PATIENT
INFORMATION LEAFLET
This
leaflet contains important information about your
medicine; read it carefully.
Keep
this leaflet; you may want to read it again.
If you
have any questions or are not sure about anything,
ask your doctor or pharmacist.
Cisplatin 1 mg/ml Sterile Concentrate
- The
active substance is cisplatin
- The
other ingredients are mannitol, sodium chloride,
dilute hydrochloric acid and Water for Injections.
The
marketing authorisation holder and company responsible
for batch release in the European Union is
1. What
Cisplatin Sterile Concentrate is and what it is used for
Cisplatin
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
The 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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