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Fetal Heart Tracing

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282. Orphacol - cholic acid

toxicity studies to be the target organs for cholic acid toxicity. A negative chronotropic effect was observed in vivo in rats at intravenous cholic acid doses between 10 and 40 mg/kg (Joubert 1978). This effect was shown to be dose-dependent in vitro and causes both a vagally mediated and direct effect on heart rate. This effect was reduced with atropine or vagotomy. Ganglion blockade and decerebration further diminishes this effect (Joubert 1978). At low concentrations on cat cardiac muscle, cholic (...) in a number of species (rat, sheep and rhesus monkeys) gives contradictory evidence to whether cholic acid transfers between mother and foetus. Bile acids and cholic acid are normally present in fetal serum (Little et al. 1975; Hassan and Subbiah Assessment report EMA/596651/2013 Page 20/74 1980; Campos et al. 1986; Perez et al. 1994) so fetal exposure to endogenous levels of cholic acid and the potential placental transfer can be considered to be physiological (Hassan and Subbiah 1980). Metabolism Cholic

2013 European Medicines Agency - EPARs

283. Selincro - nalmefene

assessment report Page 13/73 absorption with rather high bioavailability was observed in rats and dogs, whereas in humans only moderate bioavailability was found. Distribution Nalmefene is widely distributed, with the highest values found in liver, kidney and pancreas. It crosses the placental barrier and binds to melanin. In nursing rats, it was found in the milk at concentrations 3 times that of plasma 1 h post dose, but decreased to half the plasma concentration by 24 h post-dose. Only trace amounts (...) during the period of organogenesis induced only slight materno-toxicity, but induced significantly decreased foetal body weights and increased skeletal variations indicating retardation of foetal development. Selincro CHMP assessment report Page 20/73 No treatment-related teratogenicity was observed in either rats or rabbits. With regards to the environmental risk assessment, nalmefene is unlikely to bioaccumulate to a significant extent and is unlikely to present a risk to surface water. Furthermore

2013 European Medicines Agency - EPARs

284. Labazenit - budesonide / salmeterol

minutes of intravenous administration of 14 C-salmeterol xinafoate, radioactive drug-related material was distributed throughout the tissues. By 30 minutes, the highest concentrations of radioactive material were found in the kidneys, liver, followed by intestinal content, heart, pituitary, bone marrow, lung and stomach/small intestine wall. Lower concentrations of radioactivity were retrieved in blood, whereas only trace amounts were detected in the central nervous system. The levels of radioactivity (...) . A high uptake of budesonide was also noted in organs and tissues from the reproductive system, such as the epithelium of the head of the epididymis and ductus deferens. In the pregnant mouse, high amounts of radioactivity were found in the corpora lutea, the placenta and the foetal membranes. In the foetus, the distribution of radioactivity is similar to that of the mother. Salmeterol/budesonide No distribution PK studies were performed on the fixed dose combination salmeterol/budesonide which

2013 European Medicines Agency - EPARs

285. Abilify Maintena (aripiprazole)

brain following its oral administration. Aripiprazole was extensively serum protein bound and the binding site was determined to be albumin site II specific. The ex vivo protein binding of aripiprazole was 99.75% and was similar to the protein binding determined by equilibrium dialysis in vitro. Following [14C]-aripiprazole administration to pregnant rats, drug-related radioactivity was widely distributed in maternal tissues. Distribution of radioactivity to the fetus was low and only a trace amount (...) of radioactivity was detected in the amniotic fluid even though concentrations of radioactivity in the placenta were 1.3-4.5 times higher than that in maternal plasma. Highest fetal tissues concentrations were observed in the fetal liver; lower concentrations were noted in fetal kidney, heart, blood, lung, and brain. Drug-derived radioactivity was secreted in the milk within 0.5 h after oral administration of [14C]-aripiprazole to lactating rats. In addition, the milk vs. blood concentration ratios were

2013 European Medicines Agency - EPARs

286. HyQvia - human normal immunoglobulin

on fertility in guinea pig) in section 5.3 of the SmPC. Embryo-toxicity Embryo-foetal development studies in mice demonstrated that exposure of the embryo at doses = 9 mg/kg/day of the enzyme (also given SC) results in increased resorption rates which is caused by defects of the heart formation via degradation of its hyaluronic acid. A safety window of almost 400 compared to the intended human dose seems sufficient. The provided mouse toxicokinetic data address the potential effect of circulating anti (...) components are present in the following maximum amounts: 18.8 mg/ml glycine, and trace amounts of polysorbate 80, Assessment report EMA/239112/2013 Page 10/68 tri-n-butyl phosphate, and octoxynol 9. The product contains no preservatives. The finished product specifications meet the relevant Ph. Eur. Monographs 0918 and 0338. Regarding the stability of the IG 10% drug product, the applicant presented 5 stability studies. The stability studies were designed to cover all manufacturing facilities and filling

2013 European Medicines Agency - EPARs

287. Istodax - romidepsin

-diphenyltetrazolium bromide MWCB master working cell bank NADPH nicotinamide adenine dinucleotide phosphate-oxidase NCE normochromatic erythrocytes NCI National Cancer Institute ND not determined NHL non-Hodgkin’s lymphoma NK natural killer NMR nuclear magnetic resonance NOAEL no observable adverse effect level NOS not otherwise specified NYHA New York Heart Association OATP organic anion-transporting polypeptide ORR overall response rate OS overall survival Papp permeability coefficient PBT persistent (...) is a lyophilised powder for solution for injection. It is manufactured as a lyophilised, sterile finished product containing 10 mg/vial romidepsin. It is supplied in a dual-pack configuration with a diluent vial for use in reconstitution. Because of the poor water solubility of romidepsin, a tert-butyl alcohol non-aqueous co-solvent system was developed. Insoluble particles have been observed in trace amounts in romidepsin solution for lyophilisation. Appropriate measures to minimise or essentially eliminate

2013 European Medicines Agency - EPARs

288. Erivedge - vismodegib

identified as potential mediators of unintended pharmacologic activity. At a concentration of 9.2 µM, vismodegib did not have a biologically significant effect on radioligand binding to any of the off-target receptors. 04-1278-1791 Lead Profiling Screen with GDC-0449.1 05-0606 Effects of GDC-0449.1 on Cloned hERG Potassium Channels Expressed in Mammalian Cells The in vitro effects of vismodegib on the hERG channel mediated ion current (I Kr ; rapidly activating, delayed rectifier cardiac potassium (...) at steady state (0.11 µM based on a typical total drug plasma concentration of 22.3 µM). 05-1458 An Oral Gavage Cardiovascular Safety Pharmacology Study with GDC-0449.1 in Conscious Beagle Dogs Administration of vismodegib at 600 or 2000 mg/kg had no toxicologically relevant effects on ECG results (RR interval, QT interval, or QT interval corrected for variations in heart rate), blood pressure measurements including heart rate, systolic, diastolic and mean arterial pressure and pulse pressure (systolic

2013 European Medicines Agency - EPARs

289. Betmiga (mirabegron)

in HEK293 revealed an Ikr inhibition of 14.7% at 30 µmol/L although this concentration was more than 600-fold the unbound C max at the maximum recommended human dose (MRHD). Mirabegron metabolites M5 and M16 inhibited hERG current, with respective IC 50 values of 21 and 31 µmol/L, and 17.3% for M14, although at concentrations considerably higher than the human expected C max . The observed effects of mirabegron on cardiac muscle action potential were not significant, although M5 at 3 µmol/L prolonged (...) slightly APD 30 by 6.1% and shortened APD 30-90 by 7.9%, while concentrations of 30 µmol/L prolonged APD 30 by 5.6% and APD 90 by 4.7%. M16 prolonged APD 90 by 5.0% at 30 µmol/L. Assessment of mirabegron on the effect on arterially perfused canine ventricular wedge preparations did not reveal demonstrable pro-arrhythmic effects of mirabegron and its metabolites. Following oral administration in the dog, a reduction in QT interval was observed at 10 mg/kg; when corrected for heart rate, an increase

2013 European Medicines Agency - EPARs

290. Evarrest - human fibrinogen / human thrombin

of care sham surgical procedure group. ECG values were evaluated by an independent expert and revealed no treatment-related cardiovascular safety pharmacology effects when observed for cardiac arrhythmias, morphology, and conduction disturbances, heart rate, RR, PR, and QRS and QT durations. All findings were considered insignificant and unrelated to the test article application. Two-Day Evaluation of Fibrin Pad Made Using A High BAC Input Dose in the Porcine Partial Nephrectomy Model (48 Hours (...) subjected to a partial nephrectomy procedure and received treatment with Fibrin Pad batch N06F274M or the clinical comparator, Fibrin Pad batch M06F164. Safety pharmacology endpoints were evaluated using ECG data. ECG tracings collected from a subset of four animals from each treatment arm (12 animals in total) were made prior to surgery and post-surgery at 15 minutes and 1 hour for the test and comparator groups, and 15 minutes and 1 hour after completion of the total nephrectomy in the standard

2013 European Medicines Agency - EPARs

291. Giotrif - afatinib

, 2.45, 6 NOAEL 1 mg/kg. Minimal to slight atrophy of oesophagus epithelium (4/4 M), squamous stomach mucosa (1/4 M) and in the seminal vesicle (1/4 M) considered as tolerable pharmaco-dynamic drug effects. Mortality: None of the animals died prior to scheduled necropsy Clinical: soft or loose stool seen temporarily (2/8 MD 4/12 HD); slight to moderate, dose-dependent, reversible increase in heart rate which correlated with a shortening in QT-interval (MD, HD) no treatment related changes in ECG (...) dependent, consistent effects on PR-, QT-interval, QRS-complex width, heart rate or ECG morphology. Body weight: slight decrease (HD/M) Organ wt: No drug-treatment related changes of absolute or relative organ weights ( ?ovaries in drug

2013 European Medicines Agency - EPARs

292. The utility of ultrasound assessment in the management of preterm prelabor rupture of the membranes. (Abstract)

likely to be nulliparous (34.2% vs. 45.3%, p=0.03), and more likely to have a maternal fever (50.8% vs. 2.6%, p<0.001) and be delivered by cesarean section (69.2% vs. 42.4%, p<0.001), mainly due to a previous cesarean section (18.3% vs. 9.1%, p=0.005), and non-reassuring fetal heart rate tracings (32.5% vs 14.6%, p<0.001). No differences were found with regards to the median amniotic fluid volume, overall BPP score, BPP score<6, MCA PI or CPR. Median UA PI was slightly higher in the suspected CA (...) 2005 and 2017. All patients had an NST daily, and an ultrasound scan twice a week for assessment of amniotic fluid volume, biophysical profile and umbilical artery pulsatility index (UA PI) measurement. Patients with suspected fetal growth restriction also had a middle cerebral artery Doppler assessment (MCA PI). In these cases, the cerebro-placental ratio (CPR, MCA PI divided by UA PI) was calculated as well. Adverse composite neonatal outcome was defined as any one or more of the following

2019 Ultrasound in Obstetrics and Gynecology

293. Use of naltrexone in treating opioid use disorder in pregnancy. Full Text available with Trip Pro

in the fetal heart monitor tracing with drug initiation. The incidence of birth anomalies was no different between the groups. Umbilical cord blood and maternal levels for naltrexone and 6-beta-naltrexol matched; no levels were elevated, and values were undetected if naltrexone was discontinued >60 hours before delivery.These study data demonstrate that, in pregnant women who choose to completely detoxify off opioid drugs during gestation, naltrexone, as a continued form of medication-assisted treatment (...) and the maternal/fetal effects of the use of naltrexone as a medication-assisted treatment in pregnant patients with opioid use disorder.We performed a prospective cohort study collecting data on all pregnant women who were treated with naltrexone medication-assisted treatment compared with pregnant women who were treated with methadone or buprenorphine medication-assisted treatment. Based on a sample size calculation, it was determined that for a power of 90, a minimum of 160 study participants (80 in each

2019 American Journal of Obstetrics and Gynecology

294. Monitoring your baby during labour: A decision aid for women having a vaginal birth

of monitoring may provide a clearer tracing of your baby’s heart rate. Fetoscope or Pinard’s stethoscope Your care provider can listen to your baby’s heart beat directly through your abdomen using a fetoscope (a fetal stethoscope) or Pinard’s stethoscope. A Pinard’s stethoscope looks like a tiny trumpet. These methods of listening to the baby’s heart do not require the use of additional machines or technology. 4There are two options for monitoring your baby during labour: It is difficult to determine how (...) labour? Cardiotocograph (CTG) Cardiotocograph is connected to two small plastic sensors held on your abdomen by elastic belts. The sensors of the cardiotocograph machine detect your contractions and your baby’s heart beat at the same time. The machine prints a record on a paper strip and this is stored as part of your records after the birth. A cardiotocograph is also sometimes called electronic fetal monitoring. The machine makes a sound which sounds like a heart beat whenever the heart rate

2015 EUnetHTA

295. Monitoring of pregnancies at beyond 41+0 weeks of gestation

: 699–706. 41. Trimbos JB, Keirse MJ. Observer variability in assessment of antepartum cardiotocograms. Br J Obstet Gynaecol. 1978; 85: 900-6. 42. Trimbos JB, Keirse MJ. Significance of antepartum cardiotocography in normal pregnancy. Br J Obstet Gynaecol. 1978; 85: 907-13. 23 43. Figueras F et al. Visual analysis of antepartum fetal heart rate tracings: inter- and intra- observer agreement and impact of knowledge of neonatal outcome. J Perinat Med 2005; 33: 241-5. 44. Borgatta L, Shrout PE, Divon (...) in late pregnancy (after 24 weeks gestation) Cochrane Database of Systematic Reviews 2008, issue 4. Art. No.: CD001451 33. Morken NH, Klungsøyr K, Skjærven R. Perinatal mortality by gestational week and size at birth in singelton pregnancies at and beyond term: a nationwide population-based cohort study. BMC Pregnancy and Childbirth 2014, 14;172. 34. Freeman RK, Anderson G, Dorchester W. A prospective multi-institutional study of antepartum fetal heart rate monitoring. I. Risk of perinatal mortality

2015 Nordic Federation of Societies of Obstetrics and Gynecology

296. 2015 ACC/AHA/HRS Guideline for the Management of Adult Patients With Supraventricular Tachycardia Full Text available with Trip Pro

-based therapy ACC/AHA/HRS 2012 Atrial fibrillation CCS 2014 2011 Hypertrophic cardiomyopathy ACC/AHA 2011 Secondary prevention and risk reduction therapy for patients with coronary and other atherosclerotic vascular disease AHA/ACC 2011 Adult congenital heart disease ACC/AHA 2008 Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VII) NHLBI 2003 Statements Catheter ablation in children and patients with congenital heart (...) , American College of Chest Physicians; ACP, American College of Physicians; AHA, American Heart Association; CCS, Canadian Cardiovascular Society; CPR, cardiopulmonary resuscitation; ECAS, European Cardiac Arrhythmia Society; EHRA, European Heart Rhythm Association; ESC, European Society of Cardiology; HRS, Heart Rhythm Society; JNC, Joint National Committee; NHLBI, National Heart, Lung, and Blood Institute; PACES, Pediatric and Congenital Electrophysiology Society; PCNA, Preventive Cardiovascular

2015 American Heart Association

297. State-of-the-Art Methods for Evaluation of Angiogenesis and Tissue Vascularization

impact, particularly under disease conditions such as diabetes mellitus, coronary artery disease, or heart failure, which systemically affect tissue homeostasis. 2. Developmental Angiogenesis and Arteriogenesis In all vertebrate species, blood vessels form during embryogenesis in successive steps called vasculogenesis and angiogenesis, which are then followed by remodeling and maturation of the initial vascular plexus into adult vasculature. The term vasculogenesis describes the de novo specification (...) article State-of-the-Art Methods for Evaluation of Angiogenesis and Tissue Vascularization A Scientific Statement From the American Heart Association , MD , MD, PhD , MD , MD , CRE , MD, PhD, FAHA , PhD , MD, PhD , PhD, FAHA , MD , MD, PhD , PhD , PhD , PhD , MD, FAHA , PhD , and MD, FAHA MDon behalf of the American Heart Association Council on Basic Cardiovascular Sciences and Council on Cardiovascular Surgery and Anesthesia Michael Simons , Kari Alitalo , Brian H. Annex , Hellmut G. Augustin , Craig

2015 American Heart Association

298. Clinical Guidelines and Standardization of Practice to Improve Outcomes

. JAMA 1999;282:1458–65. [ ] [ ] Clark SL, Nageotte MP, Garite TJ, Freeman RK, Miller DA, Simpson KR, et al. Intrapartum management of category II fetal heart rate tracings: towards standardization of care. Am J Obstet Gynecol 2013;209:89–97. [ ] [ ] American College of Obstetricians and Gynecologists. Quality and safety in women’s health care. 2nd ed. Washington, DC: American College of Obstetricians and Gynecologists; 2010. Clark SL, Meyers JA, Frye DK, Perlin JA. Patient safety in obstetrics (...) A. The promises and pitfalls of evidence-based medicine. Health Aff 2005;24:18–28. [ ] [ ] Priori SG, Klein W, Bassant JP. Medical practice guidelines: separating science from economics. ESC Committee for Practice Guidelines 2002–2004; ESC Committee for Practice Guidelines 2000–2002; European Society of Cardiology 2002–2004. Eur Heart J 2003;24:1962–4. [ ] [ ] Brown GC, Brown MM, Sharma S. Health care in the 21st century: evidence-based medicine, patient preference-based quality, and cost effectiveness. Qual

2015 American College of Obstetricians and Gynecologists

299. The Apgar Score

(5). When a Category I (normal) or Category II (indeterminate) fetal heart rate tracing is associated with Apgar scores of 7 or higher at 5 minutes, a normal umbilical cord arterial blood pH (± 1 standard deviation), or both, it is not consistent with an acute hypoxic–ischemic event (6). Prediction of Outcome A 1-minute Apgar score of 0–3 does not predict any individual infant’s outcome. A 5-minute Apgar score of 0–3 correlates with neonatal mortality in large populations ( , ), but does (...) of resuscitation all can be recorded in the comments box. The Apgar score alone cannot be considered to be evidence of or a consequence of asphyxia. Many other factors, including nonreassuring fetal heart rate monitoring patterns and abnormalities in umbilical arterial blood gases, clinical cerebral function, neuroimaging studies, neonatal electroencephalography, placental pathology, hematologic studies, and multisystem organ dysfunction need to be considered in diagnosing an intrapartum hypoxic–ischemic event

2015 American College of Obstetricians and Gynecologists

300. Supraventricular Tachycardia: Guideline For the Management of Adult Patients With

ACCP 2012 (17) Atrial ?brillation ESC 2012 (18) 2010 (19) Device-based therapy ACC/AHA/HRS 2012 (20) Atrial ?brillation CCS 2014 (21) 2011 (22) Hypertrophic cardiomyopathy ACC/AHA 2011 (23) Secondary prevention and risk reduction therapy for patients with coronary and other atherosclerotic vascular disease AHA/ACC 2011 (24) Adult congenital heart disease ACC/AHA 2008 (25)* Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC (...) Supraventricular Tachycardia: Guideline For the Management of Adult Patients With CLINICAL PRACTICE GUIDELINE 2015 ACC/AHA/HRS Guideline for the Management of Adult Patients With Supraventricular Tachycardia A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society Writing Committee Members* Richard L. Page, MD, FACC, FAHA, FHRS, Chair José A. Joglar, MD, FACC, FAHA, FHRS, Vice Chair Mary A. Caldwell, RN

2015 American College of Cardiology

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