500 mg, 1000 mg of powder for infusion solution 
dacarbazine

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Dacarbazine medac is and what it is used for 
2. What you need to know before you are given Dacarbazine medac 
3. How to use Dacarbazine medac 
4. Possible side effects  
5. How to store Dacarbazine medac 
6. Package contents and other information 

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

Dacarbazine belongs to a group of medicines called cytotoxic drugs. These drugs affect the growth of cancer cells.

You have been prescribed Dacarbazine medac for the treatment of cancer:

  • as advanced malignant melanoma (skin cancer),
  • Hodgkin’s disease (cancer of lymph tissue),
  • soft tissue sarcoma (cancer of muscles, fat, fibrous tissue, blood vessels, or other supporting tissue in the body).

Dacarbazine medac can be used in combination with other cytotoxic drugs.

Dacarbazine contained in Dacarbazine medac may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you receive Dacarbazine medac

You will not be given Dacarbazine medac

  • if you are allergic to dacarbazine or any of the other ingredients of this medicine (listed in section 6),
  • if the number of white blood cells and/or platelets is too low ( leukopenia and/or thrombocytopenia ),
  • if you have severe liver or kidney disease,
  • if you are pregnant or breastfeeding.

Warnings and cautions

Talk to your doctor or pharmacist before taking Dacarbazine medac.

Before each treatment, you will be given blood samples to check that you have enough blood cells to be able to receive this medicine. Your liver and kidney function will also be checked.

You should not be given a live vaccine if you are receiving Dacarbazine medac, as Dacarbazine medac may weaken your immune system and increase the likelihood of you getting a serious infection.

You must not use foot mustache if you are being treated with Dacarbazine medac.

Other medicines and Dacarbazine medac

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The use of any other drug treatment without consulting your doctor is not recommended as there may be an interaction between Dacarbazine medac and other drugs.

In particular, talk to your doctor or pharmacist if you are using or are being treated with any of the following:

  • Radiation therapy or other drugs to reduce tumor growth ( cytotoxic drugs ). Using these medicines with Dacarbazine medac may increase the risk of bone marrow damage.
  • Other drugs that are metabolized by a system of liver enzymes are called cytochrome P450.
  • Methoxypsoral (for skin conditions such as psoriasis and eczema ) – if you take Dacarbazine medac at the same time as methoxypsoral, you may become more sensitive to sunlight (photosensitization).
  • Phenytoin (used to treat epileptic seizures) – Concomitant use of Dacarbazine medac and phenytoin may increase the likelihood of having seizures (convulsions).
  • Cyclosporine or tacrolimus (used to lower the body’s immune responses) – these medicines can weaken your immune system.
  • Foot mustache (used to treat skin cancer) – Concomitant use of Dacarbazine medac and foot mustache can lead to lung damage.
  • Drugs that can cause liver damage, e.g. diazepam (used to treat anxiety, muscle spasms, and cramps), imipramine (used to treat symptoms of depression), ketoconazole (used to treat fungal infections), carbamazepine (used to prevent seizures, relieve certain types of pain or control mood swings) should be avoided during chemotherapy ( chemotherapy ).
  • Anticoagulants (medicines used to prevent blood clots from forming) – Your doctor will decide if you should receive these medicines and check your blood’s tendency to clot.

You must not be given a live vaccine if you are receiving Dacarbazine medac and for 3 months after stopping treatment with Dacarbazine medac. This is because Dacarbazine medac can weaken your immune system and increase the likelihood of you getting a serious infection.

You can get a “killed” or inactivated vaccine if you receive Dacarbazine medac.

Dacarbazine medac with food, drink, and alcohol

You should not drink alcohol during chemotherapy.

Pregnancy, breastfeeding, and fertility

Dacarbazine medac should not be given if you are pregnant, think you may be pregnant, or are planning to have a baby.

You must not breast-feed while you are being treated with Dacarbazine medac.

During treatment with Dacarbazine medac, you must use an effective method of contraception. Men should continue to use contraception for at least 6 months after stopping treatment with Dacarbazine medac.

If you are considering becoming pregnant or breast-feeding, you should first discuss this with your doctor.

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Your ability to drive and use machines may be affected by central nervous system side effects (effects on the brain and nerves) or nausea or vomiting. However, you can drive and use machines between treatments with this medicine, as long as you do not feel dizzy or unsafe.

3. How to use Dacarbazine medac

This medicine is given to you under the supervision of a doctor who specializes in oncology (cancer treatment) or hematology (the study of blood diseases). You will be checked regularly during and after your treatment for any signs of side effects.

Dacarbazine is a substance that is sensitive to light. The doctor or nurse who gives you this medicine will make sure that dacarbazine is protected from daylight during treatment.

How much Dacarbazine medac will you get

Your doctor will calculate the dose you should receive. This depends on the type of cancer you have and how far advanced it is, your body surface area (m²), the number of blood cells, and other cancer drugs or treatments you are receiving. The attending physician also determines individually how long this drug will be given to you.

Your doctor may change the dose and how often the doses are given depending on your blood test results, your general condition, other treatments, and how you react to this medicine. If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.

Skin cancer (metastatic malignant melanoma )

The usual dose is 200 – 250 mg per m² body surface area, once daily. You can be given this dose 5 days in a row every 3 weeks. It is given as a quick injection into a vein or as a slow infusion into a vein that takes 15-30 minutes.

Alternatively, you can be given a larger dose of 850 mg per m² body area every 3 weeks. This is given as a slow infusion into a vein.

Cancer of the lymphatic tissue ( Hodgkin’s disease )

The usual dose is 375 mg per month of body surface area, every 15 days. You will also be given medicines called doxorubicin, bleomycin, and vinblastine (this combination is called the ABVD regimen ). It will be given as a slow infusion into a vein.

Cancer of muscles, fibrous tissue, blood vessels, or other supporting tissue in the body  (soft tissue sarcoma)

The usual dose is 250 mg per m3 of body surface area, once daily. You will receive this dose 5 days in a row, every 3 weeks. It is given as a slow infusion into a vein and takes 15-30 minutes. You will also be given medicines called doxorubicin (this combination is called the ADIC‑ regimen ).

Patients with kidney or liver problems

If you have either mild or moderate kidney or liver problems, you usually do not need to take a smaller amount of this medicine. If you have both kidney and liver problems, it takes longer for your body to excrete the medicine from your body. Your doctor may give you less of this medicine.

Use for children

Your doctor may not make any specific recommendations for the use of this medicine in children until more data become available.

If you take more Dacarbazine medac then you should

If you have been given too much Dacarbazine medac it can lead to a severe decrease in the number of blood cells, This can lead to complete loss of bone marrow function. Any symptoms include signs of infection, bruising due to increased bleeding tendency, or fatigue. They may occur after 2 weeks.

Contact your doctor, nurse, or Poison Information Center immediately if you think you have been given too much Dacarbazine medac.

The number of blood cells will be checked and supportive measures such as transfusions may be required.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects 

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

Tell your doctor immediately if you notice any of the following:

  • Signs of infection, such as sore throat and fever
  • Abnormal bruising or bleeding
  • Extreme fatigue
  • Persistent or severe vomiting or diarrhea
  • Severe allergic reaction – you may experience sudden itchy rash, swollen hands, feet, ankles, face, lips, mouth, or throat (which may make it difficult to swallow or breathe) and you may feel dizzy
  • Yellowing of the skin and eyes due to liver problems
  • Signs of brain or nerve-related problems, such as headache, impaired vision, seizures, confusion, lethargy or numbness, and tingling in the face
  • Severe liver disease is caused by blockage of blood vessels in the liver (venous occlusive disease) or Budd-Chiari syndrome in which liver cells are destroyed (liver necrosis) which can be life-threatening. If these complications are suspected, your doctor will determine which treatment is right for you.

These are serious side effects. You may need urgent medical attention.

Listed below are other side effects that may occur:

Common (may affect up to 1 in 10 people)

  • Reduced red blood cell count ( anemia )
  • Decreased white blood cell count ( leukopenia )
  • Decreased platelet count ( thrombocytopenia )

The changes in the number of blood cells are dose-dependent and delayed. Often the lowest values ​​are only reached after 3 to 4 weeks.

  • Loss of appetite ( anorexia ), nausea, and vomiting (which can be very severe)

Uncommon (may affect up to 1 in 100 people)

  • Hair loss ( alopecia )
  • Increased pigmentation of the skin ( hyperpigmentation )
  • Photosensitive skin ( photosensitivity )
  • Flu-like symptoms with fatigue, chills, fever, and muscle aches. These symptoms may occur during the administration of the medicine or a few days after receiving it. They may also return the next time you receive dacarbazine.
  • Infection is

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

  • Decreased number of all blood cells (pancytopenia)
  • Significantly reduced number of granulocytes, a special type of white blood cell ( agranulocytosis )
  • The severe allergic (anaphylactic) reaction that results in e.g. drop in blood pressure, swollen hands, feet, ankles, face, lips, mouth, and throat, which may make it difficult to swallow or breathe, rapid pulse, hives, and general itching or redness of the skin
  • Headache
  • Impaired vision
  • Confusion
  • Lethargy
  • Seizures (convulsions)
  • Abnormal sensations in the face (facial paresthesia), numbness, and redness of the face shortly after injection
  • Diarrhea
  • Elevated liver enzymes
  • Impaired renal function
  • Redness ( erythema )
  • Skin rash (maculopapular exanthema)
  • Hives ( urticaria )
  • Irritation at the injection site

If the drug is accidentally injected into the tissue around a vein, this can cause pain and lead to tissue damage.

You may get one or more of these symptoms. If you get any side effects, talk to your doctor or pharmacist.

5. How to store Dacarbazine medac

Keep this medicine 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 expiration date is the last day of the specified month.

Do not store above 25 ° C. Keep the vial in the outer carton. Sensitive to light.

The shelf life under these conditions is 3 years.

Prepared solution of Dacarbazine medac

Newly prepared solutions of Dacarbazine medac are stable for 48 hours at 28 ° C when stored protected from light. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions before use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ° C, unless reconstitution has taken place under controlled and validated aseptic conditions.

A prepared and further diluted solution of Dacarbazine medac

A prepared and further diluted solution of Dacarbazine medac is stable for 24 hours at 28 ° C under light-proof storage in polyethylene containers and glass bottles, and for 2 hours at 25 ° C in polyethylene containers. From a microbiological point of view, the reconstituted and further diluted solution of Dacarbazine medac must be used immediately.

Dacarbazine medac is for single use only.

Any contents that remain after use should be discarded by your doctor, as well as solutions whose appearance has visibly changed. The diluted infusion solution should be checked visually by your doctor and only clear solutions that are virtually free of particles should be used.

6. Contents of the packaging and other information 

Content declaration

  • The active substance is dacarbazine (as dacarbazine citrate).
  • The other ingredients are anhydrous citric acid and mannitol.

Marketing Authorization Holder and Manufacturer

medac

Society for clinical

Special preparations mbH

Theater. 6

22880 Wedel

Germany

Phone: +49 (0) 4103 8006-0

Fax: +49 (0) 4103 8006-100

This medicinal product is authorized under the European Economic Area under the names:

Belgium DACARBAZINE MEDAC 500 mg / 1000 mg, powder for solution for infusionDACARBAZINE MEDAC 500 mg / 1000 mg, powder for perfusionsolutionDACARBAZINE MEDAC 500 mg / 1000 mg, powder for the preparation of an infusion solution
Denmark Dacarbazine medac 500 mg / 1000 mg, powder for solution for infusion
Ireland Dacarbazine medac 500 mg / 1000 mg, Powder for solution for infusion
Netherlands Dacarbazine medac 500 mg / 1000 mg, Powder for solution for infusion
Portugal Dacarbazine medac 500 mg / 1000 mg, Po for solution for perfusion
Spain Dacarbazine medac 500 mg / 1000 mg, Powder for perfusion solution
UK Dacarbazine medac 500 mg / 1000 mg, Powder for solution for infusion
Germany Detimedac 500 mg / 1000 mg, powder for the preparation of an infusion solution
Austria Dacarbazine medac 500 mg / 1000 mg, powder for the preparation of an infusion solution

Muhammad Nadeem

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