20 mg / mL concentrate for infusion solution 
etoposide

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, nurse, or pharmacist.
  • If you get any side effects, talk to your doctor, nurse, or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Etoposid Ebewe is and what it is used for 
2. What you need to know before you are given Etoposid Ebewe 
3. How Etoposid Ebewe will be given to you 
4. Possible side effects 
5. How Etoposid Ebewe should be stored 
6. Contents of the packaging and other information 

What Etoposid Ebewe is and what it is used for

The name of this medicine is Etoposid Ebewe. Each vial contains etoposide.

Etoposide belongs to a group of medicines called chemotherapy drugs that are used to treat cancer.

Etoposide Ebewe is used to treat certain types of cancer in adults:

  • testicular cancer
  • small cell lung cancer
  • cancer of the blood ( acute myeloid leukemia )
  • the tumor is in the lymphatic system ( Hodgkin’s lymphoma, non-Hodgkin’s lymphoma )
  • genital cancer (gestational trophoblast neoplasia and ovarian cancer)

Etoposide Ebewe is used to treat certain types of cancer in children:

  • cancer of the blood ( acute myeloid leukemia )
  • the tumor is in the lymphatic system ( Hodgkin’s lymphoma, non-Hodgkin’s lymphoma )

The exact reason why you are prescribed Etoposid Ebewe is best discussed with your doctor.

Etoposide, found in Etoposid Ebewe, may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you receive Etoposid Ebewe

Do not use Etoposid Ebewe

  • if you are allergic to etoposide or any of the other ingredients of this medicine (listed in section 6)
  • if you have recently been vaccinated with a live vaccine, including the yellow fever vaccine
  • if you are breast-feeding or planning to breast-feed.

If any of the above apply to you, or you are not sure if it applies to you, talk to your doctor.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before receiving Etoposid Ebewe:

  • if you have any infection you.
  • if you have recently received radiation therapy or chemotherapy.
  • if you have low levels of a protein called albumin in your blood.
  • if you have liver or kidney problems.

Effective cancer treatment can quickly destroy cancer cells on a large scale. In very rare cases, this can cause harmful amounts of substances from these cancer cells to be released into the bloodstream. If this happens, it can cause problems with the liver, kidneys, heart, or blood and lead to death if left untreated.

To prevent this, your doctor will need to take regular blood tests to monitor the level of these substances during treatment with this medicine.

This medicine can cause a decrease in certain blood cells, which can lead to you getting an infection, or it can mean that your blood does not coagulate as well if you cut yourself. Blood samples will be taken at the beginning of your treatment and before each dose you receive to check that this is not happening.

If you have impaired liver or kidney function, your doctor may also want to take regular blood tests to monitor your liver and kidney function.

Other medicines and Etoposid Ebewe

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

This is especially important

  • if you are taking ciclosporin (a medicine used to reduce the activity of the immune system).
  • if you are being treated with cisplatin (a medicine used to treat cancer).
  • if you are taking phenytoin or other medicines used to treat epilepsy.
  • if you are taking warfarin (a medicine that prevents blood clots from forming).
  • if you have recently been vaccinated with any live vaccines.
  • if you are taking phenylbutazone, sodium salicylate, or acetylsalicylic acid.
  • if you are taking any anthracyclines (a group of medicines used to treat cancer).
  • if you are taking any medicines that have a similar mechanism of action to Etoposid Ebewe.

Pregnancy, breastfeeding, 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.

Etoposide Ebewe should not be used during pregnancy unless clearly necessary by your doctor.

You must not breast-feed while you are being treated with Etoposid Ebewe.

Both male and female patients who may become pregnant must use an effective contraceptive (eg a barrier method or condom) during treatment and up to 6 months after stopping treatment with Etoposid Ebewe.

Men treated with Etoposid Ebewe are advised not to make a woman pregnant during treatment and for up to 6 months after treatment. Men are also advised to seek advice on the possibility of preserving semen before treatment.

Both male and female patients who are considering having children after treatment with Etoposid Ebewe should discuss this with their doctor or nurse.

Driving and using machines

The effect on the ability to drive and use machines has not been studied. If you feel tired, unwell, dizzy, or faint, do not drive or use machines until you have discussed this with your doctor.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

This medicine contains 33% by volume of ethanol (alcohol), ie up to 2345 mg per 180 mg (average dose ), equivalent to 37 ml of beer or 15 ml of wine per average dose.

Harmful to people suffering from alcoholism.

Attention should be paid to pregnant or lactating women, children, and high-risk groups such as patients with liver disease or epilepsy.

The amount of alcohol in this medicine may affect the effectiveness of other medicines.

The amount of alcohol in this medicine may impair your ability to drive or use machines.

This medicine contains 20 mg of benzyl alcohol per ml, equivalent to 180 mg per 9 ml (average dose ).

Benzyl alcohol can cause allergic reactions.

Benzyl alcohol is associated with the risk of serious side effects such as gasping syndrome in young children.

Do not give this medicine to newborns (up to 4 weeks of age) unless your doctor tells you to.

Do not use this medicine for more than 1 week in newborns (younger than 3 years) unless your doctor or pharmacist has recommended it.

If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).

If you have liver or kidney problems, talk to your doctor or pharmacist before using this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).

How Etoposid Ebewe will be given to you

Etoposide Ebewe will be given to you by a doctor or nurse. It will be given as a slow infusion into a vein. This can take between 30 to 60 minutes.

The dose you receive will be tailored to you and calculated by your doctor. The usual dose, based on etoposide, is 50 to 100 mg / m  body surface area daily for 5 consecutive days or 100 to 120 mg / m  body surface area on days 1, 3, and 5. This treatment regimen can then be repeated depending on the results of blood tests, but this will not happen until at least 21 days after the first course of treatment.

For children treated for cancer of the blood or lymphatic system, a dose of 75 to 150 mg / m  body surface area is used daily for 2 to 5 days.

Your doctor may sometimes prescribe a different dose, especially if you are, or have been, receiving other treatment for your cancer or if you have kidney problems.

If you take more Etoposid Ebewe then you should

Because Etoposid Ebewe is given to you by a doctor or nurse, an overdose is unlikely. Should this still occur, your doctor will treat all subsequent symptoms.

If you have any further questions on the use of this product, ask your doctor, 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 get any of the following symptoms: swollen tongue or throat, difficulty breathing, rapid heartbeat, reddening of the skin, or rash. These may be signs of a severe allergic reaction.

Severe liver, kidney, or heart damage from a condition called tumor lysis syndrome, which is caused by harmful substances from the cancer cells entering the bloodstream, has sometimes been seen when Etoposid Ebewe is taken with other medicines to treat cancer.

Possible side effect s that can be experienced with Etoposide Ebewe is:

A very common side effect is (can occur in more than 1 in 10)

  • Blood pressure (this is why you will have to take blood samples between treatment courses)
  • Nausea and vomiting
  • Reduced appetite
  • Constipation
  • Temporary hair loss
  • Liver damage
  • Elevated liver enzymes
  • Jaundice (elevated bilirubin )
  • Change in skin color ( pigmentation )
  • Weakness ( asthenia )
  • General malaise
  • Abdominal pain

Common side effects are (may affect up to 1 in 10)

  • Acute leukemia
  • Diarrhea
  • Reactions at the infusion site
  • Irregular heartbeat ( arrhythmia ) or heart attack (heart attack)
  • Severe allergic reactions
  • Dizziness
  • Low blood pressure
  • High blood pressure
  • Sore lips, sores in the mouth or throat
  • Skin problems such as itching or rash
  • Inflammation in a friend
  • Infection

Less common side effects are (may affect up to 1 in 100)

  • Irritation or loss of sensation in hands and feet
  • Bleeding

Rare side effects are (may affect up to 1 in 1000 users)

  • Acid reflux
  • Redness
  • Severe allergic reactions
  • Seizures
  • Fever
  • Sleepiness or fatigue
  • Temporary blindness
  • Severe skin and/or mucous membrane reactions that may include painful blisters and fever, including widespread skin rash (Steven-Johnson syndrome and toxic epidermal necrolysis )
  • A rash that is reminiscent of a tan and that can occur on skin where you have previously received radiation treatment (“radiation recall” dermatitis ), can be serious
  • Difficulty swallowing
  • Taste changes
  • Respiratory problems

Has been reported (occurs in an unknown number of people)

  • Tumor light syndrome (complications of substances released from cancer cells entering the bloodstream)
  • Swelling of the face and tongue
  • Infertility
  • Breathing difficulties

5. How to store Etoposid Ebewe

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 carton and vial after EXP. dat. or EXP. The expiration date is the last day of the specified month.

Etoposid Ebewe is stored at the pharmacy and prepared in a special room before your doctor or nurse gives it to you.

Do not store above 25 ° C. Store in the original package.

Shelf life for dilute solution: 24 hours at 2-8 ° C.

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 packaging and other information

Content declaration

  • The active substance is etoposide.
  • The other ingredients are benzyl alcohol, 96% ethanol , anhydrous citric acid, macrogol 300, polysorbate 80.

What the medicine looks like and the contents of the pack

Etoposide Ebewe is a clear, bright yellow solution.

Pack sizes:

Individual pack containing 1 vial of 50 mg / 2.5 ml, 100 mg / 5 ml, 200 mg / 10 ml, 400 mg / 20 ml or 1,000 mg / 50 ml.

Multiple pack containing 5 or 10 vials of 50 mg / 2.5 ml, 100 mg / 5 ml, 200 mg / 10 ml, 400 mg / 20 ml or 1,000 mg / 50 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Ebewe Pharma Ges.mbH Nfg. KG

Mondseestrasse 11

A-4866 Unterach

Austria

Contact the representative of the marketing authorization holder to find out more about this medicine:

Sandoz A / S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Muhammad Nadeem

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