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Document: leaflet MAH GENERIC_PL 14510-0052 change

• leaflet MAH GENERIC_PL 10880-0142
• leaflet MAH GENERIC_PL 14510-0052
• leaflet SANDOZ_PL 14510-0052

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Docetaxel 10 mg/ml concentrate for solution for infusion

Docetaxel

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

-    Keep this leaflet. Y ou 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.

What is in this leaflet:

1.    What Docetaxel is and what it is used for.

2.    Before you use Docetaxel.

3.    How to use Docetaxel.

4.    Possible side effects.

5.    How to store Docetaxel.

6.    Further information

1. WHAT DOCETAXEL IS AND WHAT IT IS USED FOR

Docetaxel is a substance derived from the needles of yew tees.

Docetaxel contains the active ingredient docetaxel, which belongs to the group of anti-cancer medicines called taxoids.

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

Docetaxel may be used alone or with other anti-cancer treatments.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE DOCETAXEL You must not be given Docetaxel if you

•    are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

•    have not enough white blood cells.

•    have a severe liver disease.

•    are pregnant or breast feeding.

Warnings and precautions

Before each treatment with Docetaxel, you will have blood tests to check that you have enough blood cells and your liver is working properly. In case of white blood cells disturbances, you may experience associated fever or infections.

You will be asked to take premedication of an oral corticosteroid such as dexamethasone, one day before Docetaxel administration and to continue for one or two days after it, in order to reduce side effects such as allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).

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

This medicinal product contains 4100 mg alcohol per 160 mg (average dose), equivalent to less than 100 ml beer.

Please tell your doctor if you are suffering from alcoholism, liver disease or epilepsy as this may have an influence on your condition.

Other medicines and Docetaxel

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 [Nationally completed name] or the other medicine may not work as well as expected and you may be more likely to get a side effect.

Docetaxel with food and drink:

Grapefruit (fruit or juice) should not be consumed while taking Docetaxel. It can interfere with the usual effect of your medicine and you may be more likely to get a side effect.

Pregnancy and breast-feeding

Docetaxel must NOT be administered if you are pregnant or if you are planning to become pregnant. You must take adequate contraceptive precautions during therapy and for at least three months after Docetaxel is no longer administered to you. 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 thinking of becoming pregnant or breast-feeding discuss it with your doctor first before taking any medicine.

Driving and using machines

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

3. HOW TO USE Docetaxel

Docetaxel will be given 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 work out the dose you should receive.

Method and route of administration

Docetaxel will be given by infusion into one of your veins. 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. 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 hospital pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all other anticancer medicines, Docetaxel 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 bood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhea 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 (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 the following may occur, and the frequency may vary with the combinations of drug that are received:

Very common side effects (affects more than 1 user in 10)

■    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)

■    unable to sleep (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 tears in 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 feeling sick (nausea), vomiting and diarrhea, 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 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 side effects (affects 1 to 10 users in 100)

■    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 side effects (affects 1 to 10 users in 1,000)

■    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:

Keep out of the reach and sight of children.

Do not use Docetaxel after the expiry date which is stated on the carton and vials after the abbreviation ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

The infusion solution should be used within 4 hours including the one hour infusion time. Chemical and physical in-use stability has been demonstrated at room temperature (below 25 °C) or refrigerated (2-8°C). Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Reporting of side effects

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

6.    FURTHER INFORMATION What Docetaxel contains

The active substance is docetaxel. 1 ml of the concentrate for solution for infusion contains 10 mg docetaxel.

The other ingredients are:

Citric Acid Anhydrous Macrogol 300 Polysorbate 80 Ethanol 96%

One ml of the concentrate for solution for infusion contains 10 mg docetaxel.

Each vial of 2ml contains 20 mg docetaxel (10 mg/ml).

Each vial of 8 ml contains 80 mg docetaxel (10 mg/ml).

Each vial of 16 ml contains 160 mg docetaxel (10 mg/ml)

What Docetaxel looks like and contents of the pack

Docetaxel 10 mg/ml concentrate for solution for infusion is a clear, colourless to pale yellow solution. Docetaxel is presented in clear glass vials containing 2 ml (20 mg/vial), 8 ml (80 mg/vial) or 16 ml (160mg/vial).

Pack sizes:

20 mg/2ml: 1 vial, 5 and 10 vials 80 mg/8ml: 1 vial, 5 and 10 vials 160 mg/16ml: 1 vial, 5 and 10 vials

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria	Docetaxel Ebewe 10 mg/ml Konzentrat zur Herstellung einer Infusionslosung
Belgium	Docetaxel Ebewe Pharma 10 mg/ml Konzentrat zur Herstellung einer Infusionslosung Docetaxel Ebewe Pharma 10 mg/ml solution a diluer pour perfusion Docetaxel Ebewe 10 mg/ml concentraat voor oplossing voor infusie
Bulgaria	Docetaxel Ebewe 10 mg/ml KoH^mpaT 3a HH$y3HOHeH pa3TBop
Cyprus	Docetaxel Ebewe 10 mg/ml nuKvo dra^upa yia papasKeup dra^upatog ppog sy%usp
Czech Republic	Docetaxel Ebewe 10 mg/ml koncentrat pro pnpravu infuzmho roztoku
Denmark	Docetaxel Ebewe 10 mg/ml koncentrat till infusionsvaeske, oplosning
Estonia	Docetaxel Ebewe 10 mg/ml
Finland	Docetaxel Ebewe 10 mg/ml infuusiokonsentraatti, liuosta varten
France	Docetaxel Ebewe 10 mg/ml solution a diluer pour perfusion
Germany	Docetaxel NC 10 mg/ml Konzentrat zur Herstellung einer Infusionslosung
Greece	Docetaxel Ebewe 10 mg/ml nuKvo dra^upa yia papasKeup dra^upatoq ppog syyusp
Hungary	Docetaxel Ebewe 10 mg/ml koncentratum oldatos infuziohoz
Ireland	Docetaxel Ebewe 10 mg/ml concentrate for solution for infusion
Italy	Docetaxel Ebewe 10 mg/ml concentrato per soluzione per infusione
Latvia	Docetaxel Ebewe 10 mg/ml koncentrats infuziju skiduma pagatavosanai
Lithuania	Docetaxel Ebewe 10 mg/ml koncentratas infuziniam tirpalui
Luxembourg	Docetaxel Ebewe 10 mg/ml concentrate for solution for infusion
Malta	Docetaxel Ebewe 10 mg/ml concentrate for solution for infusion
Netherlands	Docetaxel Ebewe 10 mg/ml concentraat voor oplossing voor infusie
Norway	Docetaxel Ebewe 10 mg/ml konsentrat til infusjonsv^ske
Poland	Docetaxel Ebewe 10 mg/ml koncentrat do sporzpdzania roztworu do infuzji
Portugal	Docetaxel Ebewe 10 mg/ml concentrado para solu^ao para perfusao
Romania	Docetaxel Ebewe 10 mg/ml concentrat pentru solufie perfuzabila

Slovakia	Docetaxel Ebewe 10 mg/ml infuzny koncentrat
Slovenia	Docetaksel Ebewe 10 mg/ml koncentrat za raztopino za infundiranje
Spain	Docetaxel Ebewe 10 mg/ml concentrado para solution para perfusion
Sweden	Docetaxel Ebewe 10 mg/ml koncentrat till infusionsvatska, losning
United Kingdom	Docetaxel Ebewe 10 mg/ml concentrate for solution for infusion

This leaflet was last approved in 03/2014

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

Instructions for use and handling for disposal Inspection prior to use

Docetaxel concentrate for solution for infusion should be inspected visually for particulate matter and discoloration prior to dilution. If the concentrate is not clear or appears to have precipitation, it has to be discarded.

Preparation of the infusion solution The concentrate must be diluted before use.

Infusion solutions have to be prepared with either 0.9% sodium chloride or with 5% glucose and administered as an intravenous infusion.

If the vials are stored under refrigeration, allow the required number of vials of Docetaxel 10 mg/ml concentrate for solution for infusion to stand below 25°C until the solution has reached room temperature.

The required volume can be directly withdrawn from the vial.

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 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.

The required volume of Docetaxel 10 mg/ml concentrate for solution for infusion must be injected via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or 0.9% sodium chloride solution for infusion.

If a dose greater than 200mg 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 by gentle inversion and rotation in a controlled manner and avoid foaming. Shaking or vigorous agitation has to be avoided during preparation and transportation to the patient for administration.

The prepared Docetaxel infusion solution is stable for up to 4 hours and should be used within these 4 hours, including storage and the one hour infusion time to the patient. The infusion should be aseptically administered under room temperature (below 25 °C) and normal lighting conditions.

The infusion solution prepared using Docetaxel 10 mg/ml concentrate for solution for infusion, should be visually inspected carefully for precipitation prior to use. If the infusion solution is not clear or appears to have precipitation it has to be discarded. From a microbiological point of view, the product should be used immediately.

Contact of the Docetaxel concentrate with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended. In order to minimize patient exposure to the plasticizer DEHP (di-2-ethylhexyl phthalate), which may be leached from PVC infusion bags or sets, the final Docetaxel dilution for infusion should be stored in bottles or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.

To minimize the potential for precipitation of the infusion solution, the use of bags is recommended. Glass bottles are not recommended for use.

pH and osmolality of reconstituted solution

0.3 mg/mL in Glucose 5%: pH ~ 3.6; 517 mOsm/kg

0.74 mg/mL in NaCl 0.9%: pH ~ 3.3 - 3.6; 849 mOsm/kg

Guidelines for the Safe Handling of Antineoplastic Agents

Cytotoxic preparations should not be handled by pregnant staff. Trained personnel should dilute the drug. This should be performed in a designated area. The work surface should be covered with disposable plastic-backed absorbent paper.

Adequate protective gloves, masks and clothing should be worn. Precautions should be taken to avoid the drug accidentally coming into contact with skin or mucous membranes, the affected area should be cleaned thoroughly with soap and water. If accidental contamination occurs with the eyes, they should be wahsed with water thoroughly and immediately.

Use Luer-lock fittings on all syringes and sets. Large bore needles are recommended to minimise pressure and the possible formation of aerosols. The latter may also be reduced by the use of a venting needle.

Any unused contents should be discarded. Adequate care and precaution should be taken in the disposal of items used to dilute Docetaxel. Any unused product or contaminated materials should be placed in a high-risk waste bag. Sharp objects (needles, syringes, vials, etc) should be placed in a suitable rigid container. Personnel concerned with the collection and disposal of this waste should be aware of the hazard involved. Any unused product or waste material should be disposed of in accordance with standard procedures applicable to cytotoxic agents. Any excess drug solution should be flushed directly into a drain with copious amounts of water.

The medicinal product is capable for multiple use, please refer to section “storage and shelf life”.

In compatibilities

This medicinal product must not be mixed with other medicinal products. Administration

Docetaxel is for intravenous use only.

Storage and shelf life

Shelf life of medicinal product as packaged for sale:

Unopened:    24 months

After first opening:    28 days at 2°C - 8°C and at room temperature with and without light protection.

Shelf life after dilution:

Chemical and physical in-use stability has been demonstrated up to 4 hours at 2°C to 8°C with light protection and at below 25°C without light protection in Glucose 5% or Sodium Chloride 0.9%.

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.

Special precautions for storage

As packaged for sale:

Do not store above 25°C.

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

For storage condition of the diluted medicinal product, see section ‘Shelf life after dilution’.