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101. Surveillance, Diagnosis and Management of Clostridium Difficile Infection in Ireland

. These estimates are consistent with other studies.(17) The total costs for recurrent CDI has been shown to be approximately three-fold higher than for a primary episode of CDI.(16) In Europe, estimates suggest that the potential costs associated with the management of CDI are in the region of €3,000 million. This figure is likely to rise in line with an ageing population: by 2050 more than 134 million Europeans will be aged 65 years or older.(14) In the UK, NICE has estimated the impact of a 5%, 10% and 15 (...) the AIG category was dissolved and CDI became a notifiable infectious disease in its own right, as new or recurrent CDI. Table 1.1 summarises CDI cases notified to the Computerised Infectious Disease Reporting (CIDR) system from 4th May 2008 to 31st December 2013. The majority of cases were reported from patients aged 65 years or older. 1 http://www.hpsc.ie/A-Z/Gastroenteric/Clostridiumdifficile/Publications/9 A National Clinical Guideline Clostridium difficile Infection in Ireland Table 1.1: CDI

2019 National Clinical Guidelines (Ireland)

102. Masitinib mesylate (Alsitek) - Amyotrophic Lateral Sclerosis

of ALS is 1:400 for women and 1:350 for men. Peak age at onset is 58–63 years for sporadic disease and 47– 52 years for familial disease. Incidence decreases rapidly after 80 years of age. Assessment report EMA/406203/2018 Page 7/118 ALS is categorized in two forms: familial and sporadic, with the latter being the most common (90– 95%) which has no obvious genetically inherited component. In general about 5–10% of ALS is familial, with a Mendelian dominant inheritance pattern, although regional (...) candidate gene studies have identified several susceptibility genes, although the relative contribution of every identified “at risk” gene rarely exceeds an odds ratio of 2.0, and the mechanism by which risk is conferred is not known The first onset of symptoms is usually between the ages of 50 and 65. The most common symptoms that appear in both types of ALS are muscle weakness, twitching, and cramping, which eventually can lead to the impairment of muscles. In the most advanced stages, ALS patients

2018 European Medicines Agency - EPARs

103. Neratinib (Nerlynx) - Breast cancer, breast neoplasms

-stage HER2-overexpressed/amplified breast cancer at high risk of recurrence (node positive and within 1 year of completion of prior adjuvant trastuzumab based therapy). 2.1.2. Epidemiology, screening tools/prevention Breast cancer is the most frequently diagnosed malignancy in women and the leading cause of cancer mortality in women worldwide. In 2012, the estimated age-adjusted annual incidence of breast cancer Assessment report EMA/CHMP/525204/2018 Page 9/169 in 40 European countries was 94.2/100 (...) 000 and the mortality was 23.1/100 000 1 . There is a steep age gradient, with about a quarter of breast cancers occurring before age 50, and 2000/2000 None RPT-48223 GLP Mouse 3M:3F/Group 0, 200, 700, 2000 - IP 700/200 Mortality at 2000 & 700 mg/kg. 200 mg/kg: Soft faeces. No weight loss or macroscopic findings. RPT-48224 GLP Rat 3M:3F/Group 0, 200, 700, 2000 - oral 2000/700 2000 mg/kg: animals euthanized with changes to adrenals, GI tract, spleen, thymus, pancreas, kidneys, liver, and ovaries

2018 European Medicines Agency - EPARs

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

during any dosing interval at steady state BA bioavailability BCS biopharmaceutical classification system BCRP breast cancer resistance protein BE bioequivalence bid twice (two times) a day BMD bone mineral density BMI body mass index BSA body surface area CFU colony forming units CHMP Committee for Medicinal Products for Human use CKD chronic kidney disease cLDA constrained longitudinal data analysis CL/F apparent clearance of drug C max maximum observed plasma concentration CQA Critical Quality (...) 2015. The applicant applied for the following indication: Steglatro is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as: Monotherapy When diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications. Add-on combination therapy In combination with other glucose-lowering medicinal products, including insulin, when these, together

2018 European Medicines Agency - EPARs

105. Ertugliflozin l-pyroglutamic acid / metformin hydrochloride (Segluromet) - Diabetes Mellitus, Type 2

under the curve AUCinf area under the concentration-time curve from 0 to infinity AUClast area under the concentration –time curve from zero to time of last measurable concentration BCS biopharmaceutical classification system bid twice daily BMD bone mineral density BMI body mass index Broad pool pooled safety data from all seven ertugliflozin phase III studies BUN blood urea nitrogen CFU colony forming units CHMP Committee for Medicinal Products for Human use CI confidence interval cLDA constrained (...) by the EMA/CHMP on 22 October 2015. The applicant applied for the following indication: Segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: • in patients not adequately controlled on their maximally tolerated dose of metformin alone • in patients on their maximally tolerated doses of metformin along with other glucose-lowering medicinal products, including insulin, when these do not provide adequate

2018 European Medicines Agency - EPARs

106. Bictegravir / emtricitabine / tenofovir alafenamide / fumarate (Biktarvy) - HIV Infections

, emtricitabine or tenofovir (see section 5.1). Pharmaceutical form(s): Film-coated tablet Strength(s): 50 mg / 200 mg / 25 mg Route(s) of administration: Oral use Packaging: bottle (HDPE) Package size(s): 30 tablets and 90 (3 x 30) tablets Assessment report EMA/293559/2018 Page 3/104 Table of contents 1. Background information on the procedure 9 1.1. Submission of the dossier 9 1.2. Steps taken for the assessment of the product 10 2. Scientific discussion 11 2.1. Problem statement 11 2.1.1. Disease (...) the concentration versus time curve over the dosing interval B/F/TAF bictegravir/emtricitabine/tenofovir alafenamide (coformulated) BCS Biopharmaceutics Classification System BIC bictegravir BIC Bictegravir sodium BLQ below the limit of quantitation BMD bone mineral density BMI body mass index CHB chronic hepatitis B CI confidence interval Clast last observed quantifiable concentration of the drug Cmax maximum observed concentration of drug CMH Cochran-Mantel-Haenszel COBI cobicistat (Tybost) CPK creatine

2018 European Medicines Agency - EPARs

107. Dolutegravir sodium rilpivirine hydrochloride (Juluca) - HIV Infections

% Batch size 233,333 (approx.) 120,000 67,000* Expiry date 7-2017 12-2018 12-2016 * Although the final film-coated tablet batch of the test formulation comprised only 67,000 tablets, the compression batch size comprised 117 kg of tablet cores (corresponding to about 234,000 units which corresponds to about 54% of full production scale). Population studied 118 healthy male and female subjects aged between 18 and 55 years with a BMI of 18.5-31 kg/m 2 were enrolled and randomized. 113 subjects completed (...) , one subject was excluded due to a result “not determined” in Period 1 because AUC 0-8 >20%, R 2 65 years of age were limited. Pharmacokinetic interaction studies Dolutegravir Dolutegravir is eliminated mainly through metabolism by UGT1A1. Dolutegravir is also a substrate of UGT1A3, UGT1A9, CYP3A4, Pgp, and BCRP; therefore medicinal products that induce those enzymes may decrease dolutegravir plasma concentration and reduce the therapeutic effect of dolutegravir. Co- administration of dolutegravir

2018 European Medicines Agency - EPARs

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

in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control - when metformin and/or a sulphonylurea (SU) do not provide adequate glycaemic control. - when metformin and/or a sulphonylurea (SU) and one of the monocomponents of Steglujan do not provide adequate glycaemic control. - in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets. (See sections 4.2, 4.4, 4.5, and 5.1 for available (...) and the scientific discussion within the Committee, issued a positive opinion for granting a marketing authorisation to Steglujan on 25 January 2018. Assessment report EMA/86941/2018 Page 9/139 2. Scientific discussion 2.1. Problem statement 2.1.1. Disease or condition The indication as initially proposed for Steglujan is: “Steglujan, fixed-dose combination of ertugliflozin and sitagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve

2018 European Medicines Agency - EPARs

109. Olaparib (Lynparza) - advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer

Olaparib (Lynparza) - advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer Published 09 December 2019 1 SMC2209 olaparib 100mg and 150mg film-coated tablets (Lynparza®) AstraZeneca UK Limited. 8 November 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland (...) after chemotherapy but a CA-125 level above the upper limit of the normal range). Patients had an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, normal organ and bone- marrow function. 3 Following completion of platinum-based chemotherapy, patients were centrally randomised, in a 2:1 ratio to receive olaparib 300mg orally twice daily or placebo. Randomisation was stratified according to clinical response after platinum-based chemotherapy (complete or partial). 3 Patients were

2019 Scottish Medicines Consortium

110. Acute myelogenous leukaemia

of Auer rods From the collection of Drs K. Raj and P. Mehta; used with patient consent [Citation ends]. History and exam pallor ecchymoses or petechiae fatigue dizziness palpitations dyspnoea infections or fever lymphadenopathy hepatosplenomegaly mucosal bleeding skin or testicular mass skin infiltration gingival enlargement bone pain abdominal pain age over 65 years previous treatment with chemotherapy previous haematological dyspoiesis genetic factors constitutional karyotype abnormalities radiation (...) in the peripheral blood and normal haematopoiesis is reduced. Definitive diagnosis requires bone marrow biopsy. Presence of blast cells in ≥20% of the bone marrow cells confirms the diagnosis. Cytogenetic abnormalities are prognostically important and affect patient management. Most patients are treated with chemotherapy induction, consolidation, and maintenance regimens. Haematopoietic stem cell transplantation may also be used in select patients. It is important to rapidly identify acute promyelocytic

2017 BMJ Best Practice

111. Brucellosis

culture serological tests CSF analysis CSF culture synovial fluid analysis synovial fluid culture FBC LFTs bone marrow culture tissue biopsy plain film x-rays of affected joints chest x-ray bone scan CT or MRI scan of spine CT or MRI scan of head PCR for detection and diagnosis of Brucella species matrix-assisted laser desorption/ionisation time of flight mass spectrometry (MALDI-TOF-MS) Treatment algorithm ACUTE Contributors Authors Senior Lecturer (Honorary Consultant) Liverpool School of Tropical (...) position of the National Health Service, the National Institute for Health Research, the Department of Health, or Public Health England. Specialist Trainee in Clinical Microbiology Royal Liverpool University Hospital Liverpool UK Disclosures AG is an author of several references cited in this monograph. Consultant in Infectious Diseases Whipps Cross Hospital London UK Disclosures ST declares that she has no competing interests. Peer reviewers Infectious Diseases Consultant Unit of Infectious Diseases

2017 BMJ Best Practice

112. Risk factors for breast cancer: A review of the evidence 2018

Genomic changes 11 3.2.2 Epigenetic changes 12 3.2.3 Hormonal influences 12 3.2.4 Metabolic changes 13 3.2.5 The immune system 13 3.2.6 Stem and progenitor cells 13 3.2.7 The tumour microenvironment and interactions with stroma 13 3.3 Windows of susceptibility 14 Breast cancer risk factors 15 4 4.1 General factors 15 4.1.1 Age 15 4.1.2 Geographic location and residence 16 4.1.3 Remoteness and urbanisation 18 4.1.4 Socioeconomic status 19 4.2 Personal characteristics 21 4.2.1 Birthweight 21 4.2.2 (...) polymorphisms 47 4.3.11 STK11 gene mutation 50 4.3.12 TP53 gene mutation 52 4.4 Breast pathology 54 4.4.1 Previous benign breast disease 54 4.4.2 LCIS 55 4.4.3 DCIS 59 4.4.4 Previous primary invasive breast cancer 60 4.5 Endogenous hormones 63 4.5.1 Age at menarche 63 4.5.2 Parity 64 4.5.3 Age at first birth 65 4.5.4 Breastfeeding 67 4.5.5 Age at menopause 68 4.5.6 Circulating hormones—steroids 69 4.5.7 PCOS 72 4.6 Exogenous hormones 74 4.6.1 Hormonal contraception—combined 74 4.6.2 Hormonal contraception

2018 Cancer Australia

113. Responsible use of high-risk medical devices: the example of 3D printed medical devices

the procedure. 3 In February 2012, with the help of a 3D printer, doctors and engineers at Hasselt University successfully performed the world’s first patient-specific prosthetic jaw transplant for an 83-year-old woman suffering from a chronic bone disease.” 4 Today, Leuven University Hospital, routinely simulate orthognathic surgical cases in 3D-software, design and print the surgical templates on high-end 3D printers in the hospital. This occurs in over 150 patients per year. A full-time engineering team

2018 Belgian Health Care Knowledge Centre

114. Payment methods for hospital stays with a large variability in the care process

. psychiatry 22 Hospital payment methods for variable and complex care KCE Report 302 In Germany, all exclusion mechanisms are applied (see Figure 5). The German DRG system defines 45 DRGs (in 13 major diagnostic categories or MDCs) without a national cost-weight, including for example bone narrow transplant patients and tuberculosis patients. Furthermore 192 products/services, including 96 pharmaceuticals, are excluded, which accounted for 2 billion € in 2014 (about 3% of total payments). It is also (...) /departments are reimbursed on either case-based or per diem payments for their services. In the USA-Medicare Part A, there is clear focus on the exclusion of local- hospitals/departments and cancer-hospitals/departments (Figure 6). Children’s hospitals are also excluded – but this is reasoned by the nature of the Medicare insurance scheme (insurance covers people who are age 65 or under 65 and disabled). Medicare pays excluded hospitals for inpatient care on the basis of their Medicare allowable incurred

2018 Belgian Health Care Knowledge Centre

115. Asthma

stepwise treatment, depending on the person's age, and the severity of their asthma symptoms, may include: An inhaled corticosteroid (ICS) at a low dose in adults/paediatric low dose in children. Add-on therapies, such as a leukotriene receptor antagonist, or a long-acting inhaled beta- 2 agonist, a maintenance and reliever therapy regimen, increased doses of ICS, theophylline, and/or a long-acting muscarinic agent. If symptoms are still not adequately controlled, consider referral to a specialist (...) with non-adherence to asthma medicines, psychosocial problems, and repeated episodes of unscheduled care for asthma). Acute exacerbations of asthma are generally managed with a short course of oral prednisolone and a short-acting beta- 2 agonist. Hospital admission is necessary for people with life-threatening asthma or severe asthma which does not adequately respond to initial treatment. Video content relating to this topic includes: Have I got the right topic? From age 1 month onwards. This Prodigy

2017 Prodigy

116. Bruising

of Health and Care Excellence (NICE) guideline Suspected cancer: recognition and referral [ ]. The recommendation to check a blood film is based on expert opinion in review articles that this can confirm whether there is true thrombocytopenia; and platelet and leukocyte morphology and characteristics can suggest haematological malignancies and hyperproliferative conditions [ ; ]. Pancytopenia indicates bone marrow disease [ ]. The recommendation to consider checking clotting is based on expert opinion (...) film is helpful to confirm whether there is true thrombocytopenia; and platelet and leukocyte morphology and characteristics can suggest haematological malignancies or hyperproliferative conditions [ ]. Pancytopenia indicates bone marrow disease [ ]. Blood results can be normal in the presence of mild coagulation or platelet disorders This recommendation is based on expert opinion in review articles [ ; ]. What else might it be? Skin conditions which might be mistaken for bruising include: Linear

2017 Prodigy

117. Perinatal Mortality Guideline

Perinatal Mortality Guideline Definitions Clinical Note: For the purposes of review of Perinatal Mortality, “Perinatal” will be defined as from greater than or equal to 20 weeks gestational age and less than 28 days of life. There has been variation in the definition of perinatal mortality, both internationally and within North America. For consistency of data collection, PSBC promotes the use of definitions as outlined by the British Columbia Vital Statistics Act. 1 www.bclaws.ca/civix/document/id (...) of the pregnancy, of a product of conception in which, after the expulsion or extraction, there is any of: breathing, beating of the heart, pulsation of the umbilical cord or unmistakable movement of voluntary muscle, whether or not the umbilical cord has been cut or the placenta is attached. Abortus – a fetus weighing less than or equal to 500 grams or having completed less than 20 weeks gestational age at the time of expulsion or removal from the uterus regardless of whether signs of life are present

2017 British Columbia Perinatal Health Program

118. Dental Management of Pediatric Patients Receiving Chemotherapy, Hematopoietic Cell Transplantation, and/or Radiation Therapy

of Pediatric Dental Patients Receiving Chemotherapy and/or Radiation and adopted in 1986, this document was last revised in 2013. The revision included a new literature search of the PubMed ® /MEDLINE database using the terms: pediatric cancer, pediatric oncology, hematopoietic cell transplantation, bone marrow transplantation, immunosuppressive therapy, mucositis, stomatitis, chemotherapy, radiotherapy, acute effects, long-term effects, dental care, oral health, pediatric dentistry, practice guideline (...) ; field: all; limits: within the last 10 years, humans, English, birth through age 18. Two thousand sixty- five articles matched these criteria. Ninety-five papers were chosen for review from this list and from the references within selected articles. When data did not appear sufficient or were inconclusive, recommendations were based upon expert and/ or consensus opinion by experienced researchers and clinicians. Keywords Hematopoietic Stem Cell transplantation (HCT), Low-level laser therapy (LLLT

2018 American Academy of Pediatric Dentistry

119. Best Practices for Pain Management in Infants, Children, Adolescents, and Individuals with Special Health Care Needs

physical and psychological consequences for the patient. Appreciation of pediatric pain can help practitioners develop clinical approaches to prevent or substantially relieve dental pain. When pharmacological intervention is necessary to man- age pain, the practitioner must understand the consequences, morbidities, and toxicities associated with the use of specific therapeutic agents. These recommendations are intended to provide dental professionals and other stakeholders with cur- rent best practices (...) in children. 67,68 This tech- nique requires the active cooperation of the patient and is most effective when used for children over eight years old. 57 Hypnosis Hypnotherapy aims to alter sensory experiences and dissociate from pain experiences, and hypnosis is best for school-aged or older children. 26 There is strong evidence that hypnosis is effective in reducing needle-related pain and distress in chil- dren and adolescents. 66,69 There is no evidence that hypnosis alone is capable of producing

2018 American Academy of Pediatric Dentistry

120. CRACKCast Episode 183 – The Immunocompromised Patient

! KEEP coming back to it. 1) What are the three primary defense systems of the body? Hold on to your drawers… this is going to be a wild ride… The body’s defense mechanisms = Surface barriers , such as skin, enzymes, and mucus, First line of defense against microorganisms, consist of intact skin, gastrointestinal and respiratory mucosa, cilia, bio film, gastric acid, antibacterial substances in pancreatic and biliary secretions, antimicrobial peptides and proteins on skin and mucous membranes (...) , maximum daily dose 1500 mg/day). Imipenem-cilastatin (for adults: 500 mg IV every six hours; for children: 25 mg/kg IV every six hours up to a maximum of 1 g per dose for infants older than one month of age and children) or meropenem (for adults: 1 g IV every eight hours; for children ≥3 months of age: 20 mg/kg IV every eight hours up to a maximum of 1 g per dose). We reserve the carbapenems for patients who are allergic to the other options or who are infected or colonized with an organism

2018 CandiEM

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