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Docetaxel Mylan (docetaxel, anhydrous) – Package leaflet - L01CD02

Updated on site: 06-Oct-2017

Medication nameDocetaxel Mylan
ATC CodeL01CD02
Substancedocetaxel, anhydrous
ManufacturerMylan S.A.S.

Package Leaflet: Information for the user

Docetaxel Mylan 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 or hospital pharmacist.

-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 Docetaxel Mylan 20 mg/1 ml is and what it is used for

 

2.

What you need to know before you use Docetaxel Mylan 20 mg/1 ml

3.

How to use Docetaxel Mylan 20 mg/1 ml

authorised

4.

Possible side effects

5.

How to store Docetaxel Mylan 20 mg/1 ml

6.

Contents of the pack and other information

1.

What Docetaxel Mylan 20 mg/1 ml is and what it is us d for

 

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

Docetaxel belongs to the group of anti-cancer medicines called taxoids.

Docetaxel Mylan has been prescribed by your doct r f r the treatment of breast cancer, special forms

no

longer

of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer:

- For the treatment of advanced breast cancer, docetaxel could be administered either alone or in

cisplatin.

product

combination with doxorubicin, or trastuzumab, or capecitabine.

- For the treatment of early breast cancer with or without lymph node involvement, docetaxel could be

administered in combination with

oxor bicin and cyclophosphamide.

- For the treatment of lung cancer,

cetaxel could be administered either alone or in combination with

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

-For the treatment of met st tic gastric cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.

-For the treatment of head and neck cancer, docetaxel is administered in combination with cisplatin and 5-fluoroura l.Medicinal

2. What you need to know before you use Docetaxel Mylan 20 mg/1 ml

You must not be given Docetaxel Mylan

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

-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 Mylan, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Mylan. 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 Docetaxel Mylan administration and to continue for one or two days aft r it in order to minimise certain undesirable effects which may occur after the infusion of Docetaxel Mylan in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or we ght gain). During treatment, you may be given other medicines to maintain the number of y ur blood cells. Docetaxel Mylan contains alcohol. Discuss with your doctor if you suffer from alc h l dependency or liver impairment. See also section “Docetaxel Mylan contains ethanol” below.

Other medicines and Docetaxel Mylan

authorised

 

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 Mylan 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

 

longer

 

 

 

Ask your doctor for advice before being given a y medicine.

 

 

no

 

Docetaxel Mylan must NOT be administered if you are pregnant unless clearly indicated by your

doctor.

product

 

 

 

 

 

You must not become pregnant du ing treatment with this medicine and must use an effective method of contraception during thera y, because Docetaxel Mylan may be harmful for the unborn baby. If

pregnancy occurs during your treatment, you must immediately inform your doctor. You mustMedicinalnot breast-feed while you are treated with Docetaxel Mylan.

If you are a man be ng treated with Docetaxel Mylan 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 docetax l may alter male fertility.

Driving and using machines

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

Docetaxel Mylan contains ethanol

This medicine contains 50 vol % ethanol (alcohol), i.e. up to 0.395 g per vial equivalent to 10 ml of beer or 4 ml wine per vial.

Harmful for those suffering from alcoholism.

To be taken into account if you are pregnant or if you are 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 alter the effects of other medicines.

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

3. How to use Docetaxel Mylan 20 mg/1 ml

Docetaxel Mylan 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

Frequency of administration

Docetaxel Mylan will be given by infusion into one of your veins (intravenousauthoriseduse). The infusion will last approximately one hour during which you will be in the hospital.

You should usually receive your infusion once every 3 weeks.

Your doctor may change the dose and frequency of dosing depending on yo r blood tests, your general condition and your response to Docetaxel Mylan. In particul r, ple se 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 d cide whether a dose reduction is needed.

If you have any further questions on the use of this medicine, ask your doctor, or hospital pharmacist.

longer

4.

Possible side effects

product

no

 

 

 

 

Like all medicines, this medicine can ca se 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 Mylan alone are: decrease in the number

 

Medicinalflushing, skin reactions, itching

of red blood cells or white b ood cells, hair loss, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.

The severity of adverse events of Docetaxel Mylan may be increased when Docetaxel Mylan is given in combination w th other chemotherapeutic agents.

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

chest tightness; difficulty in breathingfever or chills

back pain

low blood pressure.

More severe reactions may occur.

The hospital staff will monitor your condition closely during treatment. Tell them immediately if you notice any of these effects.

Between infusions of Docetaxel Mylan 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)

 

redness and swelling of the palms of your hands or soles of yourauthorisedfeet 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

longer

 

change or absence of menstrual period

no

 

swelling of the hands, feet, legs

 

tiredness; or flu-like symptoms

 

 

weight gain or loss.

 

 

 

 

 

 

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

 

 

 

fungal infection of the mouth (oral candidiasis)

 

 

dehydration

product

 

 

 

dizziness

 

 

 

hearing impaired

 

 

 

 

 

 

decrease in blood pressure; irregular or rapid heart beat

 

heart failure

 

 

 

 

oesophagit s

 

 

 

 

dry mouth

 

 

 

 

difficulty or painful swallowing

 

 

 

ha morrhage

 

 

 

 

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

 

Medicinal

 

 

 

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).

Reporting of side effects
If you get any side effects, talk to your doctor, 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.

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

decrease of the sodium in your blood.

5. How to store Docetaxel Mylan 20 mg/1 ml

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- se storage times and conditions are the responsibility of the user.

authorised

From a microbiological point of view, dilution must takelongerplace in controlled and aseptic conditions.

Use immediately the medicine once added into the non-PVC i fusion bag. If not used immediately, in-

use storage times and conditions are the responsibility

f the user and would normally not be longer

no

n.

than 6 hours below 25°C including the one hour infusi

Physical and chemical in-use stability of the i fusion 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 supersat rated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and shall be discarded.

What Doc taxel Mylan 20 mg/1 ml contains

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.

 

 

product

6.

Contents of the pack and other information

 

Medicinal

 

The active substance is docetaxel. Each ml of concentrate for solution for infusion contains 20 mg docetaxel (anhydrous).

One vial contains 20 mg of docetaxel.

The other ingredients are polysorbate 80, ethanol anhydrous and citric acid.

What Docetaxel Mylan 20 mg/1 ml looks like and contents of the pack

Docetaxel Mylan concentrate for solution for infusion is a pale yellow to brownish-yellow solution. The concentrate is supplied in a clear colourless glass vial with a rubber stopper and a plastic flip-off cap.

Each vial contains 1 ml of concentrate. Each box contains 1 or 5 vials.

Marketing Authorisation Holder and Manufacturer

Mylan S.A.S.

117 allée des parcs

69800 Saint Priest France

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

België/Belgique/Belgien

Mylan bvba/sprl

Tél/Tel: + 0032 2 658 61 00

България

Mylan SAS

Tel: +33 4 37 25 75 00 (France)

Ceská republika

MylanPharmaceuticals s.r.o.

Tel: +420 274 770 201

Danmark

Mylan ApS

Tlf: + 45 3694 4568

Deutschland

Mylan dura GmbH

Tel: + 49-(0) 6151 9512 0

Eesti

Mylan SAS

Tel: +33 4 37 25 75 00 (France)

Ελλάδα

Generics Pharma Hellas ΕΠΕ

Τηλ: +30 210 9936410

EspañaMedicinal

product

Mylan Pharma eut als, S.L tel: + 34 93 3786400

France

Mylan SAS

Tel: +33 4 37 25 75 00

Hrvatska

Mylan SAS

Tel: +33 4 37 25 75 00 (France)

Ireland

Mc Dermott Laboratories Ltd

Tel: + 1800 272 272

Allphar +353 1 4041600

Lietuva

Mylan SAS

Tel: +33 4 37 25 75 00 (France)

Malta

 

authorised

Luxembourg/Luxemburg

Mylan bvba/sprl

 

Tél/Tel: + 0032 2 658 61 00 (Belgium)

Magyarország

 

Mylan Kft

 

Tel: 36 1 8026993

 

 

longer

 

George Borg Barth t Ltd

Tel: +356 21244205

Neder and

Mylan B.V

noTel: + 31 (0)33 2997080

Norge

Mylan AB

Tlf: + 46 8-555 227 50 (Sverige)

Österreich

Arcana Arzneimittel GmbH Tel: +43 1 416 24 18

Polska

Mylan Sp.z.o.o

Tel: +48 22 5466400

Portugal

Mylan, Lda.

Phone: + 00351 21 412 7200

România

Mylan SAS

Tel: +33 4 37 25 75 00 (France)

Slovenija

Mylan SAS

Tel: +33 4 37 25 75 00 (France)

Ísland
Mylan AB
Tel: + 46 8-555 227 50
Italia
Mylan S.p.A
Tel: + +39/02-61246921
Κύπρος
Pharmaceutical Trading Co Ltd Τηλ: +35 7 24656165
Latvija
Mylan SAS
Tel: +33 4 37 25 75 00 (France)

Slovenská republika

Mylan sr.o

Tel: +421 2 32 604 901

Suomi/Finland

Mylan OY

Puh/Tel: + 358 9-46 60 03

Sverige

Mylan AB

Tel: + 46 8-555 227 50

United Kingdom

Generics [UK] Ltd t/a Mylan

Tel: +44 1707 853000

Other sources of information

 

 

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

http://www.ema.europa.eu

longer

authorised

 

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

The following information is intended for healthcare pr fessi nals only:

 

no

PREPARATION GUIDE FOR USE WITH DOCETAXEL MYLAN CONCENTRATE FOR

SOLUTION FOR INFUSION

 

product

 

It is important that you read the entire contents of this guide prior to the preparation of the Docetaxel Mylan 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.

membranes, wash mmediately and thoroughly with water.

If DocetaxelMedicinalMylan 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

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 Mylan concentrate for solution for infusion, which contains only 1 vial).

Docetaxel Mylan concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to be added 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.

In Docetaxel Mylan, 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, 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 stor d b tween 2°C to 8°C.

Docetaxel infusion solution is supersaturated, therefore may crystallize over t me. 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:

authorised

 

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 wast wat r. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

 

 

no

longer

 

product

 

Medicinal

 

 

 

 

 

Package Leaflet: Information for the user

Docetaxel Mylan 80 mg/4 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 or hospital pharmacist.

-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 Docetaxel Mylan 80 mg/4 ml is and what it is used for

 

2.

What you need to know before you use Docetaxel Mylan 80 mg/4 ml

3.

How to use Docetaxel Mylan 80 mg/4 ml

authorised

4.

Possible side effects

5.

How to store Docetaxel Mylan 80 mg/4 ml

6.

Contents of the pack and other information

1.

What Docetaxel Mylan 80 mg/4 ml is and what it is us d for

 

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

Docetaxel belongs to the group of anti-cancer medicines called taxoids.

Docetaxel Mylan has been prescribed by your doct r f r the treatment of breast cancer, special forms

 

 

no

longer

of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer:

- For the treatment of advanced breast cancer, docetaxel could be administered either alone or in

cisplatin.

product

 

 

combination with doxorubicin, or trastuzumab, or capecitabine.

- For the treatment of early breast cancer with or without lymph node involvement, docetaxel could be

administered in combination with

oxor bicin and cyclophosphamide.

- For the treatment of lung cancer,

cetaxel could be administered either alone or in combination with

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

-For the treatment of met st tic gastric cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.

-For the treatment of head and neck cancer, docetaxel is administered in combination with cisplatin and 5-fluoroura l.Medicinal

2. What you need to know before you use Docetaxel Mylan 80 mg/4 ml You must not be given Docetaxel Mylan

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

-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 Mylan, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Mylan. 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 Docetaxel Mylan administration and to continue for one or two days aft r it in order to minimise certain undesirable effects which may occur after the infusion of Docetaxel Mylan in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or we ght gain). During treatment, you may be given other medicines to maintain the number of y ur blood cells. Docetaxel Mylan contains alcohol. Discuss with your doctor if you suffer from alc h l dependency or liver impairment. See also section “Docetaxel Mylan contains ethanol” below.

Other medicines and Docetaxel Mylan

authorised

 

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 Mylan 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

 

longer

 

 

 

Ask your doctor for advice before being given a y medicine.

 

 

no

 

Docetaxel Mylan must NOT be administered if you are pregnant unless clearly indicated by your

doctor.

product

 

 

 

 

 

You must not become pregnant du ing treatment with this medicine and must use an effective method of contraception during thera y, because Docetaxel Mylan may be harmful for the unborn baby. If

pregnancy occurs during your treatment, you must immediately inform your doctor. You mustMedicinalnot breast-feed while you are treated with Docetaxel Mylan.

If you are a man be ng treated with Docetaxel Mylan 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 docetax l may alter male fertility.

Driving and using machines

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

Docetaxel Mylan contains ethanol

This medicine contains 50 vol % ethanol (alcohol), i.e. up to 1.58g per vial equivalent to 40 ml of beer or 17 ml wine per vial.

Harmful for those suffering from alcoholism.

To be taken into account if you are pregnant or if you are 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 alter the effects of other medicines.

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

3. How to use Docetaxel Mylan 80 mg/4 ml

Docetaxel Mylan 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

Frequency of administration

Docetaxel Mylan will be given by infusion into one of your veins (intravenousauthoriseduse). The infusion will last approximately one hour during which you will be in the hospital.

You should usually receive your infusion once every 3 weeks.

Your doctor may change the dose and frequency of dosing depending on yo r blood tests, your general condition and your response to Docetaxel Mylan. In particul r, ple se 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 d cide whether a dose reduction is needed.

If you have any further questions on the use of this medicine, ask your doctor, or hospital pharmacist.

longer

4.

Possible side effects

product

no

 

 

 

 

Like all medicines, this medicine can ca se 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 Mylan alone are: decrease in the number of redMedicinalblood cells or white b ood cells, hair loss, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.

The severity of adverse events of Docetaxel Mylan may be increased when Docetaxel Mylan is given in combination w th other chemotherapeutic agents.

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

flushing, skin reactions, itching

chest tightness; difficulty in breathingfever or chills

back pain

low blood pressure.

More severe reactions may occur.

The hospital staff will monitor your condition closely during treatment. Tell them immediately if you notice any of these effects.

Between infusions of Docetaxel Mylan 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)

 

redness and swelling of the palms of your hands or soles of yourauthorisedfeet 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

longer

 

change or absence of menstrual period

no

 

swelling of the hands, feet, legs

 

tiredness; or flu-like symptoms

 

 

weight gain or loss.

 

 

 

 

 

 

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

 

 

 

fungal infection of the mouth (oral candidiasis)

 

 

dehydration

product

 

 

 

dizziness

 

 

 

hearing impaired

 

 

 

 

 

 

decrease in blood pressure; irregular or rapid heart beat

 

heart failure

 

 

 

 

oesophagit s

 

 

 

 

dry mouth

 

 

 

 

difficulty or painful swallowing

 

 

 

ha morrhage

 

 

 

 

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

 

Medicinal

 

 

 

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).

Reporting of side effects
If you get any side effects, talk to your doctor, 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.

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

decrease of the sodium in your blood.

5. How to store Docetaxel Mylan 80 mg/4 ml

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- se storage times and conditions are the responsibility of the user.

authorised

From a microbiological point of view, dilution must takelongerplace in controlled and aseptic conditions.

Use immediately the medicine once added into the non-PVC i fusion bag. If not used immediately, in-

use storage times and conditions are the responsibility

f the user and would normally not be longer

no

n.

than 6 hours below 25°C including the one hour infusi

Physical and chemical in-use stability of the i fusion 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 supersat rated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and shall be discarded.

What Doc taxel Mylan 80 mg/4 ml contains

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.

 

 

product

6.

Contents of the pack and other information

 

Medicinal

 

The active substance is docetaxel. Each ml of concentrate for solution for infusion contains 20 mg docetaxel (anhydrous).

One vial contains 80 mg of docetaxel.

The other ingredients are polysorbate 80, ethanol anhydrous and citric acid.

What Docetaxel Mylan 80 mg/4 ml looks like and contents of the pack

Docetaxel Mylan concentrate for solution for infusion is a pale yellow to brownish-yellow solution. The concentrate is supplied in a clear colourless glass vial with a rubber stopper and a plastic flip-off cap.

Each vial contains 4 ml of concentrate. Each box contains 1 or 5 vials.

Marketing Authorisation Holder and Manufacturer

Mylan S.A.S.

117 allée des parcs

69800 Saint Priest France

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

België/Belgique/Belgien

Mylan bvba/sprl

Tél/Tel: + 0032 2 658 61 00

България

Mylan SAS

Tel: +33 4 37 25 75 00 (France)

Ceská republika

MylanPharmaceuticals s.r.o.

Tel: +420 274 770 201

Danmark

Mylan ApS

Tlf: + 45 3694 4568

Deutschland

Mylan dura GmbH

Tel: + 49-(0) 6151 9512 0

Eesti

Mylan SAS

Tel: +33 4 37 25 75 00 (France)

Ελλάδα

Generics Pharma Hellas ΕΠΕ

Τηλ: +30 210 9936410

EspañaMedicinal

product

Mylan Pharma eut als, S.L tel: + 34 93 3786400

France

Mylan SAS

Tel: +33 4 37 25 75 00

Hrvatska

Mylan SAS

Tel: +33 4 37 25 75 00 (France)

Ireland

Mc Dermott Laboratories Ltd

Tel: + 1800 272 272

Allphar +353 1 4041600

Lietuva

Mylan SAS

Tel: +33 4 37 25 75 00 (France)

Malta

 

authorised

Luxembourg/Luxemburg

Mylan bvba/sprl

 

Tél/Tel: + 0032 2 658 61 00 (Belgium)

Magyarország

 

Mylan Kft

 

Tel: 36 1 8026993

 

 

longer

 

George Borg Barth t Ltd

Tel: +356 21244205

Neder and

Mylan B.V

noTel: + 31 (0)33 2997080

Norge

Mylan AB

Tlf: + 46 8-555 227 50 (Sverige)

Österreich

Arcana Arzneimittel GmbH Tel: +43 1 416 24 18

Polska

Mylan Sp.z.o.o

Tel: +48 22 5466400

Portugal

Mylan, Lda.

Phone: + 00351 21 412 7200

România

Mylan SAS

Tel: +33 4 37 25 75 00 (France)

Slovenija

Mylan SAS

Tel: +33 4 37 25 75 00 (France)

Ísland
Mylan AB
Tel: + 46 8-555 227 50
Italia
Mylan S.p.A
Tel: + +39/02-61246921
Κύπρος
Pharmaceutical Trading Co Ltd Τηλ: +35 7 24656165
Latvija
Mylan SAS
Tel: +33 4 37 25 75 00 (France)

Slovenská republika

Mylan sr.o

Tel: +421 2 32 604 901

Suomi/Finland

Mylan OY

Puh/Tel: + 358 9-46 60 03

Sverige

Mylan AB

Tel: + 46 8-555 227 50

United Kingdom

Generics [UK] Ltd t/a Mylan

Tel: +44 1707 853000

Other sources of information

 

 

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

http://www.ema.europa.eu

longer

authorised

 

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

The following information is intended for healthcare pr fessi nals only:

 

no

PREPARATION GUIDE FOR USE WITH DOCETAXEL MYLAN CONCENTRATE FOR

SOLUTION FOR INFUSION

 

product

 

It is important that you read the entire contents of this guide prior to the preparation of the Docetaxel Mylan 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.

membranes, wash mmediately and thoroughly with water.

If DocetaxelMedicinalMylan 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

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 Mylan concentrate for solution for infusion, which contains only 1 vial).

Docetaxel Mylan concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to be added 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.

In Docetaxel Mylan, 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, 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 stor d b tween 2°C to 8°C.

Docetaxel infusion solution is supersaturated, therefore may crystallize over t me. 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:

authorised

 

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 wast wat r. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

 

 

no

longer

 

product

 

Medicinal

 

 

 

 

 

Package Leaflet: Information for the user

Docetaxel Mylan 200 mg/10 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 or hospital pharmacist.

-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 Docetaxel Mylan 200 mg/10 ml is and what it is used for

 

2.

What you need to know before you use Docetaxel Mylan 200 mg/10 ml

3.

How to use Docetaxel Mylan 200 mg/10 ml

authorised

4.

Possible side effects

5.

How to store Docetaxel Mylan 200 mg/10 ml

6.

Contents of the pack and other information

 

 

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

Docetaxel is a substance derived from the needles of yewlongertrees. Docetaxel belongs to the group of anti-cancer medicines called taxoids.

Docetaxel Mylan has been prescribed by your doctnor f r the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer:

-For the treatment of advanced breast cancer, docetaxel could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.

-For the treatment of early breast cancer with or without lymph node involvement, docetaxel could be

cisplatin.

product

administered in combination with

oxor bicin and cyclophosphamide.

- For the treatment of lung cancer,

cetaxel could be administered either alone or in combination with

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

-For the treatment of met st tic gastric cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.

-For the treatment of head and neck cancer, docetaxel is administered in combination with cisplatin and 5-fluoroura l.Medicinal

2. What you need to know before you use Docetaxel Mylan 200 mg/10 ml You must not be given Docetaxel Mylan

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

-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 Mylan, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Mylan. 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 Docetaxel Mylan administration and to continue for one or two days aft r it in order to minimise certain undesirable effects which may occur after the infusion of Docetaxel Mylan in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or we ght gain). During treatment, you may be given other medicines to maintain the number of y ur blood cells. Docetaxel Mylan contains alcohol. Discuss with your doctor if you suffer from alc h l dependency or liver impairment. See also section “Docetaxel Mylan contains ethanol” below.

Other medicines and Docetaxel Mylan

authorised

 

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 Mylan 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

 

longer

 

 

 

Ask your doctor for advice before being given a y medicine.

 

 

no

 

Docetaxel Mylan must NOT be administered if you are pregnant unless clearly indicated by your

doctor.

product

 

 

 

 

 

You must not become pregnant du ing treatment with this medicine and must use an effective method of contraception during thera y, because Docetaxel Mylan may be harmful for the unborn baby. If

pregnancy occurs during your treatment, you must immediately inform your doctor. You mustMedicinalnot breast-feed while you are treated with Docetaxel Mylan.

If you are a man be ng treated with Docetaxel Mylan 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 docetax l may alter male fertility.

Driving and using machines

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

Docetaxel Mylan contains ethanol

This medicine contains 50 vol % ethanol (alcohol), i.e. up to 3.95g per vial equivalent to 100 ml of beer or 40 ml wine per vial.

Harmful for those suffering from alcoholism.

To be taken into account if you are pregnant or if you are 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 alter the effects of other medicines.

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

3. How to use Docetaxel Mylan 200 mg/10 ml

Docetaxel Mylan 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

Frequency of administration

Docetaxel Mylan will be given by infusion into one of your veins (intravenousauthoriseduse). The infusion will last approximately one hour during which you will be in the hospital.

You should usually receive your infusion once every 3 weeks.

Your doctor may change the dose and frequency of dosing depending on yo r blood tests, your general condition and your response to Docetaxel Mylan. In particul r, ple se 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 d cide whether a dose reduction is needed.

If you have any further questions on the use of this medicine, ask your doctor, or hospital pharmacist.

longer

4.

Possible side effects

product

no

 

 

 

 

Like all medicines, this medicine can ca se 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 Mylan alone are: decrease in the number

 

Medicinalflushing, skin reactions, itching

of red blood cells or white b ood cells, hair loss, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.

The severity of adverse events of Docetaxel Mylan may be increased when Docetaxel Mylan is given in combination w th other chemotherapeutic agents.

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

chest tightness; difficulty in breathingfever or chills

back pain

low blood pressure.

More severe reactions may occur.

The hospital staff will monitor your condition closely during treatment. Tell them immediately if you notice any of these effects.

Between infusions of Docetaxel Mylan 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)

 

redness and swelling of the palms of your hands or soles of yourauthorisedfeet 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

longer

 

change or absence of menstrual period

no

 

swelling of the hands, feet, legs

 

tiredness; or flu-like symptoms

 

 

weight gain or loss.

 

 

 

 

 

 

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

 

 

 

fungal infection of the mouth (oral candidiasis)

 

 

dehydration

product

 

 

 

dizziness

 

 

 

hearing impaired

 

 

 

 

 

 

decrease in blood pressure; irregular or rapid heart beat

 

heart failure

 

 

 

 

oesophagit s

 

 

 

 

dry mouth

 

 

 

 

difficulty or painful swallowing

 

 

 

ha morrhage

 

 

 

 

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

 

Medicinal

 

 

 

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).

Reporting of side effects
If you get any side effects, talk to your doctor, 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.

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

decrease of the sodium in your blood.

5. How to store Docetaxel Mylan 200 mg/10 ml

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- se storage times and conditions are the responsibility of the user.

authorised

From a microbiological point of view, dilution must takelongerplace in controlled and aseptic conditions.

Use immediately the medicine once added into the non-PVC i fusion bag. If not used immediately, in-

use storage times and conditions are the responsibility

f the user and would normally not be longer

no

n.

than 6 hours below 25°C including the one hour infusi

Physical and chemical in-use stability of the i fusion 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 supersat rated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and shall be discarded.

What Doc taxel Mylan 200 mg/10 ml contains

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.

 

 

product

6.

Contents of the pack and other information

 

Medicinal

 

The active substance is docetaxel. Each ml of concentrate for solution for infusion contains 20 mg docetaxel (anhydrous).

One vial contains 200 mg of docetaxel.

The other ingredients are polysorbate 80, ethanol anhydrous and citric acid.

What Docetaxel Mylan 200 mg/10 ml looks like and contents of the pack

Docetaxel Mylan concentrate for solution for infusion is a pale yellow to brownish-yellow solution. The concentrate is supplied in a clear colourless glass vial with a rubber stopper and a plastic flip-off cap.

Each vial contains 10 ml of concentrate. Each box contains 1 or 5 vials.

Marketing Authorisation Holder and Manufacturer

Mylan S.A.S.

117 allée des parcs

69800 Saint Priest France

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

België/Belgique/Belgien

Mylan bvba/sprl

Tél/Tel: + 0032 2 658 61 00

България

Mylan SAS

Tel: +33 4 37 25 75 00 (France)

Ceská republika

MylanPharmaceuticals s.r.o.

Tel: +420 274 770 201

Danmark

Mylan ApS

Tlf: + 45 3694 4568

Deutschland

Mylan dura GmbH

Tel: + 49-(0) 6151 9512 0

Eesti

Mylan SAS

Tel: +33 4 37 25 75 00 (France)

Ελλάδα

Generics Pharma Hellas ΕΠΕ

Τηλ: +30 210 9936410

EspañaMedicinal

product

Mylan Pharma eut als, S.L tel: + 34 93 3786400

France

Mylan SAS

Tel: +33 4 37 25 75 00

Hrvatska

Mylan SAS

Tel: +33 4 37 25 75 00 (France)

Ireland

Mc Dermott Laboratories Ltd

Tel: + 1800 272 272

Allphar +353 1 4041600

Lietuva

Mylan SAS

Tel: +33 4 37 25 75 00 (France)

Malta

 

authorised

Luxembourg/Luxemburg

Mylan bvba/sprl

 

Tél/Tel: + 0032 2 658 61 00 (Belgium)

Magyarország

 

Mylan Kft

 

Tel: 36 1 8026993

 

 

longer

 

George Borg Barth t Ltd

Tel: +356 21244205

Neder and

Mylan B.V

noTel: + 31 (0)33 2997080

Norge

Mylan AB

Tlf: + 46 8-555 227 50 (Sverige)

Österreich

Arcana Arzneimittel GmbH Tel: +43 1 416 24 18

Polska

Mylan Sp.z.o.o

Tel: +48 22 5466400

Portugal

Mylan, Lda.

Phone: + 00351 21 412 7200

România

Mylan SAS

Tel: +33 4 37 25 75 00 (France)

Slovenija

Mylan SAS

Tel: +33 4 37 25 75 00 (France)

Ísland
Mylan AB
Tel: + 46 8-555 227 50
Italia
Mylan S.p.A
Tel: + +39/02-61246921
Κύπρος
Pharmaceutical Trading Co Ltd Τηλ: +35 7 24656165
Latvija
Mylan SAS
Tel: +33 4 37 25 75 00 (France)

Slovenská republika

Mylan sr.o

Tel: +421 2 32 604 901

Suomi/Finland

Mylan OY

Puh/Tel: + 358 9-46 60 03

Sverige

Mylan AB

Tel: + 46 8-555 227 50

United Kingdom

Generics [UK] Ltd t/a Mylan

Tel: +44 1707 853000

Other sources of information

 

 

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

http://www.ema.europa.eu

longer

authorised

 

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

The following information is intended for healthcare pr fessi nals only:

 

no

PREPARATION GUIDE FOR USE WITH DOCETAXEL MYLAN CONCENTRATE FOR

SOLUTION FOR INFUSION

 

product

 

It is important that you read the entire contents of this guide prior to the preparation of the Docetaxel Mylan 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.

membranes, wash mmediately and thoroughly with water.

If DocetaxelMedicinalMylan 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

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 Mylan concentrate for solution for infusion, which contains only 1 vial).

Docetaxel Mylan concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to be added 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.

In Docetaxel Mylan, 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, 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 stor d b tween 2°C to 8°C.

Docetaxel infusion solution is supersaturated, therefore may crystallize over t me. 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:

authorised

 

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 wast wat r. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

 

 

no

longer

 

product

 

Medicinal

 

 

 

 

 

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