Mechanism of Action of Topical Hemostatic and Adhesive Tissue Agents
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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. -
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. -
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 -
Beverly, A., Ong, G., Wilkinson, KL, Doree, C., Welton, NJ, & Estcourt, LJ
Beverly, A., Ong, G., Wilkinson, K. L., Doree, C., Welton, N. J., & Estcourt, L. J. (2019). Drugs to reduce bleeding and transfusion in adults undergoing cardiac surgery: A systematic review and network meta analysis. Cochrane Database of Systematic Reviews, 2019(9), [CD013427]. https://doi.org/10.1002/14651858.CD013427 Publisher's PDF, also known as Version of record Link to published version (if available): 10.1002/14651858.CD013427 Link to publication record in Explore Bristol Research PDF-document This is the final published version of the article (version of record). It first appeared online via Cochrane Collaboration at https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013427/full . Please refer to any applicable terms of use of the publisher. University of Bristol - Explore Bristol Research General rights This document is made available in accordance with publisher policies. Please cite only the published version using the reference above. Full terms of use are available: http://www.bristol.ac.uk/red/research-policy/pure/user-guides/ebr-terms/ Cochrane Database of Systematic Reviews Drugs to reduce bleeding and transfusion in adults undergoing cardiac surgery: a systematic review and network meta- analysis (Protocol) Beverly A, Ong G, Wilkinson KL, Doree C, Welton NJ, Estcourt LJ Beverly A, Ong G, Wilkinson KL, Doree C, Welton NJ, Estcourt LJ. Drugs to reduce bleeding and transfusion in adults undergoing cardiac surgery: a systematic review and network meta-analysis. Cochrane Database of Systematic Reviews 2019, Issue 9. Art. No.: CD013427. DOI: 10.1002/14651858.CD013427. www.cochranelibrary.com Drugs to reduce bleeding and transfusion in adults undergoing cardiac surgery: a systematic review and network meta-analysis (Protocol) Copyright © 2019 The Cochrane Collaboration. -
OUH Formulary Approved for Use in Breast Surgery
Oxford University Hospitals NHS Foundation Trust Formulary FORMULARY (Y): the medicine can be used as per its licence. RESTRICTED FORMULARY (R): the medicine can be used as per the agreed restriction. NON-FORMULARY (NF): the medicine is not on the formulary and should not be used unless exceptional approval has been obtained from MMTC. UNLICENSED MEDICINE – RESTRICTED FORMULARY (UNR): the medicine is unlicensed and can be used as per the agreed restriction. SPECIAL MEDICINE – RESTRICTED FORMULARY (SR): the medicine is a “special” (unlicensed) and can be used as per the agreed restriction. EXTEMPORANEOUS PREPARATION – RESTRICTED FORMULARY (EXTR): the extemporaneous preparation (unlicensed) can be prepared and used as per the agreed restriction. UNLICENSED MEDICINE – NON-FORMULARY (UNNF): the medicine is unlicensed and is not on the formulary. It should not be used unless exceptional approval has been obtained from MMTC. SPECIAL MEDICINE – NON-FORMULARY (SNF): the medicine is a “special” (unlicensed) and is not on the formulary. It should not be used unless exceptional approval has been obtained from MMTC. EXTEMPORANEOUS PREPARATION – NON-FORMULARY (EXTNF): the extemporaneous preparation (unlicensed) cannot be prepared and used unless exceptional approval has been obtained from MMTC. CLINICAL TRIALS (C): the medicine is clinical trial material and is not for clinical use. NICE TECHNOLOGY APPRAISAL (NICETA): the medicine has received a positive appraisal from NICE. It will be available on the formulary from the day the Technology Appraisal is published. Prescribers who wish to treat patients who meet NICE criteria, will have access to these medicines from this date. However, these medicines will not be part of routine practice until a NICE TA Implementation Plan has been presented and approved by MMTC (when the drug will be given a Restricted formulary status). -
ORIGINALE DELIBERAZIONE DEL COMMISSARIO N. 16 Del 14/01/2021
AZIENDA U.L.S.S. n. 9 SCALIGERA Sede legale: via Valverde, 42 – 37122 VERONA ORIGINALE DELIBERAZIONE DEL COMMISSARIO N. 16 del 14/01/2021 Il Commissario dell’Azienda U.L.S.S. n. 9 SCALIGERA, dott. Pietro Girardi, nominato con D.P.G.R.V. n. 185 del 30/12/2020, coadiuvato dai Direttori: - dott. Giuseppe Cenci Direttore Amministrativo - - dr.ssa Denise Signorelli Direttore Sanitario - dott. Raffaele Grottola Direttore dei Servizi Socio-Sanitari ha adottato in data odierna la presente deliberazione: OGGETTO PRIMO E SECONDO APPALTO SPECIFICO FARMACI . RINNOVO DELLA VALIDITA’ DELLE CONVENZIONI E DEI CONTRATTI DI ACCORDO QUADRO FINO AL 22/07/2021. DELIBERA A CONTRARRE Il Proponente: IL DIRETTOR E UOC Provveditorato,Economato e Gestione della Logistica F.TO ing. Corrado Salfa Note per la trasparenza:PRIMO E SECONDO APPALTO SPECIFICO FARMACI. RINNOVO DELLA VALIDITA' DELLE CONVENZIONI E DEI CONTRATTI IN ACCORDO QUADRO. Il Proponente: IL DIRETTORE UOC Provveditorato,Economato e Gestione della Logistica F.TO ing. Corrado Salfa Pag. 1 di 7 AZIENDA U.L.S.S. n. 9 SCALIGERA Sede legale: via Valverde, 42 – 37122 VERONA DELIBERAZIONE DEL COMMISSARIO N. 16 DEL 14/01/2021 Il Responsabile dell’UOC Provveditorato, Economato e Gestione della Logistica, Premesso che: 1) con deliberazione del Direttore Generale dell’Azienda ULSS n.9 Scaligera di Verona n.683 del 25/10/2018 è stato disposto di aderire alle convenzioni, stipulate da UOC CRAV dell’Azienda Zero, per la fornitura dei farmaci di cui all’allegato n.1 e parte integrante del medesimo provvedimento, che risultavano aggiudicati con decreto del Direttore dell’Unità Organizzativa Acquisti Centralizzati SSR – CRAV n. -
Centene Employee
Centene Employee PREFERRED DRUG LIST The Centene Employee Formulary includes a list of drugs covered by your prescription benefit. The formulary is updated often and may change. To get the most up-to-date information, you may view the latest formulary on our website at https://pharmacy.envolvehealth.com/members/formulary.html or call us at 1-844-262-6337. Updated: December 1, 2020 Table of Contents What is the Centene Employee Formulary?...................... .....................................................................ii How are the drugs listed in the categorical list?................................... .................................................ii How much will I pay for my drugs?.......................................................................................................ii How do I find a drug on the Drug List?..................................................................................................iii Are there any limits on my drug coverage?.............................................................................................iv Can I go to any pharmacy?......................................................................................................................iv Can I use a mail order pharmacy?...........................................................................................................v How can I get prior authorization or an exception to the rules for drug coverage?................................v How can I save money on my prescription drugs?.................................................................................v -
August 2021 California Signaturevalue 4 Tier HMO Formulary
Pharmacy | Formulary | California 2021 California SignatureValue 4-Tier HMO Formulary Please note: This Formulary is accurate as of August 1, 2021 and is subject to change after this date. All previous versions of this Formulary are no longer in effect. Your estimated coverage and copay/coinsurance may vary based on the benefit plan you choose and the effective date of the plan. This Formulary can also be accessed online at myuhc.com > Pharmacy Information > Prescription Drug Lists > California plans > SignatureValue HMO plans. Plan-specific coverage documents may be accessed online at uhc.com/statedruglists > Small Group Plans > California. If you are a UnitedHealthcare member, please register or log on to myuhc.com, or call the toll-free number on your health plan ID card to find pharmacy information specific to your benefit plan. This Formulary is applicable to the following health insurance products offered by UnitedHealthcare: • SignatureValue • SignatureValue Advantage • SignatureValue Alliance • SignatureValue Flex • SignatureValue Focus • SignatureValue Harmony • SignatureValue Performance Updated 6/17/2021 6/21 © 2021 United HealthCare Services, Inc. All Rights Reserved. WF3890815-N Contents At UnitedHealthcare, we want to help you better understand your medication options. ..................................................... 3 How do I use my Formulary? ............................................. 4 What are tiers? ........................................................ 5 When does the Formulary change? ........................................ 5 Utilization Management Programs ......................................... 6 Your Right to Request Access to a Non-formulary Drug ....................... 6 Requesting a Prior Authorization or Step Therapy Exception ................... 7 How do I locate and fill a prescription through a retail network pharmacy? . 7 How do I locate and fill a prescription through the mail order pharmacy? . 7 How do I locate and fill a prescription at a specialty pharmacy? ............... -
Tachosil Patches to Be Applied by the Size of the Bleeding Area
HIGHLIGHTS OF PRESCRIBING INFORMATION • Do not use TachoSil in individuals with known hypersensitivity to These highlights do not include all the information needed to use human blood products or horse proteins. (4) TACHOSIL safely and effectively. See full prescribing information for TACHOSIL. -----------------------WARNINGS AND PRECAUTIONS------------------------ • Thrombosis can occur if TachoSil is applied intravascularly. Ensure TACHOSIL Fibrin Sealant Patch that TachoSil is applied to the surface of cardiac, vascular or Absorbable Patch for Topical Use hepatic tissue only. (5.1) Initial U.S. Approval: 2010 • Can cause hypersensitivity or allergic/anaphylactoid reactions with ---------------------------RECENT MAJOR CHANGES--------------------------- first time or repetitive application. (5.2) • Avoid use in contaminated areas of the body or in the presence of Indications and Usage (1) 7/2015 an active infection. (5.3) Dosage and Administration (2) 7/2015 • TachoSil contains collagen, which may adhere to bleeding Dosage and Administration, Method of Application (2.2) 7/2015 surfaces. (5.4) • Avoid over-packing in cavities or closed spaces, because this may Dosage and Administration, Retreatment (2.3) 7/2015 cause compression of underlying tissue. (5.5) Warnings and Precautions, Thrombosis (5.1) 7/2015 • Use the least number of patches required to cover the entire ----------------------------INDICATIONS AND USAGE--------------------------- bleeding area. Do not pack. Remove any unattached pieces of TachoSil. (5.6) TachoSil is a fibrin