Tachosil Patches to Be Applied by the Size of the Bleeding Area
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Geisinger Bloomsburg Hospital Published: July 1, 2019
Geisinger Bloomsburg Hospital Published: July 1, 2019 DESCRIPTION CHARGE 3D Rendering With Interpretation And Reporting Of Computed Tomography, Magnetic Resonance Imaging, Ultrasound, Or Other Tomographic Modality With Image Postprocessing Under $ 1,230.00 Concurrent Supervision; Requiring Image Postprocessing On An Independent Workstation Abatacept 250 Mg Iv Solr $ 8,383.48 Acarbose 50 Mg Po Tabs $ 9.55 Ace Bandage $ 22.00 Ace Harmnic Crvd Shears Ace36E $ 3,617.00 Acebutolol Hcl 200 Mg Po Caps $ 9.34 Acetaminophen 120 Mg Pr Supp $ 6.70 Acetaminophen 325 Mg Po Tabs $ 6.70 Acetaminophen 325 Mg Pr Supp $ 6.99 Acetaminophen 650 Mg Pr Supp $ 6.70 Acetaminophen 80 Mg Po Chew $ 6.70 Acetaminophen 80 Mg Pr Supp $ 6.99 Acetazolamide 125 Mg Po Tabs $ 15.66 Acetazolamide 250 Mg Po Tabs $ 28.29 Acetazolamide 62.5 Mg (1/2 X 125 Mg) Po Tabs $ 8.81 Acetazolamide Er 500 Mg Po Cp12 $ 28.93 Acetylcholine Chloride 20 Mg Io Solr $ 748.45 Acl Kit Ar-1897S $ 2,819.00 Acute Hepatitis Panel This Panel Must Include The Following: Hepatitis A Antibody (Haab), Igm Antibody (86709) Hepatitis B Core Antibody (Hbcab), Igm Antibody (86705) Hepatitis B Surface $ 672.00 Antigen (Hbsag) (87340) Hepatitis C Antibody (86803) Acyclovir 200 Mg Po Caps $ 11.57 Acyclovir 400 Mg Po Tabs $ 13.81 Adalimumab 40 Mg/0.8Ml Subq Pskt $ 19,539.52 Administration Of Influenza Virus Vaccine $ 35.00 Administration Of Pneumococcal Vaccine $ 35.00 Ado-Trastuzumab Emtansine 100 Mg Iv Solr $ 31,827.85 Ado-Trastuzumab Emtansine 160 Mg Iv Solr $ 50,909.88 Adrenocorticotropic Hormone (Acth) $ -
Recombinant Factors for Hemostasis
University of Nebraska - Lincoln DigitalCommons@University of Nebraska - Lincoln Chemical & Biomolecular Engineering Theses, Chemical and Biomolecular Engineering, Dissertations, & Student Research Department of Summer 2010 Recombinant Factors for Hemostasis Jennifer Calcaterra University of Nebraska at Lincoln, [email protected] Follow this and additional works at: https://digitalcommons.unl.edu/chemengtheses Part of the Biochemical and Biomolecular Engineering Commons Calcaterra, Jennifer, "Recombinant Factors for Hemostasis" (2010). Chemical & Biomolecular Engineering Theses, Dissertations, & Student Research. 5. https://digitalcommons.unl.edu/chemengtheses/5 This Article is brought to you for free and open access by the Chemical and Biomolecular Engineering, Department of at DigitalCommons@University of Nebraska - Lincoln. It has been accepted for inclusion in Chemical & Biomolecular Engineering Theses, Dissertations, & Student Research by an authorized administrator of DigitalCommons@University of Nebraska - Lincoln. Recombinant Factors for Hemostasis by Jennifer Calcaterra A DISSERTATION Presented to the Faculty of The Graduate College at the University of Nebraska In Partial Fulfillment of Requirements For the Degree of Doctor of Philosophy Major: Interdepartmental Area of Engineering (Chemical & Biomolecular Engineering) Under the Supervision of Professor William H. Velander Lincoln, Nebraska August, 2010 Recombinant Factors for Hemostasis Jennifer Calcaterra, Ph.D. University of Nebraska, 2010 Adviser: William H. Velander Trauma deaths are a result of hemorrhage in 37% of civilians and 47% military personnel and are the primary cause of death for individuals under 44 years of age. Current techniques used to treat hemorrhage are inadequate for severe bleeding. Preliminary research indicates that fibrin sealants (FS) alone or in combination with a dressing may be more effective; however, it has not been economically feasible for widespread use because of prohibitive costs related to procuring the proteins. -
Pharmaceuticals and Medical Devices Safety Information No
Pharmaceuticals and Medical Devices Safety Information No. 258 June 2009 Table of Contents 1. Selective serotonin reuptake inhibitors (SSRIs) and aggression ······································································································································ 3 2. Important Safety Information ······································································· 10 . .1. Isoflurane ························································································· 10 3. Revision of PRECAUTIONS (No. 206) Olmesartan medoxomil (and 3 others)··························································· 15 4. List of products subject to Early Post-marketing Phase Vigilance.....................................................17 Reference 1. Project for promoting safe use of drugs.............................................20 Reference 2. Manuals for Management of Individual Serious Adverse Drug Reactions..................................................................................21 Reference 3. Extension of cooperating hospitals in the project for “Japan Drug Information Institute in Pregnancy” ..............25 This Pharmaceuticals and Medical Devices Safety Information (PMDSI) is issued based on safety information collected by the Ministry of Health, Labour and Welfare. It is intended to facilitate safer use of pharmaceuticals and medical devices by healthcare providers. PMDSI is available on the Pharmaceuticals and Medical Devices Agency website (http://www.pmda.go.jp/english/index.html) and on the -
TACHOSIL (Fibrin Sealant Patch)
Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research MEMORANDUM To: Craig Zinderman, MD, MPH Acting Director, Division of Epidemiology (DE) Office of Biostatistics and Epidemiology (OBE), Center for Biologics Evaluation and Research (CBER) Through: Meghna Alimchandani, MD Associate Director for Medical Policy, OBE, CBER From: Faith Barash, MD, MPH Medical Officer, Pharmacovigilance Branch Office of Biostatistics and Epidemiology (OBE) Center for Biologics Evaluation and Research (CBER) Subject: Safety and Utilization Review for the Pediatric Advisory Committee Applicant: Takeda Pharma A/S Product: TACHOSIL (Fibrin Sealant Patch) STN: 125351/279 Indication: TACHOSIL is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. Meeting Date: Pediatric Advisory Committee Meeting, September 2019 1 Contents 1 INTRODUCTION ................................................................................................................................ 3 1.1 Objective ...................................................................................................................................... 3 1.2 Product Description .................................................................................................................... 3 1.3 Regulatory -
Monitoring International Trends Posted May 2016
Monitoring International Trends posted May 2016 The NBA monitors international developments that may influence the management of blood and blood products in Australia. Our focus is on: Potential new product developments and applications; Global regulatory and blood practice trends; Events that may have an impact on global supply, demand and pricing, such as changes in company structure, capacity, organisation and ownership; and Other emerging risks that could potentially put financial or other pressures on the Australian sector. A selection of recent matters of interest appears below. Highlights include: BioMarin Pharmaceutical released preliminary data on its investigational gene therapy treatment for haemophilia A. (Section 1) Data on Bluebird bio’s gene therapy in severe sickle cell disease and transfusion- dependent β-thalassemia was discussed at the American Society of Gene & Cell Therapy Annual Meeting. (Section 1) Europe’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending an extension to the marketing authorisation for Baxalta’s subcutaneous immunoglobulin, HyQvia. (Section 2) NovoNordisk submitted to the US Food and Drug Administration (FDA) a Biologics License Application for its long-acting factor IX. (Section 2) The European Commission approved Swedish Orphan Biovitrum and Biogen’s recombinant factor IX Fc Fusion protein therapy. (Section 2) The FDA granted seven years of marketing exclusivity for CSL Behring's Coagulation Factor IX (Recombinant), Albumin Fusion Protein, with an extended dosing interval]. (Section 2) In Australia, the Therapeutic Goods Administration (TGA) approved a monoclonal antibody that reverses the anticoagulant effect of dabigatran in patients who require emergency surgery or have life-threatening bleeding. -
WO 2016/133483 Al 25 August 2016 (25.08.2016) P O P C T
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization I International Bureau (10) International Publication Number (43) International Publication Date WO 2016/133483 Al 25 August 2016 (25.08.2016) P O P C T (51) International Patent Classification: SHENIA, Iaroslav Viktorovych [UA/UA]; Feodosiyskyy A61L 15/44 (2006.01) A61L 26/00 (2006.01) lane, 14-a, kv. 65, Kyiv, 03028 (UA). A61L 15/54 (2006.01) (74) Agent: BRAGARNYK, Oleksandr Mykolayovych; str. (21) International Application Number: Lomonosova, 60/5-43, Kyiv, 03189 (UA). PCT/UA20 16/0000 19 (81) Designated States (unless otherwise indicated, for every (22) International Filing Date: kind of national protection available): AE, AG, AL, AM, 15 February 2016 (15.02.2016) AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, (25) Filing Language: English DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (26) Publication Language: English HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, (30) Priority Data: MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, a 2015 01285 16 February 2015 (16.02.2015) UA PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, u 2015 01288 16 February 2015 (16.02.2015) UA SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, (72) Inventors; and TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. -
Minutes of PRAC Meeting on 09-12 July 2018
6 September 2018 EMA/PRAC/576790/2018 Inspections, Human Medicines Pharmacovigilance and Committees Division Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of the meeting on 09-12 July 2018 Chair: June Raine – Vice-Chair: Almath Spooner Health and safety information In accordance with the Agency’s health and safety policy, delegates were briefed on health, safety and emergency information and procedures prior to the start of the meeting. Disclaimers Some of the information contained in the minutes is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scope listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also change during the course of the review. Additional details on some of these procedures will be published in the PRAC meeting highlights once the procedures are finalised. Of note, the minutes are a working document primarily designed for PRAC members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the minutes cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006, Rev. 1). 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2018. -
Ehealth DSI [Ehdsi V2.2.2-OR] Ehealth DSI – Master Value Set
MTC eHealth DSI [eHDSI v2.2.2-OR] eHealth DSI – Master Value Set Catalogue Responsible : eHDSI Solution Provider PublishDate : Wed Nov 08 16:16:10 CET 2017 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 1 of 490 MTC Table of Contents epSOSActiveIngredient 4 epSOSAdministrativeGender 148 epSOSAdverseEventType 149 epSOSAllergenNoDrugs 150 epSOSBloodGroup 155 epSOSBloodPressure 156 epSOSCodeNoMedication 157 epSOSCodeProb 158 epSOSConfidentiality 159 epSOSCountry 160 epSOSDisplayLabel 167 epSOSDocumentCode 170 epSOSDoseForm 171 epSOSHealthcareProfessionalRoles 184 epSOSIllnessesandDisorders 186 epSOSLanguage 448 epSOSMedicalDevices 458 epSOSNullFavor 461 epSOSPackage 462 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 2 of 490 MTC epSOSPersonalRelationship 464 epSOSPregnancyInformation 466 epSOSProcedures 467 epSOSReactionAllergy 470 epSOSResolutionOutcome 472 epSOSRoleClass 473 epSOSRouteofAdministration 474 epSOSSections 477 epSOSSeverity 478 epSOSSocialHistory 479 epSOSStatusCode 480 epSOSSubstitutionCode 481 epSOSTelecomAddress 482 epSOSTimingEvent 483 epSOSUnits 484 epSOSUnknownInformation 487 epSOSVaccine 488 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 3 of 490 MTC epSOSActiveIngredient epSOSActiveIngredient Value Set ID 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 TRANSLATIONS Code System ID Code System Version Concept Code Description (FSN) 2.16.840.1.113883.6.73 2017-01 A ALIMENTARY TRACT AND METABOLISM 2.16.840.1.113883.6.73 2017-01 -
The Effect of Chitosan Dextran Gel As a Haemostatic and Anti-Adhesion
THE EFFECT OF CHITOSAN DEXTRAN GEL AS A HAEMOSTATIC AND ANTI ADHESION AGENT IN THE CENTRAL NERVOUS SYSTEM AND EVALUATION OF HAEMOSTATIC MECHANISM OF SKELETAL MUSCLE TISSUE Thesis submitted in March 2015 for The degree of Doctor of Philosophy In the University of Adelaide By Sukanya Rajiv, M.B.B.S, M.S The work described in this thesis was performed within The Department of Surgery Otolaryngology, Head and Neck Surgery, The University of Adelaide 1 Table of Contents TITLE PAGE________________________________________ 1 ABSTRACT________________________________________ 5 INTRODUCTION____________________________________________ 5 METHODS_________________________________________________ 5 RESULTS__________________________________________________ 7 CONCLUSION___________________________________________ 7 DECLARATION________________________________________ 9 PREFACE_____________________________________________ 10 ACKNOWLEDGEMENTS_______________________________ 11 CHAPTER 1 AIMS_____________________________________ 13 CHAPTER 2 INTRODUCTION_______________________________ 15 CHAPTER 3 NORMAL HAEMOSTASIS______________________ 21 BLOOD VESSEL/ ENDOTHELIAL CELL___________________________ 22 PLATELETS___________________________________________________ 25 COAGULATION CASCADE______________________________________ 27 INHIBITORS OF COAGULATION_________________________________ 28 FIBRINOLYTIC SYSTEM________________________________________ 29 COAGULATION SCREEN TESTS_________________________________ 30 CHAPTER 4 HEMOSTATIC TECHNIQUES IN CENTRAL NERVOUS SYSTEM___________________________________ -
Management of Bleeding and Coagulopathy Following Major Trauma
Spahn et al. Critical Care 2013, 17:R76 http://ccforum.com/content/17/2/R76 RESEARCH Open Access Management of bleeding and coagulopathy following major trauma: an updated European guideline Donat R Spahn1, Bertil Bouillon2, Vladimir Cerny3,4, Timothy J Coats5, Jacques Duranteau6, Enrique Fernández-Mondéjar7, Daniela Filipescu8, Beverley J Hunt9, Radko Komadina10, Giuseppe Nardi11, Edmund Neugebauer12, Yves Ozier13, Louis Riddez14, Arthur Schultz15, Jean-Louis Vincent16 and Rolf Rossaint17* Abstract Introduction: Evidence-based recommendations are needed to guide the acute management of the bleeding trauma patient. When these recommendations are implemented patient outcomes may be improved. Methods: The multidisciplinary Task Force for Advanced Bleeding Care in Trauma was formed in 2005 with the aim of developing a guideline for the management of bleeding following severe injury. This document represents an updated version of the guideline published by the group in 2007 and updated in 2010. Recommendations were formulated using a nominal group process, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) hierarchy of evidence and based on a systematic review of published literature. Results: Key changes encompassed in this version of the guideline include new recommendations on the appropriate use of vasopressors and inotropic agents, and reflect an awareness of the growing number of patients in the population at large treated with antiplatelet agents and/or oral anticoagulants. The current guideline also includes recommendations and a discussion of thromboprophylactic strategies for all patients following traumatic injury. The most significant addition is a new section that discusses the need for every institution to develop, implement and adhere to an evidence-based clinical protocol to manage traumatically injured patients. -
Medicines/Pharmaceuticals of Animal Origin V3.0 November 2020
Medicines/pharmaceuticals of animal origin V3.0 November 2020 Medicines/pharmaceuticals of animal origin - This guideline provides information for all clinical staff within Hospital and Health Services (HHS) on best practice for avoidance of issues related to animal products. Medicines/pharmaceuticals of animal origin - V3.0 November 2020 Published by the State of Queensland (Queensland Health), November 2020 This document is licensed under a Creative Commons Attribution 3.0 Australia licence. To view a copy of this licence, visit creativecommons.org/licenses/by/3.0/au © State of Queensland (Queensland Health) 2020 You are free to copy, communicate and adapt the work, as long as you attribute the State of Queensland (Queensland Health). For more information contact: Medication Services Queensland, Queensland Health, GPO Box 48, Brisbane QLD 4001, email [email protected] An electronic version of this document is available at https://www.health.qld.gov.au/__data/assets/pdf_file/0024/147507/qh-gdl-954.pdf Disclaimer: The content presented in this publication is distributed by the Queensland Government as an information source only. The State of Queensland makes no statements, representations or warranties about the accuracy, completeness or reliability of any information contained in this publication. The State of Queensland disclaims all responsibility and all liability (including without limitation for liability in negligence) for all expenses, losses, damages and costs you might incur as a result of the information being inaccurate -
Download Author Version (PDF)
Journal of Materials Chemistry B Accepted Manuscript This is an Accepted Manuscript, which has been through the Royal Society of Chemistry peer review process and has been accepted for publication. Accepted Manuscripts are published online shortly after acceptance, before technical editing, formatting and proof reading. Using this free service, authors can make their results available to the community, in citable form, before we publish the edited article. We will replace this Accepted Manuscript with the edited and formatted Advance Article as soon as it is available. You can find more information about Accepted Manuscripts in the Information for Authors. Please note that technical editing may introduce minor changes to the text and/or graphics, which may alter content. The journal’s standard Terms & Conditions and the Ethical guidelines still apply. In no event shall the Royal Society of Chemistry be held responsible for any errors or omissions in this Accepted Manuscript or any consequences arising from the use of any information it contains. www.rsc.org/materialsB Page 1 of 11Journal Name Journal of Materials Chemistry B Dynamic Article Links ► Cite this: DOI: 10.1039/c0xx00000x www.rsc.org/xxxxxx ARTICLE TYPE Hemostatic polymers: concept, state of the art and perspectives Fabio di Lena*a Received (in XXX, XXX) Xth XXXXXXXXX 20XX, Accepted Xth XXXXXXXXX 20XX DOI: 10.1039/b000000x 5 This article presents a critical overview of the most significant developments in the use of polymers as Manuscript hemostatic agents. The materials have been divided into two groups, that is, naturally occurring and synthetic. Remarkable examples include collagen, chitosan, bovine serum albumin/glutaraldehyde hydrogels, poly(cyano acrylate)s and poly(alkylene oxide)s.