\n\n20 mg \/ ml concentrate for solution for infusion
avelumab<\/p>\n\n\n\n
Bavencio contains the active substance avelumab, a monoclonal antibody (a kind of protein ) that attaches to a specific target in the body called PD-L1.
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PD-L1 is found on the surface of certain tumor cells and protects them from the immune system (the body’s natural defenses). Bavencio binds to PD-L1 and blocks this protective effect, which allows the immune system to attack the tumor cells.
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Bavencio is used in adults to treat:<\/p>\n\n\n\n
In renal cell carcinoma, Bavencio is used in combination with axitinib.
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It is important that you also read the package leaflet for the medicine containing axitinib. If you have any further questions on the use of axitinib, ask your doctor.
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if you are allergic to avelumab or any of the other ingredients of this medicine (listed in section 6).<\/p>\n\n\n\n
Blood tests and weight checks:<\/em><\/p>\n\n\n\n Your doctor will check your general health before and during treatment with Bavencio.<\/p>\n\n\n\n You will be given blood samples during treatment and your doctor will monitor your weight before and during treatment. Talk to your doctor before taking Bavencio:<\/em><\/p>\n\n\n\n This medicine may cause side effects (see section 4). Note that in some cases, symptoms may be delayed and may occur after your last dose. Seek medical attention immediately<\/strong> if you receive any of these:<\/p>\n\n\n\n If you get any of these symptoms while taking Bavencio, do not<\/strong> try to treat them with other medicines on your own. The doctor can<\/p>\n\n\n\n Check with your doctor or nurse before receiving Bavencio if:<\/em><\/p>\n\n\n\n Bavencio has not been studied in children and adolescents under 18 years of age.<\/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 Bavencio can cause harm to your unborn baby. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. You must not use Bavencio if you are pregnant unless your doctor explicitly recommends it. If you are a pregnant woman, you must use an effective method of contraception while you are being treated with Bavencio and for at least 1 month after the last dose. Breast-feeding<\/strong><\/p>\n\n\n\n Tell your doctor if you are breast-feeding. Amma not<\/strong> during treatment with Bavencio and for at least 1 month after the last dose one. It is not known if Bavencio passes into breast milk. A risk to the unborn child cannot be ruled out.<\/p>\n\n\n\n Do not<\/strong> drive or use machines after receiving Bavencio unless you are feeling well enough. Fatigue is a very common side effect of Bavencio and may affect your ability to drive or use machines.<\/p>\n\n\n\n Bavencio contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’. You will receive Bavencio in a hospital or doctor’s surgery under the supervision of an experienced doctor. How much Bavencio you will get<\/strong><\/p>\n\n\n\n The recommended dose of avelumab is 800 mg every two weeks. Your doctor will decide how many treatments you need. How to get Bavencio<\/strong><\/p>\n\n\n\n You will receive Bavencio as an infusion (drip) into a vein ( intravenously ) over a period of 1 hour. Bavencio is added to an infusion bag containing a sodium chloride solution before use. Before you get Bavencio<\/strong><\/p>\n\n\n\n To reduce the risk of side effects associated with the infusion, you will be given paracetamol and an antihistamine at least for the first four hours of treatment before receiving Bavencio. Depending on how your body responds to treatment, your doctor may decide to continue giving you these medicines before any subsequent treatment with Bavencio.<\/p>\n\n\n\n It is very important to you that you come to your booked visits to get Bavencio. If you miss a visit, ask your doctor when to book the next visit.<\/p>\n\n\n\n Cancel not<\/strong> treatment with Bavencio without first discussing it with your doctor. If you stop treatment, the effect of the medicine may stop. If you have any further questions on the use of this product, ask your doctor.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects may occur weeks or months after your last dose. Bavencio acts on your immune system and can cause inflammation in parts of the body (see section 2). Inflammation can cause serious damage to the body and some inflammatory conditions can be life-threatening and require treatment or discontinuation of Bavencio. Seek medical attention immediately if you experience inflammation in any part of the body,<\/strong> or if you get any of the following signs or symptoms or if they get worse.<\/p>\n\n\n\n Do not try to treat yourself with other drugs on your own.<\/strong> Other side effects are<\/strong><\/p>\n\n\n\n Some side effects may not cause any symptoms but can only be detected with blood tests. The following adverse reactions have been reported in clinical trials with avelumab alone: Very common (may affect more than 1 user in 10)<\/strong><\/p>\n\n\n\n Common (may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n Uncommon (may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n The following adverse reactions have been reported in clinical trials with avelumab in combination with axitinib: Very common (may affect more than 1 user in 10)<\/strong><\/p>\n\n\n\n Common (may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n Uncommon (may affect up to 1 in 100 people)<\/strong><\/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 vial label and carton after EXP. The expiration date is the last day of the specified month. Store in a refrigerator (2 \u00b0 C – 8 \u00b0 C). Do not freeze. Store in the original package. Sensitive to light. Do not save excess concentrate or diluted infusion solution for later use. Any unused product or waste material should be disposed of in accordance with local requirements.<\/p>\n\n\n\n The active substance is avelumab. A vial of 10 ml contains 200 mg avelumab. Each ml of concentrate contains 20 mg of avelumab. The other ingredients are mannitol, acetic acid, polysorbate 20, sodium hydroxide, water for injections (see section 2 “Bavencio has a low sodium content”).<\/p>\n\n\n\n Bavencio is a clear, colorless to pale yellow concentrate for solution for infusion(sterile concentrate). Pack size: 1 glass vial per carton.<\/p>\n\n\n\n Merck Europe BV<\/p>\n\n\n\n Gustav Mahlerplein 102<\/p>\n\n\n\n 1082 MA Amsterdam<\/p>\n\n\n\n Netherlands Manufacturer<\/strong><\/p>\n\n\n\n Merck Serono SpA<\/p>\n\n\n\n Via Delle Magnolie 15 (loc. Fraction Zona Industriale)<\/p>\n\n\n\n 70026 – Modugno (BA)<\/p>\n\n\n\n Italy<\/p>\n","protected":false},"excerpt":{"rendered":" Bavencio contains the active substance avelumab, a monoclonal antibody (a kind of protein ) that attaches to a specific target in the body called PD-L1.<\/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":[9264,9267,9270,9272,9269,9274,9268,9273,9265,9271],"class_list":["post-5902","post","type-post","status-publish","format-standard","hentry","category-b","category-medicines","tag-avelumab","tag-avelumab-side-effects","tag-bavencio","tag-bavencio-side-effects","tag-side-effects-of-avelumab","tag-side-effects-of-bavencio","tag-what-avelumab-is-used-for","tag-what-bavencio-is-used-for","tag-what-is-avelumab","tag-what-is-bavencio"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5902","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=5902"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5902\/revisions"}],"predecessor-version":[{"id":12152,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5902\/revisions\/12152"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=5902"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=5902"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=5902"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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<\/li><\/ul>\n\n\n\nChildren and young people<\/h2>\n\n\n\n
Other medicines and Bavencio<\/h2>\n\n\n\n
Pregnancy<\/h2>\n\n\n\n
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<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
Bavencio is low in sodium<\/h2>\n\n\n\n
<\/p>\n\n\n\n3. How to use Bavencio<\/h2>\n\n\n\n
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<\/p>\n\n\n\nIf you have missed a dose of Bavencio<\/h2>\n\n\n\n
If you stop getting Bavencio<\/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 Bavencio<\/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
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<\/p>\n\n\n\nWhat the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
<\/p>\n\n\n\nMarketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
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