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CISPLATIN 1MG/ML STERILE CONCENTRATE

Active substance(s): 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 very low numbers of blood cells (called ‘myelosuppression’),
(your doctor will check this with a blood test)
• if you are dehydrated
• if you are breast-feeding
• if you need to have a vaccine for ‘yellow fever’
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 cephalosporins, aminoglycosides and
amphotericin B and some substances used in medical imaging may
make the side effects of cisplatin worse; particularly kidney problems
• some water tablets called loop diuretics, antibiotics called
aminoglycosides and an anti-cancer medicine called ifosfamide may
make the hearing loss side effect of cisplatin worse
• bleomycin (anti-cancer medicine), methotrexate (used to treat cancer or
arthritis) and paclitaxel (anti-cancer medicine) may produce more side
effects if cisplatin is also being used
• the effectiveness of oral anticoagulants may be affected. Your doctor will
monitor with blood tests
• use of certain antihistamines may hide the symptoms of balance
changes (such as dizziness or tinnitus)
• the effectiveness of medicines used for the treatment of convulsions (e.g.
phenytoin) may be reduced, so blood levels may need to be checked
• cisplatin may make the side effects of the anti-cancer medicine
ifosfamide worse
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 six 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.
The vial stopper contains dry natural rubber (a derivative of latex), which
may cause allergic reactions.

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.

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 (heart attack)
• 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.
Very common side effects which may affect more than 1 person in 10 are
listed below:
• decrease in bone marrow function (which can affect the production of
blood cells)
• decrease in white blood cells, which makes infections more likely
(leukopenia)

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,
Q79272
434638

Component Specification

Requester

Item number:

Q79272

Request number:

AS5308

Country:

United Kingdom

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: Q72542 / 434060

OI template:
Amalia version:
Mulgrave version:
Dimensions:
Container(s):
Supplier:
Stock:

88S119
6
5
118 x 570 mm (20 panels)
vial
Howden Printing

Primapharm 40gsm /
Teropaque Thin Medical 40gsm

Folded dimensions: 28.5 x 118 mm
Printed both sides: Yes
Perforated:
No
Pharma code:
46 (12222)
Pharma code length: 10.5 mm
Mulgrave 4 series no.: 434638

Colours
Black:

Signed:
Date:

Version 1
Technician: LB
Date: 06/Jul/15

Version 2
Technician: KN
Date: 09/Jul/15

Version 3
Technician: JE
Date: 19/Aug/15

Version 4
Technician: XX
Date: dd/mmm/yy

Version 5
Technician: XX
Date: dd/mmm/yy

Version 6
Technician: XX
Date: dd/mmm/yy

Version 7
Technician: XX
Date: dd/mmm/yy

Version 8
Technician: XX
Date: dd/mmm/yy

Version 9
Technician: XX
Date: dd/mmm/yy

Version 10
Technician: XX
Date: dd/mmm/yy

• decrease in blood platelets, which increases the risk of bruising and
bleeding (thrombocytopenia)
• reduction of red blood cells which can cause weakness and your skin to
look pale (anaemia)
• reduced level of sodium in the blood
• high temperature
Common side effects which may affect less than 1 person in 10, but more
than 1 person in 100 are listed below:
• fast, irregular or slow heart beats
• sepsis (blood poisoning)
Uncommon side effects which may affect less than 1 person in 100, but
more than 1 person in 1,000 are listed below:
• severe allergic reaction (see above)
• damage to the ear (ototoxicity)
• reduced level of magnesium in the blood
• abnormal sperm production
Rare side effects which may affect less than 1 person in 1,000, but more
than 1 person in 10,000 are listed below:
• increased risk of acute leukaemia
• seizures (fits)
• fainting, headache, confusion and loss of vision
• loss of certain types of brain function, including brain dysfunction
characterised by spasms and reduced level of consciousness
• heart attack
• inflammation of mucous membranes of the mouth (stomatitis).
• peripheral neuropathy of the sensory nerves, characterised by tickling,
itching or tingling without cause and sometimes with loss of taste, touch,
sight, sudden shooting pains from the neck through the back and into the
legs when bending forward.
Very rare side effects which may affect less than 1 person in 10,000 are
listed below:
• heart arrest
Side effects where the number of people affected is not known are listed
below:
• signs of infection such as fever or sore throat
• haemolytic anaemia
• inappropriate release of vasopressin hormone (ADH) which may lead to
low sodium in the blood and water retention
• blood amylase (enzyme) increased
• dehydration
• reduced level of calcium, phosphate, potassium in the blood
• high level of uric acid in the blood
• muscle cramping
• spinal disease which may cause a sensation of electric shocks passing
into your limbs
• brain dysfunction (confusion, slurred speech, sometimes blindness,
memory loss, and paralysis)
• stroke
• loss of taste
• problems with your eyesight (blurred vision, odd colours, loss of vision or
eye pain)
• ringing in the ears or deafness
• heart problems
• unusually cold or white hands and feet
• tingling, numbness or tremor in your hands, feet, arms or legs
• persistent headache
• feeling or being sick
• loss of appetite, anorexia
• hiccups
• diarrhoea
• liver enzymes increased, bilirubin increased
• difficulty breathing
• problems with your kidneys or urine
• hair loss
• rash
• extreme tiredness/weakness
• swelling or soreness where the injection was given
• cramps or spasms
• burning or prickling sensation
• unexpected bruising or bleeding
• haemolytic uraemic syndrome which may cause changes to the kidneys
and blood
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 can potentially cause permanent sterility in men.
It is recommended that those who wish to become fathers in the future
discuss the possibility of cryoconservation (freezing) of their sperm prior to
treatment. Tell your doctor if you have any 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 may be supplied in packs containing:
1 or 10 x 10 mg/10 ml vial
1 or 10 x 50 mg/50 ml vial
1 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 06/2015

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.

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.
The vial stopper contains dry natural rubber (a derivative of latex), which may
cause allergic reactions.
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.
Q79272
434638

Component Specification

Requester

Item number:

Q79272

Request number:

AS5308

Country:

United Kingdom

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: Q72542 / 434060

OI template:
Amalia version:
Mulgrave version:
Dimensions:
Container(s):
Supplier:
Stock:

88S119
6
5
118 x 570 mm (20 panels)
vial
Howden Printing

Primapharm 40gsm /
Teropaque Thin Medical 40gsm

Folded dimensions: 28.5 x 118 mm
Printed both sides: Yes
Perforated:
No
Pharma code:
46 (12222)
Pharma code length: 10.5 mm
Mulgrave 4 series no.: 434638

Colours
Black:

Signed:
Date:

Version 1
Technician: LB
Date: 06/Jul/15

Version 2
Technician: KN
Date: 09/Jul/15

Version 3
Technician: JE
Date: 19/Aug/15

Version 4
Technician: XX
Date: dd/mmm/yy

Version 5
Technician: XX
Date: dd/mmm/yy

Version 6
Technician: XX
Date: dd/mmm/yy

Version 7
Technician: XX
Date: dd/mmm/yy

Version 8
Technician: XX
Date: dd/mmm/yy

Version 9
Technician: XX
Date: dd/mmm/yy

Version 10
Technician: XX
Date: dd/mmm/yy

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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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