as a secondary treatment to patients who have not responded to standard\u00a0anthracycline\u00a0treatment, or where such treatment is not possible.<\/li><\/ul>\n\n\n\nAdvanced non-small-cell lung cancer:<\/strong><\/p>\n\n\n\n- in combination with cisplatin in patients where\u00a0surgery\u00a0and\/or radiation therapy are not appropriate.<\/li><\/ul>\n\n\n\n
AIDS-related Kaposi’s sarcoma:<\/strong><\/p>\n\n\n\n- when other treatment (ie liposomal anthracycline ) has been tried but has not worked<\/li><\/ul>\n\n\n\n
Paclitaxel Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this leaflet. If you have any further questions, ask your doctor, pharmacist, or other healthcare professional.<\/p>\n\n\n\n
What you need to know before you use Paclitaxel Fresenius Kabi<\/h2>\n\n\n\nYou should not receive Paclitaxel Fresenius Kabi:<\/h2>\n\n\n\n- if you are allergic to Paclitaxel Fresenius Kabi or any of the other ingredients of this medicine (listed in section 6), in particular macrogol glycerol castin oil (polyoxyethylated castor oil).<\/li>
- if you are breastfeeding.<\/li>
- if the number of\u00a0white blood cells\u00a0in the blood is too low (\u00a0neutrophil\u00a0before treatment <1.5 x 10\u00a09\u00a0\/ l or <1.0 x 10\u00a09\u00a0\/ l for patients with\u00a0Kaposi’s sarcoma\u00a0– this will be checked by your doctor).\u00a0Blood tests will be taken to check this.<\/li>
- if you get\u00a0Paclitaxel Fresenius Kabi for\u00a0Kaposi’s sarcoma\u00a0and at the same time have a severe and uncontrolled\u00a0infection.<\/strong><\/li><\/ul>\n\n\n\n
If any of these apply to you, talk to your doctor before starting treatment with Paclitaxel Fresenius Kabi.<\/p>\n\n\n\n
Paclitaxel Fresenius Kabi is not recommended for use in children (under 18 years of age).<\/p>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Talk to your doctor before using Paclitaxel Fresenius Kabi.<\/p>\n\n\n\n
To reduce the risk of allergic reactions, you will be given other medicines before you receive Paclitaxel Fresenius Kabi.<\/p>\n\n\n\n
- If you get allergic reactions (eg difficulty breathing, shortness of breath, pressure over the chest, drop in blood pressure, dizziness, fainting, skin reactions such as rash or swelling)<\/li>
- If you get a fever, severe chills, sore throat, or cold sores (signs of bone marrow suppression).<\/li>
- If you experience numbness, tingling,\u00a0itching, increased sensitivity to touch, or weakness in the arms and legs (signs of\u00a0peripheral\u00a0neuropathy\u00a0);\u00a0a reduction in the paclitaxel dose may be required.<\/li>
- If you have severe liver problems;\u00a0in such cases, the use of Paclitaxel Fresenius Kabi is not recommended.<\/li>
- If you have heart problems<\/li>
- If you get severe or persistent diarrhea with fever and abdominal pain during or shortly after treatment with Paclitaxel Fresenius Kabi.\u00a0Your colon may be inflamed (pseudomembranous\u00a0colitis\u00a0).<\/li>
- If you have previously undergone radiation therapy to your chest (this may increase the risk of\u00a0pneumonia\u00a0).<\/li>
- If you are being treated for\u00a0Kaposi’s sarcoma\u00a0and cold sores or reddening of the mouth (signs of\u00a0mucositis\u00a0), you may need a lower\u00a0dose.<\/li><\/ul>\n\n\n\n
Given the risk of the drug entering the surrounding\u00a0tissue, it is advisable to closely monitor the infusion site for any leakage during drug administration.<\/p>\n\n\n\n
If any of these apply to you, tell your doctor immediately.<\/strong><\/p>\n\n\n\nPaclitaxel Fresenius Kabi must always be given in a vein.\u00a0If Paclitaxel Fresenius Kabi is given in an\u00a0artery, this can lead to\u00a0inflammation\u00a0in the\u00a0artery\u00a0with pain, swelling, reddening of the skin, and a feeling of heat.<\/p>\n\n\n\n
Other medicines and Paclitaxel Fresenius Kabi<\/h2>\n\n\n\n
Talk to your doctor while taking Paclitaxel Fresenius Kabi while taking any of the following:<\/p>\n\n\n\n
- medicines to treat your\u00a0infections\u00a0(ie\u00a0antibiotics\u00a0such as erythromycin, rifampicin, etc., ask your doctor, nurse, or pharmacist if you are unsure whether the medicine you are taking are\u00a0antibiotics\u00a0), and medicines to treat fungal infections (eg\u00a0ketoconazole\u00a0)<\/li>
- drugs used to help stabilize your mood, also called antidepressants (eg\u00a0fluoxetine\u00a0)<\/li>
- medicines for seizures (\u00a0epilepsy\u00a0) (eg carbamazepine,\u00a0phenytoin\u00a0)<\/li>
- drugs used to help lower blood lipid levels (eg gemfibrozil)<\/li>
- medicines used to treat heartburn or\u00a0stomach ulcers\u00a0(eg cimetidine)<\/li>
- medicines for\u00a0HIV\u00a0and\u00a0AIDS\u00a0(eg ritonavir, saquvinavir, indinavir, nelfinavir, efavirenz, nevirapine)<\/li>
- a drug called clopidogrel, which is used to prevent blood clots.<\/li><\/ul>\n\n\n\n
The alcohol in this medicine may affect the effectiveness of other medicines.\u00a0Tell your doctor or pharmacist if you are taking other medicines.<\/p>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
You must tell your doctor if you are pregnant<\/strong>\u00a0or think you may be pregnant before starting treatment with Paclitaxel Fresenius Kabi.\u00a0If there is a possibility that you may become pregnant, you must\u00a0use an effective and safe contraceptive during <\/strong>treatment.\u00a0Paclitaxel Fresenius Kabi should be used during pregnancy only if needed.<\/p>\n\n\n\nWomen and men of\u00a0childbearing potential\u00a0and their partners must use contraception for at least 6 months after stopping treatment with Paclitaxel Fresenius Kabi.\u00a0Men should investigate the possibility of freezing semen before paclitaxel treatment due to the risk of incurable\u00a0infertility.<\/p>\n\n\n\n
Tell your doctor if you are breastfeeding<\/strong>.\u00a0It is not known whether Paclitaxel Fresenius Kabi is excreted in human milk.\u00a0You must stop breastfeeding during treatment with Paclitaxel Fresenius Kabi due to the possible risk of injury to your baby.\u00a0Do not resume breastfeeding until your doctor gives the go-ahead.<\/p>\n\n\n\nAsk your doctor or pharmacist for advice before taking any medicine.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
There is no reason why you can not continue driving between treatments with Paclitaxel Fresenius Kabi, but as this medicine contains some alcohol, it may be unwise to drive or use machines immediately after treatment due to possible effects on the\u00a0central nervous system.\u00a0You should not drive or use machines if you feel dizzy and faint.<\/p>\n\n\n\n
The alcohol in this medicine may affect the ability to drive and use machines. This is because your judgment and ability to react can be affected.<\/p>\n\n\n\n
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0Descriptions of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n
Paclitaxel Fresenius Kabi contains castor oil (macrogol glycerol ricinoleate) and alcohol<\/h2>\n\n\n\n
Paclitaxel Fresenius Kabi contains castor oil which can cause severe allergic reactions. Tell your doctor if you are allergic to castor oil before starting treatment with Paclitaxel Fresenius Kabi.<\/p>\n\n\n\n
This medicine contains 393 mg of alcohol ( ethanol ) in each 1 ml corresponding to 39.3% w \/ v. The amount in 52.5 ml of this medicine corresponds to 515.8 ml of beer or 206.3 ml of wine.<\/p>\n\n\n\n
If you have epilepsy or liver problems, consult your doctor or pharmacist before using this medicine.<\/p>\n\n\n\n
If you are or have been addicted to alcohol, consult your doctor or pharmacist before using this medicine.<\/p>\n\n\n\n
How to use Paclitaxel Fresenius Kabi<\/h2>\n\n\n\n- To reduce the risk of allergic reactions, you will need to take other medicines before receiving Paclitaxel Fresenius Kabi.\u00a0These drugs can be given either in tablet form or as\u00a0an infusion\u00a0into a vein, or both.<\/li>
- You will receive Paclitaxel Fresenius Kabi as a drip into a vein (\u00a0intravenous\u00a0infusion\u00a0), via an in-line filter.\u00a0Paclitaxel Fresenius Kabi will be given to you by healthcare professionals.\u00a0They will prepare the infusion solution before you receive it.\u00a0The\u00a0dose\u00a0you receive will also depend on the answers to your blood tests.\u00a0Depending on the type of cancer you have and the severity of your illness, you will be given Paclitaxel Fresenius Kabi either alone or with another cancer medicine.<\/li>
- Paclitaxel Fresenius Kabi should always be given in a vein over a 3- or 24-hour period.\u00a0Treatment is usually every two or three weeks unless your doctor prescribes otherwise.\u00a0Your doctor will tell you how many treatments with Paclitaxel Fresenius Kabi you will need.<\/li><\/ul>\n\n\n\n
If you use more Paclitaxel Fresenius Kabi than you should <\/h2>\n\n\n\n
If you have ingested too much medicine or if e.g.\u00a0If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.<\/p>\n\n\n\n
If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n
Contact a doctor immediately if you experience symptoms of an\u00a0allergic reaction.\u00a0<\/strong>Examples of these symptoms can be:<\/p>\n\n\n\n- hot flashes,<\/li>
- skin reactions,<\/li>
- itching,<\/li>
- tight across the chest,<\/li>
- shortness of breath or difficulty breathing,<\/li>
- swelling.<\/li><\/ul>\n\n\n\n
All of these can indicate serious\u00a0side effects.<\/p>\n\n\n\n
Contact a doctor immediately if you experience:<\/strong><\/p>\n\n\n\n- fever, severe chills, sore throat, or cold sores<\/strong>\u00a0(signs of bone marrow suppression).<\/li>
- numbness or weakness in the arms and legs<\/strong>\u00a0(signs of\u00a0peripheral\u00a0neuropathy\u00a0).<\/li>
- severe or persistent diarrhea with fever and abdominal pain.<\/li><\/ul>\n\n\n\n
Very common may occur in more than 1 in 10 users<\/strong><\/p>\n\n\n\n- Mild allergic reactions, such as\u00a0redness, rash, and\u00a0itching<\/li>
- Infections: mainly upper respiratory tract infections and urinary tract infection<\/li>
- Sore throat and cold sores, sore mouth, reddening of the mouth, diarrhea, nausea, vomiting.<\/li>
- 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).<\/li>
- Muscle pain, cramps, joint pain<\/li>
- Numbness, tingling, weakness in arms and legs (all symptoms of\u00a0peripheral\u00a0neuropathy\u00a0) ** May persist for more than six months after stopping paclitaxel use.<\/li>
- Sampling may show: decreased\u00a0platelet count, which may lead to bleeding and increased tendency to get bruises and white or\u00a0red blood cells, low\u00a0blood pressure<\/li><\/ul>\n\n\n\n
Common can occur in up to 1 in 10 users<\/strong><\/p>\n\n\n\n- Transient slight changes in nails and skin, reactions at the injection site (local swelling, pain, and redness of the skin)<\/li>
- Sampling may show: a slower heart rate, a sharp increase in liver enzymes (alkaline phosphatase and\u00a0AST\u00a0)<\/li><\/ul>\n\n\n\n
Uncommon may occur in up to 1 in 100 users<\/strong><\/p>\n\n\n\n- Shock condition caused by blood poisoning (\u00a0septic\u00a0shock\u00a0)<\/li>
- Palpitations, severe cardiac arrest (AV block,\u00a0cardiomyopathy\u00a0), high\u00a0heart rate, heart attack, difficulty breathing<\/li>
- Fatigue, sweating, fainting (\u00a0syncope\u00a0), severe allergic reactions,\u00a0phlebitis\u00a0(\u00a0inflammation\u00a0of a vein), swelling of the face, lips, mouth, tongue, or throat<\/li>
- Pain in the back, chest, around hands and feet, chills, abdominal pain<\/li>
- Sampling may show Severely elevated bilirubin levels (jaundice), high\u00a0blood pressure, blood clots.<\/li><\/ul>\n\n\n\n
Rare can occur in up to 1 in 1,000 users<\/strong><\/p>\n\n\n\n- Decreased\u00a0white blood cell count\u00a0with fever and increased risk of infection (febrile\u00a0neutropenia\u00a0)<\/li>
- Nerve damage with muscle weakness in arms and legs (motor neuropathy)<\/li>
- Heart failure<\/li>
- Breathing difficulties, pulmonary embolism,\u00a0pulmonary fibrosis,\u00a0inflammation\u00a0of the lungs, shortness of breath, fluid in the lungs<\/li>
- Bowel obstruction, ulcers on the intestines,\u00a0inflammation\u00a0of the colon (ischemic\u00a0colitis\u00a0),\u00a0inflammation\u00a0of the pancreas (\u00a0pancreatitis\u00a0)<\/li>
- Itching, rash, redness of the skin (\u00a0erythema\u00a0)<\/li>
- Blood poisoning (\u00a0sepsis\u00a0), peritonitis,\u00a0pneumonia<\/li>
- High temperature (fever), dehydration, weakness, swelling (\u00a0edema\u00a0), general malaise<\/li>
- Severe, potentially fatal allergic (anaphylactic) reaction<\/li>
- Sampling may show: an increase in\u00a0creatinine levels\u00a0in the blood which is a sign of impaired kidney function<\/li><\/ul>\n\n\n\n
Very rare can occur in up to 1 in 10,000 users<\/strong><\/p>\n\n\n\n- Irregular heartbeat (\u00a0atrial fibrillation,\u00a0supraventricular\u00a0tachycardia\u00a0)<\/li>
- Sudden conditions of blood-forming cells (\u00a0acute\u00a0myeloid\u00a0leukemia,\u00a0myelodysplastic syndrome\u00a0)<\/li>
- Problems with\u00a0optic nerve\u00a0and\/or visual disturbances (visual phenomena)<\/li>
- Impaired hearing or hearing loss (ototoxicity), ringing in the ears (\u00a0tinnitus\u00a0), dizziness<\/li>
- Cough<\/li>
- Blood clots in blood vessels in the abdomen or intestines (mesenteric\u00a0thrombosis\u00a0), colitis, possibly with persistent severe diarrhea (pseudomembranous\u00a0colitis, neutropenic\u00a0colitis\u00a0), accumulation of fluid in the abdomen (\u00a0ascites\u00a0),\u00a0inflammation\u00a0of the esophagus, constipation.<\/li>
- Severe\u00a0hypersensitivity reactions\u00a0include fever, reddening of the skin, joint pain and\/or eye inflammation (Stevens-Johnson syndrome), scaly skin (\u00a0epidermal\u00a0necrolysis\u00a0), reddening of the skin with irregular red (liquid) rash (erythema multiforme), dermatitis with blisters and exfoliative rash (\u00a0exfoliative\u00a0rash\u00a0), nail solution (hands and feet should be protected from sunlight during the treatment period).<\/li>
- Loss of appetite (\u00a0anorexia\u00a0).<\/li>
- Severe, potentially fatal\u00a0hypersensitivity reaction\u00a0with\u00a0shock\u00a0(anaphylactic\u00a0shock\u00a0).<\/li>
- Failure of liver function (\u00a0hepatic\u00a0necrosis,\u00a0hepatic\u00a0encephalopathy\u00a0[fatal cases have been reported for both]).<\/li>
- Confusion state.<\/li>
- Epileptic seizures, effects on the nervous system (autonomic\u00a0neuropathy, this can lead to intestinal upset and low\u00a0blood pressure\u00a0), seizures, brain disease (\u00a0encephalopathy\u00a0), dizziness, headache, problems with coordination (\u00a0ataxia\u00a0).<\/li><\/ul>\n\n\n\n
No known frequency (can not be calculated from the available data)<\/strong><\/p>\n\n\n\n- Rapid disintegration of tumor cells (tumor lysis syndrome)<\/li>
- Fluid accumulation in the eye (macular\u00a0edema\u00a0), the experience of flashes of light in the eye (\u00a0photos\u00a0), spots in the field of\u00a0vision\u00a0et<\/li>
- Inflammation\u00a0of the veins (\u00a0phlebitis\u00a0)<\/li>
- Thickening of the skin, blood vessels, and internal organs (scleroderma)<\/li>
- A disease of the immune system that attacks many organs in the body (\u00a0SLE, Systemic lupus erythematosus)<\/li>
- The formation of blood clots in the small blood vessels can lead to bleeding in various parts of the body (Disseminated intravascular\u00a0coagulation\u00a0or “DIC” has been reported. This is a serious condition that causes people to bleed too easily, get blood clots too easily or both. )<\/li>
- Redness\u00a0and swelling of the palms and soles of the feet, which can lead to the skin flaking<\/li><\/ul>\n\n\n\n
How to store Paclitaxel Fresenius Kabi<\/h2>\n\n\n\n
Keep out of sight and reach of children.<\/p>\n\n\n\n
Do not store above 25 \u00b0 C.<\/p>\n\n\n\n
Keep the vial in the original package. Sensitive to light.<\/p>\n\n\n\n
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.<\/p>\n\n\n\n
The expiration date is the last day of the specified month.<\/p>\n\n\n\n
Do not use this medicine if you notice turbidity or precipitation in the solution.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Contents of the pack and other information<\/h2>\n\n\n\nContent declaration<\/h2>\n\n\n\n- The active substance is paclitaxel.\u00a0Each ml of concentrate for solution for\u00a0infusion\u00a0contains 6 mg paclitaxel.One 5 ml\u00a0vial\u00a0contains 30 mg paclitaxel.One 16.7 ml\u00a0vial\u00a0contains 100 mg paclitaxel.One 25 ml\u00a0vial\u00a0contains 150 mg paclitaxel.One 50 ml\u00a0vial\u00a0contains 300 mg paclitaxel.One 100 ml\u00a0vial\u00a0contains 600 mg paclitaxel.<\/li>
- The other ingredients are anhydrous\u00a0ethanol, macrogol glycerol ricinoleate, and anhydrous citric acid (for\u00a0pH\u00a0adjustment).<\/li><\/ul>\n\n\n\n
What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
Concentrate for solution for infusion
Paclitaxel Fresenius Kabi is a clear, slightly yellowish solution.
Paclitaxel Fresenius Kabi is supplied in glass vials. The vials are closed with Teflon-coated rubber stoppers.<\/p>\n\n\n\n
Pack sizes:<\/strong>
Packs containing 1 or 5 glass vials.<\/p>\n\n\n\nNot all pack sizes may be marketed.<\/p>\n\n\n\n
Marketing Authorisation Holder<\/h2>\n\n\n\n
Fresenius Kabi AB
75174 Uppsala<\/p>\n\n\n\n
Manufacturer<\/strong><\/p>\n\n\n\nFresenius Kabi Deutschland GmbH
Pfingstweide 53<\/p>\n\n\n\n
611 69 Friedberg<\/p>\n\n\n\n
Germany<\/p>\n\n\n\n
or<\/p>\n\n\n\n
Corden Pharma Latina SpA<\/p>\n\n\n\n
Via Murillo No. 7<\/p>\n\n\n\n
04013 Sermoneta (LT)<\/p>\n\n\n\n
Italy<\/p>\n","protected":false},"excerpt":{"rendered":"
Paclitaxel Fresenius Kabi belongs to a group of anticancer medicines called taxanes. These drugs prevent the growth of cancer cells.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200,18527],"tags":[20574,20579,10249,20575,20578,20573,10250,20576,20577,10251],"class_list":["post-20218","post","type-post","status-publish","format-standard","hentry","category-medicines","category-p","tag-benefits-of-paclitaxel","tag-benefits-of-paclitaxel-fresenius-kabi","tag-paclitaxel","tag-paclitaxel-fresenius-kabi","tag-paclitaxel-fresenius-kabi-side-effects","tag-paclitaxel-side-effects","tag-what-is-paclitaxel","tag-what-is-paclitaxel-fresenius-kabi","tag-what-paclitaxel-fresenius-kabi-is-used-for","tag-what-paclitaxel-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/20218","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=20218"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/20218\/revisions"}],"predecessor-version":[{"id":20249,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/20218\/revisions\/20249"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=20218"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=20218"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=20218"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}