Docetaxel Zentiva (previously Docetaxel Winthrop)

Informazzjoni prinċipali

  • Isem kummerċjali:
  • Docetaxel Zentiva (previously Docetaxel Winthrop)
  • Dominju tal-mediċina:
  • Bnedmin
  • Tip ta 'mediċina:
  • Droga allopatika

Dokumenti

Lokalizzazzjoni

  • Disponibbli fi:
  • Docetaxel Zentiva (previously Docetaxel Winthrop)
    Unjoni Ewropea
  • Lingwa:
  • Ingliż

Informazzjoni terapewtika

  • Grupp terapewtiku:
  • Antineoplastic agents,
  • Żona terapewtika:
  • Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Stomach Neoplasms, Breast Neoplasms
  • Indikazzjonijiet terapewtiċi:
  • Breast cancerDocetaxel Winthrop in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.Docetaxel Winthrop in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Docetaxel Winthrop monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.Docetaxel Winthrop in combination with trastuzumab is indicated for the treatment of patients with metastatic breast
  • Sommarju tal-prodott:
  • Revision: 30

Status

  • Sors:
  • EMA - European Medicines Agency
  • L-istatus ta 'awtorizzazzjoni:
  • Authorised
  • Numru ta 'awtorizzazzjoni:
  • EMEA/H/C/000808
  • Data ta 'l-awtorizzazzjoni:
  • 19-04-2007
  • Kodiċi EMEA:
  • EMEA/H/C/000808
  • L-aħħar aġġornament:
  • 25-07-2019

Rapport ta 'Valutazzjoni Pubblika

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Telephone

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Facsimile

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Send a question via our website

www.ema.europa.eu/contact

© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.

EMA/883937/2018

EMEA/H/C/000808

Docetaxel Zentiva

(docetaxel)

An overview of Docetaxel Zentiva and why it is authorised in the EU

What is Docetaxel Zentiva and what is it used for?

Docetaxel Zentiva is a cancer medicine used to treat the following types of cancer:

breast cancer. Docetaxel Zentiva can be used on its own after other treatments have failed. It can

also be used with other cancer medicines (doxorubicin, cyclophosphamide, trastuzumab or

capecitabine) in patients who have not yet received any treatment for their cancer or after other

treatments have failed, depending on the type and stage of the breast cancer being treated;

non-small-cell lung cancer. Docetaxel Zentiva can be used on its own after other treatments have

failed. It can also be used with cisplatin (another cancer medicine) in patients who have not yet

received any treatment for their cancer;

prostate cancer, when the cancer does not respond to hormonal treatment. Docetaxel Zentiva is

used with prednisone or prednisolone (anti-inflammatory medicines);

gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any

treatment for their cancer. Docetaxel Zentiva is used with cisplatin and 5-fluorouracil (other cancer

medicines);

head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but

has not spread). Docetaxel Zentiva is used with cisplatin and 5-fluorouracil.

Docetaxel Zentiva contains the active substance docetaxel.

How is Docetaxel Zentiva used?

Docetaxel Zentiva can only be obtained with a prescription and is used in wards specialising in

chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in

the use of chemotherapy.

Docetaxel Zentiva is given as a one-hour infusion (drip) into a vein every three weeks. The dose,

duration of treatment and the medicines it is used with depend on the type of cancer being treated.

Docetaxel Zentiva is only used when the neutrophil count (the level of a type of white blood cell in the

Previously known as Docetaxel Winthrop.

Docetaxel Zentiva0F (docetaxel)

EMA/883937/2018

Page 2/3

blood) is normal (at least 1,500 cells/mm

). An anti-inflammatory medicine such as dexamethasone

should also be given to the patient, starting on the day before the Docetaxel Zentiva infusion.

For more information about using Docetaxel Zentiva, see the package leaflet or contact your doctor or

pharmacist.

How does Docetaxel Zentiva work?

The active substance in Docetaxel Zentiva, docetaxel, belongs to the group of cancer medicines known

as the taxanes. Docetaxel blocks the ability of cells to destroy the internal ‘skeleton’ that allows them

to divide and multiply. With the skeleton still in place, the cells cannot divide and they eventually die.

Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.

What benefits of Docetaxel Zentiva have been shown in studies?

Docetaxel Zentiva has been studied in over 4,000 breast-cancer patients, around 2,000 non-small-cell-

lung-cancer patients, 1,006 prostate-cancer patients, 457 gastric-adenocarcinoma patients and 897

head- and neck-cancer patients. In most of these studies, Docetaxel Zentiva was combined with other

anticancer treatments and compared either with combinations of different treatments or with the same

treatments but without Docetaxel Zentiva.

Adding Docetaxel Zentiva to other cancer treatments produced increases in the number of patients

whose cancer responded to treatment, how long the patients lived without their disease getting worse

and how long the patients survived, in all five types of cancer. When used on its own, Docetaxel

Zentiva was at least as effective as and sometimes more effective than the comparator medicines in

breast cancer, and more effective than best supportive care (any medicines or techniques to help

patients, but not other cancer medicines) in lung cancer.

What are the risks associated with Docetaxel Zentiva?

The most common side effects with Docetaxel Zentiva (which may affect more than 1 in 10 people) are

neutropenia (low levels of neutrophils), anaemia (low red blood cell counts), febrile neutropenia

(neutropenia with fever), peripheral sensory neuropathy (nerve damage in the hands and feet),

peripheral motor neuropathy (damage to the nerves causing difficulty co-ordinating movements),

dysgeusia (taste disturbances), dyspnoea (difficulty breathing), stomatitis (inflammation of the lining

of the mouth), diarrhoea, nausea (feeling sick), vomiting, alopecia (hair loss), skin reactions, nail

disorders, myalgia (muscle pain), loss of appetite, infections, fluid retention, asthenia (weakness), pain

and hypersensitivity (allergic reactions). These side effects may be more severe when Docetaxel

Zentiva is used with other cancer medicines. For the full list of side effects with Docetaxel Zentiva, see

the package leaflet.

Docetaxel Zentiva must not be used in patients who have a neutrophil count of less than 1,500

cells/mm

or who have severe problems with their liver. For the full list of restrictions, see the package

leaflet.

Why is Docetaxel Zentiva authorised in the EU?

The European Medicines Agency decided that Docetaxel Zentiva’s benefits are greater than its risks

and it can be authorised for use in the EU.

Docetaxel Zentiva0F (docetaxel)

EMA/883937/2018

Page 3/3

What measures are being taken to ensure the safe and effective use if

Docetaxel Zentiva?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Docetaxel Zentiva have been included in the summary of product characteristics

and the package leaflet.

As for all medicines, data on the use of Docetaxel Zentiva are continuously monitored. Side effects

reported with Docetaxel Zentiva are carefully evaluated and any necessary action taken to protect

patients.

Other information about Docetaxel Zentiva

Docetaxel Zentiva received a marketing authorisation valid throughout the EU on 20 April 2007. This

authorisation was based on the authorisation granted to Taxotere in 1995 (‘informed consent’).

Further information on Docetaxel Zentiva can be found on the Agency’s website:

ema.europa.eu/medicines/human/EPAR/docetaxel-zentiva

This overview was last updated in 01-2019.

Fuljett ta 'Informazzjoni għall-Pazjent: prodott - kompożizzjoni, indikazzjonijiet, effetti sekondarji, dożaġġ, interazzjonijiet, reazzjonijiet avversi, tqala, treddigħ

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Docetaxel Zentiva 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, your 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:

What Docetaxel Zentiva is and what it is used for

What you need to know before you use Docetaxel Zentiva

How to use Docetaxel Zentiva

Possible side effects

How to store Docetaxel Zentiva

Contents of the pack and other information

1.

What Docetaxel Zentiva is and what it is used for

The name of this medicine is Docetaxel Zentiva. 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 Zentiva 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 Zentiva 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 Zentiva

could be administered in combination with doxorubicin and cyclophosphamide.

- For the treatment of lung cancer, Docetaxel Zentiva could be administered either alone or in

combination with cisplatin.

- For the treatment of prostate cancer, Docetaxel Zentiva is administered in combination with

prednisone or prednisolone.

- For the treatment of metastatic gastric cancer, Docetaxel Zentiva is administered in combination with

cisplatin and 5-fluorouracil.

- For the treatment of head and neck cancer, Docetaxel Zentiva is administered in combination with

cisplatin and 5-fluorouracil.

2.

What you need to know before you use Docetaxel Zentiva

You must not be given Docetaxel Zentiva:

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

Zentiva (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 Zentiva, you will have blood tests to check that you have

enough blood cells and sufficient liver function to receive Docetaxel Zentiva. 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 Zentiva 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 Zentiva 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 Zentiva contains alcohol. Discuss with your doctor if you suffer from alcohol dependency,

epilepsy or liver impairment. See also section “Docetaxel Zentiva contains ethanol (alcohol)” below.

Other medicines and Docetaxel Zentiva

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 Zentiva 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 Zentiva 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 Zentiva 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 Zentiva.

If you are a man being treated with Docetaxel Zentiva 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

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

You may experience side effects of this medicine that may impair your ability to drive, use tools or

operate machines (see section 4 Possible side effects). If this happens, do not drive or use any tools or

machines before discussing with your doctor, nurse or hospital pharmacist.

Docetaxel Zentiva 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.

Harmful for those suffering from alcoholism.

To be taken into account in pregnant or 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).

3.

How to use Docetaxel Zentiva

Docetaxel Zentiva 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 Zentiva 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 Zentiva. 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 Zentiva 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 Zentiva may be increased when Docetaxel Zentiva 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 allergic reaction to docetaxel,

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 Zentiva 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 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

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 stimated from 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 (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)

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.

Reporting of adverse effects

If you get any side effects , talkto 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 Docetaxel Zentiva

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 Docetaxel Zentiva 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 Docetaxel Zentiva looks like and contents of the pack

Docetaxel Zentiva 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

Zentiva k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturer(s)

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

65926 Frankfurt am Main

Germany

For any information about this medicine, please contact the local representative of the

Marketing Authorisation Holder:

België/Belgique/Belgien

Zentiva, k.s.

Tél/Tel: +32 280 86 420

PV-Belgium@zentiva.com

Lietuva

Zentiva, k.s.

Tel: +370 52152025

PV-Lithuania@zentiva.com

България

Zentiva, k.s.

Тел: + 359 2 805 72 08

PV-Bulgaria@zentiva.com

Luxembourg/Luxemburg

Zentiva, k.s.

Tél/Tel: +352 208 82330

PV-Luxembourg@zentiva.com

Česká republika

Zentiva, k.s.

Tel: +420 267 241 111

PV-Czech-Republic@zentiva.com

Magyarország

Zentiva, k.s.

Tel.: +36 165 55 722

PV-Hungary@zentiva.com

Danmark

Zentiva, k.s.

Tlf: +45 787 68 400

PV-Denmark@zentiva.com

Malta

Zentiva, k.s.

Tel: +356 277 82 052

PV-Malta@zentiva.com

Deutschland

Zentiva Pharma GmbH

Tel: +49 (0) 800 53 53 010

PV-Germany@zentiva.com

Nederland

Zentiva, k.s.

Tel: +31 202 253 638

PV-Netherlands@zentiva.com

Eesti

Zentiva, k.s.

Tel: +372 52 70308

PV-Estonia@zentiva.com

Norge

Zentiva, k.s.

Tlf: +47 219 66 203

PV-Norway@zentiva.com

Ελλάδα

Zentiva, k.s.

Τηλ: +30 211 198 7510

PV-Greece@zentiva.com

Österreich

Zentiva, k.s.

Tel: +43 720 778 877

PV-Austria@zentiva.com

España

Zentiva, k.s.

Tel: +34 931 815 250

PV-Spain@zentiva.com

Polska

Zentiva Polska Sp. z o.o.

Tel: + 48 22 375 92 00

PV-Poland@zentiva.com

France

Zentiva France

Tél: +33 (0) 800 089 219

PV-France@zentiva.com

Portugal

Zentiva Portugal, Lda

Tel: +351210601360

PV-Portugal@zentiva.com

Hrvatska

Zentiva, k.s.

Tel: +385 155 17 772

PV-Croatia@zentiva.com

Ireland

Zentiva, k.s.

Tel: +353 766 803 944

PV-Ireland@zentiva.com

România

S.C. ZENTIVA S.A.

Tel: +40 021 317 3136

PV-Romania@zentiva.com

Slovenija

Zentiva, k.s.

Tel: +386 360 00 408

PV-Slovenia@zentiva.com

Ísland

Zentiva, k.s.

Sími: +354 539 0650

PV-Iceland@zentiva.com

Slovenská republika

Zentiva, a.s.

Tel: +421 2 3918 3010

PV-Slovakia@zentiva.com

Italia

Zentiva Italia S.r.l.

Suomi/Finland

Zentiva, k.s.

+39-02-38598801

PV-Italy@zentiva.com

Puh/Tel: +358 942 598 648

PV-Finland@zentiva.com

Κύπρος

Zentiva, k.s.

Τηλ: +357 240 30 144

PV-Cyprus@zentiva.com

Sverige

Zentiva, k.s.

Tel: +46 840 838 822

PV-Sweden@zentiva.com

Latvija

Zentiva, k.s.

Tel: +371 67893939

PV-Latvia@zentiva.com

United Kingdom

Zentiva Pharma UK Limited

Tel: +44 (0) 845 372 7101

PV-United-Kingdom@zentiva.com

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 DOCETAXEL ZENTIVA 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 Docetaxel

Zentiva 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 Docetaxel Zentiva 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 (Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion,

which contains only 1 vial).

Docetaxel Zentiva 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 Docetaxel Zentiva 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

Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion

docetaxel

Read all of this leaflet carefully before you start using this medicine becsue 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, your 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:

What Docetaxel Zentiva is and what it is used for

What you need to know before you use Docetaxel Zentiva

How to use Docetaxel Zentiva

Possible side effects

How to store Docetaxel Zentiva

Contents of the pack and other information

1.

What Docetaxel Zentiva is and what it is used for

The name of this medicine is Docetaxel Zentiva. 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 Zentiva 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 Zentiva 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 Zentiva

could be administered in combination with doxorubicin and cyclophosphamide.

- For the treatment of lung cancer, Docetaxel Zentiva could be administered either alone or in

combination with cisplatin.

- For the treatment of prostate cancer, Docetaxel Zentiva is administered in combination with

prednisone or prednisolone.

- For the treatment of metastatic gastric cancer, Docetaxel Zentiva is administered in combination with

cisplatin and 5-fluorouracil.

- For the treatment of head and neck cancer, Docetaxel Zentiva is administered in combination with

cisplatin and 5-fluorouracil.

2.

What you need to know before you use Docetaxel Zentiva

You must not be given Docetaxel Zentiva:

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

Zentiva (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 Zentiva, you will have blood tests to check that you have

enough blood cells and sufficient liver function to receive Docetaxel Zentiva. 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 Zentiva 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 Zentiva 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 Zentiva contains alcohol. Discuss with your doctor if you suffer from alcohol dependency,

epilepsy or liver impairment. See also section “Docetaxel Zentiva contains ethanol (alcohol)” below.

Other medicines and Docetaxel Zentiva

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 Zentiva 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 Zentiva 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 Zentiva 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 Zentiva.

If you are a man being treated with Docetaxel Zentiva 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

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

You may experience side effects of this medicine that may impair your ability to drive, use tools or

operate machines (see section 4 Possible side effects). If this happens, do not drive or use any tools or

machines before discussing with your doctor, nurse or hospital pharmacist.

Docetaxel Zentiva 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.

Harmful for those suffering from alcoholism.

To be taken into account in pregnant or 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).

3.

How to use Docetaxel Zentiva

Docetaxel Zentiva 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 Zentiva 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 Zentiva. 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 Zentiva 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 Zentiva may be increased when Docetaxel Zentiva 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 allergic reaction to docetaxel,

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 Zentiva 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 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

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 (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)

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.

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 Docetaxel Zentiva

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

Do not use this medicine after the expiry date which is stated on 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 Docetaxel Zentiva 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 Docetaxel Zentiva looks like and contents of the pack

Docetaxel Zentiva 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

Zentiva k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturer(s)

Sanofi-Aventis GmbH

Industriepark Höchst

65926 Frankfurt am Main

Germany

For any information about this medicine, please contact the local representative of the

Marketing Authorisation Holder:

België/Belgique/Belgien

Zentiva, k.s.

Tél/Tel: +32 280 86 420

PV-Belgium@zentiva.com

Lietuva

Zentiva, k.s.

Tel: +370 52152025

PV-Lithuania@zentiva.com

България

Zentiva, k.s.

Тел: + 359 2 805 72 08

PV-Bulgaria@zentiva.com

Luxembourg/Luxemburg

Zentiva, k.s.

Tél/Tel: +352 208 82330

PV-Luxembourg@zentiva.com

Česká republika

Zentiva, k.s.

Tel: +420 267 241 111

PV-Czech-Republic@zentiva.com

Magyarország

Zentiva, k.s.

Tel.: +36 165 55 722

PV-Hungary@zentiva.com

Danmark

Zentiva, k.s.

Tlf: +45 787 68 400

PV-Denmark@zentiva.com

Malta

Zentiva, k.s.

Tel: +356 277 82 052

PV-Malta@zentiva.com

Deutschland

Zentiva Pharma GmbH

Tel: +49 (0) 800 53 53 010

PV-Germany@zentiva.com

Nederland

Zentiva, k.s.

Tel: +31 202 253 638

PV-Netherlands@zentiva.com

Eesti

Zentiva, k.s.

Tel: +372 52 70308

PV-Estonia@zentiva.com

Norge

Zentiva, k.s.

Tlf: +47 219 66 203

PV-Norway@zentiva.com

Ελλάδα

Zentiva, k.s.

Τηλ: +30 211 198 7510

PV-Greece@zentiva.com

Österreich

Zentiva, k.s.

Tel: +43 720 778 877

PV-Austria@zentiva.com

España

Zentiva, k.s.

Tel: +34 931 815 250

PV-Spain@zentiva.com

Polska

Zentiva Polska Sp. z o.o.

Tel: + 48 22 375 92 00

PV-Poland@zentiva.com

France

Zentiva France

Tél: +33 (0) 800 089 219

PV-France@zentiva.com

Portugal

Zentiva Portugal, Lda

Tel: +351210601360

PV-Portugal@zentiva.com

Hrvatska

Zentiva, k.s.

Tel: +385 155 17 772

PV-Croatia@zentiva.com

Ireland

Zentiva, k.s.

Tel: +353 766 803 944

PV-Ireland@zentiva.com

România

S.C. ZENTIVA S.A.

Tel: +40 021 317 3136

PV-Romania@zentiva.com

Slovenija

Zentiva, k.s.

Tel: +386 360 00 408

PV-Slovenia@zentiva.com

Ísland

Zentiva, k.s.

Sími: +354 539 0650

PV-Iceland@zentiva.com

Slovenská republika

Zentiva, a.s.

Tel: +421 2 3918 3010

PV-Slovakia@zentiva.com

Italia

Zentiva Italia S.r.l.

Suomi/Finland

Zentiva, k.s.

+39-02-38598801

PV-Italy@zentiva.com

Puh/Tel: +358 942 598 648

PV-Finland@zentiva.com

Κύπρος

Zentiva, k.s.

Τηλ: +357 240 30 144

PV-Cyprus@zentiva.com

Sverige

Zentiva, k.s.

Tel: +46 840 838 822

PV-Sweden@zentiva.com

Latvija

Zentiva, k.s.

Tel: +371 67893939

PV-Latvia@zentiva.com

United Kingdom

Zentiva Pharma UK Limited

Tel: +44 (0) 845 372 7101

PV-United-Kingdom@zentiva.com

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 DOCETAXEL ZENTIVA 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 Docetaxel

Zentiva 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 Docetaxel Zentiva 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 (Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion,

which contains only 1 vial).

Docetaxel Zentiva 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 Docetaxel Zentiva 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

Docetaxel Zentiva 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, your hospital pharmacist or nurse.

If you get any side effects talk to your doctor, hospital pharmacist or nurse. This includes any

possible side effect not listed in this leaflet. See section 4.

What is in this leaflet:

What Docetaxel Zentiva is and what it is used for

What you need to know before you use Docetaxel Zentiva

How to use Docetaxel Zentiva

Possible side effects

How to store Docetaxel Zentiva

Contents of the pack and other information

1.

What Docetaxel Zentiva is and what it is used for

The name of this medicine is Docetaxel Zentiva. 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 Zentiva 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 Zentiva 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 Zentiva

could be administered in combination with doxorubicin and cyclophosphamide.

- For the treatment of lung cancer, Docetaxel Zentiva could be administered either alone or in

combination with cisplatin.

- For the treatment of prostate cancer, Docetaxel Zentiva is administered in combination with

prednisone or prednisolone.

- For the treatment of metastatic gastric cancer, Docetaxel Zentiva is administered in combination with

cisplatin and 5-fluorouracil.

- For the treatment of head and neck cancer, Docetaxel Zentiva is administered in combination with

cisplatin and 5-fluorouracil.

2.

What you need to know before you use Docetaxel Zentiva

You must not be given Docetaxel Zentiva:

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

Zentiva (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 Zentiva, you will have blood tests to check that you have

enough blood cells and sufficient liver function to receive Docetaxel Zentiva. 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 Zentiva 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 Zentiva 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 Zentiva contains alcohol. Discuss with your doctor if you suffer from alcohol dependency,

epilepsy or liver impairment. See also section “Docetaxel Zentiva contains ethanol (alcohol)” below.

Other medicines and Docetaxel Zentiva

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 Zentiva 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 Zentiva 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 Zentiva 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 Zentiva.

If you are a man being treated with Docetaxel Zentiva 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

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

You may experience side effects of this

medicine

that may impair your ability to drive, use tools or

operate machines (see section 4 Possible side effects). If this happens, do not drive or use any tools or

machines before discussing with your doctor, nurse or hospital pharmacist.

Docetaxel Zentiva 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.

Harmful for those suffering from alcoholism.

To be taken into account in pregnant or 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).

3.

How to use Docetaxel Zentiva

Docetaxel Zentiva 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 Zentiva 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 Zentiva. 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 Zentiva 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 Zentiva may be increased when Docetaxel Zentiva 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 allergic reaction to docetaxel,

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 Zentiva 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 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

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 (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)

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.

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 Docetaxel Zentiva

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

Do not use this medicine after the expiry date which is stated on 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 Docetaxel Zentiva 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 Docetaxel Zentiva looks like and contents of the pack

Docetaxel Zentiva 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

Zentiva k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturer(s)

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

65926 Frankfurt am Main

Germany

For any information about this medicine, please contact the local representative of the

Marketing Authorisation Holder:

België/Belgique/Belgien

Zentiva, k.s.

Tél/Tel: +32 280 86 420

PV-Belgium@zentiva.com

Lietuva

Zentiva, k.s.

Tel: +370 52152025

PV-Lithuania@zentiva.com

България

Zentiva, k.s.

Тел: + 359 2 805 72 08

PV-Bulgaria@zentiva.com

Luxembourg/Luxemburg

Zentiva, k.s.

Tél/Tel: +352 208 82330

PV-Luxembourg@zentiva.com

Česká republika

Zentiva, k.s.

Tel: +420 267 241 111

PV-Czech-Republic@zentiva.com

Magyarország

Zentiva, k.s.

Tel.: +36 165 55 722

PV-Hungary@zentiva.com

Danmark

Zentiva, k.s.

Tlf: +45 787 68 400

PV-Denmark@zentiva.com

Malta

Zentiva, k.s.

Tel: +356 277 82 052

PV-Malta@zentiva.com

Deutschland

Zentiva Pharma GmbH

Tel: +49 (0) 800 53 53 010

PV-Germany@zentiva.com

Nederland

Zentiva, k.s.

Tel: +31 202 253 638

PV-Netherlands@zentiva.com

Eesti

Zentiva, k.s.

Tel: +372 52 70308

PV-Estonia@zentiva.com

Norge

Zentiva, k.s.

Tlf: +47 219 66 203

PV-Norway@zentiva.com

Ελλάδα

Zentiva, k.s.

Τηλ: +30 211 198 7510

PV-Greece@zentiva.com

Österreich

Zentiva, k.s.

Tel: +43 720 778 877

PV-Austria@zentiva.com

España

Zentiva, k.s.

Tel: +34 931 815 250

PV-Spain@zentiva.com

Polska

Zentiva Polska Sp. z o.o.

Tel: + 48 22 375 92 00

PV-Poland@zentiva.com

France

Zentiva France

Tél: +33 (0) 800 089 219

PV-France@zentiva.com

Portugal

Zentiva Portugal, Lda

Tel: +351210601360

PV-Portugal@zentiva.com

Hrvatska

Zentiva, k.s.

Tel: +385 155 17 772

PV-Croatia@zentiva.com

Ireland

Zentiva, k.s.

Tel: +353 766 803 944

PV-Ireland@zentiva.com

România

S.C. ZENTIVA S.A.

Tel: +40 021 317 3136

PV-Romania@zentiva.com

Slovenija

Zentiva, k.s.

Tel: +386 360 00 408

PV-Slovenia@zentiva.com

Ísland

Zentiva, k.s.

Sími: +354 539 0650

PV-Iceland@zentiva.com

Slovenská republika

Zentiva, a.s.

Tel: +421 2 3918 3010

PV-Slovakia@zentiva.com

Italia

Zentiva Italia S.r.l.

Suomi/Finland

Zentiva, k.s.

+39-02-38598801

PV-Italy@zentiva.com

Puh/Tel: +358 942 598 648

PV-Finland@zentiva.com

Κύπρος

Zentiva, k.s.

Τηλ: +357 240 30 144

PV-Cyprus@zentiva.com

Sverige

Zentiva, k.s.

Tel: +46 840 838 822

PV-Sweden@zentiva.com

Latvija

Zentiva, k.s.

Tel: +371 67893939

PV-Latvia@zentiva.com

United Kingdom

Zentiva Pharma UK Limited

Tel: +44 (0) 845 372 7101

PV-United-Kingdom@zentiva.com

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 DOCETAXEL ZENTIVA 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 Docetaxel

Zentiva 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 Docetaxel Zentiva 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 (Docetaxel Zentiva 160 mg/8 ml concentrate for solution for

infusion, which contains only 1 vial).

Docetaxel Zentiva 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 Docetaxel Zentiva 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.