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Myocardial Infarction Stabilization

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481. Cabometyx (cabozantinib) - advanced renal cell carcinoma

by the release and stability data from representative batches which were manufactured at the intended commercial scale. The proposed GTI specification limits are below the threshold of toxicological concern (TTC, 1.5 µg/day) considering the highest dose of 60 mg, and are therefore considered to be acceptable. The analytical methods used have been adequately described and the non-compendial methods appropriately validated in accordance with the ICH guidelines. Satisfactory information regarding the reference (...) standards used for identity, assay and impurities testing has been presented. Batch analysis data have been provided on 16 commercial scale batches produced by the proposed manufacturer and process. In addition, batch analysis results from historical batches were presented. The results are within the specifications and demonstrate that the active ingredient can be manufactured reproducibly. Stability Stability data on ten commercial scale batches of active substance manufactured by the commercial

2016 European Medicines Agency - EPARs

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

, characterisation and process controls 13 Specification 14 Stability 14 Tipiracil hydrochloride 15 General information 15 Manufacture, characterisation and process controls 15 Specification 16 Stability 16 2.2.3. Finished medicinal product 16 Description of the product and Pharmaceutical development 16 Manufacture of the product and process controls 18 Product specification 18 Stability of the product 18 Adventitious agents 19 2.2.4. Discussion on chemical, and pharmaceutical aspects 19 2.2.5. Conclusions

2016 European Medicines Agency - EPARs

483. Sex Effects in High-impact Conditions for Women Veterans - Depression, Diabetes, and Chronic Pain

(-0.2%) and 24 months (-0.3%). There were no statistically significant effects on body mass index. Subgroup analyses were not performed. Another review, based on a 2011 AHRQ report, inspected the progression of diabetes-related complications and found significantly decreased risks of peripheral neuropathy, nonfatal myocardial infarction, and death with lifestyle interventions at 13.3 years of follow-up. 79 There were no significant differences in risk for retinopathy or nephropathy between (...) . 127,128,130,131,133,285-291 One additional review compared acupuncture, spinal manipulation, and exercise. 292 Exercise interventions included yoga and Pilates (n=6 studies), 127,128,131,133,290,291 core stability, aerobic or general exercise, 130,286 mixed programs, 285,287-289 and nonspecific programs. 292 The largest review (n=40) found that all types of exercise compared with minimal care improved pain (MD -4.83 [100-point scale], CI -9.36 to -0.30) and disability (MD -6.41, CI -9.76 to -3.05). The number

2016 Veterans Affairs Evidence-based Synthesis Program Reports

484. Home health monitoring devices compared with usual care for patients with hypertension

of a number of health states. Patients began in the ‘well’ health state (whereby they are stable but have poorly controlled hypertension), then based on transition probabilities, patients could remain in this health state or move to one of four acute health states, that is stroke, myocardial infarction, angina and heart failure. Those patients that survived the acute stage of the model progressed to the chronic phase, whereby they remained until death. The clinical data used to inform the model were drawn (...) section. In addition, this reduction in SBP is considered to be a surrogate marker and therefore serves as a proxy for final patient relevant outcomes, that is stroke or myocardial infarction. Although there are uncertainties surrounding the use of surrogate outcomes, due to the short duration of the trial, this is probably reasonable. Utility values were included in the analysis and quality of life for each health state was estimated via published literature. Patients in the ‘well’ health state were

2016 Evidence Notes from Healthcare Improvement Scotland

485. Kovaltry - octocog alfa

of the method is satisfactorily described. Reference materials The strategy for establishing and maintaining reference standards for release testing of the active substance, has been sufficiently described. Reference materials have been adequately characterised and reference standards for potency have been calibrated against relevant International Standards. Stability Real time, real condition stability data of active substance according to ICH guidelines and data generated under accelerated conditions were (...) provided. The stability results indicate that the active substance is sufficiently stable and justify the proposed shelf life in the proposed container. Assessment report EMA/CHMP/40124/2016 rev. 1 Page 11/72 2.2.3. Finished Medicinal Product Description of the product and pharmaceutical development The finished product is supplied as powder and solvent for solution for injection. The powder is white to slightly yellow solid. The reconstituted product is a clear, colourless liquid. The finished product

2016 European Medicines Agency - EPARs

486. Iblias - octocog alfa

. Reference materials The strategy for establishing and maintaining reference standards for release testing of the active substance, has been sufficiently described. Reference materials have been adequately characterised and reference standards for potency have been calibrated against relevant International Standards. Stability Real time, real condition stability data of active substance according to ICH guidelines and data generated under accelerated conditions were provided. The stability results (...) of the suitability of the compendial methods used have been provided. Stability of the product The intended shelf-life for the finished product stored at 2-8°C and protected from light is 30 months. Within this period, the finished product may be stored for up to 12 months at a temperature up to 25°C. All of the investigated batches followed a stability program based on ICH guidelines to support the shelf life assignment. The proposed storage conditions have been found acceptably justified and substantiated

2016 European Medicines Agency - EPARs

487. Portrazza - necitumumab

) cell line. The description of the gene constructs and transfection of NS0 cells has been adequately detailed. Data is shown in support of correct sequence and integration of the gene construct. A thorough description of the cell bank system has been provided, demonstrating stability of the construct and suitability of the Master Cell Bank (MCB) and Working Cell Bank (WCB) to be used for production. The monitoring and storage of cell banks are well motivated with supporting data for the set limits (...) of cell density and temperature. The stability of the MCB and WCB will be monitored and the stability analysis evaluated and documented. The protocol for the preparation of a replacement WCB is adequately described with justified controls for its capacity to express the active substance. The data from the analysis of cells of in vitro cell age limit are in support of a stable construct and expression of an active substance with a similar oligosaccharide pattern as for substance produced from either

2016 European Medicines Agency - EPARs

488. Chronic Heart Failure - Diagnosis and Management

of HF. These include: hypertension, diabetes, and prior myocardial infarction. A review of new HF cases in BC suggests that 80% of individuals were previously diagnosed with hypertension, 40% with diabetes, and 45% with ischemic heart disease. On average, these co-morbidities were apparent 8, 6 and 4 years before their diagnosis of HF, respectively. To confirm the diagnosis of HF, conduct a thorough medical history, physical examination and initial investigations (see ). Use this information (...) the patient’s quality of life. By contrast, CRT is associated with improved mortality and quality of life (improved symptom status and functional capacity). Table 6. Mortality reductions based on device ICD may be considered in patients with one of the following: History of hemodynamically significant sustained ventricular arrhythmia; Ischemic cardiomyopathy and LVEF ≤ 35% (measured at least 1 month after acute myocardial infarction, or 3 months post coronary artery revascularization); or Non-ischemic

2016 Clinical Practice Guidelines and Protocols in British Columbia

489. Acute and Chronic Heart Failure Full Text available with Trip Pro

always be obtained. HF is unusual in an individual with no relevant medical history (e.g. a potential cause of cardiac damage), whereas certain features, particularly previous myocardial infarction, greatly increase the likelihood of HF in a patient with appropriate symptoms and signs. At each visit, symptoms and signs of HF need to be assessed, with particular attention to evidence of congestion. Symptoms and signs are important in monitoring a patient's response to treatment and stability over time (...) myocardial infarction AMICA Atrial fibrillation Management In Congestive heart failure with Ablation ANP A-type natriuretic peptide ANS autonomic nervous system ARB angiotensin receptor blocker ARNI angiotensin receptor neprilysin inhibitor ARVC arrhythmogenic right ventricular cardiomyopathy AST aspartate aminotransferase ASV assisted servo-ventilation ATLAS Assessment of Treatment with Lisinopril And Survival ATTR transthyretin-mediated amyloidosis AV atrio-ventricular AVP arginine vasopressin b.i.d

2016 European Society of Cardiology

490. Cancer treatments & cardiovascular toxicity 2016 (Position Paper) Full Text available with Trip Pro

following anti-HER2 compounds and VEGF inhibitors – BMI = body mass index; CAD = coronary artery disease; HER2 = human epidermal growth factor receptor 2; HF = heart failure; MI = myocardial infarction; VEGF = vascular endothelial growth factor; VHD = valvular heart disease. Table 3 Factors associated with risk of cardiotoxicity following anti-HER2 compounds and VEGF inhibitors – BMI = body mass index; CAD = coronary artery disease; HER2 = human epidermal growth factor receptor 2; HF = heart failure; MI (...) = myocardial infarction; VEGF = vascular endothelial growth factor; VHD = valvular heart disease. 2.1.1.5 Inhibition of BCR-ABL kinase The inhibition of BCR-ABL kinase by small molecules such as imatinib has profoundly improved the prognosis of patients with several forms of chronic leukaemia and some forms of gastrointestinal stromal tumours. Although initial reports suggested a risk for imatinib-induced cardiotoxicity, analysis of large cohorts did not confirm these data. Newer, more potent inhibitors

2016 European Society of Cardiology

491. Dyslipidaemias Full Text available with Trip Pro

lipase Lp lipoprotein MetS metabolic syndrome MI myocardial infarction MTP microsomal triglyceride transfer protein MUFA monounsaturated fatty acid NICE National Institute for Health and Care Excellence NNRTI non-nucleoside reverse transcriptase inhibitor NNT number needed to treat NPC1L1 Niemann-Pick C1-like protein 1 NSTE-ACS non-ST elevation acute coronary syndrome NYHA New York Heart Association PAD peripheral arterial disease PCI percutaneous coronary intervention PCSK9 proprotein convertase (...) decisions in older people, with a firm commitment to implementing lifestyle measures such as smoking cessation in the first instance. With these considerations one can propose the following levels of total CV risk ( Table ). Table 4 Risk categories ACS = acute coronary syndrome; AMI = acute myocardial infarction; BP = blood pressure; CKD = chronic kidney disease; DM = diabetes mellitus; GFR = glomerular filtration rate; PAD = peripheral artery disease; SCORE = systematic coronary risk estimation; TIA

2016 European Society of Cardiology

492. Qtern (saxagliptin / dapagliflozin propanediol monohydrate) - Diabetes Mellitus, Type 2

of Questions LT Long-term MA Marked abnormality MA Marketing Authorisation MAH Marketing Authorisation holder MDRD Modification in Diet and Renal Disease Qtern Assessment report Page 5/91 MEB Medicines and Evaluation Board MI Myocardial infarction MOA Mechanism of action MPA Medical Products Agency MRHD Maximum recommended human dose MTT NF Meal tolerance test USP National Formulary NHANES National Health and Nutrition Examination Survey NYHA New York Heart Association NOAEL no observed-adverse-effect (...) -density polyethylene (LDPE) bags within a HDPE drum with a secure fitting lid. The suitability is supported by stability results. The polyethylene bags comply with the Ph. Eur. requirements and with the relevant EC regulations for plastic materials and articles intended to come into contact with foodstuffs. Specification The active substance release specification includes appropriate tests and limits for: appearance and colour (visual inspection), identity (IR-ATR or Raman, HPLC), assay (HPLC

2016 European Medicines Agency - EPARs

493. Eptifibatide Accord

Application Mg Milligrams MI Myocardial infarction Min Minute (s) NMR Nuclear Magnetic Resonance NMT Not more than NQMI Non-Q-wave myocardial infarction PCI Percutaneous coronary intervention Ph. Eur. European Pharmacopoeia RH Relative Humidity SmPC Summary of product characteristics SMs Starting materials STEMI ST-segment elevation myocardial infarction RMP Risk management plan UA Unstable angina UV Ultraviolet Assessment report EMA/21867/2016 Page 4/25 1. Background information on the procedure 1.1 (...) ) of Directive 2001/83/EC and refers to a reference product for which a Marketing Authorisation is or has been granted in the Union on the basis of a complete dossier in accordance with Article 8(3) of Directive 2001/83/EC. The applicant applied for the following indication: Eptifibatide Accord is intended for use with acetylsalicylic acid and unfractionated heparin. Eptifibatide Accord is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-Q-wave

2016 European Medicines Agency - EPARs

494. Venous thromboembolic diseases: diagnosis, management and thrombophilia testing

on the classification of chronic kidney disease see chronic kidney disease [NICE guideline CG182]). Right v Right ventricular dysfunction entricular dysfunction Acute PE may lead to right ventricular pressure overload and dysfunction. This can be detected by echocardiography, CT pulmonary angiography (CTPA), or elevated biomarkers because of myocardial stretch (for example brain natriuretic peptide) or transmural right ventricular infarction. Combinations of these indices can be used for risk stratification. Unpro (...) Pulmonary embolism 1.2.7 Consider pharmacological systemic thrombolytic therapy for patients with PE and haemodynamic instability instability (see also recommendation 1.2.1 on pharmacological interventions for DVT and PE). [2012] [2012] 1.2.8 Do not offer pharmacological systemic thrombolytic therapy to patients with PE and haemodynamic stability stability with or without right ventricular dysfunction (see also recommendation 1.2.1 on pharmacological interventions for DVT and PE). If patients develop

2012 National Institute for Health and Clinical Excellence - Clinical Guidelines

495. Retinal Vein Occlusion (RVO)

al (2014) found a higher overall increased mortality compared to controls for CRVO (5.9 deaths/100 person years compared to 4.3 deaths/100 person years (HR, 1.45:95% CI,1.19 – 1.76).21 However, when the data was adjusted for overall occurrence of cardiovascular disorders including hypertension, peripheral vascular disease, ischaemic heart disease, myocardial infarction, congestive cardiac failure, cerebrovascular disease and diabetes, the mortality rate was comparable to that in the control (...) population (HR 1.19;95% CI,0.96 – 1.46).21 Using the same methodology, this finding of no specific increase in mortality was also found for BRVO.47 Participants with BRVO at baseline did not have an increased 8-year risk of mortality due to ischaemic heart disease in the Beaver Dam study.47 A population based study reported that RVO did not predict acute myocardial infarction. 47 Similarly, other reports show that RVO is not associated with cerebrovascular mortality.20,49 However, Cugati et al (2007

2015 Royal College of Ophthalmologists

496. Syncope and Chest Pressure, then an Unusual Bradycardia with Shock

is not benign. Especially in the setting of acute ischemia or infarction — resultant acceleration of the sinus rate may prove deleterious by increasing myocardial oxygen demand ( which may precipitate tachyarrhythmias, including VT! ). Atropine works best for treating bradycardia due to increased vagal tone ( and vagal tone tends to be increased especially d uring the early hours of acute inferior infarction ). Atropine is not advised to treat bradycardia/AV block in a patient with acute inferior MI — IF he (...) and pacing was on standby . The rhythm stabilized without any other intervention than that one dose of atropine. She was transferred to a tertiary care center via helicopter. She was stable on transfer. At the tertiary care center, her troponin peaked at 0.25 ng/mL (approximately equal to 250 ng/L) and she underwent cardiac catheterization. Angiogram Her graft LAD and native circumflex were both stented . TIMI flow was not mentioned. A post-cath EKG was obtained (EKG 3). Dr. Smith's interpretation: Sinus

2020 Dr Smith's ECG Blog

497. Detecting, managing and monitoring haemostasis: viscoelastometric point-of-care testing (ROTEM, TEG and Sonoclot systems)

). Page 12 of 58the time until initial fibrin formation, the kinetics of fibrin formation and clot development, the ultimate strength and stability of the fibrin clot, and fibrinolysis. The Sonoclot system (Sienco Inc.) The Sonoclot system (Sienco Inc.) 4.10 The Sonoclot system is also a viscoelastometric device used for measuring coagulation and platelet function. It provides information on haemostasis including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis

2014 National Institute for Health and Clinical Excellence - Diagnostics Guidance

498. Perceval S Sutureless Valve for Aortic Valve Replacement

Outcomes Single arm studies reported mortality associated with the procedure in the form of peri- operative, in-hospital, and 30-day mortality, and procedure-relevant adverse events of reintervention for valve displacement, paravalvular regurgitation or leak (PVR), or bleeding, Perceval S Sutureless Valve for Aortic Valve Replacement 6 need for renal replacement therapy, new arrhythmias, particularly those requiring pacemaker implantation, stroke/TIA, myocardial infarction, and endocarditis. Operative (...) to 12.7% 20 patients in the case series, although studies were not consistent as to when and how PVR was measured. Perioperative stroke was reported in 1.5% 12 of patients in the meta-analysis and in none 19 to 7.1% 18 (representing one patient in a small study) of patients in the case series. Myocardial infarction occurred in 0 20 to 0.8% 16 patients. Endocarditis was reported for 2.2% of patients in the meta-analysis, 12 was not reported in two case series, 17,20 and in the other one occurred in 0.4

2015 Canadian Agency for Drugs and Technologies in Health - Rapid Review

499. Harm of HPV vaccine: Latest information and examination of epidemiological studies

events in the SAG method group: six serious adverse events including two deaths due to myocardial infarction and pulmonary embolism occurred in the SAG group. On the other hand, only one adverse event occurrence was reported in the 3DS group. The odds ratio was 10.8 (p=0.0318). In addition, in the SAG group, pain management was poorer than that in 3DS group [16]. It should be concluded that the 3DS method is superior to SAG method both in terms of treatment adherence and pain management. No "Plain

2015 Med Check - The Informed Prescriber

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