This dose may be determined from the curosurf dosing chart on the. Surfactant therapy for acute respiratory failure in children. Poractant alfa is an extract of natural porcine lung surfactant. Curosurf poractant alfa for the treatment of infants at risk for or. Treatment of the rabbits with bovactant 50 mgkg improved the oi values but to a lesser extent than poractant alfa, which accounted for significantly better oi values favoring poractant alfa at 5 and 30 min following. They differ in their source, composition, pharmaceutical form, and clinical dose. Curosurf poractant alfa intratracheal suspension is indicated for the rescue treatment of respiratory distress syndrome rds in premature infants. Pdf a randomized, multicenter masked comparison trial of.
Curosurf poractant alfa intratracheal suspension is available in sterile, readytouse, rubberstoppered clear glass vials containing one vial per carton. However, the price of poractant alfa is higher and may not be costeffective in. A study on the safety and efficacy of reveglucosidase alfa in. Curosurf reduces mortality and pneumothoraces associated with rds. Respiratory distress after ductus arteriosus ligation. Poractant alfa is an extract of natural porcine lung surfactant consisting of 99% polar lipids mainly phospholipids and 1% hydrophobic low molecular weight proteins surfactant associated proteins spb and spc.
Therefore, infants receiving curosurf should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to respond to respiratory changes. The administration of poractant curosurf through a duallumen endotracheal tube without a change in position or interruption of mechanical ventilation was. In this study, we assessed the influence of exogenous poractant alfa curosurf instillation on the in vivo phagocytosis of apoptotic neutrophils by alveolar macrophages. The particle size distribution of surfactant aerosols poractant alfa, 80 mgml generated by the customized eflowneos nebulizer system was determined in vitro by laser diffraction helosbf, sympatec gmbh, clausthalzellerfeld, germany. Available in any file format including fbx, obj, max, 3ds, c4d. Jun 15, 2007 exogenous surfactant is used to treat acute respiratory failure in children, although the benefits and harms in this setting are not clear. A large subset of the data presented in the article mortality in preterm infants with respiratory distress syndrome treated with poractant alfa.
How much these differences affect the acute pulmonary response to treatment is. A pulmonary surfactant derived from porcine lung surfactant. Beractant and poractant alfa in premature neonates with. In vitro characterization and in vivo comparison of the. By francesca ricci, xabier murgia, roberta razzetti, nicola pelizzi and fabrizio salomone download pdf 151 kb. Curosurf poractant alfa for the treatment of infants at. Efficacy of surfactantta, calfactant and poractant alfa for preterm infants with respiratory distress syndrome.
Dey laboratories application no 20744 approval date. Pdf beractant and poractant alfa in premature neonates. The aim of this study was to investigate the feasibility of delivering nebulized surfactant poractant alfa in vitro and in vivo with an adapted, neonatetailored aerosol delivery strategy. Objectives to compare the efficacy and safety of poractant alfa and bovine lipid extract surfactant in preterm infants. Efficacy and peridosing effects of poractant alfa and a lyophilized form of. Pdf to compare calfactant ca and poractant alfa pa administration traits, shortterm clinical responses, and resource use in the neonatal. Tracheal instillation of surfactant to premature newborns improves their survivability but may transiently obstruct airways resulting in undesirable acute effects on. Poractant alfa versus bovine lipid extract surfactant for. It is an extract of natural porcine lung surfactant consisting of 99% polar lipids mainly phospholipids and 1% hydrophobic low molecular weight proteins surfactant associated proteins spb and spc. Pulmonary distribution of lucinactant and poractant alfa and their. As with other surfactants, marked improvement on oxygenation may occur within minutes of the administration of poractant alfa.
We spend countless hours researching various file formats and software that can open, convert, create or otherwise work with those files. Pdf comparison of poractant alfa and lyophilized lucinactant in a. Sales of curosurfr poractant alfa, a pulmonary surfactant, exceeded euro200m, growing by 14. Refer to specific instruction provided by manufacturer for proper dosing technique. Curosurf poractant alfa intratracheal suspension is a sterile, nonpyrogenic pulmonary surfactant intended for intratracheal use only. Curosurf should be administered by, or under the supervision of clinicians. The administration of exogenous surfactants, including curosurf, can rapidly affect oxygenation and lung compliance. Importance lung ultrasonography lus is a bedside technique useful to diagnose neonatal respiratory problems, but, to our knowledge, no data are available about its use for monitoring lung function or eventually guiding surfactant therapy objective to determine the diagnostic accuracy of a neonataladapted lus score to evaluate oxygenation and predict need for surfactant administration. Each ml of suspension contains 80 mg poractant alfa surfactant extract that includes 76 mg of phospholipids and. Orphan drugs are intended to treat, prevent or diagnose rare diseases. Tab titers directed against the gilt portion of reveglucosidase alfa were of much lower titer, with a mean sd of 967 2718 and. Complications among premature neonates treated with beractant and poractant alfa complications among premature neonates treated with beractant and poractant alfa gharehbaghi, manizheh.
The incidence of death was similar between the beractant and poractant alfa groups in three studies 15,16,17 but significantly lower with beractant versus poractant alfa in 1 study 274 2. This is the talk page for discussing improvements to the poractant alfa article. Insure strategy selective surfactant following ncpap failure. Administration of poractant alfa was associated with. Particle size distribution of undiluted poractant alfa aerosols generated by a customized eflowneos nebulizer system was determined by laser diffraction. By coen hmp willems, florian urlichs, silvia seidenspinner, steffen kunzmann, christian p speer and boris w kramer. Poractant alfa curosurf is a natural, porcinederived. Stop administration of poractant alfa and take appropriate measures if any of the following occur. In vitro characterization and in vivo comparison of the pulmonary outcomes of poractant alfa and calsurf in ventilated preterm rabbits plos one, mar 2020 xiaojing guo, siwei luo, davide amidani, claudio rivetti, giuseppe pieraccini, barbara pioselli, silvia catinella, xabi murgia. Efficacy of surfactantta, calfactant and poractant alfa.
Poractant alfa 200 mgkg was instilled intratracheally in the lungs of three months old adult male c57black 6 mice, followed by apoptotic neutrophil instillation. Report alpha please fill this form, we will try to respond as soon as possible. Poractant alfa curosurf worlds leading surfactant composition. The aim of this study was to provide an overview of the availability and. Aug 31, 2017 treatment of the rabbits with poractant alfa 100 mgkg rapidly restored the mean oi to baseline values, already at 5 min.
Complications among premature neonates treated with beractant and poractant alfa. A modified bovine surfactant extract that can be used as an intratracheal suspension for the prevention and treatment of neonatal respiratory distress syndrome. The nlm drug information portal gives users a gateway to selected drug information from the national library of medicine and other key government agencies. Nonintubated surfactant application vs conventional therapy. The apgar score was 488, needing positive pressure followed by nasal continuous airway positive pressure ncpap. Frontiers in vivo evaluation of the acute pulmonary. Pdf complications among premature neonates treated with. In vitro characterization and in vivo comparison of the pulmonary outcomes of poractant alfa and calsurf in ventilated preterm rabbits plos one, mar 2020 xiaojing guo, siwei luo, davide amidani, claudio rivetti, giuseppe pieraccini, barbara pioselli, silvia catinella, xabi murgia, fabrizio salomone, yaling xu, et al. Curosurf poractant alfa is an intratracheal suspension available in vials. Use filters to find rigged, animated, lowpoly or free 3d models.
Poractant alfa is an extract of natural porcine lung surfactant consisting of 99% polar lipids mainly phospholipids and 1% hydrophobic low molecular weight proteins surfactant associated proteins spb. An openlabel comparison of calfactant and poractant alfa administration traits and impact on neonatal intensive care unit resources gerdes js, seiberlich w, sivieri em, et al. The recommended initial dose of curosurf poractant alfa is 2. This study compared administration characteristics including administration time, patient recovery time, reflux and bradycardia. Updated and expanded content, as well as increased online coverage, keeps you fully current with new guidelines, practice parameters, and more.
Poractant alfa is a pulmonary surfactant sold under the brand name curosurf by chiesi farmaceutici. A study on the safety and efficacy of reveglucosidase alfa. The administration of exogenous surfactants, including curosurf. Methods poractant alfa 200 mgkg was instilled intratracheally in the lungs of three months old adult male c57black 6 mice, followed by apoptotic neutrophil instillation. Curosurf poractant alfa intratracheal suspension company. Simple steps to install, account opening and start using alfa on your android device a. In vitro and in vivo comparison between poractant alfa and the new generation synthetic surfactant chf5633.
Nonintubated surfactant application vs conventional. Follow instructions carefully regarding installation of drug and ventilation of infant. Snomedct poractant alfa substance 386999001, snomedct porcine derived. Pdf beractant and poractant alfa in premature neonates with. Study design randomized, partiallyblinded, multicenter trial. Please sign and date your posts by typing four tildes. Beractant and poractant alfa in premature neonates with respiratory distress syndrome. The availability and affordability of orphan drugs for. Design, setting, and participants the nonintubated surfactant application trial was a multicenter, randomized, clinical, parallelgroup study conducted between april 15, 2009, and march 25, 2012, in level iii neonatal intensive care units in germany. Infants poractant alfa or bovine lipid extract surfactant. This is not a forum for general discussion of the articles subject.
Poractant alfa is a sterile, nonpyrogenic pulmonary surfactant intended for intratracheal use only. Work with patient and familycaregivers to find forms of exercise e. Exogenous surfactant is used to treat acute respiratory failure in children, although the benefits and harms in this setting are not clear. On day 2 or 3 after birth, 30 28% infants in the intervention group were mechanically ventilated versus 51 46% in the standard treatment group number needed to treat 6, 95% ci 320, absolute risk reduction 018, 95% ci 030005, p0008. Poractant alfa definition of poractant alfa by medical. Jeffrey s gerdes at the childrens hospital of philadelphia. Restoring pulmonary surfactant membranes and films at the. Read download file report abuse a novel porcine graft for regeneration of bone defects mdpi may 12, 2015.
Eighteen newborn piglets n 6group with surfactantdeficient respiratory distress syndrome were randomized to three continuous positive airway pressureventilated. Curosurf poractant alfa dosing, indications, interactions. In recent years, china healthcare policy makers and patients have become increasingly concerned about orphan drug issues. A retrospective study ga won jeon, 1 minkyung oh, 2 and jong beom sin 1 1 department of pediatrics, busan paik hospital, inje university college of medicine, busan, korea 2 department of pharmacology and clinical trial center, inje university busan paik hospital, busan, korea. Review guidelines for storage, preparation, dosing, and administration of curosurf. Curosurf poractant alfa for the treatment of infants. Lung ultrasonography, oxygenation, and surfactant need.
However, very few studies have assessed the availability and affordability of orphan drugs for rare diseases in china. For patients with asthma, design and implement appropriate aerobic exercise and respiratory muscle training programs to maintain optimal pulmonary function. Curosurf is an extract of natural porcine lung surfactant consisting of 99% polar lipids mainly phospholipids and 1% hydrophobic low molecular weight proteins surfactant associated proteins spb and spc. One dose of poractant alfa was administered in the first hour of life. There, surfactant forms interfacial films at the airwater interface, reducing dramatically surface tension and thus stabilizing the airexposed interface to prevent. Nebulized poractant alfa reduces the risk of respiratory. Biocrucesbizkaia health research institute animal facility. Do not suction airway for 1 h after poractant alfa instillation unless. In response to mortality in preterm infants with respiratory distress. Jan 02, 2020 curosurf poractant alfa is a sterile, nonpyrogenic pulmonary surfactant intended for intratracheal use only. Transient episodes of bradycardia, decreased oxygen saturation, reflux of poractant alfa into endotracheal tube, or airway obstruction.
Pulmonary surfactant is a complex of lipids and proteins assembled and secreted by the alveolar epithelium into the thin layer of fluid coating the respiratory surface of lungs. Each ml of suspension contains 80 mg poractant alfa surfactant extract that includes 76 mg of phospholipids and 1 mg of protein of which 0. A retrospective study ga won jeon, 1 minkyung oh, 2 and jong beom sin 1. The primary outcome was being alive and extubated at 48 hours post. Administered as one or two aliquots depending upon the instillation procedure.
Fill the catheter with poractant alfa and discard excess through the catheter so that only the total dose to be given remains in the syringe. Curosurf summary of product characteristics smpc emc. Antireveglucosidase alfa antibodies developed more slowly in the 5 mgkg cohort than the 10 and 20 mgkg cohorts and the mean sd titer for the 20 mgkg cohort at week 24 was 1677 2643 see additional file 2. Alfa your life and check banking off your daily to do list. Curosurf poractant alfa is intended for intratracheal use only. Briefly, this technique measures the angular variation in the intensity of scattered light when a laser is. Pdf an open label comparison of calfactant and poractant alfa. Efficacy of surfactantta, calfactant and poractant alfa for. Upload document file or like to download immediately close. Aug 24, 2017 antireveglucosidase alfa antibodies developed more slowly in the 5 mgkg cohort than the 10 and 20 mgkg cohorts and the mean sd titer for the 20 mgkg cohort at week 24 was 1677 2643 see additional file 2. Nebulized poractant alfa reduces the risk of respiratory fai. However, the price of poractant alfa is higher and may not be.