CARBOPLATIN 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

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, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist 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.

What Carboplatin is Carboplatin contains carboplatin, which belongs to a group of medicines known as platinum coordination compounds which are used to treat cancer. You will normally be given this injection in hospital. What Carboplatin is used for Carboplatin is used to treat some cancers of the ovary and lung (ovarian cancer of epithelial origin, small-cell lung cancer). 2. What you need to know before you use Carboplatin Do not use Carboplatin: if you are allergic to carboplatin or other ingredients of this medicine (listed in section 6). if you are breast-feeding. if you are allergic to another medicine that belongs to the group of platinum containing compounds. if you have severe problems with your kidneys (glomerular filtration rate < 30 ml/min). if you have an imbalance of your blood cells (severe myelosuppression). if you have a tumour that bleeds. if you are receiving yellow fever vaccine at the same time. If any of these apply to you and you have not already discussed this with your doctor or pharmacist, you should do so as soon as possible and before receiving the injection. Carboplatin is usually given to patients in hospital. Normally you should not handle this medicine. Your doctor 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 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 likely to drink any alcohol whilst being treated with this injection. If your kidneys are not working properly the effects of carboplatin on the blood building system are increased and prolonged compared to patients with normal kidney function. Your doctor will want to monitor you more regularly if your kidneys are not working properly. If any of these apply to you and you have not already discussed this with your doctor or pharmacist, you should do so as soon as possible and before receiving the injection. Other medicines and Carboplatin Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor if you are taking any of the following medicines as they may interact with Carboplatin: When undergoing treatment with carboplatin, you must not be administered yellow fever vaccines (see also Do not use Carboplatin) because there is an increased risk that you develop yellow fever, which may lead to death. Any vaccinations containing live viruses should not be administered when treated with carboplatin

as there is a risk that you develop the disease you are vaccinated against, which may lead to death. Carboplatin can reduce the effects of anti-epileptic medicine (e.g. phenytoin and fosphenytoin). Carboplatin may have an adverse impact on the effectivity of agents preventing blood clotting (anticoagulants). Therefore, blood-clotting ability should be checked more often during combined use. The simultaneous use of carboplatin with chelating agents (agents which can chemically bind to carboplatin) can strengthen the adverse effects of carboplatin. Carboplatin toxicity may severely affect the kidneys and hearing ability when administered at the same time as medicines that are known to harm the kidneys and ears, e.g. antibiotics called aminoglycosides (medicine to prevent/treat certain infections) or loop diuretics (water tablets). Using carboplatin at the same time as cyclosporine, tacrolimus and sirolimus (used to suppress the immune system in autoimmune diseases or organ transplantation) can weaken the immune system with the risk of increased production of white blood cells. 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 or pharmacist for advice before taking this medicine. Pregnancy You must not be treated with Carboplatin during pregnancy unless clearly indicated by your doctor.

If you are being treated with Carboplatin whilst pregnant, you should discuss with your doctor the possible risk for effects on your unborn child. Women of childbearing potential must use an effective method of contraception both before and during treatment with Carboplatin. If pregnancy occurs during treatment with Carboplatin, genetic counselling is recommended, since Carboplatin can cause genetic damage. Breast-feeding It is not known whether carboplatin is excreted into the breast milk. Therefore, you should not breastfeed during treatment with Carboplatin. Fertility Carboplatin can cause genetic damage. Men treated with Carboplatin are advised not to father a child during and up to 6 months after treatment. They should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility. Driving and using machines Carboplatin may cause nausea, vomiting, vision abnormalities and hearing disorders, indirectly impairing your ability to drive and use machines. 3. How to use Carboplatin Your injection will always be administered by your doctor. It is usually given in a drip by slow injection (infusion) in a vein (intravenously) and will usually take between 15 to 60 minutes to be administered. If you require any further information, ask your doctor who will administer or has administered the injection.

Your dose will be dependent on your height and weight, functioning of your blood building system and your kidney function. Your doctor will choose the best dose for you. The injection will normally be diluted before use. Adults The recommended dose is 400 mg/m of your body surface area (calculated from your height and weight). Elderly patients The recommended adult doses may be used although the doctor may choose to use a different dose. Kidney problems If you suffer from kidney problems your doctor may reduce the dose and may perform frequent blood tests as well monitoring your kidney function. Use in children and adolescents There has not been enough usage of carboplatin in children to allow the recommendation of a specific dose. You may feel sick or be sick while you are being treated with Carboplatin. Your doctor may give you another medicine to reduce these effects before you are treated with Carboplatin. There will usually be a gap of four weeks between each dose of Carboplatin. Your doctor will want to perform some blood tests each week after giving you Carboplatin so that he/she can decide on the correct next dosage for you. If you receive more Carboplatin than you should It is unlikely that you will be given too much injection. However, in the event that this occurs you

may experience myelosuppression (inhibition of blood cell production in the bone marrow), kidney and liver problems as well as hearing problems. If you are worried that too much has been administered or if you have any questions about the dose being given, you should talk to the doctor administering your medicine. If you miss a dose of Carboplatin It is unlikely that you miss a dose of your medicine as your doctor will have instructions on when to give you your medicine. If you think you have missed a dose please talk to your doctor. If you stop using Carboplatin Your doctor will normally decide when you should stop treatment with Carboplatin. If you have any further questions on the use of this medicine ask your doctor, pharmacist or nurse. 4. Possible side effects Like all medicines, Carboplatin can cause side effects, although not everybody gets them. Important side effects or symptoms to look out for and what to do if you are affected If you think you have any of the following side effects or symptoms, please contact your doctor immediately. Very common side effects (affecting more than 1 in 10 people): reduction in the number of white blood cells (makes infections more likely) anaemia (a condition in which there is a decrease of red blood cells which can make the skin pale and cause weakness or breathlessness)

The following information is intended for healthcare professionals only: Use/Handling Carboplatin is a mutagenic and potentially carcinogenic substance. Precautions for safe handling of hazardous substances are to be taken for preparation and application. Preparation must be carried out by trained personal wearing adequate protective gloves, disposable gowns and masks. Carboplatin should not be used with aluminiumcontaining parts (e.g. infusion assemblies, syringes and injection needles) as carboplatin reacts with aluminium. This can lead to precipitation and thus to reduced antineoplastic activity. Shelf life after opening the container and preparing the solution for infusion ready-to-use: Chemical and physical in-use stability has been demonstrated in glucose 50 mg/ml (5 %) solution for infusion for 72 hours at room temperature and in sodium chloride 9 mg/ml (0.9 %) solution for infusion for 24 hours at 2 to 8 C, when stored protected from light. However, it is recommended to use solution for infusion reconstituted with sodium chloride 9 mg/ml (0.9 %) solution for infusion immediately after reconstitution. From a microbiological point of view, 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 reconstitution/dilution has taken place in controlled and validated aseptic conditions.

Dilution: The product may be diluted with glucose 50 mg/ml (5 %) solution for infusion to concentrations of 0.4 2 mg/ml or sodium chloride 9 mg/ml (0.9 %) solution for infusion to a concentration of 2 mg/ml. Disposal Any unused product or waste material should be disposed of in accordance with local requirements.

reduction in blood platelets (increases the risk of bleeding or bruising) feeling (nausea) or being sick (vomiting) Common side effects (affecting less than 1 in 10 people): infections (possible signs of infections are e.g. sore throat, fever, chills) unusual bruising or bleeding (e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)) allergic reactions including rash, redness, hives, itching, high temperature severe allergic reaction (anaphylaxis). This type of reaction is most likely to occur within minutes of receiving Carboplatin. Symptoms of a severe allergic reaction include sudden wheeziness or tightness of the chest, swelling of the eyelids, face or lips, rash, itching and high temperature. peripheral neuropathy (a disorder of the nerves which can cause weakness, tingling or numbness) pins and needles decrease of deep tendon reflexes (reflex of muscles to contract when a muscle tendon is struck) sensory disturbance (mainly abnormal sensations of the skin such as numbness, pins and needles, tingling) visual disturbance including rare cases of sight loss damage to the ear (ototoxicity), e.g. ringing in the ears, hearing loss cardiovascular disorder (side effects affecting the circulatory system) lung disease serious lung condition associated with shortness of breath, difficulties in breathing and/or scarring of the lungs (interstitial lung disease) difficulty in breathing or wheezing

diarrhoea, constipation, inflammation of mucous membranes Uncommon side effects (affecting less than 1 in 100 people): 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 Not known (cannot be estimated from the available data): feeling unwell with a high temperature due to low levels of white blood cells (febrile neutropenia) stroke heart failure embolism (blocking of an artery) redness, swelling and pain or dead skin around the injection site (injection site reactions) leakage into the surrounding tissue (injection site extravasation) Other possible side effects If you think you have any of the following side effects or symptoms, please contact your doctor as soon as possible. Very common side effects (affecting more than 1 in 10 people): abdominal pain Common side effects (affecting less than 1 in 10 people): taste alteration hair loss skin disorder musculoskeletal disorder (condition affecting the muscles, joints, tendons and nerves) unusual feelings of tiredness or weakness (asthenia)

Not known (cannot be estimated from the available data): insufficient body liquids (dehydration) loss of appetite low blood pressure high blood pressure inflammation of the lining (mucosa) of the mouth hives (skin allergy with development of itchiness and weals) rash redness of the skin itching feeling of general discomfort (malaise) Certain other unwanted effects can only be detected by your doctor, these include: Very common side effects (affecting more than 1 in 10 people): kidney damage decreased creatinine clearance (the creatinine clearance shows how well your kidneys are working) increased levels of urea in your blood abnormal liver enzyme levels decreases in the levels of salts in your blood, mostly without obvious signs or symptoms Common side effects (affecting less than 1 in 10 people): conditions affecting the urinary and genital tracts increased levels of bilirubin in your blood increased levels of creatinine in your blood increased uric acid levels in the blood which may lead to gout Uncommon side effects (affecting less than 1 in 100 people): reduced kidney function

Very rare side effects (affecting less than 1 in 10,000 people): promyelocytic leukaemia (a cancer of the blood and bone marrow) 6 years after monotherapy and radiation treatment has been reported Not known (cannot be estimated from the available data): reduced liver function, damage or death of liver cells cancer caused by chemotherapy reduction of blood cell production in the bone marrow (bone marrow failure) haemolytic-uraemic syndrome (a disease characterised by acute kidney failure, decreased number of red blood cells [microangiopathic haemolytic anaemia] and a low platelet count) low blood levels of sodium which can cause confusion, muscle twitching or abnormal heart rhythm (hyponatraemia) If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. 5. How to store Carboplatin You will be not asked to store your medicine. It will be brought to you ready to be administered straight away. There are no special storage conditions for this medicine during administration. Your doctor or pharmacist should ensure that Carboplatin is stored out of the sight and reach of children. Your doctor or pharmacist will ensure that you do not receive Carboplatin after the expiry date which

is stated on the label after EXP. The expiry date refers to the last day of that month. Your doctor or pharmacist should ensure that the vial is kept in the outer carton, in order to protect from light, at below 25 C. It must not be frozen. When mixed with other solutions the solution should be used immediately or can be stored no longer than 24 hours at 2 8 C. Your doctor or pharmacist will ensure that these storage requirements are met. Medicines should not be thrown away via wastewater or household waste. Your doctor or pharmacist will throw away medicines no longer used. These measures will help protect the environment. 6. Contents of the pack and other information What Carboplatin contains The active substance is carboplatin. The other ingredient is water for injections. What Carboplatin looks like and contents of the pack Carboplatin is a colourless to pale yellow, clear concentrate for solution for infusion. Each ml of solution contains 10 mg carboplatin. Each 5 ml vial contains 50 mg of carboplatin. Each 15 ml vial contains 150 mg of carboplatin. Each 45 ml vial contains 450 mg of carboplatin. Each 60 ml vial contains 600 mg of carboplatin. Each 100 ml vial contains 1000 mg of carboplatin. Packages containing 1 and 10 vials. Not all pack sizes may be marketed.

Marketing authorisation holder and Manufacturer medac Gesellschaft fr klinische Spezialprparate mbH Fehlandtstr. 3 20354 Hamburg Germany Phone: +49 4103 8006-0 Fax: +49 4103 8006-100 Production site Theaterstr. 6 22880 Wedel Germany Phone: +49 4103 8006-0 Fax: +49 4103 8006-100 This medicinal product is authorised in the Member States of the EEA under the following names: Czech Republic Carbomedac 10 mg/ml koncentrt pro ppravu infuznho roztoku Denmark Carbomedac 10 mg/ml koncentrat til infusionsvske, oplsning Germany Carbomedac 10 mg/ml Konzentrat zur Herstellung einer Infusionslsung Poland Carbomedac 10 mg/ml koncentrat do sporzdzania roztworu do infuzji Slovak Republic Carbomedac 10 mg/ml infzny koncentrt Slovenia Karboplatin medac 10 mg/ml koncentrat za raztopino za infundiranje

Sweden

Carbomedac 10 mg/ml koncentrat till infusionsvtska, lsning United Kingdom Carboplatin 10 mg/ml concentrate for solution for infusion This leaflet was last revised in 08/2012.

90000-VPGB AB