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CARBOPLATIN 10MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): CARBOPLATIN

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

Package leaflet: Information for the user

Carboplatin with food, drink and alcohol
There is no known interaction between carboplatin and
alcohol. However you should check with your doctor as
carboplatin may affect the liver's ability to cope with alcohol.

2. Carboplatin is usually given to patients in hospital.
Normally you should 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.

Carboplatin 10 mg/ml concentrate
for solution for infusion
Carboplatin

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 for
advice before taking this medicine.
If any of these apply to you and you have not already
discussed this with your doctor or nurse, you should do as
soon as possible and before receiving Carboplatin.

Warnings and precautions
Talk to your doctor before you are given Carboplatin:
If you are pregnant or if there is a chance you may be
pregnant
If you are breastfeeding
If you are likely to drink alcohol whilst being treated with
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 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 or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.

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
foetus. 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 child bearing
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.

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. Your doctor will want to monitor you more
regularly if your kidneys are not working properly.

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 to use Carboplatin
4. Possible side effects
5. How to store Carboplatin
6. Contents of the pack and other information

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

1. What Carboplatin is and what it is used for

Other medicines and Carboplatin
Tell your doctor or nurse if you are taking, have recently taken
or might take any other medicines, including medicines
obtained without a prescription.
You should tell your doctor if you are taking any of the
following medicines as they may interact with Carboplatin.
- other medicines that are known to affect blood cell
formation in the bone marrow
- other medicines that are known to be toxic to your kidneys
(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
oedema])
- chelating agents (substances binding to carboplatin thereby
decreasing the effect of carboplatin)
- phenytoin ( used to treat various types of convulsions and
seizures)
- warfarin (used to prevent the formation of blood clots).

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

Carboplatin must 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.

Carboplatin contains carboplatin, which belongs to a group of
medicines known as platinum coordination compounds,
which are used to treat cancer.
Carboplatin is used against advanced cancer of the ovary and
small cell cancer of the lung.
2. What you need to know before you are given Carboplatin
Do not use Carboplatin
- if you are allergic to carboplatin or to any of the other
ingredients of this medicine (listed in section 6)
- if you are allergic to another drug that belongs to the group
of platinum containing compound
- if you have severe problems with your kidneys (creatinine
clearance at or below 20 ml/min)
- if you have an imbalance of your blood cells (severe
myelosuppression)
- if you have a tumour that bleeds
- if you are pregnant or breast feeding

AWS TYPE

Country
EUUK - UNITED KINGDOM

PIL

Language

Location

English

SPIL - Halol

044BP1627B

Void artwork Code No:044BP1627A

CD-PDD-

365 x 198 mm

Reason: New draft from Europe

REMARKS:

Specification / Type of paper
Super Fine 40 GSM Tissue Paper ITC

Driving and using machines
Carboplatin does not affect your ability to drive and use
machines. However you should take extra care when you are
first given carboplatin, especially if you feel dizzy or unsure of
yourself.

Adult
The recommended dose is 400 mg/m2of your body surface
area (calculated from your height and weight).
Elderly
The recommended adult doses may be used although the
doctor may choose to use a different dose.
Renal impairment
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. Carboplatin
will be given by a doctor experienced in the use of cancer
treatment.
Use in 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 Carboplatin.
There will be usual gap of 4 weeks between each dose of
Carboplatin. Your doctor will want to perform some blood
tests each week after giving you Carboplatin. 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. If you are worried that too much
has been administered or 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 very unlikely that you will miss a dose of your medicines,
as yours doctor will have instructions on when to give you
your medicine. If you think you have missed dose please talk
to your doctor.

365 mm
Front Side

Name of Product:
Carboplatin 10 mg/ml Concentrate for Solution for Infusion

Actual Size

Ask your doctor or nurse for advice before using any
medicine.

Carboplatin will always be administered by 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 or who has administered Carboplatin. 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. Carboplatin will
normally be diluted before use.

BLACK

Carboplatin 10 mg/ml concentrate for solution for
infusion
Incompatibilities
Needles, syringes, catheters or intravenous sets
containing aluminum parts that may come into
contact with carboplatin should not be used for
preparation or administration of carboplatin.
Shelf life
Do not store above 25 °C. Do not refrigerate or freeze.
Keep container in the outer carton in order to protect from
light.
Unopened product: 2 years
Diluted product: 8 hours at room temperature
(15-25°C), or 24 hours under refrigeration (2-8°C).
From a microbiological point of view, the product
should be used immediately. If not used immediately,
in use storage times and conditions 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 under controlled and
validated aseptic conditions.
Instructions for handling, use and disposal
The medicinal product is for single use only. Any
unused infusion solution should be discarded.
Instructions for dilution
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). When diluted as directed, carboplatin is
chemically and physically stable for 8 hours at room
temperature (15-25°C) and for 24 hours at 2-8°C.
From a microbiological point of view, the infusion
preparation 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 2-8ºC, unless dilution has
taken place under controlled and validated conditions.

Checked by
Sign

Technical Approved by

Date Sign

Size: 365x198 mm

95

Artwork Prepared by :
Sun Pharmaceutical Industries Limited
Packaging Devoloment Department [PDD]
SPIL - Vadodara

Prepared by
Date

The following information is intended for healthcare
professionals only: Instructions for use

FONTS SPECIFICATION

Color codes:

Sign

Carboplatin

100

No. of Colors : 1

Folding
365--3---45.62mm
198--3 zigzag---33mm

Carboplatin 10 mg/ml concentrate
for solution for infusion

The solution is to be inspected visually for particulate
matter and discoloration prior to administration

Folding
365--3---45.62mm
198--3 zigzag---33mm

Code

Fertility
Carboplatin can cause genetic damage. Women of
childbearing potential should be 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.

3. How to use Carboplatin

Approved by RA

Date Sign

Date

Patient info. Leaflet

Swiss 721 CN BT - 10 pt

Title and Tiltle Heading

Swiss 721 CN BT - 13 pt and 11 pt

Body Text

Swiss 721 CN BT - 8 pt

75

25

5

0

Carboplatin Inj-10mg-ml-PIL-EU-New Draft-365x198mm-REV1-16-12-13
16/12/2013 5:18:40 PM

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 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. Liquid waste may be flushed with copious
amounts of water.
7 The work surface should be covered with disposable
plastic-backed 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.
Disposal
Any unused medicinal product or waste material should
be disposed of in accordance with local requirements.

If you stop using Carboplatin
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 cause 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 (angio-oedema)
- stomatitis/mucositis (e.g. sore lips or mouth ulcers).
Very common side effects (may affect more than 1 in 10
people)
- changes in your red and white blood cells and platelets
(myelosuppression). Your doctor may want to monitor you.
- anaemia (a condition in which there is a decreased number
of red blood cells which lead to tiredness)
- increase in the level of the creatinine and urea in your
blood. Your doctor may want to monitor you.
- slight loss of hearing
- abnormal liver enzymes levels. Your doctor may want to
monitor you.
- increased uric acid levels in your blood which may lead to
gout
- feeling or being sick
- abdominal pain and cramp
- unusual feelings of tiredness or weakness
- decrease in the level of salts in your blood. Your doctor
may want to monitor you.
- damage to the kidneys (renal toxicity).
Common side effects (may affect up to 1 in 10 people)
- unusual bruising or bleeding (haemorrhagic complications)
- reduced function of your kidneys
- 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)
- hair loss
- feeling unwell
- decreased serum levels of calcium
- flu-like syndrome
- loss or lack of body strength
- fever.

Uncommon side effects (may affect up to 1 in to 100
people)
- secondary malignancies
- 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
- redness, swelling and pain or dead skin around the
injection site (injection site reaction)
- infection.
Rare side effects (may affect up to 1 in 1,000 people)
- feeling unwell with a high temperature due to low levels of
white blood cells (febrile neutropenia)
- life threatening infections and bleeding
- taste alteration
- loss of appetite (anorexia)
- severely impaired liver function, damage or death of liver
cells. Your doctor may want to monitor you.
- temporary visual disturbances including temporary sight
loss
- inflammation of the optic nerve that may cause a complete
or partial loss of vision (optic neuritis)
- haemolytic-uraemic syndrome (a disease characterised by
acute renal failure, decreased number of red blood cells
(microangiopathic haemolytic anaemia) and a low platelet
count)
- severe allergic reactions (anaphylaxis/anaphylactic
reactions)
- symptoms of a severe allergic reaction include sudden
wheeziness or tightness of chest, swelling of the eyelids,
face or lips, facial flushing, hypotension, tachycardia,
urticaria, dyspnoea, dizziness and anaphylactic shock.
Very rare side effects (may affect up to 1 in 10,000 people)
- heart failure, blockage in blood vessels of your heart, high
blood pressure
- bleeding in the brain, which may result in a stroke or loss of
consciousness
- scarring of the lungs which causes shortness of breath
and/or cough (pulmonary fibrosis).
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

This medicinal product is authorised in the Member
States of the EEA under the following names

Keep this medicine out of the sight and reach of children.
Germany
You will not be asked to store this medicine. It will be brought
to you ready to be administered straight away.
Your doctor or pharmacist will ensure that you do not receive
this medicine after the expiry date which is stated on the label
and on the outer carton after EXP. The expiry date refers to the
last day of that month.

Spain

France
Italy

Medicines should not be disposed of via waste water or
household waste.
When the infusion has finished, any remaining carboplatin will
be disposed of carefully by the doctor or nurse. These
measures will help to protect the environment.

Netherlands

United Kingdom
6. Contents of the pack and other information
What Carboplatin contains
-

Carboplatin SUN 10 mg/ml Konzentrat
zur Herstellung einer Infusionslösung
Carboplatino SUN 10 mg/ml
concentrado para solución para
perfusión
CARBOPLATINE SUN 10 mg/ml
solution à diluer pour perfusion
Carboplatino SUN 10 mg/ml
concentrato per soluzione per
infusione
Carboplatin SUN 10 mg/ml concentraat
voor oplossing voor intraveneuze
infusie
Carboplatin 10 mg/ml Concentrate for
Solution for Infusion

This leaflet was last revised in 12/2013.

The active substance is carboplatin.
a vial of 5 ml of concentrate contains 50 mg carboplatin
a vial of 15 ml of concentrate contains 150 mg carboplatin
a vial of 45 ml of concentrate contains 450 mg carboplatin
a vial of 60 ml of concentrate contains 600 mg carboplatin.
The other ingredient is water for injections.
044BP1627B

The solution should only be used if the solution is clear and
free from particles.

What Carboplatin looks like and contents of the pack
Carboplatin 10 mg/ml is a clear colourless solution in a vial,
which requires further dilution before use.
It is available in: vials of 5 ml, 15 ml, 45 ml, and 60 ml and
boxes of 1, 5 and 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

044BP1627B

Folding
365--3---45.62mm
198--3 zigzag---33mm

365 mm
Back Side

Size: 365x198 mm
100

95

75

25

5

0

Carboplatin Inj-10mg-ml-PIL-EU-New Draft-365x198mm-REV1-16-12-13
16/12/2013 5:18:40 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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