DACARBAZINE 200 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance: DACARBAZINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

200 mg
Powder for solution for injection or infusion
Dacarbazine
Read all of this leaflet carefully before you start having this
medicine.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor, nurse or
pharmacist.
– This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
– If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor, nurse
or pharmacist.
In this leaflet:
1. What Dacarbazine is and what it is used for
2. Before you have Dacarbazine
3. How you have Dacarbazine
4. Possible side effects
5. How to store Dacarbazine
6. Further information

1. WHAT DACARBAZINE IS AND WHAT IT IS USED
FOR
What Dacarbazine is
Dacarbazine belongs to a group of medicines called “cytotoxic
drugs”, often called chemotherapy. Treatment with Dacarbazine
should only be carried out by doctors who specialise in
the treatment of cancer (oncologists) or blood problems
(haematologists).
What Dacarbazine is used for
Dacarbazine is used to treat a type of skin cancer called
“metastatic malignant melanoma”. This is a type of skin cancer
which has spread to another part of your body.
Dacarbazine is also used together with other medicines for:
– Advanced cancer of a part of your immune system called
the “lymphatic system”. This type of cancer is often called
“Hodgkin’s disease”.
– Advanced soft tissue sarcoma in adults (exceptions:
mesothelioma, Kaposi sarcoma). Soft tissue sarcomas are
malignant tumours which arise from the soft tissues of the
body. Tumours may be found in many places such as around
your nerves, muscles or blood vessels.
How Dacarbazine works
Dacarbazine helps to stop your cancer cells growing and
multiplying.

2. BEFORE YOU HAVE DACARBAZINE
Do not have Dacarbazine if:
– You are allergic (hypersensitive) to dacarbazine or any of the
other ingredients of this medicine (listed in Section 6)
– You are pregnant or are breastfeeding your child
– You have a low number of white blood cells (leukopenia) or a
low number of platelets (thrombocytopenia)
– You have severe liver or kidney problems
– In combination with yellow fever vaccine
Do not have Dacarbazine if any of the above apply to you. If you
are not sure, talk to your doctor, nurse or pharmacist before using
Dacarbazine.
Take special care with Dacarbazine
Your doctor will need to ensure appropriate administration
of dacarbazine in order to prevent tissue damage and pain.
Extravasation (injection of the solution into the tissue around the
vein) can lead to tissue damage and severe pain.

Tests:
During your treatment the following things will be checked:
– Liver size and how well your liver is working (through blood
tests). This is to check that the veins in your liver are not being
blocked. If your liver is affected, treatment will be stopped.
– Amount of red, white and platelet blood cells in your blood
(through blood tests). This is to check that your bone marrow
is working properly to help create blood cells. If your bone
marrow is affected, treatment may be stopped for a while or
stopped completely.
Men who are being treated with dacarbazine are advised to take
contraceptive measures during therapy and for 6 months after the
end of therapy.
Using other medicines
Please tell your doctor or nurse if you are taking or have recently
taken any other medicines. This includes medicines obtained
without a prescription, including herbal medicines. This is
because Dacarbazine can affect the way some other medicines
work. Also some other medicines can affect the way Dacarbazine
works.
In particular, do not have this medicine and tell your doctor, nurse
or pharmacist if you are using any of the following:
– Phenytoin – for fits (seizures)
– Other medicines which might damage your liver.
Do not use Dacarbazine if any of the above apply to you. If you are
not sure, talk to your doctor, nurse or pharmacist before having
Dacarbazine.
Tell your doctor, nurse or pharmacist if you are using any of the
following:
– Radiation treatment or other medicines to reduce tumour
growth (chemotherapy). Using these medicines with
Dacarbazine can increase the damage to your bone marrow.
– Other medicines that are metabolized by a system of liver
enzymes called cytochrome P450.
– Methoxypsoralen – for skin problems such as psoriasis and
eczema. Having Dacarbazine with Methoxypsoralen can make
you more sensitive to sunlight (photosensitisation).
– Fotemustine – You should not use dacarbazine earlier than
one week after fotemustine administration to avoid damage
to your lungs.
– Cyclosporin or tacrolimus: these medicines may reduce the
function of your immune system.
If any of the above apply to you (or you are not sure), please tell
your doctor, nurse or pharmacist before having Dacarbazine.
Your doctor will decide whether use of medicines to improve the
blood flow should be given to you and will check your clotting
tendency of the blood.
Using vaccines
There is different advice for different types of vaccines:
– Yellow-fever – You must not have a yellow-fever vaccine if you
are having Dacarbazine.
– Live vaccines – You should not have a “live” vaccine if you
are having Dacarbazine. This is because Dacarbazine may
weaken your immune system and make you more likely to
catch a serious infection.
– Killed vaccines – You may have a “killed” or inactivated
vaccine if you are having Dacarbazine.
Having Dacarbazine with food and drink
– Do not eat just before having Dacarbazine. This could make
you feel less sick or be less sick.
– Do not drink alcohol during your treatment.
Pregnancy and breast-feeding
– Do not have Dacarbazine if you are pregnant or planning to
become pregnant. This is because the medicine can damage
your unborn child.
– During treatment men and women need to use a reliable
method of contraception. If you become pregnant, tell your
doctor straight away.
– Men who are being treated with Dacarbazine also need to use
a reliable method of contraception for 6 months after the end
of therapy.
– Do not breast-feed during your treatment with Dacarbazine.
Driving and using machines
You may feel sleepy, confused or having impaired vision while
having Dacarbazine. You may also feel or be sick. If any of these
happen, do not drive or use any tools or machines.

3. HOW YOU HAVE DACARBAZINE
Your doctor will decide how long your treatment should last. This
will depend upon:
– The type of cancer you have and how advanced it is
– Which treatment you are being given and how well you are
responding to it
– Whether you are having any side effects
How much you will be given
The amount you are given is worked out depending on your size
(m2 body surface area).

Skin cancer that has spread (metastatic malignant melanoma)
– The usual dose is 200 – 250 mg per m2 body surface area,
once a day.
– You are given this 5 days in a row, every 3 weeks. You then
have a break.
– It will be given as a fast injection into your vein or as a slow
infusion into your vein lasting 15 to 30 minutes.
– Alternatively, you can be given one larger dose of 850 mg per
m2 body surface area, every 3 weeks. This will be given as a
slow infusion into your vein.
Cancer of your lymphatic system (Hodgkin’s disease)
– The usual dose is 375 mg per m2 body surface area, every
15 days.
– You will also be given medicines called doxorubicin, bleomycin
and vinblastin (this combination is called the ABVD regimen).
– You will usually do this 6 times.
– It will be given as a slow infusion into the vein.
Cancer of the tissues that join your body togeher (soft tissue
sarcoma)
– The usual dose is 250 mg per m2 body surface area, once a
day.
– You will also be given a medicine called doxorubicin (this
combination is called the ADIC regimen).
– You are given this 5 days in a row, every 3 weeks. You then
have a break.
– It will be given as a slow infusion into the vein lasting 15 – 30
minutes.
Patients with kidney or liver problems
If you have either mild or moderate kidney or liver problems, you
do not usually need to have less of this medicine. If you have both
kidney and liver problems, your body will take longer to use the
medicine and remove it from your system. Your doctor may give
you less of this medicine.
Elderly people
There are no special instructions for the use of Dacarbazine in
elderly people.
Children
Until further data become available, no special recommendations
for the use of Dacarbazine in children can be given.
If you have more Dacarbazine than you should
If you think that you have been given too much Dacarbazine, tell
your doctor or nurse straight away.
– If an overdose is suspected, the numbers of your blood cells
will be checked and supportive measures such as transfusions
may be required.
– An overdose would cause severe damage to your bone marrow
(bone marrow toxicity). This can lead to a complete loss of
function of your bone marrow (bone marrow aplasia). This can
be delayed by up to 2 weeks.
If you have any further questions on the use of this product, ask
your doctor, nurse or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Dacarbazine can cause side effects, although
not everybody gets them.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor, nurse
or pharmacist.
Common (affects 1 to 10 users in 100)
– Loss of appetite (anorexia), feeling sick or being sick. If anyone
helps to clean up your sick, they must wear gloves. This is
because some of the medicine may pass into their skin.

Rare (affects 1 to 10 users in 10,000)
– Injection site reactions such as vein irritation
– Red skin (erythema), a rash with spots and blisters
(maculopapular exanthema) or a nettle rash (urticaria)
– Skin reactions where the medicine is injected
– Swelling of the face, lips, mouth and throat with difficulty
breathing (anaphylactic reaction)
– Feeling sleepy, having impaired vision
– Headache
– Fits (seizures)
– Pins and needles sensation in the face
– Diarrhoea. If anyone helps to clean up your diarrhoea, they
must wear gloves. This is because some of the medicine may
pass into their skin.
– Blood problems. These are dependent on how strong your
dose is and are most likely after 3 to 4 weeks. You may feel
tired, look pale, bruise more easily than usual or get more
infections than usual. They are shown by blood tests
· pancytopenia (all blood cells decreased)
· agranulocytosis (marked decrease in one type of white blood
cell called a “granulocyte”)
If the medicine is accidentally injected into the tissue around your
vein, it will be painful and there will be tissue damage.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor, nurse or
pharmacist.

In any case, the total time of storage in the refrigerator (2 to 8 °C)
after first opening of the product should not exceed 24 hours.

6. FURTHER INFORMATION
What Dacarbazine contains
– The active substance is dacarbazine. Each vial contains
200 mg dacarbazine. After reconstitution, the solution contains
10 mg / ml dacarbazine.
– The other ingredients are citric acid monohydrate and mannitol
(E 421).
What Dacarbazine looks like and contents of the pack
Dacarbazine is a powder for solution for injection or infusion. It is
a white powder that is made up into a clear liquid for injection or
infusion. It is packed in cartons each containing 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Lipomed GmbH
Hegenheimer Strasse 2
D-79576 Weil / Rhein
Germany
Telephone number: +49-7621-1693 472
Fax number: +49-7621-1693 474
E-Mail: lipomed@lipomed.com
This medicinal product is authorised in the Member States of
the EEA under the following names:
Austria: Dacarbazin Lipomed 200 mg Pulver zur Herstellung einer
Injektions- oder Infusionslösung
Germany: Dacarbazin Lipomed 200 mg Pulver zur Herstellung
einer Injektions- bzw. Infusionslösung
Spain: Dacarbazina Lipomed 200 mg polvo para solución
inyectable o para perfusión EFG
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
United Kingdom: Dacarbazine 200 mg powder for solution for
injection or infusion
Cyprus:

Romania:

Keep out of the reach and sight of children.

This leaflet was last approved in 09/2012

Do not use Dacarbazine after the expiry date which is stated on
the carton and bottle after EXP. The expiry date refers to the last
day of that month.

The following information is intended only for doctors and/or
medical personnel

Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
Do not store above 25 °C.
Store in the original package in order to protect from light.

Shelf life of the reconstituted solution
Chemical and physical in-use stability has been demonstrated for
1 hour at 25 °C and for 24 hours at 4 °C and protected from light.

If extravasation occurs the injection must be immediately
interrupted and the remaining dose administered in a different
vein.

Notes on safe handling
Dacarbazine is an antineoplastic agent (it reduces the growth
of cancer cells). Before preparing a solution, local cytotoxic (cell
damaging) guidelines should be referred to regarding handling
of cytotoxic agents. Dacarbazine should only be opened by
trained staff. As with all cytotoxic agents, precautions should
be taken to avoid exposing staff. Handling of cytotoxic drugs
should be generally avoided during pregnancy. Preparation of the
solution for administration should be carried out in a designated
handling area and working over a washable tray or disposable
plastic-backed absorbent paper. It is recommended that suitable
eye protection, disposable gloves, face mask and a disposable
apron are worn. Syringes and infusion sets should be assembled
carefully to avoid leaks (use of Luer lock fittings is recommended).
Once completed, any exposed surface should be thoroughly
cleaned and the hands and face washed. In the event of spillage,
operators should put on gloves, face masks, eye-protection and
a disposable apron and mop up the spilled material with an
absorbent material laid out in the area for that purpose. The area
should then be cleaned and all contaminated material transferred
to a cytotoxic spillage bag or bin or sealed for incineration.
Preparation of the solution for intravenous dosing
(administration into a vein)
Dacarbazine solutions should be prepared immediately before
use. Dacarbazine is sensitive to light. During the treatment the
infusion container and infusion set has to be protected from light,
for example by using a light-resistant PVC infusion set. Other
infusion sets should, for example, be wrapped in light resistant
aluminium foil.
Preparation and administration of the solution for injection /
infusion
Dacarbazine 200 mg powder for solution for injection or infusion
will be reconstituted with 19.7 ml of water for injections, that
means the powder will be completely dissolved. The resulting
solution contains 10 mg / ml dacarbazine. The solution will be
given as a slow injection – it will be injected slowly into a vein.
At higher doses, the reconstituted solution will be diluted with
200 ml glucose 5 % or sodium chloride solution 0.9 % and infused
intravenously over 15 to 30 minutes (given slowly into a vein).
Dacarbazine is for single use only.

Denmark: Dacarbazine Lipomed 200 mg pulver til injektions- og
infusionsvæske, opløsning
Finland: Dacarbazine Lipomed 200 mg injektio- / infuusiokuivaaine liuosta varten
Norway: Dacarbazine Lipomed 200 mg pulver til injeksjons- /
infusjonsvæske, oppløsning
Ireland: Dacarbazine Lipomed 200 mg powder for solution for
injection or infusion
Poland:

5. HOW TO STORE DACARBAZINE

Do not use Dacarbazine if the solution is cloudy or has bits floating
in it.

The solution must be administered carefully to avoid extravasation
(injection of the solution into the tissue around the vein), as this
can cause local pain and tissue damage.

It is recommended that the patency of the vein is tested with 5
to 10 ml of isotonic sodium chloride solution or glucose 5 %. The
same solution will be used to rinse the remaining medicine out of
the infusion tube.

Administration of the injection / infusion
After reconstitution (preparation of the solution) with water for
injections and without further dilution with isotonic sodium
chloride solution or glucose 5 %, Dacarbazine preparations
are hypo-osmolar (ca. 100 mOsmol / kg) which means that the
solutions contain a lower concentration of dissolved substances
than blood; it should therefore be given by slow intravenous
injection, e. g., over 1 minute and not as an i. v. bolus injection
(fast injection) over a few seconds.
Dacarbazine is sensitive to light. Reconstituted solutions must
therefore be protected from light, including during the infusion
(light-resistant infusion set).

Dacarbazine solution is chemically incompatible with the
medicinal products heparin, hydrocortisone, L-cysteine and
sodium hydrogen carbonate; this means that dacarbazine
solution should not be mixed with medicines that contain these
substances. This medicinal product must not be mixed with other
medicinal products except those mentioned above.

Shelf life of the reconstituted solution
Chemical and physical in-use stability has been demonstrated for
1 hour at 25 °C and for 24 hours at 4 °C and protected from light.
From a microbiological point of view, the reconstituted solution
should 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 longer than
24 hours in the refrigerator (2 to 8 °C) and protected from light,
unless reconstitution has taken place in controlled and validated
aseptic conditions.
Shelf life of diluted solution for infusion
Chemical and physical in-use stability has been demonstrated for
30 minutes at 25 °C and for 8 hours at 4 °C and protected from
light.
From a microbiological point of view, the diluted solution should
be used immediately.
If the diluted solution for infusion is not used immediately, the
duration and conditions of storage are the responsibility of the
user. The diluted solution for infusion should not be stored for
longer than 8 hours in the refrigerator (2 to 8 °C) and protected
from light, unless reconstitution has taken place in controlled and
validated aseptic conditions.
In any case, the total time of storage in the refrigerator (2 to 8 °C)
after first opening of the product should not exceed 24 hours.

201209

Uncommon (affects 1 to 10 users in 1,000)
– Flu-like symptoms such as tiredness, chills, fever or muscle
pain. These are more likely in the first few days of each
treatment cycle
– Abnormal kidney function or increased liver enzymes (shown
in tests)
– Liver damage (hepatotoxicity)
– Blockage of a vein in your liver (also called Budd-Chiari
syndrome)
– Liver tissue damage (necrosis) due to blockage of a vein in your
liver. The signs include fever, stomach pain, yellow eyes and
skin (jaundice). Your doctor would also be able to see that your
liver was larger and you would have changes in the numbers
of your blood cells. This is most likely in your second cycle.
– Dark patches on your skin (hyperpigmentation)
– Increased sensitivity of your skin to sunlight (photosensitivity)
– Hair loss (alopecia)
– Feeling confused
– Flushed face
– Transient rash
– Blurred vision

Shelf life of diluted solution for infusion
Chemical and physical in-use stability has been demonstrated for
30 minutes at 25 °C and for 8 hours at 4 °C and protected from
light.

DAC-553.L.200.020.UK10

– Blood problems. These are dependent on how strong your
dose is and are most likely after 3 to 4 weeks. You may feel
tired, look pale, bruise more easily than usual or get more
infections than usual. They are shown by blood tests:
· anaemia (decreased red blood cells)
· leukopenia (decreased white blood cells)
· thrombocytopenia (decreased platelets)
· bone marrow suppression (decreased formation of all blood
cells in the bone marrow)

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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