Carboplatin-ebeve

Package Leaflet: Information for the Patient

Carboplatin-Ebewe, 10 mg/ml, Concentrate for Solution for Infusion

Carboplatin

Read All of This Leaflet Carefully Before You Start Using This Medicine Because It Contains Important Information for You.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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 is Carboplatin-Ebewe and What is it Used For
• 2. Before You Use Carboplatin-Ebewe
• 3. How to Use Carboplatin-Ebewe
• 4. Possible Side Effects
• 5. How to Store Carboplatin-Ebewe
• 6. Contents of the Pack and Other Information

1. What is Carboplatin-Ebewe and What is it Used For

Carboplatin is used to treat advanced ovarian cancer of epithelial origin as a first-line treatment or when other treatments have been ineffective, and to treat small cell lung cancer.

2. Before You Use Carboplatin-Ebewe

When Not to Use Carboplatin-Ebewe

• if you are allergic to carboplatin or other platinum-containing medicines;
• in patients with severe bone marrow suppression;
• in patients with severe kidney failure (unless the doctor considers the use of the medicine necessary);
• in patients with bleeding tumors;
• in patients with hearing disorders;
• in patients vaccinated against yellow fever at the same time;
• in pregnant or breastfeeding women.

Warnings and Precautions

Before using Carboplatin-Ebewe, you should discuss it with your doctor. Carboplatin should only be used under the supervision of a doctor with experience in the use of cancer chemotherapy, in specialized departments, under conditions that ensure adequate monitoring and observation of the patient. The use of carboplatin may cause kidney function disorders. Both before treatment with carboplatin and during its administration, the doctor will order tests to assess kidney and liver function. The doctor will also order regular neurological tests and tests to assess hearing. Due to the possibility of a decrease in platelet count - thrombocytopenia (especially in elderly patients), white blood cell count (leukopenia), and red blood cell count (anemia), the doctor will recommend regular blood tests during treatment with carboplatin (during the first course of treatment, once a week) and after its completion. If you have a fever (temperature 38°C or higher) or chills, which may indicate an infection, you should immediately inform your doctor, as there is a possible risk of developing a blood infection. In patients with severe bone marrow suppression, blood transfusions may be necessary, especially during combined therapy with other medicines with a similar effect on the bone marrow. The simultaneous use of carboplatin and chemotherapy in these patients may lead to infectious complications, including death. If you experience severe fatigue and shortness of breath with a decrease in red blood cell count (symptoms of hemolytic anemia) and/or a decrease in platelet count, abnormal bruising, and kidney disease, in which the patient urinates very little or not at all (symptoms of hemolytic-uremic syndrome), you should immediately inform your doctor. Carboplatin-Ebewe may cause allergic reactions, even life-threatening ones. If you experience shortness of breath, rash, rapid heartbeat, facial swelling, you should immediately contact your doctor or nurse. Carboplatin-Ebewe, especially when used in high doses, may cause vision and/or hearing disorders. All symptoms of vision or hearing disorders observed during treatment should be immediately reported to your doctor or nurse. If you experience headaches, mental disorders, seizures, and vision disturbances (from blurred vision to loss of vision), you should tell your doctor. If you plan to undergo any vaccination, you must inform your doctor before receiving Carboplatin-Ebewe. Live vaccines given to patients with impaired immunity due to chemotherapy may cause severe infections. It has been found that the use of anti-emetic drugs before carboplatin treatment reduces the frequency and severity of nausea and vomiting. During carboplatin treatment, drugs will be given to help reduce the likelihood of a life-threatening complication known as tumor lysis syndrome, caused by biochemical disorders in the blood caused by the breakdown of dying cancer cells, which release their contents into the bloodstream. Impact on fertility, see section "Pregnancy, Breastfeeding, and Fertility".

Carboplatin-Ebewe and Other Medicines

You should tell your doctor or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take. It is especially important to inform your doctor about radiation therapy and the use of the following medicines:

• anticoagulant medicines (blood thinners)
• antiepileptic medicines (such as phenytoin)
• other medicines that suppress bone marrow function
• medicines that suppress the immune system (such as cyclosporine, tacrolimus, sirolimus)
• aminoglycoside antibiotics
• diuretics.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor, pharmacist, or nurse for advice before using this medicine. You should not use Carboplatin-Ebewe during pregnancy unless your doctor has explicitly recommended it. Animal studies have shown a possible risk of fetal abnormalities. If you are treated with carboplatin during pregnancy, you should discuss the possible risk to your unborn child with your doctor. Women of childbearing potential must use effective contraceptive measures during carboplatin treatment and for at least 6 months after treatment. Due to the fact that carboplatin can cause genetic damage, genetic counseling is recommended in case of pregnancy during treatment with carboplatin. Genetic counseling is also recommended for patients who plan to have children after treatment. The use of Carboplatin-Ebewe during pregnancy and breastfeeding is contraindicated. Men are advised to use effective contraceptive methods and not to father a child during carboplatin treatment and for at least 3 months after treatment. Treatment with carboplatin may cause irreversible infertility, so men should consider the possibility of storing sperm.

Driving and Using Machines

Carboplatin may cause nausea, vomiting, vision and hearing disorders, and concentration disorders. Patients who experience any effects of the medicine that may adversely affect their ability to drive or operate machines should avoid these activities.

3. How to Use Carboplatin-Ebewe

Carboplatin-Ebewe can only be administered under the supervision of a specialist doctor in clinical oncology with experience in the use of anticancer chemotherapy. The duration of treatment and the daily dose of the medicine are determined by the attending physician. The duration of treatment depends on the patient's condition. The doctor will monitor the body's response to treatment, the patient's health, and the duration of therapy.

Use of a Higher Than Recommended Dose of Carboplatin-Ebewe

Expected overdose complications may be related to bone marrow suppression, liver, kidney, hearing, and vision disorders. If you think you have received a higher dose of the medicine than recommended, you should immediately tell your doctor or nurse.

4. Possible Side Effects

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

Allergic Reactions

You should immediately tell your doctor if you experience any symptoms that may indicate a severe allergic reaction and chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome. Very Common Side Effects(more than 1 in 10 people): decreased platelet count (thrombocytopenia), decreased neutrophil count (neutropenia), decreased white blood cell count (leukopenia), anemia, vomiting, nausea, abdominal pain, abnormal kidney function test results (decreased creatinine clearance), increased blood urea levels, increased alkaline phosphatase activity, increased AspAT activity, abnormal liver function test results, decreased sodium, potassium, calcium, magnesium levels in the blood. Common Side Effects(between 1 and 10 in 100 people): infections, bleeding, allergic reactions (including severe ones), peripheral neuropathy, tingling, weakened reflexes, sensory disturbances, taste disturbances, vision disturbances, hearing disturbances, cardiovascular disorders, respiratory disorders, interstitial lung disease, bronchospasm, diarrhea, constipation, mucosal disorders, hair loss, skin disorders, musculoskeletal disorders, genitourinary disorders, weakness, increased bilirubin, creatinine, uric acid levels in the blood. Side Effects with Unknown Frequency(which cannot be estimated from available data): secondary tumors, bone marrow failure, febrile neutropenia, hemolytic-uremic syndrome, dehydration, anorexia, hyponatremia, stroke, heart failure, embolism, hypertension, hypotension, a group of symptoms such as headache, mental disorders, seizures, and vision disturbances (from blurred vision to loss of vision), you should tell your doctor (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder), pancreatitis, pneumonia, oral mucositis, hives, rash, flushing, itching, necrosis at the injection site, reaction at the injection site, extravasation at the injection site, redness at the injection site, malaise, muscle spasms, muscle weakness, confusion, loss of vision or vision disturbances, irregular heartbeat, kidney failure or abnormal blood test results (symptoms of tumor lysis syndrome, which may be caused by rapid cancer cell death) (see section 2). Reporting Side Effects If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 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, you can help provide more information on the safety of this medicine.

5. How to Store Carboplatin-Ebewe

The medicine should be stored out of the sight and reach of children. Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of that month. The batch number on the packaging is marked as "Lot". Store below 25°C. Store in the original packaging to protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Carboplatin-Ebewe Contains

The active substance of the medicine is carboplatin. 1 ml of the concentrate contains 10 mg of carboplatin. A 5 ml vial contains 50 mg of carboplatin. A 15 ml vial contains 150 mg of carboplatin. A 45 ml vial contains 450 mg of carboplatin. A 60 ml vial contains 600 mg of carboplatin. A 100 ml vial contains 1000 mg of carboplatin. The other ingredient of the medicine is water for injections.

What Carboplatin-Ebewe Looks Like and Contents of the Pack

Carboplatin-Ebewe is a clear, colorless or almost colorless solution in a Type I glass vial with a halobutyl rubber stopper and an aluminum cap, in a cardboard box. The vials may be placed in protective packaging made of plastic (ONKO-Safe or Sleeving). Pack sizes: 1 vial containing 5 ml of concentrate for solution for infusion 1 vial containing 15 ml of concentrate for solution for infusion 1 vial containing 45 ml of concentrate for solution for infusion 1 vial containing 60 ml of concentrate for solution for infusion 1 vial containing 100 ml of concentrate for solution for infusion

Marketing Authorization Holder and Manufacturer

EBEWE Pharma Ges.m.b.H. Nfg. KG Mondseestrasse 11 A-4866 Unterach, Austria

Manufacturer

Fareva Unterach GmbH Mondseestraße 11 4866 Unterach, Austria For more detailed information, please contact: Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warszawa tel. +48 22 209 70 00 Date of Last Revision of the Leaflet:02/2025 <Company Logo >
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Information Intended for Healthcare Professionals Only:

The medicine is intended for intravenous administration only.

Information on Dosage

Previously untreated adult patients with normal kidney function receive carboplatin at a dose of 400 mg/m² body surface area as a short-term intravenous infusion (administered over 15 to 60 minutes). Subsequent cycles of therapy can be repeated after a 4-week interval and/or when the neutrophil count is at least 2000 cells/mm³ and the platelet count is at least 100,000 cells/mm³.

Bone Marrow Disorders

To adjust the dose, it is recommended to determine the maximum decrease in hematological parameters during carboplatin treatment. In patients who experience moderate or severe hematological toxicity, it is recommended to consider reducing the dose by 25% or discontinuing treatment - both in monotherapy and in combined treatment regimens. In patients with risk factors such as previous treatment that caused bone marrow suppression and/or radiation therapy, or poor general condition (2-4 on the Zubrod-ECOG scale or below 80 on the Karnofsky scale), the initial dose of the medicine should be reduced by 20-25% (to 300-320 mg/m²). In the initial courses of carboplatin treatment, it is recommended to perform weekly blood morphology tests to determine the lowest blood cell count (nadir) and adjust the dose in subsequent treatment cycles.

Kidney Function Disorders

In patients with creatinine clearance less than 60 ml/min, there is an increased risk of significant bone marrow suppression. The frequency of severe leukopenia, neutropenia, or thrombocytopenia was approximately 25% during the use of the recommended doses: There are insufficient data on the use of carboplatin in patients with creatinine clearance 15 ml/min or less to determine the recommended dosage. The above recommendations apply to the initial treatment cycle. Subsequent doses should be adjusted according to the patient's tolerance to treatment and acceptable level of myelosuppression. In patients with kidney function disorders, the dose of carboplatin should be reduced and adjusted according to the glomerular filtration rate. The recommended dosage in these patients depends on the creatinine clearance value and should be calculated using the Calvert formula, which takes into account the glomerular filtration rate (GFR in ml/min) measured in the patient and the target value of the area under the carboplatin concentration-time curve (AUC in mg/ml x min):

Note: Based on the Calvert formula, the total dose of carboplatin is calculated in mg, not in mg/m².

Combined Treatment

Carboplatin is used in combination with other anticancer medicines in dosages depending on the chosen treatment regimen. The dosage should be modified according to the adopted treatment regimen and laboratory blood test results. There are no specific recommendations for dosing in children due to the lack of sufficient data on the use of carboplatin in this age group. In patients over 65 years of age, it is necessary to adjust the dose of carboplatin during the initial and subsequent treatment cycles according to the patient's overall health.

Information on Storage of the Medicine After First Opening and After Dilution

After Opening The concentrate should be withdrawn from the vial immediately before use. From a microbiological point of view, the product should be used immediately. If it is not used immediately, the user is responsible for the storage conditions and storage time of the remaining product in the vial. The remaining product in the vial after the first withdrawal should not be stored for more than 24 hours at a temperature between 2°C and 8°C, unless the withdrawal was done under controlled, verified aseptic conditions. In this case, the concentrate stored in the refrigerator or at room temperature, protected from light, maintains its physicochemical stability for 28 days. After Dilution From a microbiological point of view, the product should be used immediately. If it is not used immediately, the user is responsible for the storage conditions and storage time of the prepared solution. The prepared solutions should not be stored for more than 24 hours at a temperature between 2°C and 8°C, unless the dilution was done under controlled, verified aseptic conditions. Physical and chemical stability has been demonstrated for 28 days for solutions with a concentration of 0.4 mg/ml and 4 mg/ml, diluted with 5% glucose solution, stored in the refrigerator (at a temperature between 2°C and 8°C) or at a temperature between 20°C and 25°C, protected from light. If the infusion solution is stored at room temperature without protection from light, it should be used immediately after preparation.

Instructions for Preparation of the Medicine for Administration and Disposal of Remaining Medicine

Carboplatin is administered after preparation of the infusion solution as a short-term intravenous infusion lasting 15 to 60 minutes. The concentrate can be diluted with 5% glucose solution to a concentration of 0.4 mg/ml (400 micrograms/ml). Due to the toxic properties of the substance, the following safety rules should be observed: preparation, administration, and disposal of the preparation can only be carried out by trained personnel, and as with all cytostatic medicines, caution should be exercised to avoid contact with the medicine, especially for pregnant women; pregnant women should not come into contact with cytotoxic agents; personnel preparing carboplatin should wear protective clothing: safety glasses, gowns, single-use gloves, and single-use masks; all equipment and materials used to prepare the medicine or clean the preparation area, including gloves, should be placed in hazardous waste bags and incinerated at high temperature (1000°C); chemical neutralization of the remaining solution involves dilution with a large amount of water and standing for 48 hours. In case of accidental contact with the skin, it should be rinsed with a large amount of water. You should contact your doctor. All materials used for cleaning should be disposed of as described above.

Incompatibilities

The preparation and administration of the medicinal product should not use needles or infusion sets containing aluminum parts that may come into contact with carboplatin. Aluminum reacts with carboplatin, causing its inactivation and/or precipitation.