Actavis. concentrate for solution for infusion

Transcription

1 10-14 concentrate for solution for infusion Carboplatin 10 mg/ml 1. WHAT CARBOPLATIN ACTAVIS IS AND WHAT IT IS USED FOR What Carboplatin Actavis is Carboplatin Actavis contains carboplatin, which belongs to a group of medicines known as platinum coordination compounds, which are used to treat cancer. What Carboplatin Actavis is used for Carboplatin Actavis is used against advanced cancer of the ovary and small cell cancer of the lung. 2. BEFORE YOU ARE GIVEN CARBOPLATIN ACTAVIS Do not use Carboplatin Actavis If you are allergic (hypersensitive) to carboplatin or to any of the ingredients of Carboplatin Actavis If you are allergic to another drug that belongs to the group of platinum containing compound. If you have severe problems with your kidneys (creatinine clearance at or below 20 ml/min) If you have an imbalance of your blood cells (sever myelosuppression) If you have tumour that bleeds If you are pregnant or breast feeding If any of these apply to you and you have not you should do so as soon as possible and before receiving the infusion. Carboplatin Actavis is usually given to patients in hospital. Normally you should 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. Carboplatin Actavis 10 mg/ml Actavis If you are breast feeding If you are likely to drink any alcohol whilst being treated with this infusion. 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 you should do so as soon as possible and before receiving the infusion. Your infusion 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. Taking other medicines You should tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. You should tell your doctor if you are taking any of the following medicines as they may interact with Carboplatin Actavis: Other medicines that are known to affect blood cell formation in the bone marrow Other medicines that are known to be toxic to your kidneys (e.g. aminoglycosides antibiotics) Other medicines that are known to damage the hearing or balance functions of the ear (e.g. aminoglycosides antibiotics; furosemide (used to treat heart failure and edema) Chelating agents (substances binding to carboplatin thereby decreasing the effect of carboplatin) Phenytoin (used to treat various types of convulsions and seizures) Warfarin (used to prevent the formation of blood clots) Take special care while receiving infusion with Using Carboplatin Actavis with food and drink Carboplatin Actavis Carboplatin Actavis can be used independently If you are pregnant or if there is a chance you may of food. There is no known interaction between become pregnant Carboplatin Actavis and alcohol. However you ACTAVIS-CARBOPLATIN ACTAVIS 10 MG/ML - p.1/5

2 ACTAVIS-CARBOPLATIN ACTAVIS 10 MG/ML - p.2/5 should check with our doctor as Carboplatin Actavis may affect the liver s ability to cope with alcohol. Pregnancy and breast-feeding Tell your doctor if you are trying to become pregnant, are already pregnant, or are breast-feeding before being treated with Carboplatin Actavis. If any of these applies to you and you have not you should do as soon as possible and before receiving the Infusion. Pregnancy You must not be treated with Carboplatin Actavis during pregnancy unless clearly indicated by your doctor. Animal studies have shown a possible risk of abnormalities in the developing foetus. If you are being treated with Carboplatin Actavis whilst pregnant, you should discuss with your doctor the possible risk of effects on your unborn child. Women of childbearing potential must use an effective method of contraception both before and during treatment with carboplatin. Since carboplatin can cause genetic damage, if pregnancy occurs during treatment with carboplatin, genetic counselling is recommended. Genetic counselling is also recommended for patients wishing to have children after treatment with Carboplatin Actavis. Breast-feeding It is not known whether carboplatin is excreted into the breast milk. Therefore, during treatment with Carboplatin Actavis you should discontinue breastfeeding. Fertility Carboplatin can cause genetic damage. Women of childbearing potential should be advised avoid becoming pregnant by using effective contraception 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 or irreversible infertility. Driving and using machines Carboplatin does not affect your ability to drive and use machines. However you should take extra care when you are first given the infusion, especially if you feel dizzy or unsure of yourself. 3. HOW YOU ARE GIVEN CARBOPLATIN ACTAVIS Your infusion will always be administered by nurse or doctor. It is usually given in a drip by slow infusion into a vein (intravenously) and will usually take between 15 to 60 minutes to be administered. If you require any further information, ask your doctor or nurse who will administer or has administered the infusion. Your dose will be dependent on your height and weight, function of your blood building system and your kidney function. Your doctor will choose the best dose for you. The infusion will normally be diluted before use. Adults The usual dose is 400 g/m² of your body surface area (calculated from your height and weight). Elderly The usual adult doses may be used although the doctor may choose to use a different dose. 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. The infusion 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 a specific dose. You may feel sick while you are being treated with Carboplatin Actavis. Your doctor may give you another medicine to reduce these effects before you are treated with Carboplatin Actavis. There will be a usual gap of four weeks between each dose of Carboplatin Actavis.

3 ACTAVIS-CARBOPLATIN ACTAVIS 10 MG/ML - p.3/5 Your doctor will want to perform some blood tests each week after giving you Carboplatin Actavis so that he/she can decide on the correct next dosage for you. If you receive more Carboplatin Actavis 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 if you have any questions about the dose being given, you should talk to the doctor or nurse administering your medicine. If you miss a dose of Carboplatin Actavis It is very 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 or nurse. If you stop using Carboplatin Actavis If you have any further questions on the use of this product, ask your doctor or nurse. 4. POSSIBLE SIDE EFFECTS Like all medicines, Carboplatin Actavis can cause 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 soar 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 (angio-oedema). Stomatitis/mucositis (e.g. sore lips or mouth ulcers). Very common side effects (occurring in more than 1 in 10 patients): 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 lead 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 enzyme levels. Your doctor may want to monitor you Increased uric acid levels in the 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 side effects (occurring in more than 1 in 100 and less than 1 in 10 patients): Unusual bruising or bleeding (haemorrhagic complications) Reduced function of your kidneys. Diarrhoea, constipation, sore lips or mouth ulcers (mucositis) Allergic reaction including rash, urticaria, skin reddening, itching, high temperature Ringing in the ears (tinnitus), hearing impairment and hearing loss Pins and needles (peripheral neuropathy) Hair loss Feeling unwell Decreased serum levels of calcium Flu-like syndrome Loss or lack of bodily strength Fever Uncommon side effects (occurring in more than 1 in 1000 and less than 1 in 100 patients): 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 Rare side effects (occurring in less than 1 in 1000 patients): 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.

4 ACTAVIS-CARBOPLATIN ACTAVIS 10 MG/ML - p.4/5 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 characterized by acute renal failure, decreased number of red blood cells [microangiopathic haemolytic anaemia] and a low platelet count). Severe allergic reactions (anaphylaxis/ anaphylactoid reactions). Symptoms of a severe allergic reaction 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 side effects (occurring in less than 1 in 10,000 people) Heart failure, blockage in blood vessels of your heart, high blood pressure. Bleeding in the brain, this may result in a stroke or loss of consciousness. Scarring of the lungs which causes shortness of breath and/or cough (pulmonary fibrosis) If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. 5. HOW TO STORE CARBOPLATIN ACTAVIS Keep out of the reach and sight of children. Do not use Carboplatin Actavis after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Before opening vials: Store below 25 C in the original package protected from light. Do not Freeze. After dilution: Chemical and physical in-use stability has been demonstrated for 8 hours at 25 C. From a microbiological point of view, the product must 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. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Carboplatin Actavis contains The active substance is carboplatin. One ml contains 10 mg carboplatin. The other ingredient is water for injections What Carboplatin Actavis looks like and contents of the pack Carboplatin Actavis is a clear, colourless solution Pack sizes: 1x5 ml, 5x5 ml, 1x15 ml, 1x45 ml, 1x60 ml Not all pack sizes may be marketed. Marketing Authorization Holder Actavis Group PTC ehf., Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland Manufacturer Actavis Italy S.p.A., Via Pasteur 10, Nerviano (MI), Italy A wholly owned subsidiary of Actavis Group hf, Iceland This leaflet was last approved in June For any inquiries: Please forward to meeainfo@actavis.com The following information is intended for medical or healthcare professionals only: Instruction for use Cytotoxic Handling of Carboplatin Actavis As with other antineoplastic agents, Carboplatin Actavis must be prepared and handled with caution. The following protective measures should be taken when handling Carboplatin Actavis Personnel should be trained in appropriate techniques for reconstitution and handling 1. Carboplatin Actavis should be prepared for administration only by professionals who have been trained in the safe use of chemotherapeutic agents. Personnel handling Carboplatin Actavis should wear protective clothing: goggles, gowns and disposable gloves and masks. 2. A designated area should be defined for syringe preparation (preferably under a laminar flow sys-

5 ACTAVIS-CARBOPLATIN ACTAVIS 10 MG/ML - p.5/5 tem), with the work surface protected by disposable, plastic-backed, absorbent paper 3. All items used for reconstitution, administration or cleaning (including gloves) should be placed in high-risk, waste-disposal bags for high temperature incineration. 4. Spillage or leakage should be treated with dilute sodium hypochlorite (1% available chlorine) solution, preferably by soaking, and then water. All contaminated and cleaning materials should be place 5. in high-risk, waste- disposal bags for incineration. Accidental contact with the skin or eyes should be treated immediately by copious lavage with water, or soap and water, or sodium bicarbonate solution. However, do not abrade the skin by using a scrub brush. Medical attention should be sought. Always wash hands after removing gloves. Preparation of infusion solution Carboplatin Actavis must be diluted before use. It may be diluted with dextrose or Sodium Chloride, to concentrations as low as 0.5 mg/ml (500 micrograms/ml). Disposal Medicines should not be disposed of via wastewater or household waste. All material used for preparation, administration or otherwise coming into contact with Carboplatin should undergo disposal according to local guidelines for the handling of cytotoxic compounds.