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Pruritus in Pregnancy

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161. Transfusion reaction

), and transfusion-related acute lung injury (TRALI). Delayed immune-mediated transfusion reactions occur within days to weeks of transfusion and include delayed haemolytic transfusion reaction, graft-versus-host disease, and post-transfusion purpura. History and exam presence of risk factors chills flushing dyspnoea fever chest, abdominal, flank, and back pain hypotension bleeding from mucous membranes, GI tract, or urinary tract headache nausea and vomiting anxiety pain along the infused extremity pruritus (...) urticaria angio-oedema jaundice rales red urine stridor or bronchospasm pallor maculopapular rash diarrhoea disseminated purpura exfoliative dermatitis with mucocutaneous involvement prior pregnancy previous transfusion hx of transplantation IgA deficiency immunocompromise hx of transfusion reaction Diagnostic investigations direct antiglobulin test visual inspection of post-transfusion blood sample repeat ABO testing on post-transfusion blood sample post-transfusion urinalysis serum IgA levels anti-IgA

2018 BMJ Best Practice

162. Acute varicella-zoster

. Varicella-zoster virus (VZV) is an exclusively human virus. The incubation period is about 14 days (range 9 to 21 days). Varicella is characterised by fever, malaise, and a generalised pruritic, vesicular rash. The disease normally presents in childhood and is usually self-limiting. Adverse outcomes are more common in immunocompromised people, adolescents, adults, and pregnant women. History and exam presence of risk factors fever vesicular rash vesicles on mucous membranes pruritus headache fatigue (...) Acute varicella-zoster Acute varicella-zoster - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  Acute varicella-zoster Last reviewed: February 2019 Last updated: March 2019 Summary Adults, pregnant women, immunosuppressed patients, and neonates are at high risk of complications, including pneumonia, neurological sequelae, hepatitis, secondary bacterial infection, and death. Patients in high-risk categories should

2018 BMJ Best Practice

163. Gonorrhoea infection

for uncomplicated gonorrhoea is dual therapy with single-dose intramuscular ceftriaxone plus single-dose oral azithromycin. The treatment of N gonorrhoeae is important in the prevention of infertility, chronic pelvic pain, and ectopic pregnancy in women. If acquired congenitally from an infected mother, the neonate can present with ophthalmia neonatorum, which left untreated can cause blindness. Definition Neisseria gonorrhoeae is a gram-negative diplococcus bacterium that is closely related to other human (...) pelvic pain in women tenderness and/or swelling of the epididymis mucopurulent or purulent exudate at the endocervix urethral irritation in men dysuria in men tenderness and/or swelling of testis tenderness and/or swelling of prostate anal pruritus mucopurulent discharge from the rectum rectal pain tenesmus rectal bleeding vaginal discharge cervical friability uterine, adnexal, or cervical motion tenderness uterine mass anterior cervical lymphadenopathy conjunctivitis fever skin lesions (papules

2018 BMJ Best Practice

164. Vaginitis

include discharge, pruritus, and dyspareunia. It is recommended to screen for sexually transmitted infections (STIs; also known as sexually transmitted diseases [STDs]) in all patients with infective vaginitis. Sexual partners of patients with Trichomonas vaginalis should be treated and offered screening for other STIs. Definition Vaginitis is inflammation of the vagina due to changes in the composition of the vaginal micro-environment from infection, irritants, or from hormonal deficiency (e.g (...) ., atrophic vaginitis). Bacterial vaginosis, trichomoniasis, and candidiasis are types of infections that cause vaginitis. History and exam presence of risk factors vaginal discharge dysuria discharge adherent to vaginal mucosa prior episodes pruritus vulvodynia vaginal dryness dyspareunia erythema pale epithelium shiny epithelium decreased elasticity friable epithelium fever vaginal bleeding abdominal pain strawberry cervix douching poor or excessive hygiene antibiotic use change in feminine hygiene

2018 BMJ Best Practice

165. Acute cystitis

suprapubic pain prior history of urinary tract infections (UTIs) and treatment history recent urinary tract instrumentation flank pain abdominal pain fever vaginal discharge vaginal pruritus dyspareunia structurally or functionally abnormal bladder frequent sexual intercourse history of urinary tract infection (UTI) congenital abnormality spermicidal jelly urinary catheter asymptomatic bacteriuria diabetes spinal cord injuries pregnancy immunodeficiency older age lack of circumcision age <15 years (...) of trimethoprim/sulfamethoxazole or trimethoprim, or 5 days of nitrofurantoin. For complicated cases of cystitis, first line is empirical therapy with a fluoroquinolone antibiotic for 7 to 14 days; treatment should be adjusted based on the results of the urine culture. Complicating characteristics include pregnancy; recent instrumentation, including catheterisation or indwelling catheter; male patient; diabetes, immunosuppression; structurally or functionally abnormal urinary bladder; history of recurrent

2018 BMJ Best Practice

166. Haemorrhoids

protrude outside the anal canal causing symptoms. [Figure caption and citation for the preceding image starts]: Rubber band on redundant haemorrhoidal tissue Kurt G. Davis, MD [Citation ends]. [Figure caption and citation for the preceding image starts]: Bands placed above the dentate line Kurt G. Davis, MD [Citation ends]. History and exam presence of risk factors rectal bleeding perianal pain/discomfort anal pruritus tender palpable perianal lesion anal mass age between 45 and 65 years constipation (...) pregnancy or space-occupying pelvic lesion hepatic insufficiency ascites Diagnostic investigations anoscopic examination colonoscopy/flexible sigmoidoscopy FBC stool for occult haem Treatment algorithm ACUTE ONGOING Contributors Authors Senior Lecturer and Consultant in Colorectal Surgery National Bowel Research Centre (NBRC) Blizard Institute Barts and The London School of Medicine & Dentistry Queen Mary University of London London UK Disclosures MAT held a clinical research training fellowship (2000

2018 BMJ Best Practice

167. Vestronidase alfa (Mepsevii) - Mucopolysaccharidosis VII

(47.8%), vomiting (47.8%), upper respiratory tract infection (43.5%), infusion site extravasation (34.8%), rash (30.4%), diarrhoea (30.4%) and pyrexia (30.4%). The most common adverse reactions from 4 clinical trials in patients treated with Mepsevii were anaphylactoid reaction (13%), urticaria (13%), infusion site swelling (13%), infusion site extravasation (8.7%), pruritus (8.7%), diarrhoea (8.7%) and rash (8.7%). Serious adverse event/deaths/other significant events No deaths were reported in any

2018 European Medicines Agency - EPARs

168. Headache

) strengthens measures to avoid use of valproate medicines in pregnancy In March 2018, the EMA announced stronger measures aimed at avoiding the exposure of babies to valproate medicines (...) migraine the reduction was either 1.3 or 1.8 days, depending on the dose taken. The most common side effects were injection site reactions, constipation, muscle spasms and pruritus. The Food and Drug Administration in the US approved erenumab in May 2018 for the preventive treatment of migraine in adults. Summary (...) Medicines Agency (EMA) strengthens measures to avoid use of valproate medicines in pregnancy In March 2018, the EMA announced stronger measures aimed at avoiding the exposure of babies to valproate (...) not getting through to women, despite earlier steps aimed at ensuring this. Summary Migraine has a high prevalence in children (10%) and is a significant source of morbidity. Careful consideration of the broad differential diagnosis is important when evaluating a child with headache . The expectations

2018 Trip Latest and Greatest

171. Nitisinone (Nityr) - Tyrosinemias

(Reference Product: 5 AEs; Test Product 1: 1 AE; Test Product 2: 3 AEs). The adverse events were mild in intensity. There was no clinically significant and/or consistent drug-related change in vital signs, physical findings or safety laboratory values after administration of a total dose of 10 mg nitisinone per treatment period. Generally the safety data is in line with that of the reference product although an extra patient experienced pruritus with test product 2 versus Test product 1 or reference (...) , Date for submission of interim or final reports (planned or actual) Post-approval surveillance study (PASS)/ Nitisinone Tablets for Hereditary Tyrosinemia type 1 (HT-1) in Canada Category 3 To evaluate the long-term safety of Nitisinone tablets in the treatment of HT-1 and monitor its safety profile during pregnancy Long-term safety of Nitisinone tablets and to monitor its safety profile during pregnancy. Planned Planned Interim update (if the study is started) to be included in ASR to Health

2018 European Medicines Agency - EPARs

172. Erenumab (Aimovig) - Migraine

related to immune function, primarily infections in the future PSURs. An enhanced pre- postnatal development study was performed in cynomolgus monkey. It was agreed that this study did not identify any concerns for use during pregnancy. However, CGRP may be of importance to regulate uterine vascular resistance during pregnancy. There is a theoretical risk that CGRP inhibition may be a risk in pregnant women with risk factors for eclampsia. Based on such theoretical concerns, and also a more general (...) been observed in both plasma and tumors from specific cancers. The functional significance of the CGRP receptor and the ligand is unclear. However, any role for CGRP would likely be pro-carcinogenic and functional inhibition of CGRP would not be associated with carcinogenic risk. Reproduction Toxicity An enhanced pre- postnatal development study was performed in cynomolgus monkey. There were no AMG 334-related effects on pregnancy/postpartum outcomes. For foetuses that were aborted or stillborn

2018 European Medicines Agency - EPARs

173. Oxycodone

for post-caesarean section analgesia: A randomised controlled trial. 187-93 10.4103/0019-5049.177877 Epidural morphine after caesarean section may cause moderate to severe pruritus in women. Epidural (...) oxycodone has been shown in non-obstetric trials to reduce pruritus when compared to morphine. We hypothesised that epidural oxycodone may reduce pruritus after caesarean section. A randomised controlled trial was conducted in pregnant women at term who underwent caesarean section with combined (...) section and to compare the incidence and severity of pruritus. Secondary objectives are to compare other side effects of epidural administered oxycodone and morphine (nausea 2014 11. RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone , Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder. RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies

2018 Trip Latest and Greatest

174. Caplacizumab (Cablivi) - thrombotic thrombocytopenic purpura (aTTP)

as similarly described for other proteins and attributed to accumulation of iodine. When a complex of 125 I-caplacizumab and human vWF was injected into the mice, the majority of radioactivity was found in the liver and in blood with minor amounts in the kidney. The results suggest that vWF- bound caplacizumab targets the liver. In contrast, unbound caplacizumab appeared to distribute to the kidneys. In pregnant guinea pigs, exposure to traces of caplacizumab in foetuses was demonstrated Assessment Report (...) ). In addition, skeletal examination (according to DAWSON) revealed no treatment related malformations, variations or retardations. The embryo-foetal toxicity study in guinea pigs showed that high and relevant maternal exposure leading to some PD response did not lead to maternal toxicity beyond some bleeding events or defects in placenta function. The placental transfer study with caplacizumab in pregnant guinea pigs qualitatively demonstrated foetal exposure to caplacizumab but exact concentrations could

2018 European Medicines Agency - EPARs

175. Ciclosporin (Verkazia) - Conjunctivitis, Keratitis

conjunctivitis, infectious conjunctivitis or ocular rosacea in children. Clinically, VKC is characterised by both conjunctival (hyperaemia, oedema, discharge) and corneal signs (superficial keratitis, corneal ulcerations, plaques, scars). Patients have a characteristic ropey, stringy mucous and/or serous discharge. Typical symptoms include photophobia, burning, pruritus, and blepharospasm. Intense ocular itching, followed by tearing and ropey, stringy mucous and/or serous discharge, and foreign body (...) in pregnant or breast-feeding women were available with either oral CsA or ophthalmic dosage forms, however Ryffel (1983) reported no teratogenic effects of CsA in rats and rabbits up to maternal toxic doses of 30mg/kg, but there was some evidence for reproductive toxicity at high (>maternal toxic) doses, at which foetal death and growth retardation of the off-spring occurred. Local tolerance Local tolerance was investigated in four 28-day studies in rabbits with instillations in the eyes four times a day

2018 European Medicines Agency - EPARs

179. Efavirenz/Emtricitabine/Tenofovir disoproxil - HIV

. •Statement that malformations have been observed in foetuses from efavirenz-treated monkeys. •Statement that a moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) indicates oo malformations or foetaJJneonatal toxicity associated with emtricitabine and tenofovir disoproxil. Prominent wording io Efavirenz/Emtricitabine/Tenofovir disoproxil PIL: •Warning that women should not get pregnant during treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil and for 12 weeks (...) sometimes characterized by a fulminant course has been reported post-marketing in patients with no pre-existing hepatic disease or other identifiable risk factors. • The following hepatobiliary disorders: ADRs are listed in the tabulated summary of adverse reactions for the efavirenz component: hepatitis acute, hepatic failure. None proposed Neural tube developmental Content in SmPC: None Assessment report EMA/846772/2017 Page 28/38 abnormalities Section 4.6 in SmPC: •Advisory statement that pregnancy

2018 European Medicines Agency - EPARs

180. Emicizumab (Hemlibra) - Hemophilia A

(ISRs) were reported very commonly from clinical trials. All ISRs observed in the Hemlibra clinical trials were reported as being non serious and generally mild to moderate in intensity. Most ISRs resolved without treatment. The most commonly reported ISR symptoms were injection site erythema (7.4 %), injection site pruritus (5.3%) and injection site pain (5.3%) (SmPC section 4.8). Safety data below patients age 1 are not available. In order to address the question to which extent the quantitatively

2018 European Medicines Agency - EPARs

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