CARBOPLATIN 10MG/ML CONCENTRATE FOR SOLUTION FOR INJ BP

Active substance: CARBOPLATIN

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PACKAGE LEAFLET
Carboplatin 10mg/ml Concentrate for Solution for Injection BP
Carboplatin
Read all of this leaflet carefully before you are given this medicine.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or nurse.
In this leaflet:


1. What is carboplatin and what is it used for?



2. Before you are given carboplatin



3. How carboplatin will be given to you



4. Possible side effects



5. Storing carboplatin
The active substance in the injection is carboplatin.
The other ingredient is water for injections.

Marketing Authorisation Holder and Manufacturer:
EBEWE Pharma Ges.m.b.H. Nfg. KG,
A-4866 Unterach, Austria
1. WHAT IS CARBOPLATIN AND WHAT IS IT USED FOR?
Carboplatin 10mg/ml Concentrate for Solution for Injection BP is a concentrate for solution
for infusion. It is available as a single 5ml vial containing 50mg of carboplatin, a single 15ml
vial containing 150mg of carboplatin, a single 45ml vial containing 450mg of carboplatin and
a single 60ml vial containing 600mg of carboplatin.
Carboplatin 10mg/ml Concentrate for Solution for Injection BP is a clear colourless or almost
colourless solution free from particles.
Carboplatin belongs to a group of medicines known as cytotoxics, which are used in the
treatment of cancer. Carboplatin is used to treat cancer of the ovaries and lung.

2. BEFORE YOU ARE GIVEN CARBOPLATIN
You will not be given carboplatin:


if you are allergic to carboplatin, drugs containing platinum or any of the other
ingredients,



if you have severe kidney problems,



if you have impaired bone marrow function



if you are taking certain antibiotics known as aminoglycosides (e.g. neomycin,
streptomycin) or other medicines that may damage kidney function, because they may
increase the toxicity of carboplatin



Your doctor will take special care when giving you carboplatin if you have mild to
moderate liver or kidney problems or blood disorders



if you have previously been treated with cisplatin

Consult your doctor if any of the above warnings applies to you or has applied to you in the
past.
Your doctor will check your kidney function, liver function and blood before, during and after
every treatment cycle. If the results of any of these tests are abnormal treatment will only be
resumed when all readings are back to normal. Your doctor will also make checks on your
nervous system (reflexes, etc) at regular intervals.
You may be given a drug to stop you feeling sick or being sick after your treatment with
carboplatin starts.
You will be carefully monitored at all times during your treatment.
Pregnancy
Carboplatin should not be given to you if you are pregnant, because it can cause serious birth
defects.
Female patients should also avoid getting pregnant for at least six months after being treated
with carboplatin. Male patients receiving carboplatin should take adequate precautions to
ensure that their partner does not become pregnant for the same period. If you are considering
becoming parents after the treatment, you should discuss this with your doctor.
Men who wish to father children in the future should seek advice about freezing sperm before
the carboplatin treatment is started.
Breast-feeding
Carboplatin should not be given to you if you are breast-feeding.

Driving and using machines:
If you are experiencing side effects which could affect your ability to drive or operate
machines, you should avoid driving or operating machinery until these have worn off.
Being given carboplatin at the same time as other medication
Being given carboplatin at the same time as other medication which affects the functioning of
the liver or kidneys, including alcohol, could make carboplatin more toxic.
Tell your doctor or pharmacist about medicines you are currently taking or have taken
recently. This also applies to medicines you may have bought yourself from a pharmacy or
supermarket.
3. HOW CARBOPLATIN WILL BE GIVEN TO YOU
Carboplatin will only be given to you under the supervision of a doctor specialised in this type
of treatment.
The carboplatin concentrate will be diluted with a solution of glucose before it is injected into
a vein (intravenously) through a drip over a period of 15-60 minutes.
The dosage of carboplatin depends on whether you have had carboplatin before and whether
you are having other cancer therapy. The usual dose of carboplatin is 400mg per square metre
of body surface area, calculated from your height and weight. The dosage of carboplatin may
be adjusted If you suffer from kidney problems or bone marrow depression (a reduced ability
to produce blood cells), if you are elderly, or if carboplatin is being given to you in
combination with other treatments.
Your general condition and your response to the treatment will be closely observed before,
during and after the carboplatin treatment.
4. POSSIBLE SIDE EFFECTS
Like any other medication, carboplatin may cause side-effects.
Most patients experience either vomiting or nausea after a carboplatin injection, but these
symptoms usually disappear within 24 hours. Your doctor may give you an anti-emetic to stop
you from being sick.
Carboplatin can make you more likely to be prone to infections. If you think you have an
infection, a sore throat, mouth ulcers, fever, chills or achiness during treatment you should tell
your doctor immediately.
Less commonly, carboplatin causes loss of appetite, a tendency to bleed or bruise easily,
anaemia, kidney problems, rash, itchiness, reddening and blistering of the skin, high
frequency hearing loss or ringing in the ears, numbness and pins and needles, liver problems,
fever, chills, weakness, hair loss and altered taste.

Certain other unwanted side effects can only be detected by your doctor by testing your blood,
liver and kidney function.
Very rarely, severe allergic reactions to carboplatin may occur, with difficulty breathing,
swelling of the face, lips and eyes, rash, rapid pulse and profuse sweating. If you develop any
of these symptoms, contact your doctor or nurse immediately.
Carboplatin can harm unborn babies or cause miscarriage (see section on pregnancy). It can
also affect fertility in men and women.
During the treatment with carboplatin your general condition will be closely monitored.
If you notice any side-effects not mentioned in this leaflet, please tell your doctor or nurse.
5. STORING CARBOPLATIN
Keep out of the reach and sight of children.
Do not store above 25°C. Keep the container in the outer carton in order to protect form light.
Do not use after the expiry date stated on the label.
After dilution, the product should be used within 24 hours if stored at 2-8°C.
This leaflet was prepared in January 2008
--------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
Instructions for Use/Handling
This product is for single dose use only.
Solutions should only be used if clear and particle free.
Trained personnel should prepare carboplatin for infusion in designated areas. Protective
clothing (including gloves) should be worn. The eyes should be protected. In the event of
contact with the eyes, wash with water and/or saline.
Pregnant staff should not handle cytotoxics.
Any unused product, syringes, containers, absorbent material or other waste material should
be disposed of using adequate care and precautions. 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.
Carboplatin for infusion may be prepared by dilution with Glucose 5% Solution.
Incompatibilities
Needles or intravenous sets containing aluminium parts that may come into contact with
carboplatin should not be used for preparation or administration of carboplatin.

Posology and method of administration
Dosage and Administration:
Carboplatin should be used by the intravenous route only. The recommended dosage of
carboplatin in previously untreated adult patients with normal kidney function is 400 mg/m²
as a single i.v. dose administered by a 15 to 60 minutes infusion. Alternatively, see Calvert
formula below:
Dose (mg) = target AUC (mg/ml x min) x [GFR ml/min + 25]
Patient treatment status
Previously untreated
Previously treated
Previously untreated

Planned chemotherapy
Single agent carboplatin
Single agent carboplatin
Carboplatin plus
cyclophosphamide

Target AUC
5-7 mg/ml.min
4-6 mg/ml.min
4-6 mg/ml

Note: With the Calvert formula, the total dose of carboplatin is calculated in mg, not mg/m².
Therapy should not be repeated until four weeks after the previous carboplatin course and/or
until the neutrophil count is at least 2,000 cells/mm³ and the platelet count is at least 100,000
cells/mm³.
Reduction of the initial dosage by 20-25% is recommended for those patients who present
with risk factors such as prior myelosuppressive treatment and low performance status
(ECOG-Zubrod 2-4 or Karnofsky below 80).
Determination of the haematological nadir by weekly blood counts during the initial courses
of treatment with carboplatin is recommended for future dosage adjustment.
Impaired Renal Function:
The optimal use of carboplatin in patients presenting with impaired renal function requires
adequate dosage adjustments and frequent monitoring of both haematological nadirs and renal
function.
Combination Therapy:
The optimal use of carboplatin in combination with other myelosuppressive agents requires
dosage adjustments according to the regimen and schedule to be adopted.
Paediatrics:
There is insufficient information to support a dosage recommendation in the paediatric
population
Elderly:
Dosage adjustment, initially or subsequently, may be necessary, dependent on the physical
condition of the patient.
Shelf life
18 months (unopened)

After dilution:
24 hours under refrigeration (2 - 8°C)

Special precautions for storage
Do not store above 25 °C. Keep container in the outer carton.
After dilution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C for
solutions with a final concentration of carboplatin 0.4mg/ml or 2.0mg/ml after dilution of the
carboplatin10mg/ml with glucose solution 5%.
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 dilution has taken place in
controlled and validated aseptic conditions.

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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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