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CARBOPLATIN CONCENTRATE FOR INFUSION 10MG/ML

Active substance(s): CARBOPLATIN / CARBOPLATIN / CARBOPLATIN

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93.130.379-H

The following information is intended for
medical or healthcare professionals only

Carboplatin 10 mg/ml
Concentrate for Infusion
Further to the information included in section
3, practical information on the preparation/handling of the medicinal product is
provided here.
Incompatibilities
This medicinal product should not be mixed
with other medical products except 5%
Glucose for Injection or 0.9% NaCl for
Injection.
This product should not be used with aluminium-containing infusion assemblies, syringes
and injection needles. The antineoplastic
activity can be reduced.
Handling
The solution for infusion must be visually
inspected for particulate matter before use.
Guidelines for the safe handling of anti-neoplastic agents:
1. Trained personnel should handle the drug
2. This should be performed in a designated
area
3. Adequate protective gloves should be worn.
4. Precautions should be taken to avoid the
drug accidentally coming into contact with the
eyes. In the event of contact with the eyes,
wash with water and/or saline.
5. The cytotoxic preparation should not be
handled by pregnant staff.
6. Adequate care and precautions should be
taken in the disposal of items (syringes,
needles etc) used to reconstitute cytotoxic
drugs. Excess material and body waste may be
disposed of by placing in double sealed
polythene bags and incinerating at a temperature of 1000°C. Liquid waste may be flushed
with copious amounts of water.
Dilution
1. The work surface should be covered with
disposable plastic-backed absorbent paper.
2. Use Luer-Lock fittings on all syringes and
sets. Large bore needles are recommended to
minimise pressure and the possible formation
of aerosols. The latter may also be reduced by
the use of a venting needle.
The product may be diluted with 5% Glucose
for Injection, or 0.9% NaCl for Injection, to
concentrations as low as 0.5 mg/ml (500
micrograms/ml).
Method of administration
Carboplatin should be used by the intravenous
route only. The solution for infusion is administered by a short term (15 to 60 minutes)
infusion.
Special precautions for storage
When diluted as directed, carboplatin
solutions should be used within three hours
when stored at room temperature (15 - 25°C)
protected from light or within 24 hours when
stored at 2 - 8°C if dilution is carried out
under validated aseptic conditions. Since no
antibacterial preservatives are contained in the
formulation, it is recommended that any
carboplatin solution be discarded three hours
after dilution if stored at room temperature
protected from light or after 24 hours, if
stored under refrigeration. This product is for
single dose use only.

93.130.379-H
67879-N

• During treatment with carboplatin
you will be given medicines which
help reduce a potentially
life-threatening complication
PACKAGE LEAFLET: INFORMATION
FOR THE USER
known as tumour lysis syndrome,
which is caused by chemical
Carboplatin 10 mg/ml
disturbances in the blood due to
concentrate for infusion
the breakdown of dying cancer
Read all of this leaflet carefully
cells that release their content to
before you are given this medicine
the bloodstream.
because it contains important
• If you have headache, altered
information for you.
mental functioning, seizures and
• Keep this leaflet. You may need to
abnormal vision from blurriness to
read it again.
vision loss, tell your doctor
• If you have any further questions, • If you develop extreme tiredness
ask your doctor, pharmacist or
with decreased number of red
nurse.
blood cells, and shortness of
• If you get any side effects, talk to
breath (haemolytic anaemia),
your doctor, pharmacist or nurse.
alone or combined with low
This includes any possible side
platelet count, abnormal bruising
effects not listed in this leaflet. see
(thrombocytopenia) and kidney
section 4.
disease where you pass little or no
urine (symptoms of
What is in this leaflet:
haemolytic-uraemic syndrome),
1. What Carboplatin is and what it is
tell your doctor.
used for
• If you have fever (temperature
2. What you need to know before
greater than or equal to 38°C), or
you are given Carboplatin
chills, which could be signs of
3. How Carboplatin is given
infection, tell your doctor
4. Possible side effects
immediately. You may be at risk of
5. How to store Carboplatin
getting an infection of the blood.
6. Contents of the pack and other
Other medicines and Carboplatin
information

1 What Carboplatin is and
what it is used for
Carboplatin is a platinum containing
compound. It is an anti-cancer agent,
which is used either alone or in
combination with other drugs.
Carboplatin is used to treat ovarian
cancer and lung cancer.
Ask your doctor or nursing staff if you
need additional information.

2 What you need to know
before you are given
Carboplatin
You must not be given Carboplatin:
• if you are allergic to carboplatin or
any of the other ingredients of this
medicine (listed in section 6) or
other platinum containing
compounds
• if you are breast-feeding
• if you have severe kidney problems
• if you have any bone marrow
problems
• if you have a tumour that bleeds
• if you are to receive a yellow fever
vaccination or have just received
one.
Warnings and precautions
Talk to your doctor before you are
given Carboplatin:
• if you have ever suffered an
allergic reaction to platinumcontaining medicines, such as
cisplatin or oxaliplatin (see “You
must not be given Carboplatin ”)
• if you are elderly (over 65 years
old).
Other precautions whilst you are
receiving Carboplatin
• Your nervous system function will
be checked regularly.
• Your doctor may give you blood or
urine tests to check your blood
composition, kidney or liver
function before, during and after
treatment with Carboplatin. This is
necessary to continue therapy.
• Your doctor may prescribe anti
sickness medicines to prevent
nausea and vomiting.
• Good oral hygiene (rinsing the
mouth frequently and effective
brushing of the teeth with a soft
brush 2–3 times daily) may help to
prevent developing a sore mouth.

Tell your doctor or pharmacist if you
are taking/using, have recently
taken/used or might take/use any
other medicines as some could
interact with carboplatin, for example:
• Blood thinning medicines e.g.
warfarin. An increased frequency
of blood coagulation monitoring is
required.
• Live or live-attenuated vaccines
(for yellow fever vaccine see
section 2, “You must not be given
Carboplatin”)
• Any drugs which have a side effect
of decreasing the number of blood
cells, such as clozapine, as this
effect may become worse when
carboplatin is used in combination
with these medicines.
• Any drugs which can cause
damage to either your kidneys or
inner ears e.g.
o Capreomycin, an antibacterial
drug used to treat tuberculosis
o Aminoglycoside antibacterials,
such as gentamicin,
streptomycin
o Polymixin antibiotics, such as
colistin
o Diuretics such as bumetanide
or furosemide
Carboplatin may increase the toxic
effects of these drugs. The
combination of carboplatin with
these drugs should be avoided.
• Phenytoin and fosphenytoin (used
to treat various types of
convulsions and seizures), as the
level of the medicine in your blood
may decrease when used in
combination with carboplatin; this
may lead to reappearance of
seizures. An increase of your
phenytoin dose may be necessary.
• Other medicines which decrease
the activity of the immune system
(e.g. ciclosporin, tacrolimus,
sirolimus)
• Chelating drugs (drugs that bind
to carboplatin and in this way
decrease the effect of carboplatin)
Pregnancy, breast-feeding and
fertility
Pregnancy
• Carboplatin should not be given to
you if you are pregnant unless
clearly indicated by your doctor,
due to the possible risk of

abnormalities in the developing
foetus.
• If you become pregnant or suspect
that you may be pregnant during
therapy, you must tell your doctor
immediately. If you are pregnant
or become pregnant during
therapy, genetic counselling should
be provided.
• Female patients should use an
effective method of contraception,
e.g. the barrier method or
condoms, to avoid getting
pregnant during treatment, and
for at least 6 months after
treatment with carboplatin.
• Male patients receiving treatment
with carboplatin should also take
adequate contraception
precautions to ensure that their
partner does not become pregnant
during treatment, and for at least
6 months after treatment.
Breast-feeding
• You must not breast-feed during
your treatment with carboplatin.
Fertility
Both male and female patients who
are considering having a child after
the treatment should discuss this with
their doctor. Male patients should
seek advice on conservation of sperm
prior to treatment because of the
possibility of irreversible anti-fertility
effect.
Driving and using machines
• Carboplatin may cause you to feel
or be sick. DO NOT drive or
operate machinery until you are
sure you are not affected.

3 How Carboplatin is given
• Carboplatin should only be
administered by specifically
qualified doctors.
• Carboplatin will be diluted and
then administered to you by the
intravenous (into the vein) route
only.
• You will have regular tests
performed to monitor your
condition.
• There is likely to be about 4 weeks
between each dose of carboplatin.
The recommended dose is:
• Adults
400 mg/m2 given as a single
intravenous (into the vein) dose
over a period of 15 to 60 minutes.
• The Elderly
For elderly patients (over 65 years
old), the dosage may need
adjusting depending on your
physical condition.
• If you have received treatment
previously or have kidney
problems
Your dosage will be adjusted to
suit you.
• Children and adolescents
Carboplatin is not recommended
for use in children and
adolescents..
If you received more Carboplatin than
you should
There is no specific antidote for
carboplatin overdosage. If you
received too much carboplatin, the
doctor will stop the therapy and treat
the symptoms.
If administration of Carboplatin is
forgotten
Your doctor will decide on what time
you will receive this medicine. If you
think you have missed a dose, please
contact your doctor as soon as
possible.

4 Possible side effects
Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
If you get any of the following
serious side effects, tell your doctor
immediately, or seek urgent medical
advice:
• Abnormal bruising, bleeding, or
signs of infection such as sore
throat and high temperature
• Serious allergic reactions: swelling
of the lips, face, mouth or neck
leading to severe difficulty in
breathing; skin rash or hives;
swelling of the hands, feets,
ankles.
Other side effects:
Very common : may affect more than
1 in 10 people
• reduction in the number of
plateletsassociated with bruises
and abnormal bleeding
(thrombocytopenia), reduction in
the number of white blood cells
associated with increased infection
risk (leukopenia, neutropenia),
reduction in the number of red
blood cells (anaemia: this may
cause tiredness)
• nausea, abdominal pain, vomiting
• toxicity of the kidneys
• unusually high concentration of
uric acid in the blood
(hyperuricaemia)
• abnormal liver function tests
• changes in blood chemistry
(decreased level of blood sodium,
blood potassium, blood calcium
and blood magnesium)
Common: may affect up to 1 in 10
people
• signs of infection such as fever or
sore throat
• bleeding (haemorrhagic)
complications
• allergic reactions such as rash,
fever with no apparent cause and
itch
• a disorder of the nerves (peripheral
neuropathy). You may feel a
tingling and/or numbness in the
fingers, toes, around the mouth or
in the throat, which may
sometimes occur in association
with cramps. These effects are
often triggered by exposure to
cold e.g. opening a refrigerator or
holding a cold drink. You may also
have difficulty in performing
delicate tasks, such as buttoning
clothes
• sensation of tingling, pricking, or
numbness of the skin with no
apparent physical cause
(paraesthesia), decreased tendon
reflex
• taste disturbance
• temporary worsening of eyesight
or changes to your vision, loss of
vision
• hearing loss, hearing problems
• heart disorders
• tightness of the chest or wheezing,
tightness of the chest caused by
cramping of the respiratory tract
muscles (bronchospasm)
• intestinal lung disease (a group of
lung disorders in which the deep
lung tissue become inflamed)
• diarrhoea, constipation
• sore lips or mouth ulcers (mucous
membrane disorders)
• problems with your kidneys or
urine
• hair loss (alopecia)
• rash and/or itchy skin
• pain or discomfort in your bones,
joints, muscles, or surrounding

structures (musculoskeletal
disorders)
• extreme tiredness/weekness
(asthenia)
• increased level of bilirubin and
creatinine in your blood
• increased level of uric acid in your
blood which may lead to gout

light or 24 hours at 2 - 8ºC when
carried out under validated aseptic
conditions. The storage times relate to
the commencement of drug
administration.

Only use this product if it is a clear,
colourless to faintly yellow solution,
free from fibres and particles of
Not known: frequency cannot be
foreign matter.
estimated from available data
Once opened any unused solution
• lung infection (pneumonia)
should be discarded using the
• secondary malignancies (cancerous appropriate precautions. These
tumour that spreads from its
measures will help protect the
original location to establish
environment.
secondary tumours in other parts
of the body)
6 Contents of the pack and
other information
• reduced function of the bone
marrow; reduction in the number What Carboplatin contains
of white blood cells accompanied
• The active substance is carboplatin
with fever (febrile neutropenia);
10mg/ml.
disease characterised by abnormal

The other ingredients are mannitol
breakdown of red blood cells,
and
water for injections.
failure of the kidney and a reduced
number of platelets (haemolytic
What Carboplatin looks like and
uraemic syndrome)
contents of the pack
• dry mouth, tiredness, and
• Carboplatin concentrate for
headache due to excessive loss of
infusion comes as a clear,
body water (dehydration), lack of
colourless to faintly yellow
appetite (anorexia)
solution, free from particles.
• decreased sodium levels in the
The product is available in packs
blood (hyponatraemia)
containing a single 5 ml, 15 ml, 45 ml
• stroke
or 60 ml vial and packs containing 10
• A group of symptoms such as
vials of 5 ml and 10 vials of 15 ml.
headache, altered mental
• Each 5 ml vial contains 50 mg of
functioning, seizures and abnormal
the active ingredient carboplatin.
vision from blurriness to vision loss • Each 15 ml vial contains 150 mg
(symptoms of reversible posterior
of the active ingredient
leukoencephalopathy syndrome, a
carboplatin.
rare neurological disorder)
• Each 45 ml vial contains 450 mg
• heart failure, obstruction in blood
of the active ingredient
vessels (embolism), high blood
carboplatin.
pressure, low blood pressure
• Each 60 ml vial contains 600 mg
of the active ingredient
• sore mouth or throat, with
carboplatin.
inflamed, reddened and swollen
lining of the mouth or ulcers in
Not all pack sizes may be marketed.
your mouth or throat (stomatitis)
Marketing Authorisation Holder and
• pancreatitis
• skin disorders such as hives, rash, Manufacturer
The Marketing Authorisation holder is
skin redness (erythema), and
Teva UK Limited, Eastbourne,
itching
BN22 9AG.
• muscle cramping, muscle
weakness, confusion, visual loss or The company responsible for
disturbances, irregular heartbeat, manufacture is Pharmachemie B.V.,
kidney failure or abnormal blood Haarlem, Holland.
test results (symptoms of tumor
This medicinal product is authorised
lysis syndrome which can be
in the Member States of the EEA
caused by the rapid breakdown of under the following names:
tumour cells) (see section 2).
Germany:
Carboplatin-Gry
• injection site reactions such as
10mg/ml
pain, redness, swelling, nettle rash
Italy:
Carboplatino Teva
and dead skin
10 mg/ml
• general ill feeling (malaise), fever
Spain:
Carboplatino Teva
and chills.
10 mg/ml Concentrado
Reporting of side effects
para solución para
If you get any side effects, talk to
perfusión
your doctor, pharmacist or nurse. This United
includes any possible side effects not Kingdom:
Carboplatin 10 mg/ml
listed in this leaflet. You can also
Concentrate for Infusion
report side effects directly via the
This leaflet was last revised:
Yellow Card Scheme at:
December 2016
www.mhra.gov.uk/yellowcard
PL00289/0847
By reporting side effects you can help
provide more information on the
safety of this medicine.

5 How to store Carboplatin
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
label/carton after EXP. The expiry date
refers to the last day of that month.
Do not store above 25ºC. Keep the
container in the outer carton.
After dilution in 0.9% NaCl solution
or 5% glucose solution, storage
should be restricted to three hours at
room temperature protected from

93.130.379-H
67879-N

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.

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