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Urine Uric Acid

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201. Allopurinol / lesinurad (Duzallo) - Gout

increase excretion of uric acid into the urine, by inhibition of transporters mediating reabsorption of uric acid by the kidney. Lesinurad also belongs to the oral uricosuric agents. c) intravenous pegloticase, a pegylated recombinant uricase. Uricase is an enzyme which converts uric acid to more soluble allantoin for renal excretion. Initiation of ULT could actually induce an arthritis gout attack, as instability of crystals deposits due to a sudden drop of Serum uric acid (sUA, also referred (...) and OAT4. Allopurinol is a xanthine-oxidase (XO) inhibitor. Allopurinol and its main metabolite oxypurinol lower the level of uric acid in plasma and urine by inhibition of xanthine oxidase, the enzyme catalyzing the oxidation of hypoxanthine to xanthine and xanthine to uric acid. The combination of lesinurad and allopurinol targets both excretion and production of uric acid, providing a dual-mechanism approach to effectively lower sUA levels. Secondary pharmacodynamic studies Lesinurad was tested

2018 European Medicines Agency - EPARs

203. ESC/ESH Management of Arterial Hypertension (Full text)

influencing cardiovascular risk in patients with hypertension Demographic characteristics and laboratory parameters Sex (men >women) Age Smoking (current or past history) Total cholesterol and HDL-C Uric acid Diabetes Overweight or obesity Family history of premature CVD (men aged <55 years and women aged <65 years) Family or parental history of early-onset hypertension Early-onset menopause Sedentary lifestyle Psychosocial and socioeconomic factors Heart rate (resting values >80 beats/min) Asymptomatic (...) Peripheral artery disease Atrial fibrillation Demographic characteristics and laboratory parameters Sex (men >women) Age Smoking (current or past history) Total cholesterol and HDL-C Uric acid Diabetes Overweight or obesity Family history of premature CVD (men aged <55 years and women aged <65 years) Family or parental history of early-onset hypertension Early-onset menopause Sedentary lifestyle Psychosocial and socioeconomic factors Heart rate (resting values >80 beats/min) Asymptomatic HMOD Arterial

2018 European Society of Cardiology PubMed abstract

204. Adalimumab (Halimatoz) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis

arthritis KIPC Key in process control KPP Key Process Parameter LAL Limulus amoebocyte lysate LLOQ Lower limit of quantification LMW Low molecular weight LOD Limit of detection LOQ Limit of quantitation LTa Lymphotoxin a (also referred to as TNFß in the literature) MAA Marketing authorization application MCB Master Cell Bank MMC Multimodal chromatography MMRM Mixed model repeated measures MoA Mechanism of Action mRNA Messenger Ribonucleic Acid mTNF Membrane bound TNF mTNFa Membrane bound TNF a NAb (...) in the EU on 8 September 2003; the Marketing Authorisation Holder is AbbVie Ltd. The Applicant requested EMA scientific advice concerning quality, non-clinical and clinical development on 19 May 2011 (Procedure No.: EMEA/H/SA/2108/1/2011/III). 2.2 Quality aspects 2.2.1 Introduction The finished product (FP) is presented as solution for injection in a pre-filled syringe or pen containing 40 mg of adalimumab as active substance (AS). Other ingredients are adipic acid, citric acid monohydrate, sodium

2018 European Medicines Agency - EPARs

205. Adalimumab (Hefiya) - Juvenile Rheumatoid Arthritis, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis

Key Process Parameter LAL Limulus amoebocyte lysate LLOQ Lower limit of quantification LMW Low molecular weight LOD Limit of detection LOQ Limit of quantitation LTa Lymphotoxin a (also referred to as TNFß in the literature) MAA Marketing authorization application MCB Master Cell Bank MMC Multimodal chromatography MMRM Mixed model repeated measures MoA Mechanism of Action mRNA Messenger Ribonucleic Acid mTNF Membrane bound TNF mTNFa Membrane bound TNF a NAb Neutralizing antibody NK Natural Killer (...) /520007/2018 Page 14/128 The Applicant requested EMA scientific advice concerning quality, non-clinical and clinical development on 19 May 2011 (Procedure No.: EMEA/H/SA/2108/1/2011/III). 2.2 Quality aspects 2.2.1 Introduction The finished product (FP) is presented as solution for injection in a pre-filled syringe or pen containing 40 mg of adalimumab as active substance (AS). Other ingredients are adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid

2018 European Medicines Agency - EPARs

206. Inotersen sodium (Tegsedi) - Amyloidosis

EMA/411876/2018 Page 4/142 List of abbreviations A/C Urine albumin/creatinine ratio ADA Antidrug antibodies AE Adverse event AESI Adverse event of special interest ALT Alanine aminotransferase ANCOVA Analysis of covariance aPTT Activated partial thromboplastin time ASO Antisense oligonucleotide AST Aspartate aminotransferase ATTR Transthyretin amyloidosis AUC/ AUC 0-168h Area under the curve / Area under the curve baseline to 168 hours BMI Body mass index BCRP Human breast cancer resistance (...) Interventricular septum Assessment report EMA/411876/2018 Page 5/142 IXRS Interactive voice/web-response system LBM Lean body mass LCRIS Local cutaneous reaction at the injection site LLN Lower limit of normal LSM Least squares mean LV Left ventricular 2’-MOE 2’-O-(2-methoxyethyl) mBMI Modified body mass index MMRM Mixed Effects Model with Repeated Measures mNIS+7 Modified Neuropathy Impairment Score+7 mRNA Messenger ribonucleic acid NIS Neuropathy Impairment Score NIS-C NIS-cranial nerve muscle strength NIS

2018 European Medicines Agency - EPARs

207. Adalimumab (Hyrimoz) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease, Papulosquamous Skin Diseases, Hidradenitis Suppurativa, Ankylosing Spondylitis, Uveitis

of excipients Adipic acid Citric acid monohydrate Sodium chloride Mannitol Polysorbate 80 Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections 54 6.2 Incompatibilities In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 6.3 Shelf life 30 months 6.4 Special precautions for storage Store in a refrigerator (2°C–8°C). Do not freeze. Keep the pre-filled syringe / pre-filled pen in the outer carton in order (...) OF THE MEDICINAL PRODUCT Hyrimoz 40 mg solution for injection in pre-filled syringe adalimumab 2. STATEMENT OF ACTIVE SUBSTANCE One 0.8 ml pre-filled syringe contains 40 mg adalimumab. 3. LIST OF EXCIPIENTS Excipients: adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid, sodium hydroxide, water for injections. 4. PHARMACEUTICAL FORM AND CONTENTS solution for injection 1 pre-filled syringe 2 pre-filled syringes 5. METHOD AND ROUTE(S) OF ADMINISTRATION Read

2018 European Medicines Agency - EPARs

208. Diagnosis and Management of Glycogen Stored Diseases type VI and IX a practice resource of ACMG

and hypoglycemia include liver ultrasound, serum transaminases (AST, ALT), ?-glutamyl transferase (GGT), liver function tests (prothrombin time, albumin), blood glucose, lactate, uric acid, basic chemistry, creatine kinase (CK), plasma total and free carnitine, acylcarnitine profile, urinalysis, urine organic acids, cholesterol, triglycer- ides, and complete blood count (CBC) with manual differential white cell count. It is important to check for presence of plasma ketones as serum ß-OHB during episodes (...) difficulties and overnight irritability are common. Due to the protean and nonspecific symptoms in GSDs VI and IX, they are almost certainly underdiagnosed. GSD IX has been diagnosed in adults who were being evaluated for hepatic cirrhosis. Unlike GSD I, lactic acid and uric acid concentrations are usually normal, 24 although postprandial lactic acid can be elevated. 25 Clinical variability in GSD VI Glycogen storage disease type VI (GSD VI) has variable severity and can present in infancy/early childhood

2019 American College of Medical Genetics and Genomics

209. Bladder Stones

management of bladder stones specifically; therefore, we refer the reader to the general guidance on the medical management of urinary tract stones in Chapter 3.4.9 of the EAU Urolithiasis Guidelines [ ]. Stones composed of uric acid or struvite can be dissolved by chemolysis. Uric acid stones can be dissolved by oral urinary alkalinisation when a pH > 6.5 is consistently achieved, typically using an alkaline citrate or sodium bicarbonate. Careful monitoring is required during therapy [ ]. Irrigation (...) chemolysis is possible for struvite or uric acid stones; a two-way or three-way Foley catheter can be used [ ]. See also Chapter 3.4.4. of EAU Urolithiasis Guidelines [ ]. 3.3.3. Bladder stone interventions Minimally invasive techniques for the removal of bladder stones have been widely adopted to reduce the risk of complications and shorten hospital stay and convalescence. Bladder stones can be treated with open, laparoscopic, robotic assisted laparoscopic, endoscopic (transurethral or percutaneous

2019 European Association of Urology

210. Urolithiasis

tomography of the kidneys, ureters and bladder for urolithiasis. J Med Imaging Radiat Oncol, 2017. 61: 582. 52. Poletti, P.A., et al. Low-dose versus standard-dose CT protocol in patients with clinically suspected renal colic. AJR Am J Roentgenol, 2007. 188: 927. 53. Zheng, X., et al. Dual-energy computed tomography for characterizing urinary calcified calculi and uric acid calculi: A meta-analysis. Eur J Radiol, 2016. 85: 1843. 54. Niemann, T., et al. Diagnostic performance of low-dose CT (...) of percutaneous chemolysis in the management of urolithiasis: review and results. Urolithiasis, 2013. 41: 323. 127. Bernardo, N.O., et al. Chemolysis of urinary calculi. Urol Clin North Am, 2000. 27: 355. 128. Tiselius, H.G., et al. Minimally invasive treatment of infection staghorn stones with shock wave lithotripsy and chemolysis. Scand J Urol Nephrol, 1999. 33: 286. 129. Rodman, J.S., et al. Dissolution of uric acid calculi. J Urol, 1984. 131: 1039. 130. Becker, G. Uric acid stones. Nephrology, 2007. 12

2019 European Association of Urology

211. Paediatric Urology

in diagnosing urinary tract infections in small children. Pediatr Nephrol, 2011. 26: 1923. 329. Whiting, P., et al. Rapid tests and urine sampling techniques for the diagnosis of urinary tract infection (UTI) in children under five years: a systematic review. BMC Pediatr, 2005. 5: 4. 330. Koch, V.H., et al. [Urinary tract infection: a search for evidence]. J Pediatr (Rio J), 2003. 79 Suppl 1: S97. 331. Ma, J.F., et al. Urinary tract infection in children: etiology and epidemiology. Urol Clin North Am, 2004 (...) . 31: 517. 332. Ramage, I.J., et al. Accuracy of clean-catch urine collection in infancy. J Pediatr, 1999. 135: 765. 333. Roberts, K.B., et al. Urinary tract infection: clinical practice guideline for the diagnosis and management of the initial UTI in febrile infants and children 2 to 24 months. Pediatrics, 2011. 128: 595. 334. Tosif, S., et al. Contamination rates of different urine collection methods for the diagnosis of urinary tract infections in young children: an observational cohort study. J

2019 European Association of Urology

214. Guideline on the evaluation and medical management of the kidney stone patient - 2016 update

of Evidence 3, Grade C Recommendation): 14-20 • Children ( 5.8 serum bicarbonate serum potassium Pure apatite stone Hypocitraturia Serum electrolytes Urine pH Ammonium chloride load test* Potassium citrate *Optional; PTH: parathyroid hormone; ?: high; ?N: at the high end of normal range; : low.CUAJ • November-December 2016 • Volume 10, Issues 11-12 E354 dion et al. Focus of treatment for uric acid stones should, therefore, primarily be to correct urine pH above 5.5 and increase urine volume rather than (...) , and ammonium excretion. This results in unbuffered hydrogen ions and a lowering of the urinary pH. 134 Based on the num- ber of metabolic syndrome traits, the risk of stone formation may go up two-fold. 135 Dietary and medical prophylaxis options are shown in Fig. 2. In patients with uric acid stones, alkalinization of the urine targeting a urine pH of 6.5 is the first-line therapy. Allopurinol may be used as adjunctive therapy in patients with hyperuricemia or hyperuricosuria (Level of Evidence 1-3, Grade

2017 CPG Infobase

215. Association of Uric Acid With Change in Kidney Function in Healthy Normotensive Individuals. (Abstract)

of eGFR decrease in both women and men (HR, 1.13 [95% CI, 1.04-1.39] per each 1-mg/dL increase in uric acid level); in multivariable analyses adjusting for age, sex, body mass index, blood glucose level, total cholesterol level, mean blood pressure, urine albumin-creatinine ratio, and serum triglyceride level, the association remained highly significant (HR, 1.28 [95% CI, 1.12-1.48]). Results were similar using different estimating equations and when the association was examined in sex-specific (...) Association of Uric Acid With Change in Kidney Function in Healthy Normotensive Individuals. Despite recent evidence, the role of uric acid as a causal factor in the pathogenesis and progression of kidney disease remains controversial, partly because of the inclusion in epidemiologic studies of patients with hypertension, diabetes, and/or proteinuria.Prospective observational cohort.900 healthy normotensive adult blood donors (153 women, 747 men) evaluated at baseline and after 5 years.Serum

2010 American Journal of Kidney Diseases

216. The alkalizer citrate reduces serum uric Acid levels and improves renal function in hyperuricemic patients treated with the xanthine oxidase inhibitor allopurinol. (Full text)

The alkalizer citrate reduces serum uric Acid levels and improves renal function in hyperuricemic patients treated with the xanthine oxidase inhibitor allopurinol. Hyperuricemia, an integral component of metabolic syndrome, is a major health problem causing gout and renal damage. Urine alkalizers such as citrate preparations facilitate renal excretion of the uric acid, but its supportive effect on xanthine oxidase inhibitors has not been tested yet. We performed a randomized, prospective study (...) of the effect of a combination of allopurinol and a citrate preparation on renal function in patients with hyperuricemia, employing 70 patients who had hyperuricemia with serum uric acid levels ≥7.0 mg/dL, or those diagnosed as having hyperuricemia in the past.They were randomly enrolled into two study groups: the allopurinol monotherapy (MT) group or combination treatment (CT) group with allopurinol and a citrate preparation. Allopurinol (100-200 mg/day) in the absence or presence of a citrate preparation

2010 Endocrine research Controlled trial quality: uncertain PubMed abstract

217. Sodium and Potassium Intake: Effects on Chronic Disease Outcomes and Risks

sodium intake and CVD outcomes have been carefully reviewed and critiqued. 18 Limitations may include methods used for sodium intake assessment, residual confounding, and possible reverse causality. Assessment of sodium intake in observational studies as well as in older randomized controlled trials has typically relied on the use of food frequency questionnaires or spot urine ES-3 assays of urinary sodium excretion. However, these methods have repeatedly been shown to be highly prone to both random (...) and systematic error. More accurate but still error prone methods include 24- to 72-hour food diaries or recall assessment or 8-hour (overnight) urine assays. The most accurate method of assessing sodium intake in observational studies, particularly decreases in sodium intake, is the repeated 24-hour urinary sodium excretion with validation. 19, 20 In light of the limitations of the existing observational studies, the current state of knowledge needs to be reconsidered. Potassium DRIs The 2005 IOM committee

2018 Effective Health Care Program (AHRQ)

218. When and how to treat hyponatremia in the ED

- or hypervolemia. Edema, ascites, pulmonary effusion Investigations Urine sodium excretion (<20-30 mmol/L), fractional excretion of uric acid, trial of volume expansion Urine sodium excretion (>20-30 mmol/L), trial of volume expansion Urine sodium excretion (<20-30 mmol/L), Elevated BUN Notes on Treatment Correction of volume deficit, treatment of underlying disease, avoiding over-rapid correction. In case of cerebral salt wasting, do NOT restrict fluids See guidelines for recommended treatment by specific (...) levels, particularly in patients with chronic hyponatremia, can lead to osmotic demyelination syndrome (ODS) , a profoundly debilitating condition. In 2011, a patient successfully sued her physician and nurse for overcorrection of sodium levels, leading to ODS and lifelong disability 6 . In all cases, avoid overcorrection of more than 10 mmol/L in 24 hours. Water diuresis (i.e. high urine output) is often the first sign of impending rapid correction (e.g. primary polydipsia, correction of hypovolemia

2018 CandiEM

219. Paediatric Urology

in diagnosing urinary tract infections in small children. Pediatr Nephrol, 2011. 26: 1923. 329. Whiting, P., et al. Rapid tests and urine sampling techniques for the diagnosis of urinary tract infection (UTI) in children under five years: a systematic review. BMC Pediatr, 2005. 5: 4. 330. Koch, V.H., et al. [Urinary tract infection: a search for evidence]. J Pediatr (Rio J), 2003. 79 Suppl 1: S97. 331. Ma, J.F., et al. Urinary tract infection in children: etiology and epidemiology. Urol Clin North Am, 2004 (...) . 31: 517. 332. Ramage, I.J., et al. Accuracy of clean-catch urine collection in infancy. J Pediatr, 1999. 135: 765. 333. Roberts, K.B., et al. Urinary tract infection: clinical practice guideline for the diagnosis and management of the initial UTI in febrile infants and children 2 to 24 months. Pediatrics, 2011. 128: 595. 334. Tosif, S., et al. Contamination rates of different urine collection methods for the diagnosis of urinary tract infections in young children: an observational cohort study. J

2018 European Association of Urology

220. Urolithiasis

tomography of the kidneys, ureters and bladder for urolithiasis. J Med Imaging Radiat Oncol, 2017. 61: 582. 52. Poletti, P.A., et al. Low-dose versus standard-dose CT protocol in patients with clinically suspected renal colic. AJR Am J Roentgenol, 2007. 188: 927. 53. Zheng, X., et al. Dual-energy computed tomography for characterizing urinary calcified calculi and uric acid calculi: A meta-analysis. Eur J Radiol, 2016. 85: 1843. 54. Niemann, T., et al. Diagnostic performance of low-dose CT (...) of percutaneous chemolysis in the management of urolithiasis: review and results. Urolithiasis, 2013. 41: 323. 127. Bernardo, N.O., et al. Chemolysis of urinary calculi. Urol Clin North Am, 2000. 27: 355. 128. Tiselius, H.G., et al. Minimally invasive treatment of infection staghorn stones with shock wave lithotripsy and chemolysis. Scand J Urol Nephrol, 1999. 33: 286. 129. Rodman, J.S., et al. Dissolution of uric acid calculi. J Urol, 1984. 131: 1039. 130. Becker, G. Uric acid stones. Nephrology, 2007. 12

2018 European Association of Urology

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