Oxaliplatin Eugia

Package Leaflet: Information for the User

Oxaliplatin Eugia, 5 mg/mL, Concentrate for Solution for Infusion

Oxaliplatinum

Read all of this leaflet carefully before using this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

• 1. What Oxaliplatin Eugia is and what it is used for
• 2. What you need to know before you use Oxaliplatin Eugia
• 3. How to use Oxaliplatin Eugia
• 4. Possible side effects
• 5. How to store Oxaliplatin Eugia
• 6. Contents of the pack and other information

1. What Oxaliplatin Eugia is and what it is used for

The active substance of Oxaliplatin Eugia is oxaliplatin, which belongs to a group of platinum-based medicines used to treat cancer. Oxaliplatin Eugia is used to treat advanced colorectal cancer, especially after the primary tumor has been completely removed, and in cases of metastatic colorectal cancer. Oxaliplatin Eugia is used in combination with other anticancer medicines such as 5-fluorouracil and folinic acid.

2. What you need to know before you use Oxaliplatin Eugia

When not to use Oxaliplatin Eugia:

• If you are allergic to oxaliplatin or any of the other ingredients of this medicine.
• During breastfeeding.
• If you have a low blood cell count.
• If you have tingling and numbness in your fingers and/or toes and problems with performing precise tasks such as buttoning.
• If you have severe kidney problems.

Warnings and precautions

Before starting treatment with Oxaliplatin Eugia, discuss with your doctor or pharmacist:

• If you have ever had an allergic reaction to platinum-based medicines such as carboplatin or cisplatin. Allergic reactions can occur during any infusion of oxaliplatin.
• If you have moderate or mild kidney problems.
• If you have had low blood cell counts after previous treatment with oxaliplatin. Before starting treatment, your doctor will perform blood tests to check if your blood cell counts are suitable.
• If you have symptoms of nerve damage, such as weakness, numbness, taste disturbances, or unusual sensations after previous treatment with oxaliplatin. These symptoms can be caused by cold temperatures. You should inform your doctor if you notice any of these symptoms, especially if they are unpleasant and/or last longer than 7 days. Your doctor will perform neurological tests before and during treatment, especially if you are taking other medicines that can cause nerve damage. Symptoms of nerve damage may persist after treatment has ended.
• If you are also receiving 5-fluorouracil, due to an increased risk of diarrhea, vomiting, mouth sores, and abnormal blood test results.
• If you have liver problems.
• If you have or have had heart problems, such as an abnormal heart rhythm or heart problems in your family history.
• If you have recently received or plan to receive any vaccines. You should not receive "live" or "attenuated" vaccines, such as the yellow fever vaccine, while being treated with oxaliplatin.
• If you are pregnant or planning to become pregnant (see "Pregnancy, breastfeeding, and fertility").
• Male patients should also read the section on fertility.

Oxaliplatin Eugia with other medicines

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

Pregnancy, breastfeeding, and fertility

Pregnancy

• Oxaliplatin Eugia should not be used during pregnancy unless clearly necessary. Female patients of childbearing potential must use effective contraception during treatment and for 4 months after the end of treatment.
• If you are pregnant or planning to become pregnant, it is essential to discuss this with your doctor before starting treatment.
• If you become pregnant during treatment, you must inform your doctor immediately.

Breastfeeding

• You must not breastfeed during treatment with Oxaliplatin Eugia.

Fertility

• Oxaliplatin can cause infertility, which may be irreversible. Male patients should seek advice on the possibility of storing sperm before starting treatment.
• Male patients are advised to avoid fathering a child and to use effective contraception during treatment and for 6 months after the end of treatment.

Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Treatment with Oxaliplatin Eugia may increase the risk of dizziness, nausea, and vomiting, as well as other neurological symptoms that can affect your gait and balance. If these symptoms occur, you should not drive or operate machinery. If you experience vision disturbances during treatment with Oxaliplatin Eugia, you should not drive or operate machinery and perform hazardous tasks.

3. How to use Oxaliplatin Eugia

Oxaliplatin Eugia is for use in adults only.

Dosage

The dose of Oxaliplatin Eugia is calculated based on your body surface area. It is calculated based on your height and weight. The usual dose for adults is 85 mg/m². The dose you receive will also depend on your blood test results and whether you have had any side effects from Oxaliplatin Eugia in the past.

Method and route of administration

• Oxaliplatin Eugia is prescribed by a doctor specializing in cancer treatment.
• You will be treated by medical staff who will prepare the required dose of Oxaliplatin Eugia.
• Oxaliplatin Eugia is given as a slow injection into one of your veins (intravenous infusion) over 2 to 6 hours.
• Oxaliplatin Eugia is given at the same time as folinic acid, and before 5-fluorouracil infusion.

Frequency of administration

You will usually receive Oxaliplatin Eugia as an intravenous infusion every 2 weeks.

Duration of treatment

Your doctor will decide on the duration of treatment. Treatment can last up to 6 months in cases where oxaliplatin is used after complete removal of the tumor.

Overdose

This medicine is given by medical staff, so it is unlikely that you will be given too much or too little. If you are given too much Oxaliplatin Eugia, side effects may be worse. Your doctor may give you appropriate treatment for side effects. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Oxaliplatin Eugia can cause side effects, although not everybody gets them. If you experience any side effects, it is essential to inform your doctor before the next treatment cycle.

Seek immediate medical attention if you experience any of the following:

• Symptoms of an allergic reaction with sudden symptoms such as rash, itching, or hives, difficulty swallowing, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing, extreme fatigue (you may feel like you are going to faint). In most cases, these symptoms occurred during or immediately after infusion, but delayed allergic reactions have also been observed several hours or even days after infusion. Very common (may affect more than 1 in 10 people).

Unusual bruising or bleeding. Very common (may affect more than 1 in 10 people).

• Symptoms of infection, such as sore throat and high fever. Common (may affect up to 1 in 10 people).
• Persistent or severe diarrhea or vomiting. Very common (may affect more than 1 in 10 people).
• Blood in vomit or black, tarry stools. Rare (may affect up to 1 in 10,000 people).
• Mouth sores or ulcers. Very common (may affect more than 1 in 10 people).
• Unexplained respiratory symptoms, such as dry or wet cough, difficulty breathing, or wheezing. Very common (may affect more than 1 in 10 people).
• A group of symptoms such as headache, mental disturbances, seizures, and vision disturbances from blurred vision to loss of vision (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder). Rare (may affect up to 1 in 1,000 people).
• Severe fatigue with decreased red blood cell count and shortness of breath (hemolytic anemia) occurring with or without decreased platelet count and kidney disease, where the patient produces little or no urine. Frequency not known (cannot be estimated from the available data).

Other known side effects of Oxaliplatin Eugia include:

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

• Oxaliplatin Eugia affects the nerves (peripheral neuropathy). You may feel tingling and/or numbness in your fingers and toes, in the mouth or throat, sometimes occurring with muscle spasms. This side effect is often triggered when you are exposed to cold, e.g., when opening the refrigerator or holding a cold drink. You may also experience difficulty performing precise tasks such as buttoning. Although these symptoms usually disappear completely, there is a possibility that symptoms of peripheral neuropathy may persist after treatment has ended.
• You may experience a tingling sensation like an electric shock that runs down your arms or chest when you bend your neck.
• Oxaliplatin Eugia may sometimes cause unpleasant sensations in the throat, especially when swallowing, as well as a feeling of shortness of breath. These sensations, if they occur, usually appear during or within a few hours of the end of the infusion and may be triggered by exposure to cold temperatures. They are unpleasant but do not last long and disappear without the need for any treatment. Your doctor may decide to adjust your treatment.
• Oxaliplatin Eugia may cause diarrhea, mild nausea (queasiness), and vomiting; however, your doctor will give you an anti-vomiting medicine, which is usually given before treatment and can be taken after the end of the treatment cycle.
• Oxaliplatin Eugia causes a temporary decrease in blood cell counts. A decrease in red blood cell count can cause anemia, a decrease in platelet count can cause unusual bleeding or bruising, and a decrease in white blood cell count can increase the risk of infection. Before starting treatment and before each subsequent cycle, your doctor will perform blood tests to check if you have a sufficient number of blood cells.
• Discomfort at the injection site or in the surrounding area during infusion.
• Chills (shivering), mild or moderate fatigue, body aches.
• Weight changes, decreased or lost appetite, taste disturbances, constipation.
• Headache, back pain.
• Numbness of the nerves going to the muscles, stiffness of the neck, unusual sensation of the tongue that can disrupt speech.
• Abdominal pain.
• Mild hair loss (alopecia).
• Changes in blood test results, including those indicating abnormal liver function.

Common(may affect up to 1 in 10 people)

• Indigestion and heartburn, hiccups, flushing, dizziness.
• Increased sweating and nail disorders, skin peeling.
• Chest pain.
• Common cold.
• Bone and joint pain.
• Pain when urinating and changes in kidney function, changes in the frequency of urination, dehydration.
• Blood in urine and stools, inflammation of blood vessels, blood clots in the lungs.
• High blood pressure.
• Depression, insomnia.
• Conjunctivitis, vision disturbances.
• Decreased calcium levels in the blood.
• Falls.

Uncommon(may affect up to 1 in 100 people)

• Bowel obstruction or inflammation.
• Nervousness.

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

• Hearing loss.
• Scarring and thickening of the lungs, with difficulty breathing, sometimes leading to death (interstitial lung disease).
• Temporary, short-term loss of vision.

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

• Kidney disease, where the patient produces little or no urine (symptoms of acute renal failure).
• Vascular liver disease.

Frequency not known(cannot be estimated from the available data)

• Allergic inflammation of blood vessels (vasculitis).
• Seizures (uncontrolled body shaking).
• Spasm of the vocal cords causing difficulty breathing.
• Abnormal heart rhythm (prolonged QT interval), which can be seen on an electrocardiogram (ECG) - a condition that can lead to death.
• Heart attack (myocardial infarction), angina pectoris (chest pain or discomfort).
• Esophagitis (inflammation of the esophagus, the tube that connects the mouth to the stomach - causing pain and difficulty swallowing).
• Decreased blood flow to the intestine (intestinal ischemia) - a condition that can lead to death.
• Risk of developing new tumors. In patients receiving Oxaliplatin Eugia in combination with other medicines, leukemia, a type of blood cancer, has been reported. You should discuss with your doctor the possibility of an increased risk of this type of cancer when taking Oxaliplatin Eugia and certain other medicines.
• Non-cancerous abnormal growths in the liver (focal nodular hyperplasia).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. Side effects can be reported to the national reporting system via the website [insert website]. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oxaliplatin Eugia

Keep this medicine out of the sight and reach of children. Oxaliplatin Eugia should not come into contact with the eyes or skin. In case of accidental spillage, immediately inform your doctor or nurse. After the infusion is completed, any remaining Oxaliplatin Eugia will be carefully disposed of by your doctor or nurse. Do not use this medicine after the expiry date which is stated on the carton and vials after EXP. The expiry date refers to the last day of that month. There are no special storage instructions for this medicine. It has been shown that the diluted solution is chemically and physically stable for 48 hours at a temperature of 2°C to 8°C and for 24 hours at 25°C. From a microbiological point of view, the prepared infusion solution should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user. The storage period should not exceed 24 hours at 2°C to 8°C, unless dilution has been made in controlled and validated aseptic conditions (not more than 48 hours). Before administration, the solution should be inspected. Only clear solutions without visible particles should be used. This medicine is for single use only. Any unused solution should be disposed of (see section "Disposal of unused solution" below). Do not dispose of medicines in the sewage system or in household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Oxaliplatin Eugia contains

The active substance is oxaliplatin. Each vial contains 50 mg, 100 mg, or 200 mg of oxaliplatin. The other ingredient is water for injection.

What Oxaliplatin Eugia looks like and contents of the pack

Concentrate for solution for infusion. Clear, colorless solution, essentially free from visible particles. Each vial contains 50 mg, 100 mg, or 200 mg of oxaliplatin in water for injection. The vials are packaged in cardboard boxes. The pack contains one vial. 1 vial with 10 mL of concentrate for solution for infusion contains 50 mg of oxaliplatin. 1 vial with 20 mL of concentrate for solution for infusion contains 100 mg of oxaliplatin. 1 vial with 40 mL of concentrate for solution for infusion contains 200 mg of oxaliplatin. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Eugia Pharma (Malta) Ltd. Vault 14, level 2 Valletta Waterfront Floriana, FRN 1914 Malta e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd. HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta Generis Farmacêutica, S.A. Rua João de Deus 19, Venda Nova 2700-487 Amadora Portugal Arrow Génériques 26 Avenue Tony Garnier 69007 Lyon France

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Oxaliplatin Eugia 5 mg/ml concentraat voor oplossing voor infusie / solution à diluer pour perfusion / Konzentrat zur Herstellung einer Infusionslösung France: OXALIPLATINE ARROW LAB 5mg/ml, solution à diluer pour perfusion Germany: Oxaliplatin PUREN 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung Italy: Oxaliplatino Aurobindo Italia Poland: Oxaliplatin Eugia Portugal: Oxaliplatina Generis Spain: Oxaliplatino Aurovit 5 mg/ml concentrado para solución para perfusión EFG Sweden: Oxaliplatin Eugia

Date of last revision of the package leaflet:

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Information intended for healthcare professionals only:

INSTRUCTIONS FOR THE PREPARATION OF OXALIPLATIN EUGIA, 5 MG/ML, CONCENTRATE FOR SOLUTION FOR INFUSION

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Read the entire contents of these instructions before preparing the solution for infusion.

1. PRODUCT DESCRIPTION

Oxaliplatin Eugia, 5 mg/mL, concentrate for solution for infusion is a clear, colorless solution containing 5 mg/mL of oxaliplatin in water for injection.

2. PRESENTATION

Oxaliplatin Eugia is supplied in single-dose vials. Each carton contains one vial of Oxaliplatin Eugia (50 mg, 100 mg, or 200 mg). The 10 mL vial of Oxaliplatin Eugia is made of colorless glass type I containing 50 mg of oxaliplatin concentrate for solution for infusion, with a bromobutyl rubber stopper. The 20 mL vial of Oxaliplatin Eugia is made of colorless glass type I containing 100 mg of oxaliplatin concentrate for solution for infusion, with a bromobutyl rubber stopper. The 40 mL vial of Oxaliplatin Eugia is made of colorless glass type I containing 200 mg of oxaliplatin concentrate for solution for infusion, with a bromobutyl rubber stopper. Oxaliplatin Eugia in its packaging: There are no special storage instructions for this medicine. The diluted solution has been shown to be chemically and physically stable for 48 hours at a temperature of 2°C to 8°C and for 24 hours at 25°C. From a microbiological point of view, the prepared infusion solution should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user. The storage period should not exceed 24 hours at 2°C to 8°C, unless dilution has been made in controlled and validated aseptic conditions (not more than 48 hours). Before administration, the solution should be inspected. Only clear solutions without visible particles should be used. This medicine is for single use only. Any unused solution should be disposed of (see section "Disposal of unused solution" below).

3. SPECIAL PRECAUTIONS FOR HANDLING

As with other potentially toxic substances, caution should be exercised when handling and preparing solutions of oxaliplatin. Instructions for use Handling of this cytotoxic medicine by healthcare staff requires all precautions to ensure protection of the user and the environment. Preparation of solutions for injection of cytotoxic products must be performed by trained personnel with knowledge of the product being prepared, under conditions that ensure the integrity of the product, environmental protection, and in particular the protection of personnel handling the product, in accordance with hospital procedures. This requires the designation of an area exclusively for this activity. Smoking, eating, and drinking are prohibited in these areas. Personnel must be equipped with appropriate protective equipment, in particular a long-sleeved gown, protective mask, head cover, protective eyewear, sterile single-use gloves, protective covers for the work surface, and containers and bags for collecting waste. Patient excreta and vomit must be treated with caution. Pregnant women should be warned against contact with cytotoxic medicines. Any damaged container should be treated with the same precautions as contaminated waste. Contaminated waste should be incinerated in appropriately labeled rigid containers. See the "Disposal" section below. If the oxaliplatin concentrate for solution for infusion or the infusion solution comes into contact with the skin, it should be rinsed immediately with a large amount of water. In case of contact with the mucous membranes, the contaminated area should be rinsed immediately with water.

4. PREPARATION FOR INTRAVENOUS ADMINISTRATION

Special precautions for administration

• DO NOT use aluminum-containing injection materials.
• DO NOT administer undiluted solutions.
• For dilution, use only 5% (50 mg/mL) glucose solution for infusion. DO NOT dilute the infusion solution with sodium chloride solution or solutions containing chlorides.
• DO NOT mix with other medicines in the same bag or administer simultaneously in the same infusion set.
• DO NOT mix with medicines with an alkaline pH or solutions containing bases, in particular 5-fluorouracil, folinic acid preparations containing trometamol as an excipient, or other active substances that are trometamol salts. Medicines or solutions with an alkaline pH affect the stability of oxaliplatin.

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

Oxaliplatin at a dose of 85 mg/m² in intravenous infusion, diluted in 250 to 500 mL of 5% (50 mg/mL) glucose solution, is administered at the same time as intravenous infusion of folinic acid, diluted in 5% (50 mg/mL) glucose solution. The infusion lasts from 2 to 6 hours and is administered through a Y-connector placed directly before the injection site. These two medicines should not be mixed in the same infusion bag. Folinic acid should not contain trometamol as an excipient and should be diluted only with isotonic 5% (50 mL) glucose solution. Dilution should never be performed with alkaline solutions, sodium chloride solution, or solutions containing chlorides.

Instructions for use with 5-fluorouracil

Oxaliplatin should always be administered before fluoropyrimidine derivatives, e.g., 5-fluorouracil. After administration of oxaliplatin, the infusion set should be flushed, and then 5-fluorouracil should be administered.

• USE ONLY the recommended solvents (see below).
• USE ONLY clear solutions without visible particles.

4.1 Preparation of the infusion solution

Withdraw the required amount of concentrate from the vial(s) and then dilute in 250 mL to 500 mL of 5% (50 mg/mL) glucose solution to achieve a concentration of not less than 0.2 mg/mL to 0.7 mg/mL. The range of concentrations for which the physico-chemical stability of oxaliplatin has been demonstrated is from 0.2 mg/mL to 2 mg/mL. Administer intravenously. It has been shown that the solution diluted with 5% (50 mg/mL) glucose solution is chemically and physically stable for 48 hours at a temperature of 2°C to 8°C and for 24 hours at 25°C. From a microbiological point of view, the prepared infusion solution should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user. The storage period should not exceed 24 hours at 2°C to 8°C, unless dilution has been made in controlled and validated aseptic conditions (not more than 48 hours). Before administration, the solution should be inspected. Only clear solutions without visible particles should be used. This medicine is for single use only. Any unused solution should be disposed of (see section "Disposal of unused solution" below). NEVER use sodium chloride solutions or solutions containing chlorides for dilution. The compatibility of the oxaliplatin infusion solution has been tested with representative PVC-based administration sets.

4.2 Infusion of the solution

Administration of oxaliplatin does not require prior hydration of the patient. Oxaliplatin diluted in 250 to 500 mL of 5% (50 mg/mL) glucose solution to achieve a concentration of not less than 0.2 mg/mL should be administered through a peripheral vein or a central venous access device over 2 to 6 hours. When oxaliplatin is administered with 5-fluorouracil, the oxaliplatin infusion should be performed before the administration of 5-fluorouracil.

4.3 Disposal of unused solution

Unused solution as well as all materials used for dilution and administration should be disposed of in accordance with standard hospital procedures for the disposal of cytotoxic agents, taking into account local requirements for the disposal of hazardous waste.