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in a guideline does not imply coverage. A decision to adopt any particular recommendation must be made by the provider in light of the circumstances presented by the individual patient. 2 Summary of Changes as of October 2016 Added recommendations for screening and intervention for PREGNANT WOMEN: • Abstinence is recommended for pregnant women and for women planning pregnancy. • Pregnant women should be screened with the AUDIT-C at least once per trimester and at the 6- week postpartum visit. o The timeframe (...) for the questions should be the last 3 months rather than the last year. o The threshold for “binge drinking” in the third question is 4 or more drinks on one occasion. • Pregnant women should be screened for alcohol use disorder (AUD) using the Alcohol Symptom Checklist if: o They score a 3 or greater on the AUDIT-C, or o They are currently drinking at any level since learning of their pregnancy, regardless of their AUDIT-C score. • Pregnant women who are negative for AUD should receive brief behavioral
Pemphigoid gestationis and intravenous immunoglobulin therapy Pemphigoid gestationis, which is also known as herpes gestationis, is a rare, pregnancy-associated, autoimmune bullous disease. Treatment depends on the severity of the disease for each patient and the safety and use of these drugs during pregnancy and breastfeeding must be taken into consideration to guide their use. We describe the therapeutic response of two cases of pemphigoid gestationis that did not respond to conventional (...) immunosuppressive therapy or adverse effects limited their use. Both patients eventually received treatment with intravenous immunoglobulin therapy, which resulted in clinical remission. This clinical improvement with disappearance of lesions and a reduction in pruritus was paralleled in a decline in Bullous Pemphigoid Disease Activity Index activity scores, which is a validated scoring system to measure the related condition, bullous pemphigoid.
Phenotypic spectrum and diagnostic pitfalls of ABCB4 deficiency depending on age of onset Genetic variants in the adenosine triphosphate-binding cassette subfamily B member 4 (ABCB4) gene, which encodes hepatocanalicular phosphatidylcholine floppase, can lead to different phenotypes, such as progressive familial intrahepatic cholestasis (PFIC) type 3, low phospholipid-associated cholelithiasis, and intrahepatic cholestasis of pregnancy. The aim of this multicenter project was to collect (...) ) or adult age (≥18 years). All 26 patients diagnosed in childhood presented with pruritus (median age 1 year). Hepatomegaly and splenomegaly were present in 85% and 96% of these patients, respectively, followed by jaundice (62%) and portal hypertension (69%). Initial symptoms preceded diagnosis by 1 year, and 13 patients received a liver transplant (median age 6.9 years). Of note, 9 patients were misdiagnosed as biliary atresia, Alagille syndrome, or PFIC type 1. In the 12 patients with diagnosis
-eclampsia/Eclampsia, Management: Green-top Guideline No 10A. London: RCOG, 2006. NICE CG. Hypertension in pregnancy: diagnosis and management. NICE, 2010. www.nice.org.uk/guidance/cg1 07 B-P11 Pregnant women – monitoring of thyrotoxicosis treatment (UK) In women taking anti-thyroid drugs, TFTs should be performed prior to conception, at time of diagnosis of pregnancy or at antenatal booking Newly diagnosed hyperthyroid patients require monthly testing during pregnancy until stabilised. Pregnant women (...) receiving anti- thyroid drugs should be tested frequently (perhaps monthly) Association for Clinical Biochemistry, British Thyroid Association and British Thyroid Foundation. UK guidelines for the use of thyroid function tests. London: ACB, BTA, 2006. B-P12 Pregnant women – monitoring thyrotoxicosis treatment (USA) It is recommended that women treated with anti-thyroid drugs in pregnancy, fT4 and TSH should be monitored approximately every 2–6 weeks Stagnaro-Green A, Abalovich M, Alexander E, Azizi F
~0.04 µM and decreased to 5 at a plasma concentration of 8.33 µM. In this species, the terminal plasma clearance described the terminal liver clearance with an elimination half-life of ~9 hours. Grazoprevir elimination from the dog liver was complete by ~72 hours. Placental Transfer in Rat and Rabbit Grazoprevir crosses the placenta of pregnant rats and rabbits. The foetal to maternal plasma concentration ratios range from 0.0138 to 0.894 in rat and 0.0128 to 0.0706 in rabbit. In Vitro Plasma (...) in pregnant rats and rabbits following 1000 mg/kg/day oral dosing from Gestation Day (GD) 6/7 to GD 20 with placental transfer evaluated on GD 20. Elbasvir Assessment report EMA/419807/2016 Page 32/151 crossed the placenta of both rats and rabbits with fetal plasma concentrations being 0.6 to 5% that of the maternal plasma. In Vitro Plasma Protein Binding and Blood-to-Plasma Concentration Ratio Elbasvir binding to plasma proteins was extensive. In mouse, rat, dog, monkey, and human the unbound fraction
2017 Background Obstetric cholestasis (OC) or intrahepatic cholestasis of pregnancy has been described as a multifactorial condition of pregnancy characterised by intense pruritus with the absence of a skin rash, with abnormal liver function tests, neither of which have an alternative cause and both of which resolve after birth(1). It is associated with a significantly increased risk of adverse perinatal outcomes, including stillbirth (2). The use of vitamin K as part of the management of OC (...) for the management of OC is a commonly asked question. In addition, there have been reports of neonatal toxicity following menadiol sodium diphosphate administration in late pregnancy or during delivery (4). Answer Menadiol sodium phosphate is a water-soluble synthetic vitamin K derivative that can be given orally for the prevention or treatment of vitamin K deficiency due to malabsorption, as it is absorbed without dependence on the presence of bile salts (3,4). Phytomenadione however, is the fat-soluble
with a patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results 10. Pregnant or breast feeding; females of child-bearing potential were required to test negative for pregnancy at the time of enrolment based on a urine or serum pregnancy test. Both male and female patients of reproductive potential were required to agree to use a reliable method of birth control, during the study and for 3 months following the last dose of study drug
pregnancy and in women of childbearing potential not using contraception and should not be used during breast-feeding. These warnings have been adequately highlighted in section 4.6 of the SmPC. Toxicokinetic data Study RX07.07 was GLP compliant toxicokinetic study. Five out of 48 measurements had non-zero plasma level at baseline and an unacceptably high PE concentration was observed at 24h. Local Tolerance The local tolerance of OMS302 was assessed in the single-dose toxicology study (Study RX07.07
administration does its concentration in peripheral blood approach these concentrations. Such situations are considered unlikely to persist due to the self-limiting toxicity of CA as evidenced by pruritus and diarrhoea as well as elevated serum bile acids, transaminases, and particularly GGT (Güldütuna et al. 1993; Gonzales et al. 2009). Precautions against chronic overdose have been specified in the SmPC (see section 4.8) and include regular monitoring of serum and urine bile acid levels as well as liver
to evaluate the carcinogenic potential of oritavancin. When administered intravenously at doses up to 30 mg/kg, oritavancin did not affect the fertility or reproductive performance of male and female rats. Studies in pregnant rats and rabbits do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. There was no evidence of transplacental transfer of oritavancin in pregnant rats. The exposure in rats at the NOAEL (...) contribute to the treatment difficulties [Bishop, 2006]. Current treatments approved for the treatment of ABSSSI include daptomycin, linezolid, tigecycline, ceftaroline and vancomycin. Vancomycin continues to be widely used to cover MRSA. These therapies consist of multi-dose and multi-day regimens with some requiring dosage adjustments for renal Assessment report EMA/183786/2015 Page 10/92 insufficiency (vancomycin), therapeutic monitoring (vancomycin), precautionary use in pregnant women (tigecycline