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Docetaxel 10 Mg/Ml Concentrate For Solution For Infusion

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Document: leaflet MAH GENERIC_PL 10880-0142 change

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PL 10880/0142

Hexal AG

Docetaxel 10 mg/ml Concentrate for Solution for Infusion

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Docetaxel 10 mg/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, pharmacist or nurse.

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

What is in this leaflet:

1.    What Docetaxel is and what it is used for

2.    What you need to know before you use Docetaxel

3.    How to use Docetaxel

4.    Possible side effects

5.    How to store Docetaxel

6.    Contents of the pack and other information

1. WHAT DOCETAXEL IS AND WHAT IT IS USED FOR

The name of this medicine is Docetaxel 10 mg/ml Concentrate for Solution for Infusion. 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.

Docetaxel 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 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 could be administered in combination with doxorubicin and cyclophosphamide.

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

•    for the treatment of prostate cancer, Docetaxel is administered in combination with prednisone or prednisolone.

•    for the treatment of metastatic gastric cancer, Docetaxel is administered in combination with cisplatin and 5-fluorouracil.

•    for the treatment of head and neck cancer, Docetaxel is administered in combination with cisplatin and 5-fluorouracil.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE DOCETAXEL Do not use Docetaxel if

•    you are allergic to docetaxel or any of the other ingredients of this medicine.

•    the number of white blood cells is too low.

•    you have a severe liver disease.

Warnings and precautions

Before each treatment with Docetaxel 10 mg/ml Concentrate for Solution for Infusion, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel. 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 Docetaxel 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 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.

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

Other medicines and Docetaxel

Tell your doctor, nurse or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.

This is because Docetaxel 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.

Docetaxel 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 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

If you are a man being treated with Docetaxel 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. Docetaxel contains ethanol (alcohol)

This medicinal product contains 75 vol % ethanol (alcohol), i.e. up to 4.7g (6 ml) per 80mg vial, equivalent to 120ml of beer or 48ml wine per 80mg vial.

Harmful for those suffering from alcoholism.

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

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

The amount of alcohol in this medicinal product may impair the patient's ability to drive or use machines.

3. HOW TO USE DOCETAXEL

Docetaxel will be administered to you by a healthcare professional.

Usual dosage

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 will be given by infusion into one of your veins (intravenous use). The infusion will last approximately 1 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. 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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

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

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

The severity of adverse events of Docetaxel may be increased when Docetaxel 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) may occur:

•    flushing, skin reactions, itching

•    chest tightness; difficulty in breathing

•    fever or chills

•    back pain

•    low blood pressure.

More severe reactions may occur.

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

Between infusions of Docetaxel the following may occur, and the frequency may vary with the combinations of drugs 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 of 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)

•    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.

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 in your blood.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE DOCETAXEL

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

Do not use this medicine after the expiry date which is stated on the label and on the carton. The expiry date refers to the last day of that month.

Do not store above 25°C or below 2C°. Do not freeze.

After first opening, before dilution:

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, dilution must take place in controlled and aseptic conditions.

After dilution:

Use the medicine immediately once added into the infusion bag. If not used immediately, in-use storage times and conditions are the responsibility of the user and should not be longer than 48 hours below 25°C (including the one hour infusion).

Docetaxel infusion solution is supersaturated, therefore may crystallise 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 Docetaxel 10 mg/ml Concentrate for Solution for Infusion contains

The active substance is docetaxel.

1 ml concentrate for solution for infusion contains 10 mg docetaxel (anhydrous).

The other ingredients are ethanol anhydrous, citric acid anhydrous, polysorbate 80.

What Docetaxel 10 mg/ml Concentrate for Solution for Infusion looks like and contents of the pack

Docetaxel 10 mg/ml Concentrate for Solution for Infusion is a clear pale yellow solution.

The medicinal product is supplied in a glass container called vial with a bromobutyl-rubber stopper.

20 mg vial: each vial contains 2 ml concentrate for solution for infusion.

80 mg vial: each vial contains 8 ml concentrate for solution for infusion.

160 mg vial: each vial contains 16 ml concentrate for solution for infusion.

Pack sizes:

1, 5 and 10 vial(s)

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Hexal AG,

Industriestr. 25,

83607 Holzkirchen,

Germany

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1, 39179 Barleben - Germany Or

Lek Pharmaceuticals d.d.

Verovskova 57, 1526 Ljubljana - Slovenia

Or

EBEWE Pharma Ges.m.b.H. Nfg.KG Mondseestrasse 11, 4866 Unterach - Austria

This leaflet was last revised in 12/2014.

Docetaxel 10 mg/ml Concentrate for Solution for Infusion The following information is intended for medical or healthcare professionals only:

Instructions for use

CYTOSTATIC

FORMULATION

Docetaxel is a concentrate for solution for infusion which can directly be used to prepare 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.

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 Docetaxel solutions. The use of gloves is recommended.

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

PREPARATION FOR THE INFUSION SOLUTION

More than one 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 concentrate for solution for infusion volume containing 10 mg/ml Docetaxel from the appropriate number of vials using graduated syringes fitted with a needle. For example, a dose of 140 mg docetaxel would require 14 ml docetaxel concentrate for solution for infusion.

Inject the required concentrate for solution for infusion volume into a 250 ml infusion bag or bottle containing either 5% glucose solution or 0.9% sodium chloride solution. 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. To prevent multiple piercing of the infusion bag or bottle during the preparation of the infusion solution, the correct volume of concentrate in accordance with the required dose must be measured and transferred to the infusion bag or bottle as a single injection only.

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

From a microbiological point of view, 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 48 hours. It should be used within 48 hours (including the one hour infusion IV administration).

As with all parenteral products, Docetaxel concentrate for solution for infusion and 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.

PIL.10880.0142.006d 12/12/14 JG

V012: PI update - PRAC _PSUR

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