Paclitaxel 6mg/Ml Concentrate For Solution For Infusion
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PACLITAXEL 6 MG / 1 ML CONCENTRATE FOR SOLUTION FOR INFUSION |
PL 14510/0035 07/09/2015 |
PACKAGE LEAFLET
Paclitaxel 6 mg/ml concentrate for solution for infusion
Paclitaxel
Read all of this leaflet carefully before you are give this medicine.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or nurse.
In this leaflet:
1. What paclitaxel is and what it is used for
2. Before you are give paclitaxel
3. How paclitaxel will be given to you
4. Possible side effects
5 Storing paclitaxel
The active substance in the injection is paclitaxel.
The other ingredients are citric acid (anhydrous), macrogol glycerol ricinolate, ethanol 96% and nitrogen.
1. WHAT PACLITAXEL IS AND WHAT IT IS USED FOR
Paclitaxel 6mg/ml concentrate for solution for infusion is a concentrated form of paclitaxel which must be diluted before use. It is available in single vials containing 30mg of paclitaxel in 5ml, 100mg of paclitaxel in 16.7ml, 150mg of paclitaxel in 25 ml and 300mg of paclitaxel in 50ml.
Paclitaxel 6mg/ml Concentrate for Solution for Infusion is a clear, colourless to pale yellow solution free from particles.
Paclitaxel belongs to a group of medicines known as cytotoxics, which are used in the treatment of cancer. Paclitaxel may be used to treat ovarian cancer, breast cancer, lung cancer and AIDS-related Kaposi’s sarcoma.
2. BEFORE YOU ARE GIVEN PACLITAXEL CONCENTRATE FOR SOLUTION FOR INFUSION
You will not be given Paclitaxel concentrate for solution for infusion:
• if you are allergic to paclitaxel or any of the other ingredients
• if you have a very low level of white blood cells in your blood
• if you have a serious infection
• if you are pregnant, breast-feeding or trying for a baby.
Your doctor will take special care when giving you paclitaxel:
• if you have liver problems
• if you are also receiving radiotherapy
Consult your doctor if any of the above warnings applies to you or has applied to you in the past.
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PACLITAXEL 6 MG / 1 ML CONCENTRATE FOR SOLUTION FOR INFUSION |
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Before your treatment starts you will be treated with a steroid (such as dexamethasone), an antihistamine (such as diphenhydramine) and an H2-blocker (such as cimetidine). For certain types of treatment you may need to have your heart monitored before, during and after treatment with paclitaxel. Your doctor will also check your blood before, during and after every treatment. If the results of any of these tests are abnormal treatment will only be resumed when all readings are back to normal.
This medicinal product contains the ingredient macrogol glycerol ricinolate which may cause serve allergic reactions. If you know that you are allergic to this ingredient you should let your doctor know.
Pregnancy
Paclitaxel should not be give to you if you are pregnant, because it can cause serious birth defects. Female patients should also avoid getting pregnant while being treated with paclitaxel and for at least six months afterwards. Male patients receiving paclitaxel should take adequate precautions to ensure that their partner does not become pregnant for the same period. If you are considering becoming parents after the treatment, you should discuss with you doctor.
Men who wish to father children in the future should see advice about freezing sperm before the paclitaxel treatment is started.
Breast-feeding
Paclitaxel should not be give to you if you are breast-feeding, as paclitaxel might pass into breast milk and affect the baby.
Children, under 18 years
This product is not recommended for use in children under 18 years Driving and using machines.
Paclitaxel concentrate for solution for infusion contains alcohol. Each treatment this will be the equivalent of taking two glasses of wine or four glasses of beer. This may cause side-effects which could affect your ability to drive. If this happens, you should avoid driving or operating machinery until these have worn off.
Being given paclitaxel at the same time as other medication
Paclitaxel is often used in combination with another drug, cisplatin. It is important that paclitaxel is administered before cisplatin. Care will be taken if you have gynaecological cancer and are being treated with paclitaxel and cisplatin.
If you have breast cancer you may be treated with another drug called doxorubicin. It is important that doxorubicin is given 24 hours after your treatment with paclitaxel.
Care is required if paclitaxel is administered at the same time as certain drugs which affect liver function including some drugs used to treat virus infusions (e.g. ritonavir), some drugs used to treat depression (e.g. fluvoxamine) and rosiglitazone (used in diabetes). Erythrocyin and rifampicin, used to treat infections; fluoxetine, a drug used to treat depressions; gemfibrozil, a drug used to treat heart disease; carbamazepine and phenytoin used for epilepsy, efavirenz, and nevirapine, drugs to treat HIV.
Care is required if paclitaxel is administered at the same time as protease inhibitors such as nelfinavir and ritonavir.
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PACLITAXEL 6 MG / 1 ML CONCENTRATE FOR SOLUTION FOR INFUSION |
PL 14510/0035 07/09/2015 |
Tell your doctor or pharmacist about medicines you are currently taking or have taken recently. This also applies to medicines you hay have bought yourself from a pharmacy or supermarket.
3. HOW PACLITAXEL CONCENTRATE FOR SOLUTION FOR INFUSION WILL BE GIVEN TO YOU
Paclitaxel concentrate for solution for infusion will only be given to you under the supervision of a doctor specialised in this type of treatment.
The dosage of paclitaxel depends on the condition you are being treated for, your response to the therapy and other medication you are being given. The paclitaxel concentrate should be diluted before use with a solution of sodium chloride or dextrose and given as an infusion (drip) into a vein.
When receiving paclitaxel for first-line treatment of ovarian cancer
The usual dosage of paclitaxel is 175mg per square metre of body surface area given over three hours, or 135mg per square metre of body surface area given over a 24 hour period, followed by treatment with 75mg of cisplatin per square metre of body surface area. There is a three week interval between each course of treatment.
When receiving paclitaxel of second-line treatment of ovarian cancer
The usual dosage of paclitaxel is 175mg per square metre of body surface area given over three hours, every three weeks for four courses of treatment.
When receiving paclitaxel for adjuvant treatment of breast cancer
The usual dosage of paclitaxel is 175mg per square metre of body surface area given over three hours. It is usually given in combination with another drug, trastuzumab. There is a three week interval between treatment courses.
When receiving paclitaxel for first-line treatment of breast cancer
The usual dosage of paclitaxel is 175mg per square metre of body surface area given over three hours. It is usually given in combination with another drug, trastuzumab. There is a three week interval between treatment courses.
Paclitaxel can also be used in combination with doxorubicin. The usual dosage is 220 mg per square metre given over three hours with a three week interval between treatment courses.
When receiving paclitaxel for second-line treatment of breast cancer
The usual dosage of paclitaxel is 175mg per square metre of body surface area given over three hours. There is a three week interval between treatment courses.
When receiving paclitaxel for treatment of advanced non-small cell lung cancer The usual dosage of paclitaxel is 175mg per square metre of body surface area given over three hours followed by treatment with 80mg of cisplatin per square metre of body surface area. There is a three week interval between each course of treatment. Further treatments will depend on how well you react to the treatment.
When receiving paclitaxel for treatment of ADIS related Kaposi’s Sarcoma
The usual dosage is 100mg per square metre given over three hours every two weeks.
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PACLITAXEL 6 MG / 1 ML CONCENTRATE FOR SOLUTION FOR INFUSION |
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Your general condition and your response to the treatment will be closely observed, before, during and after the paclitaxel treatment.
4. POSSIBLE SIDE EFFECTS
Like any other medication, paclitaxel may cause side-effects, particularly if given in combination with other anticancer drugs and radiotherapy.
The most common unwanted effects are temporary heir loss, nausea, vomiting, diarrhoea, sore mouth, numbness and tingling in the ands and feet aching muscles and joints, urinary tract and chest infections, flushing, rash, low blood pressure, blood problems and bradycardia (slowing of the heart beat).
Less commonly, paclitaxel may cause high or low blood pressure, heart problems, general weakness and paralysis, dizziness, fits (convulsions), problems with vision, loss of hearing and ringing the ears, temporary heir loss, nail and skin discolourations, bowel problems, liver problems, or a serious rash with reddening and flaking of the skin, thrombosis (blood clot), temperature, chills, back pain, chest pain, stomach pain, pain in fingers and toes and sweating.
Rarely, paclitaxel may cause pneumonia, sepsis (an infection), leukaemia, loss of appetite, confusion, fits (convulsions) with dizziness and headache, problems with vision, loss of hearing and ringing in the ears, a heart rhythm problem known as atrial fibrillation, shock, breathing problems, cough, liver problems, bowel problems including constipations, pseudomembranous colitis (inflammation of the colon), a serous rash with reddening and flaking of the skin, general weakness or paralysis, high temperature, fluid retention, serve tiredness and dehydration.
As well as killing cancer cells, the medicine may also affect some of your own cells especially the cells in your blood. This makes you more prone to infections and to bleeding or bruising easily. If you think you have an infection, a sore throat, moth ulcers, fever, chills or achiness you should contact your doctor.
Swelling and pain (known as extravasation) may occur temporarily at the injection site. If extravasation occurs, tell your doctor or nurse immediately.
Allergic reactions to paclitaxel or to macrogol glycerol ricinolate can occurs, with wheezing, flushing, a skin rash or swelling of your lips, eyes or tongue. You should contact your doctor immediately if you develop such symptoms.
Paclitaxel, in combination with radiation therapy, can cause inflammation of the lung with breathlessness. If you develop a persistent cough, experience pain of difficulty breathing or become breathless, you should see medical attention.
Paclitaxel can harm unborn babies (see section on pregnancy). It may also affect fertility in men and women.
During the treatment with paclitaxel your general condition will be closely monitored.
If you notice any side-effects not mentioned in this leaflet, please tell your doctor or nurse.
5. STORING PACLITAXEL
Keep out of the reach and sight of children. Do not store above 25°C.
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PACLITAXEL 6 MG / 1 ML CONCENTRATE FOR SOLUTION FOR INFUSION |
PL 14510/0035 07/09/2015 |
Store in the original container
Do not use after the expiry date stated on the label.
Chemical and physical in use stability has been demonstrated for 24 hours at 25°C.
Form a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 25°C. Other in use storage times and conditions are the responsibility of the user.
This leaflet was last revised on 09/2015
PIL 14510/00353d N002: SPC & PIL in line with Article 45 KP