2.5 mg\/ml\u00a0powder for concentrate for solution for\u00a0infusion\u00a0bendamustine
hydrochloride<\/p>\n\n\n\n
Ribovact is a medicine used to treat certain cancers ( cytostatics ).<\/p>\n\n\n\n
Ribovact is used alone or in combination with other medicines to treat the following cancers:<\/p>\n\n\n\n
– chronic lymphocytic leukemia if combination chemotherapy with fludarabine is not appropriate<\/p>\n\n\n\n
– non-Hodgkin’s lymphoma\u00a0when the results of previous rituximab treatment were short-lived or completely absent<\/p>\n\n\n\n
multiple myeloma when high-dose chemotherapy with autologous stem cell transplantation (with own stem cells ) or treatment with thalidomide or bortezomib is not appropriate.<\/p>\n\n\n\n
Talk to your doctor, pharmacist, or nurse before using Ribovact<\/strong><\/p>\n\n\n\n If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.<\/p>\n\n\n\n Pregnancy<\/strong><\/p>\n\n\n\n Ribovact can damage hereditary systems and has caused malformations in experimental animals. Ribovact must not be used during pregnancy unless your doctor has told you to. If you have to take medication during pregnancy, discuss the risk of birth defects with your doctor, and also discuss genetic counseling.<\/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 Ribovact. If you become pregnant while being treated with Ribovact, contact your doctor immediately and ask for genetic counseling.<\/p>\n\n\n\n Breast-feeding<\/strong><\/p>\n\n\n\n Ribovact must not be used during breastfeeding.\u00a0If Ribovact treatment is necessary while breastfeeding, breastfeeding must be stopped.<\/p>\n\n\n\n Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breastfeeding.<\/p>\n\n\n\n Fertility<\/strong><\/p>\n\n\n\n Men treated with Ribovact should avoid having children during treatment and 6 months after stopping treatment. Find out the possibilities of storing sperm before starting treatment – treatment with Ribovact can lead to permanent infertility (sterility).<\/p>\n\n\n\n If you are a man, you should avoid having children when you are treated with Ribovact and for another 6 months after stopping treatment.\u00a0Ribovact can lead to\u00a0infertility, so it may be a good idea to find out how to store your sperm before starting treatment.<\/p>\n\n\n\n Ribovact has a major impact on the ability to drive and use machines.\u00a0Do not drive or use machines if you experience\u00a0side effects, e.g.\u00a0dizziness or impaired coordination.<\/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 Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n Ribovact is given as a drip into a vein for 30-60 minutes. The dosage varies and the drug can be given either as a single treatment or in combination with other drugs.<\/p>\n\n\n\n Treatment should not be initiated if the value of the white\u00a0blood cells\u00a0and\/or platelets in the blood is too low.<\/p>\n\n\n\n These values \u200b\u200bare tested regularly.<\/p>\n\n\n\n Chronic lymphocytic leukemia<\/strong><\/p>\n\n\n\n Non-Hodgkin’s lymphoma<\/strong><\/p>\n\n\n\n Multiple\u00a0myeloma<\/strong><\/p>\n\n\n\n Treatment must be stopped if the number of white blood cells drops to established levels. Treatment can continue when the number of white blood cells and the number of platelets have increased.<\/p>\n\n\n\n Liver or kidney failure<\/strong><\/p>\n\n\n\n Dosage may need to be adjusted according to the degree of liver failure (30% in patients with moderate hepatic impairment). No dose adjustment is required in patients with renal impairment. The attending physician decides on any dose adjustments.<\/p>\n\n\n\n Method of administration<\/strong><\/p>\n\n\n\n Ribovact treatment must be performed under the supervision of a physician experienced in the treatment of cancer. Your doctor will prescribe the dose of Ribovact that is right for you and will take the necessary precautions.<\/p>\n\n\n\n The treating physician gives the prescribed infusion solution as a rapid intravenous infusion for 30-60 minutes.<\/p>\n\n\n\n Duration of treatment<\/strong><\/p>\n\n\n\n There are no set time limits for how long Ribovact cures should be given. The duration of treatment depends on the disease and 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 Ribovact, ask your doctor or nurse.<\/p>\n\n\n\n If a dose of Ribovact 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 switch to another treatment.<\/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 Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Some of the side effects listed below may be detected by tests performed by your doctor.<\/p>\n\n\n\n When assessing\u00a0side effects, the following definitions of the occurrence of side effects are used:<\/p>\n\n\n\n In very rare cases, tissue damage (\u00a0necrosis\u00a0) has occurred, as the drug has ended up outside the blood vessel (extravasation).\u00a0If the patient has a burning sensation at the site where the needle was inserted, it may be because the medicine has ended up outside the blood vessel.\u00a0If the medicine reaches the\u00a0tissues\u00a0in this way, pain and skin damage may occur.\u00a0The skin damage heals poorly.<\/p>\n\n\n\n A\u00a0side effect\u00a0that limits the use of Ribovact is weakened bone marrow function.\u00a0In general, bone marrow function recovers and returns to normal after treatment.\u00a0Impaired bone marrow function can lead to a decrease in the number of blood cells, which in turn can lead to an increased risk of\u00a0infection,\u00a0anemia,\u00a0or an increased risk of bleeding.<\/p>\n\n\n\n Very Common<\/strong><\/p>\n\n\n\n \u2022 Low white blood cell count (<\/strong> disease-fighting cells in your blood)<\/p>\n\n\n\n Decreased hemoglobin value (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 \u2022 Infection is<\/p>\n\n\n\n \u2022 Nausea<\/p>\n\n\n\n \u2022 Vomiting<\/p>\n\n\n\n \u2022 Mucositis<\/p>\n\n\n\n \u2022 Headache<\/p>\n\n\n\n \u2022 Increased creatinine value in the blood (a chemical residue produced by your muscles)<\/p>\n\n\n\n \u2022 Increased urea value in the blood (a chemical residue)<\/p>\n\n\n\n \u2022 Fever<\/p>\n\n\n\n \u2022 Fatigue<\/p>\n\n\n\n Usual<\/strong><\/p>\n\n\n\n \u2022 Bleeding<\/p>\n\n\n\n \u2022 Disrupted metabolism due to dying cancer cells that release slag products into the blood<\/p>\n\n\n\n Reduced red blood cell count (\u00a0anemia\u00a0), which may cause paleness, weakness, or shortness of breath<\/p>\n\n\n\n Low neutrophil count (a common type of white blood cell count important to fight infections )<\/p>\n\n\n\n \u2022 Hypersensitivity reaction that causes inflammation in the skin, hives<\/p>\n\n\n\n Elevated values \u200b\u200bof liver enzymes AST \/ ALT (which may indicate inflammation or damage to cells in the liver)<\/p>\n\n\n\n \u2022 An increase in alkaline phosphatases (an enzyme made mainly in the liver and skeleton)<\/p>\n\n\n\n Elevated bilirubin levels (a substance formed during the normal breakdown of red blood cells )<\/p>\n\n\n\n \u2022 Low potassium in the blood (a nutrient that is necessary for the function of nerve and muscle cells, including those in your heart)<\/p>\n\n\n\n \u2022 Disrupted heart function<\/p>\n\n\n\n \u2022 Rhythm disturbances in the heart<\/p>\n\n\n\n \u2022 Low or high blood pressure<\/p>\n\n\n\n \u2022 Impaired lung function<\/p>\n\n\n\n \u2022 Diarrhea<\/p>\n\n\n\n \u2022 Constipation<\/p>\n\n\n\n \u2022 Pain in the mouth (inflammation of the mouth)<\/p>\n\n\n\n \u2022 Loss of appetite<\/p>\n\n\n\n \u2022 Hair loss<\/p>\n\n\n\n \u2022 Skin changes<\/p>\n\n\n\n \u2022 Missed period<\/p>\n\n\n\n \u2022 Pain<\/p>\n\n\n\n \u2022 Insomnia<\/p>\n\n\n\n \u2022 Chills<\/p>\n\n\n\n \u2022 Dehydration<\/p>\n\n\n\n \u2022 Dizziness<\/p>\n\n\n\n Itchy rash ( urticaria )<\/p>\n\n\n\n Less common<\/strong><\/p>\n\n\n\n \u2022 Accumulation of fluid in the pericardium (which surrounds the heart)<\/p>\n\n\n\n \u2022 Inefficient production of blood cells in the bone marrow<\/p>\n\n\n\n \u2022 Acute leukemia<\/p>\n\n\n\n \u2022 Heart attack, chest pain<\/p>\n\n\n\n \u2022 Heart failure<\/p>\n\n\n\n Rare<\/strong><\/p>\n\n\n\n \u2022 Blood poisoning ( sepsis )<\/p>\n\n\n\n \u2022 Severe allergic hypersensitivity reactions (anaphylactic reactions)<\/p>\n\n\n\n \u2022 Impaired bone marrow function, which can make you feel sick or can be seen on blood tests<\/p>\n\n\n\n \u2022 Symptoms reminiscent of anaphylaxis (anaphylactoid reactions)<\/p>\n\n\n\n Drowsiness<\/p>\n\n\n\n \u2022 Silent voice<\/p>\n\n\n\n \u2022 Acute circulatory failure (decreased blood pressure and blood flow leading to a deterioration in the supply of oxygen and other nutrients to the body)<\/p>\n\n\n\n \u2022 Reddening of the skin<\/p>\n\n\n\n \u2022 Skin rash ( dermatitis )<\/p>\n\n\n\n Itching _<\/p>\n\n\n\n \u2022 Rash in the form of spots and blemishes (maculopapular rash)<\/p>\n\n\n\n \u2022 Heavy sweating<\/p>\n\n\n\n Very rare<\/strong><\/p>\n\n\n\n \u2022 Primary atypical pneumonia<\/p>\n\n\n\n Degradation of red blood cells<\/p>\n\n\n\n \u2022 Rapid drop in blood pressure with skin reactions or rash (anaphylactic shock )<\/p>\n\n\n\n \u2022 Disturbed sense of taste<\/p>\n\n\n\n \u2022 Disturbed sensation ( paresthesia )<\/p>\n\n\n\n \u2022 Damage to peripheral nerves (discomfort and pain in the extremities )<\/p>\n\n\n\n \u2022 Severe conditions that result in blockade of specific receptors in the nervous system<\/p>\n\n\n\n \u2022 Disorder of the nervous system<\/p>\n\n\n\n \u2022 Disrupted coordination<\/p>\n\n\n\n \u2022 Inflammation of the heart<\/p>\n\n\n\n \u2022 Fast pulse<\/p>\n\n\n\n Inflammation of veins<\/p>\n\n\n\n Increase in connective tissue in the lungs<\/p>\n\n\n\n \u2022 Esophageal inflammation with bleeding<\/p>\n\n\n\n \u2022 Bleeding in the stomach or intestines<\/p>\n\n\n\n \u2022 Sterility<\/p>\n\n\n\n \u2022 Multiple organ damage<\/p>\n\n\n\n No known frequency of side effects<\/strong><\/p>\n\n\n\n \u2022 Liver failure<\/p>\n\n\n\n \u2022 Kidney failure<\/p>\n\n\n\n \u2022 irregular and often fast heart rate (\u00a0atrial fibrillation\u00a0)<\/p>\n\n\n\n \u2022 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,\u00a0infection\u00a0of the respiratory tract (eg\u00a0bronchitis\u00a0), and\/or fever.<\/p>\n\n\n\n Rash in combination therapy with rituximab<\/p>\n\n\n\n \u2022 Pneumonitis ( pneumonia )<\/p>\n\n\n\n \u2022 Bleeding from the lungs<\/p>\n\n\n\n Tumors\u00a0(\u00a0myelodysplastic syndrome,\u00a0acute myeloid leukemia\u00a0[AML], tracheal carcinoma) have been reported following treatment with Ribovact.\u00a0No obvious association with Ribovact could be established.<\/p>\n\n\n\n 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 Severe rash including Stevens-Johnson syndrome and\u00a0toxic epidermal necrolysis.\u00a0These can appear as reddish dot-like spots or circular\u00a0plaques, 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\u00a0flu-like symptoms.<\/p>\n\n\n\n Widespread rash, high body temperature, enlarged\u00a0lymph nodes,\u00a0and involvement of other body organs (drug side effect with\u00a0eosinophilia\u00a0and systemic symptoms also known as DRESS or drug hypersensitivity syndrome).<\/p>\n\n\n\n If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the label and the outer carton.<\/p>\n\n\n\n The expiration date is the last day of the specified month.<\/p>\n\n\n\n Store the packaging in the outer carton. Sensitive to light.<\/p>\n\n\n\n Shelf life after opening the medicine pack or preparing the infusion solution<\/strong><\/p>\n\n\n\n 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 at refrigerator temperature for 2 days.\u00a0Ribovact does not contain any preservatives.\u00a0Therefore, solutions stored longer than the stated shelf life must not be used.<\/p>\n\n\n\n The user is responsible for the product being handled aseptically.<\/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 The active substance is bendamustine hydrochloride.<\/p>\n\n\n\n One vial contains 25 mg bendamustine hydrochloride or 100 mg bendamustine hydrochloride.<\/p>\n\n\n\n After\u00a0reconstitution, 1 ml of concentrate contains 2.5 mg of bendamustine hydrochloride.<\/p>\n\n\n\n Contains mannitol.<\/p>\n\n\n\n Brown glass vial with rubber stopper and removable aluminum lid.<\/p>\n\n\n\n The powder is white and crystalline.<\/p>\n\n\n\n Ribovact is available in packs of<\/p>\n\n\n\n 5, 10, or 20 vials of 25 mg bendamustine hydrochloride<\/p>\n\n\n\n and<\/p>\n\n\n\n 5 vials of 100 mg bendamustine hydrochloride.<\/p>\n\n\n\n Not all pack sizes may be marketed.<\/p>\n\n\n\n Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n Astellas Pharma GmbH<\/p>\n\n\n\n Ridlerstrasse 57<\/p>\n\n\n\n 80339 Munich<\/p>\n\n\n\n Germany<\/p>\n\n\n\n Manufacturer<\/strong><\/p>\n\n\n\n Haupt Pharma Wolfratshausen GmbH<\/p>\n\n\n\n Pfaffenrieder Stra\u03b2e 5<\/p>\n\n\n\n D-82515 Wolfratshausen<\/p>\n\n\n\n Germany<\/p>\n\n\n\n Information is provided by<\/strong><\/p>\n\n\n\n Mundipharma AB<\/p>\n\n\n\n M\u00f6lndalsv\u00e4gen 30B<\/p>\n\n\n\n 412 63 Gothenburg<\/p>\n\n\n\n Tel .: 031 773 75 30<\/p>\n\n\n\n Fax: 031 773 75 49<\/p>\n","protected":false},"excerpt":{"rendered":" Ribovact 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":[2200,18529],"tags":[18036,22993,22994,22992,18035,7729,22990,22991],"class_list":["post-22098","post","type-post","status-publish","format-standard","hentry","category-medicines","category-r","tag-benefits-of-hydrochloride","tag-benefits-of-ribovact","tag-ribovact-dosage","tag-ribovact-side-effects","tag-what-hydrochloride-is-used-for","tag-what-is-hydrochloride","tag-what-is-ribovact","tag-what-ribovact-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22098","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=22098"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22098\/revisions"}],"predecessor-version":[{"id":22130,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22098\/revisions\/22130"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=22098"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=22098"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=22098"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
How to use ribs act<\/h2>\n\n\n\n
100 mg Ribovact per square meter body area (calculated by weight and height)<\/td> Day 1 and 2<\/td><\/tr><\/thead> The course is repeated at 4-week intervals up to 6 times.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n 120 mg Ribovact per square meter of body surface area (calculated by weight and length)<\/td> Day 1 and 2<\/td><\/tr><\/thead> The course is repeated at 3-week intervals at least 6 times.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n 120-150 mg Ribovact per square meter body area (calculated by weight and height)<\/td> Day 1 and 2<\/td><\/tr><\/thead> 60 mg prednisone per square meter of body surface area (calculated by weight and height)\u00a0intravenously\u00a0or orally.<\/td> Day 1-4<\/td><\/tr> The course is repeated at 4-week intervals at least 3 times.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n If you forget to use Ribovact<\/h2>\n\n\n\n
If you stop using Ribovact<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
Very common<\/strong><\/td> With more than 1 user out of 10<\/td><\/tr> Usual<\/strong><\/td> With 1-10 users out of 100<\/td><\/tr> Less common<\/strong><\/td> With 1-10 users out of 1000<\/td><\/tr> Rare<\/strong><\/td> With 1-10 users out of 10,000<\/td><\/tr> Very rare<\/strong><\/td> With less than 1 user out of 10,000<\/td><\/tr> No known frequency of side effects<\/strong><\/td> The frequency can not be calculated from the available data<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n How to store Ribovact<\/h2>\n\n\n\n
Contents of the package 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
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n