List of Selected Drugs
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Appendix a Common Abbreviations Used in Medication
UNIVERSITY OF AMSTERDAM MASTERS THESIS Impact of Medication Grouping on Fall Risk Prediction in Elders: A Retrospective Analysis of MIMIC-III Critical Care Database Student: SRP Mentor: Noman Dormosh Dr. Martijn C. Schut Student No. 11412682 – SRP Tutor: Prof. dr. Ameen Abu-Hanna SRP Address: Amsterdam University Medical Center - Location AMC Department Medical Informatics Meibergdreef 9, 1105 AZ Amsterdam Practice teaching period: November 2018 - June 2019 A thesis submitted in fulfillment of the requirements for the degree of Master of Medical Informatics iii Abstract Background: Falls are the leading cause of injury in elderly patients. Risk factors for falls in- cluding among others history of falls, old age, and female gender. Research studies have also linked certain medications with an increased risk of fall in what is called fall-risk-increasing drugs (FRIDs), such as psychotropics and cardiovascular drugs. However, there is a lack of consistency in the definitions of FRIDs between the studies and many studies did not use any systematic classification for medications. Objective: The aim of this study was to investigate the effect of grouping medications at different levels of granularity of a medication classification system on the performance of fall risk prediction models. Methods: This is a retrospective analysis of the MIMIC-III cohort database. We created seven prediction models including demographic, comorbidity and medication variables. Medica- tions were grouped using the anatomical therapeutic chemical classification system (ATC) starting from the most specific scope of medications and moving up to the more generic groups: one model used individual medications (ATC level 5), four models used medication grouping at levels one, two, three and four of the ATC and one model did not include med- ications. -
Fosavance, INN-Alendronic Acid and Colecalciferol
EMA/175858/2015 EMEA/H/C/000619 EPAR summary for the public Fosavance alendronic acid and colecalciferol This is a summary of the European public assessment report (EPAR) for Fosavance. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fosavance. What is Fosavance? Fosavance is a medicine that contains two active substances: alendronic acid and colecalciferol (vitamin D3). It is available as tablets (70 mg alendronic acid and 2,800 international units [IU] colecalciferol; 70 mg alendronic acid and 5,600 IU colecalciferol). What is Fosavance used for? Fosavance (containing either 2,800 or 5,600 IU colecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of low vitamin D levels. Fosavance 70 mg/5,600 IU is for use in patients who are not taking vitamin D supplements. Fosavance reduces the risk of fractures (broken bones) in the spine and the hip. The medicine can only be obtained with a prescription. How is Fosavance used? The recommended dose of Fosavance is one tablet once a week. It is intended for long-term use. The patient must take the tablet with a full glass of water (but not mineral water), at least 30 minutes before any food, drink or other medicines (including antacids, calcium supplements and vitamins). To avoid irritation of the oesophagus (the tube that leads from the mouth to the stomach), the patient should not lie down until after their first food of the day, which should be at least 30 minutes after taking the tablet. -
Injectable PLGA Adefovir Microspheres; the Way for Long Term Therapy of T Chronic Hepatitis-B ⁎ Margrit M
European Journal of Pharmaceutical Sciences 118 (2018) 24–31 Contents lists available at ScienceDirect European Journal of Pharmaceutical Sciences journal homepage: www.elsevier.com/locate/ejps Injectable PLGA Adefovir microspheres; the way for long term therapy of T chronic hepatitis-B ⁎ Margrit M. Ayouba, , Neveen G. Elantounyb, Hanan M. El-Nahasa, Fakhr El-Din S. Ghazya a Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Zagazig University, Zagazig, Egypt b Department of Internal Medicine, Faculty of Medicine, Zagazig University, Zagazig, Egypt ARTICLE INFO ABSTRACT Keywords: For patient convenience, sustained release Adefovir Poly-d,l-lactic-co-glycolic acid (PLGA) microspheres were Adefovir formulated to relieve the daily use of the drug which is a problem for patients treated from chronic hepatitis-B. Biodegradable microspheres PLGA microspheres were prepared and characterized by entrapment efficiency, particle size distribution and Poly-lactic-co-glycolic acid scanning electron microscopy (SEM). In-vitro release and in-vivo studies were carried out. Factors such as drug: Entrapment efficiency polymer ratio, polymer viscosity and polymer lactide content were found to be important variables for the preparation of PLGA Adefovir microspheres. Fourier transform infrared (FTIR) analysis and differential scanning calorimetry (DSC) were performed to determine any drug-polymer interactions. One way analysis of variance (ANOVA) was employed to analyze the pharmacokinetic parameters after intramuscular injection of the pure drug and the selected PLGA microspheres into rats. FTIR and DSC revealed a significant interaction between the drug and the polymer. Reports of SEM before and after 1 and 24 h release showed that the microspheres had nonporous smooth surface even after 24 h release. -
Hepsera, INN- Defovir Dipivoxil
SCIENTIFIC DISCUSSION This module reflects the initial scientific discussion for the approval of Hepsera. For information on changes after approvalplease refer to module 8B 1. Chemical, pharmaceutical and biological aspects Composition Hepsera is presented as an immediate release tablet containing 10 mg of adefovir dipivoxil, as active substance. The other ingredients in this formulation are commonly used in tablets Hepsera is supplied in high-density polyethylene bottle (HDPE), with silica gel desiccant canisters or sachets, and polyester fiber packing material. The closure system consists of a child-resistant polypropylene screw cap lined with an induction activated aluminium foil liner. Active substance Adefovir dipivoxil is an ester prodrug of the nucleotide analogue, adefovir. A structural modification of the parent drug has been carried out in order to increase the lipophilicity and to enhance the oral bioavailability of adefovir. The active substance is a white to off-white crystalline powder. It is soluble in ethanol, sparingly soluble in 0.1N HCl and very slightly soluble in water adjusted to pH 7.2 but relatively highly soluble at physiological pH. The active substance does not contain any chiral center and does not exhibit any optical isomerism. In laboratory studies the anhydrate crystal form has been observed to convert gradually into a dihydrate crystal form when adefovir dipivoxil was exposed to high humidity conditions (75% R.H., 25ºC) over an approximately one-month period. However, the only crystal form produced during the active substance synthesis and utilised in non-clinical and clinical studies has been the anhydrous crystal form. Adefovir dipivoxil undergoes also hydrolysis in aqueous solution and to a smaller degree in the solid state after exposure to humidity and heat for extended periods. -
Adrovance, INN-Alendronic Acid
EMA/194587/2011 EMEA/H/C/000759 EPAR summary for the public Adrovance alendronic acid / colecalciferol This is a summary of the European public assessment report (EPAR) for Adrovance. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Adrovance. What is Adrovance? Adrovance is a medicine that contains two active substances: alendronic acid and colecalciferol (vitamin D3). It is available as white tablets (capsule-shaped: 70 mg alendronic acid and 2,800 international units [IU] colecalciferol; rectangular: 70 mg alendronic acid and 5,600 IU colecalciferol). What is Adrovance used for? Adrovance (containing either 2,800 or 5,600 IU colecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of low vitamin D levels. Adrovance 70 mg/5,600 IU is for use in patients who are not taking vitamin D supplements. Adrovance reduces the risk of broken bones in the spine and the hip. The medicine can only be obtained with a prescription. How is Adrovance used? The recommended dose of Adrovance is one tablet once a week. It is intended for long-term use. The patient must take the tablet with a full glass of water (but not mineral water), at least 30 minutes before any food, drink or other medicines (including antacids, calcium supplements and vitamins). To avoid irritation of the oesophagus (gullet), the patient should not lie down until after their first food of the day, which should be at least 30 minutes after taking the tablet. -
Specifications of Approved Drug Compound Library
Annexure-I : Specifications of Approved drug compound library The compounds should be structurally diverse, medicinally active, and cell permeable Compounds should have rich documentation with structure, Target, Activity and IC50 should be known Compounds which are supplied should have been validated by NMR and HPLC to ensure high purity Each compound should be supplied as 10mM solution in DMSO and at least 100µl of each compound should be supplied. Compounds should be supplied in screw capped vial arranged as 96 well plate format. -
The Impact of a Changed Legislation on Reporting of Adverse Drug Reactions in Sweden, with Focus on Nurses Reporting
The impact of a changed legislation on reporting of adverse drug reactions in Sweden, with focus on nurses reporting Sofia A. Karlsson, Ingela Jacobsson, Marit Danell Boman, Katja M. Hakkarainen, Henrik Lövborg, Staffan Hägg and Anna K Jönsson Linköping University Post Print N.B.: When citing this work, cite the original article. The original publication is available at www.springerlink.com: Sofia A. Karlsson, Ingela Jacobsson, Marit Danell Boman, Katja M. Hakkarainen, Henrik Lövborg, Staffan Hägg and Anna K Jönsson, The impact of a changed legislation on reporting of adverse drug reactions in Sweden, with focus on nurses reporting, 2015, European Journal of Clinical Pharmacology, (71), 5, 631-636. http://dx.doi.org/10.1007/s00228-015-1839-6 Copyright: Springer Verlag (Germany) http://www.springerlink.com/?MUD=MP Postprint available at: Linköping University Electronic Press http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-118037 The impact of a changed legislation on reporting of adverse drug reactions in Sweden, with focus on nurses’ reporting Sofia A Karlsson1, Ingela Jacobsson2, Marit Danell Boman3, Katja M Hakkarainen4,5, Henrik Lövborg2, Staffan Hägg2,5, Anna K Jönsson2 Affiliations: 1. Department of Public Health and Community Medicine, the Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden 2. Department of Clinical Pharmacology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden 3. Division of Clinical Pharmacology, University Hospital of Umeå, Umeå, Sweden 4. Nordic School of -
Australian Public Assessment Report for Abatacept (Rch)
Australian Public Assessment Report for Abatacept (rch) Proprietary Product Name: Orencia Sponsor: Bristol-Myers Squibb Australia Pty Ltd June 2011 About the Therapeutic Goods Administration (TGA) · The TGA is a division of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices. · TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. · The work of the TGA is based on applying scientific and clinical expertise to decision- making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. · The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. · To report a problem with a medicine or medical device, please see the information on the TGA website. About AusPARs · An Australian Public Assessment Record (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. · AusPARs are prepared and published by the TGA. · An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations, and extensions of indications. · An AusPAR is a static document, in that it will provide information that relates to a submission at a particular point in time. · A new AusPAR will be developed to reflect changes to indications and/or major variations to a prescription medicine subject to evaluation by the TGA. -
Characterising the Risk of Major Bleeding in Patients With
EU PE&PV Research Network under the Framework Service Contract (nr. EMA/2015/27/PH) Study Protocol Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU Version 3.0 1 June 2018 EU PAS Register No: 16014 EMA/2015/27/PH EUPAS16014 Version 3.0 1 June 2018 1 TABLE OF CONTENTS 1 Title ........................................................................................................................................... 5 2 Marketing authorization holder ................................................................................................. 5 3 Responsible parties ................................................................................................................... 5 4 Abstract ..................................................................................................................................... 6 5 Amendments and updates ......................................................................................................... 7 6 Milestones ................................................................................................................................. 8 7 Rationale and background ......................................................................................................... 9 8 Research question and objectives .............................................................................................. 9 9 Research methods .................................................................................................................... -
(12) Patent Application Publication (10) Pub. No.: US 2017/0209462 A1 Bilotti Et Al
US 20170209462A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2017/0209462 A1 Bilotti et al. (43) Pub. Date: Jul. 27, 2017 (54) BTK INHIBITOR COMBINATIONS FOR Publication Classification TREATING MULTIPLE MYELOMA (51) Int. Cl. (71) Applicant: Pharmacyclics LLC, Sunnyvale, CA A 6LX 3/573 (2006.01) A69/20 (2006.01) (US) A6IR 9/00 (2006.01) (72) Inventors: Elizabeth Bilotti, Sunnyvale, CA (US); A69/48 (2006.01) Thorsten Graef, Los Altos Hills, CA A 6LX 3/59 (2006.01) (US) A63L/454 (2006.01) (52) U.S. Cl. CPC .......... A61 K3I/573 (2013.01); A61K 3 1/519 (21) Appl. No.: 15/252,385 (2013.01); A61 K3I/454 (2013.01); A61 K 9/0053 (2013.01); A61K 9/48 (2013.01); A61 K (22) Filed: Aug. 31, 2016 9/20 (2013.01) (57) ABSTRACT Disclosed herein are pharmaceutical combinations, dosing Related U.S. Application Data regimen, and methods of administering a combination of a (60) Provisional application No. 62/212.518, filed on Aug. BTK inhibitor (e.g., ibrutinib), an immunomodulatory agent, 31, 2015. and a steroid for the treatment of a hematologic malignancy. US 2017/0209462 A1 Jul. 27, 2017 BTK INHIBITOR COMBINATIONS FOR Subject in need thereof comprising administering pomalido TREATING MULTIPLE MYELOMA mide, ibrutinib, and dexamethasone, wherein pomalido mide, ibrutinib, and dexamethasone are administered con CROSS-REFERENCE TO RELATED currently, simulataneously, and/or co-administered. APPLICATION 0008. In some aspects, provided herein is a method of treating a hematologic malignancy in a subject in need 0001. This application claims the benefit of U.S. -
Assessing the Availability, Service Quality, and Price of Essential Medicines In
Assessing the Availability, Service Quality, and Price of Essential Medicines in Private Pharmacies in Afghanistan Norio Kasahara A dissertation submitted in partial fulfillment of the requirements for the degree of Doctor of Philosophy University of Washington 2015 Reading Committee: Louis P. Garrison, Jr., Chair Joseph B. Babigumira Andy Stergachis Program Authorized to Offer Degree: Pharmaceutical Outcomes Research and Policy ©Copyright 2015 Norio Kasahara ii Table of Contents Abstract ................................................................................................................................................................................... ................................................................................................ ................................................................................................ .................................................................................. ............... vvv Acknowledgements ................................................................................................................................................................................... ................................................................................................ ................................................................................. ............ viiviivii Summary ................................................................................................................................................................................... ............................................................................................... -
Medication Assisted Treatment MAT
Medication Assisted Treatment MAT The Root Center provides medication assisted treatment (MAT) for substance use disorders to those who qualify. MAT uses medications in combination with counseling and behavioral therapies to provide a “whole-patient” approach. The ultimate goal of MAT is full recovery, including the ability to live a self-directed life. This treatment approach has been shown to: improve patient survival, increase retention in treatment, decrease illicit opiate and other drug use as well as reduce other criminal activity among people with substance use disorders, increase patients’ ability to gain and maintain employment, and improve birth outcomes among women who have substance use disorders and are pregnant. These approved medications assist with urges, cravings, withdrawal symptoms, and some act as a blocking mechanism for the euphoric effects of alcohol and opioids. Currently, Root offers methadone for opioid use disorder and is considering adding other medications listed below. Opioid Use Disorder Overdose Prevention Methadone Methadone is an opioid treatment medication that reduces withdrawal Naloxone symptoms in people addicted to heroin or other narcotic drugs without Naloxone is a medication which causing the “high” associated with the drug. saves lives by reversing the effects of an opioid overdose. Root Center Methadone is used as a pain reliever and as part of drug addiction patients, their friends and family detoxification and maintenance programs. It is available only from members, can receive a prescription a certified pharmacy. for Naloxone as early as the initial evaluation and throughout treatment. Buprenorphine The medication is administered Buprenorphine is an opioid treatment medication and the combination at the time of the overdose.