Prospecto: information for the user

Carboplatino Aurovitas 10 mg/ml concentrate for infusion solution EFG

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1.What is Carboplatino Aurovitas and how it is used

2.What you need to know before starting to use Carboplatino Aurovitas

3.How to use Carboplatino Aurovitas

4.Possible side effects

5.Storage of Carboplatino Aurovitas

6.Contents of the package and additional information

What is Carboplatino Aurovitas

This medication contains carboplatin, which belongs to a group of medications called platinum coordination compounds, which are used to treat cancer.

How is Carboplatino Aurovitas used

This medication is used to combat advanced ovarian cancer and small cell lung cancer.

No use Carboplatino Aurovitas

•If you are allergic to carboplatin or any of the other components of this medication (listed in section 6).

•If you have severe kidney problems (creatinine clearance of 30 ml/min or less).

•If you have a severe blood cell count disorder (severe myelosuppression).

•If you have a bleeding tumor.

•Concomitantly with the yellow fever vaccine.

If you find yourself in any of these situations and have not already discussed them with your doctor or nurse, it is recommended to inform your doctor or nurse as soon as possible and before receiving the infusion.

Carboplatin is usually administered to patients in the hospital. In general, you should not handle this medication. Your doctor or nurse will administer the medication and closely monitor your condition frequently during and after treatment. They will usually perform blood tests before each administration.

Warnings and Precautions

Consult your doctor ornursebefore starting to use carboplatin:

•If you are pregnant or if there is a possibility that you are pregnant.

•If you are breastfeeding.

•If you are likely to consume alcoholic beverages during treatment with this medication.

•If you have headaches, mental function alterations, seizures, and abnormal vision, ranging from blurred vision to loss of vision, inform your doctor.

•Inform your doctor if you feel extreme fatigue with a decrease in red blood cell count and shortness of breath (symptoms of hemolytic anemia) alone or combined with a decrease in platelet count, abnormal bleeding (thrombocytopenia), and kidney disease that leads to little or no urination (symptoms of hemolytic uremic syndrome).

•If you have a fever (temperature of 38°C or higher) or chills, which could be signs of infection, inform your doctor immediately. You may be at risk of contracting blood infection.

If your kidneys do not function properly, the effects of carboplatin on the blood (hematopoietic system) increase and last longer compared to patients with normal renal function. Your doctor will perform regular checks if your kidneys do not function properly.

During treatment with carboplatin, you will be given medications that help reduce the risk of a potentially fatal complication known as tumor lysis syndrome, which is caused by chemical alterations in the blood due to the destruction of dead cancer cells that release their contents into the blood.

If you find yourself in any of these situations and have not already discussed them with your doctor or nurse, it is recommended to inform your doctor or nurse as soon as possible and before receiving this medication.

This medication can be diluted with another solution before being administered. You should discuss this with your doctor and ensure it is suitable for you.

Other Medications and Carboplatino Aurovitas

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.

You should inform your doctor if you are taking any of the following medications, as they may interact with carboplatin:

•Other medications that are toxic to your kidneys (e.g., aminoglycoside antibiotics).

•Other medications that damage auditory or balance functions in the ear (e.g., aminoglycoside antibiotics, furosemide (used to treat heart failure and edema)).

•Other medications that reduce the activity of the immune system (e.g., cyclosporines, tacrolimus, sirolimus, and other cancer medications).

•The yellow fever vaccine and other live vaccines.

•Medications to prevent blood clot formation, e.g., warfarin.

•Phenobarbital and fosphenytoin (used to treat various types of seizures and attacks).

•Chelating agents (substances that bind to carboplatin, reducing its effect).

•Diuretics (used to treat hypertension and edema).

Use of Carboplatino Aurovitas with Food, Drinks, and Alcohol

No interactions between carboplatin and alcohol are known. However, you should discuss this with your doctor, as carboplatin may affect the liver's ability to process alcohol.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

If you find yourself in any of these situations and have not already discussed them with your doctor or nurse, it is recommended to inform your doctor or nurse as soon as possible and before receiving this medication.

Pregnancy

You should not be treated with carboplatin during pregnancy unless your doctor clearly indicates it.

Animal studies have shown a possible risk of fetal developmental abnormalities. If you are being treated with carboplatin while pregnant, you should discuss the possible risks to the fetus with your doctor. Women of childbearing age should use an effective contraceptive method before and during treatment with carboplatin. Since carboplatin can cause genetic damage, if pregnancy occurs during treatment with carboplatin, genetic counseling is recommended. Genetic counseling is also recommended for patients who wish to have children after treatment with carboplatin.

Breastfeeding

The excretion of carboplatin in breast milk is unknown. Therefore, during treatment with carboplatin, breastfeeding should be suspended.

Fertility

Carboplatin can cause genetic damage. Women are advised to avoid pregnancy during treatment using an effective contraceptive method. Women who become pregnant or become pregnant during treatment should receive genetic counseling.

Men treated with carboplatin are advised to avoid conception during and up to 6 months after treatment. You should request advice on sperm preservation before treatment, as carboplatin may cause irreversible infertility.

Consult your doctor or pharmacist before using any medication.

Driving and Operating Machines

Carboplatin does not affect the ability to drive and operate machines. However, you should exercise special caution when carboplatin is administered for the first time, especially if you feel dizzy or insecure.

This medication will always be administered by a nurse or a doctor. It is usually administered through intravenous infusion by drip, and it will usually last between 15 and 60 minutes. In case of doubt, consult your doctor or the nurse who has administered or will administer the infusion to you. Your dose will depend on your height and weight, your blood system condition (hematopoietic) and your kidney condition. Your doctor will select the optimal dose for you. The infusion will usually be diluted before use.

Adults

The usual dose is 400 mg/m2of body surface area (calculated from your weight and height).

Older Adults

You can use the usual adult dose, although your doctor may choose to use a different dose.

Kidney Problems

The amount administered may vary depending on kidney function. If you have kidney problems, your doctor may reduce the dose and may perform frequent blood tests in addition to monitoring your kidney function. The infusion will be administered by a doctor who is an expert in the use of cancer treatments.

Use in Children and Adolescents

There is not enough experience with carboplatino in children to allow for a specific dose recommendation.

You may feel dizzy while being treated with carboplatino. Your doctor may give you another medication to reduce these effects before treating you with this medication.

Usually, there will be a 4-week interval between each dose of carboplatino. Your doctor will perform blood tests every week after administering the medication to decide what is the next suitable dose for you.

If You Receive More Carboplatino Aurovitas Than You Should

It is unlikely that you will receive too much carboplatino. However, if this happens, you may develop kidney problems, liver problems, vision problems, hearing problems and you may have a low white blood cell count in your blood. If you are concerned that you have been given too much, or if you have doubts about the dose administered, you should consult the doctor who is administering the medication.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone91 562 04 20, indicating the medication and the amount administered.

If you have any other questions about the use of this medication, ask your doctor or nurse.

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

Inform your doctor immediately if you notice any of the following reactions:

•Unusual bruising, bleeding, or signs of infection such as sore throat and fever.

•Intense itching of the skin (with blisters) or swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing or breathing (angioedema), and chest pain, which may be a sign of a possible severe allergic reaction called Kounis syndrome, you may feel like you are going to faint.

•Stomatitis/mucositis (irritated lips or mouth ulcers).

Very common: may affect more than 1 in 10 people

•Suppression of the bone marrow characterized by a severe decrease in white blood cells in the blood, making you more prone to infections (leucopenia, neutropenia).

•Reduction of platelets, increasing the risk of bleeding and bruising (thrombocytopenia)

•Anemia (a disorder in which the red blood cells decrease, causing fatigue).

•Decreased renal function (elevated levels of creatinine and urea in the blood). You may need medical follow-up.

•Mild hearing loss (high-frequency hearing loss).

•Abnormal liver enzyme levels and abnormal liver function tests. You may need medical follow-up.

•Increased levels of uric acid in the blood that may cause gout (hyperuricemia).

•Sensation of dizziness or nausea.

•Abdominal pain and cramps.

•Unusual feelings of fatigue or weakness.

•Decreased levels of salts in the blood (sodium, potassium, calcium, magnesium). You may need medical follow-up.

Common: may affect up to 1 in 10 people

•Unusual bruising or bleeding (hemorrhagic complications).

•Dyspepsia, constipation, irritated lips or mouth ulcers (mucositis).

•Allergic reactions, including skin rash, urticaria, skin redness, itching, fever.

•Tinnitus, hearing alteration, and hearing loss.

•Numbness (peripheral neuropathy), weakness, numbness, or tingling.

•Hair loss.

•Feeling unwell.

•Pseudogripal syndrome.

•Loss or lack of physical strength.

•Pulmonary disorders, scarring, and thickening of the lungs with difficulty breathing, sometimes fatal (interstitial lung disease), difficulty breathing.

•Reduced reflexes of bones and tendons.

•Infections.

•Sensorial alteration.

•Taste alteration.

•Visual disorders, including temporary loss of vision.

•Cardiovascular disorders.

•Skin disorders.

•Red skin rash with itching (urticaria).

•Itching sensation (pruritus).

•Red rash (erythematous eruption).

•Musculoskeletal disorders.

•Urinary and genital tract disorders (urogenital disorders).

•Increased levels of creatinine, bilirubin, and uric acid in the blood. Your doctor may need to follow up.

Uncommon: may affect up to 1 in 100 people

•Cancer caused by chemotherapy or radiation (secondary malignant neoplasms).

•Fever and chills without signs of infection.

•Redness, swelling, and pain, or dead skin around the injection site (reaction at the injection site).

Rare: may affect up to 1 in 1,000 people

•Sensation of unwellness with fever due to low white blood cell count in the blood (neutropenic fever).

•Loss of appetite (anorexia).

•Severe liver function disorder, liver cell damage or death. You may need medical follow-up.

•Optic nerve inflammation that may cause partial or total loss of vision (optic neuritis).

•Severe allergic reactions (anaphylaxis/anaphylactoid reactions).

•The symptoms of a severe allergic reaction include sudden wheezing or chest tightness, swelling of the eyelids, face, or lips, facial redness, hypotension, tachycardia, urticaria, dyspnea, dizziness, and anaphylactic shock.

•Low sodium levels in the blood (hyponatremia).

Very rare: may affect up to 1 in 10,000 people

•Heart failure.

•Cerebral hemorrhage, which may cause a stroke or loss of consciousness.

•Sudden blockage of an artery (embolism), high blood pressure, low blood pressure.

Adverse effects of unknown frequency (cannot be estimated from available data):

•Haemolytic-uraemic syndrome (a disease characterized by acute kidney failure/low urine production/no urine production, severe anemia, and low platelet count).

•Unusual bruising or bleeding and signs of infection.

•Dehydration.

•Abdominal pain or mouth ulcers (stomatitis).

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

•A group of symptoms such as headache, altered mental function, convulsions, and vision alteration ranging from blurred vision to loss of vision (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder).

•Pancreatitis.

•Pulmonary infection.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medicationafter the expiration date that appears on the box and vials after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Store the vial in the outer packaging to protect it from light.

Carboplatin should not come into contact with the eyes or skin. If any accidental spill occurs, report immediately to the doctor or nurse.

After the infusion has finished,carboplatinmust be eliminated with caution by the doctor or nurse.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition ofCarboplatino Aurovitas

-The active ingredient iscarboplatin. 1 mlof concentrate for solution for infusioncontains 10 mg of carboplatin. Available in vials with 50 mg, 150 mg, 450 mg, and 600 mg of carboplatin.

-The other components are mannitol and water for injection.

Appearance of the productand contents of the package

Concentrate for solution for infusion.

Clear, colorless, or slightly yellowish solution, essentially free of visible particles. Each vial contains 5 ml, 15 ml, 45 ml, or 60 ml of carboplatin concentrate for solution for infusion, respectively.

Packaging sizes: 1 vial and 10 vials.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

For more information about this medication, please contact the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Germany:Carboplatin PUREN 10 mg/ml concentrate for the preparation of an infusion solution

Belgium:Carboplatin Eugia 10 mg/ml concentrate for solution for infusion /solution à diluer for perfusion /Concentrate for the preparation of an infusion solution

Spain:Carboplatino Aurovitas 10 mg/ml concentrate for solution for infusion EFG

France:Carboplatine Arrow Lab 10 mg/ml, solution à diluer for perfusion

Italy:Carboplatino Aurobindo Italia

Poland:Carboplatin Eugia

Portugal:Carboplatina Generis

Last review date of this leaflet: July 2023

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

This information is intended solely for healthcare professionals:

The medication is for single use only. The infusion solution should be discarded if not used.

Dilution instructions

Carboplatin may react with aluminum to form a black precipitate and/or lose potency. For the preparation or administration of carboplatin, do not use needles, syringes, catheters, or intravenous administration equipment containing aluminum parts that may come into contact with carboplatin.

The product should be diluted before infusion with a 5% glucose injection or a 0.9% sodium chloride injection to achieve concentrations as low as 0.5 mg/ml (500 micrograms/ml).

Carboplatin can be diluted further with 5% glucose and administered as an intravenous infusion. Chemical and physical stability has been demonstrated in use for 56 days at final concentrations of 0.2 mg/ml and 3.5 mg/ml when stored at 2-8°C in PVC-free infusion bags protected from light.

Carboplatin can also be diluted further with 0.9% sodium chloride and administered as an intravenous infusion. Chemical and physical stability has been demonstrated in use at final concentrations of 0.2 mg/ml and 3.5 mg/ml for 24 hours at 2-8°C and up to 8 hours at 22°C in PVC-free infusion bags protected from light.

However, from a microbiological point of view, the product should be used immediately. If not used immediately, storage times and conditions before use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless the dilution has been performed in validated and controlled aseptic conditions.

The solution should be visually inspected to check for particles or discoloration before administration. The solution should only be used if it is clear and free of particles.

Guidelines for safe handling of antineoplastic agents:

1.Carboplatin should only be prepared for administration by professionals who have been trained in the safe use of chemotherapeutic agents.

2.This should be done in a designated area.

3.Protective gloves, mask, and apron should be used.

4.Precautions should be taken to avoid accidental contact with the eyes. In case of eye contact, wash with water and/or saline solution.

5.Cytotoxic preparations should not be handled by pregnant employees.

6.Care should be taken and appropriate precautions should be taken in the disposal of materials (needles, syringes, etc.) used to reconstitute cytotoxic drugs. Waste materials and body waste can be disposed of by placing them in polyethylene bags with double seal and incinerating at a temperature of 1,000°C.

7.The work surface should be covered with absorbent paper with a disposable plastic backing.

8.Use equipment with Luer-Lock closure in syringes and equipment. It is recommended to use large-caliber needles to reduce pressure and the possible formation of aerosols. These can also be reduced by using a needle with ventilation.

Disposal

The disposal of unused medication and materials used for reconstitution, dilution, and administration should be carried out in accordance with the hospital's procedures for antineoplastic agents, taking into account local regulations for the disposal of hazardous waste.