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Cough fracture

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221. Adempas (riociguat)

thrombosis, leading to increased pulmonary vascular resistance (PVR), abnormal pulmonary vascular tone, progressive right ventricular dysfunction/failure and, ultimately, premature death. CTEPH is a chronic, debilitating disease characterised clinically by dyspnoea, fatigue, chest pain, dizziness, peripheral oedema, coughing, haemoptysis, and, in advanced disease, fainting and syncope. It most often results from obstruction of the pulmonary vascular bed by non-resolving thromboemboli. CTEPH can arise

2014 European Medicines Agency - EPARs

224. Ledipasvir/Sofosbuvir

detected in addition to L31M. Subsequently, the levels of S282T decreased 11-fold in 5 days. The Applicant reports the subject subsequently achieved SVR12 following rescue treatment with LDV/SOF+RBV for 24 weeks. Safety The most frequently reported overall AEs were nausea, anemia, and upper respiratory tract infection. Five treatment-emergent SAEs were reported in four subjects and were considered unrelated to study drug (delirium, peptic ulcer, spinal compression fracture, suicidal ideation/anemia

2014 FDA - Drug Approval Package

225. Olodaterol inhalation solution (Striverdi Respimat)

1222.51 and 1222.52. Common adverse events that occurred in=2% patients/treatment T+PBO T+O Total SOC/PT n (%) n (%) n (%) Number of patients 1134 (100.0) 1133 (100.0) 2267 (100.0) Total with adverse events 489 (43.1) 484 (42.7) 973 (42.9) Respiratory, thoracic and mediastinal 207 (18.3) 192 (16.9) 399 (17.6) disorders Chronic obstructive pulmonary disease 116 (10.2) 126 (11.1) 242 (10.7) Cough 28 (2.5) 17 (1.5) 45 (2.0) Gastrointestinal disorders 92 (8.1) 89 (7.9) 181(8.0) Dry mouth 29 (2.6) 32 (2.8

2014 FDA - Drug Approval Package

226. Secukinumab (Cosentyx)

Amy S. Woitach, DO BLA 125-504 Cosentyx (secukinumab) 52 Palpitations 2 (0.18) 0 (0.00) 2 (0.07) 0 (0.00) 0 (0.00) Pulmonary edema 2 (0.18) 0 (0.00) 2 (0.07) 0 (0.00) 0 (0.00) Rib fracture 0 (0.00) 2 (0.17) 2 (0.07) 0 (0.00) 0 (0.00) Tendon rupture 0 (0.00) 2 (0.17) 2 (0.07) 0 (0.00) 0 (0.00) Vomiting 2 (0.18) 0 (0.00) 2 (0.07) 0 (0.00) 0 (0.00) Infections, including pneumonia and bacterial abscess, were reported more frequently with secukinumab treatment, but not reported for either placebo

2014 FDA - Drug Approval Package

227. Sonidegib (Odomzo)

patients. Juvenile Animal Data In a 5-week juvenile rat toxicology study, effects of sonidegib were observed in bone, teeth, reproductive tissues, and nerves at doses =10 mg/kg/day (approximately 1.2 times the recommended human dose based on AUC). Bone findings included thinning/closure of bone growth plate, decreased bone length and width, and hyperostosis. Findings in teeth included missing or fractured teeth, and atrophy. Reproductive tissue toxicity was evidenced by atrophy of testes, ovaries

2014 FDA - Drug Approval Package

228. Extravasation and infiltration

; difficult to secure inadequately secured needle in implanted port inadequately secured catheter inappropriate needle length for Implanted Intravenous Access Port (IVAP) (ie too short to reach back of reservoir) development of fibrin sheath/thrombus at catheter tip IVAP (port)/catheter separation, catheter fracture or catheter dislodgement flushing with a small gauge syringe Drug-related vesicant potential volume of drug/fluid infiltrated concentration of vesicant drug/fluid repeated use of the same vein (...) , tunneled CVC Subclavian insertion medial to midclavicular line Loss of blood return; swelling and erythema in clavicular area with infusion Clavicular pain or burning with infusion CVC tip displacement through SVC IVAP, tunneled CVC, PICC Early: difficult insertion; Late: unknown; thrombosis of SVC or great veins may increase risk Intractable cough with infusion, pleural effusions, abnormal CXR/CT Substernal chest pain, dyspnea, fatigue CVC tip displacement from SVC IVAP, tunneled CVC, PICC Unknown

2014 Publication 1593

229. Pharmacological Management of Cancer Pain in Adults

and Kyphoplasty for osteoporotic vertebral compression fractures was conducted by HIQA in 2013 (30). Despite the fact that the HTA focused on use of the procedure for osteoporotic vertebral collapse, data on use of the procedure for management of malignant vertebral collapse was also gathered. The HTA noted that that there were approximately 66 vertebroplasties undertaken in 2011 indicating that it is used infrequently. As there is no HIPE code for kyphoplasty, it is coded using the vertebroplasty code (31 (...) fractures. Dublin: Health Information and Quality Authority; 2013.) DRG Code Description Cost/case (€) 128A Other musculosketal procedures with catastrophic complications 14,134 128B Other musculosketal procedures without catastrophic complications 4,669 128 Other musculosketal procedures 1,799 - Outpatient Appointment 130 Data Summary from the HSE National Casemix programme based on activity and costs reported by 39 participating hospitals. (Note there is no specific code for vertebroplasty

2015 National Clinical Guidelines (Ireland)

230. Early Management of Head Injury in Adults

, disorientation and slow thinking] • objective neurological deficits (such as weakness, loss of balance, change in vision, praxis, paresis/paraplegia, sensory loss and aphasia) that may or may not be transient 2. Anatomical changes • scalp and/or facial wound or swelling • skull fracture (facial, basilar or vault) and/or clinical signs of skull fracture*** • diagnosed intracranial lesion such as brain parenchyma injury, injury to intracranial blood vessels, injury to the dura mater, intracranial haemorrhage (...) an acceleration/deceleration movement without direct external trauma to the head • a foreign body penetrating the brain • forces generated from events such as blast or explosion, or other forces yet to be defined4 Early Management of Head Injury in Adults **The anatomical or mechanical changes in the brain such as axonal injury which may not be visualised in the CT scan does not rule out such injury. ***Clinical signs of skull base fractures such as periorbital ecchymosis (“Raccoon’s eyes”), retro-auricular

2015 Ministry of Health, Malaysia

232. Urinary Incontinence

an enlarged bladder or other abdominal mass, and perineal and digital examination of the rectum (prostate) and/or vagina. Examination of the perineum in women includes an assessment of oestrogen status and a careful assessment of any associated pelvic organ prolapse (POP). A cough test may reveal SUI if the bladder is sufficiently full and pelvic floor contraction together with urethral mobility can be assessed digitally. 3.2 Patient questionnaires This section includes symptom scores, symptom

2015 European Association of Urology

233. Prevention of Acute Exacerbations of COPD

the rest of the world. An exacerbation of COPD (periodic escalations of symptoms of cough, dyspnea, and sputum production) is a major contributor to worsening lung function, impairment in quality of life, need for urgent care or hospitalization, and cost of care in COPD. Research conducted over the past decade has contributed much to our current understanding of the pathogenesis and treatment of COPD. Additionally, an evolving literature has accumu- lated about the prevention of acute exacerbations (...) for many reasons: smokers with mild COPD who produce cough and phlegm achieve substantial symptom reductions in the fi rst year aft er smoking cessation with less lung function decline and less symptoms upon sustained cessation; cigarette smoking may be associated with infections such as pneumonia; among other general health benefi ts. Th e benefi t from smoking cessation outweighs the risks, and a myriad of strategies have been summarized by other guidelines and reviews. In general, eff ective smoking

2015 American College of Chest Physicians

234. Heart Failure Management in Skilled Nursing Facilities Full Text available with Trip Pro

of the large randomized clinical trials of HF therapy included SNF residents, and very few included patients >80 years of age with complex comorbidities. Several issues make it important to address HF care in SNFs. The healthcare environment and characteristics of SNF residents are distinct from those of community-dwelling adults. Comorbid illness unrelated to HF (eg, dementia, hip fracture) increases with age >75 years, and these conditions may complicate both the initial HF diagnosis and ongoing (...) in the SNF, possibly with hospice care. On admission and with a change in status, goals of care should be identified. This conversation should include preferences for hospitalization in the event of HF decompensation. Furthermore, for a median duration of 7 days before overt HF decompensation, several signs and symptoms worsen. Monitoring for presence of increasing fatigue, dyspnea on exertion, cough, edema, and weight gain should signal nursing staff to intervene to avoid further decompensation

2015 American Heart Association

235. Gastroesophageal Reflux Disease (GERD)

syndromes can be categorized as conditions that have an established association with GERD (cough, laryngitis, asthma, dental erosions) and those that have only a proposed association (pharyngitis, sinusitis, idiopathic pulmonary fibrosis, otitis media) [6]. Reflux-related symptoms occur with frequency and severity across a continuum. There are individuals who experience occasional, mild reflux symptoms that do not © World Gastroenterology Organization 2015 WGO Global Guidelines GERD 5 trouble them (...) for GERD and for these other comorbidities. • GERD frequently coexists with other gastrointestinal syndromes such as irritable bowel syndrome. • In Japan, osteoporosis with vertebral fractures and kyphosis is widely considered to be one of the risk factors for erosive esophagitis, especially among elderly women, and when severe, these skeletal conditions have been associated with Barrett’s epithelium [29–31]. 2.2 Symptomatology GERD has a wide spectrum of clinical symptom-based and injury-based

2015 World Gastroenterology Organisation

237. Guidelines for HIV mortality measurement

) or on lines (b) and (c). An example of a death certificate with four steps in the chain of events leading directly to death is: ? I(a) Pulmonary embolism – line (a) disease or condition immediately (directly) leading to death; ? I(b) Pathological fracture – line (b) disease or condition, if any, leading to (a); ? I(c) Secondary carcinoma of femur – line (c) records the other disease or condition, if any, leading to (b); ? I(d) Carcinoma of breast – line (d) records the other disease or condition, if any (...) . In such cases, a code from the range B20–B24 would be selected. However, the following infectious and parasitic diseases should not be accepted as “due to” HIV (or any other disease or condition, including malignant neoplasms or immunosuppression): ? cholera (A00) ? botulism (A05.1) ? plague, tularaemia, anthrax, brucellosis (A20–A23) ? leptospirosis (A27) ? tetanus, diphtheria, whooping cough, scarlet fever, meningococcal disease (A33–A39) ? diseases due to Chlamydia psittaci (A70) ? rickettsioses (A75–A79

2015 World Health Organisation HIV Guidelines

240. Kadcyla (trastuzumab emtansine (genetical recombination))

Vomiting 93 (19.0) 4 (0.8) 143 (29.3) 22 (4.5) Asthenia 86 (17.6) 2 (0.4) 81 (16.6) 7 (1.4) Arthralgia 85 (17.3) 3 (0.6) 38 (7.8) 0 Pyrexia 85 (17.3) 0 37 (7.6) 2 (0.4) ALT increased 83 (16.9) 14 (2.9) 43 (8.8) 7 (1.4) Cough 83 (16.9) 1 (0.2) 60 (12.3) 1 (0.2) Dry mouth 77 (15.7) 0 24 (4.9) 1 (0.2) Myalgia 69 (14.1) 3 (0.6) 18 (3.7) 0 Back pain 64 (13.1) 3 (0.6) 50 (10.2) 2 (0.4) Abdominal pain upper 57 (11.6) 2 (0.4) 41 (8.4) 1 (0.2) Dyspnoea 56 (11.4) 3 (0.6) 36 (7.4) 2 (0.4) Insomnia 54 (11.0) 2

2013 Pharmaceuticals and Medical Devices Agency, Japan

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