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Skin Discoloration

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123. ASCIA Clinical Update - Allergic Rhinitis

) +/- Strands of mucus +/- Clear watery discharge +/- Exclude presence of large polyps Eyes - Signs of allergic conjunctivitis include: Red, oedematous eyelids Conjunctiva papillae Allergy Testing Pharmacotherapy for allergic rhinitis can be initiated without waiting for diagnostic allergy testing. However, testing increases the accuracy of diagnosis and identification of potential aeroallergen triggers. Diagnostic allergy testing involves either: Skin prick testing (SPT) or Serum specific IgE (ssIgE (...) ) levels (formerly known as RAST tests) to aeroallergens to determine the presence of sensitisation (IgE antibodies) and possible clinical relevance against suspected aeroallergen/s. Both SPT and ssIgE testing detect the presence of IgE antibodies to potential allergens. These tests are considered to be surrogates for nasal allergy because they do not directly assess the response of the nasal mucosa to allergens. Skin prick testing (SPT) involves pricking the person with commercially available

2017 Australasian Society of Clinical Immunology and Allergy

125. CRACKCast E064 – Chemical Injuries

in Perspective Chemicals are everywhere, >10,000 new ones are made every year → be afraid! Most susceptible organs: skin, eyes, lungs Most commonly release substances: Volatile organic compounds (VOC’s) Herbicides Acids Ammonia Cement Drain cleaner Gasoline Pathophysiology: Most cause damage through a chemical reaction with the skin 1) Describe the difference between Alkali and Acid injuries Acidic compounds: Cause protein denaturation and coagulative necrosis with the skin The necrosis forms eschar → which (...) LIMITS the depth of acid penetration Their free hydrogen ions are easily neutralized on the skin by copious water irrigation Alkali compounds: Produce saponification and liquefactive necrosis of body fat – they produce soluble protein complexes which “permit the passage of hydroxyl ions deep into the tissue” and limiting the contact of the alkali complex on the surface of the skin. Because there is no eschar formation they usually penetrate DEEPER into the tissue 2) Describe a HAZMAT response

2017 CandiEM

126. Pressure ulcers: prevention and management

or discomfort reported by the patient and the skin should be checked for: skin integrity in areas of pressure colour changes or discoloration [2] variations in heat, firmness and moisture (for example, because of incontinence, oedema, dry or inflamed skin). All ages: care planning Develop and document an individualised care plan for neonates, infants, children, young Pressure ulcers: prevention and management (CG179) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk (...) be checked for: skin integrity in areas of pressure colour changes or discoloration [4] variations in heat, firmness and moisture (for example, because of incontinence, oedema, dry or inflamed skin). 1.1.6 Use finger palpation or diascopy to determine whether erythema or discolouration (identified by skin assessment) is blanchable. 1.1.7 Start appropriate preventative action (see recommendations 1.1.1–1.1.17) in adults who have non-blanching erythema and consider repeating the skin assessment at least

2014 National Institute for Health and Clinical Excellence - Clinical Guidelines

127. Uptravi (selexipag) - pulmonary arterial hypertension

). In-vivo: Selexipag decreased the mean arterial blood pressure and increased the heart rate (in normotensive rats at i.d. doses of 10 mg/kg for MAP and > 3 mg/kg for HR; in conscious spontaneous hypertensive rats (SHRs) at oral doses of 1 - 10 mg/kg) and increased femoral skin blood flow in anaesthetized rats Uptravi (Selexipag) Assessment Report Page 17/117 (at i.d. doses of 1 - 10 mg/kg). No tachyphylaxis was observed after 4 weeks of administration in anaesthetized rats or after 10 days

2016 European Medicines Agency - EPARs

128. Tagrisso - osimertinib

dose (2 days washout), 5 days repeat dose (100 mg/kg) MTD: MTD =400 mg/kg (single dose) and MTD (corneal epithelial erosion/ulceration detected by ophthalmology, ?food consumption, ?body weight and clinical signs). Taken off-dose from Days 8 to 10, dose reduced to 12 mg/kg from Day 11. Histopathological findings in duodenum (atrophy), ileum and skin (atrophy). Recovery: Corneal translucency (1F, 1M). No other findings. MTD based on ocular clinical signs (conjunctival reddening, closed/partly closed (...) considered to be secondary to the wild type EGFR-related degenerative and inflammatory changes seen in the skin and GI tract. These effects were reversible in the 1-month rat study (not seen in dogs at 1 month). The finding in the mesenteric lymph node (minimal to mild sinus erythrocytes and erythrophagocytosis) seen in rats at 1 and 3 months, which reversed following 1 month off-dose, was not associated with any other degenerative changes or pigment derived from red blood cell breakdown

2016 European Medicines Agency - EPARs

129. Pemetrexed Accord

). Pemetrexed Accord was reconstituted with 0.9% Sodium Chloride as per the SmPC instructions in section 6.6. The reconstituted solutions were observed at 25 °C and 2-8 °C temperature for signs of discoloration and/or precipitation at suitable intervals for a period of initial, 24, 48 and 72 hrs. The solutions were analysed for assay, related substances, particulate matter and pH. The results showed that the reconstituted product is well stable up-to recommended time points when reconstituted as indicated (...) the RMP version 3.0 (dated 15 October 2015) with the following content: Safety concerns Important identified risks • Bullous skin reactions including SJS and TEN • Gastrointestinal disorders • Interstitial pneumonitis • Noncompliance with folic acid and vitamin B12 regimens, manifested mainly as haematological and gastrointestinal toxicities • Radiation pneumonitis • Radiation recall • Sepsis • Renal disorders • Bone marrow suppression Important potential risks N/A Missing information N

2016 European Medicines Agency - EPARs

130. Episalvan - birch bark extract

Pharmacopoeia) PIF Photo-Irritation-Factor PIP Paediatric Investigational Plan PK Pharmacokinetics PP Per protocol set s.c. Subcutaneous SAE Serious adverse event SAWP Scientific advice working party SD Standard Deviation SEM Standard Error of the Mean SmPC Summary of Product Characteristics SOC System organ class STAT3 Signal Transducer and Activator of Transcription 3 STSG Split-thickness skin graft t 1/2 Half-Life TBSA Total body surface area TE Triterpene dry extract from birch bark, i. e., i.e., API (...) 2015. • During the meeting on 19 November 2015, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, issued a positive opinion for granting a Marketing Authorisation to Episalvan. • The CHMP adopted a report on similarity of Episalvan with NexoBrid on 23 April 2015. Assessment report EMA/833320/2015 Page 8/104 2. Scientific discussion 2.1. Introduction Human skin consists of three layers, epidermis, dermis and subcutis. Epidermis and dermis

2016 European Medicines Agency - EPARs

131. Lonsurf (trifluridine / tipiracil) - adult patients with metastatic colorectal cancer (CRC)

cell, reticulocytes(M), fibrinogen (M) ?, Corpuscular vol ?(M), total protein ?, ?-globulin ?, cholesterol ? (F), bilirubin ?(F), 07CA07 GLP Rat M+F/12 0, 5, 15, 50, 150 Oral gavage 3 months/ 2 months recovery period for 6 animals/ sex/dose 15 =50: White blood cell count ?(F) Disarrangement of odontoblasts and oseodentin ? in incisors, apoptotic bodies in epithelial cells small intestine ?, fatty infiltration in bone marrow ? 150: Discoloration, breakage and malocclusion of incisors ?, bw ? fc (...) month/ 1 month recovery period for 2 animals/ sex/dose, except 1.56 mg/kg/day 25 1.56+25: slight to mild atrophy of intestines 09CB04 Non-GLP Non-pivo tal Monkey M/2 0, 50, 100, 150 1 month N.D. =50: adverse effects in lymphatic and hematopoietic system, gastrointestinal tract, kidney, liver, adrenal gland, testis, epididymis and skin. =100: mortality (100: 2M, 150: 2M) Table 16: Pivotal and non-pivotal repeat-dose toxicity studies with TPI Study ID Species/S ex/ Number/G roup Dose (mg/kg) /Route

2016 European Medicines Agency - EPARs

132. Point prevalence survey of healthcare-associated infections and antimicrobial use in European acute care hospitals ? protocol version 5.3

, OTHER THAN PNEUMONIA 64 GI: GASTROINTESTINAL SYSTEM INFECTION 65 REPR: REPRODUCTIVE TRACT INFECTION 67 SST: SKIN AND SOFT TISSUE INFECTION 68 SYS: SYSTEMIC INFECTION 70 NEO: SPECIFIC NEONATAL CASE DEFINITIONS 71 Algorithm for diagnosis of catheter-related infections 72 Microorganism code list 73 Microorganism code list (PPS selection), by category 73 Antimicrobial resistance markers and codes 77 Surgery categories 78 NHSN surgery codes 78 Examples of non-NHSN surgery 80 References 81 TECHNICAL (...) list (with only main specialties), consultant/patient specialty codes for healthy neonates added ? Diagnosis (site) code list for antimicrobial use: surgical site infection (SSI) was added as a subcategory of both skin or soft tissue infections (SST) and bone or joint infections (BJ); addition of cystic fibrosis (CF) as a separate entry ? Antimicrobial ATC codes: updated with new codes added since 2011 ? HAI case definitions: ? Surgical site infection (SSI): follow-up period of deep incisional

2016 European Centre for Disease Prevention and Control - Technical Guidance

133. Zepatier (elbasvir / grazoprevir) - Hepatitis C, Chronic

to 100 mg/kg/day in Study Week 12. Recovery assessment was not included as part of this study. At 300 mg/kg/day increases in the incidence and frequency of unformed/liquid faeces (females only) and post-dosing emesis compared to controls; yellow discoloration of the faeces and, in a single animal, skin and eyes (bulbar conjunctiva); decreases in erythroid parameters and increases in fibrinogen and platelets; increases in serum total bilirubin (up to 11-fold compared to controls; predominantly direct

2016 European Medicines Agency - EPARs

134. Fexeric - ferric citrate coordination complex

no physiologic process for iron excretion. Iron losses are small and can occur through skin exfoliation, sloughing off of intestinal cells, menstruation in females, and minimally through biliary and urinary excretion (as reviewed by Geisser, 2011). Iron loss also occurs with haemodialysis. Oral potassium citrate at doses of 30 to 100 mEq/day (3.24 g/day to 10.8 g/day) is used for the treatment of kidney stones, including those associated with hypocitraturia and unduly acidic urine pH (Hall, 2009,Pak, 1994 (...) hyperplasia. Discoloration occurred in mediastinal and mesenteric lymph nodes together with accumulation of brown pigment in macrophages, sinus ectasia/cysts in rats. One male dog receiving 2000 mg/kg/day was euthanized in week 40 for poor condition that was considered to be due to test-article related liver toxicity, as assessed by standard clinical chemistry, including iron parameters, and microscopic pathology. Reversibly decreased serum and urine phosphorus levels occurred, together with increased

2015 European Medicines Agency - EPARs

135. Kyprolis - carfilzomib

to the IV bolus administration at the same dose, the Cmax was 28-fold lower, whereas the AUC, CL and T½ values were comparable. In addition, the level of proteasome inhibition achieved with IV bolus and 30-minute infusion were identical. Carfilzomib showed high plasma protein binding in vitro, and has rapid and wide tissue distribution upon IV administration in vivo. The highest levels of radiolabel were found in liver, muscle, skin and small intestine. At 0.5 and 24 hours after dosing, the tissue (...) (=90%) DRF toxicity study of PR-171 in male Cynomolgus monkeys TR-0008-171 Study SNBL.048.03 No GLP Cynomolgus monkeys (2-3/group) Single IV (1,1.16,2,4) + daily IV dose (1 mg/kg) for 5 days At 1 mg/kg: 1 animal dead 2 days post dose (fluid in the thoracic and pericardial cavities, congestion of the liver and kidneys, discoloration of the GI mucosa, degenerative changes in the myocardium) At 2 mg/kg: emesis At 4 mg/kg: 1 animal dead 2 days after dosing (fluid in the thoracic and pericardial

2015 European Medicines Agency - EPARs

136. Cotellic - cobimetinib

submitted and the scientific discussion within the Committee, issued a positive opinion for granting a Marketing Authorisation to Cotellic. 2. Scientific discussion 2.1. Introduction Cutaneous melanoma is the most aggressive form of all skin cancers. An estimated 85294 people will be diagnosed with melanoma in 2015 in the EU, and approximately 16630 people are expected to die Assessment report EMA/685908/2015 Page 10/139 of the disease annually 1 . The survival for stage IV melanoma patients has been (...) from the observed peak concentration at 8 hours postdose. The highest concentrations in pigmented skin and non-pigmented skin (5200 and 4440 ng equivalents 14C-GDC-0973/g, respectively) were observed at 4 hours postdose. The radioactivity concentrations in pigmented skin generally declined and dropped to a concentration of 501 ng equivalents/g at 672 hours postdose. The radioactivity concentrations in non-pigmented skin generally declined and dropped to non-detectable levels (ND) by 72 hours

2015 European Medicines Agency - EPARs

137. Otezla - apremilast

skin xenograft model in mice. The studies and the relevant findings are summarised in Table 2: Table 2: In vivo pharmacodynamic activity of apremilast Study Number Treatment Duration Stimulus Dose/ Route of Administration Study Type Species/Sex Major Findings Acute TNF-a Production, Inflammation, and Hyperalgesia 5042-107 3.5 hours LPS 0.01 - 1 mg/kg, PO BALB/c mice Females Apremilast inhibited LPS- induced serum TNF-a levels with an ED 50 of 0.05 mg/kg. AP279R, AP284R, AP291R 2.5 hours LPS 0.01 (...) in control animals. Xenograft-induced psoriasis TECH1102006 14 days Human skin xenograft, psoriatic NK cells 5 mg/kg, PO divided BID beige-SCID mice Apremilast demonstrated reductions (= 50%) in both the epidermal thickness and keratinocyte proliferation index, psoriasiform histological features and immunohistochemical expression of the inflammatory markers TNF-a, HLA-DR and ICAM-1. Results were comparable to positive controls (cyclosporine). EMA/CHMP/476353/2014 Page 25/189 UVB-induced apoptosis AP2599

2015 European Medicines Agency - EPARs

138. Vargatef - nintedanib

. A yellow discoloration of urine was noted 60 min following the 100 and 300 mg/kg dose. Nocturnal motility: BIBF 1120 chloride was administered orally in doses of 50, 100 and 300 mg/kg in groups of 7 mice. There was no inhibition or activation of locomotion by BIBF 1120 at any of the doses tested as compared to vehicle-treated animals (U02-1589). Electrophysiological assessment in vitro (U02-1288): Two assays (hERG and action potential configuration) assessing the effects of BIBF 1120 base

2015 European Medicines Agency - EPARs

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