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Pruritus in Pregnancy

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163. 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

164. 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

165. 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

166. 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

167. 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

171. 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

172. 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

175. Varicella Zoster Virus glycoprotein E antigen (Shingrix) - Herpes Zoster

70 years having a four times increased risk of PHN than those younger than 60 years. Besides increase in age, immunosuppression from any cause, including hematologic malignancies, HIV and immunosuppressive medications, is an important risk factor for herpes zoster, increasing the risk of HZ by at least 10-fold. An increased risk of HZ has been reported in infants whose mothers had had varicella in pregnancy. Prompt antiviral therapy, if available, is recommended for herpes zoster in healthy (...) immunodeficiency viruses; those receiving immunosuppressive therapy, including high-dose corticosteroids; or those who are or may be pregnant. Unmet medical need Shingrix was developed to address the medical need to prevent HZ and HZ-related complications such as post-herpetic neuralgia (PHN) in older adults (=50 YOA) and to address the unmet medical need to prevent HZ and HZ complications in IC adults =18 YOA. The term HZ/su indicates the herpes zoster subunit candidate vaccine (50 µg gE/AS01 B) during

2018 European Medicines Agency - EPARs

176. Sexually Transmitted Infections in primary care consultations: development of an online tool to guide healthcare practitioners

anatomical site? Which diagnostic tests are to be performed for a pre-defined risk group? Population Included: Symptomatic or asymptomatic sexually active men and women (pregnant and non-pregnant), including adolescents Excluded: Children aged 2/multiple partners past 12/6 months (including swingers) 3, 8, 18, 19 • Inconsistent condom use 3, 17 • STI 1 year), including HIV positive patients: • First choice: BPG 2.4 million units IM weekly for 3 consecutive weeks (day 1, day 8 and day 15) • Second choice (...) : Doxycycline 100 mg orally twice daily for 28 days (be aware of photosensitisation) Pregnant women Referral to 2 nd line for treatment and follow-up In case of penicillin allergy • When in doubt, first assess the risk of anaphylaxis. If patients have a history compatible with an IgE mediated allergy then alternative therapies (such as doxycycline) should be used. • Patients should also be referred for skin testing to confirm allergy and for consideration of penicillin desensitisation. Table 12 – Hepatitis

2019 Belgian Health Care Knowledge Centre

177. Care around stillbirth and neonatal death

in Queensland, Australia: A population-based study. Aust N Z J Obstet Gynaecol 2017; 57(1): 33-9. 4. Kerber K, Mathai M, Lewis G, et al. Counting every stillbirth and neonatal death through mortality audit to improve quality of care for every pregnant woman and her baby. BMC Pregnancy and Childbirth 2015; 15 (Suppl 2). 5. Perinatal and Maternal Mortality Review Committee. Tenth annual report of the Perinatal and Maternal Mortality Review Committee: Reporting mortality: Reporting mortality 2014. Wellington (...) investigated or classified in terms of their cause, with around 50% at term classified as “unexplained” 3 . The lack of a diagnosis adds to parents’ distress, as they struggle to understand “what went wrong” and “will it happen again” in a subsequent pregnancy. In 20-30% of stillbirths, deficiencies in the quality of care are implicated. National perinatal mortality audit programs can help to reduce these deaths 4,5 . This update of the guideline has been undertaken through a partnership between PSANZ

2019 Centre of Research Excellence in Stillbirth

178. British Association for Sexual Health and HIV national guideline for the management of vulvovaginal candidiasis

regimen (recurrent VVC in pregnancy): • Induction: topical imidazole therapy can be increased to 10-14 days according to symptomatic response (Grade 2C) • Maintenance: Clotrimazole pessary 500mg intravaginally weekly (1C) Recommended regimens (acute and recurrent VVC in breastfeeding): • Treatment regimens using topical imidazoles should be as per the recommendations listed above for non-pregnant women with acute and recurrent VVC. General considerations: • Asymptomatic colonisation with Candida (...) in 4 pregnant women was significantly associated with shorter anogenital distance suggesting a potential anti-androgenic effect. 117 • It is important to note that exposure to standard dose fluconazole at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional foetal monitoring. 118 VVC and pregnancy outcome: • Previous studies did not find evidence of an association between Candida colonisation and premature delivery or low birth

2019 British Association for Sexual Health and HIV

179. Perioperative Anaphylaxis Management Guidelines

and I.V. fluids. The adrenaline should be continued when these agents are added. 3.7 High airway pressure is less likely to be the predominant feature of anaphylaxis. Alternative treatments for resistant bronchospasm may be used where clinically appropriate. Alternative causes of high airway pressure such as airway device or circuit malfunction and tension pneumothorax should be sought and eliminated as the cause. 3.8 Management of perioperative anaphylaxis in the pregnant patient includes manual left (...) uterine displacement to minimise aortocaval compression. It may also require a perimortem caesarean delivery in order to facilitate resuscitation of the mother. 4. POST CRISIS MANAGEMENT – See card 6 4.1 Steroids have been of benefit in the management of other allergic diseases and they are recommended as part of secondary management. They may be useful in cases where there is a protracted reaction. 4.2 Antihistamines are useful for the symptomatic treatment of urticaria, angioedema and pruritus. 4.3

2019 Australian and New Zealand College of Anaesthetists

180. Management of Atopic Eczema

). Prevalence of schizophrenia and affective disorders are also higher in AE compared with control (1.2% vs 0.5% and 7.7% vs 4.5% respectively). 23, level II-2 Prevalence of AE is increased with exposure to active and passive smoking. However, it is not associated with maternal smoking during pregnancy. 24, level II-2 • Co-morbidities e.g. skin infection, atopic disease, food allergy, cardiovascular disease, psychological and psychosocial dysfunction may co-exist in AE.7 Management of Atopic Eczema 5 (...) . AGGRAVATING/TRIGGERING FACTORS There are many potential aggravating factors which can worsen flares in AE, either independently or in combination. Potential aggravating/ triggering factors include the following: • aeroallergen • physical irritants • environmental factors • food • microbial colonisation/infection • patient factors (e.g. pregnancy) 5.1 Aeroallergen House dust worsens itch in AE. 25, level III Severity of skin symptoms is associated with indoor house dust mites levels (p 50% deteriorate

2019 Ministry of Health, Malaysia

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