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Taxespira (Docetaxel Hospira UK Limited ) (docetaxel trihydrate) – Package leaflet - L01CD02

Updated on site: 10-Oct-2017

Medication nameTaxespira (Docetaxel Hospira UK Limited )
ATC CodeL01CD02
Substancedocetaxel trihydrate
ManufacturerHospira UK Limited

Package leaflet: Information for the patient

Taxespira 20 mg/1 ml concentrate for solution for infusion

Taxespira 80 mg/4 ml concentrate for solution for infusion

Taxespira 120 mg/6 ml concentrate for solution for infusion

Taxespira 140 mg/7 ml concentrate for solution for infusion

Taxespira 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, 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

1.What Taxespira is and what it is used for

2.What you need to know before you use Taxespira

3.How to use Taxespira

4.Possible side effects

5.How to store Taxespira

6.Contents of the pack and other information

1.What Taxespira is and what it is used for

The name of this medicine is Taxespira. 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.

Taxespira 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, Taxespira 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, Taxespira could be administered in combination with doxorubicin and cyclophosphamide.

For the treatment of lung cancer, Taxespira could be administered either alone or in combination with cisplatin.

For the treatment of prostate cancer, Taxespira is administered in combination with prednisone or prednisolone.

For the treatment of metastatic gastric cancer, Taxespira is administered in combination with cisplatin and 5-fluorouracil.

For the treatment of head and neck cancer, Taxespira is administered in combination with cisplatin and 5-fluorouracil.

2.What you need to know before you use Taxespira

You must not be given Taxespira

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

if the number of your white blood cells is too low.

if you have a severe liver disease.

Warnings and precautions

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

Tell your doctor, hospital pharmacist or nurse if you have vision problems. In case of vision problems, in particular blurred vision, you should immediately have your eyes and vision examined.

If you develop acute or worsening problems with your lungs (fever, shortness of breath or cough), please tell your doctor, hospital pharmacist or nurse immediately. Your doctor may stop your treatment immediately.

You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Taxespira 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 Taxespira 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.

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

Other medicines and Taxespira

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 Taxespira or the other medicine may not work as well as expected and you may be more likely to get a side effect.

Pregnancy, breast-feeding and fertility

Ask your doctor for advice before being given any medicine.

Taxespira 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 Taxespira 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 Taxespira.

If you are a man being treated with Taxespira you are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because Docetaxel may alter male fertility.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

Taxespira contains ethanol (alcohol)

20mg/1ml

This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395mg ethanol anhydrous per 1 ml, equivalent to 10 ml of beer or 4 ml wine per 1 ml vial.

80mg/ 4 ml:

This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1580 mg ethanol anyhdrous per 4 ml vial, equivalent to 40 ml of beer or 17 ml wine per 4 ml vial,

120mg/ 6 ml:

This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2370 mg ethanol anhydrous per 6 ml vial, equivalent to 60 ml of beer or 25 ml wine per 6 ml vial.

140mg/ 7 ml:

This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2765 mg ethanol anhydrous per 7 ml vial, equivalent to 70 ml of beer or 29 ml wine per 7 ml vial.

160mg/ 8 ml:

This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3160 mg ethanol anhydrous per 8 ml vial, equivalent to 80 ml of beer or 33 ml wine per 8 ml vial.

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).

Harmful for those suffering from alcoholism.

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

The amount of alcohol in this medicine may alter the effects of other medicine.

The amount of alcohol in this medicine may impair the patient’s ability to drive or use machines.

3.How to use Taxespira

Taxespira 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

Taxespira 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 Taxespira. 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 the 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 Taxespira alone are: decrease in the number of red blood cells or white blood cells, alopecia (hair loss), nausea, vomiting, sores in the mouth, diarrhoea and tiredness.

The severity of adverse events of Taxespira may be increased when Taxespira is given in combination with other chemotherapeutic agents.

During the infusion at the hospital the following allergic reactions (may affect more than 1 in 10 people):

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 Taxespira 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 blood cells (anaemia), or white blood cells (which are important in fighting infection) and platelets (important in blood clotting)

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

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)

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 periods

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 (thrush)

dehydration

dizziness

hearing impaired

decrease in blood pressure; irregular or rapid heart beat

heart failure

oesophagitis (inflammation of the gullet)

dry mouth

difficulty or painful swallowing

haemorrhage (bleeding)

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

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

fainting

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

inflammation of the colon, small intestine; intestinal perforation

blood clots.

Frequency unknown:

interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing. Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)

pneumonia (infection of the lungs)

pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)

blurred vision due to swelling of the retina within the eye (cystoid macular oedema)

decrease of the sodium in your blood.

Reporting of side effects

If you get any side effects talk to your doctor, 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 Taxespira

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°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.

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 Taxespira contains

- The active substance is docetaxel (as trihydrate). Each ml of solution contains 20 mg of docetaxel (as trihydrate).

20mg/ 1 ml

One vial of 1 ml of concentrate contains 20 mg docetaxel.

80mg/ 4 ml

One vial of 4 ml concentrate contains 80 mg docetaxel.

120mg/6 ml

One vial of 6 ml concentrate contains 120 mg docetaxel.

140mg/7 ml

One vial of 7 ml concentrate contains 140 mg docetaxel.

160mg/8 ml

One vial of 8 ml concentrate contains 160 mg docetaxel.

- The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid monohydrate.

What Taxespira looks like and contents of the pack

Taxespira concentrate for solution for infusion is a pale yellow to brownish-yellow solution provided in glass vials.

Vials containing 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml and 160 mg/8 ml are available in packs containing a single vial.

Not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer

Hospira UK Limited

Horizon,

Honey Lane,

Hurley,

Maidenhead,

SL6 6RJ,

United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BE / LU / NL

CY

Pfizer S.A. / N.V.

Pharmaceutical Trading Co Ltd

Tél/Tel: +32 2 554 62 11

Tel: 24656165

BG / EL / MT / PL / RO / UK

LV

Hospira UK Limited

Pfizer Luxembourg SARL filiāle Latvijā

Tel: + 44 (0) 1628 515500

Tel.: + 371 670 35 775

CZ

LT

Pfizer, spol. s r.o.

Pfizer Luxembourg SARL filialas Lietuvoje

Tel: +420-283-004-111

Tel. + 370 52 51 4000

DK

HU

Pfizer ApS

Pfizer Kft.

Tlf: + 45 44 20 11 00

Tel: + 36 1 488 37 00

DE

NO

Pfizer Pharma PFE GmbH

Pfizer AS

Tel: + 49 (0)800 8535555

Tlf: +47 67 52 61 00

EE

AT

Pfizer Luxembourg SARL Eesti filiaal

Pfizer Corporation Austria Ges.m.b.H

Tel: +372 666 7500

ES

PT

Pfizer GEP, S.L.

Hospira Portugal Lda

Tel: +34 91 490 99 00

Tel: +351 21 423 55 00

FR

SI

Pfizer PFE France

Pfizer Luxembourg SARL

Tél: + 33 (0)1 58 07 34 40

Pfizer, podružnica za svetovanje s področja

 

farmacevtske dejavnosti, Ljubljana

 

Tel: +386 (0)1 52 11 400

HR

SK

Pfizer Croatia d.o.o.

Pfizer Luxembourg SARL, organizačná zložka

Tel: +385 1 3908 777

Tel: +421–2–3355 5500

IE

FI

Hospira Ireland Sales Limited

Pfizer PFE Finland Oy

Tel: 1800 633 363 (toll free)

Puh/Tel: +358 (0)9 430 040

+44 (0) 1304 616161

 

IS

SE

Icepharma hf.

Pfizer AB

Sími: +354 540 8000

Tel: +46 (0)8 550 520 00

IT

 

Pfizer Italia Srl

 

Tel: +39 06 33 18 21

 

This leaflet was last revised in {month YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

PREPARATION GUIDE FOR USE WITH TAXESPIRA CONCENTRATE FOR SOLUTION FOR INFUSION

It is important that you read the entire contents of this guide prior to the preparation of the Taxespira 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 Taxespira 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 (Taxespira 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).

DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).

DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 120 mg/6 ml concentrate for solution for infusion, which contains only 1 vial).

DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 140 mg/7 ml concentrate for solution for infusion, which contains only 1 vial).

DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).

Taxespira 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 Taxespira 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 Taxespira 20 mg/1 ml concentrate for solution for infusion.

Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe fitted with a 21G needle.

In Taxespira 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml and 160 mg/8 ml vials the concentration of docetaxel is 20 mg/ml.

Inject the required dose (in mg) via a single injection (one shot) into a 250 ml non-PVC infusion bag containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion or with 5% glucose solution in a glass bottle. 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 in non-PVC bags or bottles has been demonstrated up to 48 hours when stored between 2°C to 8°C, and for up to 6 hours when stored below 25°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. These measures will help protect the environment.

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