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Composition : DOCETAXEL-120MG
Route Of Administration : PARENTERAL
Pack : 1

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Drug Ingredient Information



Information for patients
Drug Information The name of this medicine is Docetaxel. Docetaxel is a substance derived from the needles of yew trees. Docetaxel belongs to the group of anticancer medicines called taxoids. Docetaxel 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 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 administered in combination with doxorubicin and cyclophosphamide. •For the treatment of lung cancer, Docetaxel could be administered either alone or in combination with cisplatin. •For the treatment of prostate cancer, Docetaxel is administered in combination with prednisone or prednisolone. •For the treatment of metastatic 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-fluorouracil.
Drug Alert
Alert •you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel. •the number of white blood cells is too low. •you have a severe liver disease.
Before Consuming the Medicine
Avoid Drug •you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel. •the number of white blood cells is too low. •you have a severe liver disease.
Drug Special Care Before each treatment with Docetaxel, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel. 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 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 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. 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.
Drug Drug Interactions 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 or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Drug Pregnancy Interaction Ask your doctor for advice before being given any medicine. Docetaxel 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 Docetaxel 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 Docetaxel 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.
Drug Breast feeding Interaction You must not breast-feed while you are treated with Docetaxel.
Drug Machinery Interaction There is no reason why you cannot drive between courses of Docetaxel except if you feel dizzy or are unsure of yourself. In higher doses (7.5ml concentrate (150mg) contains 3g ethanol) the amount of alcohol may impair your ability to drive or use machines.
Drug More Information no data available
How to take the Medicine
Consumption Info no data available
Drug quanitty The dose will depend on your weight and your general condition. Your doctor will calculate your body surface area in square metres (m²) and will determine the dose you should receive. 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. 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.
Drug Dose Docetaxel will be administered to you by a healthcare professional.Docetaxel will be given by infusion into one of your veins. The infusion will last approximately one hour during which you will be in the hospital. Docetaxel 20mg/ml Concentrate for Solution for Infusion
Excess Drug Consumption Dail 1066. OR Contact doctor immediately
Forgot Drug Consumption Contact Your doctor
Stop Drug Consumption Do not stop the drug untill your doctor says you to do so.
Possible Side Effects
General Information •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 •short term 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 Drug Side Effects •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)
Rare Drug Side Effects •fainting •at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling •inflammation of the colon, small intestine; intestinal perforation •blood clots
Very Rare Drug Side Effects no data available
Drug Side Effects Symptoms Like all other anticancer medicines, Docetaxel 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 (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
How to Store the Medicine
How to Store the Medicine Keep out of the reach and sight of children. Docetaxel 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. Vials after opening: The solution should be used immediately after opening of the vial. However, the physical, chemical and microbiological stability of the drug product after first vial opening has been demonstrated for 28 days at 2-8°C and at 25°C and normal lighting conditions. After dilution: The diluted solution should be used immediately after preparation. If not used immediately the in-use storage times and conditions are the responsibility of the user and would not normally be longer than 3 days at 2-8°C protected from light or 8 hours at room temperature (about 25°C) including the one hour infusion. Dispose any unused product or waste material accordance with local requirements.

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