DACARBAZINA 200 mg Powder For Injectable/Infusion Solution

Зміст інструкції

1. Dacarbazina Lipomed 500 mg powder for solution for infusion, 1000 mg powder for solution for infusion
   1. What is Dacarbazina Lipomed and what is it used for
   2. What you need to know before you receive Dacarbazina Lipomed
   3. How to use Dacarbazina Lipomed
   4. Possible side effects
   5. How to store Dacarbazina Lipomed
   6. Contents of the pack and other information
2. Dacarbazina Lipomed 200 mg powder for injectable solution or for infusion solution
   1. What is Dacarbazina Lipomed and what is it used for
   2. What you need to know before you receive Dacarbazina Lipomed
   3. How to use Dacarbazina Lipomed
   4. Possible side effects
   5. How to store Dacarbazina Lipomed
   6. Contents of the pack and other information

Dacarbazina Lipomed 500 mg powder for solution for infusion, 1000 mg powder for solution for infusion

dacarbazina

Generic medicine

Read this leaflet carefully before you receive 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 or pharmacist.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Dacarbazina Lipomed is and what it is used for
• 2. What you need to know before you receive Dacarbazina Lipomed
• 3. How to use Dacarbazina Lipomed
• 4. Possible side effects
• 5. How to store Dacarbazina Lipomed
• 6. Contents of the pack and other information

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

Dacarbazina belongs to a group of medicines known as cytostatic agents. These agents
influence the growth of cancer cells.
Dacarbazina Lipomed has been prescribed by your doctor for the treatment of a cancer, such as
advanced malignant melanoma (skin cancer), advanced Hodgkin's lymphoma
(cancer of the lymphatic tissue) or advanced soft tissue sarcoma in adults (cancer of the
muscles, adipose tissue, fibrous tissue, blood vessels or other supporting tissues).
Dacarbazina Lipomed may be administered in combination with other cytostatic agents.

2. What you need to know before you receive Dacarbazina Lipomed

Do not use Dacarbazina Lipomed

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

Warnings and precautions
Talk to your doctor or pharmacist before you are given Dacarbazina Lipomed.
Before each administration, blood tests will be performed to check that you have
enough blood cells to receive this medicine. Liver and kidney function will also be monitored.
You should not be vaccinated with live vaccines during treatment with Dacarbazina Lipomed, as
this medicine can weaken the immune system and make it easier to contract a serious
infection.
Do not take fotemustine during treatment with Dacarbazina Lipomed.

Other medicines and Dacarbazina Lipomed
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
It is not advisable to use any treatment without talking to your doctor first, because there could
be interactions between Dacarbazina Lipomed and other medicines.
In particular, tell your doctor, nurse or pharmacist if you are using or are being treated
with any of the following medicines:

• Radiotherapy treatment or other tumour growth inhibitors (chemotherapy). The use of these medicines in combination with Dacarbazina Lipomed may worsen damage to the bone marrow.
• Other medicines metabolised by an enzyme system in the liver called cytochrome P450.
• Methoxpsoralene (for skin problems such as psoriasis and eczema): concomitant use of Dacarbazina Lipomed with methoxpsoralene may increase sensitivity to sunlight (photosensitisation).
• Phenytoin (used to treat seizures): concomitant use of Dacarbazina Lipomed and phenytoin may increase the likelihood of seizures.
• Cyclosporine or tacrolimus (used to reduce the body's immune reactions): these medicines can weaken the immune system.
• Fotomustine (used to treat skin tumours): concomitant use of Dacarbazina Lipomed and fotemustine may cause lung damage.
• The use of medicines that can cause liver damage, such as diazepam (used to treat anxiety, muscle spasms and seizures), imipramine (used to treat symptoms of depression), ketoconazole (used to treat fungal infections), carbamazepine (used to prevent seizures, reduce certain types of pain or to control mood disorders) should be avoided during chemotherapy.
• Anticoagulants (medicines used to prevent blood clots): your doctor will decide whether you need to take these medicines and will check your blood's tendency to clot.

You should not be vaccinated with live vaccines during treatment with Dacarbazina Lipomed and within
3 months after the end of therapy with this medicine. Dacarbazina Lipomed can
indeed weaken the immune system and make it easier to contract a serious infection.
During treatment with Dacarbazina Lipomed you may receive killed or inactivated vaccines.

Dacarbazina Lipomed with food, drinks and alcohol
Avoid eating shortly before the administration of Dacarbazina Lipomed. This may
reduce nausea or vomiting. You should avoid alcoholic beverages during chemotherapy.

Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking or receiving any medicine.
Dacarbazina Lipomed should not be given to you if you are pregnant or planning a
pregnancy. You should use adequate contraception during therapy.
Do not breastfeed during treatment with Dacarbazina Lipomed.
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding, ask
your doctor for advice before receiving this medicine.
During treatment with Dacarbazina Lipomed and for 6 months after the end of therapy, men should be informed about the possibility of using effective contraceptive measures.

Driving and operating machinery
Your ability to drive and operate machinery may be affected due to side effects affecting the
central nervous system (brain and nerves) or due to nausea and
vomiting. However, there is no reason to give up driving or using machinery between cycles of therapy
with Dacarbazina Lipomed, unless you feel dizzy or insecure.

3. How to use Dacarbazina Lipomed

This medicine will be administered under the direction of a doctor specializing in oncology
(cancer treatment), who has the equipment necessary to monitor
all clinical effects regularly during and after therapy.
Dacarbazina is a substance sensitive to exposure to light. The doctor or nurse who
administers this medicine will ensure that Dacarbazina is protected from exposure to
daylight during administration.
Shortly before administration, Dacarbazina Lipomed powder will be dissolved in 50 mL of water
for injectable preparations. The resulting solution will be further diluted with 200-300 mL of an
isotonic solution of sodium chloride or 5% glucose and will be administered to you by intravenous
infusion (infusion into a vein) in 20-30 minutes.
The dose depends on the blood cell count and concomitant chemotherapy. The dose you
receive is calculated by the doctor based on your body surface area (m²), blood cell
count, and other medicines or cancer therapies administered.
The doctor may change the dose and frequency of administrations. This will depend on blood tests,
your general condition, further therapies, and your response to Dacarbazina
Lipomed. If you have any questions about your treatment, please ask your doctor, nurse, or pharmacist.

Use in children and adolescents
Specific recommendations for the use of Dacarbazina Lipomed in
children and adolescents cannot be made until further data are available.
If you have any doubts about the use of this medicine, please ask your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Your doctor will discuss these with you and explain the risks and benefits of your treatment.
Immediately inform your doctor if any of the following side effects occur:

• Signs of infection, such as sore throat and high temperature.
• Bruising or unusual bleeding.
• Extreme fatigue.
• Persistent or severe vomiting or diarrhea.
• Severe allergic reactions - these can appear as a sudden itchy rash (urticaria), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing) and a feeling of faintness.
• Yellowing of the skin and eyes due to liver problems.
• Signs of problems affecting the brain or nerves, such as headache, vision disturbances, convulsions, confusion, lethargy (state of apathy) or numbness and tingling of the face.

These are all serious side effects. You may urgently need medical attention.
Below is a list of all known side effects:

Common side effects (may affect up to 1 in 10 people)

• Anemia (reduction in the number of red blood cells).
• Leukopenia (reduction in the number of white blood cells).
• Thrombocytopenia (reduction in the number of platelets in the blood). Changes in blood cell counts are dose-dependent and delayed. The lowest values often appear only after 3-4 weeks.
• Anorexia (loss of appetite), nausea and vomiting. All of these side effects can be serious.
• Bone marrow suppression (decreased formation of all blood cells in the bone marrow).

Uncommon side effects (may affect up to 1 in 100 people)

• Alopecia (hair loss).
• Hyperpigmentation (increased skin pigmentation).
• Photosensitivity (increased sensitivity of the skin to sunlight).
• Occasionally, flu-like symptoms with fatigue, chills, fever and muscle pain are observed during or often a few days after the administration of dacarbazine. These disorders may recur on subsequent infusion.
• Infections.
• Transient rash.
• Blurred vision.
• Hepatotoxicity (liver damage).

Rare side effects (may affect up to 1 in 1000 people)

• Pancytopenia (reduction in the number of all blood cells).
• Agranulocytosis (severe reduction in the number of granulocytes, a particular type of white blood cells).
• Anaphylactic reactions (severe allergic reaction that causes, for example, a drop in blood pressure, swelling of the hands, feet, ankles, face, lips, mouth and throat, which can cause difficulty swallowing or breathing, rapid pulse, urticaria and generalized itching or redness of the skin).
• Headache.
• Vision disorders.
• Confusion.
• Lethargy (state of apathy).
• Convulsions.
• Facial paresthesia (abnormal sensations of the face), numbness and flushing of the face immediately after injection.
• Diarrhea.
• Veno-occlusive disease (VOD) (serious liver disease due to obstruction of the blood vessels of the liver) with hepatic necrosis (destruction of liver cells) which can be life-threatening. Symptoms include fever, abdominal pain, enlarged liver and yellowing of the skin. If this complication is suspected, your doctor will consider appropriate treatment.
• Increased liver enzymes.
• Impaired kidney function.
• Erythema (redness of the skin).
• Maculopapular rash (skin rash).
• Urticaria.
• Irritation at the application site.

If the medicine is accidentally administered into the tissues around the vein, this will cause
pain and tissue damage.
You may experience one or more of these symptoms; in this case, inform your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. You can also report side effects directly
https://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 Dacarbazina Lipomed

Do not store at a temperature above 25°C. Keep the vial in the outer packaging to
protect the medicine from light.
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 on the pack after
"Exp.". The expiry date refers to the last day of that month.
Dacarbazina Lipomed is for single use only.
Any residual contents after use should be disposed of by the doctor, nurse or pharmacist. This also applies
to solutions in which the appearance of the product has changed. The diluted infusion solution should be
visually inspected by the doctor, nurse or pharmacist, and used only if clear and
practically free of particles.

Shelf life of the reconstituted solution
Chemical and physical stability in use has been demonstrated for 8 hours at room temperature and protected from
light, and for 5 days at 2-8°C and protected from light. From a microbiological point of view, the reconstituted
solution must be used immediately.
If the reconstituted solution is not used immediately, the duration and conditions of
storage are the responsibility of the user. The reconstituted solution must not be
stored for more than 24 hours in a refrigerator (2-8°C) protected from light, unless the reconstitution has not
been carried out under controlled and validated aseptic conditions.

Shelf life of the diluted infusion solution
Chemical and physical stability in use has been demonstrated for 8 hours at room temperature and protected from
light, and for 5 days at 2-8°C and protected from light. From a microbiological point of view, the diluted
infusion solution must be used immediately.
If the diluted infusion solution is not used immediately, the duration and conditions of
storage are the responsibility of the user. The diluted infusion solution must not be
stored for more than 24 hours in a refrigerator (2-8°C) protected from light, unless the reconstitution and
dilution have been carried out under controlled and validated aseptic conditions.
From a microbiological point of view, it is recommended not to exceed a total storage time
of 24 hours after opening the product.

6. Contents of the pack and other information

What Dacarbazina Lipomed contains

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

Description of the appearance of Dacarbazina Lipomed and contents of the pack
The medicinal product Dacarbazina Lipomed is a white lyophilized powder available in brown vials for
injectable preparations (hydrolytic class I), closed with grey bromobutyl rubber stoppers for
lyophilization. The vials containing Dacarbazina Lipomed 500 mg are sealed with aluminium with
grey tear-off caps, the vials containing Dacarbazina Lipomed 1000 mg are
sealed with aluminium with red tear-off caps.
Each single-dose vial of Dacarbazina Lipomed 500 mg contains 500 mg of dacarbazine, as
dacarbazine citrate.
After reconstitution of Dacarbazina Lipomed 500 mg with 50 ml of water for injections,
1 ml of solution contains 10 mg of dacarbazine.
Each single-dose vial of Dacarbazina Lipomed 1000 mg contains 1,000 mg of dacarbazine, as
dacarbazine citrate.
After reconstitution of Dacarbazina Lipomed 1000 mg with 50 ml of water for injections,
1 ml of solution contains 20 mg of dacarbazine.
Before reconstitution, Dacarbazina Lipomed is a white lyophilized powder. The reconstituted solutions
are clear and pale yellow in colour. The diluted infusion solutions are clear and
almost colourless.
Dacarbazina Lipomed 500 mg and 1000 mg are packaged in cartons. Each carton contains
1 vial.

Marketing authorisation holder and manufacturer
Lipomed GmbH
Hegenheimer Strasse 2
D-79576 Weil am Rhein
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria: Dacarbazin Lipomed 500 mg Pulver zur Herstellung einer Infusionslösung
Germany: Dacarbazin Lipomed 500 mg Pulver zur Herstellung einer Infusionslösung
France: Dacarbazine Lipomed 500 mg poudre pour solution pour perfusion
Italy: Dacarbazina Lipomed 500 mg polvere per soluzione per infusione
Denmark: Dacarbazine Lipomed 500 mg pulver til infusionsvæske, opløsning
Finland: Dacarbazine Lipomed 500 mg infuusiokuiva-aine liuosta varten
Norway: Dacarbazine Lipomed 500 mg pulver til infusjonsvæske, oppløsning
Ireland: Dacarbazine Lipomed 500 mg powder for solution for infusion
Austria: Dacarbazin Lipomed 1000 mg Pulver zur Herstellung einer Infusionslösung
Germany: Dacarbazin Lipomed 1000 mg Pulver zur Herstellung einer Infusionslösung
France: Dacarbazine Lipomed 1000 mg poudre pour solution pour perfusion
Italy: Dacarbazina Lipomed 1000 mg polvere per soluzione per infusione
Denmark: Dacarbazine Lipomed 1000 mg pulver til infusionsvæske, opløsning
Finland: Dacarbazine Lipomed 1000 mg infuusiokuiva-aine liuosta varten
Norway: Dacarbazine Lipomed 1000 mg pulver til infusjonsvæske, oppløsning
Ireland: Dacarbazine Lipomed 1000 mg powder for solution for infusion
---------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for doctors or healthcare professionals:
Dacarbazine is an antineoplastic agent. Before starting, consult local guidelines
relating to the handling of cytotoxic agents.
Dacarbazine solutions must be prepared only by trained personnel and, as with all
cytotoxic agents, precautions must be taken to avoid exposure of personnel. Handling of cytotoxic drugs should generally be avoided during pregnancy. Preparation of the solution for administration must be carried out in an area designated for
handling, working on a washable surface or on disposable plastic-backed absorbent paper.
Wear suitable eye protection, disposable gloves, mask and disposable gown. Syringes and infusion sets must be assembled carefully to avoid leaks (the use of Luer lock fittings is recommended).
After work, all exposed surfaces must be thoroughly cleaned and the operator must wash
hands and face.
In case of splashes, the operator must wear gloves, mask, eye protection and disposable
gown and remove the splashes with absorbent material placed for this purpose in the work area. The area must then be cleaned and all contaminated material must be transferred to a
bag or container for cytotoxic material or sealed for incineration.
Reconstituted solutions must be adequately protected from light even during
administration (light-resistant infusion set).

Shelf life of the reconstituted solution
Chemical and physical stability in use has been demonstrated for 8 hours at room temperature and protected from
light, and for 5 days at 2 -8°C and protected from light. From a microbiological point of view, the reconstituted solution
must be used immediately.
If the reconstituted solution is not used immediately, the duration and conditions of
storage are the responsibility of the user. The reconstituted solution must not be
stored for more than 24 hours in the refrigerator (2-8°C) protected from light, unless the reconstitution has not
been carried out under controlled and validated aseptic conditions.

Shelf life of the diluted infusion solution
Chemical and physical stability in use has been demonstrated for 8 hours at room temperature and protected from
light, and for 5 days at 2-8°C and protected from light. From a microbiological point of view, the diluted infusion solution
must be used immediately.
If the diluted infusion solution is not used immediately, the duration and conditions of
storage are the responsibility of the user. The diluted infusion solution must not be
stored for more than 24 hours in the refrigerator (2-8°C) protected from light, unless the reconstitution and
dilution have been carried out under controlled and validated aseptic conditions.
From a microbiological point of view, it is recommended not to exceed a total storage time
of 24 hours after opening the product.

Dacarbazina Lipomed 200 mg powder for injectable solution or for infusion solution

Dacarbazina

Read this leaflet carefully before you receive this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Dacarbazina Lipomed is and what it is used for
• 2. What you need to know before you receive Dacarbazina Lipomed
• 3. How to use Dacarbazina Lipomed
• 4. Possible side effects
• 5. How to store Dacarbazina Lipomed
• 6. Contents of the pack and other information

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

Dacarbazina belongs to a group of medicines known as cytostatic agents. These agents
influence the growth of cancer cells.
Dacarbazina Lipomed has been prescribed by your doctor for the treatment of cancer, such as
advanced stage malignant melanoma (skin cancer), advanced stage Hodgkin's lymphoma
(cancer of the lymphatic tissue) or advanced stage soft tissue sarcoma (cancer of the muscles, of
fatty tissue, fibrous tissue, blood vessels or other supporting tissues). Dacarbazina
Lipomed may be administered in combination with other cytostatic agents.

2. What you need to know before you receive Dacarbazina Lipomed

Dacarbazina must not be administered to you:

• if you are allergic to dacarbazina or any of the excipients of this medicine (listed in section 6),
• if the number of white blood cells and/or platelets in your blood is too low (leukopenia and/or thrombocytopenia),
• if you have a severe liver or kidney disease,
• if you are pregnant or breastfeeding
• in association with the yellow fever vaccine

Warnings and precautions
Particular caution is necessary if Dacarbazina Lipomed is administered in the following cases:
During treatment with Dacarbazina Lipomed and also for 6 months after the end of the
therapy, men must use safe contraceptive methods.
The doctor will perform blood tests before each administration, to check that you
have enough blood cells to receive Dacarbazina Lipomed. The liver and kidney function will also be monitored.
Consult your doctor or pharmacist before receiving Dacarbazina Lipomed.

Other medicines and Dacarbazina Lipomed
It is not advisable to use any treatment without first talking to your doctor, because there could
be interactions between Dacarbazina Lipomed and other medicines.
In particular, this medicine must not be administered to you and you must inform your doctor,
nurse or pharmacist if you are taking or receiving any of the following medicines:

• phenytoin - for the treatment of seizures (epilepsy)
• yellow fever vaccine
• live vaccines, because dacarbazina can weaken the immune system and increase the likelihood of contracting a serious infection.

Dacarbazina Lipomed must not be administered to you if you are using any of these medicines. If you
have doubts, consult your doctor, nurse or pharmacist before you are administered Dacarbazina
Lipomed.
Inform your doctor, nurse or pharmacist if you are receiving any of the following treatments:

• fotemustine - you must not receive dacarbazina and fotemustine at the same time, to avoid lung damage.
• cyclosporine or tacrolimus: these medicines can reduce the function of the immune system. If you are using one of these medicines or if you have doubts, consult your doctor, nurse or pharmacist before you are administered Dacarbazina Lipomed. The doctor will decide whether to administer you medicines that improve blood flow and will check blood coagulation.

Inform your doctor or pharmacist if you are taking or using, have recently taken or used or
may take or use any other medicine.
During chemotherapy, avoid medicines that can cause liver damage (e.g. diazepam,
imipramine, ketoconazole or carbamazepine).

Dacarbazina Lipomed with food, beverages and alcohol
Avoid eating shortly before the administration of Dacarbazina Lipomed. This will help to
avoid nausea or vomiting. You should avoid alcoholic beverages during chemotherapy.

Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking or receiving any medicine.
Dacarbazina Lipomed must not be administered to you if you are pregnant or planning a
pregnancy. You must use adequate contraceptive precautions during therapy.
You must not breastfeed during treatment with Dacarbazina Lipomed.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before receiving this medicine.
During treatment with Dacarbazina Lipomed and for 6 months after the end of therapy, men
should be informed about the opportunity to adopt effective contraceptive measures.

Driving and operating machinery
The ability to drive vehicles and operate machinery may be affected due to adverse effects on the
central nervous system (on the brain and nerves) or due to nausea and
vomiting. However, there is no reason to give up driving or using machinery between therapy cycles
with Dacarbazina Lipomed, unless you feel dizzy or insecure.

3. How to use Dacarbazina Lipomed

This medicine will be administered under the direction of a doctor specializing in oncology
(cancer treatment), who has the necessary equipment available to monitor
all clinical effects regularly during and after therapy.
Dacarbazina is a substance sensitive to exposure to light. The doctor or nurse who
administers this medicine will ensure that the dacarbazina is protected from exposure to
daylight during administration.
Just before administration, Dacarbazina Lipomed powder will be dissolved in 20 ml of water for
injections.
The resulting solution will be administered by slow injection into a vein or will be further
diluted with 200-300 ml of an isotonic solution of sodium chloride or 5% glucose and will be
administered by intravenous infusion (infusion into a vein) in 15-30 minutes.
The dose will depend on the blood cell count and concomitant chemotherapy. The dose
you receive is calculated by the doctor based on your body surface area (m²), blood cell count and other medicines or cancer therapies administered.
The doctor may change the dose and frequency of administrations. This will depend on blood tests, your general condition, further therapies and your response to Dacarbazina
Lipomed. If you have any questions about your treatment, please ask your doctor, nurse or pharmacist.

Use in children and adolescents
Specific recommendations for the use of Dacarbazina Lipomed in
children and adolescents cannot be made by the doctor until further data are available.
If you have any doubts about the use of this medicine, please ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Your doctor will discuss them with you and explain the risks and benefits of your treatment.
Tell your doctor immediately if any of the following side effects occur:

• Signs of infection, such as sore throat and high temperature.
• Bruising or unusual bleeding.
• Extreme fatigue.
• Persistent or severe vomiting or diarrhoea.
• Serious allergic reactions - these can include a sudden itchy rash (urticaria), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing) and a feeling of faintness.
• Yellowing of the skin and eyes due to liver problems.
• Signs of problems with the brain or nerves, such as headache, vision disturbances, convulsions, confusion, lethargy (state of apathy) or numbness and tingling of the face.

These are all serious side effects. You may need urgent medical attention.
Below are listed all the known side effects:

Common side effects (1-10 in 100 patients treated)

• Anaemia (reduction in the number of red blood cells)
• Leucopenia (reduction in the number of white blood cells)
• Thrombocytopenia (reduction in the number of platelets in the blood) Changes in blood cell counts are dose-dependent and delayed. The lowest values often appear only after 3-4 weeks.
• Anorexia (loss of appetite), nausea and vomiting. All of these side effects can be serious.
• Bone marrow suppression (reduced formation of all blood cells in the bone marrow)

Uncommon side effects (1 to 10 in 1,000 patients treated)

• Alopecia (hair loss).
• Hyperpigmentation (increased skin pigmentation).
• Photosensitivity (increased sensitivity of the skin to sunlight).
• Occasionally, flu-like symptoms with fatigue, chills, fever and muscle pain are observed during or often a few days after the administration of dacarbazine. These disorders may recur on subsequent infusion.
• Infections.
• Transient rash.
• Blurred vision.
• Hepatotoxicity (liver damage).

Rare side effects (1-10 in 10,000 patients treated)

• Pancytopenia (reduction in the number of all blood cells).
• Agranulocytosis (severe reduction in the number of granulocytes, a particular type of white blood cells).
• Anaphylactic reactions (severe allergic reaction that causes, for example, a drop in blood pressure, swelling of the hands, feet, ankles, face, lips, mouth and throat, which can cause difficulty swallowing or breathing, rapid pulse, urticaria and generalised itching or skin redness).
• Headache.
• Vision disorders.
• Confusion.
• Lethargy (state of apathy).
• Convulsions.
• Facial paraesthesia (abnormal sensations of the face), numbness and flushing of the face immediately after injection.
• Diarrhoea.
• Veno-occlusive disease (VOD) (serious liver disease due to obstruction of the blood vessels of the liver) with hepatic necrosis (destruction of liver cells) which can be life-threatening. If this complication is suspected, your doctor will consider appropriate treatment.
• Increased liver enzymes.
• Impaired renal function.
• Erythema (redness of the skin).
• Maculopapular rash (skin rash).
• Urticaria.
• Irritation at the site of application.

If this medicine is accidentally administered into the tissues around the vein, you will feel
pain and the tissues will be damaged.
You may have one or more of these symptoms; in this case, tell your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell
your doctor or pharmacist. You can also report side effects directly through the
national reporting system:
Website:
https://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 Dacarbazina Lipomed

Do not store at a temperature above 25°C. Keep the vials in the outer packaging to
protect the medicine from light.
Keep this medicine out of the sight and reach of children.
This medicine must not be used after the expiry date which is stated on the label and on the
pack after “Exp.”. The expiry date refers to the last day of that month.
Dacarbazina Lipomed is for single use only.
Any unused medicine or waste materials should be disposed of by the doctor, nurse or pharmacist. This also applies
to solutions in which the appearance of the product has changed. The injectable solution or the
diluted infusion solution must be visually inspected by the doctor, nurse or pharmacist, and
used only if clear and practically free from particles.

Shelf life of the reconstituted solution
Chemical and physical stability in use has been demonstrated for 8 hours at room temperature and protected from
light, and for 5 days at 2 -8°C and protected from light. From a microbiological point of view, the reconstituted
solution must be used immediately.
If the reconstituted solution is not used immediately, the duration and conditions of
storage are the responsibility of the user. The reconstituted solution must not be
stored for more than 24 hours in a refrigerator (2-8°C) protected from light, unless the reconstitution has not
been carried out under controlled and validated aseptic conditions.

Shelf life of the diluted infusion solution
Chemical and physical stability in use has been demonstrated for 8 hours at room temperature and protected from
light, and for 5 days at 2-8°C and protected from light. From a microbiological point of view, the diluted
infusion solution must be used immediately.
If the diluted infusion solution is not used immediately, the duration and conditions of
storage are the responsibility of the user. The diluted infusion solution must not be
stored for more than 24 hours in a refrigerator (2-8°C) protected from light, unless the reconstitution and
dilution have been carried out under controlled and validated aseptic conditions.
From a microbiological point of view, it is recommended not to exceed a total storage time
of 24 hours after opening of the product.

6. Contents of the pack and other information

What Dacarbazina Lipomed contains

• The active substance is dacarbazine (as dacarbazine citrate).
• The excipients are citric acid monohydrate and mannitol (E 421).

Description of the appearance of Dacarbazina Lipomed and contents of the pack
The medicinal product Dacarbazina Lipomed is a white, lyophilized powder available in brown vials for
injectable preparations (hydrolytic class I), closed with bromobutyl rubber stoppers for
lyophilization. The vials containing Dacarbazina Lipomed 200 mg are sealed with aluminum with
red tear-off closure caps.
Each single-dose vial of Dacarbazina Lipomed 200 mg contains 200 mg of dacarbazine, as
dacarbazine citrate.
After reconstitution of Dacarbazina Lipomed 200 mg with 20 ml of water for injections,
1 ml of solution contains 10 mg of dacarbazine.
Before reconstitution, Dacarbazina Lipomed is a white, lyophilized powder. Reconstituted solutions
are clear and pale yellow in color. Diluted solutions for infusion are clear and
almost colorless.
Dacarbazina Lipomed 200 mg is packaged in cartons. Each carton contains 10 vials.

Marketing authorization holder and manufacturer
Lipomed GmbH
Hegenheimer Strasse 2
79576 Weil am Rhein
Germany
Tel. +49 7621 1693 472
Fax +49 7621 1693 474
[email protected]

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria: Dacarbazin Lipomed 200 mg Pulver zur Herstellung einer Injektions- oder Infusionslösung
Germany: Dacarbazin Lipomed 200 mg Pulver zur Herstellung einer Injektions- bzw. Infusionslösung
France: Dacarbazine Lipomed 200 mg poudre pour solution injectable ou perfusion
Italy: Dacarbazina Lipomed 200 mg polvere per soluzione iniettabile o per soluzione per infusione
Cyprus: Dacarbazine Lipomed 200 mg κόνις για ενέσιμο διάλυμα ή διάλυμα προς έγχυση
Denmark: Dacarbazine Lipomed 200 mg pulver til injektions- og infusionsvæske, opløsning
Finland: Dacarbazine Lipomed 200 mg injektio-/infuusiokuiva-aine liuosta varten
Norway: Dacarbazine Lipomed 200 mg pulver til injeksjons-/infusjonsvæske, oppløsning
Ireland: Dacarbazine Lipomed 200 mg powder for solution for injection or infusion
Romania: Dacarbazină Lipomed 200 mg pulbere pentru soluţie injectabilă sau perfuzabilă
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The following information is intended exclusively for healthcare professionals.
Dacarbazine is an antineoplastic agent. Before starting, consult local guidelines
regarding the handling of cytotoxic agents.
Dacarbazine solutions should only be prepared by trained personnel and, as with all
cytotoxic agents, precautions should be taken to avoid exposure of personnel. Handling of cytotoxic
drugs should generally be avoided during pregnancy. The preparation of the solution for administration
should be carried out in an area designated for handling, working on a washable surface or on
plastic-backed disposable absorbent paper.
Wear appropriate eye protection, disposable gloves, mask and disposable gown. The
syringes and infusion sets should be assembled carefully to avoid leaks (use of Luer lock fittings is
recommended).
After work, all exposed surfaces should be thoroughly cleaned and the operator should wash
hands and face.
In case of splashes, the operator should wear gloves, mask, eye protection and disposable gown
and remove the splashes with absorbent material placed for this purpose in the work area. The area
should then be cleaned and all contaminated material should be transferred to a bag or container for
cytotoxic material or sealed for incineration.
Reconstituted solutions must be adequately protected from light even during
administration (light-resistant infusion set).

Shelf life of the reconstituted solution
Chemical and physical stability in use has been demonstrated for 8 hours at room temperature and protected from
light, and for 5 days at 2 -8°C and protected from light. From a microbiological point of view, the reconstituted
solution must be used immediately.
If the reconstituted solution is not used immediately, the duration and conditions of
storage are the responsibility of the user. The reconstituted solution should not be
stored for more than 24 hours in a refrigerator (2-8°C) protected from light, unless the reconstitution has not
been carried out under controlled and validated aseptic conditions.

Shelf life of the diluted solution for infusion
Chemical and physical stability in use has been demonstrated for 8 hours at room temperature and protected from
light, and for 5 days at 2-8°C and protected from light. From a microbiological point of view, the solution for
infusion must be used immediately.
If the solution for infusion is not used immediately, the duration and conditions of
storage are the responsibility of the user. The solution for infusion should not be
stored for more than 24 hours in a refrigerator (2-8°C) protected from light, unless the reconstitution and
dilution have been carried out under controlled and validated aseptic conditions.
From a microbiological point of view, it is recommended not to exceed a total storage time
of 24 hours after opening the product.