(Ferric Citrate) for the TREATMENT of HYPERPHOSPHATEMIA? Iron De Ciency Anemia HERE ARE SOME THINGS THAT MAY BE HELPFUL to KNOW Actual Size
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Assessment Report
17 September 2020 EMA/522604/2020 Corr.1 Committee for Medicinal Products for Human Use (CHMP) Assessment report Velphoro Common name: sucroferric oxyhydroxide Procedure No. EMEA/H/C/002705/X/0020/G Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us An agency of the European Union Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 6 1.1. Submission of the dossier ...................................................................................... 6 1.2. Steps taken for the assessment of the product ......................................................... 7 2. Scientific discussion ................................................................................ 8 2.1. Problem statement ............................................................................................... 8 2.1.1. Disease or condition ........................................................................................... 8 2.1.2. Epidemiology and risk factors, screening tools/prevention ...................................... 8 2.1.3. Biologic features ............................................................................................... -
Supermicar Data Entry Instructions, 2007 363 Pp. Pdf Icon[PDF
SUPERMICAR TABLE OF CONTENTS Chapter I - Introduction to SuperMICAR ........................................... 1 A. History and Background .............................................. 1 Chapter II – The Death Certificate ..................................................... 3 Exercise 1 – Reading Death Certificate ........................... 7 Chapter III Basic Data Entry Instructions ....................................... 12 A. Creating a SuperMICAR File ....................................... 14 B. Entering and Saving Certificate Data........................... 18 C. Adding Certificates using SuperMICAR....................... 19 1. Opening a file........................................................ 19 2. Certificate.............................................................. 19 3. Sex........................................................................ 20 4. Date of Death........................................................ 20 5. Age: Number of Units ........................................... 20 6. Age: Unit............................................................... 20 7. Part I, Cause of Death .......................................... 21 8. Duration ................................................................ 22 9. Part II, Cause of Death ......................................... 22 10. Was Autopsy Performed....................................... 23 11. Were Autopsy Findings Available ......................... 23 12. Tobacco................................................................ 24 13. Pregnancy............................................................ -
Clinical Characteristics of Tumor Lysis Syndrome in Childhood Acute Lymphoblastic Leukemia
www.nature.com/scientificreports OPEN Clinical characteristics of tumor lysis syndrome in childhood acute lymphoblastic leukemia Yao Xue1,2,22, Jing Chen3,22, Siyuan Gao1,2, Xiaowen Zhai5, Ningling Wang6, Ju Gao7, Yu Lv8, Mengmeng Yin9, Yong Zhuang10, Hui Zhang11, Xiaofan Zhu12, Xuedong Wu13, Chi Kong Li14, Shaoyan Hu15, Changda Liang16, Runming Jin17, Hui Jiang18, Minghua Yang19, Lirong Sun20, Kaili Pan21, Jiaoyang Cai3, Jingyan Tang3, Xianmin Guan4* & Yongjun Fang1,2* Tumor lysis syndrome (TLS) is a common and fatal complication of childhood hematologic malignancies, especially acute lymphoblastic leukemia (ALL). The clinical features, therapeutic regimens, and outcomes of TLS have not been comprehensively analyzed in Chinese children with ALL. A total of 5537 children with ALL were recruited from the Chinese Children’s Cancer Group, including 79 diagnosed with TLS. The clinical characteristics, treatment regimens, and survival of TLS patients were analyzed. Age distribution of children with TLS was remarkably diferent from those without TLS. White blood cells (WBC) count ≥ 50 × 109/L was associated with a higher risk of TLS [odds ratio (OR) = 2.6, 95% CI = 1.6–4.5]. The incidence of T-ALL in TLS children was signifcantly higher than that in non-TLS controls (OR = 4.7, 95% CI = 2.6–8.8). Hyperphosphatemia and hypocalcemia were more common in TLS children with hyperleukocytosis (OR = 2.6, 95% CI = 1.0–6.9 and OR = 5.4, 95% CI = 2.0–14.2, respectively). Signifcant diferences in levels of potassium (P = 0.004), calcium (P < 0.001), phosphorus (P < 0.001) and uric acid (P < 0.001) were observed between groups of TLS patients with and without increased creatinine. -
(October), 2005
VOL 46, NO 4, SUPPL 1, OCTOBER 2005 CONTENTS American Journal of AJKD Kidney Diseases K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Children With Chronic Kidney Disease Tables............................................................................................................................... S1 Figures ............................................................................................................................. S1 Acronyms and Abbreviations........................................................................................ S2 Algorithms ....................................................................................................................... S3 Work Group Members..................................................................................................... S4 K/DOQI Advisory Board Members................................................................................. S5 Foreword.......................................................................................................................... S6 Introduction ..................................................................................................................... S8 Guideline 1. Evaluation of Calcium and Phosphorus Metabolism ............................ S12 Guideline 2. Assessment of Bone Disease Associated with CKD................................ S18 Guideline 3. Surgical Management of Osteodystrophy ............................................. S23 Guideline 4. Target Serum Phosphorus Levels......................................................... -
2012 CKD Guideline
OFFICIAL JOURNAL OF THE INTERNATIONAL SOCIETY OF NEPHROLOGY KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease VOLUME 3 | ISSUE 1 | JANUARY 2013 http://www.kidney-international.org KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease KDIGO gratefully acknowledges the following consortium of sponsors that make our initiatives possible: Abbott, Amgen, Bayer Schering Pharma, Belo Foundation, Bristol-Myers Squibb, Chugai Pharmaceutical, Coca-Cola Company, Dole Food Company, Fresenius Medical Care, Genzyme, Hoffmann-LaRoche, JC Penney, Kyowa Hakko Kirin, NATCO—The Organization for Transplant Professionals, NKF-Board of Directors, Novartis, Pharmacosmos, PUMC Pharmaceutical, Robert and Jane Cizik Foundation, Shire, Takeda Pharmaceutical, Transwestern Commercial Services, Vifor Pharma, and Wyeth. Sponsorship Statement: KDIGO is supported by a consortium of sponsors and no funding is accepted for the development of specific guidelines. http://www.kidney-international.org contents & 2013 KDIGO VOL 3 | ISSUE 1 | JANUARY (1) 2013 KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease v Tables and Figures vii KDIGO Board Members viii Reference Keys x CKD Nomenclature xi Conversion Factors & HbA1c Conversion xii Abbreviations and Acronyms 1 Notice 2 Foreword 3 Work Group Membership 4 Abstract 5 Summary of Recommendation Statements 15 Introduction: The case for updating and context 19 Chapter 1: Definition, and classification -
The Importance of Phosphate Control in Chronic Kidney Disease
nutrients Review The Importance of Phosphate Control in Chronic Kidney Disease Ken Tsuchiya 1,* and Taro Akihisa 2 1 Department of Blood Purification, Tokyo Women’s Medical University, Tokyo 162-8666, Japan 2 Department of Nephrology, Tokyo Women’s Medical University, Tokyo 162-8666, Japan; [email protected] * Correspondence: [email protected] Abstract: A series of problems including osteopathy, abnormal serum data, and vascular calcification associated with chronic kidney disease (CKD) are now collectively called CKD-mineral bone disease (CKD-MBD). The pathophysiology of CKD-MBD is becoming clear with the emerging of αKlotho, originally identified as a progeria-causing protein, and bone-derived phosphaturic fibroblast growth factor 23 (FGF23) as associated factors. Meanwhile, compared with calcium and parathyroid hor- mone, which have long been linked with CKD-MBD, phosphate is now attracting more attention because of its association with complications and outcomes. Incidentally, as the pivotal roles of FGF23 and αKlotho in phosphate metabolism have been unveiled, how phosphate metabolism and hyperphosphatemia are involved in CKD-MBD and how they can be clinically treated have become of great interest. Thus, the aim of this review is reconsider CKD-MBD from the viewpoint of phosphorus, its involvement in the pathophysiology, causing complications, therapeutic approach based on the clinical evidence, and clarifying the importance of phosphorus management. Keywords: CKD-MBD; FGF23; aKlotho; phosphate-binder Citation: Tsuchiya, K.; Akihisa, T. The Importance of Phosphate Control in Chronic Kidney Disease. Nutrients 2021, 13, 1670. https://doi.org/ 1. Introduction 10.3390/nu13051670 The series of changes that occur in renal dysfunction, including decreases in serum calcium levels due to impairment in vitamin D activation, hypersecretion of parathyroid Academic Editor: Pietro hormone (PTH; i.e., secondary hyperparathyroidism), bone decalcification, and weak Manuel Ferraro bones (osteomalacia), were collectively regarded as renal osteodystrophy. -
Magnesium Replacement to Protect Cardiovascular and Kidney Damage? Lack of Prospective Clinical Trials
International Journal of Molecular Sciences Review Magnesium Replacement to Protect Cardiovascular and Kidney Damage? Lack of Prospective Clinical Trials Juan R. Muñoz-Castañeda 1,2,† ID , María V. Pendón-Ruiz de Mier 1,2,†, Mariano Rodríguez 1,2,* and María E. Rodríguez-Ortiz 1 1 Nephrology Service, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), University Hospital Reina Sofía, University of Córdoba, 14004 Córdoba, Spain; [email protected] (J.R.M.-C.); [email protected] (M.V.P.-R.d.M.); [email protected] (M.E.R.-O.) 2 Red de Investigación Renal (REDinREN), Instituto de Salud Carlos III, 28029 Madrid, Spain * Correspondence: [email protected]; Tel.: +34-957-213790 † Both authors share first authorship. Received: 9 January 2018; Accepted: 21 February 2018; Published: 27 February 2018 Abstract: Patients with advanced chronic kidney disease exhibit an increase in cardiovascular mortality. Recent works have shown that low levels of magnesium are associated with increased cardiovascular and all-cause mortality in hemodialysis patients. Epidemiological studies suggest an influence of low levels of magnesium on the occurrence of cardiovascular disease, which is also observed in the normal population. Magnesium is involved in critical cellular events such as apoptosis and oxidative stress. It also participates in a number of enzymatic reactions. In animal models of uremia, dietary supplementation of magnesium reduces vascular calcifications and mortality; in vitro, an increase -
Dietary Phosphorus As a Marker of Mineral Metabolism and Progression of Diabetic Kidney Disease
nutrients Review Dietary Phosphorus as a Marker of Mineral Metabolism and Progression of Diabetic Kidney Disease Agata Winiarska, Iwona Filipska , Monika Knysak and Tomasz Stompór * Department of Nephrology, Hypertension and Internal Medicine, University of Warmia and Mazury in Olsztyn, 10561 Olsztyn, Poland; [email protected] (A.W.); fi[email protected] (I.F.); [email protected] (M.K.) * Correspondence: [email protected]; Tel.: +48-89-5386219 Abstract: Phosphorus is an essential nutrient that is critically important in the control of cell and tissue function and body homeostasis. Phosphorus excess may result in severe adverse medical consequences. The most apparent is an impact on cardiovascular (CV) disease, mainly through the ability of phosphate to change the phenotype of vascular smooth muscle cells and its contribution to pathologic vascular, valvular and other soft tissue calcification. Chronic kidney disease (CKD) is the most prevalent chronic disease manifesting with the persistent derangement of phosphate homeostasis. Diabetes and resulting diabetic kidney disease (DKD) remain the leading causes of CKD and end-stage kidney disease (ESRD) worldwide. Mineral and bone disorders of CKD (CKD-MBD), profound derangement of mineral metabolism, develop in the course of the disease and adversely impact on bone health and the CV system. In this review we aimed to discuss the data concerning CKD-MBD in patients with diabetes and to analyze the possible link between hyperphosphatemia, certain biomarkers of CKD-MBD and high dietary phosphate intake on prognosis in patients with diabetes and DKD. We also attempted to clarify if hyperphosphatemia and high phosphorus intake Citation: Winiarska, A.; Filipska, I.; Knysak, M.; Stompór, T. -
Guidelines for Renal Anemia in Chronic Kidney Disease
tap_836 240..275 Therapeutic Apheresis and Dialysis 14(3):240–275 doi: 10.1111/j.1744-9987.2010.00836.x © 2010 The Authors Journal compilation © 2010 International Society for Apheresis 2008 Japanese Society for Dialysis Therapy: Guidelines for Renal Anemia in Chronic Kidney Disease Yoshiharu Tsubakihara,1 Shinichi Nishi,2 Takashi Akiba,3 Hideki Hirakata,4 Kunitoshi Iseki,5 Minoru Kubota,6 Satoru Kuriyama,7 Yasuhiro Komatsu,8 Masashi Suzuki,9 Shigeru Nakai,10 Motoshi Hattori,11 Tetsuya Babazono,12 Makoto Hiramatsu,13 Hiroyasu Yamamoto,14 Masami Bessho,15 and Tadao Akizawa16 1Department of Kidney Disease and Hypertension, Osaka General Medical Center, Osaka, 2Blood Purification Center, Niigata University Medical and Dental Hospital, 9Kidney Center, Shinrakuen Hospital, Niigata, 3Department of Blood Purification, Kidney Disease General Medical Center, 11Department of Pediatric Nephrology, Kidney Center, and 12Department of Medicine, Diabetes Center, Tokyo Women’s Medical University, 6Oji Hospital, 7Division of Nephrology, Saiseikai Central Hospital, 8Kidney Center, St. Luke’s International Hospital, 14Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine, 16Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo 4Kidney Unit, Fukuoka Red Cross Hospital, Fukuoka, 5Dialysis Unit, University of The Ryukyus, Okinawa, 10Division of Clinical Engineering Technology, Fujita Health University College, Aichi, 13Department of Nephrology, Okayama Saiseikai General Hospital, -
Serum Calcium and Serum Phosphate Levels in Transfusion Dependent
54 This journal is the official publication of Bangladesh Society of Physiologists (BSP) Web URL: www.banglajol.info/index.php/JBSP Abstracted /indexed in Index Copernicus, Director of Open Access Journal, Index Medicus for South East Asia Region, Google Scholar, 12OR, infobse index, Open J gate, Cite factor, Scientific indexing services pISSN-1983-1213; e-ISSN-2219-7508 Article Article information : Serum calcium and serum phosphate levels Received on 22/7/2018 Accepted on 10/10/2018 in transfusion dependent beta thalassemia DOI: https://doi.org/10.3329/jbsp.v13i2.39478 Mst. Ariza Sultana 1, Qazi Shamima Akhter 1 Corresponding author: 1. Department of Physiology, Dhaka Medical College, Dhaka. Mst. Ariza Sultana, Lecturer, Department of Physiology, Dhaka Medical College, Dhaka. Abstract Email: [email protected]. Background: Patients with transfusion dependent beta thalassemia with severeanemia require regular blood transfusion Cite this article: Sultana A, Akhter QS. Serum calcium and to improve quality of life. This can lead to iron overload which serum phosphate levels in transfusion dependent beta thalassemia might cause various complications including hypocalcaemia. J Bangladesh Soc Physiol 2018;13(2): 54-58 Objective : To estimate the serum calcium and phosphate levels in transfusion dependent beta thalassemia patients. Methods: This cross-sectional study was conducted in the Department of Physiology, Dhaka Medical College, Dhaka from July 2016 to June 2017. After fulfilling the ethical aspect, a total number of 60 subjects were selected with the age ranging from 5 to 25 years. Among them, 40 transfusion dependent beta thalassemia patients were selected as the study group and 20 age and sex matched apparently healthy individuals were considered as control group for comparison. -
Free Executive Summary
Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc http://www.nap.edu/catalog/10026.html DIETARY REFERENCE INTAKES DRI FOR Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc A Report of the Panel on Micronutrients, Subcommittees on Upper Reference Levels of Nutrients and of Interpretation and Uses of Dietary Reference Intakes, and the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes Food and Nutrition Board Institute of Medicine NATIONAL ACADEMY PRESS Washington, D.C. Copyright © National Academy of Sciences. All rights reserved. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc http://www.nap.edu/catalog/10026.html NATIONAL ACADEMY PRESS • 2101 Constitution Avenue, N.W. • Washington, DC 20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This project was funded by the U.S. Department of Health and Human Services Office of Disease Prevention and Health Promotion, Contract No. 282-96-0033, T03; the National Institutes of Health Office of Dietary Supplements; the Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Division of Nutrition and Physical Activity; Health Canada; the Institute of Medicine; the Dietary Reference Intakes Private Foundation Fund, including the Dannon Institute and the Inter- national Life Sciences Institute; and the Dietary Reference Intakes Corporate Donors’ Fund. -
ZEMPLAR (Paricalcitol) Capsules, for Oral Use
HIGHLIGHTS OF PRESCRIBING INFORMATION Pediatric: Ages Increase each dose by 1 mcg three times a week every 4 These highlights do not include all the information needed to use 10 to 16 years weeks or decrease each dose by 2 mcg three times a week at ZEMPLAR safely and effectively. See full prescribing information for any time based on iPTH, serum calcium and phosphorus ZEMPLAR. levels.* * Not more frequently than every other day. ZEMPLAR (paricalcitol) capsules, for oral use Initial U.S. Approval: 1998 • CKD Stage 5: To avoid hypercalcemia only treat patients after their baseline serum calcium has been reduced to 9.5 mg/dL or lower (2.2). ---------------------------RECENT MAJOR CHANGES-------------------------- Dosage and Administration, Pediatric Patients (2.3) 10/2016 ----------------------DOSAGE FORMS AND STRENGTHS-------------------- ---------------------------INDICATIONS AND USAGE--------------------------- Capsules: 1 mcg and 2 mcg (3). ZEMPLAR is a vitamin D analog indicated in adults and pediatric patients 10 -------------------------------CONTRAINDICATIONS----------------------------- years and older for the prevention and treatment of secondary • Evidence of hypercalcemia (4). hyperparathyroidism associated with: • Evidence of vitamin D toxicity (4). • Chronic kidney disease (CKD) Stages 3 and 4 (1.1). • CKD Stage 5 in patients on hemodialysis or peritoneal dialysis (1.2). ------------------------WARNINGS AND PRECAUTIONS---------------------- • Hypercalcemia: Excessive administration of ZEMPLAR capsules can -----------------------DOSAGE AND ADMINISTRATION---------------------- cause over suppression of PTH, hypercalcemia, hypercalciuria, Initial Dosage: CKD Stages 3 and 4 (2.1, 2.3) hyperphosphatemia, and adynamic bone disease. Prescription-based doses 1 mcg orally daily or 2 mcg Adult: Baseline iPTH ≤ 500 pg/mL of vitamin D and its derivatives should be withheld during ZEMPLAR three times a week* treatment (5.1).