Contraceptives
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Statistical Analysis Plan: IT001-302
Statistical Analysis Plan: IT001-302 Study Title: A prospective, Phase 3, randomized, multi-center, double-blind, double dummy study of the efficacy, tolerability and safety of intravenous sulopenem followed by oral sulopenem-etzadroxil with probenecid versus intravenous ertapenem followed by oral ciprofloxacin or amoxicillin-clavulanate for treatment of complicated urinary tract infections in adults. Study Number: IT001-302 Study Phase: Phase 3 Product Name: Sulopenem (CP-70,429), Sulopenem-etzadroxil (PF-03709270)/Probenecid Indication: Complicated urinary tract infection Study Statistician: Michael Zelasky Study Clinician: Steven I. Aronin, M.D. Sponsor: Iterum Therapeutics International Limited 20 Research Parkway, Suite A Old Saybrook, CT 06475 Final SAP Date: September 25, 2019 Revised SAP Date: February 11, 2020 Protocol Version: January 16, 2020 Confidentiality Statement This document is strictly confidential. It was developed by Iterum Therapeutics US Limited should not be disclosed to a third party, with the exception of regulatory agencies and study audit personnel. Reproduction, modification or adaptation, in part or in total, is strictly forbidden without prior written approval by Iterum Therapeutics US Limited Digitally signed by Anita F Das DN: cn=Anita F Das, o, ou, [email protected]. Anita F Das com, c=US Date: 2020.02.12 12:57:12 -08'00' Sulopenem IV; Sulopenem etzadroxil Iterum Therapeutics Statistical Analysis Plan: IT001-302 11 February 2020 TABLE OF CONTENTS TABLE OF CONTENTS........................................................................................................... -
Topical and Systemic Antifungal Therapy for Chronic Rhinosinusitis (Protocol)
CORE Metadata, citation and similar papers at core.ac.uk Provided by University of East Anglia digital repository Cochrane Database of Systematic Reviews Topical and systemic antifungal therapy for chronic rhinosinusitis (Protocol) Head K, Sacks PL, Chong LY, Hopkins C, Philpott C Head K, Sacks PL, Chong LY, Hopkins C, Philpott C. Topical and systemic antifungal therapy for chronic rhinosinusitis. Cochrane Database of Systematic Reviews 2016, Issue 11. Art. No.: CD012453. DOI: 10.1002/14651858.CD012453. www.cochranelibrary.com Topical and systemic antifungal therapy for chronic rhinosinusitis (Protocol) Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 BACKGROUND .................................... 1 OBJECTIVES ..................................... 3 METHODS ...................................... 3 ACKNOWLEDGEMENTS . 8 REFERENCES ..................................... 9 APPENDICES ..................................... 10 CONTRIBUTIONSOFAUTHORS . 25 DECLARATIONSOFINTEREST . 26 SOURCESOFSUPPORT . 26 NOTES........................................ 26 Topical and systemic antifungal therapy for chronic rhinosinusitis (Protocol) i Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Protocol] Topical and systemic antifungal therapy for chronic rhinosinusitis Karen Head1, Peta-Lee Sacks2, Lee Yee Chong1, Claire Hopkins3, Carl Philpott4 1UK Cochrane Centre, -
Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017
Q UO N T FA R U T A F E BERMUDA PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 BR 111 / 2017 The Minister responsible for health, in exercise of the power conferred by section 48A(1) of the Pharmacy and Poisons Act 1979, makes the following Order: Citation 1 This Order may be cited as the Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017. Repeals and replaces the Third and Fourth Schedule of the Pharmacy and Poisons Act 1979 2 The Third and Fourth Schedules to the Pharmacy and Poisons Act 1979 are repealed and replaced with— “THIRD SCHEDULE (Sections 25(6); 27(1))) DRUGS OBTAINABLE ONLY ON PRESCRIPTION EXCEPT WHERE SPECIFIED IN THE FOURTH SCHEDULE (PART I AND PART II) Note: The following annotations used in this Schedule have the following meanings: md (maximum dose) i.e. the maximum quantity of the substance contained in the amount of a medicinal product which is recommended to be taken or administered at any one time. 1 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 mdd (maximum daily dose) i.e. the maximum quantity of the substance that is contained in the amount of a medicinal product which is recommended to be taken or administered in any period of 24 hours. mg milligram ms (maximum strength) i.e. either or, if so specified, both of the following: (a) the maximum quantity of the substance by weight or volume that is contained in the dosage unit of a medicinal product; or (b) the maximum percentage of the substance contained in a medicinal product calculated in terms of w/w, w/v, v/w, or v/v, as appropriate. -
Cord Prolapse
CLINICAL PRACTICE GUIDELINE CORD PROLAPSE CLINICAL PRACTICE GUIDELINE CORD PROLAPSE Institute of Obstetricians and Gynaecologists, Royal College of Physicians of Ireland and the Clinical Strategy and Programmes Division, Health Service Executive Version: 1.0 Publication date: March 2015 Guideline No: 35 Revision date: March 2017 1 CLINICAL PRACTICE GUIDELINE CORD PROLAPSE Table of Contents 1. Revision History ................................................................................ 3 2. Key Recommendations ....................................................................... 3 3. Purpose and Scope ............................................................................ 3 4. Background and Introduction .............................................................. 4 5. Methodology ..................................................................................... 4 6. Clinical Guidelines on Cord Prolapse…… ................................................ 5 7. Hospital Equipment and Facilities ....................................................... 11 8. References ...................................................................................... 11 9. Implementation Strategy .................................................................. 14 10. Qualifying Statement ....................................................................... 14 11. Appendices ..................................................................................... 15 2 CLINICAL PRACTICE GUIDELINE CORD PROLAPSE 1. Revision History Version No. -
Metronidazole/Nifuratel 841
Metronidazole/Nifuratel 841 African trypanosomiasis. Although there is no established al- Monensin (BAN, USAN, rINN) Nicarbazin (BAN) ternative treatment for Trypanosoma brucei rhodesiense infec- Lilly-67314; Monensina; Monensinum. 4-{2-[2-Ethyl-3′-methyl- Nicarbazina. An equimolecular complex of 1,3-bis(4-nitro- tions that are resistant to melarsoprol (see p.827), metronidazole 5′-(tetrahydro-6-hydroxy-6-hydroxymethyl-3,5-dimethylpyran- phenyl)urea (C13H10N4O5) and 4,6-dimethylpyrimidin-2-ol 1 and suramin were effective in 1 patient. 2-yl)perhydro-2,2′-bifuran-5-yl]-9-hydroxy-2,8-dimethyl-1,6-di- (C6H8N2O). 1. Foulkes JR. Metronidazole and suramin combination in the treat- oxaspiro[4.5]dec-7-yl}3-methoxy-2-methylpentanoic acid. Никарбазин ment of arsenical refractory rhodesian sleeping sickness—a case Монензин C H N O = 426.4. study. Trans R Soc Trop Med Hyg 1996; 90: 422. 19 18 6 6 C36H62O11 = 670.9. CAS — 330-95-0. Preparations CAS — 17090-79-8. ATC Vet — QP51AE03. ATC Vet — QP51AH03. BP 2008: Metronidazole Gel; Metronidazole Intravenous Infusion; Metron- idazole Oral Suspension; Metronidazole Suppositories; Metronidazole Tab- lets; NHO CH3 USP 31: Metronidazole Gel; Metronidazole Injection; Metronidazole Tab- CH3 CH H lets. 3 N Proprietary Preparations (details are given in Part 3) O O- O- Arg.: Bexon; Colpofilin; Dazotron; Epaq†; Etronil; Flagyl; Format; Ginkan; H H CH3 OO + CH3 + Gynotran; Metral; Metrocev; Metrolocal; Nalox; Noritate†; Padet; Repligen; HO H3C N N Rozex; Taremis; Tolbin; Tricofin; Trimstat†; Austral.: Flagyl; Metrogyl; -
Training Manual
Training of Trainers Program on Analysis of Veterinary Drug Residues including Antibiotics TRAINING MANUAL Name: __________________________________ Email: __________________________________ Organized by: FSSAI & GFSP in association with PBTI at Punjab Biotechnology Incubator, Mohali, Punjab February, 2018 MANUAL FOR VETERINARY DRUG RESIDUE ANALYSIS INCLUDING ANTIBIOTICS Food Safety and Standards Authority of India Ministry of Health and Family Welfare, Government of India Manual for veterinary drug residue analysis including antibiotics, 2018. © 2018 by Food Safety and Standards Authority of India, New Delhi. All rights reserved. No part of this book may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical or photocopying, recording or otherwise without the prior written permission of the publisher or authors. ABOUT THE MANUAL The current manual borrows its majority of content and structure from the Training of Trainers (ToT) manual prepared by IFSTL partners USFDA, USDA and JIFSAN and with their consent. This manual is complementary to the workshop laboratory manual and lecture notes. The manual is meant to provide future trainers with an opportunity to make notes on various aspects of logistics associated with giving the training to a group. COPYRIGHT NOTICE The contents of the manual are protected by the terms of the Food Safety and Standard Authority of India (FSSAI), Ministry of Health and Family Welfare, Govt. of India. Permission to use whole or parts of texts contained in this manual in printed or electronic form must be obtained and is usually subject to royalty agreements. Proposals for non-commercial reproductions and translations are welcomed and considered on a case-by-case basis. -
Use of Nifuratel to Treat Infections Caused by Atopobium Species
(19) & (11) EP 2 243 482 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 27.10.2010 Bulletin 2010/43 A61K 31/422 (2006.01) A61P 15/02 (2006.01) A61P 31/04 (2006.01) A61P 13/02 (2006.01) (2006.01) (21) Application number: 09158221.3 A61P 15/00 (22) Date of filing: 20.04.2009 (84) Designated Contracting States: (72) Inventor: Mailland, Federico AT BE BG CH CY CZ DE DK EE ES FI FR GB GR CH-6900 Lugano (CH) HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO SE SI SK TR (74) Representative: Pistolesi, Roberto et al Designated Extension States: Dragotti & Associati Srl AL BA RS Via Marina 6 20121 Milano (IT) (71) Applicant: Polichem SA 1526 Luxembourg (LU) (54) Use of nifuratel to treat infections caused by atopobium species (57) The present invention is directed to the use of genitalia in both sexes, as well as bacterial vaginosis, or nifuratel, or a physiologically acceptable salt thereof, to mixed vaginal infections in women, when one or more treat infections caused by Atopobium species. The in- species of the genus Atopobium are among the causative vention is further directed to the use of nifuratel to treat pathogens of those infections. bacteriuria, urinary tract infections, infections of external EP 2 243 482 A1 Printed by Jouve, 75001 PARIS (FR) EP 2 243 482 A1 Description [0001] The present invention relates to the use of nifuratel, or a physiologically acceptable salt thereof, to treat infections caused by Atopobium species. -
Tractocile, Atosiban
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Tractocile 6.75 mg/0.9 ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 0.9 ml solution contains 6.75 mg atosiban (as acetate). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless solution without particles. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Tractocile is indicated to delay imminent pre-term birth in pregnant adult women with: regular uterine contractions of at least 30 seconds duration at a rate of 4 per 30 minutes a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of 50% a gestational age from 24 until 33 completed weeks a normal foetal heart rate 4.2 Posology and method of administration Posology Treatment with Tractocile should be initiated and maintained by a physician experienced in the treatment of pre-term labour. Tractocile is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with Tractocile 6.75 mg/0.9 ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of Tractocile 37.5 mg/5 ml concentrate for solution for infusion during three hours, followed by a lower dose of Tractocile 37.5 mg/5 ml concentrate for solution for infusion (subsequent infusion 100 micrograms/min) up to 45 hours. The duration of the treatment should not exceed 48 hours. The total dose given during a full course of Tractocile therapy should preferably not exceed 330.75 mg of atosiban. -
Tocolytics Used As Adjunctive Therapy at the Time of Cerclage Placement: a Systematic Review
Journal of Perinatology (2015) 35, 561–565 © 2015 Nature America, Inc. All rights reserved 0743-8346/15 www.nature.com/jp ORIGINAL ARTICLE Tocolytics used as adjunctive therapy at the time of cerclage placement: a systematic review J Smith1,2 and EA DeFranco3,4 OBJECTIVE: To review the published literature on whether the use of empiric perioperative tocolytic medications could provide additional benefit when used in combination with cerclage. STUDY DESIGN: Systematic review of published medical literature reporting the efficacy of empiric tocolytics used as a perioperative adjunct to vaginal cerclage in high-risk patients. A PubMed search without date criteria of various tocolytics and cerclage yielded 42 studies. Review articles were excluded, as were reports of abdominal cerclage, emergent cerclage, or cerclage for the purpose of delayed interval delivery in twin gestations. RESULT: Only five publications on the topic of perioperative tocolytic use at the time of history or ultrasound-indicated vaginal cerclage placement were identified. These included zero clinical trials, three retrospective cohort studies, one case series and one case report. Only one cohort study compared cerclage with indomethacin and cerclage without indomethacin and suggested no difference between the groups. The other two published cohort studies had no referent group who received cerclage without tocolysis. One case series and one case report were also published reporting cerclage with empiric beta-mimetic and progesterone adjunctive therapy. CONCLUSION: There is a paucity of published data on the topic of adjunctive perioperative tocolytics with cerclage. Adequately powered clinical trials on perioperative use of tocolysis with cerclage compared with a standard cerclage placement alone are needed to establish efficacy. -
Pharmaceutical Services Division and the Clinical Research Centre Ministry of Health Malaysia
A publication of the PHARMACEUTICAL SERVICES DIVISION AND THE CLINICAL RESEARCH CENTRE MINISTRY OF HEALTH MALAYSIA MALAYSIAN STATISTICS ON MEDICINES 2008 Edited by: Lian L.M., Kamarudin A., Siti Fauziah A., Nik Nor Aklima N.O., Norazida A.R. With contributions from: Hafizh A.A., Lim J.Y., Hoo L.P., Faridah Aryani M.Y., Sheamini S., Rosliza L., Fatimah A.R., Nour Hanah O., Rosaida M.S., Muhammad Radzi A.H., Raman M., Tee H.P., Ooi B.P., Shamsiah S., Tan H.P.M., Jayaram M., Masni M., Sri Wahyu T., Muhammad Yazid J., Norafidah I., Nurkhodrulnada M.L., Letchumanan G.R.R., Mastura I., Yong S.L., Mohamed Noor R., Daphne G., Kamarudin A., Chang K.M., Goh A.S., Sinari S., Bee P.C., Lim Y.S., Wong S.P., Chang K.M., Goh A.S., Sinari S., Bee P.C., Lim Y.S., Wong S.P., Omar I., Zoriah A., Fong Y.Y.A., Nusaibah A.R., Feisul Idzwan M., Ghazali A.K., Hooi L.S., Khoo E.M., Sunita B., Nurul Suhaida B.,Wan Azman W.A., Liew H.B., Kong S.H., Haarathi C., Nirmala J., Sim K.H., Azura M.A., Asmah J., Chan L.C., Choon S.E., Chang S.Y., Roshidah B., Ravindran J., Nik Mohd Nasri N.I., Ghazali I., Wan Abu Bakar Y., Wan Hamilton W.H., Ravichandran J., Zaridah S., Wan Zahanim W.Y., Kannappan P., Intan Shafina S., Tan A.L., Rohan Malek J., Selvalingam S., Lei C.M.C., Ching S.L., Zanariah H., Lim P.C., Hong Y.H.J., Tan T.B.A., Sim L.H.B, Long K.N., Sameerah S.A.R., Lai M.L.J., Rahela A.K., Azura D., Ibtisam M.N., Voon F.K., Nor Saleha I.T., Tajunisah M.E., Wan Nazuha W.R., Wong H.S., Rosnawati Y., Ong S.G., Syazzana D., Puteri Juanita Z., Mohd. -
Indomethacin in Pregnancy: Applications and Safety
Original Article 175 Indomethacin in Pregnancy: Applications and Safety Gael Abou-Ghannam, M.D. 1 Ihab M. Usta, M.D. 1 Anwar H. Nassar, M.D. 1 1 Department of Obstetrics and Gynecology, American University of Address for correspondence and reprint requests Anwar H. Nassar, Beirut Medical Center, Hamra, Beirut, Lebanon M.D., American University of Beirut Medical Center, P.O. Box 113-6044/B36, Hamra 110 32090, Beirut, Lebanon (e-mail: [email protected]). Am J Perinatol 2012;29:175–186. Abstract Preterm labor (PTL) is a major cause of neonatal morbidity and mortality worldwide. Among the available tocolytics, indomethacin, a prostaglandin synthetase inhibitor, has been in use since the 1970s. Recent studies have suggested that prostaglandin synthetase inhibitors are superior to other tocolytics in delaying delivery for 48 hours and 7 days. However, increased neonatal complications including oligohydramnios, Keywords renal failure, necrotizing enterocolitis, intraventricular hemorrhage, and closure of the ► indomethacin patent ductus arteriosus have been reported with the use of indomethacin. Indometh- ► tocolysis acin has been also used in women with short cervices as well as in those with idiopathic ► preterm labor polyhydramnios. This article describes the mechanism of action of indomethacin and its ► short cervix clinical applications as a tocolytic agent in women with PTL and cerclage and its use in ► polyhydramnios the context of polyhydramnios. The fetal and neonatal side effects of this drug are also ► fetal side effects summarized and guidelines for its use are proposed. Preterm labor (PTL) is a major cause of neonatal morbidity in women with PTL and cerclage and its use in the context of and mortality worldwide.1 Care of premature infants has polyhydramnios. -
Course Manual Division of Physiology, Nutrition and Pathology
REFERENCE ONLY Mi' Winter School on 'RECENT ADVANCES IN DIAGNOSIS AND MANAGEMENT OF DISEASES Organising Committee IN MARICULTURE' Prof. (Dr) Mohan Joseph Modayil Director, CMFRI jth ^Q 27'^ November, 2002 Course Director Dr. K. C. George Principal Scientist, Course Manual Division of Physiology, Nutrition and Pathology Co-ordinators DP. R. Paul Raj, Head, P N P Division Dr. P. C. Thomas, Principal Scientist I C A R Shpi. N.K. Sanil, Scientist (Sr. Scale) Dr. (Mrs.) K.S. Sobhana, Scientist (Sr. Scale) Indian Council of Agricultural Research Central ^Aarine Fisheries Research Institute P B. No. 1603, Tatapuram P.O., Cochin 682 014 -gH4.|ffaT -r^mt Library •^ Qc^l^nf Mf,r,nc r^hcncs Rcso.rcn l,r tifirte Technical paper - 26 ANTIBIOTIC RESIDUES IN FARMED SHRIMP - A MAJOR HAZARD Dr.P.K. Surendran Head, Microbiology, Fermentation & Biotechnology Division Central Institute a/Fisheries Technology, Cochin-682 029 Antibiotics in aquaculture Even though use of antibiotics in aquaculture practice is unscientific, unwanted and harmful, antibiotics are being used for (i) therapeutic (ii) prophylactic and/or growth promoting purposes. Also, some manufactures are incorporating certain antibiotics in shrimp feed as a preservative. The devastating shrimp diseases like white spot syndrome disease and yellow head disease are caused by viruses. Antibiotics have no therapeutic value against viruses at all. Still many of our aquaculture farmers are dumping antibiotic formulations in their farms against viral diseases. Further, even bacterial diseases carmot be treated with antibiotics, since in the aquaculture environment, effectiveness of antibiotic therapy is not at all proved. The world over, use of antibiotics in aquaculture is banned.