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Bone Age Film

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81. Cutaneous T-cell lymphoma

cells on blood film skin biopsy polymerase chain reaction (PCR) for T-cell receptor flow cytometry basic metabolic panel LFTs serum LDH human T-cell lymphotropic virus (HTLV)-I serology bone marrow biopsy lymph node biopsy CT scan HIV test FDG-PET scan Treatment algorithm ONGOING Contributors Authors Professor of Targeted Therapy and Oncology University of Manchester Manchester Academic Health Sciences Centre Manchester UK Disclosures TMI declares that he has no competing interests. Consultant (...) lesions unilesional acral site involvement lymphadenopathy constitutional symptoms palmar-plantar keratoderma alopecia leonine facies onychodystrophy hepatomegaly ectropion bullous, granulomatous, ichthyosiform, and purpuric lesions age >60 years male gender black ethnicity (mycosis fungoides); white ethnicity (Sézary's syndrome) exposure to infectious agents chromosomal abnormality environmental exposure to industrial chemicals, herbicides, pesticides Diagnostic investigations FBC screen for Sézary's

2018 BMJ Best Practice

82. Plantar fasciitis

-static dyskinesia pain exacerbated by walking barefoot pain improved with non-steroidal anti-inflammatory drug (NSAID) use no hx of acute injury to the heel self-limiting pain unilateral heel pain positive dorsiflexion-eversion test positive Windlass test negative Tinel's sign obesity equinus pes planus pes cavus age >40 years old hx of prolonged standing runners Diagnostic investigations foot x-ray technetium (Tc-MDP 3-phase) bone scan MRI HLA-B27 rheumatoid factor ultrasound Treatment algorithm (...) Plantar fasciitis Plantar fasciitis - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  Plantar fasciitis Last reviewed: February 2019 Last updated: March 2018 Summary Most commonly affects people between 40 and 60 years of age who are overweight or obese. Also occurs in 10% of runners. Diagnosis is usually based on a thorough history and physical examination. There is no laboratory test that can confirm or rule out

2018 BMJ Best Practice

83. Osteochondritis dissecans

onset, non-specific joint pain, exacerbation of symptoms with exercise (especially stair- or hill-climbing), recurrent effusion, catching or locking. Radiographs: minimum of 2 views of the involved joint (more specified for knee and ankle) performed for diagnosis. While the aetiology remains unclear, early recognition is essential as many treatment options exist. Definition Osteochondritis dissecans is an acquired, potentially reversible idiopathic lesion of subchondral bone resulting (...) of dorsiflexed ankle or anterolateral aspect of plantar-flexed ankle effusion present locking of joint catching of joint decreased range of motion knee involvement, age 10 to 15 years elbow involvement, age 11 to 21 years talus involvement, second to fourth decade absence of history of trauma involving the knee or elbow antalgic gait in osteochondritis dissecans involving the knee or talus external rotation gait in osteochondritis dissecans involving the knee relieving factors: non-steroidal anti

2018 BMJ Best Practice

84. Vitamin D deficiency

sunlight exposure increased skin pigmentation age >50 years inadequate dietary and supplemental vitamin D intake malabsorption obesity medication use genetic mutations tumour chronic kidney disease granulomatous disorders primary hyperparathyroidism hyperthyroidism Diagnostic investigations serum 25-hydroxyvitamin D serum alkaline phosphatase serum calcium fasting serum phosphate plain-film radiographs of knees and wrists intact PTH serum 1,25-dihydroxyvitamin D bone density (DEXA) scan Treatment (...) not typically present with overt clinical signs and symptoms until the deficiency is severe and prolonged. Children with established vitamin D deficiency present with features of rickets (skeletal abnormalities, developmental delay, failure to thrive), whereas adults present with signs and symptoms of osteomalacia (bone pain and tenderness, proximal muscle weakness reported as difficulty in rising from a sitting position). In addition to the skeletal effects, it is now recognised that vitamin D deficiency

2018 BMJ Best Practice

85. Chronic lymphocytic leukaemia

, the disorder is called small lymphocytic lymphoma. History and exam shortness of breath and fatigue lymphadenopathy splenomegaly hepatomegaly presence of risk factors B symptoms recurrent infections petechiae age over 60 years male sex white ethnicity family history of CLL Diagnostic investigations WBC count with differential blood film haemoglobin platelet count flow cytometry fluorescent in situ hybridisation (FISH) molecular genetic analysis direct antiglobulin test (DAT) immunoglobulin levels bone (...) Chronic lymphocytic leukaemia Chronic lymphocytic leukaemia - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  Chronic lymphocytic leukaemia Last reviewed: February 2019 Last updated: February 2018 Summary An indolent haematological cancer that occurs with increasing age. Usually presents with absolute lymphocytosis as an incidental finding on routine FBC or with asymptomatic lymphadenopathy. Diagnosed by FBC

2018 BMJ Best Practice

86. Extrapulmonary tuberculosis

node fine-needle aspiration (FNA) pleural fluid analysis ascitic fluid analysis bone films CSF analysis urinalysis nucleic acid amplification test (NAAT) lymph node biopsy pleural biopsy synovial biopsy liver biopsy bone marrow biopsy blood culture peritoneal biopsy gastric aspirate bronchoscopy thoracoscopy susceptibility testing interferon-gamma release assays (IGRAs) genotyping HIV test empiric treatment CT scan chest or abdomen colonoscopy pericardial fluid analysis pericardial biopsy Treatment (...) by Mycobacterium tuberculosis . In many cases, M tuberculosis infection becomes latent before progression to active TB disease. Patients who are infected but who have no clinical, bacteriological, or radiographic evidence of active TB are said to have latent TB infection. When there is progression from latent infection to active disease, it most commonly involves the lungs and is communicable in this form, but may affect almost any organ system including the lymph nodes, CNS, bones/joints, genito-urinary tract

2018 BMJ Best Practice

87. Osteochondritis dissecans

onset, non-specific joint pain, exacerbation of symptoms with exercise (especially stair- or hill-climbing), recurrent effusion, catching or locking. Radiographs: minimum of 2 views of the involved joint (more specified for knee and ankle) performed for diagnosis. While the aetiology remains unclear, early recognition is essential as many treatment options exist. Definition Osteochondritis dissecans is an acquired, potentially reversible idiopathic lesion of subchondral bone resulting (...) of dorsiflexed ankle or anterolateral aspect of plantar-flexed ankle effusion present locking of joint catching of joint decreased range of motion knee involvement, age 10 to 15 years elbow involvement, age 11 to 21 years talus involvement, second to fourth decade absence of history of trauma involving the knee or elbow antalgic gait in osteochondritis dissecans involving the knee or talus external rotation gait in osteochondritis dissecans involving the knee relieving factors: non-steroidal anti

2018 BMJ Best Practice

88. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza) - Human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza) - Human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza ® ). Reference number 2418. Page 1 of 3 Enc 9 Appx 2 AWMSG Secretariat Assessment Report – Limited submission Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza ®? ) 800 mg/150 mg/200 mg/10 mg film-coated tablet Company: Janssen-Cilag Ltd Licensed indication under (...) consideration: Treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). ? 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. Marketing authorisation date: 26 September 2017 Comparator(s) ? Darunavir/cobicistat (Rezolsta ® ) in combination with emtricitabine

2018 All Wales Medicines Strategy Group

89. Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) adults infected with human immunodeficiency virus-1 (HIV-1)

Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) adults infected with human immunodeficiency virus-1 (HIV-1) AWMSG SECRETARIAT ASSESSMENT REPORT Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy ® ) 50 mg/200 mg/25 mg film-coated tablets Reference number: 3414 FULL SUBMISSION This report has been prepared by the All Wales Therapeutics & Toxicology Centre (AWTTC). Please direct any queries to AWTTC: All Wales Therapeutics & Toxicology Centre (AWTTC) University Hospital (...) Llandough Penlan Road Llandough Vale of Glamorgan CF64 2XX awttc@wales.nhs.uk 029 2071 6900 This report should be cited as: All Wales Therapeutics & Toxicology Centre. AWMSG Secretariat Assessment Report. Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy ® ) 50 mg/200 mg/25 mg film-coated tablets. Reference number: 3414. October 2018. Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy ® ). Reference number 3414. Page 1 of 15 This assessment report will be considered for review three years

2018 All Wales Medicines Strategy Group

91. 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

92. 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

93. Letermovir (Prevymis) - to prevent illness caused by cytomegalovirus (CMV) in adults having an allogeneic haematopoietic stem cell transplant

of the product that could not be solved within the timeframe of accelerated assessment. The applicant was required to prepare a plan to further evaluate and develop a terminal sterilisation process for the product. 2.2. Quality aspects 2.2.1. Introduction The finished product is presented as: A. Film-coated tablets containing 240 mg or 480 mg of letermovir as active substance. Other ingredients are: Tablet core: Microcrystalline cellulose (E460), Croscarmellose sodium (E468), Povidone (E1201), Colloidal (...) anhydrous silica (E551), Magnesium stearate (E572). Film-coating: Lactose monohydrate, Hypromellose (E464), Titanium dioxide (E171), Triacetin (E1518), Iron oxide yellow (E172), Iron oxide red (only for 480 mg tablets) (E172), Carnauba wax (E903). The film-coated tablets are available in Polyamide/Aluminium/PVC – Aluminium blister cards containing 28 tablets, as described in section 6.5 of the SmPC. and, B. Concentrate for solution for infusion containing 240 mg or 480 mg of letermovir as active

2018 European Medicines Agency - EPARs

94. 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

96. Efavirenz/Emtricitabine/Tenofovir disoproxil - HIV

the linear trapezoidal method AUC 0-8 Area under the plasma concentration time curve extrapolated to infinity, calculated as AUC0-T + CLQC/?z, where CLQC is the estimated concentration at time TLQC AUC 0-T/8 Relative Percentage of AUC T with respect of AUC 8 BMD Bone Mineral Density C max Maximum observed plasma concentration CHMP Committee for Human Medicinal Products CYP Cytochrome DAD Diode array detection DS Disoproxil succinate DSC Differential Scanning Calorimetry DF Disoproxil fumarate ERA (...) Krka is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of 5 times the ULN, intenuption or discontinuation of treatment must be considered. • Advice to monitor the liver enzymes of patients treated with other medicinal products associated with liver toxicity. • Warning that reports of hepatic failure have

2018 European Medicines Agency - EPARs

97. 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

98. 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

99. 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

100. 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

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