{"id":5948,"date":"2020-12-29T14:54:55","date_gmt":"2020-12-29T14:54:55","guid":{"rendered":"https:\/\/zeepedia.com\/?p=5948"},"modified":"2021-07-06T06:38:35","modified_gmt":"2021-07-06T06:38:35","slug":"bendamustine-accord","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/bendamustine-accord\/","title":{"rendered":"Bendamustine Accord &#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 Accord is and what it is used for<\/h2>\n\n\n\n<p>Bendamustine Accord is a medicine used to treat certain cancers (&nbsp;cytostatics&nbsp;).<br><\/p>\n\n\n\n<p>Bendamustine Accord is used as a single medicine or in combination with other medicines 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 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 Accord may also be approved for the treatment of other conditions not mentioned in this product information.&nbsp;Ask your doctor, pharmacist, or another 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 using the Bendamustine Accord<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Bendamustine Accord<\/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 breast-feeding.&nbsp;If treatment with Bendamustine Accord is necessary while breast-feeding, breast-feeding must be stopped (see &#8220;Pregnancy, breast-feeding and fertility&#8221;)<\/li><li>if you have a severe liver failure (liver damage)<\/li><li>if the skin or whites of the eyes are yellow due to problems with the liver or blood<\/li><li>if you have severe bone marrow function (bone marrow depression) and the values \u200b\u200bfor your&nbsp;white blood cells&nbsp;(&nbsp;leukocytes&nbsp;) or&nbsp;platelets&nbsp;(&nbsp;platelets&nbsp;) are very low<\/li><li>if you have undergone major surgery within 30 days before starting treatment<\/li><li>if you have an&nbsp;infection, especially if it is associated with low&nbsp;white blood cell count&nbsp;(leukocytopenia)<\/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><strong>Talk to your doctor, pharmacist, or nurse before using Bendamustine Accord<\/strong><\/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 Accord, before each new course, and between courses.<\/li><li>if you have an&nbsp;infection.&nbsp;Contact your doctor if you have signs of&nbsp;infection, e.g.&nbsp;fever or lung problems.<\/li><li>if you get any skin reaction when you are treated with Bendamustine Accord.&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 Accord.&nbsp;Your doctor can make sure you get enough fluids (hydrated) and can 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;Remember if you experience infusion-related reactions after the first course.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Bendamustine Accord<\/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 Accord is used together with medicines that inhibit the formation of&nbsp;blood cells&nbsp;in the&nbsp;bone marrow, this can lead to a greater effect on the&nbsp;bone marrow. &nbsp;<br><\/p>\n\n\n\n<p>About Bendamustine Accord is used with a medicine that affects your&nbsp;immune response&nbsp;can lead to greater impact on the&nbsp;immune response&nbsp;message.<br><\/p>\n\n\n\n<p>Cytostatics&nbsp;may weaken the effect of vaccination with live&nbsp;viruses.&nbsp;Cytostatics also increases the risk of&nbsp;infection&nbsp;when vaccinated with live&nbsp;viruses&nbsp;(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><em>Pregnancy<\/em><\/p>\n\n\n\n<p>Bendamustine Accord can damage the hereditary system and has caused malformations in experimental animals.&nbsp;Bendamustine Accord must not be used during pregnancy unless clearly prescribed by your doctor.&nbsp;If you have to take the medicine during pregnancy, discuss the risk of birth defects with your doctor, and genetic counseling is recommended.<br><\/p>\n\n\n\n<p>Women of&nbsp;childbearing potential&nbsp;must use effective contraception both before and during treatment with Bendamustine Accord.&nbsp;If you become pregnant during treatment with Bendamustine Accord, contact your doctor immediately and ask for genetic counseling.<br><\/p>\n\n\n\n<p><em>Breast-feeding<\/em><\/p>\n\n\n\n<p>Bendamustine Accord should not be used during breast-feeding.&nbsp;If treatment with Bendamustine Accord is necessary during the breastfeeding period, you must stop breast-feeding.<\/p>\n\n\n\n<p>Ask your doctor or pharmacist for advice before taking any medicine.<br><\/p>\n\n\n\n<p><em>Fertility<\/em><\/p>\n\n\n\n<p>If you are a man, you should avoid having children during the treatment with Bendamustine Accord and 6 months after the end of treatment.&nbsp;There is also a risk that treatment with Bendamustine Accord will lead to&nbsp;infertility.&nbsp;You should therefore investigate the possibilities of sperm storage before starting treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Bendamustine Accord 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, e.g.&nbsp;dizziness or impaired coordination.&nbsp;You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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 Accord<\/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 Accord is given as a drip into a vein 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.&nbsp;Treatment should not be initiated if the value of the white&nbsp;blood cells&nbsp;(&nbsp;leukocytes&nbsp;) and\/or platelets in the blood is too low.&nbsp;These values \u200b\u200bare tested regularly.<br><\/p>\n\n\n\n<p><em>Chronic lymphocytic leukemia<\/em><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>100 mg Bendamustine Accord per square meter of body surface area (calculated by height and weight).<\/td><td>Day 1 and 2<\/td><\/tr><tr><td>The treatment is repeated every 4 weeks.&nbsp;The treatment can be repeated up to 6 times.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><em>Non-Hodgkin&#8217;s lymphoma<\/em><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>120 mg Bendamustine Accord per square meter of body surface area (calculated by height and weight).<\/td><td>Day 1 and 2<\/td><\/tr><tr><td>The treatment is repeated every 3 weeks.&nbsp;The treatment is repeated at least 6 times.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><em>Multiple&nbsp;myeloma<\/em><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>120\u2013150 mg Bendamustine Accord per square meter of body surface area (calculated by height and weight).<\/td><td>Day 1 and 2<\/td><\/tr><tr><td>60 mg prednisone per square meter of body surface area (calculated by height and weight) by&nbsp;injection&nbsp;or orally.<\/td><td>Day 1\u20134<\/td><\/tr><tr><td>The treatment is repeated every 4 weeks.&nbsp;The treatment is repeated at least 3 times.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>Treatment must be stopped if the number of&nbsp;white blood cells&nbsp;drops to established levels.&nbsp;Treatment can be continued when the&nbsp;white blood cell count&nbsp;and&nbsp;platelet count&nbsp;have increased.<br><\/p>\n\n\n\n<p><em>Liver or&nbsp;kidney failure<\/em><\/p>\n\n\n\n<p>Dosage&nbsp;may need to be adjusted according to the degree of liver failure (30% in patients with moderate hepatic impairment).&nbsp;No dose adjustment is required in patients with renal impairment.&nbsp;The attending physician decides on any dose adjustments.<br><\/p>\n\n\n\n<p><em>Method of administration<\/em><\/p>\n\n\n\n<p>Treatment with Bendamustine Accord must be done under the supervision of a physician experienced in the treatment of cancer.&nbsp;Your doctor will prescribe the&nbsp;dose of&nbsp;Bendamustine Accord that is right for you and will take the necessary precautions.<br><\/p>\n\n\n\n<p>The attending physician gives the prescribed infusion solution as a rapid&nbsp;intravenous infusion&nbsp;(drip into a vein) for 30-60 minutes.<br><\/p>\n\n\n\n<p><em>Length of treatment<\/em><\/p>\n\n\n\n<p>There are no set time limits for how long treatment with Bendamustine Accord should be given.&nbsp;The duration of treatment depends on the disease and the effect of the treatment.<br><\/p>\n\n\n\n<p>If you have any further questions on the use of Bendamustine Accord, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to use Bendamustine Accord<\/h2>\n\n\n\n<p>If a&nbsp;dose&nbsp;of Bendamustine Accord is missed, your 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 Accord<\/h2>\n\n\n\n<p>The attending physician decides whether to discontinue treatment or to switch to another drug.<br><\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/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>Some of the&nbsp;side effects&nbsp;listed below may be detected by tests performed by your doctor.<br><\/p>\n\n\n\n<p>In very rare cases, tissue damage (&nbsp;necrosis&nbsp;) has occurred, as the drug has inadvertently ended up outside the blood vessel (extravasation).&nbsp;A burning sensation in which the infusion needle is inserted may be a sign that&nbsp;administration is&nbsp;taking place outside the blood vessels.&nbsp;The consequences of such&nbsp;an administration&nbsp;can be painful and difficult to heal<\/p>\n\n\n\n<p>skin damage.<br><\/p>\n\n\n\n<p>A dose-limiting&nbsp;side effect&nbsp;of Bendamustine Accord is impaired bone marrow function, which usually 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;anemia,&nbsp;or an increased risk of bleeding.<br><\/p>\n\n\n\n<p><strong>Very common&nbsp;<\/strong><strong>(may affect more than 1 user in 10)<\/strong><\/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>Reduced hemoglobin (the&nbsp;protein&nbsp;in&nbsp;red blood cells&nbsp;that transport 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><strong>Common&nbsp;<\/strong><strong>(may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Bleeding<\/li><li>Disrupted metabolism due to dying cancer cells that release slag products into the blood<\/li><li>Decreased number of&nbsp;red blood cells, which can make the skin pale and cause weakness or shortness of breath (&nbsp;anemia&nbsp;)<\/li><li>Low neutrophil count (a common type of&nbsp;white blood cell&nbsp;important for fighting&nbsp;infections&nbsp;)<\/li><li>Hypersensitivity reactions, e.g.&nbsp;allergic&nbsp;dermatitis&nbsp;(&nbsp;dermatitis&nbsp;) and&nbsp;hives&nbsp;(&nbsp;urticaria&nbsp;)<\/li><li>Elevated liver enzyme levels (AST \/ ALT) may indicate&nbsp;inflammation&nbsp;or damage to cells in the liver<\/li><li>Elevated levels of alkaline phosphatase (an&nbsp;enzyme&nbsp;made mainly in the liver and skeleton)<\/li><li>Elevated levels of bile pigments (a substance formed during the normal breakdown of&nbsp;red blood cells&nbsp;)<\/li><li>Low potassium levels in the blood (a nutrient necessary for the function of nerve and muscle cells, including those in your heart)<\/li><li>Disorders of heart function<\/li><li>Cardiac arrhythmias (&nbsp;arrhythmia&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>Soreness in the mouth (&nbsp;stomatitis&nbsp;)<\/li><li>Loss of appetite<\/li><li>Hair loss<\/li><li>Skin changes<\/li><li>Absence of menstruation (&nbsp;amenorrhea&nbsp;)<\/li><li>Pain<\/li><li>Insomnia<\/li><li>Overindulge<\/li><li>Dehydration<\/li><li>Dizziness<\/li><li>Itchy rash (&nbsp;urticaria&nbsp;).<br><\/li><\/ul>\n\n\n\n<p><strong>Uncommon&nbsp;<\/strong><strong>(may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Accumulation of fluid in the pericardium (fluid penetrates between the two layers of the pericardium)<\/li><li>Impaired formation of all types of&nbsp;blood cells&nbsp;in the bone marrow (the fungus-like material on the inside of your bones where blood cells are formed)<\/li><li>Acute&nbsp;leukemia<\/li><li>Heart attack, chest pain<\/li><li>Heart failure<\/li><\/ul>\n\n\n\n<p><strong>Rare&nbsp;<\/strong><strong>(may affect up to 1 in 1,000 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Infection&nbsp;in the blood (&nbsp;sepsis&nbsp;)<\/li><li>Severe allergic&nbsp;hypersensitivity reactions&nbsp;(anaphylactic reactions)<\/li><li>Symptoms reminiscent of anaphylactic reactions (anaphylactoid reactions)<\/li><li>Drowsiness<\/li><li>Lose voice (aphony)<\/li><li>Acute&nbsp;circulatory failure&nbsp;(decreased&nbsp;blood pressure&nbsp;and blood flow which leads to a deterioration of the supply of oxygen and other nutrients to the body and removal of toxic substances)<\/li><li>Redness (&nbsp;erythema&nbsp;)<\/li><li>Inflammation&nbsp;of the skin (&nbsp;dermatitis&nbsp;)<\/li><li>Itching&nbsp;(&nbsp;pruritus&nbsp;)<\/li><li>Spotty rash (macular exanthema)<\/li><li>Heavy sweating (&nbsp;hyperhidrosis&nbsp;)<\/li><li>Impaired bone marrow function, which can make you feel sick or can be seen on blood tests.<\/li><\/ul>\n\n\n\n<p><strong>Very rare&nbsp;<\/strong><strong>(may affect up to 1 in 10,000 people)<\/strong><\/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>The rapid drop in blood pressure with skin reactions or rash (anaphylactic&nbsp;shock&nbsp;)<\/li><li>Changed sense of taste<\/li><li>Emotional disorders (&nbsp;paresthesia&nbsp;)<\/li><li>Discomfort and pain in arms and legs (&nbsp;peripheral&nbsp;neuropathy&nbsp;)<\/li><li>Severe conditions that result in blockade of specific&nbsp;receptors&nbsp;in the nervous system<\/li><li>Disorder of the nervous system<\/li><li>Coordination difficulties (&nbsp;ataxia&nbsp;)<\/li><li>Brain inflammation (&nbsp;encephalitis&nbsp;)<\/li><li>Increased heart rate (&nbsp;tachycardia&nbsp;)<\/li><li>Inflammation&nbsp;of the veins (&nbsp;phlebitis&nbsp;)<\/li><li>Connective tissue formation in the lungs (&nbsp;pulmonary fibrosis&nbsp;)<\/li><li>Bleeding and&nbsp;inflammation&nbsp;of the esophagus (hemorrhagic&nbsp;esophagitis&nbsp;)<\/li><li>Bleeding in the stomach or intestines<\/li><li>Infertility<\/li><li>Multiple organ failure<\/li><\/ul>\n\n\n\n<p><strong>Has been reported&nbsp;<\/strong><strong>(occurs in an unknown number of users)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Kidney failure<\/li><li>Liver failure&nbsp;<\/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;acute&nbsp;myeloid&nbsp;leukemia&nbsp;(AML), bronchial cancer) have been reported following treatment with Bendamustine Accord.&nbsp;No clear association with bendamustine could be established.<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):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Severe rash, including Steven Johnson&#8217;s syndrome and&nbsp;toxic epidermal necrolysis.&nbsp;These can appear as reddish spot-like spots or circular&nbsp;plaques, 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.<\/li><li>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).<\/li><\/ul>\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 Accord<\/h2>\n\n\n\n<p>Keep this medicine out of sight&nbsp;<strong>&#8211;<\/strong>&nbsp;and the sight 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 temperature instructions.&nbsp;Keep the vial in the outer carton.&nbsp;Sensitive to light.<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 stable in polyethylene bags at 25 \u00b0 C for 3.5 hours and at 2-8 \u00b0 C for two days.&nbsp;Bendamustine Accord contains no&nbsp;preservatives.&nbsp;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.<br><\/p>\n\n\n\n<p>The user is responsible for the aseptic handling of the product.<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<p>The active substance is bendamustine hydrochloride.<br><\/p>\n\n\n\n<p>1&nbsp;vial&nbsp;contains 25 mg bendamustine hydrochloride (as bendamustine hydrochloride monohydrate).<br><\/p>\n\n\n\n<p>1&nbsp;vial&nbsp;contains 100 mg bendamustine hydrochloride (as bendamustine hydrochloride monohydrate).<br><\/p>\n\n\n\n<p>After&nbsp;reconstitution, 1 ml of concentrate contains 2.5 mg bendamustine hydrochloride (as bendamustine hydrochloride monohydrate).<br><\/p>\n\n\n\n<p>The other ingredient is mannitol.<\/p>\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>Vial&nbsp;of amber glass with bromobutyl rubber stopper and tear-off aluminum cap.<br><\/p>\n\n\n\n<p>Bendamustine Accord is available in packs of 5, 10, or 20 vials of 25 mg bendamustine hydrochloride and 1 or 5 vials of 100 mg bendamustine hydrochloride.<br><\/p>\n\n\n\n<p>Not all pack sizes may be marketed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p><strong>Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n<p>Accord Healthcare BV<\/p>\n\n\n\n<p>Winthontlaan 200<\/p>\n\n\n\n<p>3526 kV Utrecht<\/p>\n\n\n\n<p>Netherlands<br><\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Accord Healthcare Limited<\/p>\n\n\n\n<p>Sage House<\/p>\n\n\n\n<p>319 Pinner Road<\/p>\n\n\n\n<p>North Harrow<\/p>\n\n\n\n<p>Middlesex HA1 4HF<\/p>\n\n\n\n<p>UK<br><\/p>\n\n\n\n<p>Accord Healthcare BV&nbsp;<br>Winthontlaan 200<\/p>\n\n\n\n<p>3526 KV Utrecht<\/p>\n\n\n\n<p>Netherlands<br><\/p>\n\n\n\n<p>Accord Healthcare Polska Sp.z oo,<\/p>\n\n\n\n<p>ul.&nbsp;Lutomierska 50,95-200 Pabianice, Poland<br><\/p>\n\n\n\n<p><strong>This medicinal product is authorized under the European Economic Area under the names:<\/strong><br><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><thead><tr><th scope=\"col\"><strong>Name of Member State<\/strong><\/th><th scope=\"col\"><strong>Name of the medicine<\/strong><\/th><\/tr><\/thead><tbody><tr><td>Austria<\/td><td>Bendamustine Accord 2.5 mg \/ ml powder for concentrate for infusion solution<\/td><\/tr><tr><td>Denmark<\/td><td>Bendamustine Hydrochloride Accord<\/td><\/tr><tr><td>Finland<\/td><td>Bendamustine Accord 2.5 mg \/ ml kuiva-aine V\u00e4likonsentraatiksi infusion infett\u00e4t varten<\/td><\/tr><tr><td>Ireland<\/td><td>Bendamustine 25 mg \/ 100mg Powder for concentrate for Solution for&nbsp;Infusion<\/td><\/tr><tr><td>Iceland<\/td><td>Bendamustine Accord 2.5 mg \/ ml powder for concentrate for solution for infusion<\/td><\/tr><tr><td>Norway<\/td><td>Bendamustine Accord<\/td><\/tr><tr><td>Poland<\/td><td>Bendamustine Accord<\/td><\/tr><tr><td>Spain<\/td><td>Bendamustine Accord 2.5 mg\/ml powder for concentrate for solution for perfusion<\/td><\/tr><tr><td>Slovakia<\/td><td>Bendamustine Accord 2.5 mg \/ ml dose of infusion concentrate<\/td><\/tr><tr><td>Belgium<\/td><td>Bendamustine Accord 2.5 mg\/ml powder for concentrate for infusion solution<\/td><\/tr><tr><td>Bulgaria<\/td><td>Bendamustine Accord 2.5 mg \/ ml Concentrate for concentrate infusion<\/td><\/tr><tr><td>Cyprus<\/td><td>Bendamustine Accord 2.5 mg \/ ml<\/td><\/tr><tr><td>Czech Republic<\/td><td>Bendamustine Accord 2.5 mg \/ ml concentrate for concentrate for infusion<\/td><\/tr><tr><td>Germany<\/td><td>Bendamustine Accord 2.5 mg\/ml powder for the preparation of an infusion solution concentrate<\/td><\/tr><tr><td>Estonia<\/td><td>Bendamustine Accord<\/td><\/tr><tr><td>Greece<\/td><td>Bendamustine Accord 2.5 mg \/ ml powder for concentrated solution for&nbsp;infusion<\/td><\/tr><tr><td>Hungary<\/td><td>Bendamustine Accord 2.5mg \/ ml for infusion infusion or concentrates<\/td><\/tr><tr><td>Italy<\/td><td>Bendamustine Accord<\/td><\/tr><tr><td>Latvia<\/td><td>Bendamustine Accord 2.5 mg \/ ml powder for the infusion of concentrated concentrate<\/td><\/tr><tr><td>Lithuania<\/td><td>Bendamustine Accord 2.5 mg\/ml milteliai concentrate infuziniam tirpalui<\/td><\/tr><tr><td>Malta<\/td><td>Bendamustine hydrochloride Accord 2.5 mg \/ ml powder for concentrate for solution for&nbsp;infusion<\/td><\/tr><tr><td>Netherlands<\/td><td>Bendamustine Accord 2.5 mg \/ ml powder for concentrate for solution for infusion<\/td><\/tr><tr><td>Portugal<\/td><td>Bendamustine Accord 2.5 mg \/ ml concentrated for perfusion solution<\/td><\/tr><tr><td>Romania<\/td><td>Bendamustine Accord 2.5 mg \/ ml powder for concentrate for perfused solution<\/td><\/tr><tr><td>Slovenia<\/td><td>Bendamustine Accord 2.5 mg \/ ml prescription concentrate for infusion<\/td><\/tr><tr><td><\/td><td><\/td><\/tr><tr><td>UK<\/td><td>Bendamustine hydrochloride Accord 2.5 mg \/ ml Powder for concentrate for solution for&nbsp;infusion<\/td><\/tr><tr><td>France<\/td><td>BENDAMUSTINE ACCORD 2.5 mg \/ ml, powder for dilution solution for&nbsp;perfusion<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Bendamustine Accord 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":[9170,9174,9172,9154,9163,9164,9173,9156,9171,9155],"class_list":["post-5948","post","type-post","status-publish","format-standard","hentry","category-b","category-medicines","tag-bendamustine-accord","tag-bendamustine-accord-powder","tag-bendamustine-accord-side-effects","tag-bendamustine-hydrochloride","tag-bendamustine-hydrochloride-powder","tag-bendamustine-hydrochloride-side-effects","tag-what-bendamustine-accord-is-used-for","tag-what-bendamustine-hydrochloride-is-used-for","tag-what-is-bendamustine-accord","tag-what-is-bendamustine-hydrochloride"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5948","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=5948"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5948\/revisions"}],"predecessor-version":[{"id":12142,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5948\/revisions\/12142"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=5948"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=5948"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=5948"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}