Docetaxel Seacross 80 mg/4 ml, concentraat voor oplossing voor infusie

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

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

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

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

You must not be given Docetaxel Seacross

• if you are allergic to docetaxel or any of the other ingredients of this medicine (listed in section 6).
• if the number of white blood cells is too low.
• if you have a severe liver disease.

Warnings and precautions

Before each treatment with Docetaxel Seacross, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Seacross. 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 Docetaxel Seacross administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of Docetaxel Seacross in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).

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

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

Other medicines and Docetaxel Seacross

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 Seacross 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.

Docetaxel Seacross 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 Seacross 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 Seacross.

If you are a man being treated with Docetaxel Seacross 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.

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Driving and using machines

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

Docetaxel Seacross contains ethanol (alcohol).

[Docetaxel Seacross 20 mg/1 ml]

This medicinal product contains approximately 55 vol % ethanol (alcohol), i.e. 0.46 g (0.57 ml) ethanol 96 % per vial of 1 ml fill volume, equivalent to 12 ml beer, 5 ml wine per vial.

[Docetaxel Seacross 80 mg/4 ml]

This medicinal product contains approximately 55 vol % ethanol (alcohol), i.e. up to 1.83 g (2.26 ml) ethanol 96 % per vial of 4 ml fill volume, equivalent to 46 ml beer, 20 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.

Docetaxel Seacross will be administered to you by a healthcare professional.

Usual dose

The dose will depend on your weight and your general condition. Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive.

Method and route of administration

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

Frequency of administration

You should usually receive your infusion once every 3 weeks.

Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Seacross. 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 Seacross 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 Seacross may be increased when Docetaxel Seacross 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 Docetaxel Seacross 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 colour of your nails, which may detach
• muscle aches and pains; back pain or bone pain
• change or absence of menstrual period
• swelling of the hands, feet, legs
• tiredness; or flu-like symptoms
• weight gain or loss.

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

• oral candidiasis
• dehydration
• dizziness
• hearing impaired
• decrease in blood pressure; irregular or rapid heart beat
• heart failure
• oesophagitis
• dry mouth
• difficulty or painful swallowing
• haemorrhage
• raised liver enzymes (hence the need for regular blood tests).

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

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

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on outer carton and on the label of the vial after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°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 8 hours in infusion bottle or 6 hours in infusion bag below 25°C including the one hour infusion.

Physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2 to 8°C.

Docetaxel infusion solution is supersaturated, therefore may 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.

What Docetaxel Seacross contains

• The active substance is docetaxel.

[Docetaxel Seacross 20 mg/1 ml]

One ml docetaxel concentrate contains 20 mg docetaxel.

[Docetaxel Seacross 80 mg/4 ml]

One ml docetaxel concentrate contains 20 mg docetaxel.

- The other ingredients are polysorbate 80, ethanol 96% and citric acid monohydrate.

What Docetaxel Seacross looks like and contents of the pack

Docetaxel Seacross concentrate for solution for infusion is a clear viscous, colourless to brownish-yellow sterile solution.

[Docetaxel Seacross 20 mg/1 ml]

The concentrate is supplied in a 2 ml colourless glass vial with a green flip-off closure. Each box contains one vial of 1 ml concentrate (20 mg docetaxel).

[Docetaxel Seacross 80 mg/4 ml]

The concentrate is supplied in a 4 ml colourless glass vial with a red flip-off closure. Each box contains one vial of 4 ml concentrate (80 mg docetaxel).

Marketing Authorisation Holder

Seacross Pharmaceuticals Limited

Landmark House

17 Hanover Square

Mayfair

LONDON

W1S 1HU

United Kingdom

Manufacturer

Aegis Ltd

17, Athinon Street, Ergates, Industrial Area

(P.O. Box 28629)

2081 Nicosia

Zypern

Thymoorgan Pharmazie GmbH

Schiffgraben 23

38690 Vienenburg

Deutschland

Tecnimede – Sociedade Técnico-Medicinal, SA Quinta da Cerca, Caixaria

2565-187 Dois Portos Portugal

Docetaxel Seacross 20 mg/1 ml, concentraat voor oplossing voor infusie: RVG 108100 Docetaxel Seacross 80 mg/4 ml, concentraat voor oplossing voor infusie: RVG 108101

This leaflet was last revised in oktober 2013

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The following information is intended for healthcare professionals only:

PREPARATION GUIDE FOR USE WITH Docetaxel Seacross 20 mg/1 ml [ Docetaxel Seacross 80 mg/4 ml ] CONCENTRATE FOR SOLUTION FOR INFUSION

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

RECOMMENDATIONS FOR THE SAFE HANDLING

Docetaxel Seacross is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling and preparing its solutions. The use of gloves is recommended.

If Docetaxel Seacross 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 several vials (concentrate and solvent) with this medicinal product (Docetaxel Seacross 20 mg/1 ml [ Docetaxel Seacross 80 mg/4 ml ] concentrate for solution for infusion, which contains only 1 vial).

Docetaxel Seacross 20 mg/1 ml [Docetaxel Seacross 80 mg/4 ml] concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.

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

In Docetaxel Seacross 20 mg/1 ml [Docetaxel Seacross 80 mg/4 ml] vial the concentration of docetaxel is 20 mg/ml.

• Then, inject via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. If a dose greater than 190 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.
• Mix the infusion bag or bottle manually using a rocking motion.
• From 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 (PP) or infusion bottle (PE), the docetaxel infusion solution, if stored below 25°C, is stable for 8 hours in infusion bottle or for 6 hours in infusion bag. It should be used within 6-8 hours (including the one hour infusion IV administration). In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C.

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

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

DISPOSAL

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