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Paediatric Drugs

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https://www.readbyqxmd.com/read/28900869/enabling-development-of-paediatric-medicines-in-europe-10-years-of-the-eu-paediatric-regulation
#1
Paolo A Tomasi, Gunter F Egger, Chrissi Pallidis, Agnes Saint-Raymond
The year 2017 marks the tenth anniversary of entry into force of the Paediatric Regulation in the European Union (EU). This law aimed to stimulate the development of paediatric medicines and provide more information on their use, as a response to the lack of evidence and approval of medicines for children. The European Medicines Agency (EMA) has had a central role in the implementation of the Regulation. Pharmaceutical companies need to submit a paediatric investigation plan (PIP) to the EMA's Paediatric Committee (PDCO) for every new medicine, unless an exemption (waiver) is granted...
September 12, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28895096/palivizumab-prophylaxis-against-respiratory-syncytial-virus-infection-in-children-with-immunocompromised-conditions-or-down-syndrome-a-multicenter-post-marketing-surveillance-in-japan
#2
Tomoko Kashiwagi, Yukiko Okada, Ken Nomoto
OBJECTIVE: The aim of this study was to assess the safety and effectiveness of palivizumab for the prevention of lower respiratory tract infection (LRI) caused by respiratory syncytial virus (RSV) in children with immunocompromised conditions or Down syndrome. METHODS: In this multicenter, post-marketing surveillance study (December 2013 to December 2015), children aged ≤24 months with immunocompromised conditions or Down syndrome (without hemodynamically significant congenital heart disease) receiving palivizumab immunoprophylaxis during two RSV seasons were observed until 30 days after the final palivizumab injection...
September 11, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28889403/do-paediatric-investigation-plans-pips-advance-paediatric-healthcare
#3
Klaus Rose, Philip D Walson
Since 2007, new drugs need a paediatric investigation plan (PIP) for EU registration. The PIPs' justifications can be traced back to concerns expressed by Shirkey that label warnings against paediatric use made children "therapeutic orphans", and the American Academy of Pediatrics' claim that all children differ considerably from adults. US legislation first encouraged, then also required, separate, adult-style safety and efficacy studies in all paediatric subpopulations. This triggered paediatric regulatory studies by the pharmaceutical industry...
September 9, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28861756/management-of-supraventricular-tachycardia-in-infants
#4
Chalese Richardson, Eric S Silver
Supraventricular tachycardia is the most common tachyarrhythmia encountered in infants. In older children and adults, definitive treatment of the supraventricular tachycardia substrate with catheter ablation is a common approach to management. However, in infants, the risks of catheter ablation are significantly higher, and the patients often outgrow the potential to experience episodes. Therefore, antiarrhythmic medications are often utilized to minimize the likelihood of experiencing episodes. This article reviews the common arrhythmia mechanisms encountered in infants and the medications used to treat these patients...
August 31, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28853040/state-of-the-art-management-of-acute-vaso-occlusive-pain-in-sickle-cell-disease
#5
REVIEW
Latika Puri, Kerri A Nottage, Jane S Hankins, Doralina L Anghelescu
Acute vaso-occlusive crisis (VOC) is a hallmark of sickle cell disease (SCD). Multiple complex pathophysiological processes can result in pain during a VOC. Despite significant improvements in the understanding and management of SCD, little progress has been made in the management of pain in SCD, although new treatments are being explored. Opioids and non-steroidal anti-inflammatory drugs (NSAIDs) remain the mainstay of treatment of VOC pain, but new classes of drugs are being tested to prevent and treat acute pain...
August 29, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28831753/pharmacological-management-of-restless-legs-syndrome-and-periodic-limb-movement-disorder-in-children
#6
Geoffrey Rulong, Thomas Dye, Narong Simakajornboon
Restless legs syndrome (RLS) and periodic limb movement disorder (PLMD) are under-recognized sleep disorders in children and adolescents. Several recent epidemiological studies have shown that RLS and PLMD are common in the pediatric population, and if left untreated, may lead to cardiovascular and neurocognitive consequences. Therefore, early diagnosis and intervention may help preventing long-term consequences. The management of RLS and PLMD in children involves both non-pharmacologic and pharmacologic approaches...
August 22, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28808948/tiotropium-bromide-in-children-and-adolescents-with-asthma
#7
Hengameh H Raissy, H William Kelly
Evidence is emerging on the use of long-acting muscarinic antagonists (LAMAs) in the management of asthma. Tiotropium bromide (Spiriva(®) Respimat(®)) is the only LAMA approved in children and adolescents. As the use of tiotropium becomes more common in clinical practice, it is necessary to review the existing data to identify patients who may benefit from the addition of this medication to their daily asthma regimen. This review discusses recent evidence on the safety and efficacy of tiotropium bromide in the management of asthma in children and adolescents...
August 14, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28808938/advances-in-vaccines-to-prevent-viral-respiratory-illnesses-in-children
#8
Aleisha J Anderson, Tom L Snelling, Hannah C Moore, Christopher C Blyth
Childhood vaccination has played a critical role in the reduction of morbidity and mortality from communicable diseases, including specific respiratory pathogens. Acute lower respiratory infection (ALRI) of both bacterial and viral aetiology continues to impact global child health. Key bacterial pathogens including Streptococcus pneumoniae and Haemophilus influenza type b are specifically targeted with current vaccination programmes, while at present there are less effective strategies for the prevention of viral disease...
August 14, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28786083/anesthesia-practice-in-pediatric-radiation-oncology-mayo-clinic-arizona-s-experience-2014-2016
#9
Narjeet Khurmi, Perene Patel, Sarang Koushik, Thomas Daniels, Molly Kraus
OBJECTIVE: Understanding the goals of targeted radiation therapy in pediatrics is critical to developing high quality and safe anesthetic plans in this patient population. An ideal anesthetic plan includes allaying anxiety and achieving optimal immobilization, while ensuring rapid and efficient recovery. METHODS: We conducted a retrospective chart review of children receiving anesthesia for radiation oncology procedures from 1/1/2014 to 7/31/2016. No anesthetics were excluded from the analysis...
August 7, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28786082/incidence-survival-and-treatment-of-localized-and-metastatic-neuroblastoma-in-germany-1979-2015
#10
Frank Berthold, Claudia Spix, Peter Kaatsch, Fritz Lampert
BACKGROUND: A comprehensive clinical long-term survey over the complete spectrum of neuroblatoma disease is lacking in the literature. OBJECTIVE: Our objective was to describe the incidence, risk profiles, therapies, and outcomes for the total cohort of German patients with neuroblastoma including all clinical stages and risk groups. METHODS: Epidemiological, clinical, and outcome data of neuroblastoma patients who participated in one of the six consecutive national trials between 1979 and 2015 were analyzed retrospectively...
August 7, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28776129/comparative-effectiveness-research-in-pediatric-respiratory-disease-promise-and-pitfalls
#11
Kathleen J Ramos, Ranjani Somayaji, David P Nichols, Christopher H Goss
Comparative effectiveness research (CER) has become increasing central to clinical research in medicine. CER seeks to conduct clinical trials that compare different commonly used interventions in real-world settings (pragmatic clinical trials) and use a multitude of sources of evidence (including registries and cohort studies) to inform clinical decision making. CER also ensures that stakeholders (patients, families, care providers, insurers) have a voice in the research process by integrating formal stakeholder engagement as part of the research...
August 3, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28770451/pharmacotherapy-for-seizures-in-neonates-with-hypoxic-ischemic-encephalopathy
#12
REVIEW
Elissa Yozawitz, Arthur Stacey, Ronit M Pressler
Seizures are common in neonates with moderate and severe hypoxic ischemic encephalopathy (HIE) and are associated with worse outcomes, independent of HIE severity. In contrast to adults and older children, no new drugs have been licensed for treatment of neonatal seizures over the last 50 years, because of a lack of controlled clinical trials. Hence, many antiseizure medications licensed in older children and adults are used off-label for neonatal seizure, which is associated with potential risks of adverse effects during a period when the brain is particularly vulnerable...
August 2, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28770450/pediatric-clinical-trials-conducted-in-south-korea-from-2006-to-2015-an-analysis-of-the-south-korean-clinical-research-information-service-us-clinicaltrials-gov-and-european-clinical-trials-registries
#13
Sheung-Nyoung Choi, Ji-Hyun Lee, In-Kyung Song, Eun-Hee Kim, Jin-Tae Kim, Hee-Soo Kim
BACKGROUND: The status of pediatric clinical trials performed in South Korea in the last decade, including clinical trials of drugs with unapproved indications for children, has not been previously examined. OBJECTIVE: The aim was to provide information regarding the current state of pediatric clinical trials and create a basis for future trials performed in South Korea by reviewing three databases of clinical trials registrations. METHODS: We searched for pediatric clinical studies (participants <18 years old) conducted in South Korea between 2006 and 2015 registered on the Clinical Research Information Service (CRIS), ClinicalTrials...
August 2, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28766184/frequency-and-nature-of-adverse-drug-reactions-due-to-non-prescription-drugs-in-children-a-retrospective-analysis-from-the-french-pharmacovigilance-database
#14
Geneviève Durrieu, Mathieu Maupiler, Vanessa Rousseau, Leila Chebane, François Montastruc, Emmanuelle Bondon-Guitton, Jean-Louis Montastruc
INTRODUCTION: Studies that evaluate the safety of non-prescription drugs in children remain scarce. OBJECTIVES: The aim of the present study was to compare adverse drug reactions (ADRs) due to prescription versus non-prescription drugs in children. METHODS: We conducted a retrospective analysis of ADR notifications for a pediatric population (aged <18 years) registered in the French PharmacoVigilance Database (FPVD) between January 1985 and December 2016 by the Midi-Pyrénées PharmacoVigilance Center (in the south of France)...
August 1, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28735476/annual-european-congress-of-rheumatology-madrid-spain-14-17-june-2017
#15
Rod McNab
No abstract text is available yet for this article.
July 22, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28660554/authors-reply-to-m-s-raghuraman-intranasal-dexmedetomidine-for-procedural-sedation-in-children-a-suitable-alternative-to-chloral-hydrate
#16
LETTER
Giorgio Cozzi, Stefania Norbedo, Egidio Barbi
No abstract text is available yet for this article.
August 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28660553/comment-on-intranasal-dexmedetomidine-for-procedural-sedation-in-children-a-suitable-alternative-to-chloral-hydrate
#17
LETTER
M S Raghuraman
No abstract text is available yet for this article.
August 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28623614/abobotulinumtoxina-a-review-in-pediatric-lower-limb-spasticity
#18
REVIEW
Yahiya Y Syed
AbobotulinumtoxinA (Dysport(®)) is currently the only botulinum toxin A formulation approved by the US FDA for the treatment of lower limb spasticity in pediatric patients aged ≥2 years. Intramuscular abobotulinumtoxinA was approved based on the results of a pivotal phase 3 trial in children with lower limb spasticity due to cerebral palsy. In this trial, a single treatment cycle with abobotulinumtoxinA 10-15 U/kg/leg injected into the gastrocnemius and soleus muscles significantly improved ankle plantar flexor muscle tone (primary endpoint), with abobotulinumtoxinA recipients showing a significant response to treatment relative to placebo...
August 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28547678/immunosuppression-drug-therapy-in-lung-transplantation-for-cystic-fibrosis
#19
REVIEW
Pamela Burcham, Lisa Sarzynski, Sabrina Khalfoun, Kimberly J Novak, Julie C Miller, Dmitry Tumin, Don Hayes
Cystic fibrosis (CF) is a common indication for lung transplantation (LTx) in children and adults with severe and irreversible lung disease. In the setting of LTx in the CF population, immunosuppressive medications are used to prevent allograft rejection despite the majority of these patients being chronically infected with numerous, and often antibiotic-resistant, pathogens. There is limited evidence for the optimal post-LTx immunosuppression regimen in patients with CF, particularly in children. This article provides a review of immunosuppression regimens in the pediatric and adult CF post-LTx population, investigating drug dosing and monitoring, and medication combinations...
August 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28536810/fibromyalgia-treating-pain-in-the-juvenile-patient
#20
REVIEW
Sabrina Gmuca, David D Sherry
Presently, evidence for the efficacy of medications for the treatment of juvenile fibromyalgia syndrome (JFMS) is limited. While there are medications approved by the US Food and Drug Administration (duloxetine, milnacipran and pregabalin) for adults with fibromyalgia syndrome, there are none for the treatment of JFMS. A variety of medications have been prescribed for the treatment of JFMS, including (but not limited to) non-opioid analgesics, opioids, anticonvulsants, antidepressants, and muscle relaxants...
August 2017: Paediatric Drugs
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