PACKAGE LEAFLET: INFORMATION FOR THE USER Etoposide 20 mg/ml Concentrate for Solution for Infusion Etoposide

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER Etoposide 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 side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Etoposide Injection is and what it is used for. 2. What you need to know before you use Etoposide Injection. 3. How to use Etoposide Injection. 4. Possible side effects. 5. How to store Etoposide Injection. 6. Contents of the pack and other information. 1. What Etoposide Injection is and what it is used for This medicine contains the active substance etoposide. It works by interfering production cycle of DNA and slow or stop the growth of cancer cells. Etoposide Injection is used in combination with other anti-cancer medicines to treat: small-cell lung cancer. acute monoblastic & acute myelomonoblastic leukaemia (cancer of the blood-forming tissues of bone marrow). testicular tumours (cancer of testis). 2. What you need to know before you use Etoposide Injection Do not use Etoposide Injection if you are allergic to etoposide, podophyllotoxines or podophyllotoxine-derivatives or any other ingredients of this medicine (listed in section 6). if your liver is not working properly. if your bone marrow does not produce enough blood cells. if you are breast-feeding. if you have a weak immune system and you are being vaccinated against yellow fever at the same time. Warnings and precautions Talk to your doctor or pharmacist or nurse before you use Etoposide Injection: if you have a low serum albumin level. if you have received other anticancer treatment or radiotherapy, your doctor should check the number of blood cell in your blood before treatment starts. if you have a bacterial infection, it should be treated before Etoposide Injection is given. if you have allergic reactions such as low blood pressure, irregular heartbeat, difficulty in breathing, chills, fever, flushing. injection or infusion of Etoposide must be given carefully into a vein. before the start of therapy, during the therapy, and before each course of treatment, your blood should be tested (white blood cells, platelets, haemoglobin), kidney and liver function checked, and neurological functions should be investigated. your doctor will consider the function of your liver, kidney and peripheral nervous system for the decision of treatment with Etoposide Injection. acute leukemia can occur after the treatment of etoposide.

2 Children Allergic reactions have been reported with Etoposide Injection in children. Safety and efficacy in children has not been systematically studied. Other medicines and Etoposide Injection Tell your doctor or pharmacist, if you are using other medicines, have recently used other medicines, or intend to use other medicines, such as: concurrent use of other myelosuppressive (inhibiting bone marrow activity) medicines may increase the effect. you should not be vaccinated with live vaccines (e.g yellow fever) during treatment. phenylbutazone, sodium salicylate and aspirin (pain killers) may increase the effect of etoposide. the blood clotting effect of warfarin may be reduced. co-administration of medicine like phenytoin, phenobarbital can reduce efficacy of etoposide. the effect of anthracyclines may be reduced due to cross resistance between anthracyclines and etoposide. cisplatin can increase drug level which leads to increase toxicity. cyclosporine (i.e. used after transplantation) may increase the effect of etoposide as the excretion from the body is slower. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, or if you suspect that you are pregnant or are intending to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Pregnancy Etoposide can cause malformation of embryo or foetus. Therefore Etoposide Injection should not normally be administered to pregnant women. If used during pregnancy, the patient must be aware of the potential risk to the foetus. Male and female patients should be advised during etoposide treatment and up to 6 months after treatment to take contraceptive precautions. Breast-feeding Breast-feeding must not be carried out during treatment. Fertility Etoposide can damage genes, so men being treated with Etoposide Injection are recommended to take advice before the start of treatment concerning semen preservation, as etoposide may cause infertility. Driving and using machines After the administration of etoposide, weakness, sleepiness, nausea and vomiting and acute hypersensitivity reactions may occur due to a drop in blood pressure and this may impair the ability to drive and use machines. Etoposide Injection contains alcohol This medicine contains 30.5% alcohol (ethanol) which corresponds to mg of ethanol per ml of concentrate i.e. up to 1.2 gm of ethanol per 5 ml vial, equivalent to 30 ml of beer or ml of wine and up to 3 gm of ethanol per 12.5 ml vial, equivalent to 75 ml of beer or 31.4 ml of wine. This is harmful for patient suffering from alcoholism, brain damage, pregnant women, breastfeeding women, children and high-risk groups such as patients with liver disease, or epilepsy. The effect of other medicines may be reduced or increased. Etoposide Injection contains benzyl alcohol and polysorbate 80 Etoposide Injection contains 30 mg/ml of benzyl alcohol and 80 mg/ml of polysorabte 80. It must not be given to premature babies or new born babies. It may cause toxic reactions and allergic reactions in infant and children upto 3 years old. 3. How to use Etoposide Injection Etoposide Injection will always be given to you by healthcare professionals only.

3 Adults The recommended dose of etoposide mg/m 2 intravenously per day for 5 subsequent days. Older patients The dosage does not need to be adjusted. Patients with impaired kidney function The dosage needs to be adjusted depending on your kidney function. How the medicine is used Etoposide Injection will be administered to you by doctors experienced in treating tumours. This medicine is for intravenous use. Injection adjacent to the vein must be carefully avoided. The dose will be individually calculated and prepared for you, depending on your type of cancer and general condition. Etoposide Injection is given to you in a vein over a period of not less than 30 minutes and not more than 2 hours. Duration of treatment The duration of therapy is set by the doctor, taking into account the underlying disease, the combination therapy being administered (if relevant), and the individual therapeutic circumstances. Etoposide should be discontinued if the tumour does not respond to treatment and/or progresses or if intolerable undesirable effects occur. If you use more Etoposide Injection than you should As this medicine is given to you by healthcare professional, it is unlikely that you will receive an incorrect dose. Tell your doctor or nurse if you have any concerns about the amount of medicine that you receive. If you have any further questions on the use of this product, ask your doctor or pharmacist or nurse. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor or nurse immediately if you noticed any of the following: severe allergic reactions such as fever, loss of heat, rapid heartbeat, abnormal contraction of muscles of bronchioles, shortness of breathing, stopping of breathing, low muscles tone and low blood pressure. itching, reddish or purple patches on skin, infection and bleeding. Frequencies of side effects are defined using the following convention: Very common (may affects more than 1 in 10 people) myelosuppression (decreased production of blood cells and platelets), leucopenia (few blood cell), thrombocytopenia (decreased platelet count), neutropenia (low number of white blood cell) reduction of haemoglobin, nausea, vomiting, loss of appetite, abdominal pain and constipation, alopecia (temporary hair loss), liver toxicity, pigmentation, weakness and feeling discomfort. Common (may affect up to 1 in 10 people)

4 acute leukaemia (severe blood cancer), arrhythmias (irregular heart rhythm) and myocardial infarction, dizziness, high blood pressure, redness of skin, mucositis (inflammation of mucosal membrane), stomatitis, oesophagitis (heart burn), diarrhea, skin irritation, inflammation of vein (phlebitis). Uncommon (may affect up to 1 in 100people) peripheral neuropathy (numbness or weakness of limbs), swelling of face. Rare (may affect up to 1 in 1000 people) increase the level of uric acid in blood, Seizures, transitory loss of vision, inflammation of optic nerve, tiredness, somnolence, confusion, interstitial pneumonitis (lung inflammation), pulmonary fibrosis, taste impairment, swallowing difficulties, Stevens Johnson syndrome(allergic skin reaction), toxic epidermal necrolysis, radiation recall dermatitis (i.e skin redness, swelling and/or blistering of skin). Reporting of side effects If you get any side effects, talk to your doctor or 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: By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Etoposide Injection 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 or carton after EXP. The expiry date refers to the last day of that month. Keep the vial in the outer carton in order to protect from light. Do not refrigerate or freeze. Chemical and physical in-use stability of the solution diluted to a concentration of 0.2 mg/ml and 0.4 mg/ml has been demonstrated in sodium chloride injection (0.9 % w/v) and glucose injection (5% w/v) for up to 96 hours and 48 hours at temperature C respectively. 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. Do not store the diluted product in a refrigerator (2-8 C) as this might cause precipitation. Do not use Etoposide Injection if you notice sign of precipitation or contains visible particles. 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. Contents of the pack and other information What Etoposide Injection contains: Etoposide Injection contains the active ingredient etoposide. 1 ml contains 20 mg Etoposide.

5 Each 5 ml vial contains 100 mg of etoposide. Each 10 ml vial contains 200 mg of etoposide. Each 12.5 ml vial contains 250 mg of etoposide. Each 20 ml vial contains 400 mg of etoposide. Each 25 ml vial contains 500 mg of etoposide. Each 50 ml vial contains 1000 mg of etoposide. The other ingredients are citric acid anhydrous, benzyl alcohol, polysorbate 80, Macrogol 300 and ethanol anhydrous. What Etoposide Injection looks like and contents of the pack: Etoposide Injection is a clear, colourless to pale yellow solution for infusion. Pack sizes: 1 5 ml vial 1 10 ml vial ml vial 1 20 ml vial 1 25 ml vial 1 50 ml vial Not all pack sizes may be marketed. Marketing Authorisation Holder: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom Manufacturer: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom Wessling Hungary Kft Fòti ùt 56., Budapest 1047, Hungary This medicinal product is authorized in the Member States of the EEA under the following names: Name of the Member State Austria Belgium Bulgaria Cyprus Czech Republic Denmark Germany Estonia Finland Hungary Ireland Iceland Italy Latvia Lithuanian Name of the medicinal product Etoposide Accord 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung Etoposide Accord Healthcare 20 mg/ml, Concentraat voor oplossing voor infusie Etoposide Accord 20 mg/ml koncentrát pro infuzní roztok Etoposid Accord Etoposide Accord 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung Etoposide Accord 20 mg/ml Etoposide Accord 20 mg/ml Infuusiokonsentraatti, liuosta varten ETOPOSIDE Accord 20 mg/ml Koncentrátum oldatos infúzióhoz Etópósíð Accord 20 mg / ml innrennslisþykkni, lausn til innrennslis Etoposide Accord Etoposide Accord 20 mg/ml koncentrāts infūziju šķīduma pagatavošanai Etoposide Accord 20 mg/ml koncentratas infuziniam tirpalui

6 Malta The Netherlands Norway Portugal Poland Romania Slovenia Sweden Slovak Republic Spain United Kingdom Etoposide Accord 20 mg/ml, concentraat voor oplossing voor infusie Etoposide Accord Etoposido Accord Etopozyd Accord Etoposid Accord 20 mg/ml Concentrat pentru soluţie perfuzabilă Etoposide Accord 20 mg/ml koncentrat za raztopino za infundiranje Etopósido Accord 20 mg/ml concentrado para solución para perfusión The leaflet was last revised in 11/2014. The following information is intended for medical or healthcare professionals only Posology and method of administration By intravenous infusion. Adults The recommended dose of etoposide is mg/m 2 i.v. per day for 5 subsequent days. As etoposide causes myelosuppression, the course of treatment must not be repeated more often than in intervals of 10 to 20 days. For non-haematological indications courses may not be repeated more frequently than at 21 days intervals. Repeated courses of treatment with etoposide infusion must not be given before the blood picture has been controlled for signs of myelosuppression and found satisfactory. Overall, a dosage schedule of 100 mg/m 2 for 5 days or 120 mg/m 2 every other day on days 1, 3, and 5 is used frequently. The necessary dose of etoposide must be diluted either with a 5% glucose solution or a 0.9% sodium chloride solution, in order to achieve a final concentration of mg/ml of etoposide (i.e 1 ml or 2 ml concentrate in 100 ml of diluent to achieve concentration of 0.2 mg/ml and 0.4 mg/ml respectively). This solution is administered as an intravenous solution over a period of not less than 30 minutes and not more than 2 hours. Duration of use The duration of therapy is set by the doctor, taking into account the underlying disease, the combination therapy being administered (if relevant), and the individual therapeutic circumstances. Etoposide should be discontinued if the tumour does not respond to treatment and/or progresses or if intolerable undesirable effects occur. Paravenous injection must be carefully avoided. Elderly patients The dosage does not need to be adjusted. Patients with impaired renal function The dosage needs to be adjusted according to creatinine clearance. Etoposide must not be mixed with other drugs when administered. It must not be mixed with other product except than those listed above. Instruction for Use/Handling Etoposide Injection should be handled in accordance with instruction for cytotoxic agents. If solution showing sign of precipitation or contains visible particles, it should be discarded. Etoposide Injection must be diluted prior to use with Sodium chloride injection (0.9%w/v) or glucose injection (5%w/v) to concentrate of 0.2 mg/ml to 0.4 mg/ml. The concentration of diluted product should not exceed 0.4 mg/ml because of risk of precipitation. Discard any unused contents. Infusion fluids containing Etoposide should be used immediately. For waste-disposal and safety information guidelines on safe-handling of antineoplastic drugs should be followed.

7 Any contact with the fluid should be avoided. During preparation and reconstitution a strictly aseptic working technique should be used; protective measures should include the use of gloves, mask, safety goggles and protective clothing. Use of a vertical laminar airflow (LAF) hood is recommended. Gloves should be worn during administration. Waste-disposal procedures should take into account the cytotoxic nature of this substance. Pregnant personnel are advised not to handle chemotherapeutic agents. If etoposide contacts skin, mucosae or eyes, immediately wash thoroughly with water. Soap may be used for skin cleansing. Any unused product or waste material should be disposed of in accordance with local requirements. Shelf life after dilution: Chemical and physical in-use stability of the solution diluted to a concentration of 0.2 mg/ml and 0.4 mg/ml has been demonstrated in sodium chloride injection (0.9 % w/v) and glucose injection (5% w/v) for up to 96 hours and 48 hours at temperature C respectively. 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. Do not store the diluted product in a refrigerator (2-8 C) as this might cause precipitation. Storage Keep the vial in the outer carton in order to protect from light. Do not refrigerate or freeze.