Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - taxotere

Document Subject

Generated Narrative: MedicinalProductDefinition mpba2de541591622fcd614de6be8043458

identifier: http://ema.europa.eu/identifier/EU/1/95/002/003

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-ba2de541591622fcd614de6be8043458

identifier: http://ema.europa.eu/identifier/EU/1/95/002/003

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - taxotere

Attesters

What is in this leaflet:

1. What TAXOTERE is and what it is used for
2. What you need to know before you use TAXOTERE
3. How to use TAXOTERE
4. Possible side effects
5. How to store TAXOTERE
6. Contents of the pack and other information

The name of this medicine is TAXOTERE. 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.

TAXOTERE 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, TAXOTERE 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, TAXOTERE could be administered in combination with doxorubicin and cyclophosphamide.
• For the treatment of lung cancer, TAXOTERE could be administered either alone or in combination with cisplatin.
• For the treatment of prostate cancer, TAXOTERE is administered in combination with prednisone or prednisolone.
• For the treatment of metastatic gastric cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.
• For the treatment of head and neck cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.

You must not be given TAXOTERE:

if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of TAXOTERE (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 TAXOTERE, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive TAXOTERE. 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 TAXOTERE 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 TAXOTERE in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).

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

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

• SJS/TEN symptoms may include blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash. You may also have flu-like symptoms at the same time, such as fever, chills or aching muscles.
• AGEP symptoms may include a red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever.
  If you develop severe skin reactions or any of the reactions listed above, immediately contact your doctor or healthcare professional.

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

TAXOTERE contains alcohol. Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment. See also section TAXOTERE contains ethanol (alcohol) below.

Other medicines and TAXOTERE

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 TAXOTERE 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.

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

You must not become pregnant during treatment and for 2 months after end of treatment with this medicine. You must use an effective method of contraception during treatment and for 2 months after end of treatment, because TAXOTERE 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 TAXOTERE.

If you are a man being treated with TAXOTERE you must not father a child and must use an effective method of contraception during treatment and for 4 months after end of treatment with this medicine. It is recommended 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.

TAXOTERE contains ethanol (alcohol)

This medicinal product contains 13% (w/w) ethanol 95% v/v (alcohol), i.e. up to 252 mg ethanol 95% v/v per solvent vial, equivalent to 6 ml of beer or 2.6 ml wine.

Harmful for those suffering from alcoholism.
To be taken into account in pregnant or breast-feeding women, in children and in 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).

TAXOTERE 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 (m ) and will determine the dose you should receive.

Method and route of administration

TAXOTERE 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 TAXOTERE. 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.

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 TAXOTERE 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 TAXOTERE may be increased when TAXOTERE 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 TAXOTERE 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

infection of the upper respiratory tract.

Common (may affect up to 1 in 10 people):

oral candidiasis

dehydration

dizziness

hearing impaired

decrease in blood pressure; irregular or rapid heart beat

heart failure

oesophagitis

dry mouth

difficulty or painful swallowing

haemorrhage

raised liver enzymes (hence the need for regular blood tests)

rises in blood sugar levels (diabetes)

decrease of the potassium, calcium and/or phosphate in your blood.

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

fainting

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

blood clots.

acute myeloid leukaemia 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 and/or magnesium in your blood (electrolyte balance disorders) ventricular arrhythmia or ventricular tachycardia (manifested as irregular and/or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting). Some of these symptoms can be serious. If this happens, you must tell your doctor immediately injection site reactions at the site of a previous reaction. non-Hodgkin lymphoma (a cancer affecting the immune system) and other cancers may occur in patients who are treated with docetaxel together with certain other anticancer treatments. Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash. You may also have flu-like symptoms at the same time, such as fever, chills or aching muscles.) acute Generalized Exanthematous Pustulosis (AGEP) (red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever.) tumour lysis syndrome is a serious condition revealed by changes in blood test such as increased level of uric acid, potassium, phosphorus and decreased level of calcium; and results in symptoms such as seizures, kidney failure (reduced amount or darkening of urine) and heart rhythm disturbance. If this happens, you must tell your doctor immediately.

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

Reporting of side effects If you get any side effects talk to your doctor, hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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

This medicine should not be used after the expiry date shown on the carton, blister pack and vials.

Do not store above 25 C or below 2 C. Store in the original package in order to protect from light.

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

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

What TAXOTERE concentrate vial contains

• The active substance is docetaxel (as trihydrate). Each ml of docetaxel solution contains 40 mg of docetaxel (anhydrous). One vial contains 20 mg/0.5 ml docetaxel.
• The other ingredients are polysorbate 80 and citric acid.

What solvent vial contains 13% (w/w) ethanol 95% (see section 2) in water for injections.

What TAXOTERE looks like and contents of the pack TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion is a clear viscous, yellow to brown- yellow solution.

Each blister pack contains:

one single-dose vial of concentrate and,

one single-dose vial of solvent.

Marketing Authorisation Holder Sanofi Winthrop Industrie 82 Avenue Raspail 94250 Gentilly France

Manufacturers Sanofi-Aventis Deutschland GmbH Industriepark H chst 65926 Frankfurt am Main Germany

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

Belgi /Belgique/Belgien Sanofi Belgium T l/Tel: +32 (0)2 710 54 Lietuva Swixx Biopharma UAB
Tel: +370 5 236 91
Swixx Biopharma EOOD .: +359 (0)2 4942 Luxembourg/Luxemburg Sanofi Belgium
T l/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

esk republika Sanofi s.r.o.
Tel: +420 233 086 Magyarorsz g sanofi-aventis zrt., Magyarorsz g Tel.: +36 1 505 0Danmark Sanofi A/S Tlf: +45 45 16 70 Malta sanofi S.r.l. Tel: +39. 02 39394Deutschland Sanofi-Aventis Deutschland GmbH Tel: 0800 52 52 Tel. aus dem Ausland: +49 69 305 21 Nederland Sanofi B.V. Tel: +31 20 245 4Eesti Swixx Biopharma O
Tel: +372 640 10 Norge sanofi-aventis Norge AS Tlf: +47 67 10 71
Sanofi-Aventis AEBE : +30 210 900 16 sterreich sanofi-aventis GmbH Tel: +43 1 80 185 0

Espa a sanofi-aventis, S.A. Tel: +34 93 485 94 Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 France Sanofi Winthrop Industrie
T l: 0 800 222 Appel depuis l tranger : +33 1 57 63 23 Portugal Sanofi - Produtos Farmac uticos, Lda. Tel: +351 21 35 89 Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 Rom nia Sanofi Romania SRL Tel: +40 (0) 21 317 31 Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 Slovenija Swixx Biopharma d.o.o. Tel: +386 1 235 51 sland Vistor hf. S mi: +354 535 7Slovensk republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 Italia sanofi S.r.l. Tel: 800536Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200
C.A. Papaellinas Ltd. : +357 22 741Sverige Sanofi AB Tel: +46 (0)8 634 50 Latvija Swixx Biopharma SIA Tel: +371 6616 47 United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2This leaflet was last revised in .

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: