Doxorubicin 2 mg/ml Concentrate for solution for infusion

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 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 or pharmacist.

In this leaflet:

1. What Doxorubicin 2 mg/ml is and what it is used for
2. Before you use Doxorubicin 2 mg/ml
3. How to use Doxorubicin 2 mg/ml
4. Possible side effects
5. How to store Doxorubicin 2 mg/ml
6. Further information

Do not use Doxorubicin 2 mg/ml

• if you are hypersensitive (allergic) to doxorubicin or any of the other ingredients of Doxorubicin 2 mg/ml, or to other anthracyclines or anthracenediones (anti-cancer medicines)
• if you are pregnant or breastfeeding

Intravenous medication must not be used if:

• you have decreased bone marrow function or if severe oral mucositis (inflammation of the mouth) has occurred during previous cytotoxic therapy
• you have a generalised infection
• you have severe hepatic impairment (liver damage)
• you have severe arrhythmia (irregular heart beat), cardiac impairment (problems with your heart function) or you have had a heart infarction (heart attack)
• you have had prior treatment with anthracycline in excess of a certain cumulative level

Intravesical (placed directly into the bladder through a catheter) medication must not be used if:

• you have a tumour that has penetrated the bladder wall
• you have a urinary tract infection
• you have a bladder infection
• there are problems with catheterisation (insertion of a small plastic tube into the urethra)

Take special care with Doxorubicin 2 mg/ml:

• if you have a bone marrow disease
• if you have decreased bone marrow function
• if you have had prior treatment with anthracycline
• if you have had mediastinal irradiation (radiotherapy in the region between the lungs, where the heart and major blood vessels are located)
• if you have hepatic impairment (liver damage) or blocked bile flow
• if you have severe renal impairment (kidney damage)

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, inform your doctor if you have used the following medicines:

• other anthracyclines
• other preparations with cardiac toxicity (damage to the heart muscles), such as 5- fluorouracil, cyclophosphamide and paclitaxel (anti-cancer medicines)
• preparations that have an effect on cardiac function, such as calcium antagonists
• other preparations with hepatic toxicity, such as 6-mercaptopurine (immunosuppressive medicines)
• cyclosporine (immunosuppressive medicine)
• verapamil (calcium channel blocker used for heart problems)
• digoxin (used in the treatment of abnormal heart rhythms)

Patients should not be vaccinated during treatment with Doxorubicin 2 mg/ml, and they should avoid people who have recently received a live oral polio vaccination.

Taking Doxorubicin 2 mg/ml with food and drink:

Doxorubicin 2 mg/ml may be taken with or without food. If the medicine is administered intravesically, patients should not drink any fluids in the 12 hours prior to instillation.

Pregnancy

Doxorubicin 2 mg/ml should not be used during pregnancy. During pregnancy, cytotoxic agents (chemicals which are harmful to cells) are generally administered only after careful consideration of their benefits to the mother and the risks to the foetus.

Both men and women should use effective contraception during and up to 6 months after treatment.

Breastfeeding

Doxorubicin 2 mg/ml is excreted into breast milk. Breastfeeding should be discontinued for the duration of treatment with doxorubicin.

Driving and using machines

The effect of this medicine on the ability to drive and use machinery has not been studied.

The medicinal product contains 3.54 mg sodium per 1 ml of doxorubicin hydrochloride concentrate for solution for infusion. This should be taken into consideration by patients on a controlled sodium diet.

What Doxorubicin 2 mg/ml contains

1 ml of Doxorubicin 2 mg/ml contains 2 mg of the active substance doxorubicin hydrochloride.

• Each 5ml vial contains 10 mg Doxorubicin hydrochloride.
• Each 10ml vial contains 20 mg Doxorubicin hydrochloride.
• Each 25ml vial contains 50 mg Doxorubicin hydrochloride.
• Each 50ml vial contains 100 mg Doxorubicin hydrochloride.
• Each 100ml vial contains 200 mg Doxorubicin hydrochloride.

The product contains sodium chloride (3.54 mg sodium per 1 ml).

The other ingredients are sodium chloride, hydrochloric acid and water for injections.

What Doxorubicin 2 mg/ml looks like and contents of the pack

Doxorubicin 2 mg/ml is a red, clear concentrate for solution for infusion.

It is available in the following pack sizes:

Glass vial, type I glass.

Pack sizes: 5 ml, 10 ml, 25 ml, 50 ml and 100 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder in the UK:

Manufacturer in the UK:

Manufacturer in the IE: