\n\n2.5 mg \/ ml powder for concentrate for infusion solution
bendamustine hydrochloride<\/p>\n\n\n\n
Bendamustine medac is a medicine that contains an active substance called bendamustine hydrochloride (hereafter referred to as bendamustine).<\/p>\n\n\n\n
Bendamustine medac is a medicine used to treat certain cancers ( cytostatics ).<\/p>\n\n\n\n
Bendamustine medac is used as the sole medicine or in combination with other medicines to treat the following cancers:<\/p>\n\n\n\n
Bendamustine hydrochloride contained in Bendamustine medac may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.
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Talk to your doctor or nurse before using Bendamustine medac:<\/p>\n\n\n\n
Talk to your doctor or nurse while taking Bendamustine medac:<\/p>\n\n\n\n
Men treated with Bendamustine medac should avoid having children during treatment and for 6 months after stopping treatment. Find out the possibilities of storing sperm before starting treatment – treatment with Bendamustine medac can lead to permanent infertility (sterility) (see section Pregnancy, breast-feeding and fertility ).<\/p>\n\n\n\n
There is no experience with the use of bendamustine hydrochloride in children and adolescents.<\/p>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.<\/p>\n\n\n\n
Other drugs can be affected by bendamustine hydrochloride, which in turn can affect the way bendamustine hydrochloride works. Bendamustine hydrochloride can affect and be affected by the following drugs:
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If Bendamustine medac is used with other medicines that inhibit the formation of blood cells in the bone marrow , the effect on the bone marrow can be strengthened.
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About Bendamustine medac is used with a medicine that affects your immune response , the effect on the immune response et reinforced.
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Chemotherapy can reduce the effectiveness of live virus vaccination . Cytostatics also increase the risk of infection after vaccination with live vaccine (eg vaccine against viral diseases).
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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.
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Pregnancy<\/em><\/p>\n\n\n\n Bendamustine medac can damage the hereditary system and has caused malformations in experimental animals. Bendamustine medac should not be used during pregnancy unless clearly indicated by a doctor. If you need to be treated during pregnancy, talk to your doctor about the risk of birth defects and the need for genetic counseling. Fertility<\/em><\/p>\n\n\n\n If you are a woman and could become pregnant, you must use an effective method of contraception both before and during treatment with Bendamustine medac. If you become pregnant while being treated with Bendamustine medac, contact your doctor immediately and ask for genetic counseling. If you are a man, you should avoid having children when you are treated with Bendamustine medac and for another 6 months after stopping treatment. Bendamustine medac can lead to infertility , so it may be a good idea to find out about the possibility of storing your sperm before starting treatment. Breast-feeding<\/em><\/p>\n\n\n\n Bendamustine medac must not be used during breast-feeding. If treatment with Bendamustine medac is necessary while breast-feeding, breast-feeding must be stopped. Ask your doctor or pharmacist for advice before taking any medicine.<\/p>\n\n\n\n Bendamustine hydrochloride has a significant effect on the ability to drive and use machines. Do not drive or use machines if you experience side effects, e.g. dizziness or impaired coordination. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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. Bendamustine medac is given as a drip into a vein for 30\u201160 minutes. Dosage varies and the drug can be given either as a single treatment or in combination with other drugs. Treatment should not be initiated if the white blood cell count and \/ or platelet counties lower than certain levels. These values \u200b\u200bare tested regularly. Chronic lymphocytic leukemia<\/em><\/p>\n\n\n\n Non-Hodgkin’s lymphoma<\/em><\/p>\n\n\n\n Multiple myeloma<\/em><\/p>\n\n\n\n Treatment must be stopped if the white blood cell count and \/ or platelet count drops to certain levels. Treatment can be continued when the number of white blood cells and platelets has increased. Hepatic or renal impairment<\/em><\/p>\n\n\n\n Depending on the degree of hepatic impairment, it may be necessary to adjust someone (30% adjustment in patients with moderate hepatic impairment). Bendamustine medac must not be used if you have severe hepatic impairment. No dose adjustment is required in patients with renal impairment. The attending physician decides if a dose adjustment is necessary. How the medicine is given<\/em><\/p>\n\n\n\n Treatment with Bendamustine medac must be done under the supervision of a physician experienced in the treatment of cancer. Your doctor will prescribe the dose of Bendamustine medac that is right for you and will take the necessary precautions. The prescribed infusion solution is given as an intravenous infusion for 30-60 minutes. Length of treatment<\/em><\/p>\n\n\n\n There are no set time limits for how long treatment with Bendamustine medac should be given. The duration of treatment depends on the disease and on the effect of the treatment.<\/p>\n\n\n\n If you have any further questions, or if you have any further questions on the use of Bendamustine medac, ask your doctor or nurse.<\/p>\n\n\n\n If a dose of Bendamustine medac is missed, your doctor will usually continue treatment according to the usual dosing schedule.<\/p>\n\n\n\n The attending physician decides whether to discontinue treatment or whether to switch to another treatment. If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact a doctor or seek medical attention immediately if you notice any of the following side effects (no known frequency): Severe rash, including Steven Johnson’s syndrome and toxic epidermal necrolysis. These can appear as reddish spot-like spots or circular 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 flu-like symptoms . Widespread rash, high body temperature, enlarged lymph nodes and involvement of other body organs (drug side effect with eosinophilia and systemic symptoms also known as DRESS or drug hypersensitivity syndrome). In very rare cases, tissue damage ( necrosis ) has occurred, as the drug has inadvertently ended up outside the blood vessel (extravasation). A burning sensation in which the needle is inserted may be a sign that the medicine has ended up outside the blood vessel. This can cause pain and difficult to heal skin lesions.<\/p>\n\n\n\n The side effect of Bendamustine medac that is dose-limiting is weakened bone marrow function.<\/p>\n\n\n\n In general, bone marrow function returns to normal after treatment. Bone marrow failure may lead to reduced blood cell s, which in turn can lead to increased risk of infection you, anemia ( anemia ) or increased risk of bleeding. Very common <\/strong>side effects (may affect more than 1 user in 10)<\/p>\n\n\n\n Common <\/strong>side effects (may affect up to 1 in 10 people)<\/p>\n\n\n\n Uncommon <\/strong>side effects (may affect up to 1 in 100 people)<\/p>\n\n\n\n Rare <\/strong>side effects (may affect up to 1 in 1,000 people)<\/p>\n\n\n\n Very rare <\/strong>side effects (may affect up to 1 in 10,000 people)<\/p>\n\n\n\n Has been reported<\/strong> (occurs in an unknown number of users)<\/p>\n\n\n\n Reporting of side effects<\/em><\/p>\n\n\n\n If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. <\/p>\n\n\n\n Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The first two digits indicate the month and the last four digits indicate the year. The expiration date is the last day of the specified month. Keep the vial in the outer carton. Sensitive to light. Shelf life after opening the medicine pack or preparing the infusion solution<\/strong><\/p>\n\n\n\n After reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 3.5 hours at 25 \u00b0 C \/ 60% RH and for 2 days at 2 \u00b0 C to 8 \u00b0 C in polyethylene bags.<\/p>\n\n\n\n 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 and would normally not be longer than 24 hours at 2 \u00b0 C to 8 \u00b0 C, unless reconstitution \/ dilution (etc.) has taken place under controlled and validated aseptic conditions. . Medicines 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 1 vial contains 25 mg bendamustine hydrochloride.<\/p>\n\n\n\n 1 vial contains 100 mg bendamustine hydrochloride.<\/p>\n\n\n\n After reconstitution , 1 ml of concentrate contains 2.5 mg of bendamustine hydrochloride.<\/p>\n\n\n\n White to off-white lyophilised powder in an amber glass vial with a stopper and an aluminum snap cap. Type I glass vials of 25 ml.<\/p>\n\n\n\n Type I glass vials of 50 ml. Bendamustine medac is available in packs of 1, 5 or 10 vials each containing 25 mg bendamustine hydrochloride and 1 or 5 vials each containing 100 mg bendamustine hydrochloride. Not all pack sizes may be marketed.<\/p>\n\n\n\n medac society for clinical specialties mbH<\/p>\n\n\n\n Theaterstr. 6<\/p>\n\n\n\n 22880 Wedel<\/p>\n\n\n\n Germany This medicinal product is authorized under the European Economic Area under the names:<\/strong><\/p>\n\n\n\n Bendamustine medac is a medicine that contains an active substance called bendamustine hydrochloride (hereafter referred to as bendamustine).<\/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":[9154,9158,9161,2212,9157,9162,9156,9160,9155,9159],"class_list":["post-5952","post","type-post","status-publish","format-standard","hentry","category-b","category-medicines","tag-bendamustine-hydrochloride","tag-bendamustine-medac","tag-bendamustine-medac-side-effects","tag-medicine","tag-side-effects-of-bendamustine-hydrochloride","tag-side-effects-of-bendamustine-medac","tag-what-bendamustine-hydrochloride-is-used-for","tag-what-bendamustine-medac-is-used-for","tag-what-is-bendamustine-hydrochloride","tag-what-is-bendamustine-medac"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5952","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=5952"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5952\/revisions"}],"predecessor-version":[{"id":12140,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5952\/revisions\/12140"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=5952"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=5952"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=5952"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
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<\/p>\n\n\n\n3. How to use Bendamustine medac<\/h2>\n\n\n\n
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<\/p>\n\n\n\nIf you forget to use Bendamustine medac<\/h2>\n\n\n\n
If you stop using Bendamustine medac<\/h2>\n\n\n\n
<\/p>\n\n\n\n4. Possible side effects<\/h2>\n\n\n\n
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<\/p>\n\n\n\n5. How to store Bendamustine medac<\/h2>\n\n\n\n
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<\/p>\n\n\n\n6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
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<\/p>\n\n\n\nMarketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
<\/p>\n\n\n\nDenmark<\/td> Bendamedac 2.5 mg \/ ml<\/td><\/tr> France<\/td> Bendamustine medac 2.5 mg\/ml powder for dilution solution for perfusion<\/td><\/tr> Iceland<\/td> Bendamustine medac 2.5 mg \/ ml<\/td><\/tr> Italy<\/td> Bendamustine medac<\/td><\/tr> Lithuania<\/td> Bendamustine medac 2.5 mg \/ ml milteliai infuzinio tirpalo concentratui<\/td><\/tr> Netherlands<\/td> Bendamustine HCl medac 2.5 mg \/ ml, powder for concentrate for solution for infusion<\/td><\/tr> UK<\/td> Bendamustine hydrochloride 2.5 mg \/ ml Powder for concentrate for solution for infusion<\/td><\/tr> <\/td> <\/td><\/tr> Germany<\/td> Bendamustin medac 2.5 mg \/ ml powder for concentrate for infusion<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"