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CISPLATIN 1MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): CISPLATIN / CISPLATIN

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Package leaflet: Information for the patient
Cisplatin 1mg/ml concentrate
for solution for infusion
cisplatin



Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your
pharmacist
• This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. See section 4.









The name of your medicine is ‘Cisplatin 1 mg/ml concentrate
for solution for infusion’ but in the rest of the leaflet it will be
called “Cisplatin Injection”.




What is in this leaflet
1.What Cisplatin Injection is and what it is used for
2.What you need to know before you are given Cisplatin
Injection
3.How you are given Cisplatin Injection
4.Possible side effects
5.How to store Cisplatin Injection
6.Contents of the pack and other information







1. What Cisplatin Injection is and what it is used for

Cisplatin forms part of a group of medicines called cytostatics,
which are used in the treatment of cancer. Cisplatin can be used
alone but more commonly cisplatin is used in combination with
other cytostatics.

cisplatin - you are also being administered agents to treat
hypersensitivity (antihistamines, such as buclizine, cyclizine,
loxapine, meclozine, phenothiazines, thioxanthenes and/or
trimethobenzamides)
Cisplatin given in combination with ifosphamide may result
in hearing impairment.
The effects of treatment with cisplatin can be reduced
through simultaneous administration of pyridoxine and
hexamethylmelamine
Cisplatin given in combination with bleomycin and vinblastine may result in paleness or blue coloration of the fingers
and/or toes (Raynaud’s phenomenon)
Administration of cisplatin prior to treatment with paclitaxel
or in combination with docetaxel may result in severe nerve
damage
The combined use of cisplatin with bleomycin and etoposide
may decrease lithium levels in the blood. Therefore, lithium
levels should be checked on a regular basis
Cisplatin reduces the effects of phenytoin on the treatment of
epilepsy
Penicillamine and other so called chelating agents may
reduce the effectiveness of cisplatin
Cisplatin may have an adverse impact on the efficacy of
agents preventing coagulation (anticoagulants). Therefore,
coagulation should be checked more often during combined
use.
Cisplatin and cyclosporine may result in suppression of
immune system with the risk of increased production of
white blood cells (lymphocytes)
You should not receive any vaccinations containing live
viruses within three months after the end of treatment with
cisplatin.
When undergoing treatment with cisplatin, you should not
receive yellow fever vaccinations (also see “Do not take
Cisplatin Injection”).

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.

Cisplatin is used to treat cancers of the testis, ovary, urinary
bladder, head and neck, and lung.
Cisplatin is used to treat cervical cancer in combination with
radiotherapy.

Pregnancy
Cisplatin must not be used during pregnancy unless clearly
indicated by your doctor. You must use effective contraception
during and at least 6 months after treatment with cisplatin.

Your doctor will be able to provide you with more information

Breast-feeding
You must not breastfeed while you are treated with cisplatin.

2. What you need to know before you are given
Cisplatin Injection

Fertility
Male patients treated with cisplatin are advised not to father a
child during treatment and for up to 6 months after treatment.
Further, male patients should seek advice regarding cryoconservation of sperm prior to treatment with cisplatin.

DO NOT take Cisplatin Injection:
• If you are allergic (hypersensitive) to cisplatin or other
platinum compounds or to any of the other ingredients of this
medicine (listed in section 6),
• If you have kidney problems (renal dysfunction)
• If you suffer from dehydration
• you suffer from severe suppression of bone marrow
functionality, symptoms may be: extreme tiredness, easy if
there is bruising or bleeding, occurrence of infections
• if your hearing is impaired
• if you suffer from nervous disorders caused by cisplatin
• if you are breast-feeding
• combined with live vaccines, including yellow fever vaccine.
• combined with phenytoin in prophylactic use (see “Other
medicines and Cisplatin” below).

Driving and using machines
Cisplatin may cause side effects such as feeling sleepy and/or
vomiting. If you suffer from either of these conditions, then you
should not operate any machines that require your full attention.
Cisplatin injection contains 3.5 mg sodium per ml.
This medicinal product contains less than 1 mmol sodium per
ml, i.e. essentially ‘sodium-free’. This should be considered if
you have to keep to a low sodium diet.

3. How you are given Cisplatin Injection

Warnings and Precautions:
Talk to your doctor or pharmacist or nurse before using
Cisplatin Injection
• Your doctor will carry out tests in order to determine the
levels of calcium, sodium, potassium and magnesium in your
blood, as well as to check your blood picture and your liver
and kidney functionality and neurological function.
• Cisplatin should only be administered under the strict
supervision of a specialist doctor experienced in administrating chemotherapy.
• Your hearing will be tested prior to each treatment with
cisplatin.
• If you suffer from a nervous disorder not caused by cisplatin.
• If you suffer from an infection. Please consult your doctor.
• If you intend to have children (see Pregnancy, breast-feeding
and fertility)
• With spillage of cisplatin the contaminated skin must
immediately be washed with water and soap. If cisplatin is
injected outside the blood vessels the administration must be
stopped immediately. Infiltration of cisplatin in the skin can
result in tissue damage (cellulitis, fibrosis and necrosis).

Dosage and method of administration
Cisplatin must only be given by a specialist in cancer treatment.
The concentrate is diluted with a sodium chloride solution that
contains glucose.
Cisplatin is only given by injection into a vein (an intravenous
infusion).
Cisplatin should not come into contact with any materials that
contain aluminium.
The recommended dosage of cisplatin depends on your
well-being, the anticipated effects of the treatment, and whether
or not cisplatin is given on its own (monotherapy) or in
combination with other agents (combination chemotherapy).
Cisplatin (monotherapy):
The following dosages are recommended:
• A single dosage of 50 to 120 mg/m² body surface, every 3 to
4 weeks.
• 15 to 20 mg/m² per day over a 5-day period, every 3 to 4
weeks
Cisplatin in combination with other chemotherapeutical agents
(combination chemotherapy):
• 20 mg/m² or more, once every 3 to 4 weeks.

Please consult your doctor, even if these statements were
applicable to you at any time in the past.

For treatment of cervical cancer cisplatin is used in combination
with radiotherapy:
• A typical dose is 40 mg/m² weekly for 6 weeks.

Other medicines and Cisplatin Injection
Please note that these statements may also apply to products
used some time ago or at some time in the future.

In order to avoid, or reduce, kidney problems, you are advised
to drink copious amounts of water for a period of 24 hours
following treatment with cisplatin.

Tell your doctor or pharmacist if you are taking, have recently
taken or might use any other medicine, including medicines
obtained without a prescription.
• Simultaneous use of medicines that inhibit the bone marrow
function or radiation can potentiate the adverse effects of
cisplatin on the bone marrow
• Cisplatin toxicity may increase when administered simultaneously with other cytostatics (medicine for cancer
treatment), such as bleomycin and methotrexate
• Agents to treat high blood pressure (antihypertensives
containing furosemide, hydralazine, diazoxide, and propranolol) may increase the toxic effect of cisplatin on kidneys
• Cisplatin toxicity may severely affect the kidneys when
administered simultaneously with agents that may cause side
effects in the kidneys, such as those for the prevention/
treatment of certain infections (antibiotics: cephalosporins,
aminoglycosides, and/or amphotericin B) and contrast agents
• Cisplatin toxicity may affect hearing faculties when
administered simultaneously with agents that may have a
side effect on hearing faculties, such as aminoglycosides
• If you use agents to treat gout during your treatment with
cisplatin, then the dosage of such agents may need to be
adjusted (e.g. allopurinol, colchicine, probenecid and/or
sulfinpyrazone)
• Administration of drugs that elevate your rate of bodily urine
excretion (loop diuretics) combined with cisplatin (cisplatin
dose: more than 60mg/m², urine secretion: less than 1000 ml
per 24 hours) may result in toxic effects on kidneys and
hearing
• The first signs of hearing damage (dizziness and/or tinnitus)
may remain hidden when - during your treatment with

If you receive more cisplatin than you should:
Your doctor will ensure that the correct dose for your condition
is given. In case of overdose, you may experience increased side
effects. Your doctor may give you symptomatic treatment for
these side effects. If you think you received too much cisplatin,
immediately contact your doctor.
If you have any further questions on the use of this medicine,
ask your doctor.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you experience any side effect it is important that you inform
your doctor before your next treatment.
Tell your doctor immediately, if you notice any of the
following:
• persistent or severe diarrhoea or vomiting,
• stomatitis/mucositis (sore lips or mouth ulcer),
• swelling of the face, lips mouth or throat,
• unexplained respiratory symptoms such as non-productive
cough, difficulty in breathing or crackles,
• difficulty in swallowing,
• numbness or tingling in your fingers or toes,
• extreme tiredness,
• abnormal bruising or bleeding,
• signs of infection, such as sore throat and high temperature,
• sensation of discomfort close to or at the injection site during
the infusion.

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PHARMACODE AREA

Cisplatin 1mg/ml
concentrate for solution for
infusion

PHARMACODE AREA

XXXXX

Cisplatin 1mg/ml
concentrate for solution for
infusion

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The following side effects may occur:
Very common (may affect more than 1 in 10 people):
• reduction in the number of white blood cells which makes
infections more likely (leukopenia),
• reduction in blood platelets which increases the risk of
bruising and bleeding (thrombocytopenia),
• reduction in red blood cells which can make the skin pale
and cause weakness or breathlessness (anaemia),
• reduced level of electrolytes (sodium),
• Renal dysfunction such as failure to produce urine (anuria),
• fever.
Common (may affect up to 1 in 10 people):
• blood-poisoning (sepsis),
• damage to the nervous system (neurotoxicity),
• irregular heartbeat (arrhythmia), including reduced heartbeat
(bradycardia), accelerated heartbeat (tachycardia),
• inflammation of a vein (phlebitis) at injection site,
• difficulty in breathing (dyspnoea), inflammation of the lungs
(pneumonia) and respiratory failure,
• redness and inflammation of the skin (erythema, skin ulcer)
in the area of the injection, swelling (oedema), pain at the
area of injection.
Uncommon (may affect up to 1 in 100 people):
• anaphylactoid reactions with symptoms such as swelling of
the face and fever,
• loss of hearing (ototoxicity),
• reduced level of electrolytes (magnesium),
• improper production of sperms and ova, and painful breast
growth in men (gynaecomastia).
Rare (may affect up to 1 in 1,000 people):
• increase risk of leukaemia (acute leukaemia),
• suppression of the immune system (immunosuppression),
• high levels of cholesterol in the blood (hypercholesterolemia),
• loss of certain types of brain function, including brain
dysfunction characterised by spasms and reduced levels of
consciousness (encephalopathy), as well as closure of the
carotid artery, peripheral neuropathy of the sensory nerves
(bilateral, sensory neuropathy), characterised by tickling,
itching or tingling without cause and sometimes characterised by a loss of taste, touch, sight, as well as brain dysfunction (confusion, slurred speech, sometimes blindness,
memory loss, and paralysis); sudden shooting pains from the
neck through the back into the legs when bending forwards,
spinal disease, convulsion,
• inflammation of the eye nerve combined with pain and
reduced nerve function (optic neuritis), eye movement
dysfunction,
• coronary artery disease, myocardial infarction (heart
attacks),
• increase blood pressure levels (hypertension),
• reduced albumin (protein) levels in blood,
• inflammation of mucous membranes of the mouth (stomatitis).
Very rare (may affect up to 1 in 10,000 people):
• attacks (seizures),
• sudden stop in effective and normal blood circulation due to
failure of the heart to pump blood (cardiac arrest)
Not known: frequency connot be estimated from the
available data
• Infection,
• haemolytic anaemia,
• insufficient production of the anti-diuretic hormone in the
brain (SIADH), blood amylase (enzyme) increased,
• loss of sight (blindness), difficulties in colour perception,
blurred vision, swelling (papilloedema),
• deafness, ringing in the ears,
• dehydration, reduced level of electrolytes (calcium,
phosphate, potassium) in the blood with muscle cramping
and/or changes in an electrocardiogram (ECG), involuntary
contraction of muscles (tetany),
• stroke, bleeding stroke, loss of taste (ageusia), as well as
closure of the carotid artery.
• weakness (asthenia), malaise, fever,
• muscle spasms,
• liver enzymes increased, bilirubin increased,
• loss of appetite (anorexia), nausea, vomiting, diarrhoea,
hiccups.
• blood flow dysfunction, e.g. in the brain, but also in the
fingers and toes (Raynaud’s syndrome),
• cardiac disorder
• loss of hair (alopecia), rash,
• pulmonary embolism (a blockage of the main artery of the
lung or one of its branches).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via Yellow Card
Scheme at Website: www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on the safety
of this medicine.

The other ingredients are sodium chloride, sodium hydroxide
(for pH adjustment), hydrochloric acid (for pH adjustment) and
water for injections.
What Cisplatin Injection looks like and contents of the pack
This medicinal product is a concentrate for solution for infusion.
Cisplatin is a clear, colourless to pale yellow solution in an
amber glass vial, which is practically free from particles.
For 10 ml
10 ml type I amber glass vial with a 20 mm Rubber stoppers
(Teflon coated), sealed with a 20 mm flip off tear off aluminium
seal.
For 50 ml
50 ml type I amber glass vial with a 20 mm Rubber stoppers
(Teflon coated), sealed with a 20 mm flip off tear off aluminium seal.
For 100 ml
100 ml type I amber glass vial with a 20 mm Rubber stoppers
(Teflon coated), sealed with a 20 mm flip off tear off aluminium seal.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Cipla (EU) Limited
Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW,
United Kingdom.
Manufacturer
S&D Pharma CZ, spol. s r.o
Theodor 28, Pchery (Pharmos a.s. facility), 27308,
CeskáRepublika
Cipla (EU) Limited
4th floor, 1 Kingdom Street, London, W2 6 BY,
United Kingdom
This leaflet was last revised in 12/02/2015
(Please note this is a Prescriber Information Leaflet NOT
the SPC. For full details regarding this product please refer
to the SPC.)
The following information is intended for medical or
healthcare professionals only:
Preparation and handling of the product
Like with all anti-neoplastic products caution is needed with the
processing of cisplatin. Dilution should take place under aseptic
conditions by trained personnel in an area specifically intended
for this. Protective gloves should be worn for this. Precautions
should be taken to avoid contact with the skin and mucous
membranes. If skin contact did occur anyway, the skin should
be washed with soap and water immediately. With skin contact
tingling, burns and redness have been observed. In case of
contact with the mucous membranes they should be copiously
rinsed with water. After inhalation dyspnoea, pain in the chest,
throat irritation and nausea have been reported.
Pregnant women must avoid contact with cytostatic drugs.
Bodily waste matter and vomit should be disposed with care.
If the solution is cloudy or a deposit that does not dissolve is
noticed, the bottle should be discarded.
A damaged bottle must be regarded and treated with the same
precautions as contaminated waste. Contaminated waste must
be stored in waste containers specifically marked for this. See
section “Disposal”.
Preparation of the intravenous administration
Take the quantity of the solution that is needed from the bottle
and dilute with at least 1 litre of the following solutions:
1. Normal Saline
2. 5% Dextrose in Normal saline
3. 5% Dextrose in 1/2 Normal saline containing 37.5 g of
Mannitol.
Always look at the injection before use. If the solution is not
clear or an undissolvable precipitate is formed the solution must
not be used. Only a clear solution, free from particles should be
administered.
Do not bring in contact with injection material that contains
aluminium. Do not administer undiluted.
With respect to microbiological, chemical and physical stability
with use of the undiluted solutions, see below “Special
precautions for storage”.
Disposal
All materials that have been used for the preparation and
administration, or which have been in contact with cisplatin in
any way, must be disposed of according to local cytotoxic
guidelines. Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
Incompatibilities
Do not bring in contact with aluminium. 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.

Keep this medicine out of the sight and reach of children.

Cisplatin decomposes with solution in media with low chloride
content; the chloride concentration should at least be equivalent
to 0.45% of sodium chloride.

Do not use this medicine after the expiry date which is stated on
the carton and the bottle. The expiry date refers to the last day
of that month.

Antioxidants (such as sodium metabisulphite), bicarbonates
(sodium bicarbonate), sulfates, fluorouracil and paclitaxel may
inactivate cisplatin in infusion systems.

Do not store above 25ºC. Do not refrigerate or freeze. Keep
container in the outer carton in order to protect from light.

Special precautions for storage
Medicinal product as packaged for sale:
Concentrate for solution for infusion 1 mg/ml

5. How to store Cisplatin injection

After dilution, chemical and physical in-use stability has been
demonstrated for 24 hours at 25°C, protected from light.

Undiluted solution:

From a microbiological point of view, the product should be
used immediately. If not used immediately, in-use storage times
and conditions are the responsibility of the user.

“Do not store above 25ºC .Keep container in the outer carton in
order to protect from light. Do not refrigerate or freeze

Do not store diluted solutions in the refrigerator or freezer.

Chemical and physical in-use stability has been demonstrated
after dilution with infusion fluids described in section “Preparation and handling of the product” for 24 hours at 25°C,
protected from light.

Do not use this medicine if you notice cloudy solution or
deposit that does not dissolved.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the environment.

Concentrate for solution for infusion after dilution:

From a microbiological point of view, the product should be
used immediately. If not used immediately, in-use storage times
and conditions are the responsibility of the user.
Do not store diluted solutions in the refrigerator or freezer.

6. Contents of the pack and other information
What Cisplatin Injection contains
The active substance is cisplatin. Each millilitre (ml) of solution
contains 1 milligram (mg) of cisplatin.

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UK

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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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