CARBOPLATIN 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance: CARBOPLATIN

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Carboplatin - Pack Insert - UK/IRL (Bordon)

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.
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

Carboplatin with food and drink
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.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE
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 are allergic to another drug that belongs to the group of platinum
containing compounds
• if you have severe problems with your kidneys (creatinine clearance at
or below 30 ml/min) and/or liver function
• if you have an imbalance of your blood cells (severe myelosuppression)
• if you have a tumour that bleeds
• if you are breast-feeding
• if you plan to receive a yellow fever vaccination or have just received
one.

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, it is recommended to inform your doctor or nurse
as soon as possible and before receiving this medicine.
Pregnancy
This medicine must not be used during pregnancy other than in the
most exceptional circumstances in the treatment of cancer; where the
potential benefit to the mother is considered to be greater than the risk
to the unborn baby.

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.

Breast-feeding
If treatment becomes necessary during the lactation period, breastfeeding
must be stopped.

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.

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 TO USE 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. 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. This medicine will normally be diluted
before use.

Black

Bordon code: 220639
Reason for the Artwork* : Text revised

Dimension : 300 x 360 mm

Artwork No. : 7220131894

Supersedes No. : 7220131640

Prepared
By
PDD

Checked
By
PDD

Approved By
PDD

Production

QA

Form No.: SOP/PDD/003-03 Rev. 05

CONFIDENTIAL

QM

NA

Approved
Online

I&D RA

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 take 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 must talk to the doctor
administering your medicine.
If you forget to take 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.
If you stop taking Carboplatin
If you have any further questions on the use of this product 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)
-- Stomatitis/mucositis (e.g. sore lips or mouth ulcers).
Very common: 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 leads 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: 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

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
plastic-backed
absorbent paper.

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.

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.

Adult
The usual dose is 400 mg/m² of your body surface area (calculated from

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.

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).

Warnings and precautions:
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 this medicine
If you are on radiotherapy
If you have had or are due to have any vaccination including a live or
live-attenuated vaccination.
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.
In patients with abnormal kidney function visual disturbances, including
reversible loss of vision has been reported if carboplatin is used in doses
higher than that recommended. The vision may recover totally or to a
significant extent upon discontinuation of this medicine.
Your doctor will want to monitor you more regularly if your kidneys are
not working properly.
Elderly patients are more likely to experience side effects of the
carboplatin on the blood count and nervous system.
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.
The following information is intended
for healthcare professionals only:
The medicinal product is for single use
only. Any unused infusion solution
should be discarded.

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Dimension: 300 x 360 mm

1. WHAT CARBOPLATIN IS AND WHAT IT IS USED FOR
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’. It contains active ingredient carboplatin, which belong
to a group of medicines known as platinum coordination compounds,
which are used to treat cancer.
This medicine is used against advanced cancer of the ovary and small
cell cancer of the lung.

Elderly
For elderly patients (over 65 years old), the dosage may need adjusting
depending on your physical condition and laboratory evaluation.

V003

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 affect blood cell formation in the
bone marrow
• other medicines that are known to be toxic to your kidney
(e.g. aminoglycosides antibiotics, loop diuretics, vancomycin,
capreomycin)
• other medicines that are known to damage the hearing or balance
functions of the ear (e.g. aminoglycosides antibiotics, furosemide
(loop diuretics), [used to treat heart failure and edema] vancomycin,
capreomycin)
• 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)

your height and weight).

7220131894

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.

220639

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)
carboplatin

Circulation No. 1

Country RA

NA
* Attached separate sheet if required

Times New Roman

9 pt

Draft: 05

Last modified: 10 September 2013 2:19 PM

Carboplatin - Pack Insert - UK/IRL (Bordon)

Very rare: 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).
If you get any side effects, talk to your doctor, or nurse. This includes
any possible side effects not listed in this leaflet.

Sweden

6. FURTHER 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.

Carboplatin 10 mg/ml concentrate for solution for
infusion

This leaflet was last revised in 08/2013

-- 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.
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.
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
Cyprus
Carboplatin Kabi 10 mg/ml πυκνό διάλυμα για
Παρασκευή διαλύματος προς έγχυση
Czech
Carboplatin Kabi 10 mg/ml koncentrát pro přípravu
Republic
infuzního roztoku
Germany
Carboplatin Kabi 10 mg/ml Konzentrat zur
Herstellung einer Infusionslösung
Denmark
Carboplatin Fresenius Kabi
Estonia
Carboplatin Kabi
Greece
Carboplatin Kabi 10 mg/ml πυκνό διάλυμα για έγχυση
Spain
Carboplatino Kabi 10 mg/ml concentrado para
solución para perfusión EFG
Finland
Carboplatin Fresenius Kabi 10 mg/ml
infuusiokonsentraatti, liuosta varten
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
Italy
Carboplatino Kabi 10 mg/ml concentrato per
soluzione per infusione
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

Black

Bordon code: 220639
Reason for the Artwork* : Text revised

Dimension : 300 x 360 mm

Artwork No. : 7220131894

Supersedes No. : 7220131640

Prepared
By
PDD

Slovak
Republic
United
Kingdom

Carboplatin Kabi
Carboplatina Kabi
Carboplatin Kabi 10 mg/ml concentrat pentru soluţie
perfuzabilă
Carboplatin Fresenius Kabi 10 mg/ml koncentrat till
infusionsvätska, lösning
Carboplatin Kabi 10 mg/ml, infúzny koncentrát

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

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
and carton after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
Keep the vial in the outer carton in order to protect from light.
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.

Poland
Portugal
Romania

V003

Rare: may affect up to 1 in 10,000 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 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.

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.

[ Vinod Pal ] D:\FK-DATA\Europe\Carboplatin\GBR+IRL\Bordon\July 2013\Draft\Carboplatin Pack Insert- Bordon- UK+IRL.indd

Dimension: 300 x 360 mm

uncommon: may affect up to 1 in 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
-- Unusual weight loss
-- Change in blood pressure (hyper or hypotension).

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.

7220131894

Pins and needles (peripheral neuropathy)
Hair loss
Feeling unwell
Decreased serum levels of calcium
Flu-like syndrome
Loss or lack of body strength
Fever
Interstitial lung disease (a group of lung disorders in which the deep
lung tissues become inflamed)
-- Decreased bone and tendon reflex.

220639

---------

Circulation No. 1

Checked
By
PDD

Approved By
PDD

Production

QA

Form No.: SOP/PDD/003-03 Rev. 05

CONFIDENTIAL

QM

NA

Approved
Online

I&D RA

Country RA

NA
* Attached separate sheet if required

Times New Roman

9 pt

Draft: 05

Last modified: 10 September 2013 2:19 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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