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Urine Uric Acid

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241. Hypercalciuria Associated with High Dietary Protein Intake Is Not Due to Acid Load. (Full text)

at the end of each of four phases while consuming metabolic diets with fixed calcium and sodium content. Phases 1 and 3 consisted of a control diet (CD). Phases 2 and 4 consisted of a eucaloric HPD (60 g/d animal proteins added to CD). Along with HPD in phases 2 and 4, subjects ingested 30 mEq twice daily of either potassium citrate (KCitrate, alkaline salt) or potassium chloride (KCl, control neutral salt).KCitrate completely neutralized the acid load imparted by HPD (based on changes in urine pH (...) and net acid excretion) and increased urinary citrate. Urinary calcium increased during both HPD phases compared with CD but was not significantly different between the HPD + KCl and HPD + KCitrate phases (182 ± 85 vs. 170 ± 85 mg/d; P = 0.28). Increased urinary saturation with respect to calcium oxalate and uric acid with HPD was abrogated by KCitrate.This study suggests that, at least in the short-term, mechanism(s) other than acid load account for hypercalciuria induced by HPD. The beneficial

2011 Journal of Clinical Endocrinology and Metabolism PubMed abstract

242. Chronic kidney disease in adults: assessment and management

of GFR 37 2.3 Classifying chronic kidney disease 38 2.4 Further resources 39 3 Research recommendations 40 Chronic kidney disease in adults: assessment and management (CG182) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 603.1 Self-management 40 3.2 Antiplatelet therapy 40 3.3 Renin–angiotensin–aldosterone system 41 3.4 Uric acid-lowering agents 41 3.5 Vitamin D supplements in the management of CKD–mineral (...) of at least 90 days. Stages 1 and 2 were defined by the presence of markers of kidney damage including albuminuria, urine sediment abnormalities, electrolyte and other abnormalities caused by tubular disorders, abnormalities detected by histology, structural abnormalities detected by imaging and a history of kidney transplantation. T o delineate an increased risk of adverse outcomes, the 2008 NICE guideline on chronic kidney disease suggested 2 key changes to this classification: the subdivision of stage

2014 National Institute for Health and Clinical Excellence - Clinical Guidelines

243. The Canadian Cardiovascular Society heart failure companion: bridging guidelines to your practice

Monoarticular gout. Not suitable for polyarticular gout IA triamcinolone 20 mg once IA cortisone 100 mg once None required Chronic prevention of gouty attacks Colchicine Can reduce attack frequency 0.6mgdailyortwiceperdayinfunctionof GFR Not recommended for GFR< 15 mL/min Allopurinol First-line agent for reduction of uric acid 300 mg daily orally Dose reduction for renal disease. 200 mg daily for GFR< 30 mL/min 100 mg daily for GFR< 20 mL/min 50 mg daily or 3 times weekly if ESRD Febuxostat 40-80 mg daily (...) of peripartum cardiomyopathy. J Am Coll Cardiol 2014;64:1629-36. 42. Elkayam U, Akhter MW, Singh H, et al. Pregnancy-associated cardio- myopathy: clinical characteristics and a comparison between early and late presentation. Circulation 2005;111:2050-5. 43. Liu C, Zhao Q, Zhen Y, et al. Prednisone in Uric Acid lowering in Symptomatic Heart Failure Patients With Hyperuricemia (PUSH- PATH) study. Can J Cardiol 2013;29:1048-54. 44. Velazquez EJ, Lee KL, Deja MA, et al. Coronary-artery bypass surgery

2016 CPG Infobase

244. Chronic Myeloid Leukaemia: ESMO Clinical Practice Guidelines

- diate need for therapy because of high leukocyte counts or clinical symptoms. TKI therapy should be commenced immediately after con?rmation of BCR–ABL1 positivity. It is recommended to taper the hydroxyurea dose before its discontinuation. To avoidtumourlysis syndrome,2.5–3L?uid intakeisrecom- mended per day considering the individual cardiac and/or renal situ- ation. Sodium bicarbonate may be used to set the urine pH to 6.4– 6.8 for optimal uric acid clearance. Allopurinol may increase the risk (...) be used to set the urine pH to 6.4–6.8 for optimal uric acid clearance. Allopurinol may increase the risk of xanthine accumulation with renal failure and should therefore be restricted to patients with symptomatic hyperuricemia. • If the response to TKIs is a failure, the treatment must be switched to an alternative TKI, or alloSCT should be considered. Between optimal and failure, there is a grey zone that is de?ned as ‘warning’, meaning that the response must be monitored more carefully

2017 European Society for Medical Oncology

245. Investigation of Neonatal Conjugated Hyperbilirubinaemia

lactate and bicarbonate ? Calcium, phosphate ? Bilirubin (total and conjugated) ? ALT+/-AST, Alkaline phosphatase, GGT ? Albumin ? Cholesterol and triglycerides Metabolic investigations ? Galactose-1-phosphate uridyl transferase ? Alpha-1-antitrypsin level and phenotype ? Plasma and urine amino acids ? Urine organic acids (including succinyl acetone) ? Ward test urine for protein Endocrine investigations ? Thyroid function ? Cortisol (ideally after four hour fast) If low: perform short synacthen test (...) signs), Spine X-Ray: For evidence of Alagille syndrome (butterfly vertebrae) Cardiology assessment and CXR: If heart murmur present, or if other signs of Alagille syndrome. Other investigations for rare disorders: Blood: Lactate, ammonia, pyruvate, uric acid, carnitine and acyl carnitine Very long chain fatty acids or white cell enzymes (glycogen or lysosomal storage disorders) Bile acids (quantitative and qualitative): ideally when OFF ursodeoxycholic acid. If taking urso, specify on request form

2017 British Society of Paediatric Gastroenterology Hepatology and Nutrition

246. Qtern (saxagliptin / dapagliflozin propanediol monohydrate) - Diabetes Mellitus, Type 2

tested under long term or accelerated conditions were observed. A photostability study has been performed on one pilot batch as per the ICH Q1B guideline on photostability. Results showed that the substance is not sensitive to light. A forced degradation study in aqueous solution under heat, oxidative conditions, acidic and basic conditions and UV/visible light and in solid state exposed to heat and humidity and UV/visible light was also performed in order to identify the degradation pathway

2016 European Medicines Agency - EPARs

247. Sialanar (glycopyrronium) - for treating severe drooling of saliva in children and adolescents (aged 3 years and above) with conditions affecting the nervous system, such as cerebral palsy, epilepsy and neurodegenerative diseases

assumed to be related to drug-induced enzymatic effects. As similar changes were observed with atropine sulphate and propantheline bromide, a general anticholinergic effect may Assessment report EMA/CHMP/436684/2016 Page 21/143 explain the findings. The Applicant argues that no clinical relevance of this effect is expected, as acid- secreting parietal cells undergo continuous renewal and because treatment of patients with duodenal ulcers with GP for one year did not reduce parietal cell mass (Kaye (...) of glycopyrronium, 1,1-dimethyl-3-hydroxypyrrolidinium bromide a-(2- or 3- hydroxycyclopentyl) mandelate (M 1 ), 1, 1-dimethyl-3-hydroxypyrrolidinium bromide benzoyl formate (M2) and 1,1-dimethyl-3-hydroxypyrrolidinium bromide (M5), were detected mainly in the liver and kidney Assessment report EMA/CHMP/436684/2016 Page 22/143 (Kagiwada, 1973). After oral dosing, M2 was the most prevalent metabolite in urine, followed by M1, and glycopyrronium was not detected. Similar concentrations of M1 and M2 were found

2016 European Medicines Agency - EPARs

248. Spectrila - asparaginase

information 125 2.10.1. User consultation 125 3. Benefit-Risk Balance 125 4. Recommendations 127 Assessment report EMA/CHMP/842555/2015 Page 2/132 List of abbreviations ADA Anti-drug antibodies AHA,L-AHA L-aspartic acid-ß-hydroxamate ALL Acute lymphoblastic leukaemia AML Acute Myeloid Leukaemia Ara-C 1-ß-D-arabinofuranosylcytosine AS Asparagine synthetase ASN L-asparagine asparaginase L-asparaginase ASP, L-ASP L-Aspartic acid AUC Area under the drug serum concentration versus time curve AUC0-72 Area under (...) Criteria for Adverse Events CZE Capillary Zone Electrophoresis Da Dalton DCOG Dutch Children Oncology Group DMC Data Monitoring Committee Assessment report EMA/CHMP/842555/2015 Page 3/132 DNA Desoxyribonucleic acid DXM Dexamethasone E. coli Escherichia coli e.g. For example FAS Full Analysis Set GCP Good Clinical Practices GLN, L-GLN L-glutamine GLP Good laboratory practice GLU, L-GLU L-glutamic acid Gy The international standard unit of radiation dose HPLC High pressure liquid chromatography hr hour

2016 European Medicines Agency - EPARs

249. Zurampic - lesinurad

, as similar lesions were not observed in monkeys, and there was no classic dose response. A mechanism of action for the kidney toxicity observed in humans has been proposed, related to the pathological condition of the patient, and more specifically the increased uric acid levels. It appears likely that due to this increased plasma and urine uric acid levels, crystallization occurs, leading to kidney damage. This is further substantiated by the fact that patients receiving concomitant allopurinol (...) SD standard deviation SE standard error SI International System of Units SMQ Standardised MedDRA Query SOC (MedDRA) system organ class sUA serum uric acid (also referred to as serum urate) SURI selective uric acid reabsorption inhibitor TEAE treatment-emergent adverse event UK United Kingdom ULT urate-lowering therapy URAT1 uric acid transporter 1 US United States uUA urinary uric acid vs versus XO xanthine oxidase XOI xanthine oxidase inhibitor Assessment report EMA/6459/2016 Page 5/128 1

2016 European Medicines Agency - EPARs

250. Acute and Chronic Heart Failure

3A4 DCM dilated cardiomyopathy DES desmin DHA docosahexaenoic acid DIG-PEF ancillary Digitalis Investigation Group trial DNA deoxyribonucleic acid DOSE Diuretic Optimization Strategies Evaluation DPD 3,3-diphosphono-1,2-propanodicarboxylic acid DPP4i dipeptidyl peptidase-4 inhibitor DT destination therapy e′ early diastolic tissue velocity ECG electrocardiogram Echo-CRT Echocardiography Guided Cardiac Resynchronization Therapy ECLS extracorporeal life support ECMO extracorporeal membrane (...) oxygenation ED emergency department EF ejection fraction eGFR estimated glomerular filtration rate EHRA European Heart Rhythm Association EMA European Medicines Agency EMB endomyocardial biopsy EMF endomyocardial fibrosis EMPHASIS-HF Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure EPA eicosapentaenoic acid EPHESUS Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study ESC European Society of Cardiology EU European Union EULAR European League

2016 European Society of Cardiology

251. CVD Prevention in Clinical Practice

, Management, and Avoidance CI confidence interval CKD chronic kidney disease CR cardiac rehabilitation CT computed tomography CTT Cholesterol Treatment Trialists' Collaboration CURE Clopidogrel vs. Placebo in Patients with ACS without ST-segment elevation CV cardiovascular CVD cardiovascular disease DALYs disability-adjusted life years DASH Dietary Approaches to Stop Hypertension DBP diastolic blood pressure DCCT Diabetes Control and Complications Trial DHA docosahexaenoic acid DM diabetes mellitus DPP-4 (...) dipeptidyl peptidase-4 eGFR estimated glomerular filtration rate ECDA European Chronic Disease Alliance ECG electrocardiogram ED erectile dysfunction EHN European Heart Network EMA European Medicines Agency EPA eicosapentaenoic acid EPIC European Prospective Investigation into Cancer and Nutrition EPODE Ensemble Prévenons l'Obésité des Enfants ESC European Society of Cardiology EU European Union FDA Food and Drug Administration (USA) FDC fixed dose combination FH familial hypercholesterolaemia GLP-1

2016 European Society of Cardiology

252. Odefsey (emtricitabine / rilpivirine / tenofovir alafenamide) - HIV-1

reverse transcriptase RTV ritonavir SI selectivity index (ratio of CC 50 to IC 50 ) STB elvitegravir/cobicistat/emtricitabine/ tenofovir disoproxil fumarate (coformulated; Stribild ® ) TAF tenofovir alafenamide TAF fumarate tenofovir alafenamide fumarate TAM thymidine analog mutation TDF tenofovir disoproxil fumarate (Viread ® ) Assessment report EMA/335723/2016 Page 6/120 TFV tenofovir TFV-DP tenofovir diphosphate TVD emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada ? ) UACR urine (...) albumin to creatinine ratio UGT uridine diphosphate glucuronosyltransferase UPCR urine protein to creatinine ratio List of abbreviations related to quality AS Active substance AR Assessment Report ASMF Active Substance Master File = Drug Master File BCS Biopharmaceutics Classification System CHMP Committee for Medicinal Products for Human use CFU Colony Forming Units CPP Critical process parameter CQA Critical Quality Attribute DoE Design of experiments DSC Differential Scanning Calorimetry EP

2016 European Medicines Agency - EPARs

253. Autosomal Dominant Polycystic Kidney Disease - Diet and Lifestyle Management

-protein diet (0.58 g/kg/d) or a very low protein diet (0.28 g/kg/ d supplemented with keto and amino acids). Patients were included in the study if they met the GFR criteria respective to Study A or Study B (as stated earlier), their mean arterial pressure was less than 125 mm Hg, and their dietary protein intake was greater than or equal to 0.9 g/kg body weight/d. The primary outcome for the MDRD study was GFR decline measured by 125 I-iothalamate clearance every 4 months. Klahr et al, 9 in 1995 (...) , the effect of increased ?uid intake (beyond thirst) on renal disease progression in humans with ADPKD is not known. The available data are limited and include a single post hoc analytical study, 36 two short-term interventional trials (o1 wk) without con- trol groups, 37,38 and a single long-term observational cohort study of 12 months. 39 A post hoc analysis of the well-known MDRD trial examined the relationship between GFR decline and urine volume (an indirect marker of ?uid intake). 36 During the MDRD

2015 KHA-CARI Guidelines

254. Newborn Nursing Care Pathway

to identify variances that may require further assessments Refer to: • Feeding • Weight Norm and Normal Variations • One clear void with possible uric acid crystals (orange/brownish color) • Urine pale yellow and odorless Parent education/ Anticipatory Guidance • Refer to >12 – 24 hr Variance • Refer to >12 – 24 hr Intervention • Refer to >12 – 24 hr Norm and Normal Variations • Voids within 24 hr • = 1 wet, clear, pale yellow diaper(s) 29 • Uric acid crystals in the first 24 hr Parent education (...) and pale yellow 34 Parent education/ Anticipatory Guidance • Refer to >12 – 24 hr Variance • Refer to >24 – 72 hr • Uric acid crystals may indicate dehydration after 72 hours • Urine concentrated • 12 – 24 hr Refer to: Healthy Families BC Website – www.healthyfamiliesbc.ca/parenting Physiological Health: elimination – u rine23 Newborn Guideline 13: Newborn Nursing Care Pathway Physiological Assessment 0 – 12 hours Period of Stability (POS) >12 – 24 hours >24 – 72 hours >72 hours – 7 days and beyond

2015 British Columbia Perinatal Health Program

257. BindRen (colestilan)

pH which causes uric acid to precipitate resulting in uric acid crystals (noted in the urine of both rats and dogs). There was no evidence that the increase in serum chloride levels had any effect on blood pH and no evidence of any associated lesions. Abnormally (yellow/white) coloured faeces in both rats and dogs at high dose levels were observed and this is considered to be the excretion of the test compound. In dogs, mucus was also occasionally observed in the faeces of dogs receiving 2000 mg (...) sent a letter to the CHMP on 12 October 2012 requesting some clarifications regarding the opinion. • During the CHMP meeting on 15 November 2012, the CHMP adopted a revised opinion and assessment report to address the EC’s request. BindRen Assessment report Page 6/104 Medicinal product no longer authorised2. Scientific discussion 2.1. Introduction Problem statement Hyperphosphataemia develops from an imbalance between the dietary phosphate intake and the amounts excreted in the urine. Increased

2015 European Medicines Agency - EPARs

258. Praxbind - idarucizumab

DNA Deoxyribonucleic acid DP drug product DS drug substance DSC differential scanning calorimetry dTT Diluted thrombin time DV dependent variable DVT Deep vein thrombosis EBE empirical Bayes estimates EC50 drug concentrations to achieve 50% of the maximum effect ECT Ecarin clotting time EDQM European Directorate for the Quality of Medicines and Healthcare EMA European Medicines Agency Emax maximum observed or estimated efficacy or PD effect Epsilon ( ?) residual variability in NONMEM EST (...) . Idarucizumab binds to dabigatran with a higher affinity than dabigatran binds thrombin. The biological activity of idarucizumab is determined by a thrombin clotting assay. The drug product is presented as a solution for injection/infusion containing 2.5 g/50 mL idarucizumab as active substance. Other ingredients are sodium acetate trihydrate, acetic acid, sorbitol, polysorbate 20 and water for injection. The product is available in a 50 mL glass vial (type I glass), with a butyl rubber stopper

2015 European Medicines Agency - EPARs

259. Kengrexal - cangrelor

Assessment Report ARC Academic Research Consortium ASA acetylsalicylic acid ASMF Active Substance Master File AST aspartate aminotransferase ATP adenosine triphosphate AUC area under the curve AUC 0-t area under the concentration curve from administration to last observed concentration at t. AUC1 h-t area under the concentration curve from 1 h post -administration to last observed concentration at t. ß-NAG N-acetyl-ß-D-glucosaminidase BARC Bleeding Academic Research Consortium BT bleeding time CABG (...) )-38 trial, prasugrel was associated with a 4-fold increased relative risk (absolute difference, 10.2%; p 90% for most subgroups. Metabolites are excreted mainly via the feces (male rat 60%, female rat 77%, dog 85%) with a small proportion excreted in the urine (male rat 30%, female rat 18%, dogs of both sexes 11%). This is consistent with a biliary route of excretion as the major pathway of elimination for cangrelor. No unchanged drug could be detected in excreta. The major metabolite in feces

2015 European Medicines Agency - EPARs

260. Kyprolis - carfilzomib

terminal phase.According to the ESMO clinical guidelines (2013), the diagnosis is based on the detection of the monoclonal component (M protein) in serum or urine, of bone marrow plasma cell infiltration (aspiration and/or biopsy), and on the evidence of end-organ damage caused by the proliferative disorder (CRAB criteria: hypercalcaemia, renal insufficiency, anaemia, or bone lesions). The International Staging System (ISS) identifies three stages according to the combination of ß2-microglobulin (...) of carfilzomib were peptide cleavage and epoxide hydrolysis. In rat blood and tissue homogenates, carfilzomib rapidly disappeared and 2 metabolites (M14 and M15) resulting from hydrolysis at peptide bonds rapidly formed. When incubated with hepatocytes, the diol of carfilzomib (metabolite M16) was the predominant metabolite, supporting the importance of epoxide hydrolysis. In a study conducted in plasma samples from rats and monkeys and in rat bile and urine samples, metabolites M14 and M16 were the major

2015 European Medicines Agency - EPARs

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