CARBOPLATIN 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance: CARBOPLATIN

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Package leaflet: Information for the user

Carboplatin 10 mg/ml
concentrate for solution for infusion

What Carboplatin is
Carboplatin contains carboplatin, which belongs
to a group of medicines known as platinum
coordination compounds which are used to treat
cancer.
You will normally be given this injection in hospital.

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

What Carboplatin is used for
Carboplatin is used to treat some cancers of the
ovary and lung (ovarian cancer of epithelial origin,
small-cell lung cancer).
2. What you need to know before you use
Carboplatin
Do not use Carboplatin:
• if you are allergic to carboplatin or other
ingredients of this medicine (listed in section 6).
• if you are breast-feeding.
• if you are allergic to another medicine that
belongs to the group of platinum containing
compounds.
• if you have severe problems with your kidneys
(glomerular filtration rate < 30 ml/min).
• if you have an imbalance of your blood cells
(severe myelosuppression).
• if you have a tumour that bleeds.
• if you are receiving yellow fever vaccine at the
same time.

1. What Carboplatin is and what it is used for

If any of these apply to you and you have not
already discussed this with your doctor or
pharmacist, you should do so as soon as possible
and before receiving the injection.

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

Carboplatin is usually given to patients in hospital.
Normally you should not handle this medicine.
Your doctor will administer the medicine and will

carefully and frequently monitor you during and
after treatment. You will normally have blood tests
before each administration.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
using Carboplatin
• if you are pregnant or if there is a chance you
may be pregnant.
• if you are likely to drink any alcohol whilst being
treated with this injection.
If your kidneys are not working properly the effects
of carboplatin on the blood building system are
increased and prolonged compared to patients with
normal kidney function. Your doctor will want to
monitor you more regularly if your kidneys are not
working properly.
If any of these apply to you and you have not
already discussed this with your doctor or
pharmacist, you should do so as soon as possible
and before receiving the injection.
Other medicines and Carboplatin
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Tell your doctor if you are taking any of the
following medicines as they may interact with
Carboplatin:
When undergoing treatment with carboplatin, you
must not be administered yellow fever vaccines
(see also “Do not use Carboplatin”) because there
is an increased risk that you develop yellow fever,
which may lead to death.
Any vaccinations containing live viruses should
not be administered when treated with carboplatin

as there is a risk that you develop the disease you
are vaccinated against, which may lead to death.

If you are being treated with Carboplatin whilst
pregnant, you should discuss with your doctor the
possible risk for effects on your unborn child.

Your dose will be dependent on your height and
weight, functioning of your blood building system
and your kidney function. Your doctor will choose
the best dose for you. The injection will normally be
diluted before use.

Carboplatin can reduce the effects of anti-epileptic
medicine (e.g. phenytoin and fosphenytoin).
Carboplatin may have an adverse impact on the
effectivity of agents preventing blood clotting
(anticoagulants). Therefore, blood-clotting ability
should be checked more often during combined
use.

Women of childbearing potential must use an
effective method of contraception both before and
during treatment with Carboplatin. If pregnancy
occurs during treatment with Carboplatin, genetic
counselling is recommended, since Carboplatin can
cause genetic damage.

The simultaneous use of carboplatin with chelating
agents (agents which can chemically bind to
carboplatin) can strengthen the adverse effects of
carboplatin.

Breast-feeding
It is not known whether carboplatin is excreted into
the breast milk. Therefore, you should not breastfeed during treatment with Carboplatin.

Elderly patients
The recommended adult doses may be used
although the doctor may choose to use a different
dose.

Carboplatin toxicity may severely affect the
kidneys and hearing ability when administered
at the same time as medicines that are known to
harm the kidneys and ears, e.g. antibiotics called
aminoglycosides (medicine to prevent/treat certain
infections) or loop diuretics (“water tablets”).

Fertility
Carboplatin can cause genetic damage. Men
treated with Carboplatin are advised not to father
a child during and up to 6 months after treatment.
They should seek advice on conservation of sperm
prior to treatment because of the possibility of
irreversible infertility.

Kidney problems
If you suffer from kidney problems your doctor may
reduce the dose and may perform frequent blood
tests as well monitoring your kidney function.

Using carboplatin at the same time as
cyclosporine, tacrolimus and sirolimus (used
to suppress the immune system in autoimmune
diseases or organ transplantation) can weaken
the immune system with the risk of increased
production of white blood cells.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Pregnancy
You must not be treated with Carboplatin during
pregnancy unless clearly indicated by your doctor.

Driving and using machines
Carboplatin may cause nausea, vomiting, vision
abnormalities and hearing disorders, indirectly
impairing your ability to drive and use machines.
3. How to use Carboplatin
Your injection will always be administered by your
doctor. It is usually given in a drip by slow injection
(infusion) in a vein (intravenously) and will usually
take between 15 to 60 minutes to be administered.
If you require any further information, ask your
doctor who will administer or has administered the
injection.

Adults
The recommended dose is 400 mg/m² of your
body surface area (calculated from your height
and weight).

may experience myelosuppression (inhibition of
blood cell production in the bone marrow), kidney
and liver problems as well as hearing problems.
If you are worried that too much has been
administered or if you have any questions about
the dose being given, you should talk to the doctor
administering your medicine.
If you miss a dose of Carboplatin
It is unlikely that you miss a dose of your medicine
as your doctor will have instructions on when
to give you your medicine. If you think you have
missed a dose please talk to your doctor.
If you stop using Carboplatin
Your doctor will normally decide when you should
stop treatment with Carboplatin. If you have any
further questions on the use of this medicine ask
your doctor, pharmacist or nurse.

Use in children and adolescents
There has not been enough usage of carboplatin in
children to allow the recommendation of a specific
dose.

4. Possible side effects

You may feel sick or be sick while you are being
treated with Carboplatin. Your doctor may give you
another medicine to reduce these effects before
you are treated with Carboplatin.

Important side effects or symptoms to look out
for – and what to do if you are affected

There will usually be a gap of four weeks between
each dose of Carboplatin. Your doctor will want to
perform some blood tests each week after giving
you Carboplatin so that 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
injection. However, in the event that this occurs you

Like all medicines, Carboplatin can cause side
effects, although not everybody gets them.

If you think you have any of the following side
effects or symptoms, please contact your
doctor immediately.
Very common side effects
(affecting more than 1 in 10 people):
• reduction in the number of white blood cells
(makes infections more likely)
• anaemia (a condition in which there is a decrease
of red blood cells which can make the skin pale
and cause weakness or breathlessness)

The following information is intended for healthcare
professionals only:
Use/Handling
Carboplatin is a mutagenic and potentially
carcinogenic substance. Precautions for safe
handling of hazardous substances are to be
taken for preparation and application. Preparation
must be carried out by trained personal wearing
adequate protective gloves, disposable gowns and
masks.
Carboplatin should not be used with aluminiumcontaining parts (e.g. infusion assemblies, syringes
and injection needles) as carboplatin reacts with
aluminium. This can lead to precipitation and thus
to reduced antineoplastic activity.
Shelf life after opening the container and preparing
the solution for infusion ready-to-use:
Chemical and physical in-use stability has been
demonstrated in glucose 50 mg/ml (5 %) solution
for infusion for 72 hours at room temperature and
in sodium chloride 9 mg/ml (0.9 %) solution for
infusion for 24 hours at 2 to 8 °C, when stored
protected from light. However, it is recommended
to use solution for infusion reconstituted with
sodium chloride 9 mg/ml (0.9 %) solution for
infusion immediately after reconstitution.
From a microbiological point of view, the
product should be used immediately. If not used
immediately, in-use 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/dilution has taken
place in controlled and validated aseptic conditions.

Dilution:
The product may be diluted with glucose 50 mg/ml
(5 %) solution for infusion to concentrations of
0.4 – 2 mg/ml or sodium chloride 9 mg/ml (0.9 %)
solution for infusion to a concentration of 2 mg/ml.
Disposal
Any unused product or waste material should be
disposed of in accordance with local requirements.

• reduction in blood platelets (increases the risk
of bleeding or bruising)
• feeling (nausea) or being sick (vomiting)
Common side effects
(affecting less than 1 in 10 people):
• infections (possible signs of infections are e.g.
sore throat, fever, chills)
• unusual bruising or bleeding (e.g. bleeding gums,
blood in the urine or in vomit, or the appearance
of unexpected bruises or broken blood vessels
(broken veins))
• allergic reactions including rash, redness, hives,
itching, high temperature
• severe allergic reaction (anaphylaxis). This type
of reaction is most likely to occur within minutes
of receiving Carboplatin. Symptoms of a severe
allergic reaction include sudden wheeziness or
tightness of the chest, swelling of the eyelids,
face or lips, rash, itching and high temperature.
• peripheral neuropathy (a disorder of the
nerves which can cause weakness, tingling or
numbness)
• pins and needles
• decrease of deep tendon reflexes (reflex of muscles
to contract when a muscle tendon is struck)
• sensory disturbance (mainly abnormal sensations
of the skin such as numbness, pins and needles,
tingling)
• visual disturbance including rare cases of sight loss
• damage to the ear (ototoxicity), e.g. ringing in the
ears, hearing loss
• cardiovascular disorder (side effects affecting the
circulatory system)
• lung disease
• serious lung condition associated with shortness
of breath, difficulties in breathing and/or scarring
of the lungs (interstitial lung disease)
• difficulty in breathing or wheezing

• diarrhoea, constipation, inflammation of mucous
membranes
Uncommon side effects
(affecting less than 1 in 100 people):
• central nervous symptoms often associated with
medicine you may be taking to stop you from
feeling or being sick
• fever and chills without evidence of infection
Not known
(cannot be estimated from the available data):
• feeling unwell with a high temperature due to low
levels of white blood cells (febrile neutropenia)
• stroke
• heart failure
• embolism (blocking of an artery)
• redness, swelling and pain or dead skin around
the injection site (injection site reactions)
• leakage into the surrounding tissue (injection site
extravasation)
Other possible side effects
If you think you have any of the following side
effects or symptoms, please contact your
doctor as soon as possible.
Very common side effects
(affecting more than 1 in 10 people):
• abdominal pain
Common side effects
(affecting less than 1 in 10 people):
• taste alteration
• hair loss
• skin disorder
• musculoskeletal disorder (condition affecting the
muscles, joints, tendons and nerves)
• unusual feelings of tiredness or weakness (asthenia)

Not known
(cannot be estimated from the available data):
• insufficient body liquids (dehydration)
• loss of appetite
• low blood pressure
• high blood pressure
• inflammation of the lining (mucosa) of the mouth
• hives (skin allergy with development of itchiness
and weals)
• rash
• redness of the skin
• itching
• feeling of general discomfort (malaise)
Certain other unwanted effects can only be
detected by your doctor, these include:
Very common side effects
(affecting more than 1 in 10 people):
• kidney damage
• decreased creatinine clearance (the creatinine
clearance shows how well your kidneys are
working)
• increased levels of urea in your blood
• abnormal liver enzyme levels
• decreases in the levels of salts in your blood,
mostly without obvious signs or symptoms

Very rare side effects
(affecting less than 1 in 10,000 people):
• promyelocytic leukaemia (a cancer of the blood
and bone marrow) 6 years after monotherapy and
radiation treatment has been reported

is stated on the label after EXP. The expiry date
refers to the last day of that month. Your doctor or
pharmacist should ensure that the vial is kept in the
outer carton, in order to protect from light, at below
25 °C. It must not be frozen.

Not known
(cannot be estimated from the available data):
• reduced liver function, damage or death of liver
cells
• cancer caused by chemotherapy
• reduction of blood cell production in the bone
marrow (bone marrow failure)
• haemolytic-uraemic syndrome (a disease
characterised by acute kidney failure, decreased
number of red blood cells [microangiopathic
haemolytic anaemia] and a low platelet count)
• low blood levels of sodium which can cause
confusion, muscle twitching or abnormal heart
rhythm (hyponatraemia)

When mixed with other solutions the solution
should be used immediately or can be stored
no longer than 24 hours at 2 – 8 °C. Your doctor
or pharmacist will ensure that these storage
requirements are met.

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any side effects
not listed in this leaflet.
5. How to store Carboplatin

Common side effects
(affecting less than 1 in 10 people):
• conditions affecting the urinary and genital tracts
• increased levels of bilirubin in your blood
• increased levels of creatinine in your blood
• increased uric acid levels in the blood which may
lead to gout
Uncommon side effects
(affecting less than 1 in 100 people):
• reduced kidney function

You will be not asked to store your medicine. It will
be brought to you ready to be administered straight
away. There are no special storage conditions for
this medicine during administration.
Your doctor or pharmacist should ensure that
Carboplatin is stored out of the sight and reach of
children.

Medicines should not be thrown away via
wastewater or household waste. Your doctor or
pharmacist will throw away medicines no longer
used. These measures will help protect the
environment.
6. Contents of the pack and other information
What Carboplatin contains
• The active substance is carboplatin.
• The other ingredient is water for injections.
What Carboplatin looks like and contents
of the pack
Carboplatin is a colourless to pale yellow, clear
concentrate for solution for infusion.
Each ml of solution contains 10 mg carboplatin.
Each 5 ml vial contains 50 mg of carboplatin.
Each 15 ml vial contains 150 mg of carboplatin.
Each 45 ml vial contains 450 mg of carboplatin.
Each 60 ml vial contains 600 mg of carboplatin.
Each 100 ml vial contains 1000 mg of carboplatin.
Packages containing 1 and 10 vials.

Your doctor or pharmacist will ensure that you do
not receive Carboplatin after the expiry date which

Not all pack sizes may be marketed.

Marketing authorisation holder
and Manufacturer
medac
Gesellschaft für klinische
Spezialpräparate mbH
Fehlandtstr. 3
20354 Hamburg
Germany
Phone: +49 4103 8006-0
Fax: +49 4103 8006-100

Sweden

Carbomedac 10 mg/ml
koncentrat till infusionsvätska,
lösning
United Kingdom Carboplatin 10 mg/ml
concentrate for solution
for infusion
This leaflet was last revised in 08/2012.

Production site
Theaterstr. 6
22880 Wedel
Germany
Phone: +49 4103 8006-0
Fax: +49 4103 8006-100
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Czech Republic Carbomedac 10 mg/ml
koncentrát pro přípravu infuzního
roztoku
Denmark
Carbomedac 10 mg/ml
koncentrat til infusionsvæske,
opløsning
Germany
Carbomedac 10 mg/ml
Konzentrat zur Herstellung
einer Infusionslösung
Poland
Carbomedac 10 mg/ml
koncentrat do sporządzania
roztworu do infuzji
Slovak Republic Carbomedac 10 mg/ml
infúzny koncentrát
Slovenia
Karboplatin medac 10 mg/ml
koncentrat za raztopino
za infundiranje

90000-VPGB
AB

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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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