CARBOPLATIN TEVA 10 mg/ml CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before you use Carboplatin Teva

Do not use Carboplatin Teva

• if you are allergic to carboplatin or any of the other ingredients of this medicine (listed in section 6) or to other platinum-containing compounds.
• if you are breast-feeding.
• if you have severe kidney problems.
• if you have any bone marrow problems.
• if you have a bleeding tumor.
• if you are going to receive the yellow fever vaccine or have received it.

Warnings and precautions

Tell your doctor before starting treatment with Carboplatin:

• if you have ever had an allergic reaction to platinum-containing medicines, such as cisplatin or oxaliplatin (see “Do not use Carboplatin Teva”).
• if you are elderly (over 65 years old)

Other precautions while being treated with Carboplatin Teva

• You will need to have regular checks of your nervous system.
• • Your doctor may order blood or urine tests to check the composition of your blood, kidney or liver function before, during, and after treatment with Carboplatin Teva. This is necessary to continue treatment.
  • Your doctor may prescribe anti-emetic medicines to prevent nausea and vomiting.

• Good oral hygiene (frequent mouth rinsing and effective tooth brushing with a soft brush 2-3 times a day) can help prevent the development of mouth ulcers.
• During treatment with carboplatin, you will be given medicines that help reduce a potentially life-threatening complication known as tumor lysis syndrome, caused by chemical changes in the blood due to the breakdown of dying cancer cells releasing their contents into the bloodstream.
• If you experience headache, altered mental function, seizures, and abnormal vision, from blurred vision to loss of vision, consult your doctor
• If you experience extreme fatigue with a decrease in the number of red blood cells, and difficulty breathing (hemolytic anemia), alone or combined with a low platelet count, abnormal bruising (thrombocytopenia), and kidney disease if you urinate little or not at all (symptoms of hemolytic-uremic syndrome), consult your doctor.
• If you have a fever (temperature above or equal to 38°C), or chills, which could be signs of infection, consult your doctor immediately. You may be at risk of contracting a blood infection.

Using Carboplatin Teva with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used, or might take/use any other medicines that may interact with carboplatin, such as:

• Anticoagulant medicines such as warfarin. It is necessary to increase the frequency of blood coagulation monitoring.
• Live or live-attenuated vaccines (for yellow fever vaccine see section 2 “Do not use Carboplatin Teva”)
• Any medicine that has a side effect of decreasing blood cells, such as clozapine, as this effect may be more severe if carboplatin is used in combination with these medicines.
• Medicines that damage both kidneys and ears, such as
• Capreomycin, an antibiotic used to treat tuberculosis
• Aminoglycoside antibioticssuch as gentamicin, streptomycin
• Polymyxin antibiotics, such as colistin
• Diureticssuch as bumetanide or furosemide

Carboplatin may increase the toxic effects of medicines. The combination of carboplatin with these medicines should be avoided.

• Phenytoin and fosphenytoin(used to treat various types of seizures and attacks), as it may decrease the level of this medicine in the blood when used in combination with carboplatin; this may cause the appearance of attacks. A dose increase of phenytoin may be necessary.
• Other medicines that decrease the activity of the immune system (e.g., cyclosporine, tacrolimus, sirolimus).
• Chelating medicines (medicines that bind to carboplatin and thereby decrease the effect of carboplatin).

Pregnancy, breast-feeding, and fertility

Pregnancy

• Carboplatin should not be used during pregnancy, unless your doctor advises you to do so, due to the possible risk of fetal abnormalities.
• • If you become pregnant or think you may be pregnant during treatment, you must inform your doctor immediately. If you are pregnant or become pregnant during treatment, you will be provided with genetic counseling.

• Female patientsshould use an effective contraceptive method, such as barrier methods or condoms, to avoid becoming pregnant during treatment and for 6 months after the end of treatment with carboplatin.

• Male patientsundergoing treatment with carboplatin should take adequate contraceptive measures to ensure that their partner does not become pregnant during treatment and for 6 months after the end of treatment.

Breast-feeding

You must not breast-feed your child during treatment with carboplatin.

Fertility

Both male and female patients who are planning to have a child after treatment should discuss this with their doctor. Male patients should seek advice on sperm preservation before treatment due to the possibility of irreversible anti-fertility effects.

Driving and using machines

Carboplatin may cause nausea or vomiting. Do not drive or use machines until you are sure that it has not affected you.

3. How to use Carboplatin Teva

• Carboplatin should only be administered by specialized doctors.
• Carboplatin will be diluted and then administered only by intravenous infusion (in a vein).
• You will have regular tests to monitor your disease.
• There is usually an interval of 4 weeks between each dose of carboplatin.

The recommended dose is:

• Adults

400 mg/m² administered by intravenous infusion (in a vein) over a period of 15 to 60 minutes.

• Elderly patients

In elderly patients (over 65 years old), a dose adjustment may be necessary depending on their physical condition.

• If you have received previous treatment or have kidney problems

Your dose will be adjusted to the appropriate dose for you.

• Children and adolescents

The use of carboplatin is not recommended in children and adolescents.

If you use more Carboplatin Teva than you should

There is no specific antidote for carboplatin overdose. If you receive too much carboplatin, your doctor will stop treatment and treat the symptoms.

In case of overdose or accidental ingestion, contact the Toxicology Information Service (91) 562 04 20; or consult your doctor as soon as possible after ingestion of the medicine or contact the Emergency Department of the nearest hospital.

If you forget to use Carboplatin Teva

Your doctor will decide when you will receive this medicine. If you think you have missed a dose, contact your doctor as soon as possible.

4. Possible side effects

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

If you experience any of the following serious side effects, tell your doctor immediately, or seek urgent medical attention:

• Abnormal bruising, bleeding, or signs of infection such as sore throat and high temperature
• Severe allergic reactions: swelling of the lips, face, mouth, or throat that causes severe breathing difficulties, skin rash, or hives; swelling of hands, feet, and ankles.
• Chest pain that may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Other side effects:

Very common: may affect more than 1 in 10 people

• Decrease in the number of platelets associated with bruising and abnormal bleeding (thrombocytopenia), decrease in the number of white blood cells associated with an increased risk of infection (leucopenia, neutropenia), decrease in the number of red blood cells (anemia: which can cause fatigue).
• Nausea, abdominal pain, vomiting.
• Kidney toxicity
• Exceptionally high levels of uric acid in the blood (hyperuricemia),
• Abnormal liver function test values
• Changes in blood chemistry (decrease in sodium, potassium, calcium, and magnesium levels in the blood).

Common: may affect up to 1 in 10 people

• Signs of infection such as fever and sore throat
• Bleeding complications (hemorrhages)

• Allergic reactions such as rash, fever without apparent cause, and itching

• A disorder of the nerves (peripheral neuropathy). You may feel tingling and/or numbness in the fingers of the hands, fingers of the feet, around the mouth, or in the throat, which may occur along with cramps. These effects are often caused by exposure to cold, for example, when opening the refrigerator or holding a cold drink. You may also have difficulty performing delicate tasks, such as buttoning your clothes
• Sensation of tingling, pinching, or numbness in the skin without apparent physical cause (paresthesia), decreased tendon reflexes
• Altered taste
• Temporary worsening of vision or changes in vision, loss of vision

• Hearing loss, hearing problems.
• Heart disorders
• Chest pressure or wheezing, chest pressure caused by muscle spasms in the respiratory tract (bronchospasm)

• Interstitial lung disease (a group of lung disorders in which the deep lung tissue becomes inflamed)
• Diarrhea, constipation
• Pain in the lips or mouth ulcers (mucosal disorders)
• Kidney or urine problems

• Hair loss (alopecia)
• Skin rash and/or itching
• Pain or discomfort in bones, joints, muscles, or adjacent structures (musculoskeletal disorders)
• Extreme fatigue (asthenia)
• Increased levels of bilirubin and creatinine in the blood
• Increased levels of uric acid in the blood, which can lead to gout.

• Not known (cannot be estimated from the available data)

• Lung infection (pneumonia)
• Secondary malignant processes (cancerous tumors that spread from their original location to establish secondary tumors in other parts of the body)
• Decreased bone marrow function; reduction in the number of white blood cells accompanied by fever (febrile neutropenia); disease characterized by the abnormal breakdown of red blood cells, kidney failure, and a reduced number of platelets (hemolytic-uremic syndrome)
• Dry mouth, fatigue, and headache due to excessive water loss (dehydration), loss of appetite (anorexia)
• Decreased sodium levels in the blood (hyponatremia)
• Stroke
• A set of symptoms such as headache, altered mental function, seizures, and abnormal vision, from blurred vision to loss of vision (symptoms of posterior reversible leukoencephalopathy syndrome, a rare neurological disorder)
• Heart failure, blockage of blood vessels (embolism), high blood pressure, low blood pressure
• Pain in the mouth or throat, with inflammation, redness, or swelling of the mouth or throat (stomatitis)
• Pancreatitis
• Skin disorders such as hives, rash, redness of the skin (erythema), and itching
• Muscle cramps, muscle weakness, confusion, vision changes or loss, irregular heartbeats, kidney failure, or abnormal blood test results (symptoms of tumor lysis syndrome that may be caused by the rapid breakdown of dying cancer cells) (see section 2).
• Reactions at the injection site such as pain, redness, swelling, hives, or skin necrosis.
• General malaise, fever, and chills.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System Website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Carboplatin Teva

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C. Store the container in the outer packaging

After dilution in 0.9% sodium chloride solution or 5% glucose solution, storage should be restricted to 3 hours when stored at room temperature protected from light or 24 hours when stored at 2°C - 8°C if the dilution is performed under validated aseptic conditions. The storage time refers to the time until the start of administration of the medicine.

Use the product only if the solution is clear and colorless or pale yellow, without fibers and without foreign particles

Once opened, any unused solution should be discarded using the appropriate precautions. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Carboplatin Teva

• The active ingredient of this medicinal product is carboplatin. Each ml of concentrate contains 10 mg of carboplatin.
• The other ingredients are mannitol and water for injection.

Appearance and Container Contents of the Product

The concentrate for solution for infusion of carboplatin is a clear, colorless to pale yellow solution, free from particles.

The medicinal product is available in containers containing a single vial of 5 ml, 15 ml, 45 ml or 60 ml, and in containers containing 10 vials of 5 ml and 10 vials of 15 ml.

Each 5 ml vial contains 50 mg of the active ingredient carboplatin.

Each 15 ml vial contains 150 mg of the active ingredient carboplatin.

Each 45 ml vial contains 450 mg of the active ingredient carboplatin.

Each 60 ml vial contains 600 mg of the active ingredient carboplatin.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid

Spain

Manufacturer

Pharmachemie B.V.

2031 GA Haarlem

Netherlands

Or

TEVA PHARMA B.V.

Industrieweg 23, P.O. Box 217 (Michdrecht)

Netherlands

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

Germany: Carboplatin-Gry 10mg/ml

Italy: Carboplatino Teva 10 mg/ml

Spain: Carboplatino Teva 10 mg/ml concentrate for solution for infusion

United Kingdom (Northern Ireland): Carboplatin 10 mg/ml Concentrate for Infusion

Date of the last revision of this leaflet: March 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals

Carboplatin Teva 10 mg/ml concentrate for solution for infusion

In addition to the information included in section 3, practical information on the preparation/handling of the medicinal product is provided here.

Incompatibilities

This medicinal product must not be mixed with other medicinal products except glucose 5% for injection or sodium chloride 0.9% for injection.

This medicinal product must not be used with infusion sets containing aluminum, syringes, and injection needles. The antineoplastic activity may be reduced.

Handling

The infusion solution should be inspected visually for particles before use.

Guidelines for the safe handling of antineoplastic agents:

1. The medicinal product should be handled by trained personnel.
2. This should be done in a designated area
3. Appropriate protective gloves should be used
4. Precautions should be taken to avoid accidental contact of the medicinal product with the eyes. In case of contact with the eyes, rinse with water and/or saline solution.
5. Cytotoxic preparations should not be handled by pregnant women.
6. Care should be taken and adequate precautions should be taken in the disposal of materials (syringes, needles, etc.) used to reconstitute cytotoxic medicinal products. Residual materials and body waste can be disposed of by placing them in polyethylene bags with double sealing and incinerating at a temperature of 1000 °C. Liquid waste can be disposed of by rinsing with a large amount of water.

Dilution

1. The work surface should be covered with absorbent paper with a disposable plastic lining.
2. Luer-Lock type closure accessories should be used on syringes and other materials. The use of large-caliber needles is recommended to reduce pressure and possible aerosol formation. The latter can also be reduced using a vented needle.

The medicinal product can be diluted with glucose 5% for injection or sodium chloride 0.9% for injection to achieve concentrations as low as 0.5 mg/ml (500 micrograms/ml).

Method of Administration

This product should only be administered by the intravenous route. The infusion solution is administered by infusion over a short period (15 to 60 minutes).

Special Precautions for Storage

When diluted as instructed, carboplatin solutions should be used within three hours of storage at room temperature (15 °C - 25 °C) protected from light or within 24 hours when stored at 2 °C - 8 °C if the dilution is carried out under validated aseptic conditions. As the formulation does not contain antibacterial preservatives, it is recommended to discard any carboplatin solution three hours after dilution if stored at room temperature protected from light or after 24 hours if stored under refrigeration conditions. This product is for single use only.