New Brunswick Drug Plans Formulary
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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 -
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 .................................................................................................................... -
Initial Proposed Smpc Plus Proposed Revisions
1. NAME OF THE MEDICINAL PRODUCT Leticia 28 150 micrograms/30 microgram film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 21 white or almost white film-coated tablets: Each film-coated tablet contains 150 micrograms desogestrel 30 micrograms ethinylestradiol. Excipient with known effect: 64.3 mg lactose (as lactose monohydrate). 7 green placebo (inactive) film-coated tablets: The tablet does not contain active substances. Excipients with known effect: 37.26 mg lactose anhydrous and 0.003 mg sunset yellow. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. The active tablet is white, or almost white, round shaped, biconvex film-coated tablets of 6 mm diameter, with P8 sign on one side and RG sign on other side. The placebo tablet is green, round, biconvex film-coated tablet, diameter about 6 mm, without engraving. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Oral contraception The decision to prescribe Leticia 28 should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Leticia 28 compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 Posology and method of administration Posology How to take Leticia 28 The tablets must be taken in the order directed on the package every day at about the same time of the day. Tablet taking is continuous. One tablet is taken daily for 28 consecutive days. Each subsequent pack is started after the last tablet of the previous pack. During the intake of the 7 placebo tablets bleeding usually occurs. -
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 ................................................................................................................................................................................... ............................................................................................... -
European Medicines Agency Accepts Marketing Authorization Application for Asfotase Alfa As a Treatment for Patients with Hypophosphatasia
July 24, 2014 European Medicines Agency Accepts Marketing Authorization Application for Asfotase Alfa as a Treatment for Patients with Hypophosphatasia -- Application designated for review under accelerated assessment process -- CHESHIRE, Conn.--(BUSINESS WIRE)-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the Marketing Authorization Application (MAA) for asfotase alfa, an investigational, first-in-class targeted enzyme replacement therapy for the treatment of hypophosphatasia (HPP), has been validated and granted accelerated assessment by the European Medicines Agency (EMA). The acceptance of this MAA marks the beginning of the review process in the European Union (EU) for this potential new treatment. "HPP is a devastating disease for patients and their families due to progressive deterioration of bones and muscle weakness, which can result in impaired respiratory function, severe disability and death," said Leonard Bell, M.D., Chief Executive Officer of Alexion. "If approved, asfotase alfa would be the first therapy for patients with this life-threatening disorder." The EU filing includes positive data from 68 patients with pediatric-onset HPP (ranging from newborns to 66 years of age) enrolled in three pivotal prospective studies and their extensions, as well as a retrospective natural history study in infants. In April, Alexion initiated the rolling submission of a Biologics License Application (BLA) for asfotase alfa as a treatment for patients with HPP with the U.S. Food and Drug Administration (FDA). About -
Health Reports for Mutual Recognition of Medical Prescriptions: State of Play
The information and views set out in this report are those of the author(s) and do not necessarily reflect the official opinion of the European Union. Neither the European Union institutions and bodies nor any person acting on their behalf may be held responsible for the use which may be made of the information contained therein. Executive Agency for Health and Consumers Health Reports for Mutual Recognition of Medical Prescriptions: State of Play 24 January 2012 Final Report Health Reports for Mutual Recognition of Medical Prescriptions: State of Play Acknowledgements Matrix Insight Ltd would like to thank everyone who has contributed to this research. We are especially grateful to the following institutions for their support throughout the study: the Pharmaceutical Group of the European Union (PGEU) including their national member associations in Denmark, France, Germany, Greece, the Netherlands, Poland and the United Kingdom; the European Medical Association (EMANET); the Observatoire Social Européen (OSE); and The Netherlands Institute for Health Service Research (NIVEL). For questions about the report, please contact Dr Gabriele Birnberg ([email protected] ). Matrix Insight | 24 January 2012 2 Health Reports for Mutual Recognition of Medical Prescriptions: State of Play Executive Summary This study has been carried out in the context of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross- border healthcare (CBHC). The CBHC Directive stipulates that the European Commission shall adopt measures to facilitate the recognition of prescriptions issued in another Member State (Article 11). At the time of submission of this report, the European Commission was preparing an impact assessment with regards to these measures, designed to help implement Article 11. -
Annex I Summary of Product Characteristics
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT NutropinAq 10 mg/2 ml (30 IU) solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One cartridge contains 10 mg (30 IU) of somatropin* * human growth hormone produced in Escherichia coli cells by recombinant DNA technology. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. NutropinAq is a solution for subcutaneous use. The clear, colourless, sterile solution for multidose use is contained in a glass cartridge, closed with a rubber stopper and a rubber seal. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications - Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion. - Long-term treatment of growth failure associated with Turner syndrome. - Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. - Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology. Growth hormone deficiency should be confirmed appropriately prior to treatment (see section 4.4). 4.2 Posology and method of administration Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with the therapeutic indication of use. The NutropinAq dosage and administration schedule should be individualised for each patient. Dosage Growth failure in children due to inadequate growth hormone secretion: 0.025 - 0.035 mg/kg bodyweight given as a daily subcutaneous injection. Somatropin therapy should be continued in children and adolescents until their epiphysis are closed. -
Summary of Product Characteristics
Health Products Regulatory Authority Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Audaval 0.1% Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of ointment contains 1 mg of betamethasone (0.1% w/w) as valerate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment Opaque ointment. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications Audaval preparations are indicated for the treatment of: eczema in children over 1 year elderly and adults; including atopic and discoid eczemas; prurigo nodularis; psoriasis (excluding widespread plaque psoriasis); neurodermatoses, including lichen simplex, lichen planus; seborrhoeic dermatitis; contact sensitivity reactions; discoid lupus erythematosus and they may be used as an adjunct to systemic steroid therapy in generalised erythroderma. In general, ointment preparations are particularly appropriate for dry, lichenified or scaly skin conditions whereas a cream preparation may be more suitable in the case of moist or weeping lesions. 4.2 Posology and method of administration For topical use only. If no improvement is seen after two to four weeks, the diagnosis should be reconsidered and specialist referral may be necessary. Adults, adolescents and the elderly A small quantity of Audaval should be applied to the affected area one to three times daily as directed by physician until improvement occurs. It may then be possible to maintain improvement by applying once a day, or even less often, or by using the appropriate ready diluted (1 in 4) preparation, Audaval RD 0.025% Ointment. Allow adequate time for absorption after each application before applying an emollient. If no improvement is seen within two to four weeks, reassessment of the diagnosis, or referral, may be necessary. -
Asfotase Alfa for Infants and Young Children with Hypophosphatasia: 7 Year Outcomes of a Single-Arm, Open-Label, Phase 2 Extension Trial
Articles Asfotase alfa for infants and young children with hypophosphatasia: 7 year outcomes of a single-arm, open-label, phase 2 extension trial Michael P Whyte, Jill H Simmons, Scott Moseley, Kenji P Fujita, Nicholas Bishop, Nada J Salman, John Taylor, Dawn Phillips, Mairead McGinn, William H McAlister Summary Background Our previous phase 2, open-label study of 11 infants and young children with life-threatening perinatal or Lancet Diabetes Endocrinol infantile hypophosphatasia showed 1 year safety and efficacy of asfotase alfa, an enzyme replacement therapy. We 2019; 7: 93–105 aimed to report the long-term outcomes over approximately 7 years of treatment. Published Online December 14, 2018 http://dx.doi.org/10.1016/ Methods We did a prespecified, end of study, 7 year follow-up of our single-arm, open-label, phase 2 trial in which S2213-8587(18)30307-3 children aged 3 years or younger with life-threatening perinatal or infantile hypophosphatasia were recruited from This online publication has been ten hospitals (six in the USA, two in the UK, one in Canada, and one in the United Arab Emirates). Patients received corrected. The corrected version asfotase alfa (1 mg/kg three times per week subcutaneously, adjusted to 3 mg/kg three times per week if required) for first appeared at thelancet. up to 7 years (primary treatment period plus extension phase) or until the product became commercially available; com/diabetes-endocrinology on January 22, 2019 dosage adjustments were made at each visit according to changes in the patient’s weight. The primary objectives of See Comment page 76 this extension study were to assess the long-term tolerability of asfotase alfa, defined as the number of patients with Center for Metabolic Bone one or more treatment-emergent adverse events, and skeletal manifestations associated with hypophosphatasia, Disease and Molecular evaluated using the Radiographic Global Impression of Change (RGI-C) scale (−3 indicating severe worsening, and Research, Shriners Hospital for +3 complete or near-complete healing). -
Endogenous Metabolites in Drug Discovery: from Plants to Humans
Endogenous Metabolites in Drug Discovery: from Plants to Humans Joaquim Olivés Farrés TESI DOCTORAL UPF / ANY 201 6 DIRECTOR DE LA TESI: Dr. Jordi Mestres CEXS Department The research in this T hesis has been carried out at the Systems Pharmacolo gy Group , within the Research Programme on Biomedical Informatics (GRIB) at the Parc de Recerca Biomèdica de Barcelona (PRBB). The research presented in this T hesis has been supported by Ministerio de Ciencia e Innovación project BIO2014 - 54404 - R and BIO2011 - 26669 . Printing funded by the Fundació IMIM’s program “Convocatòria d'ajuts 2016 per a la finalització de tesis doctorals de la Fundació IMIM.” Agraïments Voldria donar les gràcies a tanta gent que em fa por deixar - me ningú. Però per c omençar haig agrair en especial al meu director la tesi, Jordi Mestres, per donar - me la oportunitat de formar part del seu laboratori i poder desenvolupar aquí el treball que aquí es presenta. A més d’oferir l’ajuda necessària sempre que ha calgut. També haig de donar les gràcies a tots els companys del grup de Farmacologia de Sistemes que he anat coneguent durants tots aquests anys en què he estat aquí, en especial en Xavi, a qui li he preguntat mil coses, en Nikita, pels sdfs que m’ha anat llençant a CTL ink, i la Irene i la Cristina, que els seus treballs també m’ajuden a completar la tesis. I cal agrair també a la resta de companys del laboratori, l’Albert, la Viktoria, la Mari Carmen, l’Andreas, en George, l’Eric i l’Andreu; de Chemotargets, en Ricard i en David; i altres membres del GRIB, com són l’Alfons, en Miguel, en Pau, l’Oriol i la Carina. -
Middelinteracties Bij Patiënten Met Kanker, Behandeld Met Orale Antikankermiddelen
OVERZICHTSARTIKELEN 4 Prevalentie van potentiële genees- middelinteracties bij patiënten met kanker, behandeld met orale antikankermiddelen Prevalence of potential drug-drug interactions in cancer patients treated with oral anti-cancer drugs drs. F.M. de Man1*, drs. F. Piran2*, D.H.S. Brundel3, prof. dr. C. Neef4, prof. dr. T. van Gelder5, prof. dr. R.H.J. Mathijssen6, prof. dr. D.M. Burger7, dr. F.G.A. Jansman8 en drs. R.W.F. van Leeuwen9 Samenvatting Achtergrond: Potentiële geneesmiddelinteracties (PGI’s) Resultaten: Bij 898 geïncludeerde patiënten werden bij komen veelvuldig voor bij kankerpatiënten, maar zijn tot 426 patiënten (46%; 95%-betrouwbaarheidsinterval 42- op heden onvoldoende gekwantificeerd bij patiënten 50%) in totaal 1.359 PGI’s gevonden. Bij 143 patiënten met orale antikankerbehandeling. In dit onderzoek wordt (16%) werd een ernstige PGI gevonden. Coumarines de prevalentie en ernst van PGI’s bij poliklinische patiënten en opioïden waren het meest betrokken bij PGI’s. In de behandeld met orale antikankermiddelen beschreven. meerderheid van de gevallen was er sprake van een Methode: In 3 Nederlandse ziekenhuizen zijn via het interactie met betrekking tot het centrale zenuwstelsel, elektronische medicatievoorschrijfsysteem alle patiën- maag-darmtoxiciteit of QTc-verlenging op het elektro- ten met orale antikankermedicatie geselecteerd. PGI’s cardiogram. werden met behulp van elektronische en additionele Conclusie: PGI’s komen veel voor bij kankerpatiënten handmatige screeningsmethoden geïdentificeerd. De met orale antikankertherapie. Artsen en apothekers interacties werden geclassificeerd naar mate van ernst moeten zich bewust zijn van deze mogelijke interacties. en wetenschappelijk bewijs. (Ned Tijdschr Oncol 2014;11:133-40) Summary Background: Potential drug-drug-interactions (PDDIs) Methods: A search was conducted in a computer based in patients with cancer are common, but have not pre- medication prescription system for dispensing oral anti- viously been quantified for oral anti-cancer treatment. -
Marie Louise De Bruin Drug Induced Arrhythmias
Marie Louise De Bruin drug induced arrhythmias Quantifying the problem Cover design: Tom Frantzen CIP-gegevens Koninklijke Bibliotheek, Den Haag De Bruin, Marie Louise Drug-induced arrhythmias, quantifying the problem / Marie Louise De Bruin Thesis Utrecht - with ref.- with summary in Dutch ISBN: 90-808203-3-4 © Marie Louise De Bruin drug-induced arrhythmias, quantifying the problem Geneesmiddel-geïnduceerde hartritmestoornissen, kwantificering van het probleem (met een samenvatting in het Nederlands) Proefschrift ter verkrijging van de graad van doctor aan de Universiteit van Utrecht op gezag van de Rector Magnificus Prof. dr W.H. Gispen, ingevolge het besluit van het College voor Promoties in het openbaar te verdedigen op woensdag 1 december 2004 des namiddags om 14.30 uur door Marie Louise De Bruin Geboren op 1 april 1974 te Haarlem promotores Prof. dr H.G.M. Leufkens Utrecht Institute for Pharmaceutical Sciences (UIPS), Department of Pharmaco- epidemiology and Pharmacotherapy, Utrecht University, Utrecht, the Netherlands Prof. dr A.W. Hoes Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, the Netherlands The work in this thesis was performed at the Department of Pharmacoepidemiology and Pharmacotherapy of the Utrecht Institute for Pharmaceutical Sciences (Utrecht) and the Julius Center for Health Sciences and Primary Care (Utrecht), in collabo- ration with the PHARMO Institute (Utrecht), the Netherlands Pharmacovigilance Centre Lareb (‘s-Hertogenbosch), the WHO-Uppsala Monitoring Centre (Uppsala, Sweden) and the Academic Medical Center (Amsterdam). The research presented in this thesis was funded by the Utrecht Institute for Pharmaceutical Sciences, and an unrestricted grant from the Dutch Medicines Evaluation Board. The study presented in chapter 3.1 was funded by an unrestricted grant from Janssen Pharmaceutica NV, Beerse, Belgium.