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  • Infasurf
    / Rafa


    Active Ingredient
    Calfactant (as phospholipid) 35 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    3, 6 X 6 ml

    not in the basket chart

    Related information


    Dosage

    FOR INTRATRACHEAL ADMINISTRATION ONLY.
    Infasurf should be administered under the supervision of clinicians experienced in the acute care of newborn infants with respiratory failure who require intubation.
    Rapid and substantial increases in blood oxygenation and improved lung compliance often follow Infasurf instillation. Close clinical monitoring and surveillance following administration may be needed to adjust oxygen therapy and ventilator pressures appropriately.
    Dosage: Each dose of Infasurf is 3 mL/kg body weight at birth. Infasurf has been administered every 12 hours for a total of up to 3 doses.
    Directions for Use: Infasurf is a suspension which settles during storage. Gentle swirling or agitation of the vial is often necessary for redispersion. DO NOT SHAKE. Visible flecks in the suspension and foaming at the surface are normal for Infasurf.
    See prescribing information for full details.


    Indications

    Infasurf is indicated for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS and for the treatment (“rescue”) of premature infants who develop RDS. Infasurf decreases the incidence of RDS, mortality due to RDS, and air leaks associated with RDS.
    Prophylaxis: Prophylaxis therapy at birth with Infasurf is indicated for premature infants <29 weeks of gestational age at significant risk for RDS. Infasurf prophylaxis should be administered as soon as possible, preferably within 30 minutes after birth.
    Treatment: Infasurf therapy is indicated for infants ≤72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotracheal intubation.


    Contra-Indications

    No contraindication have been reported.


    Special Precautions

    For intratracheal use only. Patients should be carefully monitored so that oxygen therapy and ventilatory support can be modified in response to changes in respiratory status.During administration of Infasurf liquid suspension into the airway, infants often experience bradycardia, reflux of infasurf into the endotracheal tube, airway obstruction, cyanosis, dislodgment of the endotracheal tube, or hypoventilation. If any of these events occur, the administration should be interrupted and the infant’s condition should be stabilized using appropriate interventions before the administration of Infasurf is resumed. Endotracheal suctioning or reintubation is sometimes needed when there are signs of airway obstruction during the administration of the surfactant.


    Side Effects

    The most common adverse reactions associated with Infasurf dosing procedures in the controlled trials were cyanosis (65%), airway obstruction (39%), bradycardia (34%), reflux of surfactant into the endotracheal tube (21%), requirement for manual ventilation (16%), and reintubation (3%). These events were generally transient and not associated with serious complications or death.
    See prescribing information for full details.


    Manufacturer
    Ony Inc.
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