WHO Model List of Essential Medicines
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Doxycycline and Hydroxychloroquine As Treatment for High-Risk COVID-19 Patients: Experience
medRxiv preprint doi: https://doi.org/10.1101/2020.05.18.20066902; this version posted May 22, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . Doxycycline and Hydroxychloroquine as Treatment for High-Risk COVID-19 Patients: Experience from Case Series of 54 Patients in Long-Term Care Facilities Imtiaz Ahmad, MD, MPH, FCCP1 Mohammud Alam, MD2 Ryan Saadi, MD, MPH3,6 Saborny Mahmud4 Emily Saadi, BS5 1Allergy, Sleep & Lung Care, 21st Century Oncology, Fort Myers, FL 2Infectious Disease Specialist, Cordial Medical PC, Farmingdale, NY 3Center for Market Access and Medical Innovation, Warren, NJ 4 Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 5 Yale University, School of Public Health, New Haven, CT 6Quantaira Health, New York, NY Corresponding author : Imtiaz Ahmad, MD, Allergy, Sleep & Lung Care, 21st Century Oncology, Fort Myers, FL. email : [email protected] NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. medRxiv preprint doi: https://doi.org/10.1101/2020.05.18.20066902; this version posted May 22, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . Abstract: Importance: Patients in long-term care facilities (LTCF) are at a high-risk of contracting COVID-19 due to advanced age and multiple comorbidities. -
Miltefosine Combined with Intralesional Pentamidine for Leishmania Braziliensis Cutaneous Leishmaniasis in Bolivia
Am. J. Trop. Med. Hyg., 99(5), 2018, pp. 1153–1155 doi:10.4269/ajtmh.18-0183 Copyright © 2018 by The American Society of Tropical Medicine and Hygiene Miltefosine Combined with Intralesional Pentamidine for Leishmania braziliensis Cutaneous Leishmaniasis in Bolivia Jaime Soto,1* Paula Soto,1 Andrea Ajata,2 Daniela Rivero,3 Carmelo Luque,2 Carlos Tintaya,2 and Jonathan Berman4 1FUNDERMA (Fundacion ´ Nacional de Dermatolog´ıa), Santa Cruz, Bolivia; 2Servicio Departamental de Salud, Departamento de La Paz, La Paz, Bolivia; 3Hospital Dermatologico ´ de Jorochito, Santa Cruz, Bolivia; 4AB Foundation, North Bethesda, Maryland Abstract. Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of mil- tefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 μg/mm2 lesion area on days 1, 3, and 5). Ninety-two per cent of 50 patients cured. Comparison to historic controls at our site suggests that the efficacy of the two drugs was additive. Adverse effects and cost were also additive. This combination may be attractive when a prime consideration is efficacy (e.g., in rescue therapy), avoidance of parenteral therapy, or the desire to treat locally and also provide systemic protection against parasite dissemination. INTRODUCTION METHODS AND PATIENTS Cutaneous leishmaniasis (CL) in the New World gener- Study design and treatments. This was an open-label ally presents as a papule that enlarges and ulcerates over evaluation of one intervention: standard treatment with oral 1–3 months and then self-cures, but the predominant spe- miltefosine in combination with intralesional treatment with cies at our site in Bolivia, Leishmania (Viannia) braziliensis pentamidine. -
National Antibiotic Consumption for Human Use in Sierra Leone (2017–2019): a Cross-Sectional Study
Tropical Medicine and Infectious Disease Article National Antibiotic Consumption for Human Use in Sierra Leone (2017–2019): A Cross-Sectional Study Joseph Sam Kanu 1,2,* , Mohammed Khogali 3, Katrina Hann 4 , Wenjing Tao 5, Shuwary Barlatt 6,7, James Komeh 6, Joy Johnson 6, Mohamed Sesay 6, Mohamed Alex Vandi 8, Hannock Tweya 9, Collins Timire 10, Onome Thomas Abiri 6,11 , Fawzi Thomas 6, Ahmed Sankoh-Hughes 12, Bailah Molleh 4, Anna Maruta 13 and Anthony D. Harries 10,14 1 National Disease Surveillance Programme, Sierra Leone National Public Health Emergency Operations Centre, Ministry of Health and Sanitation, Cockerill, Wilkinson Road, Freetown, Sierra Leone 2 Department of Community Health, Faculty of Clinical Sciences, College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone 3 Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, 1211 Geneva, Switzerland; [email protected] 4 Sustainable Health Systems, Freetown, Sierra Leone; [email protected] (K.H.); [email protected] (B.M.) 5 Unit for Antibiotics and Infection Control, Public Health Agency of Sweden, Folkhalsomyndigheten, SE-171 82 Stockholm, Sweden; [email protected] 6 Pharmacy Board of Sierra Leone, Central Medical Stores, New England Ville, Freetown, Sierra Leone; [email protected] (S.B.); [email protected] (J.K.); [email protected] (J.J.); [email protected] (M.S.); [email protected] (O.T.A.); [email protected] (F.T.) Citation: Kanu, J.S.; Khogali, M.; 7 Department of Pharmaceutics and Clinical Pharmacy & Therapeutics, Faculty of Pharmaceutical Sciences, Hann, K.; Tao, W.; Barlatt, S.; Komeh, College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown 0000, Sierra Leone 8 J.; Johnson, J.; Sesay, M.; Vandi, M.A.; Directorate of Health Security & Emergencies, Ministry of Health and Sanitation, Sierra Leone National Tweya, H.; et al. -
Online Supplement to Incremental Costs for Psoriasis and Psoriatic
Online supplement to Incremental Costs for Psoriasis and Psoriatic Arthritis in a Population-based Cohort in Southern Sweden: Is It All Psoriasis-attributable Morbidity? The Journal of Rheumatology, doi:10.3899/jrheum.150406 Table 1. ATC-codes used to define DMARDs and topical emollients Drug group ATC-code Generic name Biologic DMARDs L04AA24 Abatacept L04AB01 Etanercept L04AA21 Efalizumab* L04AB02 Infliximab** L04AB04 Adalimumab L04AB05 Certolizumabpegol L04AB06 Golimumab L04AC03 Anakinra L04AC05 Ustekinumab L04AC07 Tocilizumab L01XC02 Rituximab Non-biologic DMARDs A07EC01 Sulfasalazine D05BB02 Acitretin L04AA15 Leflunomid L04AD01 Ciklosporin L04AX01 Azathioprine L01BA01 Methotrexate L04AX03 M01CB01 Natriumaurotiomalat M01CB03 Auranofin P01BA01 Chloroquine P01 BA02 Hydroxychloroquine Topical emollients D05AA Tjäror D05AC01 Ditranol D05AX01 Fumarsyra D05AX02 Kalcipotriol D05AX52 Kalcipotriol + betametason D07AC01 Betametason D07CC01 Betametason + antibiotika D07AC17 Flutikason D07AC13 Mometason D07AB02 Hydrokortisonbutyrat D07AD01 Klobetasol D07AB01 Klobetason DMARD=Disease Modifying AntiRheumatic Drugs *Not on the market after 20090609 **Infliximab is given as infusion in hospitals and therefore not included in the cost component ”Drugs” in our presentation of resource use and associated costs. 1 Online supplement to Incremental Costs for Psoriasis and Psoriatic Arthritis in a Population-based Cohort in Southern Sweden: Is It All Psoriasis-attributable Morbidity? The Journal of Rheumatology, doi:10.3899/jrheum.150406 Table 2A. Mean annual -
A Phase I and Pharmacokinetic Study of Irinotecan Given As a 7-Day
Vol. 10, 1657–1663, March 1, 2004 Clinical Cancer Research 1657 A Phase I and Pharmacokinetic Study of Irinotecan Given as a 7-Day Continuous Infusion in Metastatic Colorectal Cancer Patients Pretreated with 5-Fluorouracil or Raltitrexed Gianluca Masi,1 Alfredo Falcone,1 for activity, and we observed 3 (25%) partial responses, 2 Antonello Di Paolo,2 Giacomo Allegrini,1 (17%) minor responses, and 4 (33%) disease stabilizations. Romano Danesi,2 Cecilia Barbara,2 Conclusions: The administration of irinotecan as a 1 2 7-day continuous infusion every 21 days is feasible with Samanta Cupini, and Mario Del Tacca diarrhea being the dose-limiting toxicity; recommended 1Division of Medical Oncology, Department of Oncology, Civil 2 2 dose for Phase II studies is 20.0 mg/m /day. The comparison Hospital, Livorno, and Division of Pharmacology and of the present data with those obtained after a standard Chemotherapy, Department of Oncology, Transplants, and Advanced Technologies in Medicine, University of Pisa, Pisa, Italy 30–90 min. i.v. infusion of irinotecan demonstrates that continuous infusion improves the transformation of irinote- can to SN-38 and also results in increased glucuronidation of ABSTRACT the active metabolite. Antitumor activity in pretreated met- Purpose: The purpose is to determine the plasma phar- astatic colorectal cancer patients is encouraging. macokinetics, the maximum-tolerable dose and to prelimi- nary evaluate the antitumor activity of irinotecan admin- INTRODUCTION istered as a 7-day continuous infusion every 21 days in Irinotecan (CPT-11), a semisynthetic derivative of the nat- metastatic colorectal cancer patients pretreated with 5- ural alkaloid camptothecin, is a selective inhibitor of topoi- fluorouracil or raltitrexed. -
204684Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 204684Orig1s000 OFFICE DIRECTOR MEMO Deputy Office Director Decisional Memo Page 2 of 17 NDA 204,684 Miltefosine Capsules 1. Introduction Leishmania organisms are intracellular protozoan parasites that are transmitted to a mammalian host by the bite of the female phlebotomine sandfly. The main clinical syndromes are visceral leishmaniasis (VL), cutaneous leishmaniasis (CL), and mucosal leishmaniasis (ML). VL is the result of systemic infection and is progressive over months or years. Clinical manifestations include fever, hepatomegaly, splenomegaly, and bone marrow involvement with pancytopenia. VL is fatal if untreated. Liposomal amphotericin B (AmBisome®) was FDA approved in 1997 for the treatment of VL. CL usually presents as one or more skin ulcers at the site of the sandfly bite. In most cases, the ulcer spontaneously resolves within several months, leaving a scar. The goals of therapy are to accelerate healing, decrease morbidity and decrease the risk of relapse, local dissemination, or mucosal dissemination. There are no FDA approved drugs for the treatment of CL. Rarely, CL disseminates from the skin to the naso-oropharyngeal mucosa, resulting in ML. ML can also develop some time after CL spontaneous ulcer healing. The risk of ML is thought to be highest with CL caused by the subgenus Viannia. ML is characterized in the medical literature as progressive with destruction of nasal and pharyngeal structures, and death may occur due to complicating aspiration pneumonia. There are no FDA approved drugs for the treatment of ML. Paladin Therapeutics submitted NDA 204, 684 seeking approval of miltefosine for the treatment of VL caused by L. -
Targeting Fibrosis in the Duchenne Muscular Dystrophy Mice Model: an Uphill Battle
bioRxiv preprint doi: https://doi.org/10.1101/2021.01.20.427485; this version posted January 21, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. 1 Title: Targeting fibrosis in the Duchenne Muscular Dystrophy mice model: an uphill battle 2 Marine Theret1#, Marcela Low1#, Lucas Rempel1, Fang Fang Li1, Lin Wei Tung1, Osvaldo 3 Contreras3,4, Chih-Kai Chang1, Andrew Wu1, Hesham Soliman1,2, Fabio M.V. Rossi1 4 1School of Biomedical Engineering and the Biomedical Research Centre, Department of Medical 5 Genetics, 2222 Health Sciences Mall, Vancouver, BC, V6T 1Z3, Canada 6 2Department of Pharmacology and Toxicology, Faculty of Pharmaceutical Sciences, Minia 7 University, Minia, Egypt 8 3Developmental and Stem Cell Biology Division, Victor Chang Cardiac Research Institute, 9 Darlinghurst, NSW, 2010, Australia 10 4Departamento de Biología Celular y Molecular and Center for Aging and Regeneration (CARE- 11 ChileUC), Facultad de Ciencias Biológicas, Pontificia Universidad Católica de Chile, 8331150 12 Santiago, Chile 13 # Denotes Co-first authorship 14 15 Keywords: drug screening, fibro/adipogenic progenitors, fibrosis, repair, skeletal muscle. 16 Correspondence to: 17 Marine Theret 18 School of Biomedical Engineering and the Biomedical Research Centre 19 University of British Columbia 20 2222 Health Sciences Mall, Vancouver, British Columbia 21 Tel: +1(604) 822 0441 fax: +1(604) 822 7815 22 Email: [email protected] 1 bioRxiv preprint doi: https://doi.org/10.1101/2021.01.20.427485; this version posted January 21, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. -
LEUKERAN 3 (Chlorambucil) 4 Tablets 5
1 PRESCRIBING INFORMATION ® 2 LEUKERAN 3 (chlorambucil) 4 Tablets 5 6 WARNING 7 LEUKERAN (chlorambucil) can severely suppress bone marrow function. Chlorambucil is a 8 carcinogen in humans. Chlorambucil is probably mutagenic and teratogenic in humans. 9 Chlorambucil produces human infertility (see WARNINGS and PRECAUTIONS). 10 DESCRIPTION 11 LEUKERAN (chlorambucil) was first synthesized by Everett et al. It is a bifunctional 12 alkylating agent of the nitrogen mustard type that has been found active against selected human 13 neoplastic diseases. Chlorambucil is known chemically as 4-[bis(2- 14 chlorethyl)amino]benzenebutanoic acid and has the following structural formula: 15 16 17 18 Chlorambucil hydrolyzes in water and has a pKa of 5.8. 19 LEUKERAN (chlorambucil) is available in tablet form for oral administration. Each 20 film-coated tablet contains 2 mg chlorambucil and the inactive ingredients colloidal silicon 21 dioxide, hypromellose, lactose (anhydrous), macrogol/PEG 400, microcrystalline cellulose, red 22 iron oxide, stearic acid, titanium dioxide, and yellow iron oxide. 23 CLINICAL PHARMACOLOGY 24 Chlorambucil is rapidly and completely absorbed from the gastrointestinal tract. After single 25 oral doses of 0.6 to 1.2 mg/kg, peak plasma chlorambucil levels (Cmax) are reached within 1 hour 26 and the terminal elimination half-life (t½) of the parent drug is estimated at 1.5 hours. 27 Chlorambucil undergoes rapid metabolism to phenylacetic acid mustard, the major metabolite, 28 and the combined chlorambucil and phenylacetic acid mustard urinary excretion is extremely 29 low — less than 1% in 24 hours. In a study of 12 patients given single oral doses of 0.2 mg/kg of 30 LEUKERAN, the mean dose (12 mg) adjusted (± SD) plasma chlorambucil Cmax was 31 492 ± 160 ng/mL, the AUC was 883 ± 329 ng●h/mL, t½ was 1.3 ± 0.5 hours, and the tmax was 32 0.83 ± 0.53 hours. -
Novartis R&D and Investor Update
Novartis AG Investor Relations Novartis R&D and investor update November 5, 2018 Disclaimer This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “potential,” “expected,” “will,” “planned,” “pipeline,” “outlook,” “agreement to acquire,” or similar expressions, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this presentation, or regarding potential future revenues from such products, or regarding the proposed acquisition of Endocyte, Inc. (Endocyte) by Novartis including the potential outcome and expected timing for completion of the proposed acquisition, and the potential impact on Novartis of the proposed acquisition, including express or implied discussions regarding potential future sales or earnings of Novartis, and any potential strategic benefits, synergies or opportunities expected as a result of the proposed acquisition. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this presentation will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. -
Chemotherapy in Advanced Ovarian Cancer: an Overview of Randomised Clinical Trials BMJ: First Published As 10.1136/Bmj.303.6807.884 on 12 October 1991
Chemotherapy in advanced ovarian cancer: an overview of randomised clinical trials BMJ: first published as 10.1136/bmj.303.6807.884 on 12 October 1991. Downloaded from Advanced Ovarian Cancer Trialists Group Abstract cytotoxic drugs, usually doxorubicin and cyclophos- Objectives-To consider the role of platinum and phamide with or without hexamethylmelamine.45 the relative merits of single agent and combination When, however, doubt was cast on the effectiveness chemotherapy in the treatment of advanced ovarian of doxorubicin by both randomised phase III trials6-8 cancer. and phase II studies in patients not responding to Design-Formal quantitative overview using cisplatin9 several major centres adopted cisplatin plus updated individual patient data from all available cyclophosphamide as standard. Furthermore, when randomised trials (published and unpublished). other trials failed to find significant survival differences Subjects-8139 patients (6408 deaths) included in between single agent cisplatin and cisplatin in combi- 45 different trials. nation with other drugs'0 some centres reverted to Results-No firm conclusions could be reached. using single agent platinum as routine first line treat- Nevertheless, the results suggest that in terms of ment. Recently a large number oftrials have compared survival immediate platinum based treatment was cisplatin with its less nephrotoxic and neurotoxic better than non-platinum regimens (overall relative analogue carboplatin, and although follow up times risk 0-93; 95% confidence interval 0-83 to 1-05); were often short, many institutions have now adopted platinum in combination was better than single agent carboplatin as standard. platinum when used in the same dose (overall Currently it is unclear what constitutes optimal relative risk 0-85; 0*72 to 1-00); and cisplatin and chemotherapy for advanced disease and treatment carboplatin were equally effective (overall relative strategies vary both nationally and internationally. -
Chapter 1.Pdf
CHAPTER 1 INTRODUCTION AND OUTLINE OF THIS THESIS INTRODUCTION Inflammatory bowel diseases (IBD), comprising Crohn’s disease, ulcerative colitis and IBD- 1 unclassified, are chronic recurrent inflammatory disorders of the (large) intestine with a heterogeneous, but often disabling disease presentation. The prevalence of IBD is increasing worldwide and medical therapies are introduced earlier to improve health-related quality of life and postpone surgical interventions1,2. This has led to the more extensive use of immunosuppressive therapies including biologicals and thiopurines. While the use of tioguanine was soon abandoned due to toxicity concerns3, over the years efficacy data on the use of azathioprine and mercaptopurine for the treatment of IBD has grown4,5. However, due to side effects and ineffectiveness, related to unprofitable metabolism, thiopurine therapy often fails; up to 50% of patients discontinues treatment within 2 years6. Increasing the knowledge on thiopurine metabolism may provide opportunities to further explore the therapeutic usefulness of thiopurines, which both from a patient’s perspective and a pharmacoeconomic perspective is essential. THIOPURINES In the 1950’s Gertrude Elion (1918-1999) worked as an assistant to George Hitchings (1905- 1998), both employees of Burroughs-Wellcome, focussing on the advent of drugs that inhibited cell growth without doing harm to the host cells. They discovered that purine bases are essential components of nucleic acids and vital for cell growth7. Subsequently, they designed the purine antagonists diaminopurine and tioguanine that blocked the synthesis of original nucleic acids and inhibited cell growth8. For the first time a successful treatment of leukaemia became available. Some years later Elion and colleagues also developed mercaptopurine, azathioprine, allopurinol, trimethoprim and acyclovir. -
B. Package Leaflet
B. PACKAGE LEAFLET 1 Package Leaflet: Information for the User Chlorambucil 2 mg tablets chlorambucil Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions ask your doctor or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Chlorambucil is and what it is used for 2. What you need to know before you take Chlorambucil 3. How to take Chlorambucil 4. Possible side effects 5. How to store Chlorambucil 6. Contents of the pack and other information 1. What Chlorambucil is and what it is used for Chlorambucil contains a medicine called chlorambucil. This belongs to a group of medicines called cytotoxics (also called chemotherapy). Chlorambucil is used to treat some types of cancer and certain blood problems. It works by reducing the number of abnormal cells your body makes. Chlorambucil is used for: - Hodgkin's disease and Non-Hodgkin’s Lymphoma. Together, these form a group of diseases called lymphomas. They are cancers formed from cells of the lymphatic system. - Chronic lymphocytic leukaemia. A type of white blood cell cancer where the bone marrow produces a large number of abnormal white cells.