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�Cq��v��2�a�X�pl%3,�Q�C�~�:����?�[��];� ��c�ѓc\��a�ɓ:W�M{Wn;������$�;�j��".�78T�m��(�^L��A��9�}�N��9>��P�����K4�Є���Zh��Z����;5���pv?� 9�'��)���|~ �o' x�]��j�0��~ See Important Safety Information, including Boxed Warning, and full Prescribing Information. Soliris ® [package insert… … Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. US National Library of Medicine. Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported. Soliris [package insert]. Soliris [package insert]. Accessed July 2020. 2012;135(pt 6):1834-1849. Wingerchuk DM, Hogancamp WF, O’Brien PC, Weinshenker BG. With Soliris, A future with fewer relapses is possible. endstream endobj 3429 0 obj <>stream Soliris® (eculizumab) is the FIRST AND ONLY FDA-approved complement inhibitor indicated for the treatment of adults with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD).1, In the Soliris PREVENT study of patients with anti-AQP4 antibody-positive NMOSD, Soliris was superior to placebo based on time to first adjudicated on-trial relapse (primary endpoint).1, reduction in risk of relapse in adult patients treated with Soliris compared to placebo (Hazard Ratio=0.058; P<0.0001).1, of patients treated with Soliris who were relapse-free at 48 weeks vs 63% with placebo.1,2. Use caution when administering Soliris to patients with any systemic infection. *Note: for Soliris switch therapy please refer to the package insert for appropriate switch dosing. Package Insert - SHINGRIX; Demographic Subgroup Information - Zoster Vaccine Recombinant, Adjuvanted (SHINGRIX) Refer to Section 1.1 of the Clinical Review Memo for information … The active substance in Soliris, eculizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to the C5 complement protein, which is a part of the body’s defence system called … Mealy MA, Wingerchuk DM, Greenberg BM, Levy M. Epidemiology of neuromyelitis optica in the United States: a multicenter analysis. SOLIRIS® is the First and Only Approved Therapy for PNH 2 SOLIRIS… 2. See full prescribing information for ORENCIA. 7. Guidelines for … 1. Under the Soliris REMS, prescribers must enroll in the program (5.2). References 1. She is currently the … 1,2 Ashley N. Lewis, PharmD, BCPS, is a drug information specialist at University of North Carolina Hospitals (UNCH). Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com. %%EOF Boston, MA: Alexion Pharmaceuticals, Inc. Rother RP, Rollins SA, Mojcik CF, Brodsky RA, Bell L. Discovery and development of the complement inhibitor eculizumab for … Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. Read all of this leaflet carefully before you start using this medicine because it contains … �uu�q� ����YC�qZ+����q���^X��q�$Ϝ#��\@�Ρ�:2�/E�h����w��i(*惐X�,����X�0���O��������Zo Soliris [package insert]. 5. Pittock SJ, Berthele A, Fujihara K, et al. This site is intended for healthcare professionals. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) (1). SOLIRIS can cause serious side effects including serious infusion-related reactions. We use cookies to give you the best online experience. • Loirat C, Fakhouri F, Ariceta G, et al. Patients may have increased susceptibility to infections, especially with encapsulated bacteria. Under the Soliris REMS, prescribers must enroll in the program. Soliris [package insert]. Arch Neurol. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. Use caution when administering Soliris to patients with any systemic infection. Package leaflet: Information for the user . Neuromyelitis Optica Spectrum Disorder (NMOSD) Accessed July 2020. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. SOLIRIS® (eculizumab) SOLIRIS® is a Complement Inhibitor Indicated for the Treatment of Patients With PNH to Reduce Hemolysis SOLIRIS® (eculizumab) [package insert]. iokwpd��w1���Xt���ǦJ�� kR��cBN��� �I�2�KI䡫n���):�|J�� �b�?a�^S���j$�$:��֬x�d+T5a�cGIo�?A�㏬��>�}v�/�ć�w�h�2�{�o���x��JLODy+ ݟ���v�Ι���S�v�QRb��햱w�>�g��q�����vҘ��T�N"�d�M��8#��[�������k���������j5�)����x�R���KS�.���V)x�ڄ���qV*[�؂��n��]Xie��Xo���6a�PD I�2�� 1 INDICATIONS AND USAGE 1.1 Paroxysmal Nocturnal Hemoglobinuria (PNH) Soliris … Copyright © 2020, Alexion Pharmaceuticals, Inc. All rights reserved. Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections. SOLIRIS is only available through a program called the SOLIRIS REMS. Boston, MA: Alexion Pharmaceuticals, Inc. Rother RP, Rollins SA, Mojcik CF, Brodsky RA, Bell L. Discovery and development of the complement inhibitor eculizumab for … Administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. �x R�P�}� �%l+�k�O`����t�����"�̳�lL8��J�f��r���Є�SW���{D�3�l�.���r��!�qC&����k֕0�1��_�j��蒧����,e�;Ԅe>t�q3 Ԓ�~�Tx8 ȝ��'!�r�"B��/��x˙ References H��W�r�6}����d�� �N&3�;�$��Ӈ8�$_�Hr%%��Q���.��Ʊ�dƎ ����=g�����hŞ}X���|��,�>eϞ��ww2��JH��~�J��dw珟�lw�������`B�L�����2&X��Lg�,����v��O�+z*����λD������;/�����Z;�{��&���!c���ׇ��,���HVv�,�Q%Wj;�8��e�×��T'/_ �_��$��J�R���� .1\;}��,y�^�E�~�p��M*Er�����MM�6������� �w�"e�M�N���H��]�R@�! Physicians must discuss the benefits and risks of Soliris therapy with patients and provide them with a patient information brochure and a patient safety card (see Package Leaflet for a description). Soliris 300 mg concentrate for solution for infusion . Soliris … Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infections. 6�1���B� �e~�t�����*у�3 �`L��m^����|����@��6�����2�`N��5l�OD�*!9�yD2��5n)F2m$*@�*CW An international consensus approach to the management of … 2.2 Recommended Weight-Based Dosage Regimen The recommended dosing regimen for adult patients (≥ 18 years of age) with PNH consists of a loading dose followed by maintenance dosing, … Complete prescribing information is available at www.soliris.com. Howard JF Jr, Utsugisawa K, Benatar M, et al; for the REGAIN Study Group. 15. References 1. Soliris must be diluted to a final admixture concentration of 5 mg/mL using the following steps: • Withdraw the required amount of Soliris from the vial into a sterile syringe. Dilute Soliris to a final admixture concentration of 5 mg/mL using the following steps: • Withdraw the required amount of Soliris from the vial into a sterile syringe. References 1. Soliris. :�3�ʞ��~*b��a�^:4r���N���]���_������l1���y�^ߊi'�Ќ����J�40��. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ALDURAZYME safely and effectively. See full prescribing information for ALDURAZYME. ?p�?Mޑ�ۢ�}:Rc������ ��L| Under the Soliris REMS, prescribers must enroll in the program. Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com. The most frequently reported adverse reactions in the NMOSD placebo-controlled trial (≥10%) are: upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion. References 1. :��r� Soliris-treated patients had a 96% relative … 67 5.3 Monitoring After Soliris Discontinuation 68 Since Soliris therapy increases the number of PNH cells [in study 1, the proportion of PNH RBCs increased 69 among Soliris … SOLIRIS patent expiration date, news, international patents, biosimilar launch March 2021 - When will the patents on SOLIRIS expire, and when will biosimilar SOLIRIS be available? NULOJIX ® (belatacept) (in combination with basiliximab induction, mycophenolate mofetil [MMF], and corticosteroids) is indicated for prophylaxis of organ rejection in adults receiving a kidney transplant; … Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and may become rapidly life-threatening or fatal if not recognized and treated early. Y�n�*�J� 2. • Transfer the recommended dose to an infusion bag. Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Soliris while maintaining optimal therapeutic outcomes. • Transfer the recommended dose to an infusion bag. Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … All fields are required. 2/2021 Updated vaccination requirements for Soliris ®. The Medical Letter On Drugs and Therapeutics, Eculizumab (Soliris) for Paroxysmal Nocturnal ��S�X�-�狇�v�8Y�����|�ޜ}������pȻY���s����՗�٬4'9������;֭��t-�Y�\n�'����w�ap�Qn�u3����~\>��]�.��ߴ��v�����0?n�' Fҟ�?�Ք�i�}/C����.���1y=^��׬utOey�s�.�ш��o�ֱ%>�V�l�Eڣ���C��9���f�{Z >��.����7}�T���&S/7���������kB�k "�n#G����݆�Þ ����m m���M�c�8��B'��=FsO��de�o��[\�R{����6������'\�Ǔ�T��`?rt��]�\;>C�CO��{�1��e7�J�̦-���c��x�C�>J�}L��>O|�z�uB)L�j���N(�T��. Atypical Hemolytic Uremic Syndrome (aHUS) Complement-Inhibitor Therapy Naïve* Administer the doses … K��Dz��P�=C�4�#8 H���}��\� ~5VMZ�,�a��~*�1����8�E�c�oƊ���C+X��çbI��҈̼� FL���!,b �!0 Safety and efficacy of eculizumab in anti-acetycholine … Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … Resources for your patients on Soliris® (eculizumab). Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Boston, MA: Alexion Pharmaceuticals, Inc. 2. Boston, MA: Alexion Pharmaceuticals, Inc; 2019. Eculizumab in aquaporin-4–positive neuromyelitis optica spectrum disorder. 1999;53(5):1107-1114. • Dilute Soliris … Soliris [package insert]. Boston, MA: Alexion Pharmaceuticals, Inc; 2019. 6. Loirat C, Fakhouri F, Ariceta G, et al. ��{�¹v0��M��i�s�z�����-��>l{�l���xLЪ"df#=�֟�i���۸�b��r.��53�������>{��Í��+bSU�KG5)B��Ɔ���ɦ)a7�H�9'D U��q��N�g/Kx��s܆+��9��~�)][x��d0�%���xm�[�U\���dp��K�{���t��V*. endstream endobj startxref [Package Insert]. If Soliris must be initiated immediately in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide 2 weeks of antibacterial drug prophylaxis. The clinical course of neuromyelitis optica (Devic’s syndrome). SOLIRIS® is the First and Only Approved Therapy for PNH 2 SOLIRIS… The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). Alexion OneSource™ provides gMG patient support. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Soliris [package insert]. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Cheshire, CT: Alexion Pharmaceuticals, Inc.; October 2017. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. Soliris [package insert]. z�7�nVV�%��H�F�f���G|MKt��G��?��1.�]� Soliris (eculizumab) [package insert]. Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion: chest pain, trouble … Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. 8. 7/2020 Implement a policy for both Ultomiris ® & Soliris ® References 1. STUDY DESIGN1,2 Contrasting disease patterns in seropositive and seronegative neuromyelitis optica: a multicentre study of 175 patients. See Important Safety Information, including Boxed Warning, and full Prescribing Information. Soliris [package insert]. Although no specific agents are recommended, the eculizumab package insert notes that most patients in this situation received prophylactic antibiotics until at least 2 weeks after vaccination. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Alexion OneSource™ provides gMG patient support. 1/2021 Updated to include Enspryng™ and to change the policy name again. endstream endobj 3426 0 obj <>/Metadata 139 0 R/Outlines 210 0 R/Pages 3416 0 R/StructTreeRoot 215 0 R/Type/Catalog>> endobj 3427 0 obj <>/MediaBox[0 0 612 792]/Parent 3417 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 3428 0 obj <>stream Get the … • Soliris [package insert]. 0 J Neuroinflammation. SOLIRIS® (eculizumab) SOLIRIS® is a Complement Inhibitor Indicated for the Treatment of Patients With PNH to Reduce Hemolysis SOLIRIS® (eculizumab) [package insert]. 3425 0 obj <> endobj Each bag contains the following inactive ingredients: L-cysteine hydrochloride hydrate (10 mg), sodium bisulfite … By checking this box and providing my information above, I am giving Alexion permission to contact me for marketing purposes or otherwise provide me with information about Alexion’s products, services, and programs or other topics of interest, and to conduct market research or surveys. Soliris ® (eculizumab), a complement inhibitor, is the first and only medication approved by the FDA to treat adults with neuromyelitis optica spectrum … Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Soliris is not indicated for the treatment of patients with Shiga toxin E. Coli related hemolytic uremic syndrome (STEC-HUS) Speak with your doctor about how Soliris can help in the treatment of aHUS. �*�H��M*��zl��L���Ǩ ���=!LO{b�:��Ŀ��G�_�~��;����[�'>�/"��O� X٩�"�`�v�5�9 �ܞ���`��b��'*2껜}�������1'�?|Y:ڗ��p���w��M��X��\�@= Accessed March 13, 2020. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … h�bbd```b``���� ����Z���Q ��D�[������`5s@$�0 �� $�@l ���׺1012�~ � �%����� @� �� Thrombotic microangiopathy complications were observed after Soliris … SOLIRIS patent expiration date, news, international patents, biosimilar launch March 2021 - When will the patents on SOLIRIS expire, and when will biosimilar SOLIRIS be available? • Dilute Soliris … hemolytic uremic syndrome (STEC-HUS). Alexion Pharmaceuticals; 2009. !ۍ�=$�'"ٞ�j5iCjr!�F��ɋ�H��I��P N Engl J Med. WARNING: SERIOUS MENINGOCOCCAL INFECTIONS, Patients who are not currently vaccinated against. Eculizumab (Soliris) package insert; Eculizumab (Soliris) patient drug information (Chemocare) Eculizumab (Soliris) patient drug information (UpToDate) History of changes in FDA indication. endstream endobj 3430 0 obj <>stream Other Systemic Infections Due to its mechanism of action, Soliris … d�]�X�P�B����㬍G^f���y��k�EG�D�qG��G�FK ��0�����A�����A5���"�*X:�� @#8hV@����/� bIpXi20��hf`d7dWe`�����{1k>ˆ����b�?�2�h�x�P�w��+�Gl������ 2�\�t��< ����}2(�����2p}���c�` �\�� Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … Accessed July 2020. 3. Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine(s). References: Soliris [package insert]. 3443 0 obj <>/Filter/FlateDecode/ID[<7FAEC3263EDC5246A9994F89F7F28BA1>]/Index[3425 84]/Info 3424 0 R/Length 100/Prev 718362/Root 3426 0 R/Size 3509/Type/XRef/W[1 3 1]>>stream Brain. Prognostic factors and disease course in aquaporin-4 antibody-positive patients with neuromyelitis optica spectrum disorder from the United Kingdom and Japan. Eculizumab . 5;��p�8{X�.2�\.6��˯�n��x��أ����� 3508 0 obj <>stream Package leaflet: Information for the user . Howard JF Jr, Utsugisawa K, Benatar M, et al; for the REGAIN Study Group. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. h�b```��,�B ���� HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ORENCIA safely and effectively. %PDF-1.7 %���� ��sD����0� I���J�2��4UO>�`1�����G��u�4��}�Ig �4BM�kz �s���F�&�@r"��CZr� ��T�R��@��% >`�V�萘�o}�ۇ�S��� H���-}�������m8�����F X {Γ���[Jo4y:):c��l+��ȯ=��o�߄�o98�(��H���w#Dj,(���׭I�Hc���U�I��53i�7�� Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). References 1. package also contains an oxygen absorber and oxygen indicator to minimize oxidation. 2. 9/2020 Updated to include Uplizna™ and to change the policy name. By using our website, you agree to our use of cookies in accordance with our. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). … Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. New Haven, CT: Alexion Pharmaceuticals, Inc.; June 2019. Accessed August 2018. Neurology. 2019;381(7):614‑625. Before you can receive SOLIRIS, your doctor must enroll in the SOLIRIS REMS program; counsel you about the risk of meningococcal … Soliris treatment is recommended to continue for the patient’s lifetime, unless the discontinuation of Soliris is clinically indicated (see Warnings and Precautions). Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. 2012;69(9):1176-1180. PREVENT (Prevention of Relapses in Neuromyelitis Optica): Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Soliris in patients with anti-AQP4 antibody-positive NMOSD who received Soliris (N=96) or placebo (N=47). 7f*�@X�a�T�g�?���Vs���`���j�w'��NJ����k��p�m��`��`G��j��Y�����D��)!����n�U� g� 4. Data on file, Alexion Pharmaceuticals. References: Soliris [package insert]. Kitley J, Leite MI, Nakashima I, et al. _#��F����F-��W�_���QS�$�C늌��ʤf,3"n(5��#gia��},3K1�Y��y��̈���}Eނ\5��}�����eà�C�A��f�"rkL&��Pb3���#r+L�2J aEJ�ܼJɖO�R�P5)�$e+�BI��,�fe�V���������1������_�7�M��͘�8;a�׌Z���(Y�h{�����3D(��͞����+X ���,��� ��gB{,0aY΄�8�Lx�=` h>V1�%��檨�aR�L,�_i���4�4�z&���3�M�v��(��X�&�Q>P�3e���N�� $ ��{,IA�{�`$�k,�A�*�,3���3A�` �=�� An international consensus approach to the management of atypical hemolytic uremic … Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur. Under the Soliris REMS, prescribers must enroll in the program. Over time, relapses have been shown to be inevitable for the majority of patients with NMOSD.5,6,8, Learn more about the 3+ year PREVENT study.1,2. Safety and efficacy of eculizumab in anti-acetycholine … :� �]���3ؑ���It�bb"�u),=��o���ұL�X�}�{��}&��w��[��9�C���������gz�_����8ó���mu_� �{�����GH�����凓���G����zB��mcB7[k�`7�(�צ*`W��EJ�����/O�����ck�0hm�v]��� �]�_��a��ſ��g�T�,�:? Get the … ���DStr�Y�޵?��K|G��>Eχ�.zN�f<3o�~��G� kL��.�j�� H`��V�Y4*���9y5xw�3W�\����ɸ.�v(Y�KH�FZ���u���,&h�O����3�eB���qH��jP�����OT/m$��ʢ� ���EZ�P�@u� 2012;9:14. Soliris 300 mg concentrate for solution for infusion . New Haven, CT; Alexion Pharmaceuticals, Inc; July 2018. Page 5 | SOLIRIS… New Haven, CT: Alexion Pharmaceuticals, Inc.; June 2019. Soliris-treated patients experienced similar improvement in time to first adjudicated on-trial relapse with or without concomitant treatment. Eculizumab . Alexion Pharmaceuticals; 2009. … Jarius S, Ruprecht K, Wildemann B, et al. See Important Safety Information, including Boxed Warning, and full Prescribing Information. ClinicalTrials.gov. Soliris is a medicine that affects your immune system. Soliris® and Alexion® are registered trademarks and OneSource™ is a trademark of Alexion Pharmaceuticals, Inc. � Please enter your information below to receive updates about anti-AQP4 antibody-positive NMOSD and Soliris. Read all of this leaflet carefully before you start using this medicine because it contains … h��Zko�6�+�آ���(����-&�M��>xm���l����ｗ�,Ɋ-ef[�(��!��\�VZkƙ��0� ,�B`�1%gVac#����H汃6�x����

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