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 information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Etoposide Accord is and what it is used for 
2. What you need to know before you get Etoposide Accord 
3. How to get Etoposide Accord 
4. Possible side effects 
5. How to store Etoposide Accord 
6. Contents of the packaging and other information 

1. What the Etoposide Accord is and what it is used for

This medicine contains the active substance etoposide. Etoposide belongs to a group of medicines called chemotherapy drugs that are used to treat cancer.

Etoposide Accord 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 Accord 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 were prescribed Etoposide Accord is best discussed with your doctor.

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

2. What you need to know before you get Etoposide Accord

Do not take the Etoposide Accord

  • 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 applies to you, or you are not sure if it applies to you, consult your doctor.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before receiving the Etoposide Accord:

  • if you have low levels of a protein called albumin in your blood.
  • if you have recently received radiation therapy or chemotherapy.
  • whether you have an infection is
  • 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 Etoposide Accord

Tell your doctor or pharmacist 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 Etoposide Accord.

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

You must not breast-feed while you are being treated with Etoposide Accord.

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 Etoposide Accord. Men treated with Etoposide Accord are advised not to make a woman pregnant during treatment and for up to 6 months after treatment. Men are also advised to obtain information about the possibility of preserving semen before treatment.

Both male and female patients who are considering having children after treatment with the Etoposide Accord should discuss this with a doctor or nurse.

The ability to drive and use 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.

Etoposide Accord contains alcohol, benzyl alcohol, and polysorbate 80

Etoposide Accord contains alcohol

This medicine contains 30.5% alcohol ( ethanol ), which corresponds to 240.64 mg ethanol per ml concentrate, ie. up to 1.2 g ethanol per 5 ml vial corresponding to 30 ml beer or 12.55 ml wine and up to 3 g ethanol per 12.5 ml vial corresponding to 75 ml beer or 31.4 ml wine. This is harmful to those suffering from alcoholism, brain damage, pregnant or breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy. The effect of other medicines may increase or decrease.

Etoposide Accord contains benzyl alcohol

Etoposide Accord contains 30 mg/ml benzyl alcohol.

Benzyl alcohol is associated with the risk of serious side effects such as difficulty breathing in young children. It should not be given to newborns (up to 4 weeks of age) or used for more than a week in young children (under 3 years of age) unless recommended by your doctor.

If you are pregnant or breast-feeding or have a liver or kidney disease, talk to your doctor or pharmacist before using this medicine. This is because large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).

Benzyl alcohol can cause allergic reactions.

Etoposide Accord contains polysorbate 80

Etoposide Accord contains 80 mg / ml polysorbate 80.

A life-threatening syndrome, with liver and kidney failure, decreased respiratory function, decreased platelet count and swelling of the abdomen has been reported in newborn infants when they received a vitamin E injection containing polysorbate 80.

3. How to get Etoposide Accord

Etoposide Accord 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 is 50 to 100 mg / m 2 body surface area, daily for 5 consecutive days or 100-120 mg / m 2 body surface area on days 1, 3, and 5. This course of treatment can then be repeated depending on the results of the blood tests, but this will not occur 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 2 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 Etoposide Accord then you should

As this medicine 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 Etoposide Accord is taken with other drugs to treat cancer.

Possible side effect s that can be experienced with Etoposide Accord;

Very common (may affect more than 1 user in 10) :

  • blood effects (this is why you will have to take blood samples between treatment courses)
  • nausea and vomiting
  • loss of appetite
  • abdominal pain
  • constipation
  • temporary hair loss
  • liver damage (hepatotoxicity)
  • elevated liver enzymes
  • skin discoloration ( pigmentation )
  • jaundice (elevated bilirubin )
  • the feeling of weakness ( asthenia )
  • general malaise.

Common (may affect up to 1 in 10 people):

  • acute leukemia (severe blood cancer)
  • irregular heartbeat ( arrhythmia ) or a heart attack (heart attack)
  • dizziness
  • high blood pressure
  • low blood pressure
  • sore lips, sores in the mouth or throat
  • reddening of the skin
  • infection
  • diarrhea
  • skin problems such as itching or rash
  • inflammation in a friend
  • severe allergic reactions
  • reactions at the infusion site.

Uncommon (may affect up to 1 in 100 people):

  • tingling or loss of sensation in the hands and feet
  • bleeding. 

Rare (may affect up to 1 in 1,000 people):

  • seizures
  • drowsiness or fatigue
  • change in how things taste
  • difficulty swallowing
  • 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 ), this can be serious
  • fever
  • temporary blindness
  • breathing problems
  • acid reflux
  • redness.

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

  • tumor lysis syndrome (complications of substances released by the cancer cells entering the bloodstream)
  • infertility
  • swelling of the face and tongue
  • breathing difficulties.

5. How to store Etoposide Accord

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. dat. The expiration date is the last day of the specified month.

Keep the vial in the outer carton. Sensitive to light.

Do not refrigerate or freeze.

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 in sodium chloride injections (0.9% w / v) and glucose injections (5% w / v) for up to 96 hours. and 48 hours at the temperature of 20 ° C and 25 ° C, respectively. For microbiological reasons, the product should be used immediately. If not used immediately, storage time and conditions before administration responsibility of the user. Do not store the diluted product in a refrigerator (2 ° C – 8 ° C) as this may cause precipitation.

Do not use Etoposide Accord if the solution shows signs 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 packaging and other information

Content declaration

Etoposide Accord contains the active substance etoposide.

1 ml contains 20 mg etoposide.

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 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 the medicine looks like and the contents of the pack

Etoposide Accord is a clear, colorless to light yellow solution for infusion.

Pack sizes:

1 × 5 ml vial

1 × 10 ml vial

1 × 12.5 ml vial

1 × 20 ml vial

1 × 25 ml vial

1 × 50 ml vial

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Manufacturer

Accord Healthcare Ltd.

Sage House

319 Pinner Road

North Harrow

Middlesex, HA1 4HF

UK

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Muhammad Nadeem

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