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Aspartate Aminotransferase

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261. Rucaparib camsylate - Ovarian Neoplasms

aspartate aminotransferase AUC area under the plasma concentration-time curve AUC 0–12 area under the concentration versus time curve from time zero to 12 hours postdose AUC 0–24 area under the concentration versus time curve from time zero to 24 hours postdose AUC 0–24.5 area under the concentration versus time curve from time zero to 24.5 hours postdose AUC ss dose-averaged model-predicted steady-state area under the concentration-time curve AUC ss,avg further adjusted AUC ss,avg AUC last area under (...) . Importance of favourable and unfavourable effects 161 3.7.2. Balance of benefits and risks 161 3.7.3. Additional considerations on the benefit-risk balance 162 3.8. Conclusions 163 4. Recommendations 164 DIVERGENT POSITION DATED 22.03.2018 167 Assessment report EMA/CHMP/238139/2018 Page 4/167 List of abbreviations AE adverse event AEMPS Agencia Española de Medicamentos y Productos Sanitarios AESI(s) adverse event(s) of special interest ALT alanine aminotransferase AML acute myeloid leukaemia AST

2018 European Medicines Agency - EPARs

262. Peramivir (Alpivab) - Influenza, Human

aminotransferase AP Alkaline phosphatase ARDS Acute respiratory distress syndrome AST Aspartate aminotransferase AUC Area under the time concentration curve BID Twice daily BMI Body mass index CDC Centers for Disease Control and Prevention CFB Change from baseline CI Confidence interval CL Clearance CLcr Creatinine clearance Cmax Maximum concentration CSR Clinical study report CK / CPK Creatine phosphokinase COPD Chronic obstructive pulmonary disease CYP Cytochrome ECDC European Centre for Disease Prevention

2018 European Medicines Agency - EPARs

263. Beclometasone dipropionate anhydrous / formoterol fumarate dihydrate / glycopyrronium (Riarify - (previously CHF 5993 Chiesi Farmaceutici S.p.A.)) - Chronic Obstructive Pulmonary Disease

and risk benefit assessment 12 4. Recommendations 12 Assessment report EMA/155339/2018 Page 3/13 List of abbreviations ADME absorption, distribution, metabolism, and excretion ADR Adverse Drug Reaction AE adverse event AESI adverse event of special interest ALT alanine aminotransferase APSD aerodynamic particle size distribution AST aspartate aminotransferase ATS American Thoracic Society BMI body mass index BUD budesonide CAT COPD Assessment Test CDLM Capacity of Daily Living during the Morning CEC

2018 European Medicines Agency - EPARs

264. Beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium (Trydonis) - COPD, Chronic Obstructive Pulmonary Disease

12 Assessment report EMA/155337/2018 Page 3/13 List of abbreviations ADME absorption, distribution, metabolism, and excretion ADR Adverse Drug Reaction AE adverse event AESI adverse event of special interest ALT alanine aminotransferase APSD aerodynamic particle size distribution AST aspartate aminotransferase ATS American Thoracic Society BMI body mass index BUD budesonide CAT COPD Assessment Test CDLM Capacity of Daily Living during the Morning CEC Clinical Endpoint Committee CHMP Committee

2018 European Medicines Agency - EPARs

265. Dolutegravir sodium rilpivirine hydrochloride (Juluca) - HIV Infections

Abacavir AE Adverse event ALAG Absorption lag time ALT Alanine aminotransferase ART Antiretroviral therapy ARV Antiretroviral ASMF Active substance master file AST Aspartate aminotransferase ATV Atazanavir AUC Area under the concentration-time curve AUC(0-t) Area under the concentration-time curve over the dosing interval AZT Zidovudine BA Bioavailability BCS Biopharmaceutics classification system BE Bioequivalence c/mL copies/milliliter C 0avg Average pre-dose concentration C 0h Observed plasma (...) in aminotransferases are known and very common side effects of both, DTG and RPV. Altogether, no new risk with regard to the liver chemistries and no increased risk of hepatic toxicity for DTG + RPV compared with CAR could be detected. Renal Function Renal disorders AEs in the Early Switch Phase are discussed already above in section ‘Adverse events of special interest (AESIs)’. Ten (2%) subjects in the DTG + RPV group had Grade 1 maximum post-baseline emergent elevations in creatinine; there were no Grade 2

2018 European Medicines Agency - EPARs

266. Gemtuzumab ozogamicin (Mylotarg) - Leukemia, Myeloid, Acute

leukaemia AraC cytarabine AST aspartate aminotransferase AT As Treated AUC area under the plasma concentration-time curve BCRP breast cancer resistance protein BMA bone marrow aspirate BSA bovine serum albumin CD Cluster of Differentiation CDR Complementarity determining region CFU Colony Forming Units CHMP Committee for Medicinal Products for Human Use CI confidence interval CL Clearance CLL1 C-type lectin-like molecule-1 Cmax Maximum Serum Concentration CNS central nervous system COG Children's (...) balance 134 3.8. Conclusions 135 4. Recommendations 135 Assessment report EMA/155284/2018 Page 4/138 List of abbreviations Term Definition AAS Amino Acid Substitution AcBut (4-(4'acetylphenoxy)butanoic acid) ADA anti-drug antibody ADC antibody-drug conjugate ADE AraC/DNR/etoposide ADR adverse drug reaction AE adverse event ALFA Acute Leukemia French Association ALP alkaline phosphatase ALT alanine aminotransferase AML acute myeloid leukaemia ANC absolute neutrophil count APL acute promyelocytic

2018 European Medicines Agency - EPARs

267. Infliximab (Zessly) - Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease, Psoriasis, Ankylosing Spondylitis

of favourable and unfavourable effects 103 3.6.2. Balance of benefits and risks 103 3.7. Conclusions 104 4. Recommendations 104 CHMP assessment report EMA/223369/2018 Page 3/106 List of abbreviations %CV Percent coefficient of variation %RE Percent relative error Ab Antibody Abs Absolute ACR American College of Rheumatology ADA Anti-drug antibody ADCC Antibody-Dependent Cell-Mediated Cytotoxicity ADR Adverse drug reaction AE Adverse event ALT Alanine aminotransferase AST Aspartate aminotransferase AUC-SE

2018 European Medicines Agency - EPARs

268. Esmya: new measures to minimise risk of rare but serious liver injury

each treatment course, monthly during the first 2 treatment courses, and thereafter as clinically indicated. Liver testing also to be performed again 2-4 weeks after stopping treatment. Esmya should not be started if levels of alanine transaminase (ALT) or aspartate aminotransferase (AST) are more than 2 times the upper limit of normal (ULN). Treatment should be stopped in patients with ALT or AST levels more than 3 times ULN. Healthcare professionals should advise their patients about the signs

2018 European Medicines Agency - EPARs

270. Ertugliflozin l-pyroglutamic acid (Steglatro) - Diabetes Mellitus, Type 2

Page 4/139 List of abbreviations Abbreviation Definition %AR applied radioactivity in percent A 1C glycosylated haemoglobin (haemoglobin A1c) ADA American Diabetes Association AHA anti-hyperglycaemic agent AIBN ALT (SGPT) 2,2'-Azobis(2-methylpropionitrile) alanine aminotransferase AST (SGOT) aspartate aminotransferase Alu aluminium AUC area under the concentration-time curve AUC inf area under the concentration-time curve from time zero to infinity AUC tau area under the concentration-time curve

2018 European Medicines Agency - EPARs

272. Ertugliflozin l-pyroglutamic acid / sitagliptin phosphate monohydrate (Steglujan) - Diabetes Mellitus, Type 2

AMP adenosine monophosphate AST (SGOT) aspartate aminotransferase AUC area under the concentration-time curve AUC inf area under the concentration-time curve from time zero to infinity BCS biopharmaceutical classification system BE bioequivalence BMI body mass index CHMP Committee for Medicinal Products for Human use CFU colony forming units CI confidence interval CKD chronic kidney disease cLDA constrained longitudinal data analysis C max maximum observed plasma concentration CPP critical process (...) considerations on the benefit-risk balance 137 3.8. Conclusions 137 4. Recommendations 137 Assessment report EMA/86941/2018 Page 4/139 List of abbreviations Abbreviation Definition %AR Applied radioactivity in percent A1C glycosylated hemoglobin (hemoglobin A1c) AACE American Association of Clinical Endocrinologists ABPM ambulatory blood pressure monitoring ADA American Diabetes Association AHA anti-hyperglycemic agent AIBN 2,2'-Azobis(2-methylpropionitrile) ALT (SGPT) alanine aminotransferase Alu aluminium

2018 European Medicines Agency - EPARs

273. Ertugliflozin l-pyroglutamic acid / metformin hydrochloride (Segluromet) - Diabetes Mellitus, Type 2

. Additional considerations on the benefit-risk balance 157 3.8. Conclusions 157 4. Recommendations 157 Assessment report EMA/86928/2018 Page 4/159 List of abbreviations Abbreviation Definition %AR Applied radioactivity in percent A1C glycosylated haemoglobin A1c ADA American Diabetes Association AHA anti-hyperglycaemic agent AIBN 2,2'-Azobis(2-methylpropionitrile) ALT alanine aminotransferase Alu aluminium ANCOVA analysis of covariance ASaT All Subjects as Treated AST aspartate aminotransferase AUC area

2018 European Medicines Agency - EPARs

274. Management of Alcohol-Related Liver Disease

presenting with extrahepatic manifestations of AUD, such as symmetric peripheral neuropathy, pancreatitis, cardiomyopathy and others. 79 A non-invasive model, the ALD/ non-alcoholic fatty liver disease (NAFLD) index based on four parameters, mean corpuscular volume (MCV), aspartate amino- transferase (AST)/alanine aminotransferase (ALT) ratio, body mass index, and gender was proposed for the differential diag- nosis of ALD with NAFLD. 80 Screening investigations should not only include liver func- tion

2018 European Association for the Study of the Liver

275. Treatment of Hepatitis C

1.0 b 2.0 b 0.84 * (0.54–0.97) 77% 48% 75% 94% n.a. n.a. 43 APRI, aspartate aminotransferase to platelet ratio index; ARFI, acoustic radiation force impulse; AUROC, area under the receiver operating characteristic curve; FIB-4, ?brosis-4; n.a., not applicable; NPV, negative predictive value; PPV, positive predictive value. a Scales for liver stiffness cut-offs (in kPa) are different between FibroScan and Aixplorer . b Two cut-offs are provided for FIB-4 and for APRI, respectively, with their own (...) if recent seroconversion to anti-HCV antibodies can be documented, since there is no serological marker which estab- lishes that HCV infection is in the de novo acquired acute phase. Not all patients with acute hepatitis C will be anti-HCV antibody-positive at diagnosis. In these cases, acute hepatitis C canbesuspectediftheclinicalsignsandsymptomsarecompat- ible with acute hepatitis (alanine aminotransferase [ALT] level >10 times the upper limit of normal, and/or jaundice) in the absence of a history

2018 European Association for the Study of the Liver

276. Dacomitinib (Vizimpro) - non-small cell lung cancer (NSCLC)

aminotransferase (19% versus 39%), conjunctivitis (19% versus 4.0%), nausea (19% versus 22%) and increased aspartate aminotransferase (19% versus 36%). The most frequently reported serious adverse events in the dacomitinib and gefitinib groups respectively were: disease progression (3.5% versus 4.9%), diarrhoea (2.2% versus 0%), pleural effusion (2.2% versus 0.9%), pneumonia (2.2% versus 0.9%) and dyspnoea (0.4% versus 1.8%). 2 Three deaths were considered to be related to study treatment toxicity. Two

2019 Scottish Medicines Consortium

277. Management of Rheumatod Arthritis

) • changes in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (HR=0.14, 95% CI 0.04 to 0.48) However, it has significantly more renovascular AEs (oedema and hypertension). There is no difference in cardiac AEs and renal dysfunction. 31-32, level I Celecoxib 200 mg daily is as safe as placebo in the incidence of gastroduodenal ulcers =3 mm but safer compared with traditional NSAIDs (NNH=9, 95% CI 8 to 10). There is no conclusive evidence that celecoxib has more CV events than

2019 Ministry of Health, Malaysia

278. Society of Interventional Radiology Consensus Guidelines for the Periprocedural Management of Thrombotic and Bleeding Risk in Patients Undergoing Percutaneous Image-Guided Interventions—Part II: Recommendations. Full Text available with Trip Pro

) (22) . ALT = alanine aminotransferase; AST = aspartate aminotransferase; BP = blood pressure; Cr = creatinine; mo = months; NSAID = nonsteroidal antiinflammatory drug; ULN = upper limits of normal; VKA = vitamin K antagonist; y = years. Assessment of Patient Thromboembolic Risk Patients who have had a stroke or venous thromboembolic event or have an underlying malignancy or a significant cardiovascular disease history are particularly prone to thrombotic events ( Table 1 ) ( x 8 Kearon, C., Akl

2019 Society of Interventional Radiology

279. Tocilizumab (RoActemra): rare risk of serious liver injury including cases requiring transplantation

Tocilizumab (RoActemra): rare risk of serious liver injury including cases requiring transplantation Tocilizumab (RoActemra): rare risk of serious liver injury including cases requiring transplantation - GOV.UK GOV.UK uses cookies to make the site simpler. Accept cookies You’ve accepted all cookies. You can at any time. Hide Search Tocilizumab (RoActemra): rare risk of serious liver injury including cases requiring transplantation Alanine aminotransferase (ALT) and aspartate aminotransferase (...) , have been reported in patients treated with tocilizumab; some cases required liver transplantation advise patients to seek medical help immediately if they experience signs and symptoms of liver injury, such as tiredness, abdominal pain, and jaundice monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels at initiation, every 4–8 weeks during the first 6 months of treatment, and every 12 weeks thereafter in patients with rheumatological indications exercise caution when

2019 MHRA Drug Safety Update

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