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Subcutaneous Fat Necrosis

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143. Acute pain management: scientific evidence (3rd Edition)

140 6. ADMINISTRATION OF SYSTEMIC ANALGESIC DRUGS 153 6.1 Oral route 153 6.1.1 Opioids and tramadol 156 6.1.2 Non-selectiv e non-steroidal anti-inflammatory drugs and coxibs 157 6.1.3 Paracetamol 158 6.2 Intravenous route 158 6.2.1 Opioids and tramadol 158 6.2.2 Non-selectiv e non-steroidal anti-inflammatory drugs and coxibs 159 6.2.3 Paracetamol 159 6.3 Intramuscular and subcutaneous routes 160 6.3.1 Opioids and tramadol 160 6.3.2 Non-selectiv e non-steroidal anti-inflammatory drugs and coxibs

2015 National Health and Medical Research Council

144. Diagnosis and Management of Acute Pulmonary Embolism

. . . . . . . . . . . . . . . . . . . . . . . .3068 8.3.2 Foreign-material pulmonary embolism . . . . . . . . . .3068 ESC Guidelines 3034 Downloaded from https://academic.oup.com/eurheartj/article-abstract/35/43/3033/503581 by guest on 02 April 20198.3.3 Fat embolism . . . . . . . . . . . . . . . . . . . . . . . . . .3068 8.3.4 Air embolism . . . . . . . . . . . . . . . . . . . . . . . . . .3069 8.3.5 Amniotic ?uid embolism . . . . . . . . . . . . . . . . . . .3069 8.3.6 Tumour embolism . . . . . . . . . . . . . . . . . . . . . .3069 9 (...) , trauma, surgery and necrosis. Accordingly, the positive predictive value of elevated D-dimer levels is low and D-dimer testing is not useful for con?rmation of PE. A number of D-dimer assays are available. 110,111 The quantitative enzyme-linked immunosorbent assay (ELISA) or ELISA-derived assays have a diagnostic sensitivity of 95% or better and can therefore be used to exclude PE in patients with either a low or a moderate pre-test probability. In the emergency department, a negative ELISA D-dimer

2014 European Society of Cardiology

145. Tracking RNA to Pinpoint Time of Death: Better Than Bugs?

is more than the reverse of the “characteristics of life” list that begins most introductory biology textbooks. It’s useful. Could RNA profiling replace forensic entomology? The researchers used their data to create prediction software that can tell the time elapsed since organismal death from the RNAs in just four of the 36 tissues studied: subcutaneous fat, lung, thyroid, and sun-exposed skin on the lower leg. When they tested the software on 129 bodies with time of death known but blinded (...) parts and DNA to the RNA of the victim. Changing RNA Levels After Death Crucial to the new work is the “Genotype-Tissue Expression Project” portal at the Broad Institute, aka the tissue bank. It compiles RNA sequences from human tissues (fat, muscle, blood), organs (stomach, lung, heart), and body parts (lower leg). The researchers first looked at RNA in thousands of samples – including spleen, esophagus, small intestine, ovary, prostate, heart, nerves, salivary glands, and skin with and without sun

2018 PLOS Blogs Network

146. Semaglutide (Ozempic) - Diabetes Mellitus

4.4, 4.5 and 5.1. Pharmaceutical form: solution for injection Strength: 1.34 mg/ml Route of administration: subcutaneous use Packaging: cartridge (glass) in pre-filled pen Package size: 1 pre-filled pen + 6 needles Ozempic Assessment report EMA/CHMP/715701/2017 Page 3/156 Table of contents 1. Background information on the procedure 7 1.1. Submission of the dossier 7 1.2. Steps taken for the assessment of the product 8 2. Scientific discussion 9 2.1. Problem statement 9 2.1.1. Disease or condition (...) of exposure PYO patient year of observation RMP risk management plan RR rate ratio SAE serious adverse event SAP statistical analysis plan SBP systolic blood pressure s.c. sub cutaneous sema semaglutide SGLT-2 sodium-dependent glucose transporter two SMQ standardised MedDRA query SOC system organ class SU sulfonylurea SUSTAIN Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes T2D type 2 diabetes mellitus TNF-alpha tumour necrosis factor alpha TZD thiazolidinediones UACR urinary albumin

2018 European Medicines Agency - EPARs

147. Eponymythology: Atraumatic Abdominal Ecchymosis

associated with retroperitoneal haemorrhage, originally described in acute pancreatitis – Original publication: (n=1) 1919 – George Grey Turner submitted his article for publication as following a “…cursory examination of the voluminous literature on pancreatitis”, where he was unable to “…observe any mention of this sign” 1920 – George Grey Turner published ‘ Local discoloration of the abdominal wall as a sign of acute pancreatitis ‘ citing two cases of acute pancreatitis with fat necrosis (...) and retroperitoneal haemorrhage [ ] Case 1 [1912] 54 year old female with three days of abdominal pain presenting with an area of discoloration (a bluish colour), about 6 inches in diameter involving the abdominal wall surrounding the umbilicus (see …). … the patient suffered from acute pancreatitis, with much effusion into the peritoneal cavity. She lived nine days after operation, and the post-mortem examination disclosed a sloughing pancreas with much fat necrosis Case 2 [1917] 53 year old male soldier

2018 Life in the Fast Lane Blog

148. Rucaparib camsylate - Ovarian Neoplasms

/kg BID rucaparib resulted in statistically significant inhibition of 45%, 86%, and 96% respectively. There was an inverse and dose-dependent correlation between PAR and rucaparib levels in the plasma and tumour. Although the tumour to plasma (T/P) ratio was lower at higher doses of rucaparib, the levels of rucaparib in the tumour were consistently higher than the levels of rucaparib in plasma. A further PK/PD study was performed in the subcutaneous MDA-MB-436 xenograft model. Animals were treated (...) lymph nodes, and thymic atrophy (correlated with decreased thymic weights at 75 mg/kg/day). Minimal to moderate myocardial degeneration, necrosis, and fibroplasia usually located at the apex of the heart were observed in males at 75 mg/kg/day. No associated changes in troponin T levels were noted on Day 6. The NOAEL for rucaparib in this study was considered to be 5 mg/kg/day, which corresponded to a mean combined male and female C max and AUC 0-24.5 of 672 ng/mL and 992 ng·hr/mL, respectively

2018 European Medicines Agency - EPARs

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

subcutaneous injection. Methotrexate should be continued during treatment with Hyrimoz. Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Hyrimoz. Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1. 5 In monotherapy, some patients who experience a decrease in their response to Hyrimoz 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every (...) with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be reconsidered in a patient not responding within this time period. Psoriasis The recommended dose of Hyrimoz for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after

2018 European Medicines Agency - EPARs

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

. Hepatic necrosis in 1/3 females. 700 mg/kg: no evidence of macroscopic changes. Assessment report EMA/CHMP/525204/2018 Page 25/169 RPT-48225 GLP Rat 3M:3F/Group 0, 200, 700, 2000 - IP 700/200 Mortality at 2000 & 700 mg/kg, with changes to adrenal gland, GI tract, and kidney. Renal tubular ectasia at 2000 mg/kg. 200 mg/kg: enlarged liver, fibrosis of stomach, small/large intestine, spleen, pancreas. In mice, no adverse effects were seen in doses of neratinib up to 2000 mg/kg. Single intraperitoneal (...) ), and signs of hepatic inflammation and necrosis. There were moderate increases in fibrinogen, white blood cells (WBC), neutrophils, lymphocytes, and monocytes, and decreases in cholesterol, total protein and albumin. Other findings High doses in the earlier dose-range finding studies in rats showed evidence of reproductive organ toxicity, prostatic and uterine atrophy leading to reduced prostate and uterus weights. In addition male rats experienced mammary gland atrophy (neratinib doses of =15 mg/kg/day

2018 European Medicines Agency - EPARs

151. Skin Cancer Treatment (PDQ®): Health Professional Version

. b Deep invasion is defined as invasion beyond the subcutaneous fat or >6 mm (as measured from the granular layer of adjacent normal epidermis to the base of the tumor); perineural invasion for T3 classification is defined as tumor cells within the nerve sheath of a nerve lying deeper than the dermis or measuring ≥0.1 mm in caliber, or presenting with clinical or radiographic involvement of named nerves without skull base invasion or transgression. Table 2. Definitions of Pathological Regional (...) (including the squamous cell and basal cell layers), dermis, subcutaneous tissue, and other parts of the skin. Risk Factors Risk factors for nonmelanoma skin cancer include the following: Sun and UV radiation exposure (including tanning beds). Epidemiologic evidence suggests that cumulative exposure to UV radiation and the sensitivity of an individual’s skin to UV radiation are risk factors for skin cancer, though the type of exposure (i.e., high-intensity exposure and short-duration exposure vs. chronic

2017 PDQ - NCI's Comprehensive Cancer Database

152. Nutrition in Cancer Care (PDQ®): Health Professional Version

into consideration that obesity may mask malnutrition and that weight and BMI alone are not good surrogates for nutrition status.[ ] The consensus statement provides the criteria for evaluating each of the following six potential indicators of malnutrition, with the recommendation that if two or more characteristics are present, the diagnosis of malnutrition is warranted. Insufficient energy intake. Weight loss. Loss of muscle mass. Loss of subcutaneous fat. Localized or generalized fluid accumulation that may (...) components: Food- and nutrition-related history. Anthropometric measurements. Biochemical data, medical tests, and procedures. Nutrition-focused physical assessment. Medical history. Treatment plan. Within the nutrition assessment, the following factors are considered in making a diagnosis of malnutrition:[ ] Insufficient energy intake. Weight loss. Loss of muscle mass. Loss of subcutaneous fat. Localized or generalized fluid accumulation. Diminished functional status (e.g., grip strength

2017 PDQ - NCI's Comprehensive Cancer Database

153. Cancer Pain (PDQ®): Health Professional Version

the treatment dose. Supportive care therapies and pain Supportive care therapies can cause pain, as typified by bisphosphonate-associated osteonecrosis of the jaw.[ ] Corticosteroid use has also been associated with the development of avascular necrosis.[ ] Radiation-induced pain Radiation is associated with several distinct pain syndromes. First, patients may experience pain from brachytherapy and from positioning during treatment (i.e., placement on a radiation treatment table). Second, delayed tissue

2017 PDQ - NCI's Comprehensive Cancer Database

155. Palliative care - constipation

for occasional use only. Peripheral opioid–receptor antagonists Methylnaltrexone bromide(subcutaneous injection) 30 minutes – 4 hours Useful for opioid-induced constipation in terminally ill people, when response to other laxatives is inadequate. Contraindicated in known or suspected bowel obstruction. Use with caution in people with conditions which may predispose to perforation (e.g. gastrointestinal cancer, peptic ulcer, colonic pseudo-obstruction, nonsteroidal anti-inflammatory drugs, steroids (...) ). Not recommended Liquid paraffin(softener) 1–3 days Adverse effects include anal seepage and irritation, malabsorption of fat-soluble vitamins, and (rarely) lipoid pneumonia. Magnesium salts(osmotic) 1–6 hours Not routinely recommended because their purgative action can be undesirably strong. Data from the Electronic Medicines Compendium and from [ ; ; ; ; ; ; ] Time to wait for laxative effect How long is it before different laxative preparations take effect? For information on times for different laxative

2017 NICE Clinical Knowledge Summaries

156. Vyndaqel (tafamidis meglumine)

/animal) (vehicle, 7.5% VE TPGS) to male and female albino rats, radioactivity levels peaked within 2 hours post-dose in the majority of tissues and then declined gradually, but radioactivity was still present at 168 hours post-dose. The organ/plasma ratio was >1 at 0.5 hours post-dose for the liver and stomach and at ?1 hour post-dose for the harderian glands (at all time points after 6 hours post-dose), liver (at all timepoints), and perirenal fat and skin (at 168 hours post-dose). The blood/plasma

2013 Pharmaceuticals and Medical Devices Agency, Japan

157. Lyxumia (lixisenatide)

infusion to ZDF rats (4.2.1.1-13) Continuous subcutaneous infusion of lixisenatide (0.486, 4.86, 48.6 µg/kg/day), exendin-4 (4.187 µg/kg/day), or vehicle 16 was given to male obese ZDF rats (8 weeks of age, 8 rats/group) for 12 weeks and continuous subcutaneous infusion of lixisenatide (48.6 µg/kg/day) or vehicle was given to male lean ZDF rats (8 weeks of age, 8 rats/group) for 12 weeks. For obese rat groups, standard diet was switched to high-fat diet at 5.5 weeks after initiation of administration (...) Lyxumia (lixisenatide) Report on the Deliberation Results May 31, 2013 Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare [Brand name] Lyxumia Subcutaneous Injection 300 µg [Non-proprietary name] Lixisenatide (JAN*) [Name of applicant] Sanofi K.K. [Date of application] June 11, 2012 [Results of deliberation] In the meeting held on May 24, 2013, the First Committee on New Drugs concluded that the product may be approved

2013 Pharmaceuticals and Medical Devices Agency, Japan

158. Stivarga (regorafenib hydrate)

inhibitory effect of regorafenib was evaluated in athymic mice ("nude mice") by subcutaneous implantation of human colorectal cancer cell lines, Colo-205, HT-29, and HCT-15. After the implanted tumor weight reached 75 to 144 mg (5-7 days after implantation), regorafenib was orally administered once daily (QD) at the doses of 3, 10, 29, and 96 mg/kg for 9 days, and the tumor weight was measured (the figure below). In nude mice with Colo-205 and HT-29 cell lines, 10 and 29 mg/kg of regorafenib inhibited (...) ovary cell line with TIE2 forcedly expressed, *2: Human megakaryoblastic leukemic cell line, *3: Rat fibroblast cell line with BRAF V600E forcedly expressed In addition, the 28-day once-daily repeated oral administration of regorafenib as well as M-2 and M-5 (3 and 10 mg/kg QD, respectively) suppressed the tumor growth in nude mice subcutaneously implanted with human breast cancer-derived cell lines, MDA-MB-231 and HT-29. Based on the above data, the applicant explained that M-2 and M-5 contribute

2013 Pharmaceuticals and Medical Devices Agency, Japan

159. Xeljanz (tofacitinib citrate)

for treatment of rheumatoid arthritis (RA), nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids etc. have been utilized for symptomatic relief. In recent years, disease-modifying anti- rheumatic drugs (DMARDs), primarily methotrexate (MTX), are introduced early in the course of the disease and furthermore, biologics such as anti-human tumor necrosis factor (TNF) agents are used in RA patients who have had an inadequate response to these conventional treatments. The JAK family of intracellular (...) after the first dose, and the expression of macrophage-, B cell-, T-cell-, and osteoclast-related genes by the last day of dosing, compared with the vehicle group. 3.(i).A.(1).5).(d) Pharmacokinetic/pharmacodynamic modeling in CIA model (4.2.1.1.19) A pharmacokinetic/pharmacodynamic modeling study was conducted using data from prophylactic tofacitinib studies of oral administration (QD and BID) and subcutaneous infusion using an osmotic pump in the CIA model (4.2.1.1.14). When tofacitinib

2013 Pharmaceuticals and Medical Devices Agency, Japan

160. Padeliporfin (Tookad) - prostate cancer / Prostatic Neoplasms

parameter CRF case report form CSR Clinical Study Report CTCAE Common Terminology Criteria for Adverse Events CTGC Central Treatment Guidance Committee DRE digital rectal examination DSMB Data Safety Monitoring Board EC European Commission ECG electrocardiogram EMA European Medicines Agency EPN Extra-prostatic necrosis EQ-5D EuroQol-5D 5-ARI 5-a-reductase inhibitor EU European Union GC Gas Chromatography GCP Good Clinical Practice GLP Good Laboratory Practice GMP Good manufacturing practice HPLC High (...) with a light dose of 200 J/cm is efficient in inducing necrosis in the dog prostate. In addition, no major secondary effects, changes in heart rate, oximetry, or body temperature have been observed thus far. No evidence of thrombosis in other organs (lung, pulmonary artery, and liver tissues) has been observed, confirming that the VTP effect is localized to the prostate. The results of studies in other tissues such as biliary, lung and renal tissue did not reveal toxicity on haemodynamic parameters (data

2017 European Medicines Agency - EPARs

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