The findings from this large, international patient registry documented widespread implementation of pnfC1-INH self-administration outside of a health care setting consistent with current HAE guidelines. These real-world data revealed pnfC1-INH usage for a variety of reasons in patients with HAE and showed a high level of safety regardless of administration setting or reason for use.
Administration of pnfC1-INH during pregnancy was generally safe and not associated with any treatment-related AEs. In all registry pregnancies followed up to term, the birth of a healthy baby was reported.
1. The hydrolysis of di(2-ethylhexyl) terephthalate (DEHT) and di(2-ethylhexyl) phthalate (DEHP) were studied using rat gut homogenate fractions in vitro. Both isomers were hydrolysed by the intestinal fraction; however, DEHP was hydrolysed to 2-ethylhexanol (2-EH) and mono(2-ethylhexyl) phthalate (MEHP) in about equal proportions, whereas DEHT was hydrolysed to 2-EH and terephthalic acid (TPA). The half-lives for disappearance of the diesters were determined to be 12.6 min for DEHP and 53.3 min for DEHT. 2. The absorption and metabolism of DEHT were studied by administering [hexyl-2-14C]DEHT (in corn oil) by oral gavage at a dose level of 100 mg/kg to 10 adult male Sprague-Dawley rats. Urine, faeces and expired air were collected for 144 h and analysed for the presence of radioactivity, and faeces and urine were analysed for unlabelled metabolites. 3. Radioactivity was eliminated in faeces (56.5 +/- 12.1% of dose) primarily as unchanged DEHT, small amounts of MEHT and polar metabolites; excreted in urine (31.9 +/- 10.9% of dose) principally as MEHT and metabolic products of 2-EH; and expired as 14CO2 (3.6 +/- 0.9% of dose). Less than 2% of the administered radioactivity was found in the carcass. Small amounts of 14C were found in the tissues with the highest amounts found in liver and fat. 4. Metabolites identified in urine included terephthalic acid (equivalent to 51% of dose), oxidized metabolites of 2-EH and MEHT, and glucuronic and sulphuric acid conjugates (equivalent to about 10% of dose).(ABSTRACT TRUNCATED AT 250 WORDS)
resonance. The guidelines for magnetic resonance imaging in Britain laid down by the National Radiological Protection Board allow for studies during the second and third trimesters of pregnancy. Smith has reported his findings in 120 normal and abnormal pregnancies (Smith F W, presented at fourth annual meeting of Society of Magnetic Resonance in Medicine, 1985). After 26 weeks, gestation he found that the fetal head, brain, eyes, lungs, heart, liver, bladder, and limbs were routinely seen. In normal pregnancies uterine size correlated closely with birth weight. Myelination of the basal ganglia could be identified and followed from as early as 34 weeks. Studies of fetal subcutaneous fat thickness are readily carried out. Gross malformations such as hydrocephalus and hydronephrosis are easily recognised. Despite the current rather long imaging times compared with those of ultrasonic examination, these preliminary findings suggest that sufficiently good images are obtainable to allow fetal development to be studied without radiation hazard. In particular, the stage maturation of the central nervous system, liver size, and subcutaneous fat thickness allow better differentiation of the growth retarded fetus as opposed to the "genetically or physiologically" small fetus.
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