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CARBOPLATIN INJECTION SOLUTION 10MG PER ML

Active substance(s): CARBOPLATIN

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Carboplatin 10 mg/ml Intravenous Infusion
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.
• If you get any side effects, talk to your doctor. This includes any
possible side effect not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Carboplatin Intravenous Infusion is and what it is used for
2. What you need to know before you use Carboplatin Intravenous Infusion
3. How to use Carboplatin Intravenous Infusion
4. Possible side effects
5. How to store Carboplatin Intravenous Infusion
6. Contents of the pack and other information

1. WHAT CARBOPLATIN INTRAVENOUS INFUSION IS AND
WHAT IT IS USED FOR
Carboplatin Intravenous Infusion is an anti-cancer medicine. Treatment with
an anti-cancer medicine is sometimes called cancer chemotherapy.
Carboplatin is used in the treatment of some types of lung cancer and
ovarian cancer.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE CARBOPLATIN
INTRAVENOUS INFUSION
Do not use Carboplatin Intravenous Infusion
• if you have shown signs of hypersensitivity (severe allergy) to carboplatin
or similar platinum containing medicines in the past
• if you have severe kidney disease
• if you have fewer blood cells than normal (your doctor will check this with
a blood test)
• if you have a tumour that bleeds
• if you plan to receive a yellow fever vaccination or have just received one
Tell your doctor if any of the above applies to you before this medicine is
used.

Take special care with Carboplatin Intravenous Infusion
• if you are pregnant or if there is a chance you may be pregnant
• if you are breast-feeding
• if you have mild renal disease. Your doctor will want to monitor you more
regularly.
• if you are elderly (over 65 years old)
• if you have been treated with cisplatin or similar anti-cancer medicines in
the past, carboplatin may cause abnormalities in your nervous system,
such as pins and needles or hearing and vision problems. Your doctor
may regularly assess you.
Tell your doctor if any of the above applies to you before this medicine is
used.

Other medicines and Carboplatin Intravenous Infusion
Special care is needed if you are taking/using other medicines as some
could interact with carboplatin, for example:
• medicines which can reduce the number of cells in your blood, at the
same time as carboplatin, may require changes to the dosage and
frequency of your carboplatin treatment
• some antibiotics called aminoglycosides, vancomycin or capreomycin, at
the same time as carboplatin, may increase the risk of kidney or hearing
problems
• some water tablets (diuretics), at the same time as carboplatin, may
increase the risk of kidney or hearing problems
• live or live-attenuated vaccines (for yellow fever vaccine see section 2,
Do not use Carboplatin Intravenous Infusion)
• blood thinning medicines e.g. warfarin, at the same time as carboplatin,
may require an increase in frequency of blood coagulation monitoring
• phenytoin and fosphenytoin (used to treat various types of convulsions
and seizures), at the same time as carboplatin, may increase the risk of a
seizure
• other medicines which decrease the activity of the immune system
(e.g.ciclosporin, tacrolimus, sirolimus)
Tell your doctor if you are taking, have recently taken or might take any
other medicines, including medicines obtained without a prescription.

Pregnancy, breast-feeding and fertility
Tell your doctor if you are pregnant, trying to become pregnant or
breast-feeding before being treated with this medicine. Your doctor will
decide if you should receive this medicine.
Due to the possible risk of birth defects, female patients of childbearing
potential should take contraceptive measures before and during treatment
with carboplatin.
Men treated with this medicine 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.

Effects on fertility
Treatment with carboplatin may temporarily or permanently reduce fertility in
men and women. Tell your doctor if you have concerns.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Do not drive or use machines if you experience any side effect which
may lessen your ability to do so such as nausea, vomiting, worsening of
eyesight, or changes to your vision and hearing.
The vial stopper contains dry natural rubber (a derivative of latex), which
may cause allergic reactions.

3. HOW TO USE CARBOPLATIN INTRAVENOUS INFUSION
This medicine will be given by infusion (drip) into a vein over 15-60 minutes.

Dose
Your doctor will work out the correct dose of carboplatin for you and how
often it must be given.
The dose will depend on your medical condition, your size and how well
your kidneys are working. Your doctor will tell how well your kidneys are
working using blood or urine samples.
You will have regular blood tests after your dose of carboplatin. You may
also have checks for nerve damage and hearing loss.
There is likely to be about 4 weeks between each dose of carboplatin.

If you are given too much or too little Carboplatin Intravenous
Infusion
This medicine will be given to you in a hospital, under the supervision of a
doctor. It is unlikely that you will be given too much or too little, however, tell
your doctor or nurse if you have any concerns.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

If any of the following happen, tell your doctor immediately:
• abnormal bruising, bleeding, or signs of infection such as a sore throat
and high temperature
• severe allergic reaction (anaphylaxis/anaphylactic reactions) - you
may experience a sudden itchy rash (hives), swelling of the hands,

Carboplatin 10 mg/ml Intravenous Infusion
The following information is intended for medical or healthcare
professionals only
Further to the information included in section 3, practical information on the
preparation/handling of the medicinal product is provided here.

Incompatibilities
Carboplatin may interact with aluminium to form a black precipitate. Needles,
syringes, catheters or IV 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.

Handling
Carboplatin should be prepared for administration only by professionals who
have been trained in the safe use of chemotherapeutic agents.
Carboplatin solution for infusion may be further diluted in Glucose 5% and
administered as an intravenous infusion. Chemical and physical in-use stability
has been demonstrated for 56 days to final concentrations of 0.2 mg/ml and
3.5 mg/ml when stored at 2 to 8°C in non-PVC (polyolefin) infusion bags when
protected from light.
Carboplatin solution for infusion may also be further diluted in Sodium Chloride
0.9% and administered as an intravenous infusion. The infusion solution is
chemically stable for up to 24 hours when stored at 2 to 8°C and up to 8 hours
when stored at 22°C.

Q79471
4XXXXX

Component Specification

Requester

Ite m

I h a v e c h e c k e d th is a r tw o r k a g a in s t th e
r e g is te r e d te x t in c lu d in g s p e llin g , la y o u t, s iz e ,
colours, registration numbers and scientific
e q u a tio n s , th e n a m e a n d a d d r e s s a n d
tr a d e m a r k s . A ls o fo r a n y p o s s ib le c h a n g e s to
r e la te d ite m s .
T h is a r tw o r k is in c o n fo r m a n c e w ith th e
M a r k e tin g A u th o r is a tio n a n d c a n n o w p r o c e e d
to th e p r in tin g s ta g e .

n u m b e r:

R e q u e st

Q 7 9 4 7 1

n u m b e r:

A S 5 4 4 4

C o u n t r y:

U n ite d K in g d o m

P r e v io u s Ite m
O I te m p la te :
A m a lia v e r s io n :
M u lg r a v e v e r s io n :
D im e n s io n s :
C o n ta in e r ( s ) :
S u p p lie r :
S to c k :

B la c k :

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5

D a te :

6

1 1 8 x 5 7 0 m m ( 2 0 p a n e ls )
v ia l
H o w d e n P r in tin g

P r im a p h a r m 4 0 g s m /
T e r o p a q u e T h in M e d ic a l 4 0 g s m

F o ld e d d im e n s io n s : 2
P r in te d b o th s id e s : Y
P e rfo ra te d :
N
P h a rm a c o d e :
P h a r m a c o d e le n g th :
M u lg r a v e 4 s e r ie s n o

Colours

8 8 S 1 1 9

8 .5 x
e s
o
D e
X X
.: 4 x

1 1 8 m m

c im a l ( B in a r y )
m m
x x x x

N u m b e r: Q 7 6 2 2 4 / 4 3 4 5 9 3

V e r s io n 1
T e c h n ic ia n :
D a te :

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1 9 /A u g /1 5

V e r s io n 2
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V e r s io n 3
T e c h n ic ia n :
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0 7 /S e p /1 5

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T e c h n ic ia n :
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1 1 /S e p /1 5

V e r s io n 5
T e c h n ic ia n :
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T e c h n ic ia n :
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T e c h n ic ia n :
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T e c h n ic ia n :
D a te :

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V e r s io n 1 0
T e c h n ic ia n :
D a te :

X X
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feet, ankles, face, lips, mouth or throat (which may cause difficulty in
swallowing or breathing), and you may feel you are going to faint
These are serious side effects. You may need urgent medical attention.
Very common side effects (may affect more than 1 in 10 people)
• tiredness, shortness of breath and paleness caused by anaemia (a
condition in which there is a decreased number of red blood cells)
• feeling sick (nausea) or being sick (vomiting)
• stomach pain and cramp
Tests may also show:
• changes in your red and white blood cells and platelets
(myelosuppression)
• increase in the level of urea in your blood
• decrease in the level of sodium, potassium, calcium and magnesium in
your blood
• decrease in renal creatinine clearance
• abnormal liver enzyme levels
Common side effects (may affect up to 1 in 10 people)
• signs of infection such as fever or sore throat
• flu-like symptoms
• symptoms of severe allergic reaction include sudden wheeziness or
tightness of chest, swelling of the eyelids, face or lips, facial flushing, low
blood pressure, rapid heart beat, hives, shortness of breath, dizziness
and anaphylactic shock
• tingling or numbness in your hands, feet, arms or legs
• burning or prickling sensation
• decreased tendon reflex
• taste disturbance or loss of taste
• temporary worsening of eyesight or changes to your vision
• ringing in the ears or changes in your hearing
• heart disorders
• tightness of the chest or wheezing
• interstitial lung disease (a group of lung disorders in which the deep lung
tissues become inflamed)
• diarrhoea or constipation
• sore lips or mouth ulcers (mucous membrane disorders)
• hair loss
• rash and/or itchy skin
• pain or discomfort in your bones, joints, muscles, or surrounding
structures (musculoskeletal disorder)
• problems with your kidneys or urine
• extreme tiredness/weakness (asthenia)
Tests may also show:
• increased level of bilirubin and creatinine in your blood
• increased level of uric acid in your blood which may lead to gout
Rare side effects (may affect up to 1 in 1,000 people)
• temporary sight loss
Very rare side effects (may affect up to 1 in 10,000 people)
• scarring of the lungs which causes shortness of breath and/or cough
(pulmonary fibrosis)
Not known: frequency cannot be estimated from available data
• cancers caused by treatment with carboplatin (secondary malignancies)
• feeling unwell with high temperature due to low levels of white blood cells
(febrile neutropenia)
• haemolytic-uraemic syndrome (a disease characterised by acute renal
failure)
• dry mouth, tiredness, and headache due to excessive loss of body water
(dehydration)
• loss of appetite, anorexia
• stroke
• severely impaired liver function, damage or death of liver cells
• heart failure
• obstruction in blood vessel (embolism)
• changes in blood pressure (hypertension or hypotension)
• skin disorders such as hives, rash, skin redness (erythema), and itching
• swelling or soreness where the injection was given
Carboplatin may lead to problems with your blood, liver and kidneys. Your
doctor will take blood samples to check for these problems.
If you get any side effects, talk to your doctor. This includes any possible
side effects not listed in this leaflet. You can also report side effects
directly via
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more information on the
safety of this medicine.

5. HOW TO STORE CARBOPLATIN INTRAVENOUS INFUSION
Keep out of the sight and reach of children.

Expiry
Do not use this medicine after the expiry date which is stated on the vial
label and carton after ‘EXP’. Where only a month and year is stated, the
expiry date refers to the last day of that month.

Storage
This medicine comes in two types of vial, ONCO-VIAL™ and standard vials.
The ONCO-VIAL™ should be stored at 2 to 8°C. The standard vials should
not be stored above 25°C.
The vials should be kept in the outer carton in order to protect from light.
If Carboplatin for Intravenous Infusion is diluted before use, the diluted
solution should be used immediately. If not used immediately it should not
normally be stored for longer than 24 hours at 2 to 8°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Carboplatin Intravenous Infusion contains
The active substance is carboplatin. Each millilitre (ml) of solution contains
10 milligrams (mg) of carboplatin.
The other ingredient is Water for Injections.

What Carboplatin Intravenous Infusion looks like and contents of the
pack
Carboplatin Intravenous Infusion is a clear, colourless solution for infusion
which comes in glass containers called vials.
It may be supplied in packs containing:
1 x 50 mg/5 ml vial or ONCO-VIAL™
1 x 150 mg/15 ml vial or ONCO-VIAL™
1 x 450 mg/45 ml vial or ONCO-VIAL™
1 x 600 mg/60 ml vial or ONCO-VIAL™
Not all packs may be marketed.

Marketing authorisation holder and manufacturer responsible for
batch release in Europe
Hospira UK Limited
Queensway
Royal Leamington Spa
Warwickshire
CV31 3RW
United Kingdom

Manufacturers
Hospira Australia Pty Ltd
Lexia Place
Mulgrave
Victoria 3170
Australia
This leaflet was last revised in 08/2015.
From a microbiological point of view however, 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.

Contamination
In the event of contact of carboplatin with eyes or skin, wash affected area with
copious amounts of water or normal saline. A bland cream may be used to treat
transient stinging of skin. Medical advice should be sought if the eyes are affected.
In the event of a spillage, two operators should put on gloves and mop up the
spilled material with a sponge kept for that purpose. In the event of a powder
spillage, cover with a cloth and moisten with water before mopping up. Rinse
the area twice with water. Put all solutions and sponges in a plastic bag, seal
and label with the words ‘CYTOTOXIC WASTE’ and incinerate.

Disposal
Syringes and ONCO-VIALS™, containers, absorbent materials, solutions and
other material which have come into contact with carboplatin should be placed
in a thick plastic bag or other impervious container and incinerated at 1000°C.

Directions for use of the ONCO-VIAL™
ONCO-VIALS™ should be used with the appropriate Hospira administration
device.
The vial stopper contains dry natural rubber (a derivative of latex), which may
cause allergic reactions.
Q79471
4XXXXX

Component Specification

Requester

Ite m

I h a v e c h e c k e d th is a r tw o r k a g a in s t th e
r e g is te r e d te x t in c lu d in g s p e llin g , la y o u t, s iz e ,
colours, registration numbers and scientific
e q u a tio n s , th e n a m e a n d a d d r e s s a n d
tr a d e m a r k s . A ls o fo r a n y p o s s ib le c h a n g e s to
r e la te d ite m s .
T h is a r tw o r k is in c o n fo r m a n c e w ith th e
M a r k e tin g A u th o r is a tio n a n d c a n n o w p r o c e e d
to th e p r in tin g s ta g e .

n u m b e r:

R e q u e st

Q 7 9 4 7 1

n u m b e r:

A S 5 4 4 4

C o u n t r y:

U n ite d K in g d o m

P r e v io u s Ite m
O I te m p la te :
A m a lia v e r s io n :
M u lg r a v e v e r s io n :
D im e n s io n s :
C o n ta in e r ( s ) :
S u p p lie r :
S to c k :

B la c k :

S ig n e d :

5

D a te :

6

1 1 8 x 5 7 0 m m ( 2 0 p a n e ls )
v ia l
H o w d e n P r in tin g

P r im a p h a r m 4 0 g s m /
T e r o p a q u e T h in M e d ic a l 4 0 g s m

F o ld e d d im e n s io n s : 2
P r in te d b o th s id e s : Y
P e rfo ra te d :
N
P h a rm a c o d e :
P h a r m a c o d e le n g th :
M u lg r a v e 4 s e r ie s n o

Colours

8 8 S 1 1 9

8 .5 x
e s
o
D e
X X
.: 4 x

1 1 8 m m

c im a l ( B in a r y )
m m
x x x x

N u m b e r: Q 7 6 2 2 4 / 4 3 4 5 9 3

V e r s io n 1
T e c h n ic ia n :
D a te :

N R
1 9 /A u g /1 5

V e r s io n 2
T e c h n ic ia n :
D a te :

N R
2 6 /A u g /1 5

V e r s io n 3
T e c h n ic ia n :
D a te :

N R
0 7 /S e p /1 5

V e r s io n 4
T e c h n ic ia n :
D a te :

N R
1 1 /S e p /1 5

V e r s io n 5
T e c h n ic ia n :
D a te :

X X
d d /m m m /y y

V e r s io n 6
T e c h n ic ia n :
D a te :

X X
d d /m m m /y y

V e r s io n 7
T e c h n ic ia n :
D a te :

X X
d d /m m m /y y

V e r s io n 8
T e c h n ic ia n :
D a te :

X X
d d /m m m /y y

V e r s io n 9
T e c h n ic ia n :
D a te :

X X
d d /m m m /y y

V e r s io n 1 0
T e c h n ic ia n :
D a te :

X X
d d /m m m /y y

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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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