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Taxotere (docetaxel) – Package leaflet - L01CD02

Updated on site: 10-Oct-2017

Medication nameTaxotere
ATC CodeL01CD02
Substancedocetaxel
ManufacturerAventis Pharma S.A.

Package leaflet: Information for the patient

TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion docetaxel

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, hospital pharmacist or nurse.

-If you get any side effects talk to your doctor, hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What TAXOTERE is and what it is used for

2.What you need to know before you use TAXOTERE

3.How to use TAXOTERE

4.Possible side effects

5.How to store TAXOTERE

6.Contents of the pack and other information

1.What TAXOTERE is and what it is used for

The name of this medicine is TAXOTERE. Its common name is docetaxel. Docetaxel is a substance derived from the needles of yew trees.

Docetaxel belongs to the group of anti-cancer medicines called taxoids.

TAXOTERE 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:

-For the treatment of advanced breast cancer, TAXOTERE could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.

-For the treatment of early breast cancer with or without lymph node involvement, TAXOTERE could be administered in combination with doxorubicin and cyclophosphamide.

-For the treatment of lung cancer, TAXOTERE could be administered either alone or in combination with cisplatin.

-For the treatment of prostate cancer, TAXOTERE is administered in combination with prednisone or prednisolone.

-For the treatment of metastatic gastric cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.

-For the treatment of head and neck cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.

2. What you need to know before you use TAXOTERE

You must not be given TAXOTERE if

you are allergic (hypersensitive) to docetaxel or any of the other ingredients of TAXOTERE.

the number of white blood cells is too low.

you have a severe liver disease..

Warnings and precautions

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

Tell your doctor, hospital pharmacist or nurse if you have vision problems. In case of vision problems, in particular blurred vision, you should immediately have your eyes and vision examined.

If you develop acute or worsening problems with your lungs (fever, shortness of breath or cough), please tell your doctor, hospital pharmacist or nurse immediately. Your doctor may stop your treatment immediately.

You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to TAXOTERE 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 TAXOTERE 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.

TAXOTERE contains alcohol. Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment. See also section “ TAXOTERE contains ethanol (alcohol)” below.

Other medicines and TAXOTERE

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

Pregnancy, breast-feeding and fertility

Ask your doctor for advice before being given any medicine.

TAXOTERE 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 TAXOTERE may be harmful for the unborn baby. If pregnancy occurs during your treatment, you must immediately inform your doctor.

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

If you are a man being treated with TAXOTERE 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.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

TAXOTERE contains ethanol (alcohol)

This medicinal product contains 13% (w/w) ethanol 95% v/v (alcohol), i.e. up to 252 mg ethanol 95% v/v per solvent vial, equivalent to 6 ml of beer or 2.6 ml wine per vial.

Harmful for those suffering from alcoholism.

To be taken into account if you are pregnant or if you are breast-feeding women, in children and in high-risk groups such as patients with liver disease, or epilepsy.

The amount of alcohol in this medicinal product may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).

The amount of alcohol in this medicinal product may alter the effects of other medicines.

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

3.How to use TAXOTERE

TAXOTERE 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

TAXOTERE 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 TAXOTERE. 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.

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 will explain the potential risks and benefits of your treatment.

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

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

During the infusion at the hospital the following allergic reactions (may affect more than 1 in 10 people):

flushing, skin reactions, itching

chest tightness; difficulty in breathing

fever or chills

back pain

low blood pressure.

More severe reactions 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 TAXOTERE the following may occur, and the frequency may vary with the combinations of medicines that are received:

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

infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets

fever: if this happens you must tell your doctor immediately

allergic reactions as described above

loss of appetite (anorexia)

insomnia

feeling of numbness or pins and needles or pain in the joints or muscles

headache

alteration in sense of taste

inflammation of the eye or increased tearing of the eyes

swelling caused by faulty lymphatic drainage

shortness of breath

nasal drainage; inflammation of the throat and nose; cough

bleeding from the nose

sores in the mouth

stomach upsets including nausea, vomiting and diarrhoea, constipation

abdominal pain

indigestion

hair loss: in most cases normal hair growth should return. In some cases (frequency not known) permanent hair loss has been observed

redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body)

change in the color of your nails, which may detach

muscle aches and pains; back pain or bone pain

change or absence of menstrual period

swelling of the hands, feet, legs

tiredness; or flu-like symptoms

weight gain or loss.

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

oral candidiasis

dehydration

dizziness

hearing impaired

decrease in blood pressure; irregular or rapid heart beat

heart failure

oesophagitis

dry mouth

difficulty or painful swallowing

haemorrhage

raised liver enzymes (hence the need for regular blood tests).

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

fainting

at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling

inflammation of the colon, small intestine; intestinal perforation

blood clots.

Frequency unknown:

interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing. Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)

pneumonia (infection of the lungs)

pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)

blurred vision due to swelling of the retina within the eye (cystoid macular oedema)

decrease of the sodium, potassium, magnesium, and/or calcium in your blood (electrolyte balance disorders).

Reporting of side effects

If you get any side effects talk to your doctor, hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store TAXOTERE

Keep this medicine out of the sight and reach of children.

This medicine should not be used after the expiry date shown on the carton, blister pack and vials.

Do not store above 25°C or below 2°C.

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).

6. Contents of the pack and other information

What TAXOTERE concentrate vial contains

-The active substance is docetaxel (as trihydrate). Each ml of docetaxel solution contains 40 mg of docetaxel (anhydrous). One vial contains 20 mg/0.5 ml docetaxel.

-The other ingredients are polysorbate 80 and citric acid.

What solvent vial contains

13% (w/w) ethanol 95% (see section 2) in water for injections.

What TAXOTERE looks like and contents of the pack

TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion is a clear viscous, yellow to brown- yellow solution.

Each blister pack contains:

one single-dose vial of concentrate and,

one single-dose vial of solvent.

Marketing Authorisation Holder

Aventis Pharma S.A.

20 avenue Raymond Aron

92165 Antony Cedex France

Manufacturers

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

65926 Frankfurt am Main

Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

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This leaflet was last revised in .

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

The following information is intended for healthcare professionals only:

PREPARATION GUIDE FOR USE WITH TAXOTERE 20 mg/0.5 ml CONCENTRATE FOR SOLUTION FOR INFUSION AND SOLVENT FOR TAXOTERE

It is important that you read the entire contents of this guide prior to the preparation of either the TAXOTERE premix solution or the TAXOTERE infusion solution

1.FORMULATION

TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion is a clear viscous, yellow to brown- yellow solution containing 40 mg/ml docetaxel (anhydrous) in polysorbate 80 and citric acid. The solvent for TAXOTERE is a 13% w/w solution of ethanol 95% in water for injections.

2.PRESENTATION

TAXOTERE is supplied as single-dose vials.

Each box contains one TAXOTERE vial (20 mg/0.5 ml) and one corresponding solvent for TAXOTERE vial in a blister pack.

TAXOTERE vials should be stored between 2°C and 25°C and protected from light. TAXOTERE should not be used after the expiry date shown on the carton, blister pack and vials.

2.1TAXOTERE 20 mg/0.5 ml vial

The TAXOTERE 20 mg/0.5 ml vial is a 7 ml clear glass vial with a green flip-off cap.

The TAXOTERE 20 mg/0.5 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ml.

Each TAXOTERE 20 mg/0.5 ml vial contains 0.5 ml of a 40 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.61 ml). This volume has been established during the development of TAXOTERE to compensate for liquid loss during preparation of the premix (see section 4) due to foaming, adhesion to the walls of the vial and "dead-volume". This overfill ensures that after dilution with the entire contents of the accompanying solvent for TAXOTERE vial, there is a minimal extractable premix volume of 2 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 20 mg/0.5 ml per vial.

2.2Solvent for TAXOTERE 20 mg/0.5 ml vial

The solvent for TAXOTERE 20 mg/0.5 ml vial is a 7 ml clear glass vial with a transparent colourless flip-off cap.

The solvent for TAXOTERE composition is a 13% w/w solution of ethanol 95% in water for injections.

Each solvent for TAXOTERE 20 mg/0.5 ml vial contains 1.98 ml. This volume has been established based on the fill volume of the TAXOTERE 20 mg/0.5 ml vial. The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 20 mg/0.5 ml vial ensures a premix concentration of 10 mg/ml docetaxel.

3.RECOMMENDATIONS FOR THE SAFE HANDLING

TAXOTERE is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing TAXOTERE solutions. The use of gloves is recommended.

If TAXOTERE concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If TAXOTERE concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.

4.PREPARATION FOR THE INTRAVENOUS ADMINISTRATION

4.1Preparation of the TAXOTERE premix solution (10 mg docetaxel/ml)

4.1.1

If the vials are stored under refrigeration, allow the required number of TAXOTERE boxes to stand at room temperature (below 25°C) for 5 minutes.

4.1.2

Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for TAXOTERE vial by partially inverting the vial.

4.1.3

Inject the entire contents of the syringe into the corresponding

TAXOTERE vial.

4.1.4

Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds. Do not shake.

4.1.5

Allow the premix vial to stand for 5 minutes at room temperature (below 25°C) and then check that the solution is homogenous and clear (foaming is normal even after

5 minutes due to the presence of polysorbate 80 in the formulation).

The premix solution contains 10 mg/ml docetaxel and 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).

4.2Preparation of the infusion solution

4.2.1

More than one premix vial may be necessary to obtain the required dose for the patient. Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding premix volume containing 10 mg/ml docetaxel from the appropriate number of premix vials using graduated syringes fitted with a needle. For example, a dose of 140 mg docetaxel would require 14 ml docetaxel premix solution.

4.2.2

Inject the required premix volume into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. If a dose greater than 200 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of

0.74mg/ml docetaxel is not exceeded.

4.2.3

Mix the infusion bag or bottle manually using a rocking motion.

4.2.4

The TAXOTERE infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions.

4.2.5

As with all parenteral products, TAXOTERE premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.

5.DISPOSAL

All materials that have been utilised for dilution and administration should be disposed of according to standard procedures. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Package leaflet: Information for the patient

TAXOTERE 80 mg/2 ml concentrate and solvent for solution for infusion docetaxel

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, hospital pharmacist or nurse.

-If you get any side effects talk to your doctor, hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What TAXOTERE is and what it is used for

2.What you need to know before you use TAXOTERE

3.How to use TAXOTERE

4.Possible side effects

5.How to store TAXOTERE

6.Contents of the pack and other information

1. What TAXOTERE is and what it is used for

The name of this medicine is TAXOTERE. Its common name is docetaxel. Docetaxel is a substance derived from the needles of yew trees.

Docetaxel belongs to the group of anti-cancer medicines called taxoids.

TAXOTERE 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:

-For the treatment of advanced breast cancer, TAXOTERE could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.

-For the treatment of early breast cancer with or without lymph node involvement, TAXOTERE could be administered in combination with doxorubicin and cyclophosphamide.

-For the treatment of lung cancer, TAXOTERE could be administered either alone or in combination with cisplatin.

-For the treatment of prostate cancer, TAXOTERE is administered in combination with prednisone or prednisolone.

-For the treatment of metastatic gastric cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.

-For the treatment of head and neck cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.

2. What you need to know before you use TAXOTERE

You must not be given TAXOTERE if

you are allergic (hypersensitive) to docetaxel or any of the other ingredients of TAXOTERE.

the number of white blood cells is too low.

you have a severe liver disease.

Warnings and precautions

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

Tell your doctor, hospital pharmacist or nurse if you have vision problems. In case of vision problems, in particular blurred vision, you should immediately have your eyes and vision examined.

If you develop acute or worsening problems with your lungs (fever, shortness of breath or cough), please tell your doctor, hospital pharmacist or nurse immediately. Your doctor may stop your treatment immediately.

You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to TAXOTERE 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 TAXOTERE 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.

TAXOTERE contains alcohol. Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment. See also section “ TAXOTERE contains ethanol (alcohol)” below.

Other medicines and TAXOTERE

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

Pregnancy, breast-feeding and fertility

Ask your doctor for advice before being given any medicine.

TAXOTERE 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 TAXOTERE may be harmful for the unborn baby. If pregnancy occurs during your treatment, you must immediately inform your doctor.

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

If you are a man being treated with TAXOTERE 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.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

TAXOTERE contains ethanol (alcohol)

This medicinal product contains 13% (w/w) ethanol 95% v/v (alcohol), i.e. up to 932 mg ethanol 95% v/v per solvent vial, equivalent to 23 ml of beer or 9.5 ml wine per vial.

Harmful for those suffering from alcoholism.

To be taken into account if you are pregnant or if you are breast-feeding women, in children and in high-risk groups such as patients with liver disease, or epilepsy.

The amount of alcohol in this medicinal product may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).

The amount of alcohol in this medicinal product may alter the effects of other medicines.

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

3. How to use TAXOTERE

TAXOTERE 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

TAXOTERE 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 TAXOTERE. 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.

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 will explain the potential risks and benefits of your treatment.

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

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

During the infusion at the hospital the following allergic reactions (may affect more than 1 in 10 people):

flushing, skin reactions, itching

chest tightness; difficulty in breathing

fever or chills

back pain

low blood pressure.

More severe reactions 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 TAXOTERE the following may occur, and the frequency may vary with the combinations of medicines that are received:

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

infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets

fever: if this happens you must tell your doctor immediately

allergic reactions as described above

loss of appetite (anorexia)

insomnia

feeling of numbness or pins and needles or pain in the joints or muscles

headache

alteration in sense of taste

inflammation of the eye or increased tearing of the eyes

swelling caused by faulty lymphatic drainage

shortness of breath

nasal drainage; inflammation of the throat and nose; cough

bleeding from the nose

sores in the mouth

stomach upsets including nausea, vomiting and diarrhoea, constipation

abdominal pain

indigestion

hair loss: in most cases normal hair growth should return. In some cases (frequency not known) permanent hair loss has been observed

redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body)

change in the color of your nails, which may detach

muscle aches and pains; back pain or bone pain

change or absence of menstrual period

swelling of the hands, feet, legs

tiredness; or flu-like symptoms

weight gain or loss.

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

oral candidiasis

dehydration

dizziness

hearing impaired

decrease in blood pressure; irregular or rapid heart beat

heart failure

oesophagitis

dry mouth

difficulty or painful swallowing

haemorrhage

raised liver enzymes (hence the need for regular blood tests).

Uncommon (may affectup to 1 in 100 people):

fainting

at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling

inflammation of the colon, small intestine; intestinal perforation

blood clots

Frequency unknown:

interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing. Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)

pneumonia (infection of the lungs)

pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)

blurred vision due to swelling of the retina within the eye (cystoid macular oedema)

decrease of the sodium, potassium, magnesium, and/or calcium in your blood (electrolyte balance disorders).

Reporting of side effects

If you get any side effects talk to your doctor, hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store TAXOTERE

Keep this medicine out of the sight and reach of children.

This medicine should not be used after the expiry date shown on the carton, blister pack and vials.

Do not store above 25°C or below 2°C.

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).

6. Contents of the pack and other information

What TAXOTERE concentrate vial contains

-The active substance is docetaxel (as trihydrate). Each ml of docetaxel solution contains 40 mg of docetaxel (anhydrous). One vial contains 80 mg/2 ml docetaxel.

-The other ingredients are polysorbate 80 and citric acid.

What solvent vial contains

13% (w/w) ethanol 95% (see section 2) in water for injections.

What TAXOTERE looks like and contents of the pack

TAXOTERE 80 mg/2 ml concentrate for solution for infusion is a clear viscous, yellow to brown- yellow solution.

Each blister pack contains:

one single-dose vial of concentrate and,

one single-dose vial of solvent.

Marketing Authorisation Holder

Aventis Pharma S.A.

20 avenue Raymond Aron

92165 Antony Cedex France

Manufacturers

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

65926 Frankfurt am Main

Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien

Lietuva

Sanofi Belgium

UAB «SANOFI-AVENTIS LIETUVA»

Tél/Tel: +32 (0)2 710 54 00

Tel: +370 5 2755224

България

Luxembourg/Luxemburg

SANOFI BULGARIA EOOD

Sanofi Belgium

Тел.: +359 (0)2 970 53 00

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika

Magyarország

sanofi-aventis, s.r.o.

sanofi-aventis zrt., Magyarország

Tel: +420 233 086 111

Tel.: +36 1 505 0050

Danmark

Malta

sanofi-aventis Denmark A/S

Sanofi-Aventis Malta Ltd.

Tlf: +45 45 16 70 00

Tel: +356 21493022

Deutschland

Nederland

Sanofi-Aventis Deutschland GmbH

sanofi-aventis Netherlands B.V.

Tel: +49 (0)180 2 222010

Tel: +31 (0)182 557 755

Eesti

Norge

sanofi-aventis Estonia OÜ

sanofi-aventis Norge AS

Tel: +372 627 34 88

Tlf: +47 67 10 71 00

Ελλάδα

Österreich

sanofi-aventis AEBE

sanofi-aventis GmbH

Τηλ: +30 210 900 16 00

Tel: +43 1 80 185 – 0

España

Polska

sanofi-aventis, S.A.

sanofi-aventis Sp. z o.o.

Tel: +34 93 485 94 00

Tel.: +48 22 280 00 00

France

Portugal

sanofi-aventis France

Sanofi - Produtos Farmacêuticos, Lda.

Tél: 0 800 222 555

Tel: +351 21 35 89 400

Appel depuis l’étranger : +33 1 57 63 23 23

 

Hrvatska

România

sanofi-aventis Croatia d.o.o.

Sanofi Romania SRL

Tel: +385 1 600 34 00

Tel: +40 (0) 21 317 31 36

Ireland

Slovenija

sanofi-aventis Ireland Ltd. T/A SANOFI

sanofi-aventis d.o.o.

Tel: +353 (0) 1 403 56 00

Tel: +386 1 560 48 00

Ísland

Slovenská republika

Vistor hf.

sanofi-aventis Pharma Slovakia s.r.o.

Sími: +354 535 7000

Tel: +421 2 33 100 100

Italia

Suomi/Finland

sanofi-aventis S.p.A.

Sanofi Oy

Tel: +39.800.536389

Puh/Tel: +358 (0) 201 200 300

Κύπρος

Sverige

sanofi-aventis Cyprus Ltd.

Sanofi AB

Τηλ: +357 22 871600

Tel: +46 (0)8 634 50 00

Latvija

United Kingdom

sanofi-aventis Latvia SIA

Sanofi

Tel: +371 67 33 24 51

Tel: +44 (0) 845 372 7101

This leaflet was last revised in .

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

The following information is intended for healthcare professionals only:

PREPARATION GUIDE FOR USE WITH TAXOTERE 80 mg/2 ml CONCENTRATE FOR SOLUTION FOR INFUSION AND SOLVENT FOR TAXOTERE

It is important that you read the entire contents of this guide prior to the preparation of either the TAXOTERE premix solution or the TAXOTERE infusion solution

1. FORMULATION

TAXOTERE 80 mg/2 ml concentrate for solution for infusion is a clear viscous, yellow to brown- yellow solution containing 40 mg/ml docetaxel (anhydrous) in polysorbate 80 and citric acid. The solvent for TAXOTERE is a 13% w/w solution of ethanol 95% in water for injections.

2. PRESENTATION

TAXOTERE is supplied as single-dose vials.

Each box contains one TAXOTERE vial (80 mg/2 ml) and one corresponding solvent for TAXOTERE vial in a blister pack.

TAXOTERE vials should be stored between 2°C and 25°C and protected from light. TAXOTERE should not be used after the expiry date shown on the carton, blister pack and vials.

2.1TAXOTERE 80 mg/2 ml vial

The TAXOTERE 80 mg/2 ml vial is a 15 ml clear glass vial with a red flip-off cap.

The TAXOTERE 80 mg/2 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ml.

Each TAXOTERE 80 mg/2 ml vial contains 2.0 ml of a 40 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 94.4 mg/2.36 ml). This volume has been established during the development of TAXOTERE to compensate for liquid loss during preparation of the premix (see section 4) due to foaming, adhesion to the walls of the vial and "dead-volume". This overfill ensures that after dilution with the entire contents of the accompanying solvent for TAXOTERE vial, there is a minimal extractable premix volume of 8 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 80 mg/2 ml per vial.

2.2Solvent for TAXOTERE 80 mg/2 ml vial

The solvent for TAXOTERE 80 mg/2 ml vial is a 15 ml clear glass vial with a transparent colourless flip-off cap.

The solvent for TAXOTERE composition is a 13% w/w solution of ethanol 95% in water for injections.

Each solvent for TAXOTERE 80 mg/2 ml vial contains 7.33 ml. This volume has been established based on the fill volume of the TAXOTERE 80 mg/2 ml vial. The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 80 mg/2 ml vial ensures a premix concentration of 10 mg/ml docetaxel.

3. RECOMMENDATIONS FOR THE SAFE HANDLING

TAXOTERE is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing TAXOTERE solutions. The use of gloves is recommended.

If TAXOTERE concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If TAXOTERE concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.

4. PREPARATION FOR THE INTRAVENOUS ADMINISTRATION

4.1 Preparation of the TAXOTERE premix solution (10 mg docetaxel/ml)

4.1.1If the vials are stored under refrigeration, allow the required number of TAXOTERE boxes to stand at room temperature (below 25°C) for 5 minutes.

4.1.2Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for TAXOTERE vial by partially inverting the vial.

4.1.3Inject the entire contents of the syringe into the corresponding

TAXOTERE vial.

4.1.4Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds. Do not shake.

4.1.5Allow the premix vial to stand for 5 minutes at room temperature (below 25°C) and then check that the solution is homogenous and clear (foaming is normal even after

5 minutes due to the presence of polysorbate 80 in the formulation).

The premix solution contains 10 mg/ml docetaxel and 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).

4.2 Preparation of the infusion solution

4.2.1More than one premix vial may be necessary to obtain the required dose for the patient. Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding premix volume containing 10 mg/ml docetaxel from the appropriate number of premix vials using graduated syringes fitted with a needle. For example, a dose of 140 mg docetaxel would require 14 ml docetaxel premix solution.

4.2.2Inject the required premix volume into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. If a dose greater than 200 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of

0.74mg/ml docetaxel is not exceeded.

4.2.3Mix the infusion bag or bottle manually using a rocking motion.

4.2.4The TAXOTERE infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions.

4.2.5As with all parenteral products, TAXOTERE premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.

5. DISPOSAL

All materials that have been utilised for dilution and administration should be disposed of according to standard procedures. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Package leaflet: Information for the patient

TAXOTERE 20 mg/1 ml concentrate for solution for infusion docetaxel

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, hospital pharmacist or nurse.

-If you get any side effects talk to your doctor, hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What TAXOTERE is and what it is used for

2.What you need to know before you use TAXOTERE

3.How to use TAXOTERE

4.Possible side effects

5.How to store TAXOTERE

6.Contents of the pack and other information

1. What TAXOTERE is and what it is used for

The name of this medicine is TAXOTERE. Its common name is docetaxel. Docetaxel is a substance derived from the needles of yew trees.

Docetaxel belongs to the group of anti-cancer medicines called taxoids.

TAXOTERE 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:

-For the treatment of advanced breast cancer, TAXOTERE could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.

-For the treatment of early breast cancer with or without lymph node involvement, TAXOTERE could be administered in combination with doxorubicin and cyclophosphamide.

-For the treatment of lung cancer, TAXOTERE could be administered either alone or in combination with cisplatin.

-For the treatment of prostate cancer, TAXOTERE is administered in combination with prednisone or prednisolone.

-For the treatment of metastatic gastric cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.

-For the treatment of head and neck cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.

2. What you need to know before you use TAXOTERE

You must not be given TAXOTERE

if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of TAXOTERE.

if the number of white blood cells is too low.

if you have a severe liver disease.

Warnings and precautions

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

Tell your doctor, hospital pharmacist or nurse if you have vision problems. In case of vision problems, in particular blurred vision, you should immediately have your eyes and vision examined.

If you develop acute or worsening problems with your lungs (fever, shortness of breath or cough), please tell your doctor, hospital pharmacist or nurse immediately. Your doctor may stop your treatment immediately.

You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to TAXOTERE 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 TAXOTERE 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.

TAXOTERE contains alcohol. Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment. See also section “ TAXOTERE contains ethanol (alcohol)” below.

Other medicines and TAXOTERE

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

Pregnancy, breast-feeding and fertility

Ask your doctor for advice before being given any medicine.

TAXOTERE 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 TAXOTERE may be harmful for the unborn baby. If pregnancy occurs during your treatment, you must immediately inform your doctor.

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

If you are a man being treated with TAXOTERE 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.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

TAXOTERE contains ethanol (alcohol)

This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per vial, equivalent to 10 ml of beer or 4 ml wine per vial.

Harmful for those suffering from alcoholism.

To be taken into account if you are pregnant or if you are breast-feeding women, in children and high-risk groups such as patients with liver disease, or epilepsy.

The amount of alcohol in this medicinal product may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).

The amount of alcohol in this medicinal product may alter the effects of other medicines.

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

3.How to useTAXOTERE

TAXOTERE 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

TAXOTERE 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 TAXOTERE. 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.

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 will explain the potential risks and benefits of your treatment.

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

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

During the infusion at the hospital the following allergic reactions (may affectmore than 1 in 10 people):

flushing, skin reactions, itching

chest tightness; difficulty in breathing

fever or chills

back pain

low blood pressure.

More severe reactions 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 TAXOTERE the following may occur, and the frequency may vary with the combinations of medicines that are received

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

infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets

fever: if this happens you must tell your doctor immediately

allergic reactions as described above

loss of appetite (anorexia)

insomnia

feeling of numbness or pins and needles or pain in the joints or muscles

headache

alteration in sense of taste

inflammation of the eye or increased tearing of the eyes

swelling caused by faulty lymphatic drainage

shortness of breath

nasal drainage; inflammation of the throat and nose; cough

bleeding from the nose

sores in the mouth

stomach upsets including nausea, vomiting and diarrhoea, constipation

abdominal pain

indigestion

hair loss: in most cases normal hair growth should return. In some cases (frequency not known) permanent hair loss has been observed

redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body)

change in the color of your nails, which may detach

muscle aches and pains; back pain or bone pain

change or absence of menstrual period

swelling of the hands, feet, legs

tiredness; or flu-like symptoms

weight gain or loss.

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

oral candidiasis

dehydration

dizziness

hearing impaired

decrease in blood pressure; irregular or rapid heart beat

heart failure

oesophagitis

dry mouth

difficulty or painful swallowing

haemorrhage

raised liver enzymes (hence the need for regular blood tests).

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

fainting

at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling

inflammation of the colon, small intestine; intestinal perforation

blood clots.

Frequency unknown:

interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing. Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)

pneumonia (infection of the lungs)

pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)

blurred vision due to swelling of the retina within the eye (cystoid macular oedema)

decrease of the sodium, potassium, magnesium, and/or calcium in your blood (electrolyte balance disorders).

Reporting of side effects

If you get any side effects talk to your doctor, hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store TAXOTERE

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 outer carton and on the label of the vial after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

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

Use the vial immediately after its opening. If not used immediately, in-use storage times and conditions are the responsibility of the user.

From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions.

Use immediately the medicine once added into the infusion bag. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion.

Physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2 to 8°C.

Docetaxel infusion solution is supersaturated, therefore may cristallize over time. If crystals appear, the solution must no longer be used and shall be discarded.

Do not throw away any medicines via wastewater. 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 TAXOTERE contains

-The active substance is docetaxel (as trihydrate). Each ml of concentrate for solution for infusion contains 20 mg docetaxel.

-The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid.

What TAXOTERE looks like and contents of the pack

TAXOTERE concentrate for solution for infusion is a pale yellow to brownish-yellow solution. The concentrate is supplied in a 7 ml clear colourless glass vial with a green aluminium seal and a green plastic flip-off cap.

Each box contains one vial of 1 ml concentrate (20 mg docetaxel).

Marketing Authorisation Holder

Aventis Pharma S.A.

20 avenue Raymond Aron

92165 Antony Cedex France

Manufacturers

Sanofi-Aventis Deutschland GmbH Industriepark Höchst

65926 Frankfurt am Main Germany

Or

Sanofi-Aventis Zrt.

(Harbor Park) 1, Campona utca Budapest 1225

Hungary

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien

Lietuva

Sanofi Belgium

UAB «SANOFI-AVENTIS LIETUVA»

Tél/Tel: +32 (0)2 710 54 00

Tel: +370 5 2755224

България

Luxembourg/Luxemburg

SANOFI BULGARIA EOOD

Sanofi Belgium

Тел.: +359 (0)2 970 53 00

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika

Magyarország

sanofi-aventis, s.r.o.

sanofi-aventis zrt., Magyarország

Tel: +420 233 086 111

Tel.: +36 1 505 0050

Danmark

Malta

sanofi-aventis Denmark A/S

Sanofi-Aventis Malta Ltd.

Tlf: +45 45 16 70 00

Tel: +356 21493022

Deutschland

Nederland

Sanofi-Aventis Deutschland GmbH

sanofi-aventis Netherlands B.V.

Tel: +49 (0)180 2 222010

Tel: +31 (0)182 557 755

Eesti

Norge

sanofi-aventis Estonia OÜ

sanofi-aventis Norge AS

Tel: +372 627 34 88

Tlf: +47 67 10 71 00

Ελλάδα

Österreich

sanofi-aventis AEBE

sanofi-aventis GmbH

Τηλ: +30 210 900 16 00

Tel: +43 1 80 185 – 0

España

Polska

sanofi-aventis, S.A.

sanofi-aventis Sp. z o.o.

Tel: +34 93 485 94 00

Tel.: +48 22 280 00 00

France

Portugal

sanofi-aventis France

Sanofi - Produtos Farmacêuticos, Lda.

Tél: 0 800 222 555

Tel: +351 21 35 89 400

Appel depuis l’étranger : +33 1 57 63 23 23

 

Hrvatska

România

sanofi-aventis Croatia d.o.o.

Sanofi Romania SRL

Tel: +385 1 600 34 00

Tel: +40 (0) 21 317 31 36

Ireland

Slovenija

sanofi-aventis Ireland Ltd. T/A SANOFI

sanofi-aventis d.o.o.

Tel: +353 (0) 1 403 56 00

Tel: +386 1 560 48 00

Ísland

Slovenská republika

Vistor hf.

sanofi-aventis Pharma Slovakia s.r.o.

Sími: +354 535 7000

Tel: +421 2 33 100 100

Italia

Suomi/Finland

sanofi-aventis S.p.A.

Sanofi Oy

Tel: +39.800.536389

Puh/Tel: +358 (0) 201 200 300

Κύπρος

Sverige

sanofi-aventis Cyprus Ltd.

Sanofi AB

Τηλ: +357 22 871600

Tel: +46 (0)8 634 50 00

Latvija

United Kingdom

sanofi-aventis Latvia SIA

Sanofi

Tel: +371 67 33 24 51

Tel: +44 (0) 845 372 7101

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

The following information is intended for healthcare professionals only:

PREPARATION GUIDE FOR USE WITH TAXOTERE 20 mg/1 ml CONCENTRATE FOR SOLUTION FOR INFUSION

It is important that you read the entire contents of this guide prior to the preparation of the TAXOTERE infusion solution.

Recommendations for the safe handling

Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing its solutions. The use of gloves is recommended.

If TAXOTERE concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If it should come into contact with mucous membranes, wash immediately and thoroughly with water.

Preparation of the intravenous administration

Preparation of the infusion solution

DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).

TAXOTERE 20 mg/1 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.

Each vial is for single use and should be used immediately after opening. If not used immediately, in-use storage times and conditions are the responsibility of the user. More than one vial of concentrate for solution for infusion may be necessary to obtain the required dose for the patient. For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution.

Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe fitted with a 21G needle.

In TAXOTERE 20 mg/1 ml vial the concentration of docetaxel is 20 mg/ml.

Then, inject via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. If a dose greater than 190 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.

Mix the infusion bag or bottle manually using a rocking motion.

From a microbiological point of view, reconstitution /dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately. If not used

immediately, in-use storage times and conditions are the responsibility of the user.

Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours. It should be used within 6 hours (including the one hour infusion intravenous administration).

In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C.

Docetaxel infusion solution is supersaturated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and shall be discarded.

As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.

Disposal

All materials that have been utilised for dilution and administration should be disposed of according to standard procedures. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Package leaflet: Information for the patient

TAXOTERE 80 mg/4 ml concentrate for solution for infusion docetaxel

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, hospital pharmacist or nurse.

-If you get any side effects talk to your doctor, hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What TAXOTERE is and what it is used for

2.What you need to know before you use TAXOTERE

3.How to use TAXOTERE

4.Possible side effects

5.How to store TAXOTERE

6.Contents of the pack and otherinformation

1. What TAXOTERE is and what it is used for

The name of this medicine is TAXOTERE. Its common name is docetaxel. Docetaxel is a substance derived from the needles of yew trees.

Docetaxel belongs to the group of anti-cancer medicines called taxoids.

TAXOTERE 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:

-For the treatment of advanced breast cancer, TAXOTERE could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.

-For the treatment of early breast cancer with or without lymph node involvement, TAXOTERE could be administered in combination with doxorubicin and cyclophosphamide.

-For the treatment of lung cancer, TAXOTERE could be administered either alone or in combination with cisplatin.

-For the treatment of prostate cancer, TAXOTERE is administered in combination with prednisone or prednisolone.

-For the treatment of metastatic gastric cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.

-For the treatment of head and neck cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.

2. What you need to know before you use TAXOTERE

You must not be given TAXOTERE

if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of TAXOTERE.

if the number of white blood cells is too low.

if you have a severe liver disease.

Warnings and precautions

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

Tell your doctor, hospital pharmacist or nurse if you have vision problems. In case of vision problems, in particular blurred vision, you should immediately have your eyes and vision examined.

If you develop acute or worsening problems with your lungs (fever, shortness of breath or cough), please tell your doctor, hospital pharmacist or nurse immediately. Your doctor may stop your treatment immediately.

You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to TAXOTERE 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 TAXOTERE 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.

TAXOTERE contains alcohol. Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment. See also section “TAXOTERE contains ethanol (alcohol)” below.

Other medicines and TAXOTERE

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

Pregnancy, breast-feeding and fertility

Ask your doctor for advice before being given any medicine.

TAXOTERE 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 TAXOTERE may be harmful for the unborn baby. If pregnancy occurs during your treatment, you must immediately inform your doctor.

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

If you are a man being treated with TAXOTERE 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.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

TAXOTERE contains ethanol (alcohol)

This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1.58 g ethanol anhydrous per vial, equivalent to 40 ml of beer or 17 ml wine per vial.

Harmful for those suffering from alcoholism.

To be taken into account if you are pregnant or if you are breast-feeding women, in children and high-risk groups such as patients with liver disease, or epilepsy.

The amount of alcohol in this medicinal product may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).

The amount of alcohol in this medicinal product may alter the effects of other medicines.

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

3. How to use TAXOTERE

TAXOTERE 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

TAXOTERE 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 TAXOTERE. 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.

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 will explain the potential risks and benefits of your treatment.

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

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

During the infusion at the hospital the following allergic reactions (may affect more than 1 in 10 people):

flushing, skin reactions, itching

chest tightness; difficulty in breathing

fever or chills

back pain

low blood pressure.

More severe reactions 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 TAXOTERE the following may occur, and the frequency may vary with the combinations of medicines that are received

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

infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets

fever: if this happens you must tell your doctor immediately

allergic reactions as described above

loss of appetite (anorexia)

insomnia

feeling of numbness or pins and needles or pain in the joints or muscles

headache

alteration in sense of taste

inflammation of the eye or increased tearing of the eyes

swelling caused by faulty lymphatic drainage

shortness of breath

nasal drainage; inflammation of the throat and nose; cough

bleeding from the nose

sores in the mouth

stomach upsets including nausea, vomiting and diarrhoea, constipation

abdominal pain

indigestion

hair loss: in most cases normal hair growth should return. In some cases (frequency not known) permanent hair loss has been observed

redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body)

change in the color of your nails, which may detach

muscle aches and pains; back pain or bone pain

change or absence of menstrual period

swelling of the hands, feet, legs

tiredness; or flu-like symptoms

weight gain or loss.

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

oral candidiasis

dehydration

dizziness

hearing impaired

decrease in blood pressure; irregular or rapid heart beat

heart failure

oesophagitis

dry mouth

difficulty or painful swallowing

haemorrhage

raised liver enzymes (hence the need for regular blood tests).

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

fainting

at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling

inflammation of the colon, small intestine; intestinal perforation

blood clots.

Frequency unknown:

interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing. Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)

pneumonia (infection of the lungs)

pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)

blurred vision due to swelling of the retina within the eye (cystoid macular oedema)

decrease of the sodium, potassium, magnesium, and/or calcium in your blood (electrolyte balance disorders).

Reporting of adverse effects

If you get any side effects talk to your doctor, hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store TAXOTERE

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 outer carton and on the label of the vial after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

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

Use the vial immediately after its opening. If not used immediately, in-use storage times and conditions are the responsibility of the user.

From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions.

Use immediately the medicine once added into the infusion bag. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion.

Physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2 to 8°C.

Docetaxel infusion solution is supersaturated, therefore may cristallize over time. If crystals appear, the solution must no longer be used and shall be discarded.

Do not throw away any medicines via wastewater. 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 TAXOTERE contains

-The active substance is docetaxel (as trihydrate). Each ml of concentrate for solution for infusion contains 20 mg docetaxel.

-The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid.

What TAXOTERE looks like and contents of the pack

TAXOTERE concentrate for solution for infusion is a pale yellow to brownish-yellow solution.

The concentrate is supplied in a 7 ml clear colourless glass vial with a magenta aluminium seal and a magenta plastic flip-off cap.

Each box contains one vial of 4 ml concentrate (80 mg docetaxel).

Marketing Authorisation Holder

Aventis Pharma S.A.

20 avenue Raymond Aron

92165 Antony Cedex France

Manufacturers

Sanofi-Aventis Deutschland GmbH Industriepark Höchst

65926 Frankfurt am Main Germany

Or

Sanofi-Aventis Zrt.

(Harbor Park) 1, Campona utca Budapest 1225

Hungary

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien

Lietuva

Sanofi Belgium

UAB «SANOFI-AVENTIS LIETUVA»

Tél/Tel: +32 (0)2 710 54 00

Tel: +370 5 2755224

България

Luxembourg/Luxemburg

SANOFI BULGARIA EOOD

Sanofi Belgium

Тел.: +359 (0)2 970 53 00

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika

Magyarország

sanofi-aventis, s.r.o.

sanofi-aventis zrt., Magyarország

Tel: +420 233 086 111

Tel.: +36 1 505 0050

Danmark

Malta

sanofi-aventis Denmark A/S

Sanofi-Aventis Malta Ltd.

Tlf: +45 45 16 70 00

Tel: +356 21493022

Deutschland

Nederland

Sanofi-Aventis Deutschland GmbH

sanofi-aventis Netherlands B.V.

Tel: +49 (0)180 2 222010

Tel: +31 (0)182 557 755

Eesti

Norge

sanofi-aventis Estonia OÜ

sanofi-aventis Norge AS

Tel: +372 627 34 88

Tlf: +47 67 10 71 00

Ελλάδα

Österreich

sanofi-aventis AEBE

sanofi-aventis GmbH

Τηλ: +30 210 900 16 00

Tel: +43 1 80 185 – 0

España

Polska

sanofi-aventis, S.A.

sanofi-aventis Sp. z o.o.

Tel: +34 93 485 94 00

Tel.: +48 22 280 00 00

France

Portugal

sanofi-aventis France

Sanofi - Produtos Farmacêuticos, Lda.

Tél: 0 800 222 555

Tel: +351 21 35 89 400

Appel depuis l’étranger : +33 1 57 63 23 23

 

Hrvatska

România

sanofi-aventis Croatia d.o.o.

Sanofi Romania SRL

Tel: +385 1 600 34 00

Tel: +40 (0) 21 317 31 36

Ireland

Slovenija

sanofi-aventis Ireland Ltd. T/A SANOFI

sanofi-aventis d.o.o.

Tel: +353 (0) 1 403 56 00

Tel: +386 1 560 48 00

Ísland

Slovenská republika

Vistor hf.

sanofi-aventis Pharma Slovakia s.r.o.

Sími: +354 535 7000

Tel: +421 2 33 100 100

Italia

Suomi/Finland

sanofi-aventis S.p.A.

Sanofi Oy

Tel: +39.800.536389

Puh/Tel: +358 (0) 201 200 300

Κύπρος

Sverige

sanofi-aventis Cyprus Ltd.

Sanofi AB

Τηλ: +357 22 871600

Tel: +46 (0)8 634 50 00

Latvija

United Kingdom

sanofi-aventis Latvia SIA

Sanofi

Tel: +371 67 33 24 51

Tel: +44 (0) 845 372 7101

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

The following information is intended for healthcare professionals only:

PREPARATION GUIDE FOR USE WITH TAXOTERE 80 mg/4 ml CONCENTRATE FOR SOLUTION FOR INFUSION

It is important that you read the entire contents of this guide prior to the preparation of the TAXOTERE infusion solution.

Recommendations for the safe handling

Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing its solutions. The use of gloves is recommended.

If TAXOTERE concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If it should come into contact with mucous membranes, wash immediately and thoroughly with water.

Preparation of the intravenous administration

Preparation of the infusion solution

DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).

TAXOTERE 80 mg/4 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.

Each vial is for single use and should be used immediately after opening. If not used immediately, in-use storage times and conditions are the responsibility of the user. More than one vial of concentrate for solution for infusion may be necessary to obtain the required dose for the patient. For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution.

Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe fitted with a 21G needle.

In TAXOTERE 80 mg/4 ml vial the concentration of docetaxel is 20 mg/ml.

Then, inject via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. If a dose greater than 190 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.

Mix the infusion bag or bottle manually using a rocking motion.

From a microbiological point of view, reconstitution /dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately. If not used

immediately, in-use storage times and conditions are the responsibility of the user.

Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours. It should be used within 6 hours (including the one hour infusion intravenous administration).

In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C.

Docetaxel infusion solution is supersaturated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and shall be discarded.

As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.

Disposal

All materials that have been utilised for dilution and administration should be disposed of according to standard procedures. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Package Leaflet: Information for the patient

TAXOTERE 160 mg/8 ml concentrate for solution for infusion docetaxel

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, hospital pharmacist or nurse.

-If you get any side effects talk to your doctor, hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What TAXOTERE is and what it is used for

2.What you need to know before you use TAXOTERE

3.How to use TAXOTERE

4.Possible side effects

5.How to store TAXOTERE

6.Contents of the pack and other information

1. What TAXOTERE is and what it is used for

The name of this medicine is TAXOTERE. Its common name is docetaxel. Docetaxel is a substance derived from the needles of yew trees.

Docetaxel belongs to the group of anti-cancer medicines called taxoids.

TAXOTERE 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:

-For the treatment of advanced breast cancer, TAXOTERE could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.

-For the treatment of early breast cancer with or without lymph node involvement, TAXOTERE could be administered in combination with doxorubicin and cyclophosphamide.

-For the treatment of lung cancer, TAXOTERE could be administered either alone or in combination with cisplatin.

-For the treatment of prostate cancer, TAXOTERE is administered in combination with prednisone or prednisolone.

-For the treatment of metastatic gastric cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.

-For the treatment of head and neck cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.

2. What you need to know before you use TAXOTERE

You must not be given TAXOTERE

if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of TAXOTERE.

if the number of white blood cells is too low.

if you have a severe liver disease.

Warnings and precautions

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

Tell your doctor, hospital pharmacist or nurse if you have vision problems. In case of vision problems, in particular blurred vision, you should immediately have your eyes and vision examined.

If you develop acute or worsening problems with your lungs (fever, shortness of breath or cough), please tell your doctor, hospital pharmacist or nurse immediately. Your doctor may stop your treatment immediately.

You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to TAXOTERE 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 TAXOTERE 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.

TAXOTERE contains alcohol. Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment. See also section “TAXOTERE contains ethanol (alcohol)” below.

Other medicines and TAXOTERE

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

Pregnancy, breast-feeding and fertility

Ask your doctor for advice before being given any medicine.

TAXOTERE 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 TAXOTERE may be harmful for the unborn baby. If pregnancy occurs during your treatment, you must immediately inform your doctor.

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

If you are a man being treated with TAXOTERE 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.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

TAXOTERE contains ethanol (alcohol)

This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g ethanol anhydrous per vial, equivalent to 80 ml of beer or 33 ml wine per vial.

Harmful for those suffering from alcoholism.

To be taken into account if you are pregnant or if you are breast-feeding women, in children and high-risk groups such as patients with liver disease, or epilepsy.

The amount of alcohol in this medicinal product may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).

The amount of alcohol in this medicinal product may alter the effects of other medicines.

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

3. How to use TAXOTERE

TAXOTERE 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

TAXOTERE 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 TAXOTERE. 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.

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 will explain the potential risks and benefits of your treatment.

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

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

During the infusion at the hospital the following allergic reactions (may affect more than 1 in 10 people):

flushing, skin reactions, itching

chest tightness; difficulty in breathing

fever or chills

back pain

low blood pressure.

More severe reactions 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 TAXOTERE the following may occur, and the frequency may vary with the combinations of medicines that are received

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

infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets

fever: if this happens you must tell your doctor immediately

allergic reactions as described above

loss of appetite (anorexia)

insomnia

feeling of numbness or pins and needles or pain in the joints or muscles

headache

alteration in sense of taste

inflammation of the eye or increased tearing of the eyes

swelling caused by faulty lymphatic drainage

shortness of breath

nasal drainage; inflammation of the throat and nose; cough

bleeding from the nose

sores in the mouth

stomach upsets including nausea, vomiting and diarrhoea, constipation

abdominal pain

indigestion

hair loss: in most cases normal hair growth should return. In some cases (frequency not known) permanent hair loss has been observed

redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body)

change in the color of your nails, which may detach

muscle aches and pains; back pain or bone pain

change or absence of menstrual period

swelling of the hands, feet, legs

tiredness; or flu-like symptoms

weight gain or loss.

Common (may affectup to 1 in 10 people):

oral candidiasis

dehydration

dizziness

hearing impaired

decrease in blood pressure; irregular or rapid heart beat

heart failure

oesophagitis

dry mouth

difficulty or painful swallowing

haemorrhage

raised liver enzymes (hence the need for regular blood tests).

Uncommon (may affectup to 1 in 100 people):

fainting

at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling

inflammation of the colon, small intestine; intestinal perforation

blood clots.

Frequency unknown:

interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing. Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)

pneumonia (infection of the lungs)

pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)

blurred vision due to swelling of the retina within the eye (cystoid macular oedema)

decrease of the sodium, potassium, magnesium, and/or calcium in your blood (electrolyte balance disorders).

Reporting of side effects

If you get any side effects talk to your doctor, hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store TAXOTERE

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 outer carton and on the label of the vial after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

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

Use the vial immediately after its opening. If not used immediately, in-use storage times and conditions are the responsibility of the user.

From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions.

Use immediately the medicine once added into the infusion bag. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion.

Physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2 to 8°C.

Docetaxel infusion solution is supersaturated, therefore may cristallize over time. If crystals appear, the solution must no longer be used and shall be discarded.

Do not throw away any medicines via wastewater. 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 TAXOTERE contains

-The active substance is docetaxel (as trihydrate). Each ml of concentrate for solution for infusion contains 20 mg docetaxel.

-The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid.

What TAXOTERE looks like and contents of the pack

TAXOTERE concentrate for solution for infusion is a pale yellow to brownish-yellow solution.

The concentrate is supplied in a 15 ml clear colourless glass vial with a blue aluminium seal and a blue plastic flip-off cap.

Each box contains one vial of 8 ml concentrate (160 mg docetaxel).

Marketing Authorisation Holder

Aventis Pharma S.A.

20 avenue Raymond Aron

92165 Antony Cedex France

Manufacturers

Sanofi-Aventis Deutschland GmbH Industriepark Höchst

65926 Frankfurt am Main Germany

Or

Sanofi-Aventis Zrt.

(Harbor Park) 1, Campona utca Budapest 1225

Hungary

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien

Lietuva

Sanofi Belgium

UAB «SANOFI-AVENTIS LIETUVA»

Tél/Tel: +32 (0)2 710 54 00

Tel: +370 5 2755224

България

Luxembourg/Luxemburg

SANOFI BULGARIA EOOD

Sanofi Belgium

Тел.: +359 (0)2 970 53 00

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika

Magyarország

sanofi-aventis, s.r.o.

sanofi-aventis zrt., Magyarország

Tel: +420 233 086 111

Tel.: +36 1 505 0050

Danmark

Malta

sanofi-aventis Denmark A/S

Sanofi-Aventis Malta Ltd.

Tlf: +45 45 16 70 00

Tel: +356 21493022

Deutschland

Nederland

Sanofi-Aventis Deutschland GmbH

sanofi-aventis Netherlands B.V.

Tel: +49 (0)180 2 222010

Tel: +31 (0)182 557 755

Eesti

Norge

sanofi-aventis Estonia OÜ

sanofi-aventis Norge AS

Tel: +372 627 34 88

Tlf: +47 67 10 71 00

Ελλάδα

Österreich

sanofi-aventis AEBE

sanofi-aventis GmbH

Τηλ: +30 210 900 16 00

Tel: +43 1 80 185 – 0

España

Polska

sanofi-aventis, S.A.

sanofi-aventis Sp. z o.o.

Tel: +34 93 485 94 00

Tel.: +48 22 280 00 00

France

Portugal

sanofi-aventis France

Sanofi - Produtos Farmacêuticos, Lda.

Tél: 0 800 222 555

Tel: +351 21 35 89 400

Appel depuis l’étranger : +33 1 57 63 23 23

 

Hrvatska

România

sanofi-aventis Croatia d.o.o.

Sanofi Romania SRL

Tel: +385 1 600 34 00

Tel: +40 (0) 21 317 31 36

Ireland

Slovenija

sanofi-aventis Ireland Ltd. T/A SANOFI

sanofi-aventis d.o.o.

Tel: +353 (0) 1 403 56 00

Tel: +386 1 560 48 00

Ísland

Slovenská republika

Vistor hf.

sanofi-aventis Pharma Slovakia s.r.o.

Sími: +354 535 7000

Tel: +421 2 33 100 100

Italia

Suomi/Finland

sanofi-aventis S.p.A.

Sanofi Oy

Tel: +39.800.536389

Puh/Tel: +358 (0) 201 200 300

Κύπρος

Sverige

sanofi-aventis Cyprus Ltd.

Sanofi AB

Τηλ: +357 22 871600

Tel: +46 (0)8 634 50 00

Latvija

United Kingdom

sanofi-aventis Latvia SIA

Sanofi

Tel: +371 67 33 24 51

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This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

The following information is intended for healthcare professionals only:

PREPARATION GUIDE FOR USE WITH TAXOTERE 160 mg/8 ml CONCENTRATE FOR SOLUTION FOR INFUSION

It is important that you read the entire contents of this guide prior to the preparation of the TAXOTERE infusion solution.

Recommendations for the safe handling

Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing its solutions. The use of gloves is recommended.

If TAXOTERE concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If it should come into contact with mucous membranes, wash immediately and thoroughly with water.

Preparation of the intravenous administration

Preparation of the infusion solution

DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).

TAXOTERE 160 mg/8 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.

Each vial is for single use and should be used immediately after opening. If not used immediately, in-use storage times and conditions are the responsibility of the user. More than one vial of concentrate for solution for infusion may be necessary to obtain the required dose for the patient. For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution.

Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe fitted with a 21G needle.

In TAXOTERE 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.

Then, inject via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. If a dose greater than 190 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.

Mix the infusion bag or bottle manually using a rocking motion.

From a microbiological point of view, reconstitution /dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours. It should be used within 6 hours (including the one hour infusion intravenous administration).

In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C.

Docetaxel infusion solution is supersaturated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and shall be discarded.

As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.

Disposal

All materials that have been utilised for dilution and administration should be disposed of according to standard procedures. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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