Guidelines on the Management of Bleeding for Palliative Care Patients with Cancer
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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). -
OVESTIN PESSARY (0.5Mg)
NEW ZEALAND DATA SHEET 1. OVESTIN PESSARY (0.5mg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pessary contains 0.5 mg Estriol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pessary 0.5 mg - white, torpedo formed pessary. One pessary (2.5 g weight) contains 0.5 mg oestriol. Length 26.5 mm; largest diameter 14 mm. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Atrophy of the lower urogenital tract related to oestrogen deficiency, notably • for the treatment of vaginal complaints such as dyspareunia, dryness and itching. • for the prevention of recurrent infections of the vagina and lower urinary tract. • in the management of micturition complaints (such as frequency and dysuria) and mild urinary incontinence. Pre- and postoperative therapy in postmenopausal women undergoing vaginal surgery. A diagnostic aid in case of a doubtful atrophic cervical smear. 4.2 Dose and method of administration Dosage OVESTIN is an oestrogen-only product that may be given to women with or without a uterus. Atrophy of the lower urogenital tract 1 pessary per day for the first weeks, followed by a gradual reduction, based on relief of symptoms, until a maintenance dosage (e.g. 1 pessary twice a week) is reached. Pre- and post-operative therapy in postmenopausal women undergoing vaginal surgery 1 pessary per day in the 2 weeks before surgery; 1 pessary twice a week in the 2 weeks after surgery. A diagnostic aid in case of a doubtful atrophic cervical smear 1 pessary on alternate days in the week before taking the next smear. Administration OVESTIN pessaries should be inserted intravaginally before retiring at night. -
(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. -
UK Clinical Guideline for Best Practice in the Use of Vaginal Pessaries for Pelvic Organ Prolapse
UK Clinical Guideline for best practice in the use of vaginal pessaries for pelvic organ prolapse March 2021 Developed by members of the UK Clinical Guideline Group for the use of pessaries in vaginal prolapse representing: the United Kingdom Continence Society (UKCS); the Pelvic Obstetric and Gynaecological Physiotherapy (POGP); the British Society of Urogynaecology (BSUG); the Association for Continence Advice (ACA); the Scottish Pelvic Floor Network (SPFN); The Pelvic Floor Society (TPFS); the Royal College of Obstetricians and Gynaecologists (RCOG); the Royal College of Nursing (RCN); and pessary users. Funded by grants awarded by UKCS and the Chartered Society of Physiotherapy (CSP). This guideline was completed in December 2020, and following stakeholder review, has been given official endorsement and approval by: • British Association of Urological Nurses (BAUN) • International Urogynecological Association (IUGA) • Pelvic Obstetric and Gynaecological Physiotherapy (POGP) • Scottish Pelvic Floor Network (SPFN) • The Association of Continence Advice (ACA) • The British Society of Urogynaecology (BSUG) • The Pelvic Floor Society (TPFS) • The Royal College of Nursing (RCN) • The Royal College of Obstetricians and Gynaecologists (RCOG) • The United Kingdom Continence Society (UKCS) Review This guideline will be due for full review in 2024. All comments received on the POGP and UKCS websites or submitted here: [email protected] will be included in the review process. 2 Table of Contents Table of Contents ................................................................................................................................ -
Pessary for Management of Pelvic Organ Prolapse
Pessary for management of Pelvic Organ Prolapse Cathy Davis Clinical Nurse Specialist Department of Urogynaecology King’s College Hospital, London Definition of Prolapse The descent of one or more of the anterior vaginal wall, posterior vaginal wall, uterus (cervix) or vaginal vault (cuff scar after hysterectomy). The presence of any such sign should be correlated with relevant POP symptoms. (Haylen et al 2016) Risk Factors • Increased intra-abdominal pressure • Chronic cough • Chronic constipation • Weight lifting • Presence of abdominal tumours - fibroids & ovarian cysts • High impact exercise • Age/ Menopause • Obesity Risk Factors contd.... • Smoking • Multiparity • Congenital weakness – rare; due to deficiency in collagen metabolism • Injury to pelvic floor muscles • Iatrogenic/ pelvic surgery - hysterectomy Symptoms of POP • May be asymptomatic – a small amount of prolapse can often be normal • Sensation of a lump or bulge " coming down" - most common • Backache • Heaviness • Dragging or discomfort inside the vagina – often worse on standing /sitting for prolonged periods • Seeing a lump or bulge Symptoms of POP contd.... • Bladder / Urinary symptoms -Frequency -Difficulty initiating voids, low-flow, incomplete bladder emptying -Leakage on certain movements or when lifting heavy objects -Recurrent urinary tract infections • Bowel symptoms -Constipation - Incomplete bowel emptying - May have to digitate to defecate/use aides • Symptoms related to Sex – uncomfortable, lack of sensation Diagnosis of Prolapse • Vaginal examination • -
Combi Soft Gel Pessary & External Cream
Combi Soft Gel Pessary Canesten & External Cream 500mg vaginal capsule & 2% w/w cream Clotrimazole Read all of this leaflet carefully because it contains important To treat internal thrush, your doctor may recommend that you use the information for you. pessary without the help of an applicator. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. HOW TO USE CANESTEN® COMBI • This medicine has been prescribed for you. Do not give it to anyone else 3. under any circumstances. The Soft Gel Pessary: • If you have any unusual effects after using this product, tell your doctor. Unless directed otherwise by your doctor, the Soft Gel Pessary should be inserted as high as possible into the vagina, preferably before going to sleep IN THIS LEAFLET at night for convenient and comfortable treatment. Wash your hands before removing the foil from the blister pack and again 1. What is Canesten Combi and what is it used for? afterwards when you have used the applicator. 2. Before you use Canesten Combi 3. How to use Canesten Combi 1. Remove the applicator from the packaging. Pull out the plunger A until it 4. Possible side effects stops. Remove the pessary from the foil blister pack and place firmly into the 5. How to store Canesten Combi applicator B. 6. Further information 1. WHAT IS CANESTEN® COMBI AND WHAT IS IT USED FOR? Canesten Combi Soft Gel Pessary & External Cream is a full course of treatment for vaginal thrush (candidiasis) because it treats both the internal cause and external symptoms. -
U.S. Medical Eligibility Criteria for Contraceptive Use, 2010
Morbidity and Mortality Weekly Report www.cdc.gov/mmwr Early Release May 28, 2010 / Vol. 59 U.S. Medical Eligibility Criteria for Contraceptive Use, 2010 Adapted from the World Health Organization Medical Eligibility Criteria for Contraceptive Use, 4th edition department of health and human services Centers for Disease Control and Prevention Early Release CONTENTS The MMWR series of publications is published by the Office of Surveillance, Epidemiology, and Laboratory Services, Centers for Introduction .............................................................................. 1 Disease Control and Prevention (CDC), U.S. Department of Health Methods ................................................................................... 2 and Human Services, Atlanta, GA 30333. How to Use This Document ......................................................... 3 Suggested Citation: Centers for Disease Control and Prevention. [Title]. MMWR Early Release 2010;59[Date]:[inclusive page numbers]. Using the Categories in Practice ............................................... 3 Recommendations for Use of Contraceptive Methods ................. 4 Centers for Disease Control and Prevention Contraceptive Method Choice .................................................. 4 Thomas R. Frieden, MD, MPH Director Contraceptive Method Effectiveness .......................................... 4 Peter A. Briss, MD, MPH Unintended Pregnancy and Increased Health Risk ..................... 4 Acting Associate Director for Science Keeping Guidance Up to Date ................................................... -
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. -
Multiple Technology Appraisal Avatrombopag and Lusutrombopag
Multiple Technology Appraisal Avatrombopag and lusutrombopag for treating thrombocytopenia in people with chronic liver disease needing an elective procedure [ID1520] Committee papers © National Institute for Health and Care Excellence 2019. All rights reserved. See Notice of Rights. The content in this publication is owned by multiple parties and may not be re-used without the permission of the relevant copyright owner. NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE MULTIPLE TECHNOLOGY APPRAISAL Avatrombopag and lusutrombopag for treating thrombocytopenia in people with chronic liver disease needing an elective procedure [ID1520] Contents: 1 Pre-meeting briefing 2 Assessment Report prepared by Kleijnen Systematic Reviews 3 Consultee and commentator comments on the Assessment Report from: • Shionogi 4 Addendum to the Assessment Report from Kleijnen Systematic Reviews 5 Company submission(s) from: • Dova • Shionogi 6 Clarification questions from AG: • Questions to Shionogi • Clarification responses from Shionogi • Questions to Dova • Clarification responses from Dova 7 Professional group, patient group and NHS organisation submissions from: • British Association for the Study of the Liver (BASL) The Royal College of Physicians supported the BASL submission • British Society of Gastroenterology (BSG) 8 Expert personal statements from: • Vanessa Hebditch – patient expert, nominated by the British Liver Trust • Dr Vickie McDonald – clinical expert, nominated by British Society for Haematology • Dr Debbie Shawcross – clinical expert, nominated by Shionogi © National Institute for Health and Care Excellence 2019. All rights reserved. See Notice of Rights. The content in this publication is owned by multiple parties and may not be re-used without the permission of the relevant copyright owner. MTA: avatrombopag and lusutrombopag for treating thrombocytopenia in people with chronic liver disease needing an elective procedure Pre-meeting briefing © NICE 2019.