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161. Axicabtagene ciloleucel (Yescarta) - diffuse large B-cell lymphoma (DLBCL); primary mediastinal large B-cell lymphoma (PMBCL)

Axicabtagene ciloleucel (Yescarta) - diffuse large B-cell lymphoma (DLBCL); primary mediastinal large B-cell lymphoma (PMBCL) 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT YESCARTA 0.4 – 2 x 10 8 cells (...) and fludarabine 30 mg/m 2 intravenous should be administered on the 5th, 4th, and 3rd day before infusion of YESCARTA. Pre-medication • Paracetamol 500-1000 mg given orally and diphenhydramine 12.5 mg intravenous or oral (or equivalent) approximately 1 hour before YESCARTA infusion is recommended. • Prophylactic use of systemic steroids is not recommended as it may interfere with the activity of YESCARTA. Monitoring • Patients should be monitored daily for the first 10 days following infusion for signs

2018 European Medicines Agency - EPARs

162. Handbook on tuberculosis laboratory diagnostic methods in the European Union

of a BSL3 containment laboratory. Molecular techniques involving previously extracted DNA do not require a biosafety level standard [1,3,6]. Before initiating a new test, task or method in a laboratory, a risk assessment is obligatory. This will identify possible risks and allow for proper infection control measurements. In 2008, the European Committee for Standardization (CEN) published the CWA 15793 Laboratory Biorisk Management Standard, which is based on a management systems approach [9]. Both CWA (...) . Any maintenance or technical personnel should always be accompanied by an authorised staff member and only be allowed access when the laboratory is considered relatively safe and if they are wearing personal protective equipment and the appropriate gown and shoes [1]. Figure 1. Biohazard warning sign for laboratory doors Source: World Health Organization. Laboratory biosafety manual, 3rd edition. Geneva; 2004 [1] TECHNICAL REPORT Handbook on tuberculosis laboratory diagnostic methods

2018 European Centre for Disease Prevention and Control - Technical Guidance

163. Depression

wanted the latest trusted evidence on depression or other clinical topics then use Trip today. This page lists the very latest high quality evidence on depression and also the most popular articles. Popularity measured by the number of times the articles have been clicked on by fellow users in the last twelve months. What is Trip? Trip is a clinical search engine designed to allow users to quickly and easily find and use high-quality research evidence to support their practice and/or care. Trip has (...) been online since 1997 and in that time has developed into the internet’s premier source of evidence-based content. Our motto is ‘Find evidence fast’ and this is something we aim to deliver for every single search. As well as research evidence we also allow clinicians to search across other content types including images, videos, patient information leaflets, educational courses and news. For further information on Trip click on any of the questions/sections on the left-hand side of this page

2018 Trip Latest and Greatest

164. HIV

trusted evidence on hiv or other clinical topics then use Trip today. This page lists the very latest high quality evidence on hiv and also the most popular articles. Popularity measured by the number of times the articles have been clicked on by fellow users in the last twelve months. What is Trip? Trip is a clinical search engine designed to allow users to quickly and easily find and use high-quality research evidence to support their practice and/or care. Trip has been online since 1997 (...) and in that time has developed into the internet’s premier source of evidence-based content. Our motto is ‘Find evidence fast’ and this is something we aim to deliver for every single search. As well as research evidence we also allow clinicians to search across other content types including images, videos, patient information leaflets, educational courses and news. For further information on Trip click on any of the questions/sections on the left-hand side of this page. But if you still have questions please

2018 Trip Latest and Greatest

165. Obesity

the latest trusted evidence on obesity or other clinical topics then use Trip today. This page lists the very latest high quality evidence on obesity and also the most popular articles. Popularity measured by the number of times the articles have been clicked on by fellow users in the last twelve months. What is Trip? Trip is a clinical search engine designed to allow users to quickly and easily find and use high-quality research evidence to support their practice and/or care. Trip has been online since (...) 1997 and in that time has developed into the internet’s premier source of evidence-based content. Our motto is ‘Find evidence fast’ and this is something we aim to deliver for every single search. As well as research evidence we also allow clinicians to search across other content types including images, videos, patient information leaflets, educational courses and news. For further information on Trip click on any of the questions/sections on the left-hand side of this page. But if you still have

2018 Trip Latest and Greatest

166. Side effects

of evidence. If you wanted the latest trusted evidence on side effects or other clinical topics then use Trip today. This page lists the very latest high quality evidence on side effects and also the most popular articles. Popularity measured by the number of times the articles have been clicked on by fellow users in the last twelve months. What is Trip? Trip is a clinical search engine designed to allow users to quickly and easily find and use high-quality research evidence to support their practice (...) and/or care. Trip has been online since 1997 and in that time has developed into the internet’s premier source of evidence-based content. Our motto is ‘Find evidence fast’ and this is something we aim to deliver for every single search. As well as research evidence we also allow clinicians to search across other content types including images, videos, patient information leaflets, educational courses and news. For further information on Trip click on any of the questions/sections on the left-hand side

2018 Trip Latest and Greatest

167. Meclizine

. If you wanted the latest trusted evidence on meclizine or other clinical topics then use Trip today. This page lists the very latest high quality evidence on meclizine and also the most popular articles. Popularity measured by the number of times the articles have been clicked on by fellow users in the last twelve months. What is Trip? Trip is a clinical search engine designed to allow users to quickly and easily find and use high-quality research evidence to support their practice and/or care. Trip (...) has been online since 1997 and in that time has developed into the internet’s premier source of evidence-based content. Our motto is ‘Find evidence fast’ and this is something we aim to deliver for every single search. As well as research evidence we also allow clinicians to search across other content types including images, videos, patient information leaflets, educational courses and news. For further information on Trip click on any of the questions/sections on the left-hand side of this page

2018 Trip Latest and Greatest

169. Trans fats consumption in Australia

, and popcorn. Conversely, available data suggest that the levels of iTFA are currently relatively low in takeaway foods in Australia. Based on the latest nationally representative dietary survey conducted in 2011–2012, it was ascertained that Australians on average have intakes of TFA at 0.6% of daily energy, with an estimated 60–75% coming from ruminant (natural) sources, and the rest being iTFA. While TFA intake is relatively low in Australia compared to other countries, about one in ten Australians (...) continue to exceed the current World Health Organization’s (WHO) recommended limit of 1% daily energy from TFA. Analyses based on the national survey further identified a social-economic gradient for TFA consumption. Among Australians in the lowest fifth of income and education brackets, about 1/7 exceeded the WHO recommended TFA limit. Epidemiologic modeling was conducted using these up-to-date estimates of TFA consumption in Australia and the known association between TFA and CHD risk

2018 Sax Institute Evidence Check

170. International food service initiatives

that the $45 billion Australian food service sector³ is engaged in a meaningful way to improve the nutritional profile of the products they offer and market to consumers. While some food service companies are taking action – for example, reducing the salt, saturated fat, added sugar or energy content of their products and adding more fruit and vegetables to their offerings – these are largely ad hoc measures that aren’t applied across the sector. The Healthy Food Partnership, though its Food Service (...) and halting of the progression of overweight and obesity) therefore requires a multifactorial response acknowledging the inherent complexity of the environment influencing individuals. In developed nations such as Australia, the processed food supply system provides energy-dense, nutrient-poor foods (that are highly processed; rich in fat, sugar and salt; and low in essential nutrients) in large portion sizes. This food supply has been recognised as a major cause of obesity and diet-related health

2018 Sax Institute Evidence Check

171. Dietary patterns and cardiovascular disease outcomes

patterns Dietary Pattern Description of dietary pattern High protein diet 16, 17 • Mean protein intake (as % of total diet) for High protein diet 30.5±2.4% (range: 27.0–34.9%) and for standard protein 17.5±1.5% (range: 16.0–21%) 17 • Protein intake more than >25% of an individual’s total daily kJ intake 16 High protein diet V2 18 • Protein intake between higher and lower protein diets must have had a 5% difference in total energy • The median protein content of the higher-protein diets was 27 (...) % of the total energy intake (range: 16–45%) and 18% (range: 5–23%) in the lower-protein diets 18 Low-fat diet 16 • Less than =30% of an individual’s total daily kJ intake comes from fat 16 Low carbohydrate diet 19 • Carbohydrate (CHO) intake equal to or less than 120gram/day 19 Low GI/GL diets 20, 21 • No definition regarding classification of low vs high GI and low vs high GL 21 • One study did a sub-group analysis between high and low GI diets; compared GI difference of 0–10 between groups, GI difference

2018 Sax Institute Evidence Check

172. The Effectiveness and Risks of Cranial Electrical Stimulation

randomized controlled trials were included Population(s): Adult patients with one or more of the following conditions: a chronic pain condition, depression, anxiety, insomnia, and posttraumatic stress disorder (PTSD) Intervention(s): Any cranial electrical stimulation (CES) device used in the home setting Comparator(s): Usual care including appropriate known treatments Outcome(s): Chronic pain: pain severity, use of opioid analgesic medication, quality of life, and daily functioning; Depression (...) and anxiety: clinical assessments, scores on standardized Cranial Electrical Stimulation Evidence-based Synthesis Program 5 inventories; PTSD: symptom severity, quality-of-life measures, daily functioning; Insomnia: ability to initiate /maintain sleep, resolution of symptoms Timing: No restrictions Setting: Home setting, or office-based if needed for the conduct of the trial. Studies of hospitalized patients were excluded. DATA ABSTRACTION We abstracted data on the following: condition, description

2018 Veterans Affairs Evidence-based Synthesis Program Reports

173. Recommendations for the Delivery of Psychosocial Oncology Services in Ontario

in cancer • Lack of adequate nutrition for reconditioning and rehabilitation Physical/ Functional/ Rehabilitative • Pain and symptom control • Impaired energy and physical functioning • Impaired sleep • Deconditioning • Lymphedema management • Speech and swallowing impairment • Adjustments in home or work modifications due to physical limitations • Loss of muscle mass impacting activities of daily living Table 1: Psychosocial concerns of patients with cancer Table 1: Psychosocial concerns of patients (...) with cancer continued on page 1414 | Building the case: why is psychosocial oncology care important? Category Concern Practical • Need for community support (e.g., social work, nursing) • Practical needs (e.g., housing, food, disability aid, transportation, functions of daily living, drug reimbursement, daycare) • Rehabilitation issues (e.g., back-to-work difficulties, changes to home routine and set up) • Employment, school or career concerns, advocacy • Cultural or language issues • Caregiver

2018 Cancer Care Ontario

174. Multimorbidity: a priority for global health research

workshops or stakeholder meetings, or provided oral evidence. Funding from the Global Challenges Research Fund and the core grant from the Department for Business, Energy and Industrial Strategy to the Academy was used to support this project. This report is published by the Academy of Medical Sciences and has been endorsed by its Officers and Council. Contributions by the working group were made purely in an advisory capacity. The members of the working group participated in an individual capacity (...) to assess questions about the burden of multimorbidity, its determinants, and the prevention and treatment of patients with multimorbidity. Importantly, the proposed reporting system allows researchers the flexibility to consider multimorbidity in a way that is most appropriate for the precise research question and the specific context in which the study is conducted. Definition The co-existence of two or more chronic conditions, each one of which is either: • A physical non-communicable disease of long

2018 Academy of Medical Sciences

175. Semaglutide (Ozempic) - Diabetes Mellitus

from subcutis. Toxicokinetics The pharmacokinetics following repeated dosing of subcutaneous semaglutide showed a linear relationship between doses and exposures. No gender differences were noted. The dose normalised exposure was generally lower for mice, rats, rabbits and minipigs compared to monkeys and humans due to faster clearance. To ensure continued exposure, and to mimic the once-weekly exposure profile in humans, once-daily dosing was used in mice and rats, and twice-weekly dosing was used (...) performed in the cynomolgus monkey, where a few observed abnormalities as well as early embryofoetal loss in high and mid dose levels also gave rise to NOAEL at the low dose level, and less than MHRD exposure levels. These changes were observed in concordance with body weight loss in the maternal animals. Mechanistic studies showing that GLP-1R in the yolk sack of rats were important in the energy uptake in early embryonic phase, and may in part be the explanation for the observed abnormalities

2018 European Medicines Agency - EPARs

176. Burosumab (Crysvita) - X-linked hypophosphataemia/hypophosphatemia

limiting toxicity DMP Disease Monitoring Program DO Dissolved Oxygen DSC Differential Scanning Calorimetry DSHC Degradation Species of Heavy Chain DXA dual energy X-ray absorptiometry ECG electrocardiogram ECHO echocardiograph ECL Electrochemiluminescence EDC Electronic Data Capture EDV/ESV end-diastolic and end-systolic volumes EF ejection fraction Assessment report EMA/148319/2018 Page 5/130 Egr-1 Klotho-dependent Early Growth Response-1 ELISA Enzyme-linked Immunosorbent Assay EMA European Medicines (...) of multiple daily doses of oral phosphate and active vitamin D analogues. Skeletal abnormalities in children with XLH often require surgical correction. There is no consensus regarding treatment of adult patients because of concern about safety issues and lack of clinical studies demonstrating efficacy with conventional therapy. 2.1.6. About the product Burosumab (KRN23) is a recombinant human IgG1 monoclonal antibody that binds to and inhibits the excess biological activity of FGF23. The aim

2018 European Medicines Agency - EPARs

177. Outcomes based commissioning and consumers

of what motivates consumers to give up their time and energy to become involved in this kind of activity; it raises the question of whether there is a possibility that this factor might affect the type of evidence generated. It is also important to note that, in some of the cases observed by Schehrer and Sexton, consumer engagement in decision-making did not prevent decisions being overturned by elected officials who had received complaints from other constituents. 4 OUTCOMES-BASED COMMISSIONING

2018 Sax Institute Evidence Check

178. The Patient Centred Medical Home: barriers and enablers to implementation

(GPs). • Traditional payment policies (such as fee-for-service) may focus GPs/practices on activities that are not aligned with PCMH • Lack of financial incentives coupled with the cost of implementing PCMH may deter practices from pursuing it. • Consider payment models that move the focus away from specific service interactions to ones that focus on patient needs over time • Include additional incentives that focus on quality of care delivered • Explore models that allow primary care practices (...) , to operate according to PCMH-principles, a system of “paying for what one wants and improving patient care” (p. 45) was implemented. 27 The authors comment that “Although there are many legitimate criticisms of fee-for-service medicine, the fee schedule is, nevertheless, an excellent incentive mechanism that can be used to shape behavior and track activities”, and was thus used to “allow GPs to spend more time with their patients and to practice guidelines-based care… to shift the focus of care

2018 Sax Institute Evidence Check

179. Ertugliflozin l-pyroglutamic acid (Steglatro) - Diabetes Mellitus, Type 2

Attribute CTX serum c-terminal telopeptide sequence of Type 1 collagen CV cardiovascular CVOT cardiovascular outcome trial CYP cytochrome P450 DBP diastolic blood pressure DDI drug-drug interaction DOC Dissolved Oxygen Concentration DoE Design of experiments DT 50 Time required for 50% degradation/dissipation of the initial concentration DT 90 Time required for 90% degradation/dissipation of the initial concentration DXA dual-energy x-ray absorptiometry EASD European Association for the Study (...) Predicted environmental concentration in sediments PEC SW Predicted environmental concentration in surface waters P-gp P-glycoprotein Ph. Eur. European Pharmacopoeia PND postnatal day PNEC Predicted no-effect concentration PPG post-prandial glucose PTH parathyroid hormone PVC poly vinyl chloride PXRD powder X-Ray diffraction QbD quality by design QC quality control qd once daily QT time from the start of the Q wave to the end of the T wave QTc QT interval corrected QTcF QT interval corrected using

2018 European Medicines Agency - EPARs

180. Ertugliflozin l-pyroglutamic acid / sitagliptin phosphate monohydrate (Steglujan) - Diabetes Mellitus, Type 2

of change PEC SED Predicted environmental concentration in sediments PEC SW Predicted environmental concentration in surface waters P-gp P-glycoprotein Ph. Eur. European Pharmacopoeia PK pharmacokinetic(s) PNEC Predicted no-effect concentration PPG post-prandial glucose PVC poly vinyl chloride PXRD powder X-Ray diffraction QbD quality by design QC quality control qd once daily QT time from the start of the Q wave to the end of the T wave QTc QT interval corrected QTPP quality target product profile RA (...) previously reviewed by the European Food Safety Authority (EFSA) where its use in supplements up to 3 grams per day was considered to be of no concern. (This amount is significantly higher than the 3.42 mg L-PGA present in the maximum daily dose (15 mg) of ertugliflozin.) CHMP agreed that L-PGA can be considered a reagent and not a starting material in line with ICH Q11 based on the fact that L-PGA is a commonly available commodity chemical used in several industries and it may be obtained from L

2018 European Medicines Agency - EPARs

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