Carbomedac

Leaflet accompanying the packaging: information for the user

Carbomedac, 10 mg/ml, concentrate for solution for infusion

Carboplatin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Carbomedac and what is it used for
• 2. Important information before using Carbomedac
• 3. How to use Carbomedac
• 4. Possible side effects
• 5. How to store Carbomedac
• 6. Contents of the packaging and other information

1. What is Carbomedac and what is it used for

The name "Carbomedac, 10 mg/ml, concentrate for solution for infusion" includes the name, strength, and form, but in the rest of the leaflet, the name "Carbomedac" is used.

What is Carbomedac

Carbomedac contains carboplatin, which belongs to a group of medicines called platinum compounds used in cancer treatment. The patient will receive the medicine in a hospital setting.

Indications for use of Carbomedac

Carbomedac is used to treat certain types of ovarian and lung cancer (ovarian epithelial cancer, small cell lung cancer).

2. Important information before using Carbomedac

When not to use Carbomedac

if the patient is allergic to carboplatin or any of the other ingredients of this medicine (listed in section 6). if the patient is allergic to another medicine belonging to the group of platinum compounds. if the patient is breastfeeding. if the patient has severe kidney problems. if the patient has a lack of balance in blood cells (severe myelosuppression). if the patient has a bleeding tumor. if the patient is taking a yellow fever vaccine at the same time. If any of the above applies to the patient and has not been discussed with the doctor or pharmacist, it should be done as soon as possible, before receiving the injection. Carbomedac is usually given to patients in a hospital. Under normal circumstances, the patient does not come into contact with the medicine. The doctor will administer the medicine to the patient and will closely and frequently monitor the patient's condition during and after administration. Usually, before each administration of the medicine, a blood test will be performed on the patient.

Warnings and precautions

Before starting treatment with Carbomedac, the patient should discuss it with their doctor, pharmacist, or nurse.

• if the patient has ever had an allergic reaction to platinum compounds, such as oxaliplatin.
• if the patient has kidney problems. In this case, the doctor may monitor the patient's condition more frequently.
• if the patient is pregnant or may become pregnant. See "Pregnancy, breastfeeding, and fertility" below.
• if the patient has headaches, confusion, seizures, and vision disturbances, including blurred vision or loss of vision.
• if the patient experiences extreme fatigue and shortness of breath with a decrease in red blood cells, alone or in combination with a low platelet count, abnormal bruising, and kidney disease characterized by the production of a small amount of urine or no urine production (symptoms of hemolytic-uremic syndrome).
• if the patient has a fever (temperature above or equal to 38°C) or chills, which may be a sign of infection. In this case, the doctor should be notified immediately. The patient may be at risk of developing a blood infection.
• if the patient experiences vision disturbances.
• if the patient experiences abnormal skin sensations, such as tingling, numbness, and tingling.
• if the patient experiences vomiting. In this case, the doctor may prescribe anti-emetic medicines.
• if the patient experiences any hearing disturbances.
• if the patient has recently taken or plans to take any vaccines. During carboplatin treatment, "live" or "attenuated" vaccines, such as the yellow fever vaccine, should not be administered.

During carboplatin treatment, the patient will receive medicines that help reduce the likelihood of a life-threatening complication known as tumor lysis syndrome, caused by biochemical disturbances in the blood, caused by the breakdown of dying cancer cells that release their contents into the bloodstream. If any of the above applies to the patient and has not been discussed with the doctor or pharmacist, it should be done as soon as possible, before receiving the injection.

Carbomedac and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take. The patient should tell their doctor if they are taking any of the following medicines, as they may interact with Carbomedac:

• While taking medicines that may affect blood cell counts.
• While taking medicines with known toxic effects on the kidneys.
• During carboplatin treatment, yellow fever vaccines should not be taken (see also "When not to use Carbomedac") as there is an increased risk of yellow fever infection, which can be fatal.
• No live virus vaccines should be taken during carboplatin treatment, as there is a risk of developing diseases against which these vaccines are intended, which can be fatal.
• Carboplatin may reduce the effectiveness of antiepileptic medicines (e.g., phenytoin, fosphenytoin).
• Carboplatin may reduce the effectiveness of anticoagulant medicines. Therefore, when taking these medicines together, blood clotting should be monitored more frequently.
• Concomitant use of carboplatin with chelating agents (agents capable of chemically binding carboplatin) may weaken the antitumor effect of carboplatin.
• The toxic effect of carboplatin when administered concomitantly with kidney- and hearing-damaging medicines, such as aminoglycoside antibiotics (medicines used to prevent/treat certain infections) or loop diuretics (diuretic medicines), may lead to serious kidney and hearing damage.
• Concomitant administration of carboplatin with cyclosporin, tacrolimus, or sirolimus (used to suppress the immune system in autoimmune diseases or during organ transplantation) may weaken the immune system, increasing the risk of infections. A weakened immune system increases the risk of increased white blood cell production.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Pregnancy The patient should not use Carbomedac during pregnancy unless clearly indicated by their doctor. If the patient is treated with Carbomedac during pregnancy, they should discuss with their doctor the possible risk to the unborn child. Women of childbearing age must use effective contraceptive measures during and for at least 6 months after the end of treatment. If the patient becomes pregnant during treatment with Carbomedac, they should discuss with their doctor the possibility of genetic counseling, as Carbomedac may cause harm to the unborn child. Breastfeeding It is not known whether carboplatin passes into breast milk, so breastfeeding should not be done during treatment with Carbomedac. If the doctor considers it essential to use Carbomedac, breastfeeding should be stopped. Fertility Carbomedac may cause genetic damage, such as mutation of sperm cells. It is recommended that men treated with carboplatin refrain from procreation during treatment and for at least 3 months after the end of treatment and seek advice on sperm freezing, due to the possibility of irreversible infertility associated with treatment.

Driving and using machines

Carboplatin may cause nausea, vomiting, and disturbances of vision and hearing, which may reduce the patient's ability to drive and use machines. If the patient experiences any of these symptoms, they should not drive or operate machinery.

3. How to use Carbomedac

The doctor will always administer the injection to the patient. The medicine is usually given as an intravenous infusion, which lasts from 15 to 60 minutes. If the patient needs additional information, they should ask their doctor. The dose given to the patient depends on their body weight and height, blood test results, and kidney function tests. The doctor will determine the dose suitable for the patient. Before administration, the medicine must be diluted.

Use in adults

The recommended dose is 400 mg/m² body surface area (calculated based on height and weight).

Kidney problems

If the patient has kidney disease, the doctor may reduce the dose and order frequent blood tests and monitoring of kidney function. During treatment with Carbomedac, the patient may experience nausea or vomiting. The doctor may give the patient another medicine to reduce the likelihood of such side effects before administering Carbomedac. Between consecutive administrations of Carbomedac, a four-week interval is usually used. Every week after administration of Carbomedac, the doctor may perform blood tests on the patient to determine the next suitable dose.

Overdose of Carbomedac

Overdose of Carbomedac is unlikely. However, if an overdose occurs, it may cause myelosuppression (the bone marrow may not be able to produce new blood cells). This may lead to easy bruising. Kidney and liver function disturbances, as well as hearing problems, may also occur. If the patient is concerned that they have received too much medicine or has questions about the dose, they should ask their doctor.

Missed dose of Carbomedac

It is unlikely that a dose will be missed, as the doctor follows standard procedures when administering the medicine to the patient. If the patient thinks that a dose has been missed, they should talk to their doctor.

Stopping treatment with Carbomedac

The doctor usually decides when to stop treatment with Carbomedac. If the patient has any further questions about using this medicine, they should ask their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Carbomedac can cause side effects, although not everybody gets them.

Important side effects or symptoms to look out for – and what to do if they occur

If the patient thinks they have experienced any of the following side effects or symptoms, they should contact their doctor immediately.

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

• decrease in white blood cell count (which can lead to infections)
• decrease in red blood cell count, which can cause pale skin, weakness, or shortness of breath (anemia)
• decrease in platelet count (which can increase the risk of bleeding or bruising)

Common (may affect up to 1 in 10 people)

• infections (possible symptoms of infection include sore throat, fever, chills)
• unusual bleeding or bruising (e.g., bleeding from the gums, blood in urine or vomit, or unexpected bruising or bleeding)
• allergic reactions, including rash, redness, hives, itching, and high temperature
• severe allergic reactions (anaphylaxis). The occurrence of this type of reaction is most likely within a few minutes of receiving Carbomedac. Symptoms of severe allergic reaction include sudden breathing problems or feeling of tightness in the chest, swelling of the eyelids, face, or lips, rash, itching, and high temperature
• weakness of deep tendon reflexes (reflex contraction of muscles when the tendon is struck)
• abnormal skin sensations, such as tingling and numbness
• vision disturbances
• hearing loss (ototoxicity), e.g., ringing in the ears, hearing loss
• cardiovascular disorders (side effects related to the circulatory system)
• lung disease
• severe lung disease with accompanying shortness of breath, difficulty breathing, and (or) scarring in the lungs (interstitial lung disease)
• difficulty breathing or wheezing

Uncommon (may affect up to 1 in 100 people)

• symptoms from the central nervous system, often related to the medicine used to prevent nausea and vomiting
• fever and chills without confirmed infection

Rare (may affect up to 1 in 1000 people)

• loss of vision
• feeling unwell with accompanying fever caused by a low white blood cell count (febrile neutropenia)
• severe, life-threatening infection of the body and blood with organ dysfunction, commonly known as blood poisoning (sepsis/septic shock)
• skin peeling

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

• stroke, optic neuritis
• heart failure
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome
• arterial blockage (embolism)
• redness, swelling, and pain or dead skin at the injection site (injection site reactions)
• leakage into the tissue around the injection site (infiltration at the injection site)
• a group of symptoms such as headaches, impaired mental function, seizures, and vision disturbances, including blurred vision or loss of vision (symptoms of reversible posterior leukoencephalopathy syndrome - a rare neurological disorder)
• brain damage caused by a toxic substance or infection (encephalopathy)
• pancreatitis

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, PL-02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Carbomedac

The medicine should be stored out of sight and reach of children. The patient will not store the medicine. The medicine will be prepared just before administration to the patient. There are no special precautions for storage of this medicine during administration. The doctor or pharmacist is responsible for ensuring that the patient is not given Carbomedac after the expiry date stated on the label after "Expiry date" or "EXP". The expiry date refers to the last day of the month stated. The doctor or pharmacist is responsible for ensuring that the vial is stored in the outer packaging to protect it from light at a temperature below 25°C. The medicine should not be frozen. After mixing with other solutions, the solution should be used immediately or may be stored for no longer than 24 hours at 2°C - 8°C. The doctor or pharmacist will ensure that these storage conditions are met. Medicines should not be disposed of via wastewater or household waste. The doctor or pharmacist will dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Carbomedac contains

• The active substance is carboplatin.
• The other ingredient is water for injections.

What Carbomedac looks like and contents of the pack

Carbomedac is a colorless or pale yellow clear concentrate for solution for infusion. One ml of concentrate contains 10 mg of carboplatin. One vial of 5 ml contains 50 mg of carboplatin. One vial of 15 ml contains 150 mg of carboplatin. One vial of 45 ml contains 450 mg of carboplatin. One vial of 60 ml contains 600 mg of carboplatin. One vial of 100 ml contains 1,000 mg of carboplatin. The pack contains 1 or 10 vials. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6 22880 Wedel Germany Phone: +49 4103 8006-0 Fax: +49 4103 8006-100

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

Denmark Carbomedac France Carboplatine medac 10 mg/mL solution à diluer pour perfusion Germany Carbomedac 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung Norway Carbomedac 10 mg/ml konsentrat til infusjonsvæske, oppløsning Poland Carbomedac Slovakia Carbomedac 10 mg/ml koncentrát na infúzny roztok Slovenia Karboplatin medac 10 mg/ml koncentrat za raztopino za infundiranje Sweden Carbomedac 10 mg/ml koncentrat till infusionsvätska, lösning Italy Carboplatino medac

Date of last revision of the leaflet: 07/2023.

------------------------------------------------------------------------------------------------------------------------- Information intended for healthcare professionals only: Preparation of the medicine Carboplatin is a mutagenic and potentially carcinogenic substance. During preparation and administration, precautions should be taken as indicated when handling hazardous substances. The medicine should be prepared by trained personnel, wearing appropriate protective gloves, disposable gowns, and masks. Carboplatin should not be administered using administration sets, syringes, and injection needles that contain aluminum parts, as carboplatin reacts with aluminum. This may lead to precipitation and reduced antitumor effect. Shelf-life after opening of the container and preparation of the ready-to-use infusion solution The ready-to-use infusion solution has been shown to be chemically and physically stable in 5% glucose solution for infusion (50 mg/ml) for 72 hours at room temperature and in 0.9% sodium chloride solution for infusion (9 mg/ml) for 24 hours at a temperature of 2°C to 8°C, provided it is protected from light. However, it is recommended to use the infusion solution reconstituted in 0.9% sodium chloride solution for infusion (9 mg/ml) immediately after preparation. From a microbiological point of view, the product should be used immediately. If the preparation is not used immediately, the user is responsible for the further storage conditions and storage time before use, which should not normally exceed 24 hours at 2°C to 8°C, unless the reconstitution/dilution has been performed under controlled and validated aseptic conditions. Dilution The product should be diluted with 5% glucose solution for infusion (50 mg/ml) to a concentration of 0.4 mg/ml to 2 mg/ml or 0.9% sodium chloride solution for infusion (9 mg/ml) to a concentration of 2 mg/ml. Disposal Any unused medicinal product or waste material should be disposed of in accordance with local requirements.