Carboplatin Teva

Package leaflet: Information for the user

Carboplatino Teva 10 mg/ml concentrate for solution for infusion

carboplatin
Generic medicine
Please read this leaflet carefully before you are given this medicine because it
contains important information for you.

• Keep this leaflet. 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. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

Carboplatino Teva contains carboplatino, a platinum-containing compound. It is an anticancer agent used alone or in combination with other medicines.
Carboplatino Teva is used for the treatment of ovarian carcinoma and lung carcinoma.
Speak to your doctor or nurse if you need further information.

2. What you should know before being given Carboplatino Teva

Carboplatino Teva must not be administered to you 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;
• you are breastfeeding;
• you have severe kidney problems;
• you have any bone marrow disorder;
• you have a tumor that is bleeding;
• you are planning to receive a yellow fever vaccine, or have recently received one.

Warnings and precautions
Inform your doctor before being given Carboplatino Teva:

• if you have ever experienced an allergic reaction to platinum-containing medicines, such as cisplatin or oxaliplatin (see "Carboplatino Teva must not be administered to you if");
• if you are elderly (over 65 years of age).

Additional precautions while receiving Carboplatino Teva

• Your nervous system function will be monitored regularly.
• Your doctor may order blood and urine tests to monitor blood composition and kidney or liver function before, during, and after treatment with Carboplatino Teva. This is necessary to continue therapy.
• Your doctor may prescribe antiemetic medicines to prevent nausea and vomiting.
• Good oral hygiene (rinsing your mouth frequently and effective tooth cleaning with a soft toothbrush 2–3 times daily) may help prevent the development of mouth pain.
• During treatment with carboplatin, you will receive medications aimed at reducing the risk of a potentially life-threatening complication known as tumor lysis syndrome, caused by changes in blood chemistry due to the release of contents from dead tumor cells into the bloodstream following their breakdown.
• If you experience headache, altered mental function, seizures, or abnormal vision ranging from blurred vision to loss of vision, inform your doctor.
• If you develop extreme fatigue with a decrease in red blood cells and shortness of breath (hemolytic anemia), either alone or combined with a low platelet count, unusual bruising (thrombocytopenia), and kidney problems that may cause reduced or absent urine output (symptoms of hemolytic-uremic syndrome), inform your doctor.
• If you have fever (temperature greater than or equal to 38°C) or chills, which could be signs of infection, inform your doctor immediately. You may be at risk of developing a blood infection.

Other medicines and Carboplatino Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as some may interact with carboplatin, for example:

• Blood-thinning medicines. For example, warfarin. Increased frequency of blood coagulation monitoring is required.
• Live or live-attenuated vaccines (for yellow fever vaccine, see section 2 “Carboplatino Teva must not be administered to you if”).
• Any medicine that has the side effect of reducing blood cell counts, such as clozapine, because this effect may worsen when carboplatin is used in combination with these medicines.
• Any medicine that may damage the kidneys or inner ear, for example:
  • Capreomycin, an antibacterial medicine used to treat tuberculosis;
  • Aminoglycoside antibacterials, such as gentamicin, streptomycin;
  • Polymyxin antibiotics, such as colistin;
  • Diuretics, such as bumetanide or furosemide. Carboplatino Teva 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 epileptic fits), as blood levels of these medicines may decrease when used in combination with carboplatin; this may lead to recurrence of seizures. An increase in the dose of phenytoin may be necessary.
• Other medicines that suppress the immune system (e.g., cyclosporine, tacrolimus, sirolimus).
• Chelating agents (medicines that bind to carboplatin and thereby reduce its effect).

Pregnancy, breastfeeding, and fertility
Pregnancy

• Carboplatino Teva must not be administered to you if you are pregnant, unless clearly indicated by your doctor, due to the potential risk of fetal abnormalities.
• If you become pregnant or suspect you are pregnant during treatment, inform your doctor immediately. If you are pregnant or become pregnant during treatment, genetic counseling should be provided.
• Female patients must use an effective method of contraception, such as barrier methods or condoms, during treatment and for 6 months after completion of carboplatin treatment to avoid becoming pregnant.
• Male patients receiving carboplatin treatment must also take appropriate contraceptive precautions during treatment and for 3 months after completion of treatment to ensure their partners do not become pregnant.

Breastfeeding
You must not breastfeed during treatment with carboplatin.
Fertility
Patients of both sexes who are considering having children after treatment should discuss this with their doctor. Male patients should seek counseling about sperm preservation before treatment due to the possibility of irreversible infertility.
Driving and use of machines
Carboplatino Teva may cause discomfort or a feeling of discomfort. DO NOT drive or operate machinery until you are certain you do not experience these symptoms.

3. How to take Carboplatino Teva

• Carboplatino Teva may only be administered by a specifically qualified doctor.
• Carboplatino Teva will be diluted and then administered intravenously only (into the veins).
• You will have regular tests to monitor your condition.
• It is likely that 4 weeks will pass between one carboplatin dose and the next.

The recommended dose is:

• Adults 400 mg/m², given as a single intravenous dose (into the veins) over a period of 15 to 60 minutes.
• Elderly patients In elderly patients (over 65 years of age), the dosage may need to be adjusted depending on physical condition.
• If you have previously received treatment or have kidney problems The dosage will be adjusted according to your individual needs.
• Children and adolescents The use of Carboplatino Teva is not recommended in children and adolescents.

If you have been given too much Carboplatino Teva
There is no specific antidote for carboplatin overdose. If you have received too much carboplatin, your doctor will stop the treatment and treat any symptoms.
If you miss a dose of 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 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, inform your doctor immediately or seek urgent medical advice:

• 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 difficulties; skin rash or hives, swelling of the hands, feet and ankles.
• Chest pain which may indicate 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 unusual bruising and bleeding (thrombocytopenia), decrease in the number of white blood cells associated with an increased risk of infections (leucopenia, neutropenia), decrease in the number of red blood cells (anaemia: this may cause tiredness)
• Nausea, abdominal pain, vomiting
• Kidney toxicity
• Abnormally high levels of uric acid in the blood (hyperuricaemia)
• Abnormal liver function tests
• Changes in blood chemistry test values (reduced 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 or sore throat
• Bleeding complications (haemorrhage)
• Allergic reactions such as skin rash, fever without apparent cause and itching
• A nerve disorder (peripheral neuropathy). You may feel tingling and/or numbness in the fingers and toes, around the mouth or in the throat, which sometimes may occur together with cramps. These effects are often triggered by exposure to cold, such as opening a refrigerator or drinking a cold beverage. You may also have difficulty performing delicate tasks, such as buttoning clothes
• Tingling sensation, prickling or numbness of the skin without an apparent physical cause (paraesthesia), decreased tendon reflex
• Altered taste
• Temporary worsening of vision or visual disturbances, loss of vision
• Hearing loss, hearing problems
• Heart disease
• Chest tightness or breathlessness, chest tightness caused by cramping of the muscles in the airways (bronchospasm)
• Interstitial lung disease (a group of lung disorders in which the deep lung tissues become inflamed)
• Diarrhoea, constipation
• Painful 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 surrounding structures (musculoskeletal disorders)
• Extreme tiredness/weakness (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 the available data)

• Lung infections (pneumonia)
• Secondary neoplasms (malignant tumour spreading from its original site to form secondary tumours in other parts of the body)
• Reduced bone marrow function; decrease in white blood cells accompanied by fever (febrile neutropenia); disorders characterised by abnormal breakdown of red blood cells, kidney failure and reduced platelet count (haemolytic uraemic syndrome)
• Dry mouth, tiredness, and headache due to excessive loss of body water (dehydration), loss of appetite (anorexia)
• Decreased level of sodium in the blood (hyponatraemia)
• Stroke
• A group of symptoms such as headache, altered mental function, seizures and visual disturbances ranging from blurred vision to loss of vision (symptoms of reversible posterior leucoencephalopathy syndrome, a rare neurological disorder)
• Heart failure, blockage of blood vessels (embolism), high blood pressure, low blood pressure
• Painful mouth or throat, with inflamed, red or swollen lining of the mouth or ulcers in the mouth or throat (stomatitis)
• Pancreatitis
• Skin disorders such as hives, skin rash, red skin (erythema) and itching
• Muscle cramps, muscle weakness, confusion, loss or disturbances of vision, cardiac arrhythmias, kidney failure or abnormalities in blood test results (symptoms of tumour lysis syndrome, which may be caused by rapid breakdown of tumour cells) (see section 2)
• Reactions at the injection site such as pain, redness, swelling, hives and dead skin.
• General feeling of being unwell (malaise), fever and chills.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Carboplatin Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label/carton after EXP.
The expiry date refers to the last day of that month.
Do not store above 25°C. Keep the container in the outer packaging.
After dilution in 0.9% sodium chloride solution or in 5% glucose solution, the medicinal product should be used within three hours at room temperature and protected from light, or, if the dilution has been carried out under validated aseptic conditions, within 24 hours at 2°C – 8°C. The storage times are related to the start of administration of the medicinal product.
Use this product only if the solution is clear, colourless to pale yellow, and free from fibres and particulate matter.
Unused solution once opened must be discarded using appropriate precautions.
These measures will help protect the environment.

6. Package contents and other information

What Carboplatino Teva contains

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

Description of the appearance of Carboplatino Teva and contents of the pack
Carboplatino Teva concentrate for solution for infusion is a clear, particle-free solution ranging from colourless to pale yellow.
The product is available in packs containing a single vial of 5 ml, 15 ml, 45 ml or 60 ml, and 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.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Pharma B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer
Pharmachemie B.V.
Swensweg 5, Postfach 552
2003 Haarlem (The Netherlands)

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Germany: Carboplatin-Gry 10 mg/ml
Italy: Carboplatino Teva 10 mg/ml
Spain: Carboplatino Teva 10 mg/ml Concentrado para solución para perfusión
United Kingdom (Northern Ireland): Carboplatin 10 mg/ml Concentrate for Infusion

The following information is intended exclusively for physicians or healthcare professionals

Carboplatin Teva 10 mg/ml concentrate for solution for infusion
In addition to the information provided in section 3, practical guidance on the preparation/handling of the medicinal product is provided below.

Incompatibilities
This medicinal product must not be mixed with other medicinal products except for 5% Glucose for Injections or 0.9% Sodium Chloride for Injection.
This product must not be used with infusion sets, syringes, or injection needles containing aluminum, as antineoplastic activity may be reduced.

Handling
The infusion solution must be inspected visually for particulate matter before use.

Guidelines for safe handling of antineoplastic agents:

1. The drug must be handled by trained personnel.
2. This should be performed in a designated area.
3. Appropriate protective gloves must be worn.
4. Precautions must be taken to avoid accidental contact of the drug 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 personnel.
6. Adequate attention and precautions must be taken when disposing of instruments (syringes, needles, etc.) used to reconstitute cytotoxic drugs. Excess material and organic waste should be disposed of by placing them in double-sealed polyethylene bags and incinerated at a temperature of 1,000 °C. Liquid waste should be flushed with large amounts of water.

Dilution

1. The work surface should be covered with disposable, plastic-backed absorbent paper.
2. Use Luer-Lock connectors on all syringes and sets. It is recommended to use wide-bore needles to minimize pressure and the potential for aerosol formation. The latter can also be reduced by using a venting needle.

The product may be diluted with 5% glucose solution or 0.9% sodium chloride solution to minimum concentrations of 0.5 mg/ml (500 mcg/ml).

Method of administration
Carboplatin Teva must be used only for intravenous administration. The infusion solution is administered as a short infusion (15 to 60 minutes).

Special precautions for storage
When diluted as recommended, the carboplatin solution should be used within 3 hours if stored at room temperature (15°C–25°C) and protected from light, or within 24 hours if stored refrigerated (2°C–8°C), provided that dilution was performed under validated aseptic conditions. Since the formulation contains no antibacterial preservatives, it is recommended that the carboplatin solution be discarded 3 hours after dilution if stored at room temperature and protected from light, or 24 hours after dilution if refrigerated (2°C–8°C).
The product is for single use only.