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Package leaflet: Information for the user
Cisplatin 1 mg/ml Concentrate for Solution for Infusion
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 any further questions, ask your doctor, pharmacist or nurse.
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.
What is in this leaflet
What Cisplatin is and what it is used for
What you need to know before you take Cisplatin
How to take Cisplatin
Possible side effects
How to store Cisplatin
Contents of the pack and other information

What Cisplatin 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.
What is it used for?
Cisplatin can destroy cells in your body that may cause certain types of cancer (tumor of testis, tumor of
ovary, tumor of the bladder, head and neck epithelial tumor, lung cancer and for cervical cancer in
combination with radiotherapy).
Your doctor will be able to provide you with more information.

What you need to know before you take Cisplatin

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


gxCS 1_0 1mg-1ml inj UK

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Warnings and precautions
Take special care with Cisplatin :
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 fathering children).
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).
Please consult your doctor even if these statements were applicable to you at any time in the past.
Other medicines and Cisplatin
Please note that these statements may also apply to products used some time ago or at some time in the
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
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 propanolol) 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
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, cholchicine, 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 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 ifosfamide 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 vinblastin may result in paleness or flue
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.
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Cisplatin reduces the effects of phenytoin on the treatment of epilepsy.
Penicillamine may reduce the effectiveness of Cisplatin.
Cisplatin may have an adverse impact on the effectivity of agents preventing coagulation
(anticoagulants). Therefore, coagulation should be checked more often during combined use.
Cisplatin and ciclosporin may result in suppression of the 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”).
Pregnancy, breast-feeding and fathering children
Ask your doctor or pharmacist for advice before you begin to use, or are administered, Cisplatin.
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.
You must not breast-feed while you are treated with Cisplatin.
Male patients treated with Cisplatin are advised not to father a child during treatment and 6 months after
treatment. Further, men are advised to seek counselling on sperm preservation before starting treatment.
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 contains sodium
Cisplatin contains 9 mg sodium per ml. This should be considered if you have to keep a low sodium diet.

How to take Cisplatin

Dosage and method of administration
Cisplatin should 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 dose of 50 to 120 mg/m2 body surface, every 3 to 4 weeks.
15 to 20 mg/m2/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.
For treatment of cervical cancer cisplatin is used in combination with radiotherapy:
A typical dose is 40 mg/m2 weekly for 6 weeks.
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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.
If you have received 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 product, ask your doctor.

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 ulcers)
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.
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 pake and cause weakness or breathlessness
reduced level of electrolytes (sodium)
renal dysfunction such as failure to produce urine (anuria)
urine poisoning of the blood (uraemia).
Common (may affect up to 1 in 10 people):
difficulty in breathing (dyspnoea), inflammation of the lungs (pneumonia) and respiratory failure
arrhythmia, including reduced heartbeat (bradycardia), accelerated heartbeat (tachycardia)
damage to the nervous system (neurotoxicity)
blood poisoning (sepsis)
inflammation of a vein (phlebitis)
red and inflammation of the skin (erythema, skin ulcer) in the area of injection, swelling (oedema),
pain at the area of injection.
Uncommon (may affect up to 1 in 100 people):
severe hypersensitivity (anaphylactic) reactions including rash, eczema with severe itching and lump
formation (urticaria), redness and inflammation of the skin (erythema) or itching (pruritus),
anaphylactoid reactions with symptoms such as swelling of the face and fever, low blood pressure
(hypotension), accelerated heartbeat (tachycardia), breathing difficulties (dyspnoea), distress as a
result of muscle cramps in the airways (bronchospasms)
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reduced level of electrolytes (magnesium)
loss of hearing (ototoxicity)
dysfunctional spermatogenesis and ovulation and painful breast growth in men (gynaecomastia).
Rare (may affect up to 1 in 1,000 people):
increased risk of leukaemia (acute leukaemia)
suppression of immune system (immunosuppression)
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, convulsions, 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
inflammation of the eye nerve combined with pain and reduced nerve function (optic neuritis), eye
movement dysfunction
heart attack, coronary artery disease
high levels of cholesterol in the blood (hypercholestrerolemia)
increased blood pressure levels (hypertension)
inflammation of mucous membranes of the mouth (stomatitis)
reduced albumin (protein) levels in the blood.
Very rare (may affect up to 1 in 10,000 people):
heart failure (cardiac arrest)
attacks (seizures)
increased iron levels in the blood (acute leukaemia).
Not known (frequency cannot be estimated from the available data):
stroke (cerebrovascular accident)
cardiac disorder
pulmonary embolism
blood flow dysfunction, e.g. in the brain, but also in the fingers and toes (Raynaud´s syndrome)
fever, weakness (asthenia), malaise
reduced level of electrolytes (magnesium, calcium, sodium, phosphate, potassium) in the blood with
muscle cramping and/or changes in an electrocardiogram (ECG), dehydration, involuntary
contraction of muscles (tetany)
loss of sight (blindness), difficulties in colour perception, blurred vision, swelling (papilloedema)
deafness, tinnitus
increased blood amylase (enzyme) levels
loss of appetite (anorexia), nausea, vomiting, diarrhoea, hiccups
loss of hair (alopecia), rash.
If any of the side effects gets serious, talk to your doctor, pharmacist or nurse. This includes any side effects
not listed in this leaflet.
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side
effects via the internet at Alternatively you can call Free phone 0808 100
3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local

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How to store Cisplatin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial and carton after EXP. The expiry
date refers to the last day of that month.
Keep the vial in the outer carton in order to protect from light.
Do not store above 25oC.
Do not refrigerate or freeze.
After dilution:
Chemical and physical in-use stability has been demonstrated for 14 days at 15-25°C under protection from
From a microbiological point of view, the product should be used immediately. If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be
longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic
If the solution is cloudy or a deposit that does not dissolve is noticed, the vial should be discarded.
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.

Contents of the pack and other information

What Cisplatin contains
The active substance is cisplatin.
The other ingredients are sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide
(for pH adjustment) and water for injections.
1 ml concentrate for solution for infusion contains 1 mg of cisplatin.
Each 50 ml vial contains 50 mg of cisplatin.
Each 100 ml vial contains 100 mg of cisplatin.
What Cisplatin looks like and contents of the pack
Cisplatin 1 mg/ml Concentrate for solution for infusion is a clear, colourless to pale yellow solution free
from visible particles in glass vials.
50 ml vial: 100 ml moulded amber coloured Type I vial with grey bromobutyl rubber stop and white flip-off
aluminium seal.
100 ml vial: 100 ml concentrate is a 100 ml moulded amber coloured Type I vial with grey bromobutyl
rubber stop and blue flip-off aluminium seal.
Pack Sizes:
1 x 50 ml vial
1 x 100 ml vial
Not all pack sizes may be marketed.

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Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Pfizer Service Company BVBA
Hoge Wei 10, B-1930, Zaventem
This leaflet was last revised in 09/2013.

-----------------------------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Preparation and handling of the product
Refer to local cytotoxic guidelines.
Like with all anti-neoplastic products caution is needed with the processing of cisplatin.
Dilution should take place under aseptic conditions in a safety box, by trained personnel in an area specifically
intended for this, and protective coats and gloves should be used. If no safety box is available, the equipment
should be supplemented with a mask and protective glasses. 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.
In the event of spillage, operators should put on gloves and mop up 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.
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
sodium chloride 9 mg/ml (0.9%)
mixture of sodium chloride 9 mg/ml (0.9%)/ glucose 50 mg/ml (5%) (1:1), (resulting final
concentrations: sodium chloride 4.5 mg/ml (0.45%), glucose 25 mg/ml (2.5%))
sodium chloride 9 mg/ml (0.9%) and 18.75 mg/ml (1.875%) mannitol, for injection
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sodium chloride 4.5 mg/ml (0.45%), glucose 25 mg/ml (2.5%) and 18.75 mg/ml (1.875%)
mannitol, for injection
Compatibility with the above solutions has been demonstrated at concentration of 0.1 mg/ml.
Always inspect the solution for injection before use. Only a clear solution, free from particles should be
DO NOT bring in contact with injection material that contains aluminium.
DO NOT administer undiluted.
With respect to chemical and physical stability with use of the undiluted solutions, see section 6.3.
For single use only. Discard any unused contents in accordance with local cytotoxic guidelines
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. Remnants of the medicinal
products as well as all materials that have been used for dilution and administration must be destroyed
according to hospital standard procedures applicable to cytotoxic agents and in accordance with local
requirements related to the disposal of hazardous waste.
Do not bring in contact with aluminium. Cisplatin reacts with metal aluminium to form a black precipitate of
platinum. All aluminium-containing IV sets, needles, catheters and syringes should be avoided. Cisplatin
decomposes with solution in media with low chloride content; the chloride concentration should at least be
equivalent to 0.45% of sodium chloride.
Antioxidants (such as sodium metabisulphite), bicarbonates (sodium bicarbonate), sulfates, fluorouracil and
paclitaxel may inactivate cisplatin in infusion systems.
This medicinal product must not be mixed with other medicinal products except those mentioned in above
mentioned section “Preparation of the intravenous administration”.
Special precautions for storage
Unopened vials: Do not store above 25°C. Do not refrigerate or freeze. Keep the vial in the outer carton in
order to protect from light.
Undiluted solution: If the solution is not clear or an undissolvable precipitate is formed the solution must not
be used.
Diluted solution: Do not store diluted solutions in the refrigerator or freezer.
After dilution in infusion fluids mentioned above: Chemical and physical in-use stability has been
demonstrated for 14 days at 15-25°C under protection from light.
From a microbiological point of view, the product should always be used immediately.

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Expand Transcript

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.