Docetaxel Teva - patient leaflet, side effects, dosage

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What Docetaxel Teva is and what it is used for

Docetaxel Teva has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: – For the treatment of advanced breast cancer, Docetaxel Teva 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, Docetaxel Teva could be administered in combination with doxorubicin and cyclophosphamide.

• – For the treatment of lung cancer, Docetaxel Teva could be administered either alone or in combination with cisplatin.

• – For the treatment of prostate cancer, Docetaxel Teva is administered in combination with

  prednisone or prednis For the treatment of m

  
  

  with cisplatin For the treatm cisplatin and

  
  

etastatic gastric cancer, Docetaxel Teva is administered in combination uorouracil.

t of head and neck cancer, Docetaxel Teva is administered in combination with uorouracil.

you need to know before you use Docetaxel Teva

ust NOT be given Docetaxel Teva:

if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel Teva (listed in section 6).

if the number of white blood cells is too low.

if you have a severe liver disease.

Warnings and precautions

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

Discuss with your doctor if you suffer from alcohol dependency. See tains ethanol (alcohol)” below.

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 Docetaxel Teva or the other medicine may not work as well as expected and you may be more likely to get a side effect. The amount of alcohol in this medicinal product may alter the effects of other medicines.

Pregnancy, breast-feeding and fertility

Ask your doctor for advice before being given any medicine.

Docetaxel Teva must NOT be administered if you are pregnant unless clearly indicated by your doctor.

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

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

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

Driving and using machines

3. How to use Docetaxel Teva

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

Usual dose

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

Method and route of administration

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

dministration d usually receive your infusion once every 3 weeks.

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

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 Docetaxel Teva 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 Docetaxel Teva may be increased when Docetaxel Teva is given in combination with other chemotherapeutic agents.

During the infusion at the hospital the following allergic reactions may occur (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.

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

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

Between infusions of Docetaxel Teva the following m combinations of medicines that are received:

Very common (may affect more than 1 in 10

infections, decrease in the number of r fighting infection) and platelets

fever: if this happens you must tell you 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

short f breath

nasal age; 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 colour 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

infection of the upper respiratory tract.

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)
• rises in blood sugar levels (diabetes)
• decrease of the potassium, calcium and/or phosphate in your blood.

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

• fainting
• at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling
• blood clots
• acute myeloid leukemia and myelodysplastic syndrome blood cancer) may occur in

patients who are treated with docetaxel together with in other anticancer treatments.

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

• inflammation of the colon, small intestine intestinal perforation.

Frequency not known (cannot be estimated from the available data):

• 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 blurred vision due decrease of the s

ventricular a

severe short of breath, dizziness, and/or fainting). Some of these symptoms can be serious.

If this happens, you must tell your doctor immediately

injection site reactions at the site of a previous reaction

non-Hodgkin lymphoma (a cancer affecting the immune system) and other cancers may occur in patients who are treated with docetaxel together with certain other anticancer treatments.

Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash. You may also have flu-like symptoms at the same time, such as fever, chills or aching muscles.)

Acute Generalized Exanthematous Pustulosis (AGEP) (red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever.)

Tumour lysis syndrome is a serious condition revealed by changes in blood test such as increased level of uric acid, potassium, phosphorus and decreased level of calcium; and results in symptoms such as seizures, kidney failure (reduced amount or darkening of urine) and heart rhythm disturbance. If this happens, you must tell your doctor immediately.

Myositis (inflammation of the muscles -hot, red and swollen- which produces muscle pain and weakness)

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 inBy reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Docetaxel Tevar

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

This medicine should not be used after the expiry date which is stated on the carton and vi “EXP”. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not freeze.

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

The premix solution should be used immediately after preparation. stability of the premix solution has been demonstrated for 8 ho 8°C or at room temperature (below 25°C).

The infusion solution should be used within 4

6.   Contents of the pack and other

The other ingredients are polysorbate 80 and 25.1% (w/w) anhydrous ethanol (see section 2).

l Teva looks like and contents of the pack:

va concentrate for solution for infusion is a clear viscous, yellow to brown-yellow

Each carton contains:

• one 6 ml clear glass vial with a flip-off cap containing 0.72 ml concentrate and,
• one 6 ml clear glass vial with a flip-off cap containing 1.28 ml of solvent.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturer:

Pharmachemie B.V.

Swensweg 5

PO Box 552

2003 RN Haarlem

The Netherlands

TEVA Pharmaceutical Works Private Limited Company

Tancsics Mihaly ut 82

H-2100 Gödöllö,

Hungary

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

België/Belgiqu­e/Belgien

Teva Pharma Belgium N.V./S.A./AG

Tel/Tél: +32 3 820 73 73

Kùnpoç

Specifar A.B.E.E.

EMáSa

Tql: +30 211 880 5000

Latvija

UAB Teva Baltics filiäle Latvijä

Tel: +371 67 323 666

Detailed information on this medicine is

The following information is intended for healthcare professionals only:

PREPARATION GUIDE FOR USE WITH DOCETAXEL TEVA 20 mg/0.72 ml CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

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

• 1. FORMULATION

Docetaxel Teva 20 mg/0.72 ml concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution containing 27.73 mg/ml docetaxel in polysorbate 80. The solvent etaxel Teva is water for injections.

• 2. PRESENTATION

Docetaxel Teva is supplied as single-dose vials.

Each box contains one Docetaxel Teva vial (20 mg/0.72 ml) and one corr Docetaxel Teva vial in a carton.

Docetaxel Teva vials should not be stored above 25°C and should be protected from light.

Docetaxel Teva should not be used after the expiry date shown on the carton and vials.

Docetaxel Teva 20 mg/0.72 ml vial:

The Docetaxel Teva 20 mg/0.72 ml vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.

The Docetaxel Teva 20 mg/0.72 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 27.73 mg/ml.

f a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume has been established during the development of liquid loss during preparation of the premix (see section 4) due to alls of the vial and „dead-volume“. This overfill ensures that after

entire contents of the accompanying solvent for docetaxel vial, there is a ble premix volume of 2 ml containing 10 mg/ml docetaxel which corresponds mount of 20 mg/0.72 ml per vial.

ocetaxel Teva 20 mg/0.72 ml vial: vent for Docetaxel Teva 20 mg/0.72 ml vial is a 6 ml clear glass vial with a bromobutyl er stopper and a flip-off cap.

The solvent for Docetaxel Teva composition is water for injections.

Each solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml). The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva 20 mg/0.72 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.

• 3. RECOMMENDATIONS FOR THE SAFE HANDLING

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

If Docetaxel Teva concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If Docetaxel Teva 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 Docetaxel Teva premix solution (10 mg docetaxel/ml)

  
  

  4.1.1

  
  

  If the vials are stored under refrigeration, allow the required number of Doce 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 Docetaxel Teva vial by partially inverting the vial.

  
  

  vent for

  
  

  4.1.3

  
  

  Inject the entire contents of the syringe into the corresponding Doc

  
  

  4.1.4

  
  

  Remove the syringe and needle and mix manually by re seconds. Do not shake.

  
  

  eva vial.

  
  

  4.1.5

  
  

  Allow the premix vial to stand for 5 minutes at room t check that the solution is homogenous and clear (foam to the presence of polysorbate 80 in the formulation).

  
  

  ersions for at least 45

  
  

  (below 25°C) and then

  al even after 5 minutes due

  
  

  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).

  
  

  solution

  
  

  4.2

  
  

  4.2.1

  
  
  
  

  Preparation of the i

  
  

  More than one p on the requir

  
  

  ix vial may be necessary to obtain the required dose for the patient. Based 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.

  
  

  the required premix volume into a 250 ml non-PVC infusion bag or bottle containing her 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 0.74 mg/ml docetaxel is not exceeded.

  
  

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

    • 4.2.4 The Docetaxel Teva 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, Docetaxel Teva 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.

What Docetaxel Teva is and what it is used for

hat you need to know before you use Docetaxel Teva

You must NOT be given Docetaxel Teva:

• if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel Teva (listed in section 6).
• if the number of white blood cells is too low.
• if you have a severe liver disease.

Warnings and precautions

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

Tell your doctor, hospital pharmacist, or nurse immediately if you have abdominal pain or tenderness, diarrhoea, rectal haemorrhage, blood in stool or fever. These symptoms may be the first signs of a serious gastrointestinal toxicity, which could be fatal. Your doctor should address them immediately.

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.

Tell your doctor, hospital pharmacist or nurse if you have experienced an allergic reaction to previous paclitaxel therapy.

Tell your doctor, hospital pharmacist or nurse if you have heart problems.

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 Docetaxel Teva administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of Docetaxel Teva in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).

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

Severe skin problems such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with Docetaxel Teva:

• – SJS/TEN symptoms may include blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash. You may also have flu-like symptoms at the same time, such as fever, chills or aching muscles.

• – AGEP symptoms may include a red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever.

If you develop severe skin reactions or any of the reactions listed above, immediately contact your doctor or healthcare professional.

Tell your doctor, hospital pharmacist or nurse if you have kidney problems or high levels of uric acid in your blood before initiating Docetaxel Teva.

Docetaxel Teva contains alcohol. Discuss with your doctor if you suffer from alcohol dependency. See also section “Docetaxel Teva contains ethanol (alcohol)” below.

Other medicines and Docetaxel Teva

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 Docetaxel Teva or the other medicine may not work as well as expected and you may be more likely to get a side effect.

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

Pregnancy, breast-feeding and fertility

Ask your doctor for advice before being given any medicine.

Docetaxel Teva must NOT be administered if you are pregnant unless clearly indicated by your doctor.

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

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

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

Driving and using machines

3. How to use Docetaxel TevaDocetaxel Teva will be

o you by a healthcare professional.

Usual dose

The dose will depend on your weight and your general condition. Your doctor will calculate your body

:ters (m2) and will determine the dose you should receive.

Method an

of administration

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

Frequency of administration

You should usually receive your infusion once every 3 weeks.

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

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 Docetaxel Teva 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 Docetaxel Teva may be increased when Docetaxel Teva is combination with other chemotherapeutic agents.

During the infusion at the hospital the following allergic reactions may occur (may aff 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.

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

The hospital staff will monitor your notice any of these effects.

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

infection of the upper respiratory tract.

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)
• rises in blood sugar levels (diabetes)
• decrease of the potassium, calcium and/or phosphate in your blood.

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

• fainting
• at the injection site, skin reactions, phlebitis (infl

blood clots

acute myeloid leukemia and myelodysplastic syndrome (types of blood cancer) may occur in patients who are treated with docetaxel together with certain other anticancer treatments.

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

• inflammation of the colon, small intestine, which could be fatal (frequency not known); intestinal perforation.

Frequency not known (cannot be estimated from the available data):

interstitial lung disease (i

breathing.Infl 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, and/or magnesium in your blood (electrolyte balance disorders) ventricular arrhythmia or ventricular tachycardia (manifested as irregular and/or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting). Some of these symptoms can be serious.

If this happens, you must tell your doctor immediately injection site reactions at the site of a previous reaction non-Hodgkin lymphoma (a cancer affecting the immune system) and other cancers may occur in patients who are treated with docetaxel together with certain other anticancer treatments.

Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash. You may also have flu-like symptoms at the same time, such as fever, chills or aching muscles.)

Acute Generalized Exanthematous Pustulosis (AGEP) (red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever.)

Tumour lysis syndrome is a serious condition revealed by changes in blood test such as increased level of uric acid, potassium, phosphorus and decreased level of calcium; and results in symptoms such as seizures, kidney failure (reduced amount or darkening of urine) and heart rhythm disturbance. If this happens, you must tell your doctor immediately.

Myositis (inflammation of the muscles -hot, red and swollen- which produces muscle pain and weakness)

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 inBy reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Docetaxel Teva

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

This medicine should not be used after the expiry date which is stated on the carton and vials after “EXP”. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not freeze.

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

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

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

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines no longer used. These measures will help to protect the environment.

6. Contents of the pack

other information

oncentrate vial contains:

ce is docetaxel. Each vial of Docetaxel Teva 80 mg/2.88 ml concentrate contains 80 mg of docetaxel. Each ml of concentrate contains 27.73 mg docetaxel.

The other ingredients are polysorbate 80 and 25.1% (w/w) anhydrous ethanol (see section 2).

solvent vial contains:

Water for injections.

What Docetaxel Teva looks like and contents of the pack:

Docetaxel Teva concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution.

Each carton contains:

• one 15 ml clear glass vial with a flip-off cap containing 2.88 ml concentrate and,
• one 15 ml clear glass vial with a flip-off cap containing 5.12 ml of solvent.

Marketing Authorisation Holder

Česká republika

Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251 007 111

Danmark

Teva Denmark A/S

Tlf: +45 44 98 55 11

Deutschland

Teva GmbH

Tel: +49 731

Magyarország

Teva Gyógyszergyár Zrt.

Tel.: +36 1 288 64 00

Malta

Teva Pharmaceuticals Ireland

L-Irlanda

Tel: +353 19127700

Nederland

Teva Nederland B.V.

Tel: +31 800 0228 400

UAB Teva Baltics Eesti filiaal Tel: +372 661 0801

Österreich

ratiopharm Arzneimittel Vertriebs-GmbH

Tel: +43 1 97007 0

Polska

Teva Pharmaceuticals Polska Sp. z o.o.

Tel.: +48 22 345 93 00

The following information is intended for healthcare professionals only:

PREPARATION GUIDE FOR USE WITH DOCETAXEL TEVA 80 mg/2.88 ml CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

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

• 1. FORMULATION

Docetaxel Teva 80 mg/2.88 ml concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution containing 27.73 mg/ml docetaxel in polysorbate 80. The solvent etaxel Teva is water for injections.

• 2. PRESENTATION

Docetaxel Teva is supplied as single-dose vials.

Each box contains one Docetaxel Teva vial (80 mg/2.88 ml) and one corr Docetaxel Teva vial in a carton.

Docetaxel Teva vials should not be stored above 25°C and should be protected from light.

Docetaxel Teva should not be used after the expiry date shown on the carton and vials.

• 2.1 Docetaxel Teva 80 mg/2.88 ml vial:

• The Docetaxel Teva 80 mg/2.88 ml vial is a 15 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.

The solvent for Docetaxel Teva composition is water for injections.

Each solvent vial contains 5.12 ml of water for injections (fill volume: 6.29 ml). The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva 80 mg/2.88 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.

• 3. RECOMMENDATIONS FOR THE SAFE HANDLING

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

If Docetaxel Teva concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If Docetaxel Teva 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 Docetaxel Teva premix solution (10 mg docetaxel/ml)

  
  

  4.1.1

  
  

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

  
  

  4.1.2

  
  

  4.1.3

  
  

  Using a syringe fitted with a needle, aseptically withdraw the entire contents Docetaxel Teva vial by partially inverting the vial.

  Inject the entire contents of the syringe into the corresponding Docetaxel Teva vial.

  
  

  vent for

  
  

  4.1.4

  
  

  Remove the syringe and needle and mix manually by re seconds. Do not shake.

  
  

  4.1.5

  
  

  Allow the premix vial to stand for 5 minutes at room t check that the solution is homogenous and clear (foam to the presence of polysorbate 80 in the formulation).

  
  

  ersions for at least 45

  
  

  (below 25°C) and then

  al even after 5 minutes due

  
  

  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).

  
  

  solution

  
  

  4.2

  
  

  4.2.1

  
  
  
  

  Preparation of the i

  
  

  More than one p on the requir

  
  

  ix vial may be necessary to obtain the required dose for the patient. Based 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.

  
  

  the required premix volume into a 250 ml non-PVC infusion bag or bottle containing her 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 0.74 mg/ml docetaxel is not exceeded.

  
  

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

    • 4.2.4 The Docetaxel Teva 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, Docetaxel Teva premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.

• 5. DISPOSAL