Thromboembolic Events Secondary to Endoscopic Cyanoacrylate Injection: Can We Foresee Any Red Flags?
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Medical Review(S) Clinical Review
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 200327 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 200327 Priority or Standard Standard Submit Date(s) December 29, 2009 Received Date(s) December 30, 2009 PDUFA Goal Date October 30, 2010 Division / Office Division of Anti-Infective and Ophthalmology Products Office of Antimicrobial Products Reviewer Name(s) Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD Review Completion October 29, 2010 Date Established Name Ceftaroline fosamil for injection (Proposed) Trade Name Teflaro Therapeutic Class Cephalosporin; ß-lactams Applicant Cerexa, Inc. Forest Laboratories, Inc. Formulation(s) 400 mg/vial and 600 mg/vial Intravenous Dosing Regimen 600 mg every 12 hours by IV infusion Indication(s) Acute Bacterial Skin and Skin Structure Infection (ABSSSI); Community-acquired Bacterial Pneumonia (CABP) Intended Population(s) Adults ≥ 18 years of age Template Version: March 6, 2009 Reference ID: 2857265 Clinical Review Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD NDA 200327: Teflaro (ceftaroline fosamil) Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT ......................................... 9 1.1 Recommendation on Regulatory Action ........................................................... 10 1.2 Risk Benefit Assessment.................................................................................. 10 1.3 Recommendations for Postmarketing Risk Evaluation and Mitigation Strategies ........................................................................................................................ -
The National Drugs List
^ ^ ^ ^ ^[ ^ The National Drugs List Of Syrian Arab Republic Sexth Edition 2006 ! " # "$ % &'() " # * +$, -. / & 0 /+12 3 4" 5 "$ . "$ 67"5,) 0 " /! !2 4? @ % 88 9 3: " # "$ ;+<=2 – G# H H2 I) – 6( – 65 : A B C "5 : , D )* . J!* HK"3 H"$ T ) 4 B K<) +$ LMA N O 3 4P<B &Q / RS ) H< C4VH /430 / 1988 V W* < C A GQ ") 4V / 1000 / C4VH /820 / 2001 V XX K<# C ,V /500 / 1992 V "!X V /946 / 2004 V Z < C V /914 / 2003 V ) < ] +$, [2 / ,) @# @ S%Q2 J"= [ &<\ @ +$ LMA 1 O \ . S X '( ^ & M_ `AB @ &' 3 4" + @ V= 4 )\ " : N " # "$ 6 ) G" 3Q + a C G /<"B d3: C K7 e , fM 4 Q b"$ " < $\ c"7: 5) G . HHH3Q J # Hg ' V"h 6< G* H5 !" # $%" & $' ,* ( )* + 2 ا اوا ادو +% 5 j 2 i1 6 B J' 6<X " 6"[ i2 "$ "< * i3 10 6 i4 11 6! ^ i5 13 6<X "!# * i6 15 7 G!, 6 - k 24"$d dl ?K V *4V h 63[46 ' i8 19 Adl 20 "( 2 i9 20 G Q) 6 i10 20 a 6 m[, 6 i11 21 ?K V $n i12 21 "% * i13 23 b+ 6 i14 23 oe C * i15 24 !, 2 6\ i16 25 C V pq * i17 26 ( S 6) 1, ++ &"r i19 3 +% 27 G 6 ""% i19 28 ^ Ks 2 i20 31 % Ks 2 i21 32 s * i22 35 " " * i23 37 "$ * i24 38 6" i25 39 V t h Gu* v!* 2 i26 39 ( 2 i27 40 B w< Ks 2 i28 40 d C &"r i29 42 "' 6 i30 42 " * i31 42 ":< * i32 5 ./ 0" -33 4 : ANAESTHETICS $ 1 2 -1 :GENERAL ANAESTHETICS AND OXYGEN 4 $1 2 2- ATRACURIUM BESYLATE DROPERIDOL ETHER FENTANYL HALOTHANE ISOFLURANE KETAMINE HCL NITROUS OXIDE OXYGEN PROPOFOL REMIFENTANIL SEVOFLURANE SUFENTANIL THIOPENTAL :LOCAL ANAESTHETICS !67$1 2 -5 AMYLEINE HCL=AMYLOCAINE ARTICAINE BENZOCAINE BUPIVACAINE CINCHOCAINE LIDOCAINE MEPIVACAINE OXETHAZAINE PRAMOXINE PRILOCAINE PREOPERATIVE MEDICATION & SEDATION FOR 9*: ;< " 2 -8 : : SHORT -TERM PROCEDURES ATROPINE DIAZEPAM INJ. -
Classification of Medicinal Drugs and Driving: Co-Ordination and Synthesis Report
Project No. TREN-05-FP6TR-S07.61320-518404-DRUID DRUID Driving under the Influence of Drugs, Alcohol and Medicines Integrated Project 1.6. Sustainable Development, Global Change and Ecosystem 1.6.2: Sustainable Surface Transport 6th Framework Programme Deliverable 4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Due date of deliverable: 21.07.2011 Actual submission date: 21.07.2011 Revision date: 21.07.2011 Start date of project: 15.10.2006 Duration: 48 months Organisation name of lead contractor for this deliverable: UVA Revision 0.0 Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006) Dissemination Level PU Public PP Restricted to other programme participants (including the Commission x Services) RE Restricted to a group specified by the consortium (including the Commission Services) CO Confidential, only for members of the consortium (including the Commission Services) DRUID 6th Framework Programme Deliverable D.4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Page 1 of 243 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Authors Trinidad Gómez-Talegón, Inmaculada Fierro, M. Carmen Del Río, F. Javier Álvarez (UVa, University of Valladolid, Spain) Partners - Silvia Ravera, Susana Monteiro, Han de Gier (RUGPha, University of Groningen, the Netherlands) - Gertrude Van der Linden, Sara-Ann Legrand, Kristof Pil, Alain Verstraete (UGent, Ghent University, Belgium) - Michel Mallaret, Charles Mercier-Guyon, Isabelle Mercier-Guyon (UGren, University of Grenoble, Centre Regional de Pharmacovigilance, France) - Katerina Touliou (CERT-HIT, Centre for Research and Technology Hellas, Greece) - Michael Hei βing (BASt, Bundesanstalt für Straßenwesen, Germany). -
(12) United States Patent (10) Patent No.: US 9,149,560 B2 Askari Et Al
USOO9149560B2 (12) United States Patent (10) Patent No.: US 9,149,560 B2 Askari et al. (45) Date of Patent: Oct. 6, 2015 (54) SOLID POLYGLYCOL-BASED 6,149,931 A 11/2000 Schwartz et al. BOCOMPATIBLE PRE-FORMULATION 6,153,211 A 11/2000 Hubbell et al. 6,180,687 B1 1/2001 Hammer et al. 6,207,772 B1 3/2001 Hatsuda et al. (71) Applicant: Medicus Biosciences LLC, San Jose, 6,312,725 B1 1 1/2001 Wallace et al. CA (US) 6,458,889 B1 10/2002 Trollsas et al. 6,475,508 B1 1 1/2002 Schwartz et al. (72) Inventors: Syed H. Askari, San Jose, CA (US); 6,547,714 B1 4/2003 Dailey 6,566,406 B1 5/2003 Pathak et al. Yeon S. Choi, Emeryville, CA (US); 6,605,294 B2 8/2003 Sawhney Paul Yu Jen Wan, Norco, CA (US) 6,624,245 B2 9, 2003 Wallace et al. 6,632.457 B1 10/2003 Sawhney (73) Assignee: Medicus Biosciences LLC, San Jose, 6,703,037 B1 3/2004 Hubbell et al. CA (US) 6,703,378 B1 3/2004 Kunzler et al. 6,818,018 B1 1 1/2004 Sawhney 7,009,343 B2 3/2006 Lim et al. (*) Notice: Subject to any disclaimer, the term of this 7,255,874 B1 8, 2007 Bobo et al. patent is extended or adjusted under 35 7,332,566 B2 2/2008 Pathak et al. U.S.C. 154(b) by 0 days. 7,553,810 B2 6/2009 Gong et al. -
Systematic Review of Tranexamic Acid Adverse Reactions
arm Ph ac f ov l o i a g n il r a n u c o e J Journal of Pharmacovigilance Calapai et al., J Pharmacovigilance 2015, 3:4 ISSN: 2329-6887 DOI: 10.4172/2329-6887.1000171 Review Open Access Systematic Review of Tranexamic Acid Adverse Reactions Gioacchino Calapai2*, Sebastiano Gangemi1, Carmen Mannucci2, Paola Lucia Minciullo1, Marco Casciaro1, Fabrizio Calapai3, Maria Righi4 and Michele Navarra5 1Operative Unit of Allergy and Clinical Immunology, Department of Clinical and Experimental Medicine, University of Messina, Italy 2Department of Clinical and Experimental Medicine, University of Messina, Italy 3Centro Studi Pharma.Ca, Messina, Italy 4Department of Biomedical Sciences and Morphological and Functional Images, University of Messina, Italy 5Department of Drug Sciences and Health Products, University of Messina, Italy *Corresponding author: Gioacchino Calapai, Department of Clinical and Experimental Medicine, University of Messina, Via Consolare Valeria 5, 98125 Messina, Italy, Tel: +39 090 2213646; Fax: +39 090 221; E-mail: [email protected] Received date: July 06, 2015; Accepted date: July 14, 2015; Published date: July 20, 2015 Copyright: © 2015 Calapai G, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Abstract Background Tranexamic acid is a synthetic lysine derivate that exerts its antifibrinolytic effect by reversible blocking lysine binding sites on plasminogen preventing fibrin degradation. It is widely used for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Aim The aim of our work was to review the literature regarding the best evidence on tranexamic adverse reactions and to describe them according to the apparatus involved. -
Dispensing Solutions for Cyanoacrylate Adhesives White
Dispensing Solutions for Cyanoacrylate Adhesives Contents How Cyanoacrylates Work .......................................................................3 Advantages of CAs ...................................................................................4 CA Dispensing Challenges .......................................................................4 Best Practices for Dispensing CAs .....................................................5-12 Best Systems for Dispensing CAs ....................................................13-14 Useful Resources ...................................................................................15 Introduction Cyanoacrylate adhesives, also known as CAs or cyanos, are highly effective at bonding many types of materials together in assembly processes. Often referred to as super glues, they exhibit high bond strength and fast cure times that help manufacturers speed production processes for higher throughput yields. This makes them an ideal choice for assembling products in a variety of industries, including automotive, electronics, life sciences, defense, and consumer goods. Though beneficial, these moisture-cure adhesives can be a challenge, especially when your assembly process requires precise, repeatable dispensing. This paper outlines proper handling methods and dispensing solutions for successful CA dispensing. Find out how to minimize material waste by more than 60% while also minimizing operator exposure to the adhesive. Speed your production processes while producing higher quality parts with -
N-Butyl Cyanoacrylate Synthesis. a New Quality Step Using Microwaves
Molecules 2014, 19, 6220-6227; doi:10.3390/molecules19056220 OPEN ACCESS molecules ISSN 1420-3049 www.mdpi.com/journal/molecules Article n-Butyl Cyanoacrylate Synthesis. A New Quality Step Using Microwaves Yaquelin Ramos Carriles 1,*, Rubén Álvarez Brito 1, Ricardo Martínez Sánchez 2, Elayma Sánchez Acevedo 1, Paola Rodríguez Domínguez 1 and Wolf-Dieter Mueller 3 1 Chemistry-Physics Department, Faculty of Chemistry, University of Havana, Zapata and G, Vedado, Havana 10400, Cuba; E-Mails: [email protected] (R.Á.B.); [email protected] (E.S.A.); [email protected] (P.R.D.) 2 Polymers Laboratory, IMRE, University of Havana, Zapata and G, Vedado, Havana 10400, Cuba; E-Mail: [email protected] 3 Charité-Universitaetsmedizin Berlin, Assmannshauser Str.4-6, Berlin 14197, Germany; E-Mail: [email protected] * Author to whom correspondence should be addressed; E-Mail: [email protected]; Tel.: +537-878-0684; Fax: +537-837-5774. Received: 4 April 2014; in revised form: 5 May 2014 / Accepted: 13 May 2014 / Published: 15 May 2014 Abstract: Alkyl cyanoacrylates are interesting products for use in industry because of their properties enabling them to stick together a wide range of substrates. n-Butyl cyanoacrylate is one of the most successfully used tissue adhesives in the field of medicine because it exhibits bacteriostatic and haemostatic characteristics, in addition to its adhesive properties. At present, its synthesis is performed with good yields via Knoevenagel condensation using conventional sources of heating, but this requires a long processing time. The aim of this work was to look for a new way of synthesising n-butyl cyanoacrylate using microwave irradiation as the source of heating. -
Major Trauma Search Strategies Appendix
National Clinical Guidelines Centre Draft Major Trauma Search strategies appendix Clinical guideline Appendices 10 June 2015 Draft Commissioned by the National Institute for Health and Care Excellence Guideline short title Contents Disclaimer Healthcare professionals are expected to take NICE clinical guidelines fully into account when exercising their clinical judgement. However, the guidance does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of each patient, in consultation with the patient and, where appropriate, their guardian or carer. Copyright National Clinical Guideline Centre, 2015. Funding National Institute for Health and Care Excellence National Clinical Guideline Centre, 2015. Guideline short title Contents Contents Appendix A: Literature search strategies ........................................................................................ 5 National Clinical Guideline Centre, 2015. 4 <ClickGuideline this shortfield ontitle the first page and insert document title / header text> Literature search strategies Appendix A: Literature search strategies A.1 Contents Introduction Search methodology Section A.2 Standard population search strategy A.2.1 Standard major trauma population A.2.2 Haemorrhage A.2.3 Chest trauma Section A.3 Study filter terms A.3.1 Systematic reviews (SR) A.3.2 Randomised controlled trials (RCT) A.3.3 Observational studies (OBS) A.3.4 Qualitative studies (QUAL) A.3.5 Diagnostic studies (DIAG) A.3.6 Health economic studies (HE) A.3.7 Quality -
WO 2014/153004 Al 25 September 2014 (25.09.2014) 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 2014/153004 Al 25 September 2014 (25.09.2014) P O P C T (51) International Patent Classification: HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, A61L 27/58 (2006.01) A61L 27/52 (2006.01) KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, (21) International Application Number: OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, PCT/US20 14/028622 SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, (22) International Filing Date: TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, 14 March 2014 (14.03.2014) ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (26) Publication Language: English GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, (30) Priority Data: UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, 61/785,477 14 March 2013 (14.03.2013) US TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, (71) Applicant: MEDICUS BIOSCIENCES LLC [US/US]; MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, 2528 Qume Dr., Unit #1, San Jose, CA 95 13 1 (US). -
Gluture Topical Tissue Adhesive Other Means of Identification Synonyms Gluture® * Topical Vet Adhesive Recommended Use Veterinary Adhesive
SAFETY DATA SHEET 1. Identification Product identifier GLUture Topical Tissue Adhesive Other means of identification Synonyms GLUture® * Topical Vet Adhesive Recommended use Veterinary Adhesive. Recommended restrictions Not for human use Manufacturer/Importer/Supplier/Distributor information Company Name (US) Zoetis Inc. 10 Sylvan Way Parsippany, New Jersey 07054 (USA) Rocky Mountain Poison 1-866-531-8896 and Drug Center Product Support/Technical 1-800-366-5288 Services Emergency telephone CHEMTREC (24 hours): 1-800-424-9300 numbers International CHEMTREC (24 hours): +1-703-527-3887 Company Name (EU) Zoetis Belgium S.A. Mercuriusstraat 20 1930 Zaventem Belgium Emergency telephone International CHEMTREC (24 hours): +1-703-527-3887 number Contact E-Mail [email protected] 2. Hazard(s) identification Physical hazards Flammable liquids Category 4 Health hazards Skin corrosion/irritation Category 2 Serious eye damage/eye irritation Category 2A Sensitization, skin Category 1 Environmental hazards Not classified. OSHA defined hazards Not classified. Label elements Signal word Warning Hazard statement Combustible liquid. Causes skin irritation. May cause an allergic skin reaction. Causes serious eye irritation. Precautionary statement Prevention Keep away from flames and hot surfaces-No smoking. Avoid breathing mist or vapor. Wash thoroughly after handling. Contaminated work clothing must not be allowed out of the workplace. Wear protective gloves/eye protection/face protection. Response If on skin: Wash with plenty of water. If skin irritation or rash occurs: Get medical advice/attention. If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. Take off contaminated clothing and wash before reuse. -
Severe Haemophilia a in a Preterm Girl With
Berendt et al. Italian Journal of Pediatrics (2020) 46:125 https://doi.org/10.1186/s13052-020-00892-7 CASE REPORT Open Access Severe haemophilia a in a preterm girl with turner syndrome - a case report from the prenatal period to early infancy (part I) Agnieszka Berendt1* , Monika Wójtowicz-Marzec1, Barbara Wysokińska2 and Anna Kwaśniewska1 Abstract Background: Bleedings are more frequent in the population of preterm children than among those born at term, much less in older children. The reasons for such bleedings in preterms include plasma factor deficiencies, immaturity of small vessels in the germinal matrix region, prenatal hypoxia or sepsis. They affect the brain tissue, the gastrointestinal tract and the respiratory system, or are manifested by prolonged bleedings from injection sites. Haemophilia is a rare cause of haemorrhages in the neonatal period, and in the female population it is even seen as an extremely rare disorder. Its aetiology in girls is diverse: inheriting defective genes from their parents, skewed X inactivation or a single X chromosome. Case presentation: The article presents a case of a preterm girl born in the 28th week of pregnancy, who was diagnosed with severe haemophilia A stemming from the absence of the X chromosome. The girl’s father is healthy, but her mother’s brother suffers from haemophilia. On the second day of the child’s life, a prolonged bleeding from the injection site was observed. A coagulation profile revealed prolonged APTT which pointed to haemophilia A diagnosis. Moreover, a marked clinical dysmorphy, female sex and a negative family history on the father’s side led the treating team to extend the diagnostic procedures to encompass karyotype evaluation. -
3258 N:O 1179
3258 N:o 1179 LIITE 1 BILAGA 1 LÄÄKELUETTELON AINEET ÄMNENA I LÄKEMEDELSFÖRTECKNINGEN Latinankielinen nimi Suomenkielinen nimi Ruotsinkielinen nimi Englanninkielinen nimi Latinskt namn Finskt namn Svenskt namn Engelskt namn Abacavirum Abakaviiri Abakavir Abacavir Abciximabum Absiksimabi Absiximab Abciximab Acamprosatum Akamprosaatti Acamprosat Acamprosate Acarbosum Akarboosi Akarbos Acarbose Acebutololum Asebutololi Acebutolol Acebutolol Aceclofenacum Aseklofenaakki Aceklofenak Aceclofenac Acediasulfonum natricum Asediasulfoninatrium Acediasulfonnatrium Acediasulfone sodium Acepromazinum Asepromatsiini Acepromazin Acepromazine Acetarsolum Asetarsoli Acetarsol Acetarsol Acetazolamidum Asetatsoliamidi Acetazolamid Acetazolamide Acetohexamidum Asetoheksamidi Acetohexamid Acetohexamide Acetophenazinum Asetofenatsiini Acetofenazin Acetophenazine Acetphenolisatinum Asetofenoli-isatiini Acetfenolisatin Acetphenolisatin Acetylcholini chloridum Asetyylikoliinikloridi Acetylkolinklorid Acetylcholine chloride Acetylcholinum Asetyylikoliini Acetylkolin Acetylcholini Acetylcysteinum Asetyylikysteiini Acetylcystein Acetylcysteine Acetyldigitoxinum Asetyylidigitoksiini Acetyldigitoxin Acetyldigitoxin Acetyldigoxinum Asetyylidigoksiini Acetyldigoxin Acetyldigoxin Acetylisovaleryltylosini Asetyyli-isovaleryyli- Acetylisovaleryl- Acetylisovaleryltylosine tartras tylosiinitartraatti tylosintartrat tartrate Aciclovirum Asikloviiri Aciklovir Aciclovir Acidum acetylsalicylicum Asetyylisalisyylihappo Acetylsalicylsyra Acetylsalicylic acid Acidum alendronicum