Carboplatin injection solution 10 mg per ml – patient leaflet, side effects, dosage

1. What Carboplatin is and what it is used for

Carboplatin is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy. It is used in the treatment of some types of lung cancer and ovarian cancer.

2. What you need to know before you use Carboplatin

Do not use Carboplatin

• if you are allergic to carboplatin or to any of the

  ingredients of this medicine (listed in section 6)

• if you have had hypersensitivity to 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.

This medicine should be administered only by or under the direct supervision of a qualified physician who is experienced in the use of cancer chemotherapeutic agents.

Carboplatin is very toxic and treatment is likely to cause some side effects.

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 breast-feeding.

• if you have 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, this medicine may

  should not normally be stored for longer than 24 hours at 2 to 8ºC.

  1. 6.

     Contents of the pack and other information

     What Carboplatin 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 looks like and contents of the

     pack

     Carboplatin 10 mg/ml Concentrate for Solution for Infusion is a clear, colourless solution for infusion which comes in glass containers called vials (clear glass Onco-Tain^® vials and Onco-Vials^®).

     It may be supplied in packs containing: 1 x 50 mg/5 ml vial

     1 x 150 mg/15 ml vial

     1 x 450 mg/45 ml vial

     1 x 600 mg/60 ml vial

     Not all packs may be marketed.

     Marketing Authorisation Holder

     Hospira UK Limited,

     Walton Oaks,

     Walton-On-The-Hill,

     Dorking Road,

     Tadworth,

     Surrey,

     KT20 7NS,

     UK

     Manufacturer

     Pfizer Service Company BV, Hermeslaan 11,

     1932 Zaventem,

     Belgium

     This leaflet was last revised in 07/2026. Ref: gxCR 17_1

(from blurriness to vision loss). These are symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder

• toxicity of nervous system (peripheral neuropathy)

• dry mouth, tiredness, and headache due to

  excessive loss of body water (dehydration)

• loss of appetite, anorexia
• pancreatitis

• stroke (sudden numbness or weakness in the face,

  arm, or leg, especially on one side of the body)

• severely impaired liver function, damage or death of

  liver cells

• heart failure

• abnormal breakdown of red blood cells, leading to a

  deficiency in the number or quality of red blood cells

• obstruction in a blood vessel (embolism and

  veno-occlusive disease), swelling or tenderness of leg/arm

• 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

• fewer red blood cells due to their excessive

  breakdown (haemolytic anaemia)

• mental changes (encephalopathy)
• muscle

• kidney f

  pain*, joint pain* ailure

• lung infe *with combi This medici

  ction e.g. pneumonia nation use

  ne may lead to problem

  s with your blood, liver

and kidneys for these pr Reporting

. Your doctor will take bl oblems.

of side effects

ood samples to check

If you get any s pharmacist or

ide effects, talk to your doctor, nurse. This includes any possible side

effects not liste effects directly www.mhra.gov

d in this leaflet. You can also report side via the Yellow Card Scheme at: .uk/yellowcard or search for MHRA

Yellow Card in

the Google Play or Apple App Store. By

reporting side

effects you can help provide more information on the safety of this medicine.

1. 5.

   How to store Carboplatin

   Keep this medicine 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'. The expiry date refers to the last day of that month. Storage

   This medicine is available in two types of vial: Clear glass Onco-Tain^® vials and Onco-Vials^®.

   Clear glass Onco-Tain^® vials

   Do not store above 25°C. Keep the vial in the outer carton in order to protect from light.

   Onco-Vials^®

   Store in a refrigerator (2 to 8°C). Keep the vial in the outer carton in order to protect from light.

   Do not use this medicine if you notice small particles in the solution.

   If Carboplatin 10 mg/ml Concentrate for Solution for Infusion is diluted before use, the diluted solution should be used immediately. If not used immediately it

2. •

   a side effect called tumour lysis syndrome, which

   can be caused by the rapid breakdown of tumour cells and may cause muscle cramping, muscle weakness, confusion, visual loss or disturbances, irregular heartbeat, kidney failure or abnormal blood test results (see section 2).

These are serious side effects. Tell your doctor straight away if you notice any of the following symptoms. You may need urgent medical attention.

Some side effects could be serious.

Very common: 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 (myelosuppresion)

• 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: may affect up to 1 in 10 people

• signs of infection such as fever or sore throat
• flu-like symptoms
• tingling or numbness in your hands, feet, arms or

• burning or prickling sensation

  legs

• decreased tendon reflex
• taste disturbance or loss of taste
• 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

  which the deep lung tissues beco

  lung disorders in me 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

Very rare: 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)

• cancers of the blood and bone

• feeling unwell with high temperature due to low

  levels of white blood cells (febrile neutropenia)

• a group of symptoms such as headache, altered

  mental functioning, seizures and abnormal vision

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.

Carboplatin 10 mg/ml

2026-1000179A

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Carboplatin 10 mg/ml Concentrate for Solution for Infusion

carboplatin

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.

Parenteral drugs should be inspected visually for particulate matter prior to administration, whenever solution and container permit. If particulate matter is observed, shake and re-inspect. Vials with visible particulate matter should not be used.

Incompatibilities

Carboplatin interacts with aluminium to form a black precipitate of platinum causing loss of potency. 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 10 mg/ml Concentrate for 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 8ºC in non-PVC (polyolefin) infusion bags when protected from light. Carboplatin 10 mg/ml Concentrate for 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 8ºC and up to 8 hours when stored at 22ºC.

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 8ºC, 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.

If you are given too much Carboplatin than you should

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.

1. 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), wheeziness or tightness of chest, swelling of the hands, feet, ankles, face, eyelids, lips, mouth or throat (which may cause difficulty in swallowing or breathing), facial flushing, low blood pressure, rapid heartbeat, shortness of breath, dizziness you may feel you are going to faint and you may experience chest pain which can be a sign of a potentially serious allergic reaction called Kounis syndrome

• haemolytic-uraemic syndrome (a disease

  characterised by acute kidney failure), decreased urination or blood in the urine

• a side effect called tumour lysis syndrome,

  which can be caused by the rapid breakdown of tumour cells and may cause muscle cramping, muscle weakness, confusion, visual loss or disturbances, irregular heartbeat, kidney failure or abnormal blood test results (see section 2). These are serious side effects. Tell your doctor straight away if you notice any of the following symptoms. You may need urgent medical attention. Some side effects could be serious. Very common: 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 (myelosuppresion)

• 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

coagulation monitoring

• phenytoin and fosphenytoin (used to treat

  various types of convulsions and seizures), as this may increase the risk of a seizure

• other medicines which decrease the activity

  of the immune system (e.g. ciclosporin, tacrolimus, sirolimus)

• medicines which cause vomiting, as these will

  have an enhanced effect

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. To avoid possible harmful effects in the infant, breast-feeding must be stopped during carboplatin therapy and for at least one month following last dose.

Due to the possible risk of birth defects, female patients of childbearing potential should always use effective birth-control (contraception) during treatment with carboplatin, and for at least seven months after the last dose.

Men treated with this medicine are advised to use effective birth-control (contraception) during treatment, and up to four months after treatment. Advice on conservation of sperm should be sought prior to treatment because of the possibility of irreversible infertility.

Treatment with carboplatin may temporarily or permanently reduce fertility in men and women. Tell your doctor if you have concerns.

Talk to your doctor about birth control methods that are right for you and your partner.

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.

3. How to use Carboplatin

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 this medicine for you and how often it must be given. The recommended 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 pregnant or if there is a chance you

  may be pregnant.

• if you are breast-feeding.

• if you have 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, this medicine may cause abnormalities in your nervous system, such as pins and needles or hearing and vision problems. Your doctor should regularly assess you.

• if you have headache, altered mental

  functioning, seizures and abnormal vision (from blurriness to vision loss).

• if you develop extreme tiredness and shortness

  of breath with decreased number of red blood cells, (haemolytic anaemia), alone or combined with low platelet count, abnormal bruising (thrombocytopenia) and kidney disease where you pass little or no urine (symptoms of Haemolytic-uraemic syndrome).

• if you have fever (temperature greater than or

  equal to 38ºC), or chills, which could be signs of infection. You may be at risk of getting an infection of the blood.

Kidney function and blood counts should be assessed before, during and after treatment. These measures are to monitor toxicity and assist in dose adjustment.

Your doctor may give you medicines immediately before treatment with Carboplatin to prevent vomiting.

During treatment with Carboplatin, you will be given medicines which help reduce a potentially life-threatening complication known as tumour lysis syndrome, which is caused by chemical disturbances in the blood due to the breakdown of dying cancer cells that release their content to the bloodstream.

Other medicines and Carboplatin

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, for example:

• medicines or treatments such as radiation

  therapy which reduce the number of cells in your blood, as this may require changes to the dosage and frequency of your Carboplatin treatment

• some antibiotics called aminoglycosides, as

  this may increase the risk of kidney or hearing problems

• medicines which are damaging to the kidney,

  will have an enhanced effect on the kidneys

• some water tablets (diuretics), as this may

  increase the risk of kidney or hearing problems

• live or live-attenuated vaccines (or yellow

  fever vaccine see section 2, Do not use Carboplatin)

• blood thinning medicines e.g. warfarin, as this

  may require an increase in frequency of blood Package leaflet: Information for the user Carboplatin 10 mg/ml Concentrate for

Solution for Infusion

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.

• If you get any side effects, talk to your

  doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. 1. What Carboplatin is and what it is used for
2. 2.

   What you need to know before you use

   Carboplatin

3. 3. How to use Carboplatin
4. 4. Possible side effects
5. 5. How to store Carboplatin
6. 6. Contents of the pack and other information
7. 1. What Carboplatin is and what it is used for

Carboplatin is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy. It is used in the treatment of some types of lung cancer and ovarian cancer.

1. 2. What you need to know before you use Carboplatin

Do not use Carboplatin

• if you are allergic to carboplatin or to any of the

  ingredients of this medicine (listed in section 6)

• if you have had hypersensitivity to 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.

This medicine should be administered only by or under the direct supervision of a qualified physician who is experienced in the use of cancer chemotherapeutic agents.

Carboplatin is very toxic and treatment is likely to cause some side effects.

Warnings and Precautions

Talk to your doctor, pharmacist or nurse before using Carboplatin

Common: may affect up to 1 in 10 people

• signs of infection such as fever or sore throat • flu-like symptoms

• tingling or numbness in your hands, feet, arms

  or legs

• burning or prickling sensation
• decreased tendon reflex
• taste disturbance or loss of taste
• 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

Very rare: 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)

• cancers of the blood and bone

• feeling unwell with high temperature due to low

  levels of white blood cells (febrile neutropenia)

• a group of symptoms such as headache,

  altered mental functioning, seizures and abnormal vision (from blurriness to vision loss). These are symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder

• toxicity of nervous system (peripheral neuropathy)

• dry mouth, tiredness, and headache due to

  excessive loss of body water (dehydration) • loss of appetite, anorexia

• pancreatitis

• stroke (sudden numbness or weakness in the

  face, arm, or leg, especially on one side of the body)

• severely impaired liver function, damage or

  death of liver cells

• heart failure

• abnormal breakdown of red blood cells, leading

  to a deficiency in the number or quality of red blood cells

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.

• obstruction in a blood vessel (embolism and

  veno-occlusive disease), swelling or tenderness of leg/arm

• 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

• fewer red blood cells due to their excessive

  breakdown (haemolytic anaemia)

• mental changes (encephalopathy)
• muscle pain*, joint pain*
• kidney failure
• lung infection e.g. pneumonia

*with combination use

This medicine may lead to problems with your blood, liver and kidneys. Your doctor will take blood samples to check for these problems.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

1. 5. How to store Carboplatin

Keep this medicine 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'. The expiry date refers to the last day of that month.

Storage

This medicine is available in two types of vial: Clear glass Onco-Tain^® vials and Onco-Vials^®. Clear glass Onco-Tain^® vials

Do not store above 25°C. Keep the vial in the outer carton in order to protect from light.

Onco-Vials^®

Store in a refrigerator (2 to 8°C). Keep the vial in the outer carton in order to protect from light. Do not use this medicine if you notice small particles in the solution.

If Carboplatin 10 mg/ml Concentrate for Solution for 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 8ºC.

1. 6. Contents of the pack and other information

What Carboplatin 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 looks like and contents of the pack

Carboplatin 10 mg/ml Concentrate for Solution for Infusion is a clear, colourless solution for infusion which comes in glass containers called vials (clear glass Onco-Tain^® vials and Onco-Vials^®). It may be supplied in packs containing: 1 x 50 mg/5 ml vial

1 x 150 mg/15 ml vial

1 x 450 mg/45 ml vial

1 x 600 mg/60 ml vial

Not all packs may be marketed.

Marketing Authorisation Holder

Hospira UK Limited,

Walton Oaks,

Walton-On-The-Hill,

Dorking Road,

Tadworth,

Surrey,

KT20 7NS,

UK

Manufacturer

Pfizer Service Company BV,

Hermeslaan 11,

1932 Zaventem,

Belgium

This leaflet was last revised in 07/2026. Ref: gxCR 17_1

Carboplatin 10 mg/ml

2026-1000179C

If you are given too much Carboplatin than you should

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), wheeziness or tightness of chest, swelling of the hands, feet, ankles, face, eyelids, lips, mouth or throat (which may cause difficulty in swallowing or breathing), facial flushing, low blood pressure, rapid heartbeat, shortness of breath, dizziness you may feel you are going to faint

  and you may experience chest pain which can be a sign of a potentially serious allergic reaction called Kounis syndrome • haemolytic-uraemic syndrome (a disease characterised by acute

  kidney failure), decreased urination or blood in the urine • a side effect called tumour lysis syndrome, which can be caused by

  the rapid breakdown of tumour cells and may cause muscle cramping, muscle weakness, confusion, visual loss or disturbances, irregular heartbeat, kidney failure or abnormal blood test results (see section 2).

These are serious side effects. Tell your doctor straight away if you notice any of the following symptoms. You may need urgent medical attention. Some side effects could be serious.

Very common: 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

  Carboplatin 10 mg/ml Conce

  ntrate fo

  r Solution for Infusion carboplatin

  T

  he following information is intended for medical or healthcare p

  rofessionals only

  F

  urther to the information included in section 3, practical information on the pr

  eparation/handling of the medicinal product is provided here.

  P

  arenteral drugs should be inspected visually for particulate matter prior to a

  dministration, whenever solution and container permit. If particulate matter is

  observed, shake and re-inspect. Vials with visible particulate matter sh

  ould not be used.

  In

  compatibilities

  C

  arboplatin interacts with aluminium to form a black precipitate of platinum c

  ausing loss of potency. Needles, syringes, catheters or IV administration se

  ts that contain aluminium parts which may come into contact with c

  arboplatin, should not be used for the preparation or administration of the dr

  ug.

  H C h

  C in p

  of in C fu in st Fr im pr lo c

  andling

  arboplatin should be prepared for administration only by professionals who ave been trained in the safe use of chemotherapeutic agents. arboplatin 10 mg/ml Concentrate for Solution for Infusion may be further diluted glucose 5% and administered as an intravenous infusion. Chemical and hysical in-use stability has been demonstrated for 56 days to final concentrations 0.2 mg/ml and 3.5 mg/ml when stored at 2 to 8ºC in non-PVC (polyolefin) fusion bags when protected from light.

  arboplatin 10 mg/ml Concentrate for Solution for Infusion may also be rther diluted in sodium chloride 0.9% and administered as an intravenous fusion. The infusion solution is chemically stable for up to 24 hours when ored at 2 to 8ºC and up to 8 hours when stored at 22ºC.

  om a microbiological point of view however, the product should be used mediately. If not used immediately, in-use storage times and conditions ior to use are the responsibility of the user and would normally not be nger than 24 hours at 2 to 8ºC, unless dilution has taken place in ontrolled and validated aseptic conditions.

To avoid possible harmful effects in the infant, breast-feeding must be stopped during carboplatin therapy and for at least one month following last dose.

Due to the possible risk of birth defects, female patients of childbearing potential should always use effective birth-control (contraception) during treatment with carboplatin, and for at least seven months after the last dose. Men treated with this medicine are advised to use effective birth-control (contraception) during treatment, and up to four months after treatment. Advice on conservation of sperm should be sought prior to treatment because of the possibility of irreversible infertility.

Treatment with carboplatin may temporarily or permanently reduce fertility in men and women. Tell your doctor if you have concerns.

Talk to your doctor about birth control methods that are right for you and your partner.

Driving and using machines

Do not drive or use machines if you experience any side effect which may

lessen your ab

ility to do so such as n

ausea, vomiting, wor

sening of eyesight,

or changes to yo

ur vision and hearing.

1. 3.

   How to use

   Carboplatin

This medicine wil

l be given by infusion (drip) into a vein ov

er 15-60 minutes.

Dose

Your doctor will w

ork out the correct dose of this medicine for you and how often it must be given.

The recommended 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.

Your doctor may give you medicines immediately before treatment with Carboplatin to prevent vomiting.

During treatment with Carboplatin, you will be given medicines which help reduce a potentially life-threatening complication known as tumour lysis syndrome, which is caused by chemical disturbances in the blood due to the breakdown of dying cancer cells that release their content to the bloodstream.

Other medicines and Carboplatin

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, for example:

• medicines or treatments such as radiation therapy which reduce the

  number of cells in your blood, as this may require changes to the dosage and frequency of your Carboplatin treatment

• some antibiotics called aminoglycosides, as this may increase the risk of

  kidney or hearing problems

• medicines which are damaging to the kidney, will have an enhanced

  effect on the kidneys

• some water tablets (diuretics), as this may increase the risk of kidney or

  hearing problems

• live or live-attenuated vaccines (or yellow fever vaccine see section 2,

  Do not use Carboplatin)

• blood thinning medicines e.g. warfarin, as this may require an increase

  in frequency of blood coagulation monitoring

• phenytoin and fosphenytoin (used to treat various types of convulsions

  and seizures), as this may increase the risk of a seizure • other medicines which decrease the activity of the immune system (e.g.

  ciclosporin, tacrolimus, sirolimus)

• medicines which cause vomiting, as these will have an enhanced effect

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 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.

This medicine should be administered only by or under the direct supervision of a qualified physician who is experienced in the use of cancer chemotherapeutic agents.

Carboplatin is very toxic and treatment is likely to cause some side effects. 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 breast-feeding.

• if you have 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, this medicine may cause abnormalities in your nervous system, such as pins and needles or hearing and vision problems. Your doctor should regularly assess you.

• if you have headache, altered mental functioning, seizures and

  abnormal vision (from blurriness to vision loss).

• if you develop extreme tiredness and shortness of breath with

  decreased number of red blood cells, (haemolytic anaemia), alone or combined with low platelet count, abnormal bruising (thrombocytopenia) and kidney disease where you pass little or no urine (symptoms of Haemolytic-uraemic syndrome).

• if you have fever (temperature greater than or equal to 38ºC), or chills,

  which could be signs of infection. You may be at risk of getting an infection of the blood.

Kidney function and blood counts should be assessed before, during and after treatment. These measures are to monitor toxicity and assist in dose adjustment.

Package leaflet:

Information for the user Carboplatin 10 mg/ml Concentrate for Solution for Infusion

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. • If you get any side effects, talk to your doctor or nurse. This

  includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

Carboplatin is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy. It is used in the treatment of some types of lung cancer and ovarian cancer.

1. 2. What you need to know before you use Carboplatin Do not use Carboplatin
2. •

   if you are allergic to carboplatin or to any of the ingredients of this

   medicine (listed in section 6)

3. •

   if you have had hypersensitivity to similar platinum containing medicine

   s

   in the past

4. • if you have severe kidney disease

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 use to treat transient stinging of skin. Medical advice should be sought if the ey are affected.

In the event of a spillage, two operators should put on gloves and mop up t spilled material with a sponge kept for that purpose. In the event of a powd spillage, cover with a cloth and moisten with water before mopping up. Rins the area twice with water. Put all solutions and sponges in a plastic bag, se 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 1000°C.

Directions for use of the Onco-Vial^®

Onco-Vials^® should be used with the appropriate Hospira administration device.

d es

he er e al

at

Not known: frequency cannot be estimated from available data

• cancers caused by treatment with carboplatin (secondary malignancies) • cancers of the blood and bone

• feeling unwell with high temperature due to low levels of white blood

  cells (febrile neutropenia)

• a group of symptoms such as headache, altered mental functioning,

  seizures and abnormal vision (from blurriness to vision loss). These are symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder

• toxicity of nervous system (peripheral neuropathy)

• dry mouth, tiredness, and headache due to excessive loss of body water

  (dehydration)

• loss of appetite, anorexia
• pancreatitis

• stroke (sudden numbness or weakness in the face, arm, or leg,

  especially on one side of the body)

• severely impaired liver function, damage or death of liver cells • heart failure

• abnormal breakdown of red blood cells, leading to a deficiency in the

  number or quality of red blood cells

• obstruction in a blood vessel (embolism and veno-occlusive disease),

  swelling or tenderness of leg/arm

• 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

• fewer red blood cells due to their excessive breakdown (haemolytic

  anaemia)

• mental changes (encephalopathy)
• muscle pain*, joint pain*
• kidney failure
• lung infection e.g. pneumonia

*with combination use

This medicine may lead to problems with your blood, liver and kidneys. Your doctor will take blood samples to check for these problems.

What Carboplatin looks like and contents of the pack

Carboplatin 10 mg/ml Concentrate for Solution for Infusion is a clear, colourless solution for infusion which comes in glass containers called vials (clear glass Onco-Tain^® vials and Onco-Vials^®).

It may be supplied in packs containing:

1 x 50 mg/5 ml vial

1 x 150 mg/15 ml vial

1 x 450 mg/45 ml vial

1 x 600 mg/60 ml vial

Not all packs may be marketed.

Marketing Authorisation Holder

Hospira UK Limited,

Walton Oaks,

Walton-On-The-Hill,

Dorking Road,

Tadworth,

Surrey,

KT20 7NS,

UK

Manufacturer

Pfizer Service Company BV,

Hermeslaan 11,

1932 Zaventem,

Belgium

This leaflet was last revised in 07/2026. Ref: gxCR 17_1

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Carboplatin

Keep this medicine 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’. The expiry date refers to the last day of that month.

Storage

This medicine is available in two types of vial: Clear glass Onco-Tain^® vials and Onco-Vials^®.

Clear glass O

nco-Tain^® vials

Do not store abo

ve 25°C. Keep the vial in the outer carton

in order to protect

from light.

®

Onco-Vials

Store in a refrige

rator (2 to 8°C). Keep the vial in the outer

carton in order to

protect from light

.

Do not use this m

edicine if you notice small particles in the solution. If Carboplatin 10 mg/ml Concentrate for Solution for 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 8ºC.

6. Contents of the pack and other information

What Carboplatin contains

The active substance is carboplatin. Each millilitre (ml) of solution contains 10 milligrams (mg) of carboplatin.

The other ingredient is water for injections.

Tests may also show:

• changes in your red and white blood cells and platelets

  (myelosuppresion)

• 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: may affect up to 1 in 10 people

• signs of infection such as fever or sore throat • flu-like symptoms
• tingling or numbness in your hands, feet, arms or legs • burning or prickling sensation
• decreased tendon reflex
• taste disturbance or loss of taste
• 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 Very rare: may affect up to 1 in 10,000 people

• scarring of the lungs which causes shortness of breath and/or cough

  (pulmonary fibrosis)

  Carboplatin 10 mg/ml

  2026-1000179B