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Annex I Summary of Product Characteristics
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 4 1. NAME OF THE MEDICINAL PRODUCT VISTIDE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains cidofovir equivalent to 375 mg/5 ml (75 mg/ml) cidofovir anhydrous. The formulation is adjusted to pH 7.4. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion 4. CLINICAL PARTICULARS 4.1 Therapeutic Indication Cidofovir is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. Until further experience is gained, cidofovir should be used only when other agents are considered unsuitable. 4.2 Posology and Method of Administration Before each administration of cidofovir, serum creatinine and urine protein levels should be investigated. The recommended dosage, frequency, or infusion rate must not be exceeded. Cidofovir must be diluted in 100 milliliters 0.9% (normal) saline prior to administration. To minimise potential nephrotoxicity, oral probenecid and intravenous saline prehydration must be administered with each cidofovir infusion. Dosage in Adults • Induction Treatment. The recommended dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hr) administered once weekly for two consecutive weeks. • Maintenance Treatment. Beginning two weeks after the completion of induction treatment, the recommended maintenance dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hr) administered once every two weeks. Cidofovir therapy should be discontinued and intravenous hydration is advised if serum creatinine increases by = 44 µmol/L (= 0.5 mg/dl), or if persistent proteinuria = 2+ develops. • Probenecid. -
Egfr and the Risk of Community-Acquired Infections
CJASN ePress. Published on August 17, 2017 as doi: 10.2215/CJN.00250117 Article eGFR and the Risk of Community-Acquired Infections | | Hong Xu,*† Alessandro Gasparini,†‡ Junichi Ishigami,§ Khaled Mzayen, Guobin Su, ¶ Peter Barany,† Johan A¨rnlo¨v,**†† Bengt Lindholm,† Carl Gustaf Elinder,† Kunihiro Matsushita,§ and Juan Jesu´s Carrero*† Abstract Background and objectives Community-acquired infections are common, contributing to adverse outcomes and increased health care costs. We hypothesized that, with lower eGFR, the incidence of community-acquired infections increases, whereas the pattern of site-specific infections varies. Departments of 6 *Medical Epidemiology Design,setting, participants,&measurementsAmong 1,139,470health careusers(meanage =52 18 years old, 53% and Biostatistics and | women) from the Stockholm CREAtinine Measurements Project, we quantified the associations of eGFR with the Public Health † risk of infections, overall and major types, over 12 months. Sciences and Division of Renal Medicine and Baxter Novum, ResultsA total of 106,807 counts of infections were recorded throughout 1,128,313 person-years. The incidence rate Department of Clinical of all infections increased with lower eGFR from 74/1000 person-years for individuals with eGFR=90–104 ml/min Science, Intervention per 1.73 m2 to 419/1000 person-years for individuals with eGFR,30 ml/min per 1.73 m2.ComparedwitheGFRof and Technology, 90–104 ml/min per 1.73 m2, the adjusted incidence rate ratios of community-acquired infections were 1.08 (95% Karolinska Institutet, fi – 2 fi Stockholm, Sweden; con dence interval, 1.01 to 1.14) for eGFR of 30 59 ml/min per 1.73 m and 1.53 (95% con dence interval, 1.39 to ‡Department of Health , 2 1.69) for eGFR 30 ml/min per 1.73 m . -
(COVID-19) Pandemic on Antimicrobial Prevalence and Prescribing in a Tertiary Hospital in Singapore
Effects of Coronavirus Disease 2019 (COVID-19) Pandemic on Antimicrobial Prevalence and Prescribing in a Tertiary Hospital in Singapore Tat Ming Ng ( [email protected] ) Tan Tock Seng Hospital https://orcid.org/0000-0002-4570-3266 Sock Hoon Tan Tan Tock Seng Hosptal Shi Thong Heng Tan Tock Seng Hospital Hui Lin Tay Tan Tock Seng Hospital Min Yi Yap Tan Tock Seng Hospital Boon Hou Chua Tan Tock Seng Hospital Christine B Teng National University of Singapore David C Lye National Centre for Infectious Diseases, Tan Tock Seng Hospital, Singapore Tau Hong Lee National Centre for Infectious Diseases, Tan Tock Seng Hospital Research Keywords: COVID-19, antimicrobial prevalence, Singapore, resources, antimicrobial stewardship, pandemic Posted Date: November 2nd, 2020 DOI: https://doi.org/10.21203/rs.3.rs-97787/v1 License: This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License Page 1/14 Version of Record: A version of this preprint was published on February 3rd, 2021. See the published version at https://doi.org/10.1186/s13756-021-00898-8. Page 2/14 Abstract Background: The deployment of antimicrobial stewardship (AMS) teams to deal with the COVID-19 pandemic can lead to a loss of developed frameworks, best practices and leadership resulting in adverse impact on antimicrobial prescribing and resistance. We aim to investigate effects of reduction in AMS resources during the COVID-19 pandemic on antimicrobial prescribing and resistance. Methods: One of 5 full-time equivalent AMS pharmacists was deployed to support pandemic work and AMS rounds with infectious disease physicians were reduced from 5 to 2 times a week. -
Fuzeon, INN-Enfuvirtide
BIJLAGE I SAMENVATTING VAN DE PRODUCTKENMERKEN 1 1. NAAM VAN HET GENEESMIDDEL Fuzeon 90 mg/ml poeder en oplosmiddel voor oplossing voor injectie 2. KWALITATIEVE EN KWANTITATIEVE SAMENSTELLING Iedere flacon bevat 108 mg enfuvirtide. 1 ml gereconstitueerde oplossing bevat 90 mg enfuvirtide. Voor hulpstoffen, zie rubriek 6.1. 3. FARMACEUTISCHE VORM Poeder en oplosmiddel voor oplossing voor injectie. Fuzeon is een wit tot gebroken wit gevriesdroogd poeder. 4. KLINISCHE GEGEVENS 4.1 Therapeutische indicaties Fuzeon is geïndiceerd, in combinatie met andere antiretrovirale middelen, voor de behandeling van HIV-1 geïnfecteerde patiënten, die eerder behandeld zijn en waarbij behandelingsregimes met tenminste één geneesmiddel uit elk van de antiretrovirale geneesmiddelklassen van proteaseremmers, non-nucleoside reverse transcriptaseremmers en nucleoside reverse transcriptaseremmers gefaald hebben of die intolerant zijn voor eerder gebruikte antiretrovirale behandelcombinaties (zie rubriek 5.1). Bij het vaststellen van een nieuw regime voor patiënten bij wie een antiretroviraal regime gefaald heeft, dienen de behandelingsgeschiedenis van de individuele patiënten en de patronen van mutaties geassocieerd met verschillende middelen zorgvuldig in overweging te worden genomen. Indien beschikbaar, is het testen van resistentie van toepassing (zie rubriek 4.4 en 5.1). 4.2 Dosering en wijze van toediening Fuzeon dient voorgeschreven te worden door artsen die ervaring hebben met de behandeling van HIV-infecties. Fuzeon dient alleen via een subcutane injectie toegediend te worden. Volwassenen en adolescenten ≥ 16 jaar: De aanbevolen dosering van Fuzeon is 90 mg tweemaal daags subcutaan geïnjecteerd in bovenarm, dijbeen of buik. Bejaarden: Er is geen ervaring bij patiënten ouder dan 65 jaar. Kinderen ≥ 6 jaar en adolescenten: De ervaring is gebaseerd op een zeer beperkt aantal kinderen (zie rubriek 5.2). -
Annex I Summary of Product Characteristics
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT VISTIDE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains cidofovir equivalent to 375 mg/5 ml (75 mg/ml) cidofovir anhydrous. The formulation is adjusted to pH 7.4. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Cidofovir is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. Until further experience is gained, cidofovir should be used only when other agents are considered unsuitable. 4.2 Posology and method of administration Before each administration of cidofovir, serum creatinine and urine protein levels should be investigated. The recommended dosage, frequency, or infusion rate must not be exceeded. Cidofovir must be diluted in 100 millilitres 0.9% (normal) saline prior to administration. To minimise potential nephrotoxicity, oral probenecid and intravenous saline prehydration must be administered with each cidofovir infusion. Please see under section 4.4 Special warnings and special precautions for use for appropriate recommendations. Dosage in adults • Induction treatment. The recommended dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hour) administered once weekly for two consecutive weeks. • Maintenance treatment. Beginning two weeks after the completion of induction treatment, the recommended maintenance dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hour) administered once every two weeks. Dosage in elderly The safety and efficacy of cidofovir have not been established for the treatment of CMV disease in patients over 60 years of age. -
Póster EAHP 2018
nº 4CPS-095 ATC code: J05 - Antivirals for systemic use DRUG-DRUG INTERACTIONS AMONG HEPATITIS C PATIENTS TREATED WITH DIRECT ACTING ANTIVIRALS Rodríguez Vargas B1, Matilla García. E 1, Apezteguía Fernández C1, Bautista Sanz MP 1, Esteban del Hoyo L1, Santaolalla García I1, Moreno Díaz R1. 1Infanta Cristina University Hospital, Pharmacy, Madrid, Spain. Background Interferon-free combination direct acting antivirals (DAAs) regimens have improved tolerability and efficacy for HCV-infected patients but it is necesary to check drug-drug interactions (DDIs) because they have the potential to cause toxicity or loss of efficacy to treat HCV. Purpose To describe the interactions associated with the use of comedications in patients treated with DAA using a computer generated alarm tool. Material and methods Prospective observational study. All HCV-infectect patients initiating DAAs regimens were included. DDIs between DAAs and other comedications were cross-checked using Farmaweb tool. Farmaweb is a web based solution that analyzes patients´ drug prescription. Clinically relevant DDIs are classified according to University of Liverpool database as drug combination contraindicated or not recommended (type A) and potential interaction that may require close monitoring or changing dose (type B). The Anatomical Therapeutic Chemical (ATC) groups involved in DDIs were analized. Data collection was performed between January 2016–July 2017. Results 96 potentially relevant interactions were observed in 68 patients. DAAs involved in DDIs were sofosbuvir/ledipasvir (55.2%), paritaprevir/ritonavir, ombitasvir plus dasabuvir (35.4%), grazoprevir/elbasvir (5.2%) and daclatasvir (4.2%). 9 different DDIs were detected for sofosbuvir/ledipasvir, 14 for paritaprevir/ritonavir, ombitasvir plus dasabuvir, 5 for grazoprevir/elbasvir and 4 for daclatasvir. -
Vistide, INN – Cidofovir
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT VISTIDE 75 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains cidofovir equivalent to 375 mg/5 ml (75 mg/ml) cidofovir anhydrous. The formulation is adjusted to pH 7.4. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications VISTIDE is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. Until further experience is gained, VISTIDE should be used only when other agents are considered unsuitable. 4.2 Posology and method of administration The therapy should be prescribed by a physician experienced in the management of HIV infection. Before each administration of VISTIDE, serum creatinine and urine protein levels should be investigated. The recommended dosage, frequency, or infusion rate must not be exceeded. VISTIDE must be diluted in 100 millilitres 0.9% (normal) saline prior to administration. To minimise potential nephrotoxicity, oral probenecid and intravenous saline prehydration must be administered with each VISTIDE infusion. Please see under section 4.4 Special warnings and special precautions for use for appropriate recommendations, and under section 6.6 for information on obtaining probenecid. Dosage in adults Induction treatment. The recommended dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hour) administered once weekly for two consecutive weeks. Maintenance treatment. Beginning two weeks after the completion of induction treatment, the recommended maintenance dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hour) administered once every two weeks. -
HICDEP: HIV Cohorts Data Exchange Protocol
HICDEP: HIV Cohorts Data Exchange Protocol Version 1.30 – 28th of March 2008 Edited by Jesper Kjær and Bruno Ledergerber Updates maintained by: Jesper Kjær CHIP - Copenhagen HIV Programme University of Copenhagen, Faculty of Health Sciences The Panum Institute/Building 21.1 Blegdamsvej 3B 2200 Copenhagen N Denmark E-mail [email protected] HICDEP: HIV Cohorts Data Exchange Protocol Version 1.30 – 28th of March 2008 Table of contents 1 About this document .................................................................................................................................................................................................................................................................................6 2 General data format...................................................................................................................................................................................................................................................................................7 2.1 Overview of data tables..................................................................................................................................................................................................................................................................7 2.2 Diagram..........................................................................................................................................................................................................................................................................................8 -
Evaluation of Carcinogenicity Studies of Medicinal Products for Human Use Authorised Via the European Centralised Procedure
Regulatory Toxicology and Pharmacology xxx (2011) xxx–xxx Contents lists available at ScienceDirect Regulatory Toxicology and Pharmacology journal homepage: www.elsevier.com/locate/yrtph Evaluation of carcinogenicity studies of medicinal products for human use authorised via the European centralised procedure (1995–2009) ⇑ Anita Friedrich a, , Klaus Olejniczak b a Granzer Regulatory Consulting and Services, Zielstattstrasse 44, 81379 Munich, Germany b Federal Institute for Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, Germany article info abstract Article history: Carcinogenicity data of medicinal products for human use that have been authorised via the European Received 25 October 2010 centralised procedure (CP) between 1995 and 2009 were evaluated. Carcinogenicity data, either from Available online xxxx long-term rodent carcinogenicity studies, transgenic mouse studies or repeat-dose toxicity studies were available for 144 active substances contained in 159 medicinal products. Out of these compounds, 94 Keywords: (65%) were positive in at least one long-term carcinogenicity study or in repeat-dose toxicity studies. Medicinal products Fifty compounds (35%) showed no evidence of a carcinogenic potential. Out of the 94 compounds with Carcinogenicity positive findings in either carcinogenicity or repeat-dose toxicity studies, 33 were positive in both mice Rodents and rats, 40 were positive in rats only, and 21 were positive exclusively in mice. Long-term carcinogenic- ity studies in two rodent species were available for 116 compounds. Data from one long-term carcinoge- nicity study in rats and a transgenic mouse model were available for eight compounds. For 13 compounds, carcinogenicity data were generated in only one rodent species. One compound was exclu- sively tested in a transgenic mouse model. -
Japanese Hepatitis C Market Forecast: Methodology and Implications
| 1 e-Projection Sales Forecast Report Japanese Hepatitis C Market Forecast: Methodology and Implications This article was originally published in the Japanese journal, International Pharmaceutical Intelligence (国際医薬品情報), on May 9, 2016. Updates to the report as of August 2018 The actual sales of Harvoni and Sovaldi in Japan in the fiscal year 2016 were 1.6 billion yen and 713 hundred million yen, respectively, according to IQVIA Topline Market Data report (2017 figures are not disclosed). There were no significant price cuts to Harvoni and Sovaldi in April 2018. Original (Japanese) published on May 9, 2016 Translation on September 23, 2016 Correspondent author: Tosh Nagate Principal analyst, President e-Projection [email protected] Executive Summary Hepatitis C is a serious burden to the Japanese society, and the treatment of the disease represents a crucial issue. Recent advances in technology have made highly effective drugs with fewer side effects available to the patients. The development and the commercialization of direct antiviral agents (DAAs) have become a hallmark to the hepatitis C virus (HCV) treatment paradigm. These drugs have achieved a sustained virological response (SVR) rate as high as almost 100% in clinical trials, meaning virtually eliminating the virus from most of the patients. Driven by the performance of these drugs, the market for antiviral agents in Japan has almost reached five billion dollars in 2015, representing an astonishing growth rate of 125% per year. To predict the dynamics of the HCV DAA market, we have employed a simple stochastic process model to project the patient population from 2016 to 2025. -
Annex I Summary of Product Characteristics
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Hepsera 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg adefovir dipivoxil equivalent to 5.45 mg adefovir. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Tablet. White to off-white, round, flat-faced, bevelled-edge tablets, debossed with “GILEAD” and “10” on one side and a stylised shape of a liver on the other side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Hepsera is indicated for the treatment of chronic hepatitis B in adults with: · compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis · decompensated liver disease. 4.2 Posology and method of administration Therapy should be initiated by a physician experienced in the management of chronic hepatitis B. Adults: The recommended dose of Hepsera is 10 mg (one tablet) once daily taken orally with or without food. Higher doses must not be administered. The optimum duration of treatment is unknown. The relationship between treatment response and long-term outcomes such as hepatocellular carcinoma or decompensated cirrhosis is not known. Patients should be monitored every six months for hepatitis B biochemical, virological and serological markers. Treatment discontinuation may be considered as follows: In HBeAg positive patients, treatment should be administered at least until HBeAg seroconversion (HBeAg and HBV DNA loss with HBeAb detection on 2 consecutive serum samples at least 3 months apart) or until HBsAg seroconversion or in case of evidence of loss of efficacy (see 4.4). -
Master Thesis
MASTER THESIS Titel der Master Thesis / Title of the Master‘s Thesis „Teilbarkeit, Zermörserbarkeit und Sondengängigkeit von Arzneimitteln im Krankenhaus Barmherzige Schwestern Wien“ verfasst von / submitted by Mag.pharm. Anna Mayer angestrebter akademischer Grad / in partial fulfilment of the requirements for the degree of Master of Science (MSc) Wien, 2017 / Vienna 2017 Studienkennzahl lt. Studienblatt / A 992 580 Postgraduate programme code as it appears on the student record sheet: Universitätslehrgang lt. Studienblatt / Pharmazeutisches Qualitätsmanagement / Postgraduate programme as it appears on Pharmaceutical Quality Management the student record sheet: Betreut von / Supervisor: Dr. Christoph Baumgärtel, MSc Inhalt 1 Einleitung ....................................................................................................................... 6 2 Methode ........................................................................................................................ 8 3 Krankenhaus der Barmherzigen Schwestern Wien .......................................................10 4 Informationsquellen zur Sondengängigkeit von Arzneimitteln .......................................11 4.1 Fachinformation .....................................................................................................11 4.2 Andere Informationsquellen ....................................................................................11 4.2.1 Sondenlisten von Krankenhäusern, pharmatrix-Arzneimittelinformation ..........11 4.2.2 Hersteller von Sonden,