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Docetaxel Teva 20 mg concentrate and solvent for solution fo
2014-01-16 00:28:45 来源: 作者: 【 】 浏览:421次 评论:0

For doctors

 

What is it and how is it used?

The name of this medicine is Docetaxel Teva. Docetaxel is a substance derived from the needles of yew trees.
Docetaxel belongs to the group of anti-cancer medicines called taxoids.

Docetaxel Teva has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer:

What do you have to consider before using it?

You must NOT be given Docetaxel Teva if

Take special care with Docetaxel Teva

Before each treatment with Docetaxel Teva, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Teva. In case of white blood cell disturbances, you may experience associated fever or infections.

You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Teva administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of Docetaxel Teva in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).

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

Taking other medicines

Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because Docetaxel Teva or other medicines may not work as well as expected and you may be more likely to get a side effect.

Pregnancy

Ask your doctor for advice before being given any medicine.
Docetaxel Teva must NOT be administered if you are pregnant unless clearly indicated by your doctor.

You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy because Docetaxel Teva may be harmful for the unborn baby. If pregnancy occurs during your treatment, you must immediately inform your doctor.

If you are a man being treated with Docetaxel Teva you are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because docetaxel may alter male fertility.

Breast-feeding

You must not breast-feed while you are treated with Docetaxel Teva.

Driving and using machines

There is no reason why you cannot drive between courses of Docetaxel Teva except if you feel dizzy or are unsure of yourself.

How is it used?

Docetaxel Teva will be administered to you by a healthcare professional.

Usual dose

The dose will depend on your weight and your general condition. Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive.

Method and route of administration

Docetaxel Teva will be given by infusion into one of your veins (intravenous use). The infusion will last approximately one hour during which you will be in the hospital.

Frequency of administration

You should usually receive your infusion once every 3 weeks.

Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Teva. In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give her/him results of your blood tests. Such information will allow her/him to decide whether a dose reduction is needed. If you have any further questions on the use of this medicine, ask your doctor or hospital pharmacist.

What are possible side effects?

Like all medicines, Docetaxel Teva can cause side effects, although not everybody gets them.

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

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10); common (affects 1 to 10 users in 100); uncommon (affects 1 to 10 users in 1,000); rare (affects 1 to 10 users in 10,000); very rare (affects less than 1 user in 10,000); not known (frequency cannot be estimated from the available data).

The most commonly reported adverse reactions of Docetaxel Teva alone are: decrease in the number of red blood cells or white blood cells, hair loss, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.

The severity of adverse events of Docetaxel Teva may be increased when Docetaxel Teva is given in combination with other chemotherapeutic agents.

During the infusion at the hospital the following allergic reactions (experienced in more than 1 person in 10) may occur:

The hospital staff will monitor your condition closely during treatment. Tell them immediately if you notice any of these effects.

Between infusions of Docetaxel Teva the following may occur, and the frequency may vary with the combinations of medicines that are received:

Very common (experienced in more than 1 in 10 patients)

Common (experienced in less than 1 in 10 but more than 1 in 100 patients)

Uncommon (experienced in more than 1 in 1,000 but less than 1 in 100 patients)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or hospital pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Docetaxel Teva should not be used after the expiry date which is stated on the carton and vials.

Do not store above 25°C.
Do not freeze.

Store in the original package in order to protect from light.

The premix solution should be used immediately after preparation. However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).

The infusion solution should be used within 4 hours at room temperature (below 25°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.

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For doctors

What is it?

Docetaxel Teva is a concentrate and solvent to be made up into a solution for infusion (drip into a vein). It contains the active substance docetaxel.

Docetaxel Teva is a ‘generic medicine’. This means that Docetaxel Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Taxotere. For more information on generic medicines, see the question-and-answer document here.

What is it used for?

Docetaxel Teva is an anticancer medicine. It is used in the following types of cancer:

breast cancer. Docetaxel Teva can be used on its own after other treatments have failed. It can also be used with other anticancer medicines doxorubicin, cyclophosphamide, trastuzumab or capecitabine in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated

non-small cell lung cancer. Docetaxel Teva can be used on its own after other treatments have failed. It can also be used with cisplatin another anticancer medicine in patients who have not yet received any treatment for their cancer

prostate cancer, when the cancer does not respond to hormonal treatment. Docetaxel Teva is used with prednisone or prednisolone anti-inflammatory medicines

gastric adenocarcinoma a type of stomach cancer in patients who have not yet received any treatment for their cancer. Docetaxel Teva is used with cisplatin and 5-fluorouracil other anticancer medicines

head and neck cancer in patients whose cancer is advanced has started to spread. Docetaxel Teva is used with cisplatin and 5-fluorouracil.

See the Summary of Product Characteristics, also part of the EPAR, for full details.

The medicine can only be obtained with a prescription.

How is it used?

Docetaxel Teva should be used in specialised chemotherapy wards and it should only be given under the supervision of a doctor who is qualified in the use of anticancer chemotherapy.

Docetaxel Teva is given as a one-hour infusion every three weeks. The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated. Docetaxel Teva is only used when the neutrophil count (the level of a type of white blood cell) is normal (at least 1,500 cells/mm .) Dexamethasone (an anti-inflammatory medicine) should also be given to the patient, starting on the day before the Docetaxel Teva infusion. For more information, see the Summary of Product Characteristics.

How does it work?

The active substance in Docetaxel Teva, docetaxel, belongs to the group of anticancer medicines known as the taxanes. Docetaxel blocks the ability of cells to destroy the internal ‘skeleton’ that allows them to divide and multiply. With the skeleton still in place, the cells cannot divide and they eventually die. Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.

How has it been studied?

Because Docetaxel Teva is a generic medicine, the company has provided data from the published literature on docetaxel. No additional studies were needed as Docetaxel Teva is given by infusion and contains the same active substance as the reference medicine, Taxotere. In addition, the company presented studies to show that the Docetaxel Teva solution for infusion has comparable quality to that of Taxotere.

What benefits has it shown during the studies?

Because Docetaxel Teva is a generic medicine, its benefit and risk are taken as being the same as the reference medicine.

What is the risk associated?

Because Docetaxel Teva is a generic medicine, its benefit and risk are taken as being the same as the reference medicine.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Docetaxel Teva has been shown to have comparable quality to Taxotere. Therefore, the CHMP’s view was that, as for Taxotere, the benefit outweighs the identified risk. The Committee recommended that Docetaxel Teva be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Teva to Teva Pharma B.V. on 26 January 2010. The marketing authorisation is valid for five years, after which it can be renewed.

For more information about treatment with Docetaxel Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 02-2011.

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Name

 

Docetaxel Teva 20 mg concentrate and solvent for solution for
infusion

 

Composition

 

Each single-dose vial of Docetaxel Teva concentrate contains 20 mg docetaxel (anhydrous). Each ml of concentrate contains 27.73 mg docetaxel.

Excipients:
Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol.

For a full list of excipients, see section 6.1.

 

Pharmaceutical Form

 

Concentrate and solvent for solution for infusion.
The concentrate is a clear viscous, yellow to brown-yellow solution.
The solvent is a colourless solution.

 

Are you an Healthcare Professional? Access professional drug leaflets on Diagnosia.com!

 

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