DACARBAZINE 600MG POWDER FOR SOLUTION FOR INJECTION

Active substance: DACARBAZINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DACARBAZINE 600 mg POWDER FOR SOLUTION FOR INJECTION
Read all of this leaflet carefully before you start using this medicine
Keep this leaflet. You may need to read it again.
If you have any further questions ask your doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor.
In this leaflet:
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3.
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What Dacarbazine Powder for Solution for Injection is and what it is used for
Before you use Dacarbazine Powder for Solution for Injection
How to use Dacarbazine Powder for Solution for Injection
Possible side effects
How to store Dacarbazine Powder for Solution for Injection
Further information

1. WHAT DACARBAZINE POWDER FOR SOLUTION FOR INJECTION IS AND WHAT IT IS
USED FOR
Dacarbazine Powder for Solution for Injection is an anti-cancer medicine, in the form of a powder for
solution for injection. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.
Dacarbazine Powder for Solution for Injection may be used for the treatment of some types of cancer, for
example: metastatic malignant melanoma (a type of skin cancer that has spread) and Hodgkin’s disease and
some types of cancer in soft tissues.
2. BEFORE YOU USE DACARBAZINE POWDER FOR SOLUTION FOR INJECTION
Do not use Dacarbazine Powder for Solution for Injection

if you have shown signs of hypersensitivity (severe allergy) to dacarbazine on previous occasions

if you have severe liver or kidney diseases

in combination with yellow fever vaccine.

if you are pregnant, trying to become pregnant or are breast feeding
Taking/using other medicines
Special care should be taken if you are taking other medicinal products which could interact with Dacarbazine:

ciclosporin or tacrolimus (medicines used after having a transplant)

fotemustine (a medicine used in cancer treatment)

medicines which could damage your liver

warfarin (a medicine used to thin the blood). Your doctor may need to do your blood test (INR) more
often.
Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines
obtained without a prescription.
Taking with Food and Drink
You should avoid alcohol while receiving chemotherapy treatment with dacarbazine.
Pregnancy and breast feeding
Do not use Dacarbazine:

if you are pregnant or trying to become pregnant

if you are breast feeding
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Driving and using machines
Dacarbazine may influence the ability to drive or operate machinery because of nausea and vomiting or rare
adverse reactions affecting the nervous system.
Important information about one of the ingredients of Dacarbazine Powder for Solution for Injection
This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium free’.
3. HOW TO USE DACARBAZINE POWDER FOR SOLUTION FOR INJECTION
This medicinal product is for intravenous use (injection into a vein).
Your treatment will usually be given to you in hospital.
You will be given Dacarbazine as an infusion (slow injection via a drip) into a vein or a slow intravenous
injection(injection into a vein).
Tell your doctor or nurse at once if you notice any pain at the injection site during or shortly after treatment.
Pain around the injection site could mean the needle has not been properly inserted into the vein.
The dose of dacarbazine will depend on the illness for which you are being treated. The dose is calculated
according to your body surface area (expressed as mg/m2).
Depending on your illness, dosing is typically between 200 and 850 mg/m2 of dacarbazine.
As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little
or too much. However, tell your doctor or pharmacist if you have any concerns.
4. POSSIBLE SIDE EFFECTS
Like all medicines Dacarbazine Powder for Solution for Injection can have side effects although not
everybody gets them.
If any of the following happen, tell your doctor immediately:
• severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet,
ankles, face, lips, mouth and throat (which may cause difficulty in swallowing or breathing), and you may
feel you are going to faint.
This is a very serious side effect. You may need urgent medical attention. This very serious side effect is
rare.
If you experience any of the following tell your doctor as soon as possible:
Common (less than 1 in 10 patients but more than 1 in 100):

blood problems: they are dependent on how strong your dose is and are more 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:

decreased red blood cells (anaemia)

decreased white blood cells (leukopenia)

decreased platelets (thrombocytopenia)

decreased formation of all blood cells in the bone marrow (bone marrow suppression)

loss of appetite

nausea/vomiting
Uncommon (Less than 1 in 100 patients but more than 1 in 1000):

confusion
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fits (seizures)
numbness of the skin or pins and needles sensation in the face (paraesthesia)
headache
blurred vision
facial flushing
hair loss (alopecia)
transient rash
an influenza (‘flu’) type syndrome of fever, muscle pain (myalgia) and generally feeling unwell
(malaise) which may start approximately one week after treatment and may last for up to three weeks
tiredness and weakness (lethargy)
abnormal kidney and liver function (shown in tests)
liver damage (hepatotoxicity)
blockage of a vein in your liver (also called Budd-Chiari syndrome) resulting in liver tissue damage
(necrosis), in some cases even to death. The signs include fever, stomach pain and 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.

Rare (less than 1 in 1000 patients but more than 1 in 10,000)

diarrhoea

irritation at the injection site

increased sensitivity of the skin to sunlight (photosensitivity)
Very rare (less than 1 in 10,000)

swelling of the face, lips, mouth and throat with difficulty breathing (anaphylactic reactions)

redness of the skin (erythema)

rash with spots and blisters (maculopapular exanthema)

nettle rash (urticaria)

itching
Blood samples will be taken to check for changes in blood cells levels. Blood and urine tests will be
performed to check for changes in kidney function. Blood tests may be performed to check that your liver is
working properly.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor .
5. HOW TO STORE DACARBAZINE 600 mg POWDER FOR SOLUTION FOR INJECTION
Keep out of the reach and sight of children
The vials should be stored at 2 - 8°C with the vials kept in the outer carton (in order to protect from light).
This medicine should not be used after the expiry date printed on the vial label.
6. FURTHER INFORMATION
What Dacarbazine Powder for Solution for Injection contains
The medicine is presented in glass containers called vials containing 600 mg dacarbazine. Each pack
contains 1 vial.
• The active substance is dacarbazine
• The other ingredients are citric acid monohydrate, mannitol and sodium hydroxide
What Dacarbazine Powder for Solution for Injection looks like and contents of the pack
The powder is a white or pale yellow solid.
The vial containing the powder is a glass container with a rubber stopper.
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Each single-dose vial contains 600 mg of Dacarbazine. When reconstituted each ml of solution contains 10
mg of dacarbazine.
The 600 mg presentation of Dacarabazine is sold in packs containing 1 vial of powder
Marketing Authorisation Holder and Manufacturer
The Marketing authorisation holder and company responsible for batch release in the European Union is
Hospira UK Limited, Queensway,Royal Leamington Spa, Warwickshire, CV31 3RW, UK.
The Manufacturer is Hospira Pty Limited, Lexia Place, Mulgrave, Victoria 3170, Australia.
This leaflet was last approved in May 2013
----------------------------------------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
Further to the information included in Section 3 practical information on the preparation/handing of the
medicinal product is provided here.

Incompatibilities
Dacarbazine Powder for Solution for Injection is incompatible with hydrocortisone sodium succinate in
solution, forming an immediate precipitate. It is also incompatible with L-cysteine and sodium hydrogen
carbonate. It has been reported to be incompatible with heparin, although only with concentrated solutions
(25 mg/ml). Dacarbazine Powder for Solution for Injection must not be mixed with other medicinal products
except with Dextrose Injection 5% or Sodium Chloride Injection 0.9%.
Preparation Instructions
This is a cytotoxic medicinal product; please follow your local policy guidelines for instructions on the safe
handling/destruction of cytotoxics.
General Cytotoxic Handling Guidelines: The preparation of injectable solutions of cytotoxic agents must be
carried out by trained specialist personnel with knowledge of the medicines used, in conditions that
guarantee the protection of the environment and, in particular, the protection of the personnel handling the
medicines. It requires a preparation area reserved for this purpose. It is forbidden to smoke, eat or drink in
this area.
Pregnant women must be warned to avoid handling cytotoxic agents.
Personnel must be provided with appropriate handling materials, notably long sleeved gowns, protection
masks, caps, protective goggles, sterile single-use gloves, protective covers for the work area and collection
bags for waste.
In case of contact of the medicinal product with the eye, wash the eye thoroughly with water. If the substance
is splashed accidentally onto the skin, wash the skin with large amounts of water and then with a soft soap.
Rinse thoroughly.
The patient’s excreta and vomit must be handled with care.
Preparation: All operations such as reconstitution and dilution should be carried out only under aseptic
conditions in a suite or cabinet dedicated for the assembly of cytotoxics.
It is recommended that dacarbazine solutions should be prepared immediately before use.

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Dacarbazine Powder for Solution for Injection 600 mg vials should be reconstituted with 59.1 ml of Water
for Injections BP. The resulting solution contains the equivalent of 10 mg/ml of dacarbazine and has a pH of
3 to 4. The resultant solution is hypo-osmolar and therefore should be given by slow intravenous injection
over one to two minutes.
Dacarbazine is sensitive to light. Reconstituted solutions should be suitably protected from light.
If desired, the reconstituted solution can be further diluted with 125 - 250 ml of Dextrose Injection 5% or
Sodium Chloride Injection 0.9% and administered by intravenous infusion over 15 - 30 minutes. During
administration, the infusion set should be protected from exposure to daylight e.g. by using light-resistant
PVC infusion sets. If normal infusion sets are used, then these should be covered to protect from light.
Before being administered, the solution should be visually inspected in order to detect possible presence of
particles or discolouration. Dacarbazine is photosensitive, with exposure to light causing a colour change
from pale yellow to pink. The product should not be used if it appears pink in colour.
Disposal: Vials, materials that have been utilised for dilution, and any other contaminated material should be
placed in a thick plastic bag or other impervious container and incinerated.
Any broken container must be treated with the same precautions and considered as contaminated waste.
Contaminated waste should be incinerated in suitably labelled rigid containers.
Storage
Reconstituted and diluted solutions should be protected from light.
The physical and chemical in-use stability:
Storage conditions
Reconstituted solution 96 hours at 2 - 8°C
Further diluted with 5% dextrose or 0.9% sodium chloride 24 hours at 2 - 8°C
From a microbiological point of view, the product should be used immediately. If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be
longer than 24 hours at 2 to 8°C, unless reconstitution or dilution has taken place in controlled and validated
aseptic conditions.

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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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