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  • Curosurf
    / Abic


    Active Ingredient
    Phospholipid fraction from porcine lung 80 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1.5 ml, 5 ml

    not in the basket chart

    Related information


    Dosage

    Curosurf should only be administered in hospital, by those trained and
    experienced in the care and resuscitation of preterm infants, having available
    suitable equipment for ventilation and monitoring of infants with RDS.
    Rescue Treatment: the recommended dose is a single dose of 100-200 mg/kg
    (1.25-2.5 ml/kg) of body weight administered in a single dose. It is possible to
    administer additional doses of 100 mg/kg, each one at about 12-hourly intervals, in infants still requiring assisted ventilation and supplementary oxygen (maximum total dose: 300-400 mg/kg).
    It is recommended to start treatment as soon as possible after diagnosing RDS.
    Prophylaxis: a single dose of 100-200 mg/kg (1.25-2.5 ml/kg) should be
    administered as soon as possible (within 15 minutes) after birth. Further doses of 100 mg/kg can be given 6-12 hours after the first dose, and then at 12 hour
    intervals in case of occurrence of RDS requiring mechanical ventilation (max.
    total dose: 300-400 mg/kg).
    Method of administration: Curosurf is available in ready-to-use vials that should be stored in a refrigerator at +2 to +8°C. The vial should be warmed to room temperature before use, for example by holding it in the hand for a few minutes, and gently turned upside down a few times, without shaking, in order to obtain a uniform suspension.
    The suspension should be withdrawn from the vial by using a sterile needle and
    syringe following the instruction described in the leaflet (section 6.6).
    See prescribing information for full details.


    Indications

    Preterm babies with RDS (Respiratory Stress Syndrome).
    Prophylactic use in premature infants at high risk for RDS.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.
    No specific contraindications to Curosurf are yet known.


    Special Precautions

    See prescribing information for full details.


    Side Effects

    See prescribing information for full details.


    Drug interactions

    Not known.


    Overdose

    There have been no reports of overdosage following the administration of
    Curosurf. However, in the unlikely event of accidental overdose, and only if there
    are clear clinical effects on the infant’s respiration, ventilation or oxygenation, as much of the suspension as possible should be aspirated and the infant should be managed with supportive treatment, with particular attention to fluid and electrolyte balance.


    Important notes

    Storage: The product must be stored at +2 to +8°C, protected from light.
    Do not use any residual quantity in the vial after the first aspiration. Unopened, unused vials of Curosurf that have been warmed to room temperature
    can be returned to refrigerated storage within 24 hours for future use.
    Do not warm to room temperature and return to refrigerated storage more than
    once.


    Manufacturer
    Chiesi Farmaceutici S.p.A.
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