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CISPLATIN 1MG/ML STERILE CONCENTRATE

Active substance: CISPLATIN

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Cisplatin 1 mg/ml Sterile Concentrate
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.
• 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 Cisplatin Sterile Concentrate is and what it is used for
2. Before you use Cisplatin Sterile Concentrate
3. How to use Cisplatin Sterile Concentrate
4. Possible side effects
5. How to store Cisplatin Sterile Concentrate
6. Further information

1. WHAT CISPLATIN STERILE CONCENTRATE IS AND WHAT IT IS
USED FOR
Cisplatin Sterile Concentrate is an anti-cancer medicine. Treatment
with an anti-cancer medicine is sometimes called cancer
chemotherapy.
Cisplatin is used in the treatment of some types of cancer, for
example ovarian cancer, testicular cancer, bladder cancer and
cancer of the head and neck. Cisplatin may be used in combination
with other anti-cancer medicines.

2. BEFORE YOU USE CISPLATIN STERILE CONCENTRATE
Do not use Cisplatin Sterile Concentrate
• if you have shown signs of hypersensitivity (severe allergy) to
cisplatin or similar anti-cancer medicines in the past
• if you have severe kidney disease
• if you have hearing difficulties
• if you have fewer blood cells than normal (your doctor will check
this with a blood test)
Tell your doctor if the above applies to you before this medicine is
used.

Take special care with Cisplatin Sterile Concentrate
• if you have any symptoms of nerve damage (peripheral
neuropathy) such as pins and needles, numbness or poor sense
of touch
• if you have had radiation therapy to your head
Tell your doctor if either of the above applies to you before this
medicine is used.

Taking/using other medicines
Special care is needed if you are taking/using other medicines as
some could interact with cisplatin, for example:
• some antibiotics, such as gentamicin and antibiotics of the same
family, may make the side effects of cisplatin worse; particularly
kidney trouble or hearing loss
• some water tablets, such as furosemide, may make the hearing
loss side effect of cisplatin worse
• bleomycin (anti-cancer medicine) and methotrexate (used to treat
cancer or arthritis) may produce more side effects if cisplatin is
also being used
• cisplatin may reduce the effectiveness of phenytoin (used to
treat epilepsy) so the blood levels of phenytoin may need to be
checked
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
Tell your doctor if you are pregnant, trying to become pregnant or
breast-feeding. Your doctor will decide if you should receive this
medicine.
Due to the possible risk of birth defects, male and female patients
should take contraceptive measures both during treatment with
cisplatin and for at least three months after treatment has ended.
Ask your doctor or pharmacist for advice before taking any
medicine.

Driving and using machines
Do not drive or use machines if you experience any side effect which
may lessen your ability to do so.

Important information about one of the ingredients of
Cisplatin Sterile Concentrate
This medicinal product contains 1.5 mmol sodium (35 mg) per vial.
To be taken into consideration by patients on a controlled sodium
diet.

3. HOW TO USE CISPLATIN STERILE CONCENTRATE
This medicine will be diluted before it is given to you. It will then be
given by infusion (drip) into a vein over a period of 1 to 8 hours.
You will be given infusions of fluids before and after your cisplatin to
increase the amount of urine you produce. You should drink plenty
of fluids for 24 hours after treatment to help reduce side effects.
Your doctor will carry out blood tests before each treatment to check
how well your kidneys are working. You may also have a hearing
test before each treatment.

Dose
Your doctor will work out the correct dose of cisplatin for you and
how often it must be given. The dose will depend on your medical
condition and your size.
Cisplatin is usually given as a single dose every 3 to 4 weeks or as
a daily dose for 5 days every 3 to 4 weeks.

Cisplatin 1 mg/ml Sterile Concentrate
The following information is intended for medical or healthcare
professionals only
Further to the information included in section 3, practical information on
the preparation/handling of the medicinal product is provided here.

Incompatibilities
Cisplatin may interact with metal aluminium to form a black precipitate
of platinum. All aluminium-containing IV sets, needles, catheters and
syringes should be avoided.
There is a total loss of cisplatin in 30 minutes at room temperature
when mixed with metoclopramide and sodium metabisulphite in
concentrations equivalent to those that would be found on mixing with
a commercial formulation of metoclopramide.
Cisplatin and sodium bisulphite have been known to react chemically.
Such antioxidants might inactivate cisplatin before administration if they
are present in intravenous fluids.

Dilution
The vials are for single use only. Discard any unused contents.
Cisplatin 1 mg/ml Sterile Concentrate should be diluted in 2 litres of
0.9% sodium chloride injection.
Following dilution in 0.9% sodium chloride injection, chemical and
physical in-use stability has been demonstrated for up to 14 days at 20°C.
The diluted product should not be refrigerated. From a microbiological
point of view, however, the product should be used immediately. If not
used immediately, in-use storage times and conditions prior to use are
the responsibility of the user and dilution should take place in controlled
and validated aseptic conditions.
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If you are given too much or too little Cisplatin Sterile
Concentrate
This medicine will be given to you in a hospital, under the supervision
of a doctor. It is unlikely that you will be given too much or too little,
however, tell your doctor or nurse if you have any concerns.

4. POSSIBLE SIDE EFFECTS
Like all medicines, cisplatin can cause 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 or
throat (which may cause difficulty in swallowing or breathing), and
you may feel you are going to faint
• severe chest pains possibly radiating to the jaw or arm with
sweating, breathlessness and nausea
• fainting or fitting
• pain or swelling at the injection site during the injection (may be
due to the injection not going into the vein properly, which can
lead to serious damage to the tissues around the injection site)
These are serious side effects. You may need urgent medical
attention.

If any of the following happen, tell your doctor as soon as
possible:
• problems with your eyesight (blurred vision, odd colours, loss of
vision or eye pain)
• ringing in the ears or changes in your hearing
• seizures (fits)
• problems with your kidneys or urine
• persistent headache
• fast or irregular heart beats
• fainting
• stroke
• cramps or spasms
• tingling, numbness or tremor in your hands, feet, arms or legs
• burning or prickling sensation
• unexpected bruising or bleeding
• extreme tiredness/weakness
• signs of infection such as fever or sore throat
• mouth ulcers
• unusually cold or white hands and feet
• taste loss
• feeling or being sick
• loss of appetite, anorexia
• swelling or soreness where the injection was given
Cisplatin may lead to problems with your blood, liver and kidneys.
Your doctor will take blood samples to check for these problems.
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.

Effects on fertility
Treatment with cisplatin may temporarily or permanently reduce
fertility in men. Tell your doctor if you have concerns.

5. HOW TO STORE CISPLATIN STERILE CONCENTRATE
Keep out of the reach and sight of children

Expiry
This medicine must not be used after the expiry date which is stated
on the vial label and carton after ‘EXP’. Where only a month and
year is stated, the expiry date refers to the last day of that month.

Storage
The vials should not be refrigerated or frozen, and they should not
be stored above 25°C.
The vials should be kept in the outer carton in order to protect from
light.
Prepared infusions should be used immediately, however, if this
is not possible they can be stored for up to 14 days provided they
have been prepared in a way to exclude microbial contamination.
The prepared infusions should not be refrigerated.

6. FURTHER INFORMATION
What Cisplatin Sterile Concentrate contains
The active substance is cisplatin. Each millilitre (ml) of solution
contains 1 milligram (mg) of cisplatin.
The other ingredients are mannitol, sodium chloride, dilute
hydrochloric acid and Water for Injections.

What Cisplatin Sterile Concentrate looks like and contents of
the pack
Cisplatin Sterile Concentrate is a clear, colourless to pale yellow
concentrate for solution for infusion which comes in glass containers
called vials.
It
1
1
1

may be supplied in packs containing:
or 10 x 10 mg/10 ml vial
or 10 x 50 mg/50 ml vial
or 10 x 100 mg/100 ml vial

Not all pack sizes may be marketed

Marketing authorisation holder and manufacturer responsible
for batch release in Europe
Hospira UK Limited, Queensway, Royal Leamington Spa,
Warwickshire, CV31 3RW

Manufacturer
Hospira Australia Pty Ltd, Lexia Place, Mulgrave, Victoria 3170,
Australia
This leaflet was last approved in
10/2008.


Cytotoxic Handling Guidelines
Administration: Should be administered only by or under the direct
supervision of a qualified physician who is experienced in the use of
cancer chemotherapeutic agents.
Preparation: Chemotherapeutic agents should be prepared for
administration only by professionals who have been trained in the safe
use of preparation.
Operations such as reconstitution of powder and transfer to syringes
should be carried out only in the designated area.
The personnel carrying out these procedures should be adequately
protected with clothing, gloves and eye shield.
Pregnant personnel are advised not to handle chemotherapeutic
agents.
Contamination: In the event of contact with the skin or eyes, the affected
area should be washed with copious amounts of water or normal saline.
A bland cream may be used to treat the transient stinging of skin.
Medical advice should be sought if the eyes are affected.
In the event of spillage, operators should put on gloves and mop the
spilled material with a sponge kept in the area for that purpose. Rinse
the area twice with water. Put all solutions and sponges into a plastic
bag and seal it.
Disposal: Syringes, containers, absorbent materials, solution and any
other contaminated material should be placed in a thick plastic bag or
other impervious container and incinerated.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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