6 mg / ml, concentrate for solution for infusion
What Paclitaxel Pfizer is and what it is used for
Paclitaxel Pfizer prevents the growth of certain cancer cells, especially in special cancers of the breast, ovaries, and lungs, as well as a special AIDS-related cancer that originates in the connective tissue ( Kaposi’s sarcoma ).
What you need to know before using Paclitaxel Pfizer
Do not use Paclitaxel Pfizer
- if you are allergic to paclitaxel or any of the other ingredients of this medicine (listed in section 6), in particular, macrogol glycerol castin oil (polyoxyethylated castor oil)
- if you are breast-feeding
- if you have too few white blood cells ( neutrophils ). This is measured by healthcare
- if you have Kaposi’s sarcoma and at the same time have a serious infection
Warnings and cautions
Talk to your doctor or nurse before using Paclitaxel Pfizer:
- if you have heart problems or severe liver disease
- because the medicine contains alcohol (see under the heading “Paclitaxel Pfizer contains alcohol”)
- if you have previously had neurological problems in your hands and feet (ie peripheral neuropathy )
- when you have changes in the composition of your blood
- if you intend to have children. Women should avoid pregnancy during treatment with Paclitaxel Pfizer. The treating physician should be informed immediately if pregnancy should occur
- when Paclitaxel Pfizer is given in combination with radiation therapy to the lungs
Talk to your doctor or nurse if you experience visual impairment during treatment with Paclitaxel Pfizer. In case of visual impairment, especially blurred vision, have your eyes and eyesight examined immediately.
Children and young people
Other medicines and Paclitaxel Pfizer
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Talk to your doctor while taking paclitaxel while taking any of the following:
- medicines to treat your infection (ie antibiotics such as erythromycin, rifampicin, trimethoprim, etc., ask your doctor, nurse, or pharmacist if you are unsure whether the medicine you are taking is an antibiotic ), and medicines to treat fungal infections (eg ketoconazole ) _
- drugs used to help stabilize your mood, also called antidepressants (eg fluoxetine )
- medicines for seizures ( epilepsy ) (eg carbamazepine, phenytoin )
- drugs used to help lower blood lipid levels (eg gemfibrozil)
- medicines used to treat heartburn or stomach ulcers (eg cimetidine)
- medicines for HIV and AIDS (eg ritonavir, saquvinavir, indinavir, nelfinavir, efavirenz, nevirapine)
- a drug called clopidogrel, which is used to prevent blood clots
- a drug called deferasirox, which is used to treat persistently high levels of iron in the body
- a (traditional) herbal medicine containing St. John’s wort, which is used for mild depression or mild anxiety.
Pregnancy, breastfeeding, and fertility
Ask your doctor or pharmacist for advice before taking any medicine. Paclitaxel Pfizer should only be used during pregnancy when necessary. Reliable contraceptives should be used while Paclitaxel Pfizer is being used for at least 6 months after stopping treatment. Male patients should seek advice on freezing semen before treatment with paclitaxel due to the risk of infertility. There is no data on whether paclitaxel passes into breast milk. Paclitaxel Pfizer should not be used during breastfeeding.
Driving and using machines
Do not drive because Paclitaxel Pfizer contains alcohol. The amount of alcohol in this medicine may impair your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Paclitaxel Pfizer contains alcohol
This medicine contains 50 vol% ethanol (alcohol) ie up to 20 g per dose, equivalent to 52 cl beer or 21 cl wine per dose. Harmful to people suffering from alcoholism. Attention should be paid to pregnant or lactating women, children, and high-risk groups such as patients with liver disease or epilepsy. The amount of alcohol in this medicine may affect the effectiveness of other medicines. Paclitaxel Pfizer contains macrogol glycerol ricinoleate which may cause severe allergic reactions.
Paclitaxel Pfizer contains macrogol glycerol castor oil (polyoxyethylated castor oil) which may cause severe allergic reactions.
How to use Paclitaxel Pfizer
Your doctor has decided which dose and how many doses you should receive. Paclitaxel Pfizer is given under the supervision of a doctor, who can give you more information. Dose one depends on the type and severity of cancer. The drug is given as an intravenous infusion (drip) for about three hours. The treatment is normally repeated after a treatment-free interval of 3 weeks.
You will also receive a special premedication (pre-treatment) with several different medicines (both those taken by mouth and injected into a blood vessel) before each treatment with Paclitaxel Pfizer. Premedication is necessary to reduce the risk of severe hypersensitivity reactions (see section 4. Possible side effects, Uncommon ).
Children
Paclitaxel is not recommended for use in children under 18 years of age as safety and data have not been adequately studied.
Possible side effects
Like all medicines, Paclitaxel Pfizer can cause side effects, although not everybody gets them. The most common side effects are hair loss and a reduced number of blood cells. After finishing the treatment, your hair should grow back and your blood values become normal again.
Very common (affects more than 1 user in 10): Bone marrow suppression, leading to a decrease in the number of blood cells, often with infections (mainly urinary tract and upper respiratory tract infections) as a result, and anemia ( anemia ). Mild hypersensitivity reactions such as hot flashes and rash. Nerve effects in the hands and/or feet ( peripheral neuropathy ), which are characterized by ant crawling, numbness, and / or pain (may persist for more than six months after stopping paclitaxel use). Low blood pressure. Bleeding. Nausea, vomiting, diarrhea. Hair loss (most cases of hair loss occurred less than a month after paclitaxel insertion. When this happens, hair loss is pronounced (over 50%) in most patients). Muscle or joint pain. Mucositis.
Common (affects more than 1 user in 100): Slow heartbeat ( pulse ). Transient minor nail and skin changes. Injection site reactions (local swelling, pain, redness, tissue hardening, sometimes cellulite, thickening of the skin, tissue death in the skin). Elevated levels of liver enzyme.
Uncommon (affects less than 1 user in 100): Shock condition due to blood poisoning. Severe hypersensitivity reaction requiring treatment with the drop in blood pressure, swelling of the face, shortness of breath, and hives. Chills, back pain, chest pain, rapid heartbeat, abdominal pain, pain in arms and legs, profuse sweating, and high blood pressure in connection with a hypersensitivity reaction . Severe heart problems such as myocardial infarction, ventricular fibrillation, or ceased impulse conduction between the atria of the heart and ventricles. Fainting. Myocardial infarction. High blood pressure. Blood clots. Inflammation of a vein in connection with a blood clot. Elevated blood levels of bilirubin, a yellow decomposing substance of bile.
Rare (affects less than 1 in 1,000 people): Decreased number of white blood cell types (neutrophilic granulocytes ) with fever. Severe allergic reaction ( anaphylactic reaction ). Impact on nerves that control the muscles, with muscle weakness in the arms and legs as a result. Shortness of breath, fluid accumulation in the lungs, a special type of pneumonia (interstitial pneumonia ), pulmonary fibrosis, blood clots in the lungs, respiratory problems. Peritonitis. Itching, rash / redness. Weakness, malaise, fever, dehydration. Pneumonia, blood poisoning. Accumulation of fluid throughout the body (fluid swelling). Elevated blood levels of creatinine (a breakdown product of muscle tissue). Armored. Holes in the intestine. Inflammation of the colon. Inflammation of the pancreas. Heart failure.
Very rare (affects less than 1 in 10,000 people): Acute leukemia (blood cancer) or similar conditions ( myelodysplastic syndrome ). Life-threatening allergic reaction (anaphylactic shock ). Loss of appetite. Confusion state. Impact on the so-called autonomic nervous system (with intestinal paralysis and drop in blood pressure when the body changes position), epileptic seizures, seizures, effects on the brain, dizziness, dizziness, headache, difficulty coordinating movements. Visual impairment and/or visual disturbances in patients who have received a dose higher than those recommended. Impact on the sense of hearing and balance. Hearing loss, tinnitus), dizziness. Flickering in the atrium of the heart. Increased stroke rate in the atrium of the heart. Shock condition due to drop in blood pressure. Cough. Inflammation of the esophagus. Constipation. Accumulation of fluid in the abdomen. Tissue death in the liver, affects on the brain due to impaired liver function. Severe skin reactions with inflammation, such as Stevens-Johnson syndrome or epidermal necrolysis, skin inflammation with flaking skin, hives, nail dissolution (hands and feet should be protected from sunlight during treatment).
Has been reported ( occurs in an unknown number of users): Tumor light syndrome (may cause symptoms such as decreased or stopped urine production, muscle cramps, irregular heartbeat). Eye side effects such as swelling of the macula (macular edema), the appearance of flashes of light ( photos ) and dots/spots in the field of vision. Inflammation of the vein ( phlebitis ), connective tissue disease that makes the skin hard and thickened ( scleroderma ), inflammatory connective tissue disease (systemic lupus erythematosus, SLE ). Spasm of the tracheal muscles that can cause breathing difficulties ( bronchospasm ). Disseminated intravascular coagulation or “DIC” has been reported. This is a serious condition that causes people to bleed too easily, get blood clots too easily or both. Redness and swelling of the palms and soles of the feet, can lead to the skin flaking.
How to store Paclitaxel Pfizer
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C. Store in the outer carton. Sensitive to light. Freezing has no negative effect on the product.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiration date is the last day of the specified month.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is paclitaxel 6 mg/ml.
- The other ingredients are macrogol glycerol castor oil (polyoxyethylated castor oil), anhydrous ethanol, and anhydrous citric acid.
What the medicine looks like and the contents of the pack
Clear, colorless to the pale yellow viscous solution.
Pack sizes:
1 x 5 ml (30 mg paclitaxel)
1 x 16.7 ml (100 mg paclitaxel)
1 x 25 ml (150 mg paclitaxel)
1 x 50 ml (300 mg paclitaxel)
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Holder of approval for sale:: Pfizer AB, 191 90 Sollentuna, Telephone: 08-550 520 00, E-mail: eumedinfo@pfizer.com
Manufacturer:
Pfizer Service Company BVBA, Hoge Wei 10, 1930 Zaventem, Belgium