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Cisplatin Sterile Concentrate

Cisplatin 1 mg/ml Sterile Concentrate

1. What Cisplatin Sterile Concentrate is and what it is used for

Cisplatin Sterile ConcentrateCisplatin Sterile Concentrate is an anti-cancer medicine in the form of a concentrate for solution for infusion (a concentrated solution which is diluted to make a solution which can be given as a slow injection via a drip). Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.

Each millilitre (ml) of solution contains 1 milligram (mg) of cisplatin. This medicine is presented in glass containers called vials. The 10 ml vial contains 10 mg of cisplatin, the 50 ml vial contains 50 mg of cisplatin and the 100 ml vial contains 100 mg of cisplatin. It is available in packs containing a single vial and 10 vials (not all the presentations and pack sizes mentioned may be marketed)

Cisplatin is used in the treatment of certain types of cancer, for example ovarian cancer, testicular cancer, bladder cancer and head and neck cancer. Cisplatin may be used in combination with other anti-cancer medicines.

2. Before Cisplatin Sterile Concentrate is used

Cisplatin Sterile Concentrate should not be used:

  • if you have shown signs of hypersensitivity (severe allergy) to cisplatin or similar medicines on previous occasions
  • if you have severe kidney disease
  • if you have hearing difficulties
  • if you have fewer blood cells than normal (your doctor will check this)
  • if you are pregnant or trying for a baby
  • if you are breastfeeding

Special care will be taken:

if you are taking certain other medicines, such as:

  • other medicines that may affect your kidneys or hearing e.g. furosemide (water tablet), gentamicin (antibiotic)
  • other anti-cancer medicines e.g. bleomycin, methotrexate
  • phenytoin (medicine often used to treat epilepsy)

Please tell your doctor if you are taking, or have recently taken, any other medicines, including ones that are not prescribed for you.

Do not drive or use machines:

  • if you feel drowsy
  • if you experience any other effect which may impair your ability to drive or use machines

Male and female patients should take contraceptive measures during and for at least three months after therapy. As in the case with all anticancer drugs, in men this drug may cause temporary or permanent sterility.

3. How Cisplatin Sterile Concentrate is used

Cisplatin Sterile ConcentrateThe dose of medicine given to you will depend on your health, how well your kidneys are working and any other medicines you may be taking. Cisplatin is given as a single dose every 3 to 4 weeks or as a daily dose for 5 days every 3 to 4 weeks.

The medicine will be diluted in 0.9% sodium chloride (salt water) before it is given to you. It will be given slowly, usually via a drip into a vein over a period of 1 to 2 hours, but it may also be given over 6 to 8 hours. Before and after treatment you will normally be given an infusion of fluids to increase the amount of urine you produce. You should drink plenty of fluids for 24 hours after treatment.

Before treatment is started your doctor will carry out blood tests to check the levels of cells (red blood cells, white blood cells and platelets) in your blood, and also to check how well your kidneys are working. Further tests may also be done during and after treatment. You may also have a hearing test before and regularly during treatment.

As this medicine will be given to you whilst you are in hospital 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, cisplatin can have side effects.

If any of the following happen, tell your doctor immediately:

severe allergic reaction — you may experience swelling of the face, wheezing, increased heart rate, a sudden itchy rash and you may feel you are going to faint.

•     heart and circulatory problems such as chest pain or stroke.

These are very serious side-effects. You may need urgent medical attention. These very serious side-effects are rare.

If you experience any of the following tell your doctor as soon as possible: feeling or being sick loss of appetite, anorexia temporary loss or changes to your eyesight ringing in the ears or changes in your hearing changes in the number of red cells, white cells and platelets in your blood may occur and there may be alterations in your kidney function so that changes in your blood chemistry may occur. Your doctor will monitor for these by blood tests, spasms tingling or tremor in your hands and feet taste loss seizures

  • the blood flow to your fingers and toes may be affected, which could mean that they become pale in colour and can be sensitive fast or irregular heart beats, chest pain
  • swelling or soreness where the injection was given

If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

5.Storing Cisplatin Sterile Concentrate

Keep out of the reach of children.

The vials should not be stored above 25 °C. They should not be kept in the refrigerator or frozen. Vials should be kept in the outer carton to protect from light.

This medicine should not be used after the expiry date printed on the vial label and carton.

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