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CARBOPLATIN 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): CARBOPLATIN / CARBOPLATIN / CARBOPLATIN

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Carboplatin-Pack Insert-UK+IE+MT-Bordon-592x300

carboplatin
The name of this medicine is Carboplatin 10 mg/ml concentrate for
solution for infusion but in the rest of the leaflet it will be called
‘Carboplatin’.

1. WHAT CARBOPLATIN IS AND WHAT IT IS USED FOR
What Carboplatin is
It contains active ingredient carboplatin, which belong to a group of
medicines known as platinum coordination compounds, which are
used to treat cancer.

2. WHAT YOU NEED TO KNOW BEFORE YOU are given
CARBOPLATIN
Do not use Carboplatin:
• if you are allergic to carboplatin or any of the other ingredients of
this medicine (listed in section 6).
• if you have severe problems with your kidneys (creatinine clearance
at or below 30 ml/min)
• if you have an imbalance of your blood cells (severe
myelosuppression)
• if you have a tumour that bleeds
• Concomitantly with yellow fever vaccine
If any of these apply to you and you have not already discussed this
with your doctor or nurse, it is recommended to inform the doctor or
nurse as soon as possible and before receiving an infusion.

Your doctor will want to monitor you more regularly if your kidneys
are not working properly.
During treatment with carboplatin you will be given medicines which
help reduce a potentially life-threatening complication known as
tumour lysis syndrome, which is caused by chemical disturbances in
the blood due to the breakdown of dying cancer cells that release their
content to the bloodstream.

This medicine may be diluted with another solution before it is
administered. You should discuss this with your doctor and make sure
that it is suitable for you.
Other medicines and Carboplatin
Tell your doctor or nurse if you are using, have recently used any other
medicines.
You must tell your doctor if you are taking any of the following
medicines as they may interact with carboplatin.
• other medicines that are known to be toxic to your kidney (e.g.
aminoglycosides antibiotics)
• other medicines that are known to damage the hearing or balance
functions of the ear (e.g. aminoglycosides antibiotics, furosemide
used to treat heart failure and edema
• other medicines which decrease the activity of the immune system
(e.g cyclosporine, tacrolimus, sirolimus and other anticancer
medicines)
• yellow fever vaccine and other live vaccines
• blood thinning medicines e.g. warfarin
• phenytoin and fosphenytoin (used to treat various types of
convulsions and seizures)
• chelating agents (substances binding to carboplatin thereby
decreasing the effect of carboplatin)
• Loop diuretics (used to treat hypertension and edema)
Carboplatin with food, drink and alcohol
There is no known interaction between carboplatin and alcohol.
However you check with your doctor as carboplatin may affect the
liver’s ability to cope with alcohol.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or

Chemical and physical in-use stability
has been demonstrated after dilution
in Glucose 5% for 96 hours at 2°C to
8ºC and 20ºC to 25ºC.

Instructions for dilution
Carboplatin may interact with
aluminium to form a black precipitate
and/or loss of potency. Needles,
syringes, catheters or intravenous
administration sets that contain
aluminium parts which may come
into contact with carboplatin, should
not be used for the preparation or
administration of the drug.
The product must be diluted prior
to infusion, with 5 % Glucose for
Injection or 0.9% Sodium Chloride
for Injection, to concentrations as low
as 0.5 mg/ml (500 micrograms/ ml).

Carboplatin is usually given to patients in hospital. Normally you
must not handle this medicine. Your doctor or nurse will administer
the medicine and will carefully and frequently monitor you during
and after treatment. You will normally have blood tests before each
administration.

The
following
information
is
intended
for
healthcare
professionals only:
The medicinal product is for single
use only. Any unused infusion
solution should be discarded.

If your kidneys are not working properly the effects of carboplatin
on the blood (haematopoietic system) are increased and prolonged
compared to patients with normal kidney function.

If any of these apply to you and you have not already discussed this
with your doctor or nurse, it is recommended to inform the doctor or
nurse as soon as possible and before receiving the medicine.

What Carboplatin is used for
This medicine is used against advanced cancer of the ovary and small
cell cancer of the lung.

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If you are likely to drink alcohol whilst being treated with this medicine

If any of these apply to you and you have not already discussed this
with your doctor or nurse, it is recommended to inform your doctor or
nurse as soon as possible and before receiving the infusion.
Pregnancy
You must not be treated with carboplatin during pregnancy unless
clearly indicated by your doctor. Animal studies have shown a
possible risk of abnormalities in the developing fetus. If you are being
treated with carboplatin whilst pregnant, you should discuss with your
doctor the possible risk of effects on your unborn child. Women of
childbearing potential must use an effective method of contraception
both before and during treatment with carboplatin. Since carboplatin
can cause genetic damage, if pregnancy occurs during treatment with
carboplatin, genetic counselling is recommended. Genetic counselling
is also recommended for patients wishing to have children after
treatment with carboplatin.
Breast-feeding
It is not known whether carboplatin is excreted into the breast milk.
Therefore, during treatment with Carboplatin you should discontinue
breast-feeding.
Fertility
Carboplatin can cause genetic damage. Women are advised to avoid
becoming pregnant by using effective contraception before and during
treatment. For women who are pregnant or become pregnant during
therapy, genetic counselling should be provided.
Men treated with carboplatin are advised not to father a child during,
and up to 6 months after treatment. Advice on conservation of sperm
should be sought prior to treatment because of the possibility of
irreversible infertility.
Ask your doctor or nurse for advice before using any medicine.
Driving and using machines
Carboplatin does not affect your ability to drive and use machines.
However you must take extra care when you are first given carboplatin,
especially if you feel dizzy or unsure of yourself.
3. How you are given Carboplatin
This medicine will always be administered by a nurse or doctor. It is
usually given in a drip by slow injection into a vein and will usually
take between 15 and 60 minutes to be administered. If you require any
further information, ask your doctor or nurse who will administer or
has administered the infusion. Your dose will be dependent on your
height and weight, function of your blood (haematopoietic) system
and your kidney function. Your doctor will choose the best dose for
you. The infusion will normally be diluted before use.
Adult
The usual dose is 400 mg/m² of your body surface area (calculated
from your height and weight).

Elderly
The usual adult doses may be used although the doctor may choose to
use a different dose
Kidney problems
The amount given may vary, according to how well your kidneys
are working. If you suffer from kidney problems your doctor may
reduce the dose and may perform frequent blood tests as well as
monitoring your kidney function. This medicine will be given by a
doctor experienced in the use of cancer treatment.
Children and adolescents
There has not been enough usage of carboplatin in children to allow
the recommendation of specific dose.
You may feel sick while you are being treated with carboplatin. Your
doctor may give you another medicine to reduce these effects before
you are treated with this medicine.
There will be a usual gap of 4 weeks between each dose of carboplatin.
Your doctor will want to perform some blood tests each week after
giving you this medicine so he/she can decide on the correct next
dosage for you.
If you receive more Carboplatin than you should
It is unlikely that you will be given too much carboplatin. However
in the event that this occurs you may have some problems with your
kidneys ,liver, sight and hearing and have low white blood cell count.
If you are worried that too much has been administered or you have
any questions about the dose being given you must talk to the doctor
administering your medicine.
If you miss a dose of Carboplatin
It is very unlikely that you will miss a dose of your medicines, as your
doctor will have instructions on when to give you your medicine. If
you think you have missed your dose please talk to your doctor or
nurse.
If you have any further questions on the use of this medicine, ask your
doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can have side-effects, although
not everybody gets them.
Tell your doctor immediately if you notice any of the following:
-- Abnormal bruising, bleeding, or signs of infection such as a sore
throat and high temperature
-- Severe itching of the skin (with raised lumps) or swelling of the
face, lips, tongue and/or throat, which may cause difficulty in
swallowing or breathing (angioedema) and you may feel you are
going to faint.
-- Stomatitis/mucositis (e.g. sore lips or mouth ulcers).
Very common: may affect more than 1 in 10 people
-- Suppression of the bone marrow characterised by a severe
decrease of white blood cells, which makes infections more likely
(leukopenia, neutropenia)

Guidelines for the safe handling of
anti-neoplastic agents:
1. Carboplatin should be prepared
for administration only by
professionals who have been
trained in the safe use of
chemotherapeutic agents
2. This should be performed in a
designated area.
3. Adequate protective gloves, face
mask and protective clothes 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
1,000 °C.
7. The work surface should be
covered with disposable plasticbacked absorbent paper.
8. 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.

UK/IE/MT
V005

If you are breastfeeding

The solution is to be inspected
visually for particulate matter and
discoloration prior to administration.
The solution should only be used if
the solution is clear and free from
particles.

Carboplatin 10 mg/ml
7220132497
LFT00297

If you are pregnant or if there is a chance you may be pregnant

From a microbiological point of view
however, the product should be used
immediately. If not used immediately,
in-use storage conditions prior to use
are the responsibility of the user and
would normally be no longer than 24
hours at 2°C to 8°C, unless dilution
has taken place in controlled and
validated aseptic conditions.

UK/IE/MT
V005

Carboplatin 10 mg/ml

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

are planning to have a baby, ask your doctor for advice before treated
with this medicine.

Talk to your doctor or nurse before you are given Carboplatin

Chemical and physical in-use stability
has been demonstrated after dilution
in Sodium chloride 0.9% for 24 hours
at 2ºC to 8ºC and 8 hours at 20ºC to
25ºC.

7220132497
LFT00297

Folding Size: 33 x 60 mm

Read all of this leaflet carefully before you start using 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, please ask your doctor or nurse.
-- If you get any side effects, talk to your doctor or nurse. This includes
any possible side effects not listed in this leaflet see section 4.

Warnings and precautions:

-- Reduction in blood platelets, which increases the risk of bruising
and bleeding (thrombocytopenia)
-- Anaemia (a condition in which there is a decreased number of red
blood cells which leads to tiredness)
-- Reduced function of your kidneys (Increase in the level of the
creatinine and urea in your blood) Your doctor may want to monitor
you
-- Slight loss of hearing (high frequency hearing-loss)
-- Abnormal liver enzymes levels and abnormal liver function test.
Your doctor may want to monitor you
-- Increased uric acid levels in your blood which may lead to gout
(hyperuricaemia)
-- Feeling or being sick
-- Abdominal pain and cramp
-- Unusual feelings of tiredness or weakness
-- Decrease in the level of salts in your blood (sodium, potassium,
calcium, magnesium). Your doctor may want to monitor you
Common: may affect up to 1 in 10 people
-- Unusual bruising or bleeding (haemorrhagic complications)
-- Diarrhoea, constipation, sore lips or mouth ulcers (mucositis)
-- Allergic reactions including rash, urticaria, skin reddening, itching,
high temperature
-- Ringing in the ears (tinnitus), hearing impairment and hearing loss
-- Pins and needles (peripheral neuropathy) weakness, tingling or
numbness
-- Hair loss
-- Feeling unwell
-- Flu-like syndrome
-- Loss or lack of body strength
-- Lung disorders, Scarring and thickening in the lungs with
difficulties in breathing, sometimes fatal (interstitial lung disease),
difficulty breathing.
-- Decreased bone and tendon reflex.
-- Infections
-- Sensory disturbance
-- Taste alteration
-- Visual disturbances, including temporary sight loss
-- Cardiovascular disorder
-- Skin disorder
-- Itchy skin rash (urticaria)
-- Feeling itchy (Pruritus)
-- Red rash (rash erythematous)
-- Musculoskeletal disorder
-- Conditions affecting the urinary and genital tracts (urogenital
disorder)
-- Increase in the level of the creatinine, bilirubin and uric acid in your
blood. Your doctor may want to monitor you
Uncommon: may affect up to 1 in 100 people
-- Cancer caused by chemotherapy or radiation (Secondary
malignancies)
-- Fever and chills without evidence of infection

Disposal
Any unused medicinal product or
waste material should be disposed of
in accordance with local requirements.

PACKAGE LEAFLET: INFORMATION FOR THE USER
Carboplatin 10 mg/ml concentrate for solution for infusion
(50 mg/5 ml, 150 mg/15 ml, 450 mg/45 ml and
600 mg/60 ml)

Black

Times New Roman

10 pt

Ver.: 09

Last modified: 10 January 2017 4:22 PM

Carboplatin-Pack Insert-UK+IE+MT-Bordon-592x300
-- Redness, swelling and pain or dead skin around the injection site
(injection site reaction)

By reporting side effects you can help provide more information on
the safety of this medicine.

Rare: may affect up to 1 in 1000 people
-- Feeling unwell with a high temperature due to low levels of white
blood cells (febrile neutropenia)
-- Loss of appetite (anorexia)
-- Severely impaired liver function, damage or death of liver cells.
Your doctor may want to monitor you.
-- Inflammation of the optic nerve that may cause a complete or
partial loss of vision (optic neuritis)
-- Severe allergic reactions (anaphylaxis/anaphylactic reactions)
-- Symptoms of a severe allergic reactions include sudden wheeziness
or tightness of chest, swelling of the eyelids, face or lips, facial
flushing, hypotension, tachycardia, urticaria, dyspnoea, dizziness
and anaphylactic shock.
-- Low levels of sodium in your blood (hyponatraemia)

5. HOW TO STORE CARBOPLATIN
Keep this medicine out of the sight and reach of children.

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Very rare: may affect up to 1 in 10,000 people
-- Heart failure
-- Bleeding in the brain, which may result in a stroke or loss of
consciousness
-- Sudden blockage of an artery (embolism), high blood pressure, low
blood pressure
Not known side effects (frequency cannot be estimated from the
available data):
-- Haemolytic uraemic syndrome (a disease characterized by acute
renal failure /low urine output /or no urine output, decreased
number of red blood cells with extreme tiredness and low platelet
count)
-- Abnormal bruising or bleeding and signs of infection
-- Dehydration
-- Sore lips or mouth ulcers (stomatitis)
-- muscle cramping, muscle weakness, confusion, visual loss or
disturbances, irregular heartbeat, kidney failure or abnormal blood
test results (symptoms of tumor lysis syndrome which can be
caused by the rapid breakdown of tumour cells) (see section 2).
If you get any side effects, talk to your doctor, 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
www.mhra.gov.uk/yellowcard
in Ireland to
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail:
medsafety@hpra.ie
and in Malta to the ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

Do not use this medicine after the expiry date which is stated on the
label and carton after EXP. The expiry date refers to the last day of
that month.
Before opening vials: Store below 25°C
Keep the vial in the outer carton in order to protect from light.
After dilution: Chemical and physical in-use stability has been
demonstrated after dilution in Glucose 5% for 96 hours at 2ºC to 8ºC
and 20ºC to 25ºC.
Chemical and physical in-use stability has been demonstrated after
dilution in Sodium chloride 0.9% for 24 hours at 2ºC to 8ºC and 8
hours at 20ºC to 25ºC.
From a microbiological point of view however, the product should be
used immediately. If not used immediately, in-use storage conditions
prior to use are the responsibility of the user and would normally be
no longer than 24 hours at 2ºC to 8ºC, unless dilution has taken place
in controlled and validated aseptic conditions.
Do not use this medicine if you notice any signs of deterioration.
Do not throw away any medicines via waste water or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
6. Contents of the pack and other information
What Carboplatin contains
-- The active substance is carboplatin. 1 ml of concentrate for solution
for infusion contains 10 mg of carboplatin.
Each 5 ml vial contains 50 mg carboplatin
Each 15 ml vial contains 150 mg carboplatin
Each 45 ml vial contains 450 mg carboplatin
Each 60 ml vial contains 600 mg carboplatin.
-- The other ingredient is water for injections.
What Carboplatin looks like and contents of the pack
Carboplatin is a clear, colourless solution free from visible particles.
Each milliliter (ml) of concentrate contains 10 milligram (mg) of
carboplatin. This medicine is presented in a clear, colourless, type I
glass vials with flurotec rubber closures with green (for 6 ml), blue
(for 20 ml), red (for 50 ml) and yellow (for 100 ml) flip-off aluminium
overseal. The 5 ml vial contains 50 mg of carboplatin, the 15 ml vial
contains 150 mg of carboplatin, the 45 ml vial contains 450 mg of
carboplatin and the 60 ml vial contains 600 mg of carboplatin.

Marketing Authorisation Holder and Manufacturer
Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon
Hampshire, GU350NF
United Kingdom
This medicinal product is authorised in the Member States of the
EEA under the following names:
Belgium
Carboplatine Fresenius Kabi 10 mg/ml concentraat
voor oplossing voor infusie
Czech
Carboplatin Kabi 10 mg/ml koncentrát pro infuzní
Republic
roztok
Germany
Carboplatin Kabi 10 mg/ml Konzentrat zur
Herstellung einer Infusionslösung
Denmark
Carboplatin Fresenius Kabi
Estonia
Carboplatin Kabi 10 mg/ml
Spain
Carboplatino Kabi 10 mg/ml concentrado para
solución para perfusión EFG
France
Carboplatine Kabi 10 mg/ml solution à diluer pour
perfusion
Hungary
Carboplatin Kabi 10 mg/ml koncentrátum oldatos
infúzióhoz
Ireland
Carboplatin 10 mg/ml concentrate for solution for
infusion
Iceland
Carboplatin
Fresenius
Kabi
10
mg/ml
innrennslisþykkni, lausn
Latvia
Carboplatin Kabi 10 mg/ml koncentrāts infūziju
šķīduma pagatavošanai
Lithuania
Carboplatin Kabi 10 mg/ml koncentratas
infuziniam tirpalui
Luxembourg
Carboplatin Kabi 10 mg/ml Konzentrat zur
Herstellung einer Infusionslösung
Malta
Carboplatin 10 mg/ml concentrate for solution for
infusion
The
Carboplatine Fresenius Kabi 10 mg/ml concentraat
Netherlands
voor oplossing voor infusie
Norway
Carboplatin Fresenius Kabi 10 mg/ml konsentrat til
infusjonsvæske oppløsning
Poland
Carboplatin Kabi
Portugal
Carboplatina Kabi
Romania
Carboplatin Kabi 10 mg/ml concentrat pentru
soluţie perfuzabilă
Slovak
Carboplatin Kabi 10 mg/ml, infúzny koncentrát
Republic
United
Carboplatin 10 mg/ml concentrate for solution for
Kingdom
infusion
This leaflet was last revised in 12/2016

The standard vials are available in single pack of 5 ml, 15 ml, 45 ml
or 60 ml.
Not all presentations listed above may be marketed.

Black

Times New Roman

10 pt

Ver.: 09

Last modified: 10 January 2017 4:22 PM

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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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