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04:45 EDT 16th June 2019 | BioPortfolio

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Showing "Pfizer Fragmin approved paediatric patients" PubMed Articles 1–25 of 35,000+

Paediatric Extrapolation: A Necessary Paradigm Shift.

Legislative initiatives have been successful in increasing the availability of approved therapies for paediatric patients. However, additional measures to ensure the timely completion of paediatric studies are necessary to further increase the number of medicines available to children. Over the last three years, international experts convened to revise the ICH E11 guideline on clinical investigations of medicinal products in paediatric populations to harmonise approaches to paediatric extrapolation, strivin...

Paediatric Meningiomas In South Western Nigeria: A Single Institutional Experience.

Meningiomas are the second commonest intracranial tumours in many places worldwide. It is however rare in the paediatric age group and most studies have been able to document only a few patients. Meningiomas in paediatric patients have also being shown to behave differently to those in the adult population. This study was done to examine histological types of meningiomas seen in paediatric patients from a predominantly African population using the 2016 WHO grading system for intracranial tumours.

Blood Purification for Paediatric Patients.

Recent technical and experimental advances in extracorporeal blood purification therapy (eBPT) can be applied in paediatric patients, including neonates. However, there are several specific issues in performing eBPT in paediatric patients in regard to the safety and effectiveness of treatments. The aim of this review is to explore the technical aspects of acute paediatric eBPT, especially regarding renal replacement therapy and the present situation in Japan.

A review of population pharmacokinetic models of gentamicin in paediatric patients.

Gentamicin is often used for the treatment of Gram-negative infections. Due to pharmacokinetic variability in paediatric patients, appropriate dosing of gentamicin in the paediatric population is challenging. This article reviews published population pharmacokinetic models of gentamicin in paediatric patients, identifies covariates that significantly influence gentamicin pharmacokinetics, and determines whether there is a consensus on proposed dosing for intravenous gentamicin in this population.

Case Series of 331 doses of Sugammadex compared to Neostigmine in patients under 2 years old.

Sugammadex is a novel neuromuscular blockade reversal agent approved by the Food and Drug Administration in 2015, but little literature exists for patients less than 2 years old.

Activity of ceftolozane-tazobactam and comparators when tested against Gram-negative isolates collected from paediatric patients in the United States and Europe during 2012-2016 as part of a global surveillance programme.

Ceftolozane-tazobactam (C-T) is a combination of an antipseudomonal cephalosporin and a β-lactamase inhibitor. C-T was approved by the US Food and Drug Administration in 2014 and by the European Medicine Agency in 2015 for use in adults to treat complicated urinary tract infections, acute pyelonephritis, and complicated intra-abdominal infections with metronidazole. Studies for paediatric indications are planned. The Programme to Assess Ceftolozane-tazobactam Susceptibility monitors C-T resistance to Gram...

How often do SmPCs Contain Contraindications and Special Warnings that are Specific for the Paediatric Population.

3.2-3.8% of all medicine prescriptions for minor outpatients are off-label only because of the patients' age group. The younger, the more patients are affected by this issue. Only one fifth of the most commonly used medicines for newborns are licensed for this age group. The aim of this study is to analyse all German SmPCs whether they contain contraindications and warnings that specifically concern paediatric patients.

European paediatric non-alcoholic fatty liver disease registry (EU-PNAFLD): Design and rationale.

Non-alcoholic fatty liver disease (NAFLD) is the most common liver disorder in children and has the potential to progress to advanced fibrosis/cirrhosis, end-stage liver disease and hepatocellular carcinoma. However, the natural history of the condition is poorly understood and there are no approved treatments. The European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNAFLD) is a multi-centre registry of paediatric NAFLD that will serve as a prospective, observational, natural history study an...

Pegaspargase: A Review in Acute Lymphoblastic Leukaemia.

Pegaspargase (Oncaspar), a pegylated form of native Escherichia coli-derived L-asparaginase (hereafter referred as E. coliL-asparaginase), is indicated in the USA and EU for the treatment of acute lymphoblastic leukaemia (ALL) as a component of multi-agent chemotherapy in paediatric and adult patients. Relative to E. coliL-asparaginase, pegaspargase has a prolonged circulation time, thereby offering less frequent administration. Moreover, pegylation of E. coliL-asparaginase may diminish the immunogenicity o...

Valuing height: diagnosis, valuation and the case of idiopathic short stature.

This paper proposes a 'valuographic' approach to diagnosis, exploring how values and valuation practices are implicated in the contested diagnostic category of idiopathic short stature (ISS). ISS describes children who are 'abnormally' short but do not have any other detectable pathology. In the USA growth-promoting hormone therapy has been approved for ISS children, since 2003. However, no other jurisdiction has approved this treatment and the value of ISS as a diagnostic category remains disputed among he...

Opportunistic immunising in the paediatric emergency department: Are patients due vaccines?

The aim of this study was to identify if patients presenting to a paediatric emergency department were due National Immunisation Program recommended vaccines in order to determine missed opportunities for vaccination or vaccination referral.

Otological surgery in paediatric photosensitive patients.

There are a wide range of genetic and auto-immune conditions where UV light exposure poses a threat of UV irradiation to the external auditory canal, tympanic membrane and surrounding skin. Preoperative Ultraviolet Light (UV) measurements were taken in the operating theatre with standard operating microscope and an approved UV light meter prior to surgery on a patient with xeroderma pigmentosa. UV light meter readings of UV index 75 were taken at an operating distance of 290mm. Proceeding with otological su...

Nosocomial Infection by Human Bocavirus and Human Rhinovirus among Paediatric Patients with Respiratory Risks.

Nosocomial infections by respiratory viruses undetected by rapid tests are not often diagnosed. For paediatric patients with background diseases, nosocomial infection could be fatal.

Potential prediction of formulation performance in paediatric patients using biopharmaceutical tools and simulation of clinically relevant administration scenarios of nifedipine and lorazepam.

This study explores the impact of paediatric patient related factors and choice of formulation on the dissolution characteristics of nifedipine and lorazepam, two drug substances regularly applied in very young patients and in compounded formulations.

Larotrectinib: First Global Approval.

Larotrectinib (VITRAKVI) is an orally administered, small molecule, highly-selective, tropomyosin receptor kinase (TRK) inhibitor that was developed by Loxo Oncology in collaboration with Bayer AG as a treatment for adult and paediatric patients whose cancers harbour neurotrophic receptor tyrosine kinase (NTRK) gene fusions. In November 2018 larotrectinib received its first global approval in the USA for the treatment of adult and paediatric patients with solid tumours that have a NTRK gene fusion without a...

Thiol-disulphide homeostasis is an oxidative stress indicator in critically ill children with sepsis.

The aim of this study is to evaluate a novel oxidative stress marker (thiol-disulphide homeostasis) in paediatric sepsis and to determine their effects on the prognosis of sepsis. Patients diagnosed with sepsis (n= 38) and healthy controls (n= 40) were incorporated in the study. Total thiol, native thiol, disulphide, disulphide/total thiol, disulphide/native thiol, and native thiol /total thiol levels were measured in the sepsis and control groups. Additionally, the parameters were compared between survivor...

Evaluation of website information provided by paediatric surgery centres in Australia and New Zealand.

Hospital websites are an important source of information for patients, parents and healthcare providers. There are currently no standardized recommendations for the information provided on paediatric surgery websites. We aimed to assess the information available on each hospital website, in Australia and New Zealand, which provides paediatric surgical care.

Volume effect in paediatric brain tumour resection surgery: analysis of data from the Japanese national inpatient database.

Paediatric brain tumours are the second most common type of malignancies that occur during childhood. Surgical resection is usually the first step in the treatment of these patients; however, evidence pertaining to a 'volume effect' in paediatric brain tumour resection surgery and the associations among the surgical volume, clinical features and treatments are not well characterised.

Paediatric acute care: Highlights from the Paediatric Acute Care-Advanced Paediatric Life Support Conference, Hobart, 2018.

The Paediatric Acute Care Conference (PACC) is an annual conference organised by APLS Australia to advance paediatric acute care topics for clinicians in pre-hospital medicine, EDs, acute paediatrics, intensive care and anaesthesia. The PACC 2018 was held in Hobart, Tasmania. We provide a summary of some of the presentations.

Efficacy and Safety of Imatinib in Paediatric CML - A Single Centre Study.

Chronic myeloid leukaemia (CML) rarely affects the paediatric population and has an incidence of 0.06-0.12/100,000 children per year. The dire clinical course of paediatric CML is further exacerbated by the adverse effects of long-term imatinib therapy.

Systematic Analysis of the Impact of Diagnostic Delay on Bowel Damage in Paediatric Versus Adult Onset Crohn's Disease.

Length of diagnostic delay is associated with bowel strictures and intestinal surgery in adult patients with Crohn's disease [CD]. Here we assessed whether diagnostic delay similarly impacts on the natural history of paediatric CD patients.

Effects of a surfactant-based gel on acute and chronic paediatric wounds: a panel discussion and case series.

On 20 November 2018, following the International Society for Paediatric Wound Care conference, a closed panel meeting took place in which the use of a surfactant-based gel (PluroGel (PMM), Medline Industries, Illinois, US) in paediatric wound care was discussed. The authors shared their experiences, thoughts, experimental data and clinical results. The panel identified the need for a product that can gently cleanse paediatric wounds and remove devitalised tissue without causing discomfort or skin reactions,...

Clinical features and outcomes of young patients with epithelioid sarcoma: an analysis from the Children's Oncology Group and the European paediatric soft tissue Sarcoma Study Group prospective clinical trials.

Data on the clinical features, optimal treatment and outcomes of paediatric patients with epithelioid sarcoma (ES) are limited and mostly retrospective.

A modified reconstructive technique for paediatric congenital alar rim deformity.

Alar subunit retraction or notching whether acquired or congenital, can be challenging to reconstruct. Congenital cysts and benign lumps involving the nasal alar region can also result in acquired alar deformity once resected. Published reports describe different surgical methods, but we demonstrate a simple and highly satisfying technique. We present four paediatric cases with alar rim defects and demonstrate our modified surgical technique. All patients had an unremarkable recovery. Our outcomes demonstra...

Tolerability of Isoniazid Preventive Therapy in an HIV-Infected Cohort of Paediatric and Adolescent Patients on Antiretroviral Therapy from a Resource-Limited Setting: A Retrospective Cohort Study.

Treating patients with latent tuberculosis infection (LTBI) to prevent development of active disease is an essential strategy for eliminating TB. There are concerns regarding the use of isoniazid due to the potential for hepatotoxicity. This study was conducted to determine the incidence of adverse hepatic events after isoniazid preventive therapy (IPT) commencement in a cohort of HIV-infected paediatric and adolescent patients on antiretroviral therapy (ART).

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