{"id":5950,"date":"2020-12-29T14:57:03","date_gmt":"2020-12-29T14:57:03","guid":{"rendered":"https:\/\/zeepedia.com\/?p=5950"},"modified":"2021-07-06T06:38:28","modified_gmt":"2021-07-06T06:38:28","slug":"bendamustine-fresenius-kabi","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/bendamustine-fresenius-kabi\/","title":{"rendered":"Bendamustine Fresenius Kabi &#8211; Bendamustine hydrochloride uses, dose and side effects"},"content":{"rendered":"\n<p>\n\n2.5 mg \/ ml&nbsp;powder for concentrate for&nbsp;infusion&nbsp;solution&nbsp;<br>Bendamustine hydrochloride<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Bendamustine Fresenius Kabi is and what it is used for<\/h2>\n\n\n\n<p>Bendamustine Fresenius Kabi is a medicine used to treat certain cancers (&nbsp;cytostatics).<br><\/p>\n\n\n\n<p>Bendamustine Fresenius Kabi is used as the sole drug or in combination with other drugs to treat the following cancers:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>chronic lymphocytic leukemia&nbsp;if combination chemotherapy with fludarabine is not appropriate;<\/li><li>non-Hodgkin&#8217;s lymphoma&nbsp;when the results of previous rituximab treatment were short-lived or completely absent,<\/li><li>multiple&nbsp;myeloma&nbsp;when treatment with thalidomide or bortezomib is not appropriate.<\/li><\/ul>\n\n\n\n<p>Bendamustine hydrochloride contained in Bendamustine Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this product information.&nbsp;Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before you use Bendamustine Fresenius Kabi<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Bendamustine Fresenius Kabi<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to bendamustine hydrochloride or any of the other ingredients of this medicine (listed in section 6)<\/li><li>if you are breastfeeding;&nbsp;If treatment with bendamustine hydrochloride is necessary while breast-feeding, breast-feeding must be stopped (see section Pregnancy, breast-feeding and&nbsp;fertility&nbsp;).<\/li><li>if you have severe liver failure (liver damage)<\/li><li>if the skin or whites of the eyes are yellow due to liver or blood problems (jaundice)<\/li><li>if you have severe bone marrow function (bone marrow depression) and the number of&nbsp;white blood cells&nbsp;and \/ or&nbsp;platelets&nbsp;is very low<\/li><li>if you have undergone major surgery within 30 days before starting treatment<\/li><li>if you have an&nbsp;infection&nbsp;, especially if it is associated with low&nbsp;white blood cell count&nbsp;(&nbsp;leukopenia&nbsp;)<\/li><li>in connection with vaccination against yellow fever.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor, pharmacist or nurse before using Bendamustine Fresenius Kabi<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if the ability to form&nbsp;blood cells&nbsp;in your&nbsp;bone marrow&nbsp;is impaired.&nbsp;The number of&nbsp;white blood cells&nbsp;and&nbsp;platelets&nbsp;should be checked before starting treatment with Bendamustine Fresenius Kabi, before each new course and between courses.<\/li><li>if you have an&nbsp;infection&nbsp;.&nbsp;Contact your doctor if you have signs of&nbsp;infection&nbsp;, e.g.&nbsp;fever or lung problems.<\/li><li>if you get any skin reaction when treated with Bendamustine Fresenius Kabi.&nbsp;These skin reactions can be exacerbated.<\/li><li>if you get painful red or purple rashes that spread and blisters and \/ or other injuries begin to appear on the mucous membranes (eg mouth and lips), especially if you have previously had photosensitivity,&nbsp;infection&nbsp;of the respiratory tract (e.g.&nbsp;bronchitis&nbsp;) and \/ or fever.<\/li><li>if you already have any heart disease (eg heart attack, chest pain, severe heart rhythm disturbances).<\/li><li>if you feel pain in the side, have blood in the urine or if your urine volume decreases.&nbsp;If your disease is very severe, your body may not be able to get rid of all the slag from the dying cancer cells.&nbsp;This condition is called tumor lysis syndrome and can lead to&nbsp;kidney failure&nbsp;or heart problems within 48 hours of the first&nbsp;dose of&nbsp;a Bendamustine Fresenius Kabi.&nbsp;Your doctor can make sure you get enough fluids (hydrated) and give you other medicines to prevent the problem from occurring.<\/li><li>if you have a severe&nbsp;allergic reaction&nbsp;or&nbsp;hypersensitivity reaction.&nbsp;Pay attention to infusion-related reactions (eg fever, chills,&nbsp;itching,&nbsp;or rash) after the first course of treatment.<\/li><\/ul>\n\n\n\n<p>Men treated with bendamustine should avoid having children during treatment and for a further 6 months after stopping treatment.&nbsp;Find out the possibilities of preserving sperm before starting treatment as treatment can lead to permanent&nbsp;infertility&nbsp;(sterility) (see section Pregnancy, breast-feeding and&nbsp;fertility&nbsp;).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>There is no experience with the use of bendamustine hydrochloride in children and adolescents.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other drugs and Bendamustine Fresenius Kabi<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.<br><\/p>\n\n\n\n<p>If bendamustine hydrochloride is used in combination with other medicines that weaken bone marrow function, the effect on bone marrow function may be enhanced.<br><\/p>\n\n\n\n<p>If bendamustine hydrochloride is used with a medicine that affects your&nbsp;immune response&nbsp;, the effect on the&nbsp;immune response&nbsp;et reinforced.<br><\/p>\n\n\n\n<p>Cytostatics&nbsp;may weaken the effect of vaccination with live&nbsp;viruses&nbsp;.<\/p>\n\n\n\n<p>Cytostatics also&nbsp;increase the risk of&nbsp;infection&nbsp;when vaccinated with live vaccines (eg vaccines against viral diseases).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n<p>If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.<br><\/p>\n\n\n\n<p><strong>Pregnancy<\/strong><\/p>\n\n\n\n<p>Bendamustine hydrochloride can damage the hereditary system and has caused malformations in experimental animals.&nbsp;Bendamustine Fresenius Kabi must not be used during pregnancy unless clearly prescribed by a doctor.&nbsp;If you need to be treated during pregnancy, discuss the risk of birth defects with a doctor, and genetic counseling is recommended.<br><\/p>\n\n\n\n<p>If you become pregnant while being treated with Bendamustine Fresenius Kabi, contact your doctor immediately and ask for genetic counseling.<br><\/p>\n\n\n\n<p><strong><em>Contraceptives should be used by both men and women<\/em><\/strong><br><\/p>\n\n\n\n<p><em>Men<\/em><\/p>\n\n\n\n<p>If you are a man, you should avoid having children when you are treated with Bendamustine Fresenius Kabi and for another 6 months after stopping treatment.<br><\/p>\n\n\n\n<p><em>Women<\/em><\/p>\n\n\n\n<p>If you are a woman of&nbsp;childbearing potential&nbsp;, you should use an effective contraceptive both before and during treatment.<br><\/p>\n\n\n\n<p><strong>Breast-feeding<\/strong><\/p>\n\n\n\n<p>Bendamustine Fresenius Kabi must not be used during breast-feeding.&nbsp;If treatment with Bendamustine Fresenius Kabi is necessary during the breast-feeding period, you must stop breast-feeding.<br><\/p>\n\n\n\n<p><strong>Fertility<\/strong><br><\/p>\n\n\n\n<p><em>Men<\/em><\/p>\n\n\n\n<p>Treatment with Bendamustine Fresenius Kabi can lead to&nbsp;infertility&nbsp;(sterility) in men.&nbsp;If you are a man and want to be able to have children after the end of treatment, you should seek advice on sperm preservation before starting treatment.<br><\/p>\n\n\n\n<p><em>Women<\/em><\/p>\n\n\n\n<p>If you are a woman and want to be able to have children after treatment, you should talk to your doctor for advice.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Bendamustine hydrochloride has a major impact on the ability to drive and use machines.&nbsp;Do not drive or use machines if you experience&nbsp;side effects&nbsp;such as dizziness or impaired coordination.<br><\/p>\n\n\n\n<p>You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention.&nbsp;One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or&nbsp;side effects.&nbsp;Descriptions of these effects and&nbsp;side effects&nbsp;can be found in other sections.&nbsp;Read all the information in this leaflet for guidance.&nbsp;If you are not sure, talk to your doctor or pharmacist.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use Bendamustine Fresenius Kabi<\/h2>\n\n\n\n<p>Always use this medicine exactly as your doctor or pharmacist has told you.&nbsp;Ask your doctor or pharmacist if you are unsure.<br><\/p>\n\n\n\n<p>Bendamustine Fresenius Kabi is given as a drip into a vein (&nbsp;intravenously&nbsp;) for 30-60 minutes.&nbsp;Dosage&nbsp;varies and the drug can be given either as a single treatment or in combination with other drugs.<br><\/p>\n\n\n\n<p>Treatment should not be initiated if the number of&nbsp;white blood cells&nbsp;and \/ or&nbsp;plateletsis below established levels.&nbsp;These values \u200b\u200bare regularly tested by your doctor.<br><\/p>\n\n\n\n<p><strong>Chronic lymphocytic leukemia<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>100 mg Bendamustine Fresenius Kabi per square meter of body surface area (calculated based on your height and weight)<\/td><td>Day 1 and 2<\/td><\/tr><tr><td>The regimen is repeated every 4 weeks up to 6 times<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Non-Hodgkin&#8217;s&nbsp;lymphoma<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>120 mg Bendamustine Fresenius Kabi per square meter of body surface area (calculated based on your height and weight)<\/td><td>Day 1 and 2<\/td><\/tr><tr><td>The regimen is repeated every 3 weeks at least 6 times<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Multiple&nbsp;myeloma<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>120-150 mg Bendamustine Fresenius Kabi per square meter body area (calculated based on your height and weight)<\/td><td>Day 1 and 2<\/td><\/tr><tr><td>60 mg prednisone per square meter of body surface area (calculated based on your height and weight)<\/td><td>Day 1-4<\/td><\/tr><tr><td>The course is repeated every 4 weeks at least 3 times<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>Treatment should be discontinued if the number of&nbsp;white blood cells&nbsp;and \/ or&nbsp;platelets&nbsp;drops to established levels.<\/p>\n\n\n\n<p>Treatment can be continued when the number of&nbsp;white blood cells&nbsp;and&nbsp;platelets&nbsp;has increased.<br><\/p>\n\n\n\n<p><strong>Hepatic or renal impairment<\/strong><\/p>\n\n\n\n<p>Depending on the degree of hepatic impairment, it may be necessary to adjust&nbsp;someone (30% adjustment in patients with moderate hepatic impairment).&nbsp;No dose adjustment is necessary in patients with renal impairment.&nbsp;The attending physician decides if a dose adjustment is necessary.<br><\/p>\n\n\n\n<p><strong>How the medicine is given<\/strong><\/p>\n\n\n\n<p>Treatment with Bendamustine Fresenius Kabi must be performed under the supervision of a physician experienced in the treatment of cancer.&nbsp;Your doctor will prescribe the&nbsp;dose&nbsp;of Bendamustine Fresenius Kabi that is right for you and will take the necessary precautions.<br><\/p>\n\n\n\n<p>The treating physician gives the prescribed infusion solution as a rapid&nbsp;intravenousinfusion&nbsp;for 30-60 minutes.<br><\/p>\n\n\n\n<p><strong>Length of treatment<\/strong><\/p>\n\n\n\n<p>There are no set time limits for how long treatment regimens with Bendamustine Fresenius Kabi should be given.&nbsp;The duration of treatment depends on the disease and on the effect of the treatment.<br><\/p>\n\n\n\n<p>If you have any further questions, or have any questions about the treatment with Bendamustine Fresenius Kabi, talk to your doctor or nurse.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to use Bendamustine Fresenius Kabi<\/h2>\n\n\n\n<p>If a&nbsp;dose&nbsp;of Bendamustine Fresenius Kabi is missed, the doctor will usually continue treatment according to the usual dosing schedule.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop using Bendamustine Fresenius Kabi<\/h2>\n\n\n\n<p>The attending physician decides whether to discontinue treatment or whether to switch to another treatment.<br><\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">4. Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause&nbsp;side effects, although not everybody gets them.<br><\/p>\n\n\n\n<p>In very rare cases, tissue damage (&nbsp;necrosis&nbsp;) has occurred, as Bendamustine Fresenius Kabi has leaked outside the blood vessel (extravasation).&nbsp;A burning sensation at the point where the needle is inserted may be a sign that the drug is leaking outside the blood vessel.&nbsp;This can cause pain and difficult to heal skin lesions.<br><\/p>\n\n\n\n<p>A&nbsp;side effect&nbsp;that limits the&nbsp;dosage&nbsp;one of Bendamustine Fresenius Kabi is weakened bone marrow function.&nbsp;In general, bone marrow function returns to normal after treatment.&nbsp;Impaired bone marrow function can lead to a decrease in the number of blood cells, which in turn can lead to an increased risk of&nbsp;infection&nbsp;,&nbsp;anemia&nbsp;or an increased risk of bleeding.<br><\/p>\n\n\n\n<p>Contact a doctor or seek medical attention immediately if you notice any of the following&nbsp;side effects&nbsp;(no known frequency):<br><\/p>\n\n\n\n<p>Severe rash including&nbsp;Stevens-Johnson syndrome&nbsp;and&nbsp;toxic epidermal necrolysis&nbsp;.&nbsp;These can appear as reddish dot-like or circular&nbsp;plaques&nbsp;, often with blisters in the middle of the torso, flaky skin, sores in the mouth, nose, eyes and genitals and can be followed by fever and&nbsp;flu-like symptoms&nbsp;.<br><\/p>\n\n\n\n<p>Widespread rash, high body temperature, enlarged&nbsp;lymph nodes,&nbsp;and involvement of other body organs (drug&nbsp;side effect&nbsp;with&nbsp;eosinophilia&nbsp;and systemic symptoms also known as DRESS or drug hypersensitivity syndrome).<br><\/p>\n\n\n\n<p>Other side effects:<br><\/p>\n\n\n\n<p><em>Very common (may affect more than 1 user in 10)<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>low&nbsp;white blood cell count&nbsp;(disease-fighting cells in your blood)<\/li><li>impaired hemoglobin value (a&nbsp;protein&nbsp;in&nbsp;red blood cells&nbsp;that carries oxygen throughout the body)<\/li><li>low&nbsp;platelet count&nbsp;(colorless&nbsp;blood cells&nbsp;that help the blood to coagulate)<\/li><li>infection&nbsp;is<\/li><li>nausea<\/li><li>vomiting<\/li><li>mucositis<\/li><li>increased creatinine value in the blood (a chemical residue produced by your muscles)<\/li><li>increased urea value in the blood (a chemical residue)<\/li><li>fever<\/li><li>fatigue<\/li><li>headache<\/li><\/ul>\n\n\n\n<p><em>Common (may affect up to 1 in 10 people)<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>bleeding<\/li><li>disturbed metabolism due to dying cancer cells that release their contents into the bloodstream (tumor lysis syndrome)<\/li><li>decreased number of&nbsp;red blood cells&nbsp;(&nbsp;anemia&nbsp;), which can make the skin pale and cause weakness or shortness of breath<\/li><li>low number of&nbsp;neutrophils&nbsp;, (a common type of&nbsp;white blood cell&nbsp;important to fight&nbsp;infection&nbsp;)<\/li><li>hypersensitivity reactions&nbsp;, such as allergic&nbsp;inflammation&nbsp;of the skin (&nbsp;dermatitis&nbsp;) and&nbsp;hives&nbsp;(&nbsp;urticaria&nbsp;)<\/li><li>elevated levels of the liver enzymes AST \/ ALT (which may indicate&nbsp;inflammationor damage to cells in the liver)<\/li><li>elevated levels of&nbsp;enzyme&nbsp;an&nbsp;alkaline&nbsp;phosphatase (an&nbsp;enzyme&nbsp;formed mainly in the liver and skeleton)<\/li><li>elevated levels of&nbsp;bilirubin&nbsp;in the blood (a substance formed during the normal breakdown of&nbsp;red blood cells&nbsp;)<\/li><li>low potassium in the blood (a nutrient necessary for the function of nerve and muscle cells, including those in your heart)<\/li><li>abnormal heart function, such as palpitations (&nbsp;palpitation&nbsp;) or chest pain (&nbsp;angina pectoris&nbsp;)<\/li><li>arrhythmias in the heart (&nbsp;arrhythmias&nbsp;)<\/li><li>low or high&nbsp;blood pressure&nbsp;(&nbsp;hypotension&nbsp;or&nbsp;hypertension&nbsp;)<\/li><li>impaired lung function<\/li><li>diarrhea<\/li><li>constipation<\/li><li>pain in the mouth (inflammation of the mouth)<\/li><li>loss of appetite<\/li><li>hair loss<\/li><li>skin changes<\/li><li>missed menstruation<\/li><li>pain<\/li><li>insomnia<\/li><li>overindulge<\/li><li>dehydration<\/li><li>dizziness<\/li><li>itchy rash (&nbsp;urticaria&nbsp;)<\/li><\/ul>\n\n\n\n<p><em>Uncommon (may affect up to 1 in 100 people)<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>accumulation of fluid in the pericardium (fluid enters the pericardium surrounding the heart)<\/li><li>impaired formation of all types of&nbsp;blood cells&nbsp;(in the soft material inside your bones where the&nbsp;blood cells&nbsp;are formed)<\/li><li>acute&nbsp;leukemia<\/li><li>heart attack, chest pain<\/li><li>heart failure<\/li><\/ul>\n\n\n\n<p><em>Rare (may affect up to 1 in 1,000 people)<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>blood poisoning (&nbsp;sepsis&nbsp;)<\/li><li>severe allergic&nbsp;hypersensitivity reactions&nbsp;(anaphylactic reactions)<\/li><li>impaired bone marrow function, which may make you feel sick or may be seen on blood tests<\/li><li>symptoms reminiscent of anaphylactic reactions (anaphylactoid reactions)<\/li><li>drowsiness<\/li><li>lose your voice<\/li><li>acute&nbsp;circulatory failure&nbsp;(decreased&nbsp;blood pressure&nbsp;and blood flow leading to a deterioration in the supply of oxygen and other nutrients to the body)<\/li><li>reddening of the skin<\/li><li>dermatitis&nbsp;(&nbsp;dermatitis&nbsp;)<\/li><li>itching<\/li><li>skin rash (maculopapular rash)<\/li><li>heavy sweating<\/li><\/ul>\n\n\n\n<p><em>Very rare (may affect up to 1 in 10,000 people)<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>primary&nbsp;atypical&nbsp;pneumonia&nbsp;(&nbsp;pneumonia&nbsp;)<\/li><li>degradation of&nbsp;red blood cells<\/li><li>rapid drop in blood pressure, sometimes with skin reactions or rash (anaphylactic&nbsp;shock&nbsp;)<\/li><li>disturbed sense of taste<\/li><li>changes in the sense of touch (&nbsp;paresthesia&nbsp;)<\/li><li>discomfort and pain in arms and legs (&nbsp;peripheral&nbsp;neuropathy&nbsp;)<\/li><li>severe condition that results in blockade of specific&nbsp;receptors&nbsp;in the nervous system<\/li><li>nervous system disorder (anticholinergic syndrome)<\/li><li>impaired coordination<\/li><li>brain inflammation (&nbsp;encephalitis&nbsp;)<\/li><li>increased heart rate (&nbsp;tachycardia&nbsp;)<\/li><li>inflammation&nbsp;in a friend (&nbsp;phlebitis&nbsp;)<\/li><li>formation of connective tissue in the lungs (&nbsp;pulmonary fibrosis&nbsp;)<\/li><li>inflammation&nbsp;of the esophagus with bleeding (&nbsp;hemorrhagic&nbsp;esophagitis&nbsp;)<\/li><li>bleeding in the stomach or intestines<\/li><li>infertility&nbsp;(inability to have children)<\/li><li>multi-organ damage<\/li><\/ul>\n\n\n\n<p><em>Has been reported (occurs in an unknown number of users)<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>liver failure<\/li><li>kidney failure<\/li><li>irregular and often fast heart rate (&nbsp;atrial fibrillation&nbsp;)<\/li><li>painful red or purple rash that spreads and blisters and\/or other damage that begins to appear on the mucous membranes (eg mouth and lips), especially if you have previously had photosensitivity,&nbsp;infection&nbsp;of the respiratory tract (eg&nbsp;bronchitis&nbsp;) and \/ or fever<\/li><li>rash with combination therapy with rituximab<\/li><li>pneumonitis&nbsp;(&nbsp;pneumonia&nbsp;)<\/li><li>bleeding from the lungs.<\/li><\/ul>\n\n\n\n<p>Tumors&nbsp;(&nbsp;myelodysplastic syndrome&nbsp;,&nbsp;acute myeloid leukemia&nbsp;[AML], tracheal carcinoma) have been reported following treatment with bendamustine hydrochloride.&nbsp;No obvious association with bendamustine hydrochloride could be established.<br><\/p>\n\n\n\n<p>If any of the&nbsp;side effects&nbsp;gets serious, or if you notice any&nbsp;side effects&nbsp;not listed in this leaflet, please tell your doctor.<br><\/p>\n\n\n\n<p><em>Reporting of side effects<\/em><\/p>\n\n\n\n<p>If you get any side effects, talk to your doctor, pharmacist, or nurse.&nbsp;This includes any possible side effects not listed in this leaflet.&nbsp;You can also report side effects directly to the Medical Products Agency,&nbsp;www.lakemedelsverket.se.&nbsp;By reporting side effects, you can help increase drug safety information.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Bendamustine Fresenius Kabi<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<br><\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the label and carton after EXP.&nbsp;The expiration date is the last day of the specified month.<br><\/p>\n\n\n\n<p>No special storage instructions.<br><\/p>\n\n\n\n<p><strong>Shelf life after opening the medicine pack or&nbsp;preparing the&nbsp;infusion solution<\/strong><\/p>\n\n\n\n<p>Infusion solutions prepared according to the instructions given at the end of this leaflet are durable in polyethylene bags at room temperature and 60% relative humidity for 3.5 hours and in refrigerator temperature for 2 days.&nbsp;Bendamustine Fresenius Kabi contains no preservatives.&nbsp;Therefore, solutions stored longer than the stated shelf life must not be used.<br><\/p>\n\n\n\n<p>From a&nbsp;microbiological&nbsp;point of view, the solution should be used immediately.&nbsp;If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 \u00b0 C to 8 \u00b0 C, unless reconstitution \/ dilution has taken place under controlled and validated aseptic conditions.<br><\/p>\n\n\n\n<p>Do not use this medicine if you notice visible changes in the solution.<br><\/p>\n\n\n\n<p>Medicines should not be disposed of via wastewater or household waste.&nbsp;Ask your pharmacist how to dispose of medicines no longer required.&nbsp;These measures will help to protect the environment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">6. Contents of the packaging and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is bendamustine hydrochloride.<\/li><\/ul>\n\n\n\n<p>One&nbsp;vial&nbsp;contains 25 mg bendamustine hydrochloride.<\/p>\n\n\n\n<p>One&nbsp;vial&nbsp;contains 100 mg bendamustine hydrochloride.<\/p>\n\n\n\n<p>After&nbsp;reconstitution&nbsp;, 1 milliliter of concentrate contains 2.5 mg of bendamustine hydrochloride.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The other ingredient is mannitol.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n<p>Amber-colored glass vials with chlorobutyl rubber stoppers sealed with a green or blue aluminum snap cap.<br><\/p>\n\n\n\n<p>White to off-white freeze-dried powder or powder cake.<br><\/p>\n\n\n\n<p>Bendamustine Fresenius Kabi is available in packs of 1, 5, 10 or 20 vials each containing 25 mg bendamustine hydrochloride and 1 or 5 vials each containing 100 mg bendamustine hydrochloride.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorisation Holder<\/h2>\n\n\n\n<p>Fresenius Kabi AB<\/p>\n\n\n\n<p>751 74 Uppsala<br><\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Fresenius Kabi Deutschland GmbH<\/p>\n\n\n\n<p>Pfingstweide 53<\/p>\n\n\n\n<p>61169 Friedberg<\/p>\n\n\n\n<p>Germany<br><\/p>\n\n\n\n<p>Fresenius Kabi Oncology Plc.<\/p>\n\n\n\n<p>Lion Court, Farnham Road<\/p>\n\n\n\n<p>Bordon, Hampshire, GU35 0NF<\/p>\n\n\n\n<p>UK<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Bendamustine Fresenius Kabi is a medicine used to treat certain cancers ( cytostatics).<\/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":[2202,2200],"tags":[9165,9167,9154,9163,9164,9169,9157,9168,9156,9166,9155],"class_list":["post-5950","post","type-post","status-publish","format-standard","hentry","category-b","category-medicines","tag-bendamustine-fresenius-kabi","tag-bendamustine-fresenius-kabi-side-effects","tag-bendamustine-hydrochloride","tag-bendamustine-hydrochloride-powder","tag-bendamustine-hydrochloride-side-effects","tag-side-effects-of-bendamustine-fresenius-kabi","tag-side-effects-of-bendamustine-hydrochloride","tag-what-bendamustine-fresenius-kabi-is-used-for","tag-what-bendamustine-hydrochloride-is-used-for","tag-what-is-bendamustine-fresenius-kabi","tag-what-is-bendamustine-hydrochloride"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5950","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=5950"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5950\/revisions"}],"predecessor-version":[{"id":12141,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5950\/revisions\/12141"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=5950"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=5950"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=5950"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}