Carboplatin Teva 10 mg/ml concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Carboplatin Teva 10 mg/ml concentrate for solution for infusion

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse, even if it is not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Carboplatino Teva is and what it is used for

Carboplatin is a platinum-containing compound. It is an anticancer medication used alone or in combination with other drugs.

Carboplatin is used for ovarian cancer and lung cancer.

Ask your doctor or nurse if you need further information.

2. What you need to know before using Carboplatino Teva

Do not use Carboplatino Teva

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

Warnings and precautions

Talk to your doctor before starting to use Carboplatino Teva:

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

Other precautions during treatment with Carboplatino Teva

• You should have regular checks of your nervous system function.

• • Your doctor may order blood or urine tests to monitor your blood composition, kidney or liver function before, during, and after treatment with Carboplatino Teva. These tests are necessary to continue treatment.
  • Your doctor may prescribe antiemetic medicines to prevent nausea and vomiting.

• Good oral hygiene (rinsing the mouth frequently and effective tooth brushing with a soft toothbrush 2–3 times a day) may help prevent the development of mouth ulcers.

• During treatment with carboplatin, you will be given medicines to help reduce a potentially life-threatening complication known as tumor lysis syndrome, which is 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, or abnormal vision—ranging from blurred vision to vision loss—consult your doctor.

• If you experience extreme fatigue with reduced red blood cell count and difficulty breathing (hemolytic anemia), alone or combined with low platelet count, abnormal bruising (thrombocytopenia), and kidney disease such as reduced or no urine output (symptoms of hemolytic-uremic syndrome), consult your doctor.

• If you develop fever (temperature greater than or equal to 38°C) or chills, which could be signs of infection, consult your doctor immediately. You may be at risk of developing a blood infection.

Use of Carboplatino Teva with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines that could interact with carboplatin, for example:

• 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 Carboplatino Teva”).
• Any medicine that has the side effect of reducing blood cells, such as clozapine, since this effect may be more severe when carboplatin is used in combination with these medicines.
• Medicines that damage both the kidneys and ears, for example:
  • Capreomycin, an antibiotic used to treat tuberculosis
  • Aminoglycoside antibiotics such as gentamicin, streptomycin
  • Polymyxin antibiotics, such as colistin
  • Diuretics such as bumetanide or furosemide

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

• Phenytoin and fosphenytoin (used to treat various types of seizures and convulsions), as their blood levels may decrease when used in combination with carboplatin; this could lead to the occurrence of seizures. An increase in phenytoin dosage may be necessary.
• Other medicines that reduce the activity of the immune system (e.g., cyclosporine, tacrolimus, sirolimus).
• Chelating medicines (medicines that bind to carboplatin and thereby reduce its effect).

Pregnancy, breastfeeding, and fertility

Pregnancy

• Carboplatin must not be used during pregnancy unless specifically indicated by your doctor due to the potential risk of fetal abnormalities.

  • If you become pregnant during treatment or think you might be pregnant, inform your doctor immediately. If you are pregnant or become pregnant during treatment, you should be offered genetic counseling.

• Female patients must use an effective method of contraception, such as barrier methods or condoms, to avoid becoming pregnant during treatment and for 6 months after completion of carboplatin treatment.

• Male patients receiving carboplatin must take appropriate contraceptive measures to ensure their partner does not become pregnant during treatment and for 6 months after treatment ends.

Breastfeeding

You must not breastfeed during treatment with carboplatin.

Fertility

Both male and female patients who are considering having children after treatment should discuss this with their doctor. Male patients should seek advice on sperm preservation before treatment due to the possibility of irreversible antifertility effects.

Driving and use of machines

Carboplatin may cause nausea or vomiting. Do not drive or operate machinery until you are certain that it does not affect you.

3. How to use Carboplatino Teva

• Carboplatin should only be administered by specialist physicians.
• Carboplatin will be diluted and then administered intravenously (into the vein) only.
• You will have regular blood tests to monitor your condition.
• There is normally a 4-week interval between each dose of carboplatin.

The recommended dose is:

• Adults

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

• Elderly patients

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

• If you have received prior treatment or have kidney problems

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

• Children and adolescents

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

If you use more Carboplatino Teva than you should

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

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

If you forget to use Carboplatino Teva

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

4. Possible adverse effects

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

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

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

Other adverse effects:

Very common: may affect more than 1 in 10 people

• Decrease in platelet count associated with bruising and abnormal bleeding (thrombocytopenia), decrease in white blood cell count associated with increased risk of infection (leukopenia, neutropenia), decrease in red blood cells (anemia: which may cause tiredness)
• Nausea, abdominal pain, vomiting
• Kidney toxicity
• Exceptionally high concentration of uric acid in the blood (hyperuricemia)
• Abnormal liver function test results
• Changes in blood chemistry (decreased levels of sodium, potassium, calcium, and magnesium 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 nerve disorder (peripheral neuropathy). You may feel tingling and/or numbness in the fingers of the hands, toes, around the mouth, or in the throat, which may occur along with cramps. These effects are frequently triggered by exposure to cold, for example when opening a refrigerator or holding a cold drink. You may also have difficulty performing delicate tasks, such as buttoning clothes

• Tingling, prickling, or numbness of 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 tightness or wheezing, chest tightness caused by muscle spasms in the respiratory tract (bronchospasm)

• Interstitial lung disease (a group of lung disorders in which deep lung tissue becomes inflamed)

• Diarrhea, constipation

• Pain in the lips or mouth ulcers (mucosal disorders)

• Problems with your kidneys or urine

• Hair loss (alopecia)

• Skin rash and/or itching

• Pain or discomfort in bones, joints, muscles, or adjacent structures (musculoskeletal disorders)

• Extreme tiredness (asthenia)

• Increased levels of bilirubin and creatinine in the blood

• Increased level of uric acid in the blood, which may lead to gout

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

• Lung infection (pneumonia)

• Secondary malignant processes (cancerous tumors spreading from their original site to form secondary tumors elsewhere in the body)

• Decreased bone marrow function; reduced white blood cell count accompanied by fever (febrile neutropenia); a condition characterized by abnormal breakdown of red blood cells, kidney failure, and low platelet count (hemolytic uremic syndrome)

• Dry mouth, tiredness, and headache due to excessive loss of body water (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 ranging from blurred vision to vision loss (symptoms of posterior reversible encephalopathy 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, red or swollen mouth, or ulcers in the mouth or throat (stomatitis)

• Pancreatitis

• Skin disorders such as hives, rash, redness of the skin (erythema), and itching

• Muscle cramps, muscle weakness, confusion, visual disturbances or loss of vision, irregular heartbeat, kidney failure, or abnormal blood test results (symptoms of tumor lysis syndrome, which may be caused by the rapid breakdown of tumor cells) (see section 2)

• Reactions at the injection site such as pain, redness, swelling, hives, skin necrosis

• General malaise, fever, and chills

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Carboplatin Teva

Keep out of sight and reach of children.

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

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

After dilution in 0.9% sodium chloride solution or 5% glucose solution, storage should be limited to three hours when stored at room temperature protected from light, or to 24 hours when stored at 2 °C – 8 °C, provided the dilution is carried out under validated aseptic conditions. The storage period refers to the time up to the start of drug administration.

Use the product only if the solution is clear and colourless or pale yellow, free from fibres and foreign particulate matter.

After opening, any unused solution must be discarded using appropriate precautions. This will help protect the environment.

6. Contents of the container and other information

Composition of Carboplatino Teva

• The active substance in this medicine is carboplatin. Each ml of concentrate contains 10 mg of carboplatin.
• The other components are mannitol and water for injection.

Appearance of the product and contents of the container

Carboplatin concentrate for infusion solution is a clear, colourless to pale yellow solution, free from particles.

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

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

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

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Spain

Manufacturer

Pharmachemie B.V.

2031 GA Haarlem

The Netherlands

Or

TEVA PHARMA B.V.

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

The Netherlands

This medicine is authorized in the European Economic Area (EEA) Member States 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 infusion solution

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

Date of the most recent review of this summary: March 2024

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

This information is intended for healthcare professionals only

Carboplatino Teva 10 mg/ml concentrate for infusion solution

In addition to the information included in section 3, the following practical information on preparation/handling of the medicine is provided.

Incompatibilities

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

This medicine must not be used with infusion sets containing aluminium, or with syringes and injection needles. The antineoplastic activity may be reduced.

Handling

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

Guidelines for safe handling of antineoplastic agents:

1. The medicine must be handled by trained personnel.
2. This must be carried out in a designated area.
3. Appropriate protective gloves must be worn.
4. Precautions must be taken to avoid accidental contact of the medicine with the eyes. In case of eye contact, wash thoroughly with water and/or saline solution.
5. Cytotoxic preparations must not be handled by pregnant women.
6. Care must be taken and appropriate precautions taken when disposing of materials (syringes, needles, etc.) used to reconstitute cytotoxic medicines. Leftover materials and body waste may be disposed of by placing them in double-sealed polyethylene bags and incinerating at a temperature of 1,000 °C. Liquid waste may be disposed of by rinsing with a large amount of water.

Dilution

1. The work surface must be covered with absorbent paper lined with disposable plastic.
2. Luer-Lock locking fittings must be used with syringes and other materials. Use of large-bore needles is recommended to reduce pressure and the potential for aerosol formation. Aerosols may also be minimized by using a vented needle.

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

Method of administration

This product must only be administered intravenously. The infusion solution is administered by infusion over a short period of time (15 to 60 minutes).

Special precautions for storage

When diluted as instructed, carboplatin solutions must be used within three hours when stored at room temperature (15 °C–25 °C), protected from light, or within 24 hours when stored at 2 °C–8 °C, provided the dilution is performed under validated aseptic conditions. Since the formulation contains no antibacterial preservatives, it is recommended that any carboplatin solution be discarded three hours after dilution if stored at room temperature protected from light, or 24 hours after dilution if stored under refrigerated conditions. This product is for single-dose use only.