PACKAGE LEAFLET
Patient
Information Leaflet
Read
all of this leaflet carefully before you receive
this medicine.
-
Keep this leaflet. You may need to read it
again.
-
If you have further questions, please 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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1. What DepoCyte is and what it is given for
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2. Before you are given DepoCyte
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3. How is DepoCyte given
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4. Possible side effects
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5. Storing DepoCyte
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6. Further information
1. WHAT
DEPOCYTE IS AND WHAT IT IS GIVEN FOR
DepoCyte is
used to treat lymphomatous meningitis.
Lymphomatous
meningitis is a condition in which lymphoma tumour cells
have invaded the fluid or membranes that surround the
brain and spinal cord.
DepoCyte is
used in adults to kill lymphoma tumour cells.
2.
BEFORE YOU ARE GIVEN DEPOCYTE
DepoCyte should not be given:
-
If you are allergic (hypersensitive) to
cytarabine or any of the other ingredients.
-
If you have a meningeal infection.
Taking other medicines:
Please
inform your doctor or physician if you are taking or
using any other medicines, including medicines
obtained without a prescription.
Pregnancy and breast-feeding
DepoCyte
should not be given to pregnant women as it may harm
an unborn child. Women of childbearing potential
should use a reliable contraceptive to avoid
pregnancy whilst being treated with DepoCyte.
Male
patients undergoing DepoCyte treatment should use a
reliable contraceptive method.
Women
should not breast-feed during treatment as DepoCyte
may enter breast milk.
Driving and using machines
Do not
to drive during treatment
Do not
operate any tools or machines during treatment.
3. HOW
IS DEPOCYTE GIVEN
A qualified
and experienced doctor or physician in the treatment of
cancer will inject DepoCyte in the spinal fluid or
lumber sac. DepoCyte must not be administered by any
other way. Injections are given slowly over a few
minutes and you may be asked to lie flat for one hour
afterwards.
You will
also be given corticosteroids, such as dexamethasone,
usually as tablets but possibly by intravenous injection
for 5 days after you receive each DepoCyte dose to help
reduce any side-effects which might occur.
DepoCyte
must be used as supplied without further dilution. The
dose for adults is 50 mg (one vial of DepoCyte).
For the
treatment of lymphomatous meningitis, DepoCyte is given
according to the following schedules:
Start-up treatment: one vial
of DepoCyte (50 mg) administered every 14 days for 2
doses (weeks 1 and 3).
Follow-up treatment: one vial
of DepoCyte (50 mg) administered every 14 days for 3
doses (weeks 5, 7 and 9) followed by an additional dose
at week 13.
Maintenance treatment: one
vial of DepoCyte (50 mg) administered every 28 days for
4 doses (weeks 17, 21, 25 and 29).
If
you are given more DepoCyte than you should:
The
recommended dose will be given to you by the doctor
or physician as necessary. There is no antidote for
DepoCyte. Management of overdose should be directed
at maintaining vital functions.
4.
POSSIBLE SIDE EFFECTS
Like all
medicines, DepoCyte can cause side effects, althought
not everyone gets them. Side effects may occur after
each injection, usually within the first five days.
Tell the
medical staff, who will be monitoring you during this
time, if you suffer from:
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Pain, numbness or tingling (feeling of sensation of
pins and needles)
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Nausea and/or vomiting
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Weakness
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Confusion
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Fever
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Headaches
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Fatigue
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Convulsion
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Dizziness
- Neck
pain
- A
stiff or rigid neck
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Partial paralysis
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Blindness and other visual disturbances
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Shaking
- Back
pain
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Persistant or extreme sleepiness
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Hearing loss
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Infection of the meninges
If any of
the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please inform the
medical staff looking after you.
5.
STORING DEPOCYTE
Keep out of
the reach and sight of children.
Do not use
DepoCyte after the expiry date which is stated on the
carton and vial.
Store in a
refrigerator (2°C - 8°C).
Do not
freeze.
6.
FURTHER INFORMATION
What
DepoCyte contains
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The active substance is 50 mg cytarabine (10
mg/ml)
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The other active ingredients are cholesterol,
triolein, dioleoylphosphatidylcholine,
dipalmitoylphosphatidylglycerol, sodium chloride
and water for injections.
What
DepoCyte looks like and contents of the pack
Depocyte
is a vial containing a white to off-white-suspension
for injection.
Each
vial contains 5 ml of suspension for a single
injection.
Each
pack contains a single vial.
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