2.5 mg\/ml powder for concentrate for solution for infusion
bendamustine hydrochloride<\/p>\n\n\n\n
Bendamustine Actavis is a medicine used to treat certain cancers ( cytostatics ).
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Bendamustine Actavis is used as the sole drug or in combination with other drugs to treat the following cancers:<\/p>\n\n\n\n
Bendamustine hydrochloride contained in Bendamustine Actavis may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
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Talk to your doctor, pharmacist, or nurse before or during treatment with Bendamustine Actavis:<\/p>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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If Bendamustin Actavis is used in combination with other medicines that inhibit the formation of blood in the bone marrow, it may lead to an increase in the effect on the bone marrow.
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If Bendamustin Actavis is used in combination with medicines that alter your immune response, e.g. ciclosporin and tacrolimus, the effect on the immune response may be enhanced.
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Drugs such as bendamustine ( cytostatics ) may weaken the effect of vaccination with live viruses. Cytostatics also increase the risk of infection when vaccinated with live vaccines (eg vaccines against viral diseases).
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If Bendamustin Actavis is used with medicines that inhibit a specific liver enzyme (CYP1A2), such as fluvoxamine (antidepressant), ciprofloxacin (used to treat bacterial infections ), aciclovir (used to treat viral infections), and cimetidine (used to treat heartburn and stomach ulcers ) these drugs can affect each other’s effect.<\/p>\n\n\n\n
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<\/strong><\/p>\n\n\n\n Bendamustine Actavis can cause genetic damage and has caused malformations in experimental animals. Bendamustine Actavis should not be used during pregnancy unless your doctor has told you to. If you need to be treated during pregnancy, consult your doctor about the risk of potential birth defects that the treatment may cause. Genetic counseling is also recommended. Fertility<\/strong><\/p>\n\n\n\n If you are a woman of childbearing potential, you must use some effective contraceptive method both before and during treatment with Bendamustine Actavis. If you become pregnant during treatment with Bendamustine Actavis, you must immediately inform your doctor and ask for genetic counseling. If you are a man, you should avoid having children during the treatment of Bendamustin Actavis and 6 months after the end of treatment. There is also a risk that treatment with Bendamustine Actavis will lead to infertility. You should therefore investigate the possibilities of sperm storage before starting treatment. Breast-feeding<\/strong><\/p>\n\n\n\n Bendamustine Actavis must not be used during breast-feeding. If treatment with Bendamustine Actavis is necessary during the breastfeeding period, breast-feeding must be stopped.<\/p>\n\n\n\n Bendamustine Actavis has a major impact 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 Actavis is given in a vein for 30-60 minutes in different doses, either alone ( monotherapy ) or in combination with other medicines. Treatment should not be started if you have a low number of white blood cells ( leukocytes ) and\/or platelets. This is checked regularly by your doctor. Chronic lymphocytic leukemia<\/strong><\/p>\n\n\n\n Non-Hodgkin’s lymphoma<\/strong><\/p>\n\n\n\n Multiple myeloma<\/strong><\/p>\n\n\n\n Treatment should be discontinued if the number of white blood cells ( leukocytes ) and\/or platelets drops to established levels. Treatment can be continued when the number of white blood cells and platelets has increased. Hepatic or renal impairment<\/strong><\/p>\n\n\n\n Depending on how severely impaired your liver function is, it may be necessary to adjust dose one. hepatic impairment). No dose adjustment is necessary for renal impairment. Your treating physician will decide if a dose adjustment is necessary or not. How it is administered<\/strong><\/p>\n\n\n\n Treatment with Bendamustin Actavis should only be performed by a physician experienced in the treatment of cancer. Your doctor will prescribe the dose of Bendamustine Actavis that is right for you and will take the necessary precautions. Your treating physician will give the infusion solution after the prescribed preparations. The solution is given into a vein in the form of a short-term infusion over 30-60 minutes. Length of treatment<\/strong><\/p>\n\n\n\n There are no set time limits for how long treatment with Bendamustine Actavis should be given. The duration of treatment depends on the disease and the effect of the treatment. If you have any further questions on the use of Bendamustine Actavis, ask your doctor or nurse.<\/p>\n\n\n\n If a dose of Bendamustin Actavis 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. Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the side effects listed below may be detected by tests performed by your doctor. 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 infusion needle is inserted may be a sign that administration is taking place outside the blood vessels. The consequence of such administration may be pain and difficult-to-heal skin lesions. A dose-limiting side effect of Bendamustin Actavis is impaired bone marrow function, which usually returns to normal after treatment. 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 infection, anemia, or an increased risk of bleeding. Very common <\/strong> (may affect more than 1 user in 10):<\/em><\/p>\n\n\n\n Low white blood cell count (<\/strong> disease-fighting cells in your blood)<\/p>\n\n\n\n Reduction of the red pigment in the blood (hemoglobin: (a protein in red blood cells that carries oxygen throughout the body))<\/p>\n\n\n\n Low platelet count (colorless blood cells that help the blood to coagulate)<\/p>\n\n\n\n Common <\/strong>(may affect up to 1 in 10 people):<\/em><\/p>\n\n\n\n Uncommon <\/strong>(may affect up to 1 in 100 people):<\/em><\/p>\n\n\n\n Rare <\/strong>(may affect up to 1 in 1,000 people):<\/em><\/p>\n\n\n\n Very rare <\/strong>(may affect up to 1 in 10,000 people):<\/em><\/p>\n\n\n\n Has been reported <\/strong>(occurs in an unknown number of users)<\/em> :<\/p>\n\n\n\n Tumors ( myelodysplastic syndrome, acute myeloid leukemia (AML), bronchial cancer) have been reported after treatment with bendamustine. No clear association with bendamustine could be established. Contact a doctor or seek medical attention immediately if you notice any of the following side effects (no known frequency):<\/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 \u201cEXP\u201d. The expiration date is the last day of the specified month. Unopened<\/em><\/p>\n\n\n\n No special storage instructions. Ready-made concentrate<\/em><\/p>\n\n\n\n The powder should be reconstituted immediately after opening the vial.<\/p>\n\n\n\n The reconstituted concentrate should be diluted immediately with 0.9% sodium chloride solution (see instructions at the end of this leaflet). Infusion solution<\/em><\/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 under normal lighting conditions, and for 2 days at 2 \u00b0 C to 8 \u00b0 C when protected from light in polyethylene bags. From a microbiological point of view, the solution should be used immediately. If the solution is not used immediately, the responsibility for shelf life and storage before use lies with the user. This storage should normally not be longer than 24 hours at 2 \u00b0 C to 8 \u00b0 C unless reconstitution\/dilution has been performed under controlled and validated aseptic conditions. White to off-white freeze-dried powder. Amber vials (type I) of 26 ml or 60 ml with freeze-drying caps of type I rubber (bromobutyl) and an aluminum lid with polypropylene disc. The vials are enclosed in a protective cover. 26 ml vials contain 25 mg bendamustine hydrochloride and are supplied in packs of 1, 5, 10, or 20 vials.<\/p>\n\n\n\n 60 ml vials contain 100 mg bendamustine hydrochloride and are supplied in packs of 1 or 5 vials. Not all pack sizes may be marketed.<\/p>\n\n\n\n Actavis Group PTC EHF.<\/p>\n\n\n\n Reykjavikurvegur 76-78 Hafnarfjordur<\/p>\n\n\n\n Iceland Manufacturer<\/strong><\/p>\n\n\n\n SC SINDEN-PHARMA SRL<\/p>\n\n\n\n Ion Mihalache Boulevard No.11<\/p>\n\n\n\n Sector 1, 011171, Bucharest<\/p>\n\n\n\n Romania Bendamustine Actavis 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":[9175,9177,9154,9163,9179,9157,9178,9156,9176],"class_list":["post-5946","post","type-post","status-publish","format-standard","hentry","category-b","category-medicines","tag-bendamustine-actavis","tag-bendamustine-actavis-powder","tag-bendamustine-hydrochloride","tag-bendamustine-hydrochloride-powder","tag-side-effects-of-bendamustine-actavis","tag-side-effects-of-bendamustine-hydrochloride","tag-what-bendamustine-actavis-is-used-for","tag-what-bendamustine-hydrochloride-is-used-for","tag-what-is-bendamustine-actavis"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5946","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=5946"}],"version-history":[{"count":6,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5946\/revisions"}],"predecessor-version":[{"id":12143,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5946\/revisions\/12143"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=5946"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=5946"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=5946"}],"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\nHow to use Bendamustin Actavis<\/h2>\n\n\n\n
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<\/p>\n\n\n\n100 mg Bendamustin Actavis per square meter of body surface area (based on your height and weight)<\/td> on day 1 + 2<\/td><\/tr> Repeat the cycle after 4 weeks up to 6 times<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n 120 mg Bendamustin Actavis per square meter body area (based on your height and weight)<\/td> on day 1 + 2<\/td><\/tr> Repeat the cycle after 3 weeks at least 6 times<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n 120-150 mg Bendamustin Actavis per square meter body area (based on your height and weight)<\/td> on day1 + 2<\/td><\/tr> 60 mg prednisone per square meter of body surface area (based on your height and weight) intravenously or orally<\/td> on day1 – 4<\/td><\/tr> Repeat the cycle after 4 weeks at least 3 times<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
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<\/p>\n\n\n\nIf you forget to use Bendamustin Actavis<\/h2>\n\n\n\n
If you stop using Bendamustin Actavis<\/h2>\n\n\n\n
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<\/p>\n\n\n\n4. Possible side effects<\/h2>\n\n\n\n
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<\/li><\/ul>\n\n\n\n5. How to store Bendamustin Actavis<\/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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