DACARBAZINE 200 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:
- 1. What Dacarbazine Powder for Solution for Injection is and what it is used for
- 2. Before you use Dacarbazine Powder for Solution for Injection
- 3. How to use Dacarbazine Powder for Solution for Injection
- 4. Possible side effects
- 5. How to store Dacarbazine Powder for Solution for Injection
- 6. Further information
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.
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 and some other types of vaccines (live attenuated)
- in combination with phenytoin (a medicine used to prevent convulsions).
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.
Pregnancy and breast feeding
Do not use Dacarbazine:
- if you are pregnant or trying to become pregnant
- if you are breast feeding
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’.
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.
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):
- pallor (anaemia)
- loss of appetite
- nausea/vomiting
Uncommon (Less than 1 in 100 patients but more than 1 in 1000):
- confusion
- 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)
Rare (less than 1 in 1000 patients but more than 1 in 10,000)
- diarrhoea
- bruising
- increased sensitivity of the skin to sunlight (photosensitivity)
Very rare (less than 1 in 10,000)
- redness of the skin/rash
- itching
Blood samples will be taken to check for changes in blood cells levels, which is a common side effect of Dacarbazine treatment. 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. Kidney and liver problems are uncommon.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
HOW TO STORE DACARBAZINE 200 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.
Further Information
What Dacarbazine Powder for Solution for Injection contains
The medicine is presented in glass containers called vials containing 200 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.
Each single-dose vial contains 200 mg of Dacarbazine. When reconstituted each ml of solution contains 10 mg of dacarbazine.
The 200 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
The Manufacturer is
This leaflet was last approved in
08/2006
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