Document: leaflet MAH GENERIC_PL 18727-0025 change

• leaflet MAH GENERIC_PL 18727-0025
• leaflet MAH GENERIC_PL 20075-0028
• leaflet MAH GENERIC_PL 20417-0011
• leaflet MAH GENERIC_PL 20417-0012
• leaflet MAH GENERIC_PL 20417-0013
• leaflet MAH GENERIC_PL 36390-0191
• leaflet MAH GENERIC_PL 36390-0192
• leaflet MAH GENERIC_PL 36390-0193
• leaflet MAH GENERIC_PL 41947-0003
• leaflet MAH GENERIC_PL 41947-0004
• leaflet MAH GENERIC_PL 41947-0005

---

Carboplatin - Pack Insert - UK/IRL (Bordon)

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

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

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.

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.

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.

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.

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.

.............................X.................................

V « «    S 8 £2    ^    °    °

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.

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)

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.

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.

Breast-feeding

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

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.

Adult

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

--------------------------------X-----------------------------

S rj te'fl.'SJ'dSSa >. rtrtb =5 t! » a

your height and weight).

Elderly

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

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

----------------------------------X---------------------------

ci co xf-    iri ko    t>

Bordon code: 220639    Black    Times New Roman 9 pt    Draft: 05 Last modified: 10 September 2013 2:19 PM

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	I&D RA	QM	Country RA
			Approved Online		NA	NA

Carboplatin - Pack Insert - UK/IRL (Bordon)

-    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.

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).

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.

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.

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 2°C to 8°C and 20°C to 25°C. Chemical and physical in-use stability has been demonstrated after dilution in Sodium chloride 0.9% for 24 hours at 2°C to 8°C and 8 hours at 20°C to 25°C.

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.

-----------------------------x---------------------------------

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.

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.

-    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 tcukvo Staku^a yta napaaKsu^ Siaku^axo^ npo^ syypCTn
Czech Republic	Carboplatin Kabi 10 mg/ml koncentrat pro pnpravu infuznlho roztoku
Germany	Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslosung
Denmark	Carboplatin Fresenius Kabi
Estonia	Carboplatin Kabi
Greece	Carboplatin Kabi 10 mg/ml nuKvo Staku^a yta syyuCTn
Spain	Carboplatino Kabi 10 mg/ml concentrado para solucion para perfusion EFG
Finland	Carboplatin Fresenius Kabi 10 mg/ml infuusiokonsentraatti, liuosta varten
France	Carboplatine Kabi 10 mg/ml solution a diluer pour perfusion
Hungary	Carboplatin Kabi 10 mg/ml koncentratum oldatos infuziohoz
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 koncentrats infuziju sklduma pagatavosanai
Lithuania	Carboplatin Kabi 10 mg/ml koncentratas infuziniam tirpalui
Luxembourg	Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslosung
Malta	Carboplatin 10 mg/ml concentrate for solution for infusion
The Netherlands	Carboplatine Fresenius Kabi 10 mg/ml concentraat voor oplossing voor infusie
Norway	Carboplatin Fresenius Kabi 10 mg/ml konsentrat til infusjonsvsske

x

Bordon code: 220639    Black    Times New Roman 9 pt    Draft: 05 Last modified: 10 September 2013 2:19 PM

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	I&D RA	QM	Country RA
			Approved Online		NA	NA

Form No.: SOP/PDD/003-03 Rev. 05    CONFIDENTIAL    * Attached separate sheet if required