10 mg / mL concentrate for infusion solution 
docetaxel

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, pharmacist, or nurse.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Docetaxel Ebewe is and what it is used for 
2. What you need to know before you use Docetaxel Ebewe 
3. How to use Docetaxel Ebewe 
4. Possible side effects 
5. How to store Docetaxel Ebewe 6. Contents of the pack 
and other information 

What Docetaxel Ebewe is and what it is used for

The name of this medicine is Docetaxel Ebewe. The name of the active substance is docetaxel.

Docetaxel is a substance that originates in the needles of the yew tree. Docetaxel belongs to a group of anti-cancer medicines called taxoids.

Your doctor has prescribed Docetaxel Ebewe for the treatment of breast cancer, a special form of lung cancer (non-small cell lung cancer ), prostate cancer, stomach cancer, or head and neck cancer.

  • For the treatment of advanced breast cancer, Docetaxel Ebewe can be given either alone or in combination with doxorubicin or trastuzumab, or capecitabine.
  • For the treatment of early breast cancer with or without lymph node involvement, Docetaxel Ebewe can be given in combination with doxorubicin and cyclophosphamide.
  • For the treatment of lung cancer, Docetaxel Ebewe can be given either alone or in combination with cisplatin.
  • For the treatment of prostate cancer, Docetaxel Ebewe is given in combination with prednisone or prednisolone.
  • For the treatment of metastatic gastric cancer, Docetaxel Ebewe is given in combination with cisplatin and 5-fluorouracil.
  • For the treatment of head and neck cancer, Docetaxel Ebewe is given in combination with cisplatin and 5-fluorouracil.

Docetaxel contained in Docetaxel 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 using Docetaxel Ebewe

You must not be given Docetaxel Ebewe if you 

  • is allergic to docetaxel or any of the other ingredients of this medicine (listed in section 6)
  • have too few white blood cells
  • have severe liver disease

Warnings and cautions

Before each treatment with Docetaxel Ebewe, blood samples will be taken from you to check that you have enough blood cells and good liver function to get Docetaxel Ebewe. When the level of white blood cells is disturbed, you can get a fever or infection.

Talk to a doctor, pharmacist, or nurse immediately if you experience abdominal pain or soreness, diarrhea, rectal bleeding, blood in the stool, or fever. These symptoms can be the first signs of a serious injury to the stomach and intestines, which can be fatal. Your doctor should treat these symptoms immediately.

Tell your doctor, pharmacist, or nurse if you have vision problems. If you have vision problems, especially blurred vision, you should have your eyes and eyesight examined immediately.

Tell your doctor, pharmacist, or nurse if you have experienced an allergic reaction during previous paclitaxel treatment.

Talk to your doctor, pharmacist, or nurse if you have heart problems.

If you develop acute or worsening lung symptoms (fever, shortness of breath, or cough), tell your doctor, pharmacist, or nurse, immediately. Your doctor may stop treatment immediately.

You will be prescribed pre-medication with an oral corticosteroid (taken by mouth) such as dexamethasone the day before treatment with Docetaxel Ebewe. You will be given the cortisone tablets for another one to two days after starting Docetaxel Ebewe treatment. This minimizes certain side effects that may occur after infusion of Docetaxel Ebewe, especially allergic reactions and fluid retention (swelling of the hands, feet, or legs or weight gain).

During treatment, you may be given other medicines to maintain the number of blood cells.

Docetaxel Ebewe contains alcohol. Talk to your doctor if you suffer from alcoholism, epilepsy, or hepatic impairment. See also section “Docetaxel Ebewe contains ethanol(alcohol)” below.

Other medicines and Docetaxel Ebewe

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, as Docetaxel Ebewe or the other medicine may not work as well as expected and you may be more likely to get a side effect.

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

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.

Docetaxel Ebewe should NOT be given during pregnancy unless your doctor clearly prescribes it.

You must not become pregnant during treatment with this medicine and must use reliable contraception during treatment, as docetaxel may be harmful to the fetus. If you become pregnant during Docetaxel Ebewe’s treatment, you must inform your doctor immediately.

You must NOT breast-feed during treatment with Docetaxel Ebewe.

If you are a man and being treated with Docetaxel Ebewe, you should not have children for and up to 6 months after treatment. You are advised to seek advice on sperm preservation before treatment, as docetaxel may affect male fertility.

Driving and using machines

The amount of alcohol in this medicine may impair your ability to drive or use machines. This medicine may give you side effects that may affect your ability to drive and use machines (see section 4 Possible side effects ). If this happens, do not drive or use machines until you have discussed this with your doctor, pharmacist, or nurse.

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.

Docetaxel Ebewe contains ethanol (alcohol)

Vial of 2 ml:

This medicine contains 34% by volume of ethanol (alcohol), ie up to 551.8 mg per 20 mg of the medicinal product, equivalent to 13.8 ml of beer or 5.7 ml of wine per 20 mg.

Vial of 8 ml:

This medicine contains 34% by volume of ethanol (alcohol), ie up to 2,207.2 mg per 80 mg of the medicinal product, equivalent to 55.2 ml of beer or 23 ml of wine per 80 mg.

Vial of 16 ml:

This medicine contains 34% by volume of ethanol (alcohol), ie up to 4,414.4 mg per 160 mg of the medicinal product, equivalent to 110.4 ml of beer or 46 ml of wine per 160 mg.

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.

The amount of alcohol in this medicine can affect the central nervous system (the part of the nervous system that includes the brain and spinal cord).

3. How to use Docetaxel Ebewe

Docetaxel Ebewe will be given to you by healthcare professionals.

Usual dose

Dose one will depend on your weight and your general condition. Your doctor will calculate your body surface area in square meters (m 2 ) and determine the dose you should receive.

Method of administration and route of administration

Docetaxel Ebewe will be given as an infusion into one of your veins ( intravenous infusion ). Infusion one will last for about an hour and is given in the hospital.

Administration interval

Usually receive Ebewe- infusion, a one time every three weeks.

Your doctor may change the dose and dosing interval depending on how your blood tests are, how you feel and how you react to Docetaxel Ebewe treatment.

Inform your doctor especially if you get diarrhea, mouth sores, numbness or tingling, fever and give her/him your blood test results. Such information helps him/her to decide if a dose needs to be reduced.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Your doctor will discuss these with you and explain the potential risks and benefits of the treatment to you.

The most commonly reported side effects of docetaxel, when used alone, are reduction in red or white blood cell count, hair loss, nausea, vomiting, mouth ulcers, diarrhea, and fatigue.

If you receive Docetaxel Ebewe in combination with other cytostatic agents, the severity of side effects may increase.

During ongoing hospital treatment, the following allergic reactions may occur (may affect more than 1 user in 10):

  • reddening of the skin, skin reactions, itching
  • the feeling of heaviness over the chest, difficulty breathing
  • fever or chills
  • back pain
  • low blood pressure.

More severe reactions may occur.

If you have had an allergic reaction to paclitaxel, you may also experience an allergic reaction to docetaxel, which may be more severe.

The hospital staff will monitor your general condition closely during the treatment. Notify staff IMMEDIATELY if you notice any of these reactions.

Between infusions of Docetaxel Ebewe, the following may occur and the frequency may vary between given combinations of drugs:

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

  • infection, reduction in red blood cell count ( anemia ) or white blood cell count(which are important in fighting infections ) and platelets
  • fever: if you get a fever, contact your doctor immediately
  • allergic reactions described above
  • loss of appetite
  • insomnia
  • numbness or tingling or pain in joints and muscles
  • headache
  • taste change
  • inflammation of the eye or increased tear flow
  • swelling caused by deficient lymphatic drainage
  • shortness of breath
  • Suva; inflammation of the throat and nose; cough
  • nosebleeds
  • sores in the mouth
  • upset stomach including nausea, vomiting, and diarrhea, constipation
  • abdominal pain
  • indigestion
  • temporary hair loss (normal hair growth returns in most cases after treatment), permanent hair loss (has been reported, but the frequency is unknown)
  • redness and swelling of the palms and soles of the feet, which may cause skin flaking (this can also occur on the arms, face, or body)
  • change in the color of your nails and any subsequent nail detachment
  • muscle pain or aches; back pain or skeletal pain
  • menstrual disorders or missed periods
  • swelling of hands, feet, legs
  • fatigue; or flu-like symptoms
  • weight gain or weight loss

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

  • fungal infection in the mouth
  • dehydration
  • dizziness
  • impaired hearing
  • lowered blood pressure; irregular or increased heart rate
  • heart failure
  • inflammation of the esophagus
  • dry mouth
  • difficulty swallowing or swallowing pain
  • bleeding
  • elevated liver enzyme levels (hence the need for regular blood tests).

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

  • fainting
  • puncture site reactions, skin reactions, venous inflammation, or swelling
  • blood clots

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

  • inflammation of the colon, small intestine which can be fatal (has been reported); perforation of the intestine

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

  • interstitial lung disease ( inflammation of the lungs that causes coughing and shortness of breath. Pneumonia can also develop if docetaxel treatment is used with radiation therapy) 
  • pneumonia ( infection of the lungs)
  • pulmonary fibrosis (scarring and thickening of the lungs with shortness of breath)
  • blurred vision due to swelling of the retina of the eye (cystoid macular edema)
  • decreased levels of sodium, potassium, magnesium, and/or calcium in the blood (disturbances in the salt balance)
  • ventricular arrhythmia or ventricular tachycardia (manifests as irregular and/or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting). Some of these symptoms can be severe. If this happens, tell your doctor immediately
  • reactions at the injection site, at the site of the previous reaction.

5. How to store Docetaxel 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 label and carton after EXP. or EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Do not freeze.

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

Storage instructions after first opening:

Use within 28 days. Do not store above 25 ° C.

Storage instructions after dilution:

The reconstituted solution for infusion should be used within four hours, including the infusion time of one hour. Chemical and physical in-use stability has been demonstrated at room temperature (maximum 25 ºC) or in a refrigerator (2–8 ºC).

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 docetaxel. One ml of concentrate for solution for infusion contains 10 mg docetaxel.

The other ingredients are citric acid, anhydrous, macrogol 300, polysorbate 80, ethanol 96%.

What the medicine looks like and the contents of the pack

Docetaxel Ebewe 10 mg/ml concentrate for solution for infusion is a clear, colorless to pale yellow solution; pH 3.0–4.5, without visible particles.

Docetaxel Ebewe is supplied in single packs containing 1 vial (20 mg / 2 ml, 80 mg / 8 ml, 160 mg / 16 ml).

Docetaxel Ebewe is also available in multi-pack containing 5 or 10 vials (20 mg / 2 ml, 80 mg / 8 ml, 160 mg / 16 ml).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder and Manufacturer

EBEWE Pharma Ges.mbH Nfg. KG, 4866 Unterach, Austria

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark 

Muhammad Nadeem

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