Skip to Content

CISPLATIN 50

Active substance(s): CISPLATIN / CISPLATIN / CISPLATIN

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the patient
Cisplatin 50 mg powder for Injection
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 any further questions, ask your doctor or pharmacist.
! If any of the side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. See section 4.
In this leaflet
1. What Cisplatin is and what it is used for
2. What you need to know before you are given Cisplatin
3. How Cisplatin is given to you
4. Possible side effects
5. How to store Cisplatin
6. Contents of the pack and other information
Important things that you should know about your medicine:
• Cisplatin will only be given by specialist staff in hospital, as you will need to be carefully
monitored during and after treatment. In particular your blood, kidney and liver function will be
monitored and you will be given fluids to keep you hydrated.
• Cisplatin can cause allergic symptoms such as flushing, wheezing, rash and swelling of the face,
decreased blood pressure and increased heart rate. Contact your doctor immediately if you get
these symptoms.
• Tell your doctor if you are taking or have taken any other medicines, including medicines obtained
without prescription, for example aspirin.
• Cisplatin can cause blood problems which might make you more susceptible to infection and
bleeding and usually occurs between days 6 and 26 after your treatment.
• Cisplatin can affect male fertility. Please contact your doctor for more information.

1. What Cisplatin is and what it is used for
• Cisplatin is used in adults and children. The active ingredient is cisplatin.
• Cisplatin belongs to one of a group of medicines called cytotoxics, which are used to kill cancer
cells in tumours.
• Cisplatin is used to treat a wide range of tumours, in particular, testicular, cervical, lung and
bladder cancer and ovarian cancer that has the potential to spread to other parts of the body.
Cisplatin can be given alone or in combination with other medicines.
2. What you need to know before you are given Cisplatin
Do not take Cisplatin if
• you are allergic to Cisplatin or other similar medicines containing platinum or to any of the other
ingredients of this medicine (listed in section 6.
Take special care with Cisplatin
Tell your doctor if:
• You have a disease affecting the kidneys, or have ever had a disease which affects the kidneys
• You suffer from decreased bone marrow function (not enough blood cells are being made)
• You have or have ever had a disorder which affects your hearing
• Previous use of Cisplatin caused you to suffer a nervous disorder
! You have had or are due to have any vaccination
This will help your doctor decide that Cisplatin is suitable for you. They may arrange for your liver

Page 1 of 13

2016-0019151 & 2016-0016188

to be monitored regularly during the course of your treatment.
Other medicines and Cisplatin
Tell your doctor if you are taking, have recently taken or might take any other medicines, including
medicines obtained without a prescription.
There are some medicines that may interact with Cisplatin. Make sure your doctor knows if you are
taking any of the following:
• any one of a group of antibiotics known as aminoglycosides, cephaloridine (Also an antibiotic) or
any diuretics (drugs which gets rid of excess water from the body), for example furosemide
• any drugs potentially toxic to kidneys, for example amphotericin B
• aspirin or NSAIDS (Non-Steroidal Anti-Inflammatory Drugs)
• antiepileptic medicines such as phenytoin
• medicines used for treating acute arthritis (gout) such as allopurinol, probenecid or sulfinpyrazone
(dosage adjustment of these drugs may be necessary)
• other anti-tumour drugs such as Bleomycin and/or Methotrexate

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you might be pregnant or planning to have a baby do
not take Cisplatin, ask your doctor or pharmacist for advice
Driving and using machines
Cisplatin may cause certain side effects, e.g. effects on your vision or nervous system that may
reduce your driving skills and abilities to operate machinery, therefore caution should be taken
following treatment with Cisplatin.
3. How Cisplatin is given to you
• Cisplatin will be given to you by infusion into a vein (through a ‘drip’) under the direction of
specialists in hospital. The powder is dissolved to make a solution. This is then added to a salt
solution or to a sugar and salt solution, which is then given into the blood stream over a period of 6
to 8 hours.
• Your doctor will decide the dose suitable for you. It will be calculated based on your body surface
area. The usual dose (single) is 20mg for each square metre of your body surface area every 3 to 4
weeks.
• A lower dose will be given if you suffer from kidney disease or decreased bone marrow function
(not enough blood cells are being made).
• You will receive between 1 and 2 litres of fluid by infusion for 8 to 12 hours before you receive
your Cisplatin, to increase both the amount of urine you produce and how often you pass it. This is
called diuresis. Enough fluid will be given to maintain diuresis during the 24 hours after receiving
Cisplatin.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Cisplatin can cause allergic symptoms such as flushing, wheezing, rash and swelling of the face,
decreased blood pressure and increased heart rate. Contact your doctor immediately if you get these
symptoms.
Cisplatin can affect male fertility. Please contact your doctor for more information.
Other side effects include
Very common: may affect more than 1 in 10 people
! you may get infections more easily than usual, this could be due to bone marrow failure
! you may bruise more easily than usual, this could be because of a blood disorder
(thrombocytopenia)
! frequent infections could be signs of a blood problem (leukopenia)
! feeling tired, faint, dizzy, could be symptoms of anaemia
! low sodium levels in your blood (hyponatraemia)

Page 2 of 13

2016-0019151 & 2016-0016188

!

fever

Common: may affect up to 1 in 10 people
! blood poisoning (sepsis)
! irregular heartbeat (arrhythmia)
! slow heartbeat
! increased or rapid heartbeat (tachycardia)
! blood clot form in a deep vein (venous thromboembolism tremors)
Uncommon: may affect up to 1 in 100 people
! anaphylactoid reaction (e.g. wheezing, difficulty breathing, swelling of the face or tongue)
! low level of magnesium (hypomagnesaemia)
! damage to the hearing or balance functions (ototoxicity)
! sperm disorder
Rare: may affect up to 1 in 1,000 people
! acute leukaemia
! convulsion
! numbness and pain, usually in hands and feet (neuropathy peripheral)
! diseases of white matter of brain (leukoencephalopathy)
! headache
! confusion
! seizures
! visual loss
! heart attack
! inflamed mouth
Very rare: may affect up to 1 in 10,000 people
! heart stop beating (cardiac arrest)
Not known: cannot be estimated from available data
! infection
! low count of red blood cells
! blood amylase increased
! body experiencing difficulty to release water (SIADH)
! dehydration
! low levels of potassium in your body (hypokalaemia)
! low level of phosphate in the blood (hypophosphatemia)
! kidney problem (hyperuricaemia)
! low blood calcium levels (hypocalcaemia)
! spasms of hands and feet
! stroke
! sudden brief, sometimes buzzing sensation down the neck (Lhermitte’s sign)
! spinal cord disorder
! damage to the nerves that manage every day body functions (autonomic neuropathy)
! blurred vision
! colour blindness
! total or partial loss of vision (blindness cortical)
! disturbances in vision (papilledema)
! severe vision impairment (retinal pigmentation)
! ringing in the ears (tinnitus)
! deafness
! cardiac disorder
! figures and toes changing colour when cold and tingling (Raynaud’s phenomenon)
! vomiting

Page 3 of 13

2016-0019151 & 2016-0016188

!
!
!
!
!
!
!
!
!
!
!
!
!
!

nausea
loss or decreased of appetite (anorexia)
hiccups
diarrhoea
increased liver enzyme
increased serum bilirubin in blood
blood clot in the lung (pulmonary embolism)
rash
hair loss
muscle spasms
kidney failure
lack or loss of strength (weakness)
general feeling of being unwell
injection site extravasation

Reporting of side effects
If youget any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information
on the safety of this medicine.
5. How to store Cisplatin
Keep this medicine out of sight and reach of children
• The unopened vials should be stored below 25∀C. Store in the original to protect from light. The
reconstituted solution must not be cooled or refrigerated, as cooling may result in precipitation. It
should be kept below 25∀C and store in the original container to protect from light, also during
intravenous infusion. Any unused solution should be discarded.
• Do not be use this medicine after the expiry which is stated on the carton and vial label after EXP.
The expiry date refers to the last day of the month. The pharmacist will check this when your
medicine is prepared for you.
6. Contents of the pack and other information
What Cisplatin contains
The active substance is cisplatin. Each vial contains 50mg of cisplatin.
The other ingredients are sodium chloride and mannitol.
What Cisplatin looks like
Cisplatin is a yellow-white, freeze dried cake and is available in single glass vials.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pharmacia Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
United Kingdom
Manufacturer:
Actavis Italy S.p.A
Viale Pasteur, 10
20014 Nerviano,
Milan, Italy

This leaflet was last revised in 08/2016

Page 4 of 13

2016-0019151 & 2016-0016188

Ref: CS 9_0

Page 5 of 13

2016-0019151 & 2016-0016188

Cisplatin 50
cisplatin 50 mg
Powder for injection
The following information is intended for medical or healthcare professionals only:
(For further information, consult the Summary of Product Characteristics)
1. NAME OF THE MEDICINAL PRODUCT
Cisplatin 50 mg powder for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Cisplatin 50 mg
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for injection
Yellowish-white, freeze-dried cake in a vial.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Cisplatin has antitumor activity either as a single agent or in combination chemotherapy particularly
in the treatment of testicular and metastatic ovarian tumours, also cervical tumours, lung carcinoma
and bladder cancer.
4.2 Posology and method of administration
Posology
Cisplatin should be dissolved in water for injections such that the reconstituted solution contains1
mg/ml of Cisplatin. This solution should then be diluted in 2 litres of 0.9% saline or adextrose/saline
solution (to which 37.5 g of mannitol may be added) and administration should be over a 6-8 hour
period.
Adults and paediatric population
Single agent therapy
The usual dose regimen given as a single agent is 50 - 120 mg/m2 by infusion once every 3 4weeks or 15 - 20 mg/m2 by infusion daily for 5 consecutive days, every 3 - 4 weeks.
Combination chemotherapy
Dosage may be adjusted if the drug is used in combination with other antitumor chemotherapy. With
multiple drug treatment schedules Cisplatin is usually given in doses 20 mg/m2 upwards every 3 - 4
weeks. Dosage should be reduced for patients with renal impairment or depressed bone marrow
function.
Pre-treatment hydration with 1 - 2 litres of fluid infused for 8 - 12 hours prior to the Cisplatin will
initiate diuresis. Adequate subsequent hydration should maintain diuresis during the 24hours
following administration. Aluminium containing equipment should not be used for administration of
Cisplatin as it may interact with metal aluminium to form a black precipitate of platinum.
Method of administration: Intravenous infusion.
4.3 Contraindications
Hypersensitivity to the active substance or other platinum containing compounds, or to any of the
excipients listed in section 6.1.
Cisplatin is contraindicated in patients with myelosuppression, in patients who are dehydrated, and
those with pre-existing renal impairment or hearing impairment due to the fact that cisplatin is
nephrotoxic and neurotoxic (in particular ototoxic). These toxicities may be cumulative if disorders
of this type pre-exist.
Patients receiving cisplatin should not breastfeed.

Page 6 of 13

2016-0019151 & 2016-0016188

Concurrent administration of yellow fever vaccine is contraindicated
4.4 Special warnings and precautions for use
Cisplatin reacts with metallic aluminium to form a black precipitate of platinum. All aluminium
containing IV sets, needles, catheters and syringes should be avoided.
Cisplatin must be administered under close supervision by a qualified doctor specialised in the use
of chemotherapeutic agents.
Appropriate monitoring and management of the treatment and its complications are only possible if
adequate diagnosis and exact treatment conditions are available.
1. Nephrotoxicity
Cisplatin causes severe cumulative nephrotoxicity. A urine output of 100 mL/hour or greater will
tend to minimize cisplatin nephrotoxicity. This can be accomplished by prehydration with 2 litres of
an appropriate intravenous solution, and similar post cisplatin hydration (recommended 2,500
mL/m2/24 hours). If vigorous hydration is insufficient to maintain adequate urinary output, an
osmotic diuretic may be administered (eg, mannitol).
2. Neuropathies
Severe cases of neuropathies have been reported.
These neuropathies may be irreversible and may manifest by paraesthesia, areflexia and a
proprioceptive loss and a sensation of vibrations. A loss of motor function has also been reported. A
neurologic examination must be carried out at regular intervals.
3. Ototoxicity
Ototoxicity has been observed in up to 31% of patients treated with a single dose of cisplatin
50mg/m2, and is manifested by tinnitus and/or hearing loss in the high frequency range (4000 to
8000Hz). Decreased ability to hear conversational tones may occur occasionally. Ototoxic effect
may be more pronounced in children receiving cisplatin. Hearing loss can be unilateral or bilateral
and tends to become more frequent and severe with repeated doses; however, deafness after initial
dose of cisplatin has been reported rarely. Ototoxicity may be enhanced with prior simultaneous
cranial irradiation and may be related to peak plasma concentration of cisplatin. It is unclear whether
cisplatin induced ototoxicity is reversible. Careful monitoring by audiometry should be performed
prior to initiation of therapy and prior to subsequent doses of cisplatin. Vestibular toxicity has also
been reported (see section 4.8).
4. Allergic phenomena
As with other platinum-based products, hypersensitivity reactions appearing in most cases during
perfusion may occur, and necessitate discontinuation of the perfusion and an appropriate
symptomatic treatment. Cross reactions, sometimes fatal, have been reported with all the platinum
compounds (see sections 4.3 and 4.8).
5. Hepatic function and haematological formula
The haematological formula and the hepatic function must be monitored at regular intervals.
6 Carcinogenic potential
In humans, in the rare cases the appearance of acute leukaemia has coincided with use of Cisplatin,
which was in general associated with other leukaemogenic agents.
Cisplatin is a bacterial mutagen and causes chromosome aberrations in cultures on animal cells.
Carcinogenicity is possible but has not been demonstrated. Cisplatin is teratogenetic and embryo
toxic in mice.
7. Injection site reactions
Injection site reactions may occur during the administration of cisplatin. Given the possibility of
extravasation, it is recommended to closely monitor the infusion site for possible infiltration during
drug administration. A specific treatment for extravasation reactions is unknown at this time.

Page 7 of 13

2016-0019151 & 2016-0016188

Warning
This cytostatic agent had a more marked toxicity than is usually found in antineoplastic
chemotherapy.
Renal toxicity, which is above-all cumulative, is severe and requires particular precautions
during administration (see sections 4.2 and 4.8).
Nausea and vomiting may be intense and require adequate antiemetic treatment.
Close supervision must also be carried out with regard to ototoxicity, myelodepression and
anaphylactic reactions (see section 4.8).
Preparation of the intravenous solution
Warning
As with all other potentially toxic products, precautions are essential when handling the Cisplatin
solution. Skin lesions are possible in the event of accidental exposure to the product. It is advisable
to wear gloves. In the event the cisplatin solution comes into contact with the skin or mucous
membranes, wash the skin or mucous membranes vigorously with soap and water.
Conforming to the procedures appropriate for the manipulation and elimination of cytostatic agents
is recommended.
Before administering the solution to the patient, verify the clarity of the solution and the absence of
particles.
4.5 Interaction with other medicinal products and other forms of Interaction
Nephrotoxic substances:
Concomitant administration of nephrotoxic (e.g. cephalosporins, aminoglycosides, amphotericin B
or contrast media) or ototoxic (e.g. aminoglycosides) medicinal products will potentiate the toxic
effect of cisplatin on the kidneys. During or after treatment with cisplatin caution is advised with
predominantly renal eliminated substances, e.g. cytostatic agents such as bleomycin and
methotrexate, because of potentially reduced renal elimination.
The renal toxicity of ifosfamide may be greater when used with cisplatin or in patients who have
previously been given cisplatin.
Reduction of the blood’s lithium values was noticed in a few cases after treatment with cisplatin
combined with bleomycin and etoposide. It is therefore recommended to monitor the lithium values.
Ototoxic substances:
Concomitant administration of ototoxic (e.g. aminoglycosides, loop diuretics) medicinal products
will potentiate the toxic effect of cisplatin on auditory function. Except for patients receiving doses
of cisplatin exceeding 60 mg/m2, whose urine secretion is less than 1000 ml per 24 hours, no forced
diuresis with loop diuretics should be applied in view of possible damage to the kidney tract and
ototoxicity.
Ifosfamide may increase hearing loss due to cisplatin.
Weakened live vaccines:
Yellow fever vaccine is strictly contraindicated because of the risk of fatal systemic vaccinal disease
(see section 4.3.). In view of the risk of generalised illness, it is advisable to use an inactive vaccine
if available.
Oral anticoagulants:
In the event of simultaneous use of oral anticoagulants, it is advisable regularly to check the INR.
Antihistamines, Phenothiazines and others:
Simultaneous use of antihistamines, buclizine, cyclizine, loxapine, meclozine, phenothiazines,

Page 8 of 13

2016-0019151 & 2016-0016188

thioxanthenes or trimethobenzamides may mask ototoxicity symptoms (such as dizziness and
tinnitus).
Anticonvulsive substances:
Serum concentrations of anticonvulsive medicines may remain at sub therapeutic levels during
treatment with cisplatin.
Pyroxidine + altretamine combination:
During a randomised study of the treatment of advanced ovarian cancer, the response time was
unfavourably affected when pyridoxine was used in combination with altretamine
(hexamethylmelamine) and Cisplatin.
Paclitaxel:
Treatment with cisplatin prior to an infusion with paclitaxel may reduce the clearance of paclitaxel
by 33% and therefore can intensify neurotoxicity.
4.6 Fertility, pregnancy and lactation
Cisplatin may be toxic to the foetus when administered to a pregnant woman.
During treatment with Cisplatin and for a minimum of the following 6 months, appropriate
measures must be taken to avoid pregnancy; this applies to patients of both sexes.
Genetic consultation is recommended if the patient wishes to have children after ending the
treatment. Since a treatment with cisplatin may cause irreversible infertility, it is recommended that
men, who wish to become fathers in the future, ask for advice regarding cryoconservation of their
sperm prior to treatment.
Breast-feeding
Cisplatin is excreted in breast milk. Patients treated with cisplatin must not breastfeed.
4.7 Effects on ability to drive and use machines
No studies on the effects on ability to drive and use machines have been performed.
Nevertheless, the profile of undesirable effects (like nephrotoxicity) may influence the ability to
drive vehicles and use machinery.
4.8 Undesirable effects
Undesirable effects depend on the used dose and may have cumulative effects.
The most frequently reported adverse events (>10%) of cisplatin were haematological (leukopenia,
thrombocytopenia and anaemia), gastrointestinal (anorexia, nausea, vomiting and diarrhoea), ear
disorders (hearing impairment), renal disorders (renal failure, nephrotoxicity, hyperuricaemia) and
fever.
Serious toxic effects on the kidneys, bone marrow and ears have been reported in up to about one
third of patients given a single dose of cisplatin; the effects are generally dose-related and
cumulative. Ototoxicity may be more severe in children.
Frequencies are defined using the following convention: Very common (≥1/10); common (≥1/100 to
<1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000), not
known (cannot be estimated from the available data).
Table of Adverse Drug Events Reported During Clinical or Post marketing Experience
(MedDRA terms)
System Organ Class
Frequency
MedDRA Term
Not known
Infectiona
Infections and infestations
Common

Page 9 of 13

Sepsis

2016-0019151 & 2016-0016188

Blood and lymphatic system
disorders

Very common

Bone marrow failure,
thrombocytopenia, leukopenia, anaemia

Not known

Coombs positive haemolytic anaemia

Neoplasm benign,malignant
and unspecified
Immune system disorders

Rare

Acute leukaemia

Uncommon

Anaphylactoid reactionb

Endocrine disorders

Not known

Blood amylase increased, inappropriate
antidiuretic hormone secretion

Metabolism and nutrition
disorders

Not known

Dehydration, hypokalaemia,
hypophosphatemia, hyperuricaemia,
hypocalcaemia, tetany

Uncommon
Very common
Not known

Hypomagnesaemia
Hyponatraemia
Cerebrovascular accident, haemorrhagic stroke,
ischaemic stroke ageusia, cerebral arteritis,
Lhermitte’s sign, myelopathy, autonomic
neuropathy

Rare

Convulsion, neuropathy peripheral,
leukoencephalopathy, reversible posterior
leukoencephalopathy syndrome
Vision blurred, colour blindness acquired,
blindness cortical, optic neuritis, papilledema,
retinal pigmentation

Nervous system disorders

Eye disorders

Not known

Ear and labyrinth disorders

Uncommon

Ototoxicity

Cardiac disorders

Not known
Common

Tinnitus, deafness, audiogram abnormalities
Arrhythmia, bradycardia, tachycardia

Vascular disorders

Rare
Very rare
Not known
Common

Myocardial infarction
Cardiac arrest
Cardiac disorder
Venous thromboembolism

Not known

Thrombotic microangiopathy
(haemolytic uraemic syndrome), Raynaud’s
phenomenon

Not known
Rare
Not known

Respiratory, thoracic and
mediastinal disorders

Not known

Vomiting, nausea, anorexia, hiccups, diarrhoea
Stomatitis
Hepatic enzymes increased, blood bilirubin
increased
Pulmonary embolism

Skin and subcutaneous tissue
disorders
Musculoskeletal, connective
tissue and bone disorders
Renal and urinary disorders

Not known

Rash, alopecia

Not known

Muscle spasms

Not known

Renal failure acute, renal failurec, renal tubular
disorder

Reproductive system and
breast disorders

Uncommon

Abnormal spermatogenesis

General disorders and

Very common

Pyrexia

Gastrointestinal disorders
Hepatobiliary disorders

Page 10 of 13

2016-0019151 & 2016-0016188

administration site condition
Not known

Asthenia, malaise, injection site extravasationd

a: Infectious complications have led to death in some patients.
b: Symptoms reported for anaphylactoid reaction such as facial edema (PT-face oedema), wheezing,
bronchospasm, tachycardia, and hypotension will be included in the parentheses for anaphylactoid
reaction in the AE frequency table.
c: Elevations in BUN and creatinine, serum uric acid, and/or a decrease in creatinine clearance are
subsumed under renal insufficiency/failure.
d: Local soft tissue toxicity including tissue cellulitis, fibrosis, and necrosis (common) pain
(common), oedema (common) and erythema (common) as the result of extravasation.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard
4.9 Overdose
An acute overdose of Cisplatin may result in renal failure, liver failure, deafness, ocular toxicity
(including detachment of the retina), significant myelosuppression, untreatable nausea and vomiting
and/or neuritis. An overdose may be fatal.
There is no specific antidote in the event of an overdose of Cisplatin. Even if haemodialysis is
initiated 4 hours after the overdose it has little effect on the elimination of cisplatin from the body
following a strong and rapid fixation of Cisplatin to proteins.
Treatment in the event of an overdose consist of general support measures.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC code: L01XA01
In vitro studies indicate that DNA is the principal target molecule of cis-platinum. The basis for the
selectivity of the cis-isomer may reside in its ability to react in a specifically defined configuration
with DNA. Modification of the DNA template results in the selective inhibition of DNA synthesis.
The drug is cell cycle non-specific.
5.2 Pharmacokinetic properties
A biphasic plasma-decay pattern occurs in man after bolus administration. The initial plasma halflife in man is 25 - 49 minutes and the terminal half-life 3 - 4 days. In addition, a third excretory
phase with a longer half-life may be postulated from the high plasma platinum concentration found
after 21 days. During the terminal phase more than 90% of the drug is bound to plasma proteins.
The urinary elimination of the drug is incomplete: the 5-day recovery of platinum in the urine being
only 27 to 45%.
Studies in man measuring free platinum species have shown a mean terminal half-life of 48minutes
after bolus injection, which probably corresponds to the initial half-life (25 - 49 minutes) seen when
total platinum is monitored and reflects the distribution of the drug. Urinary excretion of filterable
platinum was greater after 6 hours infusion (75%) than after a 15 minute injection (40%) of the same
dose of cis-platinum. Diuresis induced by high-volume hydration or mannitol infusion was
associated with a reduction in the concentration of platinum excreted in the urine. The reduced
concentration of platinum caused by the high urine volume may play a role in renal protection.

Page 11 of 13

2016-0019151 & 2016-0016188

5.3 Preclinical safety data
No further preclinical safety data are available.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipient(s)
Sodium chloride
Mannitol
6.2 Incompatibilities
None known.
6.3 Shelf-life
3 years
6.4 Special precautions for storage
The unopened vials should be stored below 25∀C. Store in the original container to protect from
light. The reconstituted solution must not be cooled or refrigerated, as cooling may result in
precipitation. It should be kept below 25∀C and store in the original container to protect from light,
also during intravenous infusion. Any unused solution should be discarded.
6.5 Nature and contents of container
Colourless glass vials (Type II) with bromobutyl rubber stoppers and aluminium snap-caps.
6.6 Instructions for use and handling
Cisplatin powder should be dissolved in sterile Water for Injections such that the reconstituted
solution contains 1mg/ml of Cisplatin. The reconstituted solution should be diluted in 2 litres of
0.9% saline or a dextrose/saline solution (to which 37.5g of mannitol may be added).Personnel
should be trained in good technique for reconstitution and handling. Pregnant staff should be
excluded from working with Cisplatin. Care should be taken to prevent inhaling particles and
exposing the skin to Cisplatin. Adequate protective clothing should be worn, such as PVC gloves,
safety glasses, disposable gowns and masks. In the event of contact with eyes, wash with water or
saline. If the skin comes into contact with the drug wash thoroughly with water and in both cases
seek medical advice. Seek immediate medical attention if the drug is ingested or inhaled. All used
materials, needles, syringes, vials and other items which have come into contact with cytotoxic
drugs should be incinerated. Contaminated surfaces should be washed with copious amounts of
water.
7. MARKETING AUTHORISATION HOLDER
Pharmacia Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
PL 00032/0334
9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION
25 March 2002
10. DATE OF REVISION OF THE TEXT
Page 12 of 13

2016-0019151 & 2016-0016188

08/2016
11. LEGAL CATEGORY
POM
Ref: CS 9_0

Page 13 of 13

2016-0019151 & 2016-0016188

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.

Hide