Etoposide 20 Mg/Ml Concentrate For Solution For Infusion
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(Travesh Sharma) D:\Europe\Etoposide\Ireland+UK\Etoposide - Pack Insert - Ireland+UK.indd Size: 350 x 280 mm
Package leaflet: Information for the user
Etoposide 20 mg/ml concentrate for solution for infusion
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.
What is in this leaflet:
1. What etoposide is and what it is used for
2. What you need to know before you are given etoposide
3. How etoposide will be given
4. Possible side effects
5. How to store etoposide
6. Contents of the pack and other information
1. What etoposide is and what it is used for
The name of your medicine is ‘Etoposide 20 mg/ml concentrate for solution for infusion’ but in the rest of the leaflet it will be called ‘etoposide’. It contains the active ingredient etoposide. Etoposide belongs to a type of drugs known as podophyllotoxin derivatives.
Etoposide is used in adults in the treatment of small cell lung cancer, testicular cancer and cancer of the blood-forming tissues of bone marrow (acute myelomonocytic and monoblastic leukaemia). It is often used at the same time as other anti-cancer medicines.
Etoposide works by interfering with the production of new DNA, which is needed to make more cells. Therefore, when etoposide is taken up by the cancer cells, it stops the growth of new cancer cells.
2. What you need to know before you are given etoposide Do not take etoposide
- 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 is not producing 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 nurse before using etoposide.
- if you are suffering from infection.
- if your bone marrow is in low state (myelosuppression).
- If you have problems with your liver
- If you have severe kidney problems
Tell your doctor about any other treatment you receive for your illness.
Other medicines and etoposide
Tell your doctor if you are taking or have recently taken any other
medicines.
- anti-coagulants such as warfarin which are used to thin the blood
- the immunosuppressant ciclosporine (often given after an organ transplant)
- other drugs used to treat other forms of cancers such as cisplatin.
- phenytoin (medicine used in the treatment of epilepsy) may reduce the effects of etoposide
- phenylbutazone, sodium salicylate and acetylsalicylic acid (medicines used to treat inflammation, mild to moderate pain, and fever )
Etoposide can also have effects on other medicines used to treat cancer. Your doctor will take these effects into account when deciding on your treatment.
Etoposide with food and drink
Etoposide is not affected by food or drink.
Pregnancy, breast-feeding and fertility Pregnancy
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.
Women of childbearing potential must avoid pregnancy and take effective contraceptive measures during treatment with etoposide and until at the earliest 6 months after the therapy with etoposide.
Breast-feeding
Etoposide is excreted into human breast milk. Women must not breast-feed during the treatment with etoposide.
Fertility
Men treated with etoposide 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.
Driving and using machines
Do not drive or use any tools or machines shortly after treatment with etoposide as it may make you feel very sleepy or you might not be able to see for a short time.
Etoposide contains ethanol, benzyl alcohol and polysorbate 80 Ethanol
This medicinal product contains 30.5 % v/v ethanol (alcohol), which is corresponds to 241.4 mg of ethanol per ml of concentrate i.e up to 1.2 g of ethanol per 5 ml vial, equivalent to 24.1 ml of beer,
10.1 ml of wine.
up to 2.4 g of ethanol per 10 ml vial, equivalent to 48.3'ml of beer,
20.1 ml of wine.
up to 6.0 g of ethanol per 25 ml vial, equivalent to 120.7 ml of beer, 50.3 ml of wine.
up to 12.1 g of ethanol per 50 ml vial, equivalent to 214.4 ml of beer, 100.6 ml of wine.
Harmful for those suffering from alcoholism.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Benzyl alcohol
This medicine contains 30 mg/ml of benzyl alcohol. Must not be given to premature babies or neonates. May cause toxic reactions and allergic reactions in infants and children up to 3 years old.
Polysorbate 80
Etoposide contains polysorbate 80. A life threatening syndrome, with liver and kidney failure, decline in respiratory function, fall in platelet count and swelled abdomen has been reported in premature infants when administered polysorbate 80 containing vitamin E injection.
3. How etoposide will be given
Etoposide will always be given to you by a healthcare professional experience in the use of chemotherapeutic agent. This medicine will be diluted with 9 mg/ml (0.9 %) sodium chloride or 50 mg/ml (5 %) dextrose and will be given to you as an infusion (a “drip”) into a vein.
The dose of etoposide will be individually determined by your doctor. The dose you are given depends on your size: it varies with your surface area. Technically, this is measured in square meters, and is worked out from your height and weight.
The recommended dose of etoposide is 60-120 mg/m2 daily for 5 days.
You will receive a treatment cycle consisting of one dose a day during 3 - 5 days, followed by a 10 - 20 days rest.
For non-haematological indications courses may not be repeated more frequently than at 21 day intervals.
The administration will take at least 30 to 60 minutes.
The duration of the treatment and the number of treatments is determined by the doctor and may vary for each patient. Etoposide may be given alone or in combination with other medicines.
Your condition will be closely monitored during treatment. This routinely involves blood tests and controls of your liver function. Your dose may be changed depending on your kidney function. Use in children and adolescents:
Safety and effectiveness in children have not been established.
If you take more etoposide than you should
As a doctor or nurse will be giving you your medicine, 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 medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body), and feeling you are going to faint (these may be signs of severe allergic reactions or an anaphylactic shock) should be reported to a doctor immediately. Very common (may affect more than 1 in 10 people)
• Bone marrow is not producing enough cells (myelosuppression); Leading to low white blood cells (leucopenia) /or platelets (thrombocytopenia) or Low counts of red blood cells (anaemia). This usually resolves 3 weeks after the last dose.
• Feeling like vomiting (nausea) and vomiting
• Loss of appetite (anorexia)
• Abdominal pain
• Constipation
• Hair loss resulting in total baldness (alopecia, grows back after end of therapy)
• Liver damage (problems with your liver including increase in liver blood test values (bilirubin. SGOT and alkaline phosphatase)
• Pigmentation (discoloration of the skin and mucous membrane)
• Feeling of weakness (Asthenia)
• Generally feeling unwell
Common (may affect up to 1 in 10 people)
• Acute leukaemia (cancer of blood)
• Inflammation of the lining of stomach and the gullet (oesophagus) (stomatitis and esophagitis)
• Diarrhoea
• Heart attacks and rhythm disturbances (myocardial infarction, arrhythmia)
• Serious allergic reaction which causes difficulty in breathing or dizziness
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The following information is intended for healthcare professionals only:
Cytotoxic agent
Instructions on how to dilute, store and dispose of etoposide
Dilution
Etoposide 20 mg/ml concentrate for solution for infusion must be diluted immediately prior to use with either 50 mg/ ml (5%) dextrose in water, or 9 mg/ ml (0.9%) sodium chloride solution to give a final concentration of 0.2 mg/ml to 0.4 mg/ml.
At higher concentrations precipitation of etoposide may occur.
Etoposide is administered by slow intravenous infusion. Etoposide SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION.
Storage of the prepared solution
After dilution Chemical and physical inuse stability of the solution diluted to a concentration of 0.2 mg/ml or 0.4 mg/ml has been demonstrated up to 24 hours at 15°C to 25°C. From a microbiological point of view, the diluted product should be used immediately. If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at 15°C to 25°C, unless dilution has taken place in controlled and validated aseptic conditions.
Handling and disposal
The normal procedures for proper handling and disposal of anti-cancer medicinal products should be adopted:
• Staff should be trained to reconstitute the medicinal product.
• Pregnant staff should | be excluded from working with this medicinal product.
• Staff handling this medicinal product during dilution should wear protective clothing including mask, goggles and gloves.
• All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
• Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Disposal
Any unused product or waste material should be disposed of in accordance with local requirements.
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(Travesh Sharma) D:\Europe\Etoposide\Ireland+UK\Etoposide - Pack Insert - Ireland+UK.indd Size: 350 x 280 mm
• Fatigue and drowsiness, dizziness
• Low blood pressure (hypotension) may occur if the infusion is administered too rapidly
• Rash and itching (urticarial, pruritus)
• Leakage of the infusion solution into the surrounding tissue with swelling, pain phlebitis
• Hypertension (high blood pressure)
Uncommon (may affect up to 1 in 100 people)
• Damage to nerves of the hand and feet (loss of sensation) Rare (may affect up to 1 in 1,000 people)
• Seizure
• Inflammation of an optic (vision) nerve (Optic neuritis)
• Temporary loss of vision (cortical blindness transient), neurotoxicities (such as excessive sleepiness (somnolence), tiredness
• Inflammation of lungs tissue
• Formation of scar tissue in the lungs
• Taste alteration (dysgeusia)
• Severe skin reactions due to an allergic reaction (Stevens-Johnson syndrome; toxic epidermal necrolysis), symptoms include fever, general ill feeling, itching of the skin, joint aches, multiple skin lesions or blisters, which may involve the face or lips.
• Inflammation of skin (Radiation recall dermatitis)
• Dysphagia (difficulty in swallowing)
Tumour lysis syndrome (sometimes fatal) has been reported when etoposide was used with other anticancer drugs.
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. For UK - You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard For Ireland - Reports may be made by following the links to the online reporting option accessible from the IMB homepage, or by completing the downloadable report form also accessible from the IMB website, which may be completed manually and submitted to the IMB via freepost, to the following address:
IMB Pharmacovigilance
Earlsfort Terrace
IRL-Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie(http://www.imb.ie)
e-mail: imbpharmacovigilance@imb.ie
By reporting side effects you can help provide more information on the safety of this medicine.
and would normally not be longer than 12 hours at 15°C to 25°C, unless dilution has taken place in controlled and validated aseptic conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What etoposide contains
- The active substance is Etoposide. Each 1 ml concentrate for solution for infusion contains 20 mg of etoposide.
Each 5 ml vial contains 100 mg of etoposide.
Each 10 ml vial contains 200 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: macrogol 300, polysorbate 80 (E433), benzyl alcohol (E1519), ethanol and anhydrous citric acid (E 330).
What etoposide looks like and contents of the pack
Etoposide is a clear, light yellow to pale yellow solution packaged in type-I, clear, moulded glass vials of 5 ml, 10 ml, 30 ml and 50 ml, closed with 20 mm bromobutyl rubber closure and sealed with 20 mm flip-off Aluminium overseals (Green, Blue, Red and Yellow respectively).
Pack sizes: Etoposide is available in packs containing 1 vial of 5 ml, 10 ml, 25 ml and 50 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon Hampshire, GU35 0NF United Kingdom
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Austria |
Etoposid Kabi 20 mg/ml Konzentrat zur Herstellung einer Infusionslosung |
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Belgium |
Etoposide Fresenius Kabi 20 mg/ml concentraat voor oplossing voor infusie |
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Czech |
Etoposide Kabi 20 mg/ml, koncentrat pro infuzm |
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Republic |
roztok |
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Denmark |
Etoposid Fresenius Kabi |
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Estonia |
Etoposide Kabi 20 mg/ml |
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Spain |
Etoposido Kabi 20mg/ml concentrado para solution para perfusion |
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Finland |
Etoposid Fresenius Kabi 20 mg/ml infuusiokonsentraatti, liuosta varten |
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France |
Etoposide Kabi 20 mg/ml solution a diluer pour perfusion |
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Hungary |
Etoposide Kabi 20 mg/ml koncentratum oldatos infuziohoz |
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Ireland |
Etoposide 20 mg/ml concentrate for solution for infusion |
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Italy |
Etoposide Kabi |
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Latvia |
Etoposide Kabi 20 mg/ml koncentrats infuziju sklduma pagatavosanai |
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Lithuania |
Etoposide Kabi 20 mg/ml koncentratas infuziniam tirpalui |
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Malta |
Etoposide 20 mg/ml concentrate for solution for infusion |
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The |
Etoposide Fresenius Kabi 20 mg/ml concentraat |
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Netherlands |
voor oplossing voor infusie |
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Norway |
Etoposid Fresenius Kabi |
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Poland |
Etoposide Kabi |
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Portugal |
Etoposido Kabi |
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Romania |
Etopozida Kabi 20 mg/ml concentrat pentru solutie perfuzabila |
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Sweden |
Etoposid Fresenius Kabi 20 mg/ ml koncentrat till infusionsvatska, losning |
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Slovenia |
Etopozid Kabi 20 mg/ml koncentrat za raztopino za infundiranje |
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Slovak Republic |
Etoposide Kabi 20 mg/ml, infuzny koncentrat |
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United |
Etoposide 20 mg/ml concentrate for solution for |
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Kingdom |
infusion |
This leaflet was last revised in 03/2014
5. How to store etoposide
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 vial and carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. Do not freeze. Store in the original package, in order to protect from light.
Do not store the diluted product in a refrigerator (2°C to 8°C) as this might cause precipitation. Solutions showing any sign of precipitation should not be used.
After dilution
Chemical and physical in-use stability of the solution diluted to a concentration of 0.2 mg/ml or 0.4 mg/ml has been demonstrated up to 24 hours at 15°C to 25°C.
From a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user
Black Times New Roman 9 pts. Ver. 02 19 March 2014 9:31 AM