Tevadocel 20mg/Ml Concentrate For Solution For Infusion
Out of date information, search anotherPACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER /.../ 20 mg/ml concentrate for solution for infusion
docetaxel
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or your hospital pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your hospital pharmacist.
In this leaflet:
1. What /.../ is and what it is used for
2. Before you use /.../
3. How to use /.../
4. Possible side effects
5. How to store /.../
6. Further information
1. WHAT /.../ IS AND WHAT IT IS USED FOR
The name of this medicine is /.../. 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.
/.../ has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (nonsmall cell lung cancer), prostate cancer, gastric cancer or head and neck cancer:
- For the treatment of advanced breast cancer, /.../ could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
- For the treatment of early breast cancer with lymph node involvement, /.../ could be administered in combination with doxorubicin and cyclophosphamide.
- For the treatment of lung cancer, /.../ could be administered either alone or in combination with cisplatin.
- For the treatment of prostate cancer, /.../ is administered in combination with prednisone or prednisolone.
- For the treatment of metastatic gastric cancer, /.../ is administered in combination with cisplatin and 5-fluorouracil.
- For the treatment of head and neck cancer, /.../ is administered in combination with cisplatin and 5-fluorouracil.
2. BEFORE YOU USE /.../
Do not use /.../ if
• you are allergic (hypersensitive) to docetaxel or any other ingredients of /.../.
• the number of white blood cells is too low.
• you have a severe liver disease.
Take special care with /.../
Before each treatment with /.../, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive /.../. 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 /.../ 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 /.../ in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
During treatment, you may be given medication to maintain the number of your blood cells.
This medicinal product contains alcohol and may be harmful for those suffering from alcoholism and should be taken into account in high-risk groups such as patients with liver disease or epilepsy. In case any of the above conditions apply to you, discuss it with your doctor before the medicinal product is given to you.
Using other medicines
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 /.../ or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Pregnancy
Ask your doctor for advice before being given any medicine.
/.../ 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 contraceptive during therapy, because /... / may be harmful for the unborn baby. If pregnancy occurs during your treatment, you must immediately inform your doctor.
If you are a man being treated with /.../ 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.
Breast-feeding
You must not breast-feed while you are treated with /.../.
Driving and using machines
No studies on the effect on the ability to drive and use machines have been performed.
Important information about some of the ingredients of /.../
This medicinal product contains 51 vol % ethanol (alcohol). i.e. up to
- 400 mg per (1 ml) vial, equivalent to 10 ml of beer or 4 ml wine per vial.
- 1600 mg per (4 ml) vial, equivalent to 40 ml of beer or 16 ml wine per vial.
- 2800 mg per (7 ml) vial, equivalent to 70 ml of beer or 28 ml wine per vial.
- 3200 mg per (8 ml) vial, equivalent to 80 ml of beer or 32 ml wine per vial.
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 medicinal product may alter the effects of other medicines.
The amount of alcohol in this medicinal product may impair your ability to drive or use machines.
3. HOW TO USE /.../
/.../ will be administered to you by a healthcare professional.
Usual dosage
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
/.../ 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 /.../. 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 product, ask your doctor, or hospital pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all other anticancer medicines, /.../ 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 /.../ alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhea and tiredness.
The severity of adverse events of /.../ may be increased when /.../ is given in combination with other chemotherapeutic agents.
During the infusion at the hospital the following allergic reactions (experienced in more than 1 person in 10) may occur:
• 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 /.../ the following may occur, and the frequency may vary with the combinations of drugs that are received:
Very Common: (experienced in more than 1 in 10 patients)
• 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 of 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 diarrhea, 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 (experienced in less than 1 in 10 but more than 1 in 100 patients)
• 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: (experienced in more than 1 in 1,000 but less than 1 in 100)
• 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or hospital pharmacist.
5. HOW TO STORE /.../
Keep out of the reach and sight of children.
/.../ should not be used after the expiry date shown on the carton and vial.
Store below 25°C.
Store in the original package in order to protect from light.
Do not refrigerate or freeze.
6. FURTHER INFORMATION What /.../ contains
- The active substance is docetaxel. Each ml of docetaxel solution contains 20 mg of docetaxel anhydrous.
- The other ingredients are citric acid anhydrous, povidone, ethanol absolute and polysorbate 80.
What /.../ looks like and contents of the pack:
/.../ concentrate for solution for infusion is a clear, pale yellow solution.
Pack sizes:
1 x 1 ml single dose vial 1 x 4 ml single dose vial 1 x 7 ml single dose vial
I x 8 ml single dose vial
Not all pack sizes may be marketed
Marketing Authorisation Holder
<[To be completed nationally]>
{Name and address}
Manufacturer
S. C. Sindan-Pharma S.R.L
II Ion Mihalache Blvd,
011171 Bucharest, Romania
Actavis Italy S.p.A. - Nerviano Plant Viale Pasteur 10 20014 Nerviano (MI)
Italy
Merckle GmbH Ludwig-Merckle-StraBe 3 89143 Blaubeuren-Weiler Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
<{Name of the Member State}> <{Name of the medicinal product}>
<{Name of the Member State}> <{Name of the medicinal product}>
This leaflet was last approved in {MM/YYYY}. <[To be completed nationally]>
The following information is intended for medical or healthcare professionals only:
/.../ 20 mg/ml concentrate for solution for infusion Instructions on use
/.../ is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing /.../ solutions. Cytotoxic agents should be prepared for administration only by personnel who have been trained in the safe handling of such preparations. Refer to local cytotoxic guidelines before commencing. The use of gloves is recommended. If /.../ concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If /.../ concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Preparation of the solution for infusion
More than one vial of /... / 20 mg/ml concentrate for solution for infusion may be necessary to obtain the required dose for individual patients. Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding volume of 20 mg/ml docetaxel from the appropriate number of vials using graduated syringes fitted with a needle. For example, a dose of 140 mg docetaxel would require 7 ml of /./ 20 mg/ml concentrate for solution for infusion.
For doses below 192 mg of docetaxel, inject the required volume of /./ 20 mg/ml concentrate for solution for infusion into a 250 ml infusion bag or bottle containing either 250 ml of 50 mg/ml (5%) glucose solution for infusion or 9 mg/ml (0.9%) sodium chloride solution for infusion. For doses exceeding 192 mg of docetaxel more than 250 ml of the infusion solution is required, as the maximum concentration of docetaxel is 0.74 mg per ml of infusion solution.
Mix the infusion bag or bottle manually using a rocking motion. The diluted solution should be aseptically administered as a 1-hour infusion at room temperature and normal lighting conditions.
As with all parenteral products, this medicinal product should be visually inspected prior to use and solutions containing a precipitate should be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements.
Storage after opening
The solution should be used immediately after opening of the vial. 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.
Storage after dilution
Chemical and physical in-use stability of the diluted solution (0.74 mg/ ml) in the recommended solutions for infusion (50 mg/ml (5%) glucose solution for infusion or 9 mg/ml (0.9%) sodium chloride solution for infusion) has been demonstrated for 3 days when stored at 2-8°C protected from light and for 8 hours in non-PVC bags when stored below 25oC under normal lighting conditions.
From a microbiological point of view, the product should be used immediately. If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2 to 8oC, unless dilution has taken place in controlled and validated aseptic conditions.
Docetaxel infusion solution is supersaturated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and shall be discarded.
Disposal
Any unused product or waste material should be disposed of in accordance with local requirements.
8