Docetaxel Teva Generics 80 mg Powder and Solvent for Solution for Infusion version 1

NL/H/1608/002/DC    draft 1

PL 00289/1326

PACKAGE LEAFLET: INFORMATION FOR THE USER

Docetaxel Teva Generics 80 mg powder and solvent for concentrate for solution for

infusion

Docetaxel

Read all of this leaflet carefully before you start using this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or your hospital pharmacist.

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

In this leaflet:

1.    What Docetaxel Teva Generics 80 mg powder and solvent for concentrate for solution for infusion is and what it is used for

2.    Before you use Docetaxel Teva Generics 80 mg powder and solvent for concentrate for solution for infusion

3.    How to use Docetaxel Teva Generics 80 mg powder and solvent for concentrate for solution for infusion

4.    Possible side-effects

5.    How to store Docetaxel Teva Generics 80 mg powder and solvent for concentrate for solution for infusion

6.    Further information

1. WHAT DOCETAXEL TEVA GENERICS 80 mg POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR

The name of this medicine is Docetaxel Teva Generics. 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 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. BEFORE DOCETAXEL TEVA GENERICS 80 mg POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION IS ADMINISTERED TO YOU You must not be given Docetaxel Teva Generics:

-    if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel Teva Generics

-    if you already have a low number of white blood cells

-    if you have a severe liver disease

Take special care with Docetaxel Teva Generics:

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

You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Teva Generics 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 Generics in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).

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

Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other 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:

Ask your doctor for advice before being given any medicine.

Docetaxel Teva Generics 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.

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.

Breast feeding:

You must notbreast-feed while you are treated with Docetaxel Teva Generics.

Driving and using machines:

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

3. HOW DOCETAXEL TEVA GENERICS 80 mg POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION IS ADMINISTERED

Docetaxel Teva Generics will be prescribed for you by a specialist in cancer treatment. Carefully follow the advice of your doctor when Docetaxel Teva Generics is administered to you.

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 Teva Generics 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 Generics. 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, Docetaxel Teva Generics can cause side effects, although not everybody gets them.

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

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

The most commonly reported adverse reactions of Docetaxel Teva Generics 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 Generics may be increased when Docetaxel Teva Generics is given in combination with other anticancer agents.

During the infusion at the hospital the following allergic reactions (experienced in more than 1 person in 10) 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 hospital staff will monitor your condition closely during treatment. Tell them immediately if you notice any of these effects.

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

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

•    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

•    short term 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 (experienced in less than 1 in 10 but more than 1 in 100 patients)

•    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: (experienced in more than 1 in 1,000 but less than 1 in 100)

•    fainting

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

•    inflammation of the colon, small intestine; intestinal perforation

•    blood clots.

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

5. HOW TO STORE DOCETAXEL TEVA GENERICS 80 mg POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Keep out of the reach and sight of children.

Docetaxel Teva Generics should not be used after the expiry date shown on the carton and vials. The expiry date refers to the last day of that month.

Do not freeze.

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

Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours when stored either at room temperature (below 25°C) or between 2°C and 8°C.

The reconstituted solution should be inspected visually prior to use. It should only be used if the solution is clear and practically free from particles.

Chemical and physical in-use stability of the infusion solution has been demonstrated for 4 hours when stored at room temperature (below 25°C) and 24 hours when stored at between 2°C and 8°C.

From a microbiological point of view, the reconstituted solution and infusion solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6. FURTHER INFORMATION

What Docetaxel Teva Generics 80 mg powder for concentrate for solution for infusion contains

-    The active substance is docetaxel; 1 ml of reconstituted solution contains 5 mg docetaxel anhydrous. One vial contains 80 mg docetaxel.

-    The other ingredients are povidone K-12, hydroxypropylbetadex and dextrose monohydrate.

-    Each carton box contains 80 mg of docetaxel in one single-dose vial and 13.4 ml solvent (water for injections) in one single-dose vial

What Docetaxel Teva Generics solvent for concentrate for solution for infusion contains

-    The solvent vial contains 13.4 ml of water for injections.

What Docetaxel Teva Generics powder for concentrate for solution for infusion looks like and contents of the pack

Docetaxel Teva Generics, powder for concentrate for solution for infusion is a white, powder or cake in a colourless glass vial with bromobutyl rubber stopper, aluminium seal and polypropylene snap-cap. The solvent is a clear and colourless solution.

Each pack contains one single-dose vial of docetaxel and one single-dose vial of solvent (water for injections).

What Docetaxel Teva Generics solvent for concentrate for solution for infusion looks like

Solvent for Docetaxel Teva Generics, powder for concentrate for solution for infusion is a colourless liquid in a colourless glass vial with chlorobutyl rubber stopper, aluminium seal and polypropylene snap-cap.

The vials are supplied in cartons each containing two vials.

-    One single-dose vial of docetaxel powder for solution for infusion and,

-    One single-dose vial of solvent.

Marketing Authorisation Holder:

Teva UK Limited, Eastbourne, BN22 9AG, United Kingdom

Manufacturer:

Pharmachemie B.V, Swensweg 5, 2031 GA Haarlem, The Netherlands

This leaflet was last revised in March 2011.

PL 00289/1326

PREPARATION GUIDE FOR USE WITH DOCETAXEL TEVA GENERICS 80 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

(Please note this is a Prescriber Information Leaflet NOT the SPC. For full details regarding this product please refer to the SPC).

The following information is intended for medical or healthcare professionals only:

Preparation of the reconstituted solution (5 ml docetaxel/ml)

If the vials are stored under refrigeration, allow the required number of Docetaxel Teva Generics 80 mg boxes to stand at room temperature (below 25°C) for 5 minutes.

Using a syringe fitted with a needle, aseptically withdraw 13.4 ml of the solvent for Docetaxel Teva Generics 80 mg vial by partially inverting the vial.

Inject the entire contents of the syringe into the corresponding Docetaxel Teva Generics 80 mg vial.

Remove the syringe and needle and mix manually by repeated inversions until all powder is dissolved (within 5 minutes).

Visually check that the solution is homogeneous, clear and free from visible particles.

The vial contains 80 mg of docetaxel with povidone K-12, hydroxypropylbetadex and glucose monohydrate as excipients (fill volume 81.5 mg/16.3 ml).This fill volume has been established during development for ease of withdrawing 16.0 ml of reconstituted solution.

The overfill ensures that after reconstitution with 13.4 ml of the accompanying solvent for Docetaxel Teva Generics 80 mg vial, there is a minimal extractable reconstituted volume of 16 ml containing 5 mg/ml docetaxel which corresponds to the labelled amount of 80 mg per vial. The premix is for single use only.

Chemical and physical in-use stability has been demonstrated for 24 hours when stored either at room temperature (below 25°C) or between 2°C and 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Preparation of the infusion solution

More than one reconstituted 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 reconstituted volume containing 5 mg/ml docetaxel from the appropriate number of reconstituted vials using graduated syringes fitted with a needle. For example, a dose of 100 mg docetaxel would require 20 ml docetaxel reconstituted solution.

Inject the required premix 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.

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

Chemical and physical in-use stability has been demonstrated for 4 hours when stored at room temperature (below 25°C) and 24 hours when stored at between 2°C and 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

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

As with all parenteral products, Docetaxel Teva Generics 80 mg reconstituted solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.

For single use only. Discard any unused solution.

Any unused product or waste material should be disposed of in accordance with local requirements.

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