Demotaxel Mono 20 mg/ml, concentraat voor oplossing voor infusie

1. What is and what it is used for

The name of this medicine is<invented name>. Its common name is docetaxel. Docetaxel is a substance derived from the needles of yew trees.

<invented name>belongs to the group of anti-cancer medicines called taxoids.

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

2. What you need to know before you use

You must not be given <invented name>

• if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of <invented name>.
• if the number of white blood cells is too low.

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• if you have a severe liver disease.

Warnings and precautions

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

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

<Invented name> contains alcohol. Discuss with your doctor if you suffer from alcohol dependency or liver impairment. See also section “<Invented name> contains ethanol (alcohol)” below.

Other medicines and <Invented name>

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 <invented name> 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.

<Invented name> must NOT be administered if you are pregnant unless clearly indicated by your doctor.

You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because Docetaxel Accord may be harmful for the unborn baby. If pregnancy occurs during your treatment, you must immediately inform your doctor.

You must not breast-feed while you are treated with Docetaxel.

If you are a man being treated with <invented name> 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.

<Invented name> contains ethanol (alcohol) This medicinal product contains

50 vol % ethanol (alcohol), i.e. up to 0.395 g (0.5 ml) per vial, equivalent to 10 ml of beer or 4 ml wine per vial.

50 vol % ethanol (alcohol), i.e. up to 1.58 g (2 ml) per vial, equivalent to 40 ml of beer or 17 ml wine per vial.

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50 vol % ethanol (alcohol), i.e. up to 3.16 g (4 ml) per vial, equivalent to 80 ml of beer or 33 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 medicine 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

<Invented name> 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

<Invented name> 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 <invented name>. 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 Docetaxel alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.

The severity of adverse events of Docetaxel may be increased when Docetaxel 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

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• fever or chills
• back pain
• low blood pressure.

More severe reactions may occur.

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

Between infusions of Docetaxel the following may occur, and the frequency may vary with the combinations of 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 your feet which may cause your skin to peel (this may also occur on the arms, face, or body)
• change in the color of your nails, which may detach
• muscle aches and pains; back pain or bone pain
• change or absence of menstrual period
• swelling of the hands, feet, legs
• tiredness; or flu-like symptoms
• weight gain or loss.

Common (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).

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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.

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.

5. How to store

Keep this medicine out of the reach and sight 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 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 24 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 7 days when stored between 2 to 8°C.

Docetaxel infusion solution is supersaturated, therefore may crystallise 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 to protect the environment.

What <Invented name> contains

• The active substance is docetaxel. Each ml of concentrate for solution for infusion contains 20 mg docetaxel. One vial of 1 ml of concentrate contains 20 mg of docetaxel. One vial of 4 ml of concentrate contains 80 mg of docetaxel. One vial of 8 ml of concentrate contains 160 mg of docetaxel.
• The other ingredients are polysorbate 80; ethanol, anhydrous and citric acid, anhydrous.

What <Invented name> looks like and contents of the pack

<Invented name> concentrate for solution for infusion is a clear pale yellow to brownish-yellow solution.

The concentrate is supplied in a 5 ml clear glass (type I) vial with fluorotec plus rubber stopper and aluminium seal and an orange flip-off cap.

The concentrate is supplied in a 5 ml clear glass (type I) vial with fluorotec plus rubber stopper and aluminium seal and a red flip-off cap.

The concentrate is supplied in a 10 ml clear glass (type I) vial with fluorotec plus rubber stopper and aluminium seal and a red flip-off cap.

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Pack size:

Each box contains one vial of 1 ml concentrate.

Each box contains one vial of 4 ml concentrate.

Each box contains one vial of 8 ml concentrate.

Marketing Authorisation Holder

DEMO S.A.,

21st km National Road Athens-Lamia, 14568 Krioneri, Attiki

Griekenland

Manufacturer

Accord Healthcare Limited

Sage house, 319 Pinner road, North Harrow,

HA1 4HF, Middlesex

Verenigd Koninkrijk

DEMO S.A.,

21st km National Road Athens-Lamia, 14568 Krioneri, Attiki

Griekenland

In het Register ingeschreven onder:

RVG 111628

The medicinal product is authorized in the Member States of the EEA under the following names:

Name of member state	:	Name of medicinal product
NL	:	DEMOTAXEL MONO 20 mg/ml,
concentrate for solution for infusion
EL	:	DEMOTAXEL MONO

This leaflet was last approved in maart 2013.

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The following information is intended for healthcare professionals only:

PREPARATION GUIDE FOR USE WITH <Invented name> CONCENTRATE FOR SOLUTION FOR INFUSION

It is important that you read the entire contents of this guide prior to the preparation of the Docetaxel 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 <invented name> 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 (<Invented name> 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 (<Invented name> 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 (<Invented name> 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).

<Invented name> concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.

• Each vial is for single use and should be used immediately after opening. If not used immediately, in-use storage times and conditions are the responsibility of the user. More than one vial of concentrate for solution for infusion may be necessary to obtain the required dose for the patient. For example a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution.
• Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe.

In <Invented name> vial the concentration of docetaxel is 20 mg/ml.

• Then, inject via a single injection (one shot) into a 250 ml infusion bag 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 manually using a rocking motion. Avoid vigorous shaking or excessive agitation.
• 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.

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Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 24 hours. It should be used within 24 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 7 days when stored between 2°C to 8°C.

It is recommended to avoid excessive agitation of the bags.

Docetaxel infusion solution is supersaturated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and shall be discarded.

• As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.

Disposal

All materials that have been utilised for dilution and administration should be disposed of according to standard procedures. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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