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CARBOPLATIN CONCENTRATE FOR INFUSION 10MG/ML

Active substance(s): CARBOPLATIN

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TEVA UK Ref:

Version:

231-30-67879-M LEA CARBOPLATIN INJ TEVAH Dimensions:
Length:
Width:

5

19 April 2016

Colours Used:
420 mm
300 mm

Template
BLACK

93.130.379-G

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-G
67879-M

• Good oral hygiene (rinsing the
mouth frequently and effective
brushing of the teeth with a soft
PACKAGE LEAFLET: INFORMATION
brush 2–3 times daily) may help
FOR THE USER
to prevent developing a sore
mouth.
Carboplatin 10 mg/ml
• If you have headache, altered
concentrate for infusion
mental functioning, seizures and
Read all of this leaflet carefully
abnormal vision from blurriness
before you are given this medicine
to vision loss, tell your doctor
because it contains important
• If you develop extreme tiredness
information for you.
with decreased number of red
• Keep this leaflet. You may need
blood cells, and shortness of
to read it again.
breath (haemolytic anaemia),
• If you have any further
alone or combined with low
questions, ask your doctor,
platelet count, abnormal bruising
pharmacist or nurse.
(thrombocytopenia) and kidney
• If you get any side effects, talk to
disease where you pass little or
your doctor, pharmacist or nurse.
no urine (symptoms of
This includes any possible side
haemolytic-uraemic syndrome),
effects not listed in this leaflet.
tell your doctor.
see section 4.
• If you have fever (temperature
What is in this leaflet:
greater than or equal to 38°C),
or chills, which could be signs of
1. What Carboplatin is and what it
infection, tell your doctor
is used for
immediately. You may be at risk
2. What you need to know before
of getting an infection of the
you are given Carboplatin
blood.
3. How Carboplatin is given
4. Possible side effects
Other medicines and Carboplatin
5. How to store Carboplatin
6. Contents of the pack and other Tell your doctor or pharmacist if you
are taking/using, have recently
information
taken/used or might take/use any
other medicines as some could
1 What Carboplatin is and
what it is used for
interact with carboplatin, for
Carboplatin is a platinum containing example:
• Blood thinning medicines e.g.
compound. It is an anti-cancer
warfarin. An increased frequency
agent, which is used either alone or
of blood coagulation monitoring
in combination with other drugs.
is required.
Carboplatin is used to treat ovarian • Live or live-attenuated vaccines
cancer and lung cancer.
(for yellow fever vaccine see
section 2, “You must not be
Ask your doctor or nursing staff if
given Carboplatin”)
you need additional information.
• Any drugs which have a side
effect of decreasing the number
2 What you need to know
before you are given
of blood cells, such as clozapine,
Carboplatin
as this effect may become worse
when carboplatin is used in
You must not be given Carboplatin:
combination with these
• if you are allergic to carboplatin
medicines.
or any of the other ingredients of
this medicine (listed in section 6) • Any drugs which can cause
damage to either your kidneys or
or other platinum containing
inner ears e.g.
compounds
o Capreomycin, an antibacterial
• if you are breast-feeding
drug used to treat
• if you have severe kidney problems
tuberculosis
• if you have any bone marrow
o Aminoglycoside
problems
antibacterials, such as
• if you have a tumour that bleeds
gentamicin, streptomycin
• if you are to receive a yellow
o Polymixin antibiotics, such as
fever vaccination or have just
colistin
received one.
o Diuretics such as bumetanide
Warnings and precautions
or furosemide
Talk to your doctor before you are
Carboplatin may increase the
given Carboplatin:
toxic effects of these drugs. The
• if you have ever suffered an
combination of carboplatin with
allergic reaction to platinumthese drugs should be avoided.
containing medicines, such as
• Phenytoin and fosphenytoin
cisplatin or oxaliplatin (see “You
(used to treat various types of
must not be given Carboplatin ”)
convulsions and seizures), as the
• if you are elderly (over 65 years
level of the medicine in your
old).
blood may decrease when used
in combination with carboplatin;
Other precautions whilst you are
this may lead to reappearance of
receiving Carboplatin
seizures. An increase of your
• Your nervous system function
phenytoin dose may be
will be checked regularly.
necessary.
• Your doctor may give you blood
• Other medicines which decrease
or urine tests to check your
the activity of the immune
blood composition, kidney or
system (e.g. ciclosporin,
liver function before, during and
tacrolimus, sirolimus)
after treatment with Carboplatin.

Chelating drugs (drugs that bind
This is necessary to continue
to carboplatin and in this way
therapy.
decrease the effect of
• Your doctor may prescribe anti
carboplatin)
sickness medicines to prevent
nausea and vomiting.

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..

TEVA UK Ref:

Version:

231-30-67879-M LEA CARBOPLATIN INJ TEVAH Dimensions:
Length:
Width:

Colours Used:
420 mm
300 mm

Template
BLACK

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.
Not known: frequency cannot be
estimated from available data
• lung infection (pneumonia)
• secondary malignancies
(cancerous tumour that spreads
from its original location to
establish secondary tumours in
other parts of the body)
• reduced function of the bone
marrow; reduction in the number
of white blood cells accompanied
with fever (febrile neutropenia);
disease characterised by
abnormal breakdown of red
blood cells, failure of the kidney
and a reduced number of
platelets (haemolytic uraemic
syndrome)
• dry mouth, tiredness, and
headache due to excessive loss of
body water (dehydration), lack of
appetite (anorexia)
• decreased sodium levels in the
blood (hyponatraemia)
• stroke
• A group of symptoms such as
headache, altered mental
functioning, seizures and
abnormal vision from blurriness
to vision loss (symptoms of
reversible posterior
leukoencephalopathy syndrome,
a rare neurological disorder)
• heart failure, obstruction in blood
vessels (embolism), high blood
pressure, low blood pressure
• sore mouth or throat, with
inflamed, reddened and swollen
lining of the mouth or ulcers in
your mouth or throat (stomatitis)
• pancreatitis
• skin disorders such as hives, rash,
skin redness (erythema), and
itching
• injection site reactions such as
pain, redness, swelling, nettle
rash and dead skin
• general ill feeling (malaise), fever
and chills.
Reporting of side effects
If you get 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 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
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
foreign matter.
Once opened any unused solution
should be discarded using the
appropriate precautions. These
measures will help protect the
environment.

6 Contents of the pack and
other information
What Carboplatin contains
• The active substance is
carboplatin 10mg/ml.
• The other ingredients are
mannitol and water for
injections.
What Carboplatin looks like and
contents of the pack
• Carboplatin concentrate for
infusion comes as a clear,
colourless to faintly yellow
solution, free from particles.
The product is available in packs
containing a single 5 ml, 15 ml, 45 ml
or 60 ml vial and packs containing
10 vials of 5 ml and 10 vials of 15 ml.
• Each 5 ml vial contains 50 mg of
the active ingredient carboplatin.
• Each 15 ml vial contains 150 mg
of the active ingredient
carboplatin.
• Each 45 ml vial contains 450 mg
of the active ingredient
carboplatin.
• Each 60 ml vial contains 600 mg
of the active ingredient
carboplatin.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
The Marketing Authorisation holder
is Teva UK Limited, Eastbourne,
BN22 9AG.
The company responsible for
manufacture is Pharmachemie B.V.,
Haarlem, Holland.
This leaflet was last revised: April
2016
PL00289/0847

93.130.379-G
67879-M

5

19 April 2016

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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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