Prospect: information for the patient

Dacarbazina medac 500mg powder for solution for infusion

Dacarbazina medac 1.000mg powder for solution for infusion

Dacarbazina

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

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

•If you have any doubts, consult your doctor or pharmacist.

•If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Dacarbazina medac and what is it used for

2.What you need to know before Dacarbazina medac is administered to you

3.How to use Dacarbazina medac

4.Possible adverse effects

5.Storage of Dacarbazina medac

6.Contents of the package and additional information

Dacarbazina belongs to a group of medicines known as cytostatic agents. These agents affect the growth of cancerous cells.

Your doctor has prescribed Dacarbazina medac for the treatment of cancer, such as:

• advanced malignant melanoma (skin cancer);
• Hodgkin's disease (lymphatic tissue cancer);
• soft tissue sarcoma (cancer of muscles, fatty tissue, fibrous tissue, blood vessels, or other supportive tissues of the body).

Dacarbazina medac may be used in combination with other cytostatic agents.

Do not administer Medac Dacarbazine

•if you areallergicto dacarbazine or to any of the other components of this medication (listed in section6);

•if the number of white blood cells and/or platelets in your blood is too low(leucopeniaand/ortrombocytopenia);

•if you havesevere liver or kidney disease;

•if you arepregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before Dacarbazine Medac is administered.

Before each administration, blood tests will be performed to ensure you have enough blood cells to receive this medication. Your liver and kidney functions will also be monitored.

Do not receive a vaccine made with live viruses while receiving Dacarbazine Medac. This is because Dacarbazine Medac can weaken your immune system and make you more susceptible to a severe infection.

Do not use fotemustine while receiving Dacarbazine Medac.

Other medications and Dacarbazine Medac

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

Do not use any other medical treatment without informing your doctor, as interactions between Dacarbazine Medac and other medications may occur.

Specifically, inform your doctor or pharmacist if you are using or being treated with any of the following:

•Radiotherapy or other medications to reduce tumor growth (chemotherapy). The use of these medications with Dacarbazine Medac may increase bone marrow damage.

•Other medications that are metabolized by a liver enzyme system called cytochrome P450.

•Methoxypsoralen (used for skin conditions such as psoriasis and eczema): the use of Dacarbazine Medac with methoxypsoralen may make you more sensitive to sunlight (photosensitization).

•Phenytoin (used to treat seizures): the use of Dacarbazine Medac with phenytoin may make you more prone to seizures (convulsions).

•Ciclosporin or tacrolimus (used to reduce immune system reactions): these medications may weaken your immune system.

•Fotemustine (used to treat skin cancer): the use of Dacarbazine Medac with fotemustine may damage your lungs.

•During chemotherapy, avoid medications that can cause liver damage, for example: diazepam (used to treat anxiety, muscle spasms, and seizures), imipramine (used to treat depression symptoms), ketoconazole (used to treat fungal infections), carbamazepine (used to prevent seizures, modify certain types of pain, or control mood disorders).

•Anticoagulants (medications used to prevent blood clotting): your doctor will decide whether to administer these medications and will perform blood clotting tests.

Do not receive a vaccine made with live microorganisms while receiving Dacarbazine Medac, nor during the 3months following the completion of Dacarbazine Medac treatment. This is because Dacarbazine Medac can weaken your immune system and make you more susceptible to a severe infection.

You can receive a vaccine made with inactivated or killed viruses while receiving Dacarbazine Medac.

Use of Dacarbazine Medac with alcoholand other substances

Do not consume alcohol during chemotherapy.

Pregnancy, breastfeeding, and fertility

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

The medication may harm the fetus.

Do not use dacarbazine if you are pregnant, think you may be pregnant, or intend to become pregnant.

Do not breastfeed while receiving Dacarbazine Medac treatment.

Women of childbearing age/Anticonception in men and women

If you are a woman and wish to become pregnant, you must consult your doctor so that you can be referred to a specialist before the scheduled start of treatment and after treatment.

If you are a man, it is recommended that you seek advice on sperm preservation before the scheduled start of treatment.

Women of childbearing age must use effective contraceptive measures while receiving dacarbazine treatment and for 6months after treatment completion.

Males must use effective contraceptive measures and not father a child while receiving dacarbazine treatment and for 3months after treatment completion.

Driving and operating machinery

Your ability to drive or operate machinery may be affected due to the adverse effects on the central nervous system (effects on the brain and nerves), or due to dizziness and vomiting; however, there is no reason why you should not drive or use machinery between treatment courses with this medication, unless you feel dizzy or unsure.

This medication will be administered under the direction of a specialist doctor in oncology (cancer treatment) or hematology (study of blood diseases). They will perform regular checks during and after treatment to detect any signs of adverse effects.

Dacarbazine is a substance sensitive to light exposure. The doctor or nurse administering this medication will ensure that the dacarbazine is protected from sunlight during administration.

How much Dacarbazina medac will be administered

Your doctor will calculate the dose to be administered. It will depend on the type of cancer you have and how advanced it is, your body surface area (m²), blood counts, and other medications or treatments you are using to treat cancer. The doctor treating you will also decide individually for how long you will receive this medication.

Your doctor may modify the dose and administration frequencybased on the results of your blood tests, your overall condition, other treatments, and your response to this medication. If you have any doubts about your treatment, ask your doctor, nurse, or pharmacist.

Malignant melanoma metastatic skin cancer

The usual dose is 200-250mg per m² of body surface area, once a day. You will receive this dose 5days in a row, every 3weeks. It will be administered through a rapid injection into a vein or through a slow infusion into a vein for 15-30minutes.

Alternatively, you may receive a higher dose of 850mg per m² of body surface area, every 3weeks. This dose will be administered through a slow infusion into a vein.

Hodgkin's lymphoma

The usual dose is 375mg per m² of body surface area, every 15days. You will also receive other medications called doxorubicin, bleomycin, and vinblastine (this combination is called the ABVD regimen). It will be administered through a slow infusion into a vein.

Soft tissue sarcoma

The usual dose is 250mg per m² of body surface area, once a day. You will receive this dose 5days in a row, every 3weeks. It will be administered through a slow infusion into a vein for 15-30minutes.

You will also receive a medication called doxorubicin (this combination is called the ADIC regimen).

Patients with renal or hepatic problems

If you have mild or moderate renal or hepatic problems, you will usually not need to receive a lower dose of this medication. If you have bothrenal and hepatic problems, your body will take longer to use the medication and eliminate it from the system. Your doctor may administer a lower dose of this medication.

Use in children

Until additional data is available, it is not possible to provide special recommendations to your doctor for the pediatric use of this medication.

If you have been given too much Dacarbazina medac

If you have been given too much Dacarbazina medac, you may experience a severe decrease in blood cells. This can cause a complete loss of bone marrow function. Possible symptoms include signs of infection, bruising due to an increased tendency to bleed, or fatigue. These symptoms may appear up to 2weeks later.

If you think you have been given too much Dacarbazina medac, inform your doctor or nurse immediately. They will check your blood cell count and may require supportive measures such as transfusions.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Your doctor will review these side effects with you and explain the risks and benefits of your treatment.

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

•Signs of infection, such as sore throat and fever

•Bleeding or bruising

•Extreme fatigue

•Persistent or severe vomiting or diarrhea

•Severe allergic reaction: you may experience a sudden rash that causes itching, swelling of hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing) and may feel like you are going to faint

•Yellowing of the skin and eyes due to liver problems

•Signs of brain or nervous system problems, such as headaches, vision loss, seizures, confusion, drowsiness, or numbness and tingling in the face

•Severe liver problems due to blockage of liver blood vessels (veno-occlusive disease or Budd-Chiari syndrome), with liver cell destruction (hepatic necrosis), which can be fatal. If these complications are suspected, your doctor will decide on the correct treatment for you.

All of these are serious side effects. You may need urgent medical attention.

You may experience the following side effects:

Frequent(may affect up to1 in 10people)

•Decreased red blood cell count (anemia), white blood cell count (leucopenia), and/or platelet count (thrombocytopenia) in the blood

These changes in blood counts depend on the dose and are delayed; the lowest values often only occur after3 to4 weeks.

•Loss of appetite (anorexia), dizziness, and vomiting (all of which can be severe)

Rare(may affect up to1 in 100people)

•Hair loss (alopecia)

•Intensification of skin pigmentation (hyperpigmentation)

•Sensitivity to light (photosensitivity) in the skin

•Symptoms similar to the flu, with fatigue, chills, fever, and muscle pain. These symptoms may occur during treatment or within a few days after receiving the medication. They may also recur when you receive dacarbazine again.

• Infections

Rare(may affect up to1 in 1,000people)

•Decreased count of all blood cells (pancytopenia)

•Severe decrease in the count of granulocytes, a type of white blood cell (agranulocytosis)

•Severe allergic reaction (anaphylactic) that may cause, for example, a drop in blood pressure, swelling of hands, feet, ankles, face, lips, mouth, and throat that may cause difficulty swallowing or breathing, rapid heartbeat, urticaria, and generalized pruritus or skin redness

•Headaches

•Vision loss

•Confusion

•Drowsiness

•Seizures (convulsions)

•Abnormal sensations in the face (paresthesia facial), numbness, and redness of the face shortly after injection

•Diarrhea

•Elevation of liver enzymes

•Renal function impairment

•Red skin (erythema)

•Skin rash (exanthema maculopapular)

•Hives (urticaria)

•Irritation at the injection site

If this medication is accidentally injected into the tissue near the vein, it may be painful and may cause tissue damage.

You may experience one or more of these symptoms. If you experience any type of side effect, consult your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect,consult your doctor, pharmacist, or nurse, evenifthey do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the label and in the boxafter CAD.The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Store the vial in the outer packaging to protect it from light.

The shelf life under these conditions is 3years.

Reconstituted Solution of Dacarbazine medac

The freshly prepared (reconstituted) solutions of Dacarbazine medac demonstrated stability for 48hours at 2‑8°C protected from light. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times during use and the conditions prior to use are the responsibility of the user and normally should not exceed 24hours at 2‑8°C, unless the reconstitution was performed in validated and controlled aseptic conditions.

Reconstituted and additionally diluted solution of Dacarbazine medac

The reconstituted and additionally diluted solutions of Dacarbazine medac demonstrated stability for 24hours at 2‑8°C protected from light in polyethylene containers and glass bottles, and for 2hours at 25°C in polyethylene containers. From a microbiological standpoint,The freshly prepared (reconstituted) and additionally diluted solutions of Dacarbazine medac should be used immediately.

Dacarbazine medac is exclusively for single use.

After use, your doctor must discard any remaining medication, as well as solutions in which the appearance of the medication has changed. Your doctor must visually inspect the diluted solution for infusion, and only solutions that are translucent and practically free of particles should be used.

Composition of Dacarbazine medac

•The active ingredient is dacarbazine (as citrate of dacarbazine).

•The other components are anhydrous citric acid and mannitol.

Aspect of the product and content of the packaging

Dacarbazine medac is a white or pale yellow powder that is supplied in amber-colored glass vials (Type I, Ph.Eur.).

Each vial for single use of Dacarbazine medac 500 mg contains 500 mg of dacarbazine, as citrate of dacarbazine.

After reconstitution and final dilution, Dacarbazine medac 500 mg contains 1.4 – 2.0 mg/ml of dacarbazine.

Each vial for single use of Dacarbazine medac 1,000 mg contains 1,000 mg of dacarbazine, as citrate of dacarbazine.

After reconstitution and final dilution, Dacarbazine medac 1,000 mg contains 2.8 – 4.0 mg/ml of dacarbazine.

The vials of Dacarbazine medac are packaged in boxes of 1 vial.

Only some package sizes may be marketed.

Medicines should not be disposed of by flushing down the toilet or by throwing them away. Ask your pharmacist how to dispose of the packaging and the medicines that you no longer need. In this way, you will help to protect the environment.

Holder of the marketing authorization and responsible for manufacturing

medac Gesellschaft für klinischeSpezialpräparate mbH

Theaterstr.6

22880 Wedel

Germany

Telephone:+49 (0)4103 8006-0

Fax:+49 (0)4103 8006-100

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Laboratorios Gebro Pharma S.A,

Tel. +34 93 205 86 86

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland)with the following names:

GermanyDetimedac 500mg/1 000mg, Powder for the preparation of an infusion solution

AustriaDacarbazine medac 500mg/1 000mg, Powder for the preparation of an infusion solution

BelgiumDACARBAZINE MEDAC 500mg/1 000mg, powder for solution for infusion

DACARBAZINE MEDAC 500mg/1 000mg, powder for solution for infusion

DACARBAZINE MEDAC 500mg/1 000mg,Powder for the preparation of aninfusion solution

DenmarkDacarbazine medac 500mg, powder for infusion solution, solution

SpainDacarbazina medac 500mg/1.000mg, powder for solution for perfusion

IrelandDacarbazine medac 500mg/1 000mg, powder for solution for infusion

ItalyDacarbazina medac 500mg/1 000mg, powder for solution for infusion

NetherlandsDacarbazine medac 500mg/1 000mg, powder for solution for infusion

PortugalDacarbazina medac 500mg/1 000mg, pó for solution for perfusion

United KingdomDacarbazine medac 500mg/1 000mg, powder for solution for infusion

SwedenDacarbazine medac 500 mg/1 000mg, powder for infusion solution, solution

Last review date of this leaflet: 12/2023.

The detailed information about this medicine is available on 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:

Recommendations for safe handling

Dacarbazine is an antineoplastic agent and should be handled in accordance with the standardized procedures for cytostatics that have mutagenic, carcinogenic, and teratogenic effects. Before starting, local guidelines on cytotoxics should be consulted.

Dacarbazine should be opened exclusively by trained personnel, and as with all cytotoxic agents, precautions should be taken to avoid exposure to personnel. In general, during pregnancy, manipulation of cytotoxic medicines should be avoided. The preparation of the solution for administration should be carried out in a designated area for its manipulation, working on a washable tray or disposable absorbent paper with a plastic reverse.

Proper protection for the eyes, disposable gloves, mask, and disposable apron should be used. Syringes and infusion equipment should be carefully mounted to avoid leaks (the use of a Luer-type connection is recommended).

After finishing, all exposed surfaces should be thoroughly cleaned, and hands and face should be washed.

In case of spillage, personnel should wear gloves, masks, eye protection, and disposable aprons, and the spilled material should be collected with an absorbent material placed in the area for this purpose. The area should then be cleaned, and all contaminated material should be transferred to a cytotoxic spill bag or sealed for incineration.

Preparation for intravenous administration

The dacarbazine solutions should be prepared at the moment they are to be used.

Dacarbazine is photosensitive. During administration, the vial containing the infusion solution and the administration equipment should be protected from exposure to sunlight, using, for example, PVC infusion equipment resistant to sunlight. Normal infusion equipment should be wrapped, for example, in a material resistant to UV light.

a) Preparation of Dacarbazine medac 500mg:

Transfer 50ml of water for injection to the vial and agitate until a solution is obtained. The resulting solution, containing 10mg/ml of dacarbazine (solution density: p=1.007g/ml) should be further diluted with 200-300ml of a 0.9% sodium chloride solution or a 5%. The resulting infusion solution, containing 1.4-2.0mg/ml of dacarbazine, is ready for IV infusion and should be administeredover a period of20-30minutes.

b) Preparation of Dacarbazine medac 1,000mg:

Transfer 50ml of water for injection to the vial and agitate until a solution is obtained. The resulting solution, containing 20mg/ml of dacarbazine (solution density: p=1.015g/ml) should be further diluted with 200-300ml of a 0.9% sodium chloride solution or a 5%. The resulting infusion solution, containing 2.8-4.0mg/ml of dacarbazine, is ready for IV infusion and should be administeredover a period of20-30minutes.

Dacarbazine medac 500mg (1,000mg) is for single use.

The diluted infusion solution should be visually inspected, and only solutions that are translucent and practically free of particles should be used. Do not use solutions with particles present.

Dispose of any solution whose appearance has changed.

The elimination of unused medicine and all materials that have come into contact with it should be carried out in accordance with local regulations.