Bloating Y Distensión Abdominal:¿ Solamente Gas?: Una Mirada Hacia
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WHO Drug Information Vol. 12, No. 3, 1998
WHO DRUG INFORMATION VOLUME 12 NUMBER 3 • 1998 RECOMMENDED INN LIST 40 INTERNATIONAL NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES WORLD HEALTH ORGANIZATION • GENEVA Volume 12, Number 3, 1998 World Health Organization, Geneva WHO Drug Information Contents Seratrodast and hepatic dysfunction 146 Meloxicam safety similar to other NSAIDs 147 Proxibarbal withdrawn from the market 147 General Policy Issues Cholestin an unapproved drug 147 Vigabatrin and visual defects 147 Starting materials for pharmaceutical products: safety concerns 129 Glycerol contaminated with diethylene glycol 129 ATC/DDD Classification (final) 148 Pharmaceutical excipients: certificates of analysis and vendor qualification 130 ATC/DDD Classification Quality assurance and supply of starting (temporary) 150 materials 132 Implementation of vendor certification 134 Control and safe trade in starting materials Essential Drugs for pharmaceuticals: recommendations 134 WHO Model Formulary: Immunosuppressives, antineoplastics and drugs used in palliative care Reports on Individual Drugs Immunosuppresive drugs 153 Tamoxifen in the prevention and treatment Azathioprine 153 of breast cancer 136 Ciclosporin 154 Selective serotonin re-uptake inhibitors and Cytotoxic drugs 154 withdrawal reactions 136 Asparaginase 157 Triclabendazole and fascioliasis 138 Bleomycin 157 Calcium folinate 157 Chlormethine 158 Current Topics Cisplatin 158 Reverse transcriptase activity in vaccines 140 Cyclophosphamide 158 Consumer protection and herbal remedies 141 Cytarabine 159 Indiscriminate antibiotic -
ESPGHAN/European Society for Pediatric Infectious Diseases
CLINICAL GUIDELINES European Society for Pediatric Gastroenterology, Hepatology, and Nutrition/European Society for Pediatric Infectious Diseases Evidence-Based Guidelines for the Management of Acute Gastroenteritis in Children in Europe: Update 2014 ÃAlfredo Guarino (Coordinator), yShai Ashkenazi, zDominique Gendrel, ÃAndrea Lo Vecchio, yRaanan Shamir, and §Hania Szajewska ABSTRACT Results: Gastroenteritis severity is linked to etiology, and rotavirus is the most Objectives: These guidelines update and extend evidence-based indications severe infectious agent and is frequently associated with dehydration. for the management of children with acute gastroenteritis in Europe. Dehydration reflects severity and should be monitored by established score Methods: The guideline development group formulated questions, systems. Investigations are generally not needed. Oral rehydration with identified data, and formulated recommendations. The latter were graded hypoosmolar solution is the major treatment and should start as soon as with the Muir Gray system and, in parallel, with the Grading of possible. Breast-feeding should not be interrupted. Regular feeding should Recommendations, Assessment, Development and Evaluations system. continue with no dietary changes including milk. Data suggest that in the hospital setting, in non–breast-fed infants and young children, lactose-free feeds can be considered in the management of gastroenteritis. Active therapy Received March 17, 2014; accepted March 19, 2014. may reduce the duration and severity of diarrhea. Effective interventions From the ÃDepartment of Translational Medical Science, Section of include administration of specific probiotics such as Lactobacillus GG or Pediatrics, University of Naples Federico II, Naples, Italy, the Saccharomyces boulardii, diosmectite or racecadotril. Anti-infectious drugs ySchneider Children’s Medical Center, Tel-Aviv University, Tel-Aviv, should be given in exceptional cases. -
United States Patent (10) Patent No.: US 8,969,514 B2 Shailubhai (45) Date of Patent: Mar
USOO896.9514B2 (12) United States Patent (10) Patent No.: US 8,969,514 B2 Shailubhai (45) Date of Patent: Mar. 3, 2015 (54) AGONISTS OF GUANYLATECYCLASE 5,879.656 A 3, 1999 Waldman USEFUL FOR THE TREATMENT OF 36; A 6. 3: Watts tal HYPERCHOLESTEROLEMIA, 6,060,037- W - A 5, 2000 Waldmlegand et al. ATHEROSCLEROSIS, CORONARY HEART 6,235,782 B1 5/2001 NEW et al. DISEASE, GALLSTONE, OBESITY AND 7,041,786 B2 * 5/2006 Shailubhai et al. ........... 530.317 OTHER CARDOVASCULAR DISEASES 2002fOO78683 A1 6/2002 Katayama et al. 2002/O12817.6 A1 9/2002 Forssmann et al. (75) Inventor: Kunwar Shailubhai, Audubon, PA (US) 2003,2002/0143015 OO73628 A1 10/20024, 2003 ShaubhaiFryburg et al. 2005, OO16244 A1 1/2005 H 11 (73) Assignee: Synergy Pharmaceuticals, Inc., New 2005, OO32684 A1 2/2005 Syer York, NY (US) 2005/0267.197 A1 12/2005 Berlin 2006, OO86653 A1 4, 2006 St. Germain (*) Notice: Subject to any disclaimer, the term of this 299;s: A. 299; NS et al. patent is extended or adjusted under 35 2008/0137318 A1 6/2008 Rangarajetal.O U.S.C. 154(b) by 742 days. 2008. O151257 A1 6/2008 Yasuda et al. 2012/O196797 A1 8, 2012 Currie et al. (21) Appl. No.: 12/630,654 FOREIGN PATENT DOCUMENTS (22) Filed: Dec. 3, 2009 DE 19744O27 4f1999 (65) Prior Publication Data WO WO-8805306 T 1988 WO WO99,26567 A1 6, 1999 US 2010/O152118A1 Jun. 17, 2010 WO WO-0 125266 A1 4, 2001 WO WO-02062369 A2 8, 2002 Related U.S. -
(12) Patent Application Publication (10) Pub. No.: US 2011/0158930 A1 Hirata Et Al
US 2011 O15893 OA1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/0158930 A1 Hirata et al. (43) Pub. Date: Jun. 30, 2011 (54) METHOD FOR TREATMENT OF RRTABLE Related U.S. Application Data BOWEL, SYNDROME (60) Provisional application No. 61/190.559, filed on Aug. 28, 2008. (75) Inventors: Takuya Hirata, Tokyo (JP); Toshiyuki Funatsu, Tokyo (JP); Publication Classification Yoshihiro Keto, Tokyo (JP); (51) Int. Cl. Shinobu Akuzawa, Tokyo (JP) A63L/78 (2006.01) C07D 403/06 (2006.01) (73) Assignee: ASTELLAS PHARMA INC., A6IPI/00 (2006.01) Tokyo (JP) A6IPL/T2 (2006.01) (52) U.S. Cl. ................................... 424/78.01: 548/302.7 (21) Appl. No.: 13/061,384 (57) ABSTRACT A method for treatment of a patient suffering from irritable (22) PCT Fled: Aug. 27, 2009 bowel syndrome with diarrhea or mixed irritable bowel syn drome, which comprises administering to the patient a thera (86) PCT NO.: PCT/UP2009/064904 peutically effective amount of ramosetron or a pharmaceuti cally acceptable salt thereof in combination with a S371 (c)(1), therapeutically effective amount of polycarbophil or a phar (2), (4) Date: Feb. 28, 2011 maceutically acceptable salt thereof. Patent Application Publication Jun. 30, 2011 Sheet 1 of 2 US 2011/O1589.30 A1 Fig.1 s 120 aw *e 100 aS$ 100 80 isd 80 v s 60 se sk sk 60 40 6 40 se g 20 20 - a k es O -- - - - , , , g- O W 0. 0.3 1 100 300 000 0.3 g/kg 300 mg/kg 0.3 g/kg + s S. -
List of Union Reference Dates A
Active substance name (INN) EU DLP BfArM / BAH DLP yearly PSUR 6-month-PSUR yearly PSUR bis DLP (List of Union PSUR Submission Reference Dates and Frequency (List of Union Frequency of Reference Dates and submission of Periodic Frequency of submission of Safety Update Reports, Periodic Safety Update 30 Nov. 2012) Reports, 30 Nov. -
Diosmectite for Chemotherapy-Induced Diarrhea
Edinburgh Research Explorer Chemotherapy-induced diarrhoea in dogs and its management with smectite Citation for published version: Fournier, Q, Serra, JC, Williams, C & Bavcar, S 2021, 'Chemotherapy-induced diarrhoea in dogs and its management with smectite: results of a monocentric open-label randomized clinical trial ', Veterinary and Comparative Oncology, vol. 19, no. 1, pp. 25-33. https://doi.org/10.1111/vco.12631 Digital Object Identifier (DOI): 10.1111/vco.12631 Link: Link to publication record in Edinburgh Research Explorer Document Version: Peer reviewed version Published In: Veterinary and Comparative Oncology General rights Copyright for the publications made accessible via the Edinburgh Research Explorer is retained by the author(s) and / or other copyright owners and it is a condition of accessing these publications that users recognise and abide by the legal requirements associated with these rights. Take down policy The University of Edinburgh has made every reasonable effort to ensure that Edinburgh Research Explorer content complies with UK legislation. If you believe that the public display of this file breaches copyright please contact [email protected] providing details, and we will remove access to the work immediately and investigate your claim. Download date: 27. Sep. 2021 1 1 Chemotherapy-induced diarrhea in dogs and its management with 2 smectite: results of a monocentric open-label randomized clinical trial 3 Word count: 3810 4 Number of figures and tables: 2 tables, 3 figures 5 Data availability statement: The data that support the findings of this study are available 6 from the corresponding author upon reasonable request. 2 7 Abstract 8 Chemotherapy-induced diarrhea (CID) is a frequent chemotherapy adverse event in dogs. -
An Approach to Acute and Chronic Diarrhoea
Leader in digital CPD Earn 3 for Southern African Gastroenterology healthcare professionals free CEUs An approach to acute and chronic diarrhoea Learning objectives You will learn: • The causes of and risk factors for acute and chronic diarrhoea • How to screen and diagnose acute and chronic diarrhoea • The general principles of treating diarrhoea, with a focus on anti-diarrhoeal agents used adjunctively to oral rehydration and, if necessary, antimicrobials. Introduction In the healthy adult, diarrhoea is often viewed as a ‘nuisance’ disease. However, serious complications including severe dehydration and renal failure can occur and may necessitate admission to hospital. Elderly people and those in long-term care have an increased risk of death as a consequence of diarrhoea. Diarrhoea is reported to cause more deaths, an estimated 2.5 million annually, than any other condition Oral rehydration in children under five years of age living in resource-poor countries. In South Africa, therapy is central to diarrhoea accounts for 19% of deaths of children under five years of age; dehydration 1-3 the management of is the key factor in these deaths. acute diarrhoea, being Diarrhoea is classified as acute (short-term, less than 7 days), prolonged (a form of sufficient in most acute diarrhoea lasting more than 7 days), or chronic (long-term, more than 2 weeks patients to prevent in children or 4 weeks in adults). It is also classified as mild, moderate, or severe, complications due to with dehydration reflecting severity of symptoms. Oral rehydration -
Review Article Role of Antidiarrhoeal Drugs As Adjunctive Therapies for Acute Diarrhoea in Children
Hindawi Publishing Corporation International Journal of Pediatrics Volume 2013, Article ID 612403, 14 pages http://dx.doi.org/10.1155/2013/612403 Review Article Role of Antidiarrhoeal Drugs as Adjunctive Therapies for Acute Diarrhoea in Children Christophe Faure Division of Gastroenterology, Department of Pediatrics, CHU Sainte-Justine, Montreal, QC, Canada H3T 1C5 Correspondence should be addressed to Christophe Faure; [email protected] Received 25 October 2012; Revised 2 January 2013; Accepted 2 January 2013 Academic Editor: Catherine Bollard Copyright © 2013 Christophe Faure. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Acute diarrhoea is a leading cause of child mortality in developing countries. Principal pathogens include Escherichia coli, rotaviruses, and noroviruses. 90% of diarrhoeal deaths are attributable to inadequate sanitation. Acute diarrhoea is the second leading cause of overall childhood mortality and accounts for 18% of deaths among children under five. In 2004 an estimated 1.5 million children died from diarrhoea, with 80% of deaths occurring before the age of two. Treatment goals are to prevent dehydration and nutritional damage and to reduce duration and severity of diarrhoeal episodes. The recommended therapeutic regimen is to provide oral rehydration solutions (ORS) and to continue feeding. Although ORS effectively mitigates dehydration, it has no effect on the duration, severity, or frequency of diarrhoeal episodes. Adjuvant therapy with micronutrients, probiotics, or antidiarrhoeal agents may thus be useful. The WHO recommends the use of zinc tablets in association with ORS.The ESPGHAN/ESPID treatment guidelines consider the use of racecadotril, diosmectite, or probiotics as possible adjunctive therapy to ORS. -
Efficacy of Dioctahedral Smectite in Treating Patients Of
doi:10.1111/j.1440-1746.2007.04895.x GASTROENTEROLOGY Efficacy of dioctahedral smectite in treating patients of diarrhea-predominant irritable bowel syndrome Full-Young Chang, Ching-Liang Lu, Chih-Yen Chen and Jiing-Chyuan Luo Division of Gastroenterology, Taipei Veterans General Hospital and School of Medicine, National Yang-Ming University, Taipei, Taiwan Key words Abstract abdominal bloating, diosmectite, functional gastrointestinal disorder, irritable bowel Background and Aim: Dioctahedral smectite (DS) is natural adsorbent clay useful in syndrome, Rome criteria. treating acute diarrhea. The aim of this study was to determine DS efficacy on patients with diarrhea-predominant irritable bowel syndrome (D-IBS in a phase III-, 8-week- Accepted for publication 23 November 2006. randomized, double-blind, placebo-controlled trial. Methods: The 104 patients who met the D-IBS Rome II criteria were randomized to Correspondence receive either DS (n = 52) or placebo (n = 52) treatment for 8 weeks (three sachets daily). Dr Full-Young Chang, Division of The primary efficacy endpoint was the changes of the visual analog scale (VAS) score of Gastroenterology, Taipei Veterans General IBS overall disorder and pain/discomfort-related symptoms after treatment on days 28 and Hospital, 201 Shih-Pai Road, Section 2, Taipei, 56, respectively. Other outcome measures included improvement of bowel movement Taiwan 11217. Email: [email protected] disorders. The therapeutic global response was assessed by the patients and investigators at each visit, as was drug safety. Results: Both treatments diminished overall disorder at each visit (P < 0.01), with respect to primary efficacy. This effect was further observed in DS-treated patients on day 56 (P = 0.0167). -
BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available
BMJ Open: first published as 10.1136/bmjopen-2017-019186 on 20 March 2019. Downloaded from BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on September 29, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-019186 on 20 March 2019. Downloaded from Potentially inappropriate prescriptions and omissions in pediatrics: detection by POPI (Pediatrics: Omission of Prescription and Inappropriate prescription) in the emergency unit and in the ambulatory setting. ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2017-019186 Article Type: Research Date -
Lactose Intolerance and Health: Evidence Report/Technology Assessment, No
Evidence Report/Technology Assessment Number 192 Lactose Intolerance and Health Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Contract No. HHSA 290-2007-10064-I Prepared by: Minnesota Evidence-based Practice Center, Minneapolis, MN Investigators Timothy J. Wilt, M.D., M.P.H. Aasma Shaukat, M.D., M.P.H. Tatyana Shamliyan, M.D., M.S. Brent C. Taylor, Ph.D., M.P.H. Roderick MacDonald, M.S. James Tacklind, B.S. Indulis Rutks, B.S. Sarah Jane Schwarzenberg, M.D. Robert L. Kane, M.D. Michael Levitt, M.D. AHRQ Publication No. 10-E004 February 2010 This report is based on research conducted by the Minnesota Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. HHSA 290-2007-10064-I). The findings and conclusions in this document are those of the authors, who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. The information in this report is intended to help clinicians, employers, policymakers, and others make informed decisions about the provision of health care services. This report is intended as a reference and not as a substitute for clinical judgment. This report may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. -
Smecta®) in the Symptomatic Treatment of Acute Diarrhoea in Adults
IPSEN GROUP F-FR-00250-105 CONFIDENTIAL PROTOCOL: FINAL (WITH AMENDMENT NO. 4): 07 JANUARY 2019 PAGE 1/89 PROTOCOL TITLE: EFFICACY OF DIOSMECTITE (SMECTA®) IN THE SYMPTOMATIC TREATMENT OF ACUTE DIARRHOEA IN ADULTS. A MULTICENTRE, RANDOMISED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUPS STUDY STUDY PROTOCOL STUDY number: F-FR-00250-105 (Diosmectite- BN 00250) EudraCT number: n° 2015-001138-10 Final Version (with Amendment No. 4): 07 January 2019 Sponsor’s Medically Responsible Person: Study Sponsor: PPD Ipsen Pharma SAS PPD 65 quai Georges Gorse Ipsen Pharma SAS 92100 Boulogne-Billancourt, France 65 quai Georges Gorse Tel: PPD 92100 Boulogne-Billancourt, France Fax: PPD Tel: PPD Fax: PPD Monitoring Office: and/or CRO Co-ordinating Investigator: PPD PPD PPD Délégation à la Recherche Ipsen Pharma SAS Centre Hospitalier Régional Universitaire 65 quai Georges Gorse de Lille 92100 Boulogne-Billancourt, France 2, avenue Oscar Lambret, Tel: PPD 59037 Lille, France Cedex Fax: PPD Tel: PPD Fax: PPD Pharmacovigilance/Emergency Contact: PPD Ipsen Innovation, ZI de Courtaboeuf - 5 avenue du Canada - 91940 Les Ulis - France Tel: PPD Tel: PPD – PPD For SAEs reporting: Fax: PPD Email: PPD Persons supplied with this information must understand that it is strictly confidential. Information contained herein cannot be disclosed, submitted for publication or used for any purpose other than that contemplated herein without the sponsor’s prior written authorisation. IPSEN GROUP F-FR-00250-105 CONFIDENTIAL PROTOCOL: FINAL (WITH AMENDMENT NO. 4): 07 JANUARY 2019 PAGE 2/89 INVESTIGATOR’S AGREEMENT Investigator Agreement and Signature: I have read and agree to Protocol F-FR-00250-105 entitled Efficacy of the diosmectite (Smecta®) in the symptomatic treatment of acute diarrhoea in adults.