Paclitaxel 6 Mg/Ml Concentrate For Solution For Infusion
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Paclitaxel Schluttig 6 mg/ml Concentrate for Solution for Infusion
Paclitaxel
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 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 pharmacist.
In this leaflet:
1. What Paclitaxel Schluttig is and what it is used for
2. Before you use Paclitaxel Schluttig
3. How to use Paclitaxel Schluttig
4. Possible side effects
5. How to store Paclitaxel Schluttig
6. Further information
1. What Paclitaxel Schluttig is and what it is used for
Paclitaxel Schluttig belongs to a group of medicines known as cytotoxics, which are used in the treatment of cancer. Paclitaxel Schluttig may be used to treat cancer:
• advanced ovarian cancer or remaining tumour (> 1 cm) after initial surgery, in
combination with cisplatin as initial (first-line) treatment.
• advanced ovarian cancer when certain other treatments (platinum-containing combination
therapy without taxanes) have been tried but have not worked (as second-line treatment).
• advanced breast cancer when other treatments are unsuitable (as first line treatment).
• advanced breast cancer when certain other treatments (standard anthracycline-containing
therapy) have been tried but have not worked (as second line treatment).
• advanced non-small cell lung cancer if surgery and/or radiation therapy are not possible,
in combination with cisplatin.
• AIDS-related Kaposi’s sarcoma when certain other treatments (liposomal anthracyclines)
have been tried but have not worked. This is a tumour that arises from blood vessels in the skin or internal organs and typically appears as flat or raised, purple to dark brown patches on the skin. There is limited information to support treatment of this condition. Paclitaxel Schluttig is a medicine that will be given to you by a doctor or health care professional.
2. Before you use Paclitaxel Schluttig Do not use Paclitaxel Schluttig
- if you are allergic (hypersensitive) to paclitaxel, macrogolglycerol ricinoleate or any of the other ingredients of Paclitaxel Schluttig
- if you are breast-feeding
- if your levels of white blood cells (neutrophiles) or blood platelets are low
- if you suffer from Kaposi's sarcoma and at the same time from serious, uncontrolled infections
Take special care with Paclitaxel Schluttig
Tell your doctor
- if you notice marked allergic reactions (e.g. shortness of breath, low blood pressure, swelling or rash)
- if there are signs that your body does not produce enough blood cells (e.g. you may be more prone to bleeding or infections)
- if you suffer from a severe heart disease with a low heart rate and high or low blood pressure
- if you suffer from a disease of peripheral nerves (e.g. tingling or numbness in hands or feet)
- if you know that your liver function is impaired
- if you suffer from Kaposi's sarcoma and severe mucositis, because you should receive a
reduced dosage (25%)
- if you are also receiving radiotherapy of your chest,
- if you develop severe, prolonged or bloody diarrhea (symptoms of a pseudomembranous colitis) during or after treatment with Paclitaxel Schluttig.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The amount of alcohol in this medicine may alter the effects of other medicines.
Cisplatin:
- kidney damage may get worse;
- may, when given after paclitaxel, profoundly reduce blood cell numbers.
Caution should be exercised when paclitaxel is administered at the same time with medicines that influence removal of paclitaxel from the body (by the liver, e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, efavirenz, nevirapine, erythromycin, fluoxetine, gemfibrozil).
Medicines for treating AIDS (protease inhibitors): paclitaxel should be given with caution.
Doxorubicin: Paclitaxel Schluttig should be given 24 hours after doxorubicin.
Taking cimetidine before paclitaxel does not influence removal of paclitaxel from the body.
Using ketoconazol at the same time does not influence removal of paclitaxel from the body.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
Tell your doctor if you are pregnant or think you may be pregnant before receiving treatment with paclitaxel. If there is a chance that you could become pregnant, use an effective and safe method of contraception during treatment. Paclitaxel Schluttig should not be used during pregnancy unless clearly necessary.
Women and men of childbearing potential and / or their partners should use contraceptives for at least 6 months after treatment with paclitaxel.
Men should seek advice regarding cryoconservation of sperm prior to treatment with paclitaxel because of the possibility of infertility.
Breast-feeding
Paclitaxel Schluttig must not be given to you if you are breast-feeding, as paclitaxel might pass into breast milk and affect the baby. You should stop breast-feeding while you are being treated with Paclitaxel Schluttig. Do not restart breast-feeding until your doctor tells you it is safe to do so.
Driving and using machines
Immediately after a course of treatment, the amount of alcohol in this medicinal product may affect your ability to drive or use machines. In addition, some side effects such as dizziness, nausea or tiredness may affect your ability to drive or operate machinery.
Children
Paclitaxel-Schluttig is not recommended for the use in children and adolescents (under 18 years).
Important information about some of the ingredients of Paclitaxel Schluttig
Paclitaxel Schluttig contains macrogolglycerol ricinoleate, which may cause severe allergic reactions.
Paclitaxel Schluttig contains 49.9% v/v ethanol (alcohol), i.e. up to 25 g per dose, equivalent to 500 ml beer or 200 ml wine.
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.
3. How to use Paclitaxel Schluttig
Your doctor will decide about the dose of Paclitaxel Schluttig you will receive.
This medicine can only be given by nursing staff under the supervision of a doctor with experience in cancer (cytostatic) treatment.
Usual dose
When receiving Paclitaxel Schluttig for first-line treatment of ovarian cancer
The usual dosage of paclitaxel is 175 mg per square metre of body surface area given over three hours, or 135 mg per square metre of body surface area given over a 24 hour period, followed by treatment with 75 mg of cisplatin per square metre of body surface area. There is a three week interval between each course of treatment.
When receiving Paclitaxel Schluttig for second-line treatment of ovarian cancer
The usual dosage of paclitaxel is 175 mg per square metre of body surface area given over three hours,
every three weeks.
When receiving Paclitaxel Schluttig for first-line treatment of breast cancer
The usual dosage of paclitaxel is 175 mg 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 Schluttig can also be used in combination with doxorubicin. The usual dosage of paclitaxel is 220 mg per square metre given over three hours with a three week interval between treatment courses.
When receiving Paclitaxel Schluttig for second-line treatment of breast cancer (also as accompanying treatment)
The usual dosage of paclitaxel is 175 mg per square metre of body surface area given over three hours. There is a three week interval between treatment courses. As accompanying treatment it is usually given in combination with another drug, trastuzumab.
When receiving Paclitaxel Schluttig for treatment of advanced non-small cell lung cancer
The usual dosage of paclitaxel is 175 mg per square metre of body surface area given over three hours followed by treatment with 80 mg of cisplatin per square metre of body surface area. There is a three week interval between each course of treatment.
When receiving Paclitaxel Schluttig for treatment of AIDS related Kaposi’s Sarcoma
The usual dosage of paclitaxel is 100 mg per square metre given over three hours every two weeks.
Method and route of administration
Paclitaxel Schluttig must be diluted before use with a solution of sodium chloride or glucose and given as an infusion over a period of 3 hours (drip) into a vein.
Change of usual dosage and frequency of dosing
Further treatments will depend on how well you react to the treatment. Your general condition and your response to the treatment will be closely observed before, during and after the treatment with Paclitaxel Schluttig.
Before administration
To help prevent allergic reactions occurring while you are receiving your infusion your doctor will treat you with other medicines called corticosteroids (such as dexamethasone), antihistamines (such as diphenhydramine) and H2 blockers (such as cimetidine) before starting Paclitaxel Schluttig.
If you take more Paclitaxel Schluttig than you should
If you think you have been given too much paclitaxel, tell your doctor straight away. There is no specific antidote. The expected symptoms of an over-dosage are overall reduction of blood cells (bone marrow suppression), numbness or abnormal sensations in your arms and legs (peripheral neuropathy) and inflamation of the membranes lining the digestive tract (mucositis).
If you forgot to use Paclitaxel Schluttig
If you think you have missed an infusion, speak to your doctor or nurse.
If you stop using Paclitaxel Schluttig
Do not stop treatment with paclitaxel before consulting your doctor.
If you have any further question on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Paclitaxel Schluttig can cause side effects, although not everybody gets them.
You should wear sun protection on hands and feet for the duration of your treatment since your skin may be more sensitive to sunlight.
Serious side effects:
If any of the following happen, tell your doctor immediately:
Very common (affects more than 1 user in 10):
- signs of infection, i.e. fever
Common (affects 1 to 10 users in 100):
- reactions at the injection site: with symptoms of swelling, pain, reddening, induration and
occasionally inflammation and severe skin damage
Uncommon (affects 1 to 10 users in 1,000):
- marked allergic reactions requiring treatment: with symptoms of low or high blood pressure; swelling of face, lips, tongue and/or throat; shortness of breath, generalized hives, chills; pain of the back, chest, belly and extremeties; fast pulse, sweating; allergic shock (very rare)
- septic shock: with symptoms of fever, chills, low blood pressure
- severe heart complications (e.g. heart muscle disease): with symptoms of fast or irregular pulse, fainting
- heart attack with symptoms of severe chest pains possibly radiating to jaw or arm, sweating, breathlessness and nausea
Very rare (affects less than 1 user in 10,000):
- severe skin diseases: with symptoms of blistering, reddening, detachment, necrosis, hives
- life - threatening allergic reactions (anaphylactic shock)
Not known (frequency cannot be estimated from the available data):
- tumor lysis syndrome (metabolic derangement produced by rapid tumor breakdown as a consequence of therapy).
Other side effects:
Very common (affects more than 1 user in 10):
infections (mainly upper airways and urinary tract), reduced blood cell production (which may lead to not enough white and red blood cells and platelets), bleeding, mild allergic reactions (flush and rash), injury of peripheral nerves (leading for instance to tingling or numbness in hands and feet), low blood pressure, digestive tract side effects (nausea, vomiting, diarrhoea, inflammation of the mucous membranes), hair loss, joint or muscle pain.
Common (affects 1 to 10 users in 100):
low pulse, temporary and mild nail and skin changes, elevated blood values indicating problems with liver function (elevated AST, SGOT, alkaline phosphatase).
Uncommon (affects 1 to 10 users in 1,000):
high blood pressure, inflammation of blood veins, blood clots blocking veins, elevated levels of bile pigment in serum.
Rare (affects 1 to 10 users in 10,000):
pneumonia, inflammation of the inner belly lining (peritonitis), blood-poisoning (sepsis), severe allergic reactions, nerve damage leading to weakness of the extremities, shortness of breath, water in the lining around the lung, severe lung disorders (due to damage of lung tissue [lung fibrosis] or reduced blood supply [pulmonary embolism]) and insufficient lung function, digestive tract side effects (bowel obstruction and perforation, bowel inflammation due to reduced blood supply, inflammation of the pancreas), itch, rash, reddening, weakness and tiredness, dehydration, tissue swelling due to water uptake, malaise, elevated blood values indicating kidney injury (elevated creatinine), heart failure, fever accompanied by low white blood cell count (febrile netopenia).
Very rare (affects less than 1 user in 10,000):
leukaemia, blood disease due to production of immature cells, loss of appetite, confusion, nervous disorder leading to bowel obstruction and low blood pressure when standing up, epileptic attacks, seizures, brain disease, dizziness, headache, gait disturbances, visual disturbances, hearing damage and loss, noise in the ears, giddiness, heart rhythm disorders e.g. heart hurry, shock, cough, digestive tract side effects (blood clots in bowel veins, severe bowel inflammation, inflammation of the gullet, constipation), water in the belly, severe liver disorder which may also affect brain function, and nail detachment.
Not known (frequency cannot be estimated from the available data):
- swelling of the macular (macular oedema), flashes of light (photopsia) or vitreous floaters,
- inflammation of a vein (phlebitis),
- hardening of the skin (scleroderma)
- chronic inflammatory connective tissue disorder (systemic lupus erythematosus)
Patients receiving concomitant radiotherapy
Combination with radiation therapy can cause lung inflammation with breathlessness. If you develop persistent cough, experience pain or difficulty breathing or become breathless you should seek medical attention.
Patients with AIDS-related Kaposi's sarcoma
When patients were treated with paclitaxel, fever and increased serum values of bile pigment and other enzymes, indicating problems with liver function (bilirubin, alkaline phosphatase and AST (SGOT)), were observed very commonly (affects more than 1 user in 10), episodes of bleeding were observed commonly.
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 pharmacist.
5. How to store Paclitaxel Schluttig
Keep out of the reach and sight of children.
Do not use Paclitaxel Schluttig after the expiry date which is stated on the vial and outer carton after EXP.
This medicinal product does not require any special storage conditions.
Your medicine is stored in a pharmacy and is prepared especially for you based on your doctor’s prescription by specialised staff.
6. Further information What Paclitaxel Schluttig contains
The active substance is paclitaxel.
1 ml concentrate for solution for infusion contains 6 mg paclitaxel.
1 vial of 5 ml contains 30 mg paclitaxel.
1 vial of 16.7 ml contains 100 mg paclitaxel.
1 vial of 25 ml contains 150 mg paclitaxel.
1 vial of 50 ml contains 300 mg paclitaxel.
The other ingredients are macrogolglycerol ricinoleate, 49.9% v/v ethanol and citric acid, anhydrous.
What Paclitaxel Schluttig looks like and contents of the pack
This medicine is a concentrate for solution for infusion. The concentrate is a clear, colourless or slightly yellow and viscous solution, which is filled in clear glass vials sealed with rubber stoppers.
The packages contain 1 vial of 5 ml, 16.7 ml, 25 ml and 50 ml, respectively.
Not all pack sizes may be marketed.
Marketing Authorisation Holder <[To be completed nationally]>
Manufacturer cell pharm GmbH Feodor-Lynen-Str. 35 D-30625 Hannover Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria
Czech Republic Hungary Romania Slovenia Slovak Republic United Kingdom
Paclitaxel STADA 6 mg/ml Konzentrat zur Herstellung einer Infusionslosung Paclitaxel STADA 6 mg/ml koncentrat pro pnpravu infuzmho roztoku Paclitaxel STADA 6 mg/ml koncentratum oldatos infuziohoz Paclitaxel STADA 6 mg/ml concentrat pentru solutie perfuzabila Paklitaksel STADA 6 mg/ml koncentrat za raztopino za infundiranje Paclitaxel STADA 6 mg/ml infuzny koncentrat Paclitaxel 6 mg/ml concentrate for solution for infusion
This leaflet was last approved in <mm/yyyy>. <[To be completed nationally]>
The following information is intended for medical or health care professionals only:
Handling:
As with all antineoplastic agents, caution should be exercised when handling Paclitaxel Schluttig. Dilution should be carried out under aseptic conditions by trained personnel in a designated area. Adequate protective gloves should be worn. Precautions should be taken to avoid contact with the skin and mucous membranes. In the event of contact with the skin, the area should be washed with soap and water. Following topical exposure, tingling, burning and redness have been observed. In the event of contact with the mucous membranes, these should be flushed thoroughly with water. Upon inhalation, dyspnoea, chest pain, burning throat and nausea have been reported.
Pregnant women should not handle paclitaxel.
If unopened vials are refrigerated or frozen, a precipitate may form that redissolves with little or no agitation upon reaching room temperature. Product quality is not affected. If the solution remains cloudy or if an insoluble precipitate is noted, the vial should be discarded.
The Chemo-Dispensing Pin device or similar devices with spikes should not be used, since they can cause the vial stopper to collapse, resulting in the loss of sterile integrity.
Preparation for intravenous administration:
Prior to infusion, Paclitaxel Schluttig must be diluted using aseptic techniques in 0.9% sodium chloride solution for infusion, or 5% glucose solution for infusion, or a mixture of 0.9% sodium
chloride solution for infusion and 5% glucose solution for infusion, or Ringer’s solution for infusion containing 5% glucose, to a final concentration of 0.3 to 1.2 mg/ml.
Only clear solutions practically free from particles should be used.
For microbial, chemical and physical in-use stability of the diluted solutions see section “Shelf life”.
Upon preparation, solutions may show some haziness, which is attributed to the formulation vehicle and is not removed by filtration. Paclitaxel Schluttig should be administered through an in-line filter with a microporous membrane <0.22 pm. No significant losses in potency have been noted following simulated delivery of the solution through intravenous tubing containing an in-line filter.
There have been rare reports of precipitation during Paclitaxel Schluttig infusions, usually towards the end of a 24 hour infusion period. Although the cause of this precipitation has not been elucidated, it is probably linked to the supersaturation of the diluted solution. To reduce the precipitation risk, Paclitaxel Schluttig should be used as soon as possible after dilution, and excessive agitation, vibration or shaking should be avoided. The infusion sets should be flushed thoroughly before use. During infusion, the appearance of the solution should be regularly inspected and the infusion should be stopped if precipitation is present.
To minimize patient exposure to DEHP which may be leached from plasticized PVC infusion bags, sets, or other medical instruments, diluted Paclitaxel Schluttig solutions should be stored in non-PVC bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets. The use of filter devices (e.g. IVEX-2®) which incorporate short inlet and/or outlet plasticized PVC tubing has not resulted in any significant leaching of DEHP.
Shelf life:
Shelf life after opening:
Chemical and physical stability of the vials following multiple needle entries and product withdrawals has been demonstrated for 28 days after first opening.
From 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.
Shelf life after dilution:
Chemical and physical in-use stability of the solution prepared for infusion has been demonstrated:
- for 27 hours at 25°C and ambient lighting conditions, when diluted in 0.9% sodium chloride solution for infusion, or 5% glucose solution for infusion
- for 24 hours at 25°C and ambient lighting conditions, when diluted in a mixture of 0.9% sodium chloride solution for infusion and 5% glucose solution for infusion, or Ringer’s solution for infusion containing 5% glucose.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, unless dilution has taken place in controlled and validated aseptic conditions.
Only clear solutions free from particles should be used.
Disposal:
Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic compounds.
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