Oxaliplatino may have an anti-fertility effect that may be irreversible. Male patients should seek advice regarding sperm conservation before treatment.
• We advise male patients not to father children during treatment and for 6 months after treatment is completed and to take appropriate contraceptive measures during this time.

Ask your doctor or pharmacist before taking any medication.

Conducción y uso de máquinas

Treatment with oxaliplatino may increase the risk of dizziness, nausea, and vomiting, and other neurological symptoms that affect your gait and balance. If this happens, do not drive or operate machines. If you experience vision problems while receiving Oxaliplatino Accord, do not drive, operate heavy machinery, or engage in hazardous activities.

Oxaliplatino is only for adults.

For single use.

Dosage

The dose of oxaliplatino is based on body surface area. It is calculated from your height and weight.

The usual dose for adults, including elderly patients, is 85 mg/m2 of body surface area. The dose you receive will also depend on the results of blood tests and whether you have previously experienced side effects with oxaliplatino.

Method and route of administration

• A cancer treatment specialist will prescribe oxaliplatino for you.
• A healthcare professional will treat you, who will have prepared the necessary dose of oxaliplatino.
• Oxaliplatino is administered through a slow injection into a vein (intravenous infusion) over a period of 2 to 6 hours.

Oxaliplatino will be administered at the same time as folinic acid and before the infusion of 5-fluorouracil.

• Oxaliplatino will be administered to you at the same time as folinic acid and before the infusion of 5-fluorouracil.

Administration frequency

You will normally receive the infusion every two weeks.

Treatment duration

Your doctor will determine the duration of treatment.

Your treatment will last a maximum of 6 months when used after complete tumor resection.

If you use more Oxaliplatino Accord than you should

Since this medication will be administered by a healthcare professional, it is very unlikely that you will receive too much or too little.

In case of overdose, you may experience more side effects. Your doctor will give you the appropriate treatment for these side effects.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any side effect, it is important to inform your doctor about it before the next treatment.

The following side effects may be experienced.

Inform your doctor immediately ifyou notice any of the following:

• Allergic or anaphylactic reaction with sudden signs such as skin rash, itching, or hives, difficulty swallowing, swelling of the face, lips, tongue, or other parts of the body, difficulty breathing, wheezing, or difficulty breathing, extreme fatigue (you may feel like you are going to faint).
• Abnormal bruises, bleeding, or signs of infection such as sore throat and high fever.
• Persistent or severe diarrhea or vomiting.
• Presence of blood or dark brown particles in the vomit.
• Stomatitis/mucositis (painful lips or mouth ulcers).
• Respiratory symptoms such as dry or wet cough, difficulty breathing, or wheezing, difficulty breathing, and wheezing.
• A group of symptoms with or without high blood pressure.
• Stroke symptoms (such as severe and sudden headache, confusion, vision problems in one or both eyes, numbness or weakness of the face, arm, or leg, usually on one side, facial drooping, difficulty walking, dizziness, loss of balance, and difficulty speaking).
• Extreme fatigue with a decrease in the number of red blood cells (hemolytic anemia), alone or combined with a low platelet count, abnormal bruises (thrombocytopenia), and kidney disease in which little or no urine is produced (hemolytic-uremic syndrome symptoms).

Other known side effects of Oxaliplatino Accord are:

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

• Tickling or numbness in the fingers of the hand or feet, around the mouth or in the throat, which may be accompanied by cramps.
• Sensation of discomfort near or at the injection site during infusion.
• Fever, chills (shivering), mild or severe fatigue, body aches.
• Weight changes, loss of appetite, taste alterations, constipation.

• Abdominal pain.
• Abnormal bleeding, with nasal bleeding.
• Mild hair loss (alopecia).

Common(may affect up to 1 in 10 people)

• Infection due to a reduction in white blood cells.
• Severe blood infection in addition to a reduction in white blood cells (neutropenic sepsis), which can be fatal.
• Reduction in white blood cells accompanied by fever > 38.3°C or prolonged fever > 38°C for more than an hour (febrile neutropenia).
• Indigestion and heartburn, hiccups, flushing, dizziness.
• Increased sweating and nail alterations, skin peeling.
• Chest pain.
• Pulmonary disorders and nasal congestion.
• Joint and bone pain.
• Painful urination and changes in kidney function, changes in urination frequency, dehydration.
• Blood in urine/stool, venous inflammation.
• Increased blood pressure
• Depression and insomnia.
• Conjunctivitis and vision problems.
• Reduction in calcium levels in the blood.
• Fall.

Rare(may affect up to 1 in 100 people)

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

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

Unknown(cannot be estimated from available data)

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 that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Keep the vial in the outer packaging to protect it from light. Do not freeze.

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.

Chemical and physical stability has been demonstrated during use for 48 hours between 2°C and 8°C and for 24 hours at 25°C. From a microbiological standpoint, this infusion preparation should be used immediately. If not used immediately, the storage conditions and times before use are the responsibility of the user and normally would not exceed 24 hours between 2°C and 8°C unless the dilution took place under controlled and validated aseptic conditions.

Do not use this medication if you observe that the solution is not transparent and free of particles.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Oxaliplatino Accord should not come into contact with the eyes or skin. If an accidental spill occurs, inform the doctor or nurse immediately.

When the infusion is completed, the doctor or nurse will carefully eliminate Oxaliplatino Accord.

Composition of Oxaliplatino Accord

The active ingredient is oxaliplatino.

The other components are water for injection.

Aspect of the product and contents of the package

Each ml of concentrate for solution for infusion contains 5 mg of oxaliplatino.

Oxaliplatino Accord is a colorless and transparent solution without visible particles.

Each glass vial contains 50 mg, 100 mg or 200 mg of oxaliplatino and is packaged in an individual box.

10 ml of concentrate for solution for infusion contains 50 mg of oxaliplatino.

20 ml of concentrate for solution for infusion contains 100 mg of oxaliplatino.

40 ml of concentrate for solution for infusion contains 200 mg of oxaliplatino.

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Spain

Responsible for manufacturing

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, 32009,

Greece

This medicinal product is authorized in the member states of the European Economic Area with the following names

Last review date of this leaflet:March 2024

This information is intended solely for medical professionals or healthcare professionals.

GUIDE FOR PREPARATION FOR USE OF OXALIPLATINO ACCORD 5mg/ml CONCENTRATE FOR SOLUTION FOR INFUSION

Please read the entire content of this procedure before preparing OXALIPLATINO ACCORD 5 mg/ml CONCENTRATE FOR SOLUTION FOR INFUSION

1. FORMULATION

Oxaliplatino Accord 5 mg/ml concentrate for solution for infusion is a colorless and transparent solution containing 5 mg/ml of oxaliplatino.

2. PRESENTATION

It is presented in single-dose vials. 1 vial per box.

For 10 ml,

The concentrate for solution for infusion is packaged in a 10 ml capacity type 1 glass vial with a 20 mm chlorobutyl rubber stopper and a 20 mm removable aluminum seal.

For 20 ml,

The concentrate for solution for infusion is packaged in a 20 ml capacity type 1 molded glass vial with a 20 mm chlorobutyl rubber stopper and a 20 mm removable aluminum seal.

For 40 ml,

The concentrate for solution for infusion is packaged in a 50 ml capacity type 1 molded glass vial with either a 20 mm chlorobutyl rubber stopper or a 20 mm silicone stopper with a Teflon coating on the contact surface and a 20 mm removable aluminum seal.

Expiration date and storage:

Two years.

After dilution in 5% glucose solution, chemical and physical stability has been demonstrated for up to 48 hours between 2°C and 8°C and for 24 hours at 25°C.

From a microbiological point of view, the infusion preparation should be used immediately.

If not used immediately, the storage conditions and times before use are the responsibility of the user and normally would not exceed 24 hours between 2°C and 8°C unless the dilution has taken place under controlled and validated aseptic conditions.

Store the vial in the outer packaging to protect it from light. Do not freeze.

Inspect visually before use. Only use transparent solutions without particles.

This medicinal product is for single use only. Any unused solution should be discarded.

3. SAFE HANDLING RECOMMENDATIONS

As with other potentially toxic compounds, caution should be exercised when handling and preparing oxaliplatino solutions.

Handling instructions

The handling of this cytotoxic by healthcare personnel requires the utmost caution to ensure the protection of the handler and their environment.

The preparation of cytotoxic injectable solutions should be performed by specially trained personnel who are familiar with the medications used, in conditions that ensure the integrity of the medication, the protection of the environment, and especially the protection of the personnel handling the medications, in accordance with hospital policy. It requires a reserved preparation area for this purpose. Smoking, eating, or drinking is prohibited in this area.

Provide personnel with appropriate handling materials, especially long-sleeved gowns, protective masks, caps, safety glasses, disposable sterile gloves, protective aprons for the work area, containers, and waste bags.

Excreta and vomit should be handled with care.

Warn pregnant women to avoid handling cytotoxic products.

Broken containers should be treated with the same precautions and considered as contaminated waste. Contaminated waste should be incinerated in rigid containers properly labeled. See the following section "Elimination".

If Oxaliplatino Accord 5 mg/ml concentrate for solution for infusion comes into contact with the skin, wash immediately and thoroughly with water.

If Oxaliplatino Accord 5 mg/ml concentrate for solution for infusion comes into contact with mucous membranes, wash immediately and thoroughly with water.

4. PREPARATION FOR INTRAVENOUS ADMINISTRATION

Special administration precautions

Instructions for use with folinic acid (such as calcium folinate or sodium folinate)

Oxaliplatino 85 mg/m² in i.v. infusion in 250 to 500 ml of 5% glucose solution is administered at the same time as the i.v. infusion of folinic acid in 5% glucose solution, during 2 to 6 hours, using a Y-connector placed immediately before the infusion point.

These two medications should not be combined in the same infusion bag. Folinic acid should not contain trometamol as an excipient and should only be diluted using an isotonic 5% glucose solution, never in alkaline solutions or solutions containing sodium chloride or chlorine.

Instructions for use with 5-fluorouracil

Oxaliplatino should always be administered before fluoropyrimidines, i.e., 5-fluorouracil.

After oxaliplatino administration, the route is cleared, and then 5-fluorouracil is administered.

For more information on the combination of oxaliplatino with 5-fluorouracil, see the corresponding product characteristics summary from the manufacturer.

- USE ONLY the recommended solvents (see below).

- Only use transparent solutions without particles.

4.1Preparation of the infusion solution

The required amount of concentrate solution is extracted from the vial(s) and diluted with 250 to 500 ml of a 5% glucose solution to obtain a concentration of oxaliplatino not less than 0.2 mg/ml and 0.7 mg/ml. The concentration interval for which physical-chemical stability has been demonstrated is 0.2 mg/ml to 2.0 mg/ml.

Administer by intravenous infusion.

After dilution in 5% glucose solution, chemical and physical stability has been demonstrated for up to 48 hours between 2°C and 8°C and for 24 hours at 25°C.

From a microbiological point of view, this infusion preparation should be used immediately.

If not used immediately, the storage conditions and times before use are the responsibility of the user and normally would not exceed 24 hours between 2°C and 8°C unless the dilution has taken place under controlled and validated aseptic conditions.

Inspect visually before use. Only use transparent solutions without particles.

This medicinal product is for single use only. Any unused infusion solution should be discarded (see the following section "Elimination").

NEVERuse solutions containing sodium chloride or chlorine for dilution.

The compatibility of the oxaliplatino infusion solution with representative PVC administration equipment has been studied.

4.2Infusion of the solution

Oxaliplatino administration does not require prior hydration.

Oxaliplatino diluted in 250 to 500 ml of 5% glucose solution to obtain a concentration not less than 0.2 mg/ml should be administered by intravenous infusion in a peripheral vein or a central venous access during 2 to 6 hours. When oxaliplatino is administered with 5-fluorouracil, the oxaliplatino infusion should precede the administration of 5-fluorouracil.

4.3Elimination

The remains of the medicinal product as well as all materials used for dilution and administration should be destroyed in accordance with the standard hospital procedures applicable to cytotoxics in accordance with local requirements related to the elimination of hazardous waste.