Kurosurf® (Curosurf®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substancePrakantant alfaPrakantant alfa
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  • Kurosurf®
    suspension e / tracheal. 
    Torrex Chiesi Pharma GmbH     Austria
    • Dosage form: & nbspsuspension for endotracheal administration
    Composition:

    1 bottle of 1.5 ml contains:

    Active ingredient: Alpha Pojectant - 120 mg;

    Excipients: sodium chloride 13.5 mg, water for injection up to 1.5 ml.

    1 bottle of 3 ml contains:

    Active ingredient: Alpha Pojectant 240 mg;

    Excipients: sodium chloride 27 mg, water for injection up to 3 ml.

    1 ml of the suspension contains:

    Active ingredient: Alpha Pointer - 80 mg (corresponding to approximately 74 mg total phospholipids);

    Excipients: sodium chloride 9 mg, water for injection up to 1 ml.

    Description:

    From white to yellowish color suspension.

    Pharmacotherapeutic group:Surfactant
    ATX: & nbsp

    R.07.A.A   Pulmonary surfactants

    R.07.A.A.02   Phospholipids, natural

    Pharmacodynamics:Alpha Pojectant is a natural surfactant isolated from pig lungs, which contains almost exclusively polar lipids, primarily phosphatidylcholine (about 70% of total phospholipids) and about 1% of specific hydrophobic low molecular weight proteins SP-B and SP-C.

    Replenishes the lack of endogenous pulmonary surfactant. It covers the inner surface of the alveoli,reduces the surface tension in the lungs, stabilizes the alveoli, preventing their clumping at the end of the expiratory phase, promotes adequate gas exchange maintained throughout the entire respiratory cycle. Evenly distributed in the lungs and spreads to the surface of the alveoli. In preterm newborns, the oxygen level is restored, which requires a reduction in the concentration of oxygen in the gas mixture. Reduces the level of mortality and complications from respiratory diseases. The use of surfactant significantly reduces the severity of the course of respiratory distress syndrome (RDS).

    Pharmacokinetics:

    In experimental studies, the half-life is 67 hours. However, outside the lungs (in the blood serum and other organs), only trace amounts of surfactant lipids are detected 48 hours after administration.

    Indications:

    - LTreatment of RDS in premature infants with a body weight of more than 700 g;

    - prevention of RDS in premature newborns with suspected possible development of the syndrome.

    Contraindications:

    Hypersensitivity to the components of the drug.

    Pregnancy and lactation:

    Not applicable.

    Dosing and Administration:

    Endotracheal administration in intubated children who are on artificial ventilation (IVL), with constant monitoring of heart rate (HR), oxygen concentration in the arterial bed or saturation of blood with oxygen. The drug should be used only in hospital settings by doctors who have experience in the treatment and resuscitation of premature infants.

    Treatment is started as soon as possible after RDS diagnosis.

    Method of drug application

    Before use, the vial is heated to 37 ° C, gently turned upside down, avoiding shaking. The suspension is drawn from the vial using sterile needles and syringes and injected through the endotracheal tube into the lower trachea. After the introduction, manual ventilation is carried out for 1-2 minutes with an inhaled oxygen concentration equal to the initial value on the ventilator to distribute the drug evenly.

    The drug can be administered either with the child disconnected from the ventilator, or without detachment (using a catheter).

    The end of the catheter through which the drug is administered should be cut 0.5 cm above the lower end of the endotracheal tube.

    Dosage

    Emergency Therapy

    The initial single dose of 100-200 mg / kg (1.25-2.5 ml / kg). If necessary, apply one or two additional doses of 100 mg / kg with an interval of 12 hours. The maximum total dose is 300-400 mg / kg.

    Prevention

    The drug in a single dose of 100-200 mg / kg (1.25-2.5 ml / kg) must be administered within the first 15 minutes after the birth of the child with suspicion of the possible development of RDS. A repeated dose of 100 mg / kg is given through 6-12 hours. In case of diagnosis of RDS and the need for ventilation, the administration of the drug (100 mg / kg) is continued with a 12-hour interval. The maximum total dose is 300-400 mg / kg.

    Side effects:

    - Pulmonary haemorrhage;

    - allergic reactions.

    Rarely observed:

    - bradycardia;

    - arterial hypotension;

    - reduction of oxygen saturation;

    - occlusion of the endotracheal tube due to accumulation of mucus;

    - temporary (2-10 min) decrease in electrical activity of the brain.

    Overdose:To date, no overdose has been observed with Kurosurf®. Nevertheless, in case of an overdose and only if there are clear clinical manifestations (from the side of breathing, ventilation or oxygenation), the maximum possible aspiration of suspended contents from the lungs and therapy should be performed,aimed at maintaining the water-electrolyte balance
    Interaction:

    Not installed.

    Special instructions:

    Before starting treatment, the drug should be corrected for acidosis, arterial hypotension, anemia, hypoglycemia and hypothermia.

    In the case of drug reflux, administration should be stopped and, if necessary, increased peak inspiratory pressure on the ventilator to a level that is necessary for the purification of the endotracheal tube.

    If the endotracheal tube is blocked due to the accumulation of mucus in children, ventilation may be markedly impaired by administration of the drug or immediately after its administration, which occurs in the presence of pulmonary secretion in the child prior to administration of the drug. Absorption of mucus before administration of the drug may reduce the likelihood of obstruction of the endotracheal tube. If the obstruction can not be removed, the endotracheal tube should be replaced immediately.

    It is not recommended to aspirate the tracheobronchial secretion for at least 6 hours after the administration of the drug, with the exception of life-threatening conditions.

    In the case of bradycardia, arterial hypotension and a decrease in oxygen saturation of blood, the drug should be stopped and necessary measures to normalize the heart rate, after which the treatment can be continued.

    Children born after a prolonged anhydrous period (more than 3 weeks) may react poorly to substitution therapy with the drug, which may be associated with lung hypoplasia.

    It can be expected that the administration of the drug will reduce the severity of RDS or the risk of its occurrence, but it can not be assumed that therapy will completely eliminate the mortality and morbidity associated with premature birth, since prematurely born children may be exposed to other complications due to their immaturity.

    The use of the drug for the prevention should be carried out in accordance with the following recommendations:

    - premature newborns with a gestational age of 24 to 25 weeks: prevention is recommended;

    - premature newborns with a gestational age of 26 to 28 weeks: prevention is recommended in the absence of antenatal use of corticosteroids.

    Taking into account risk factors in preterm infants with a gestational age of less than 28 weeks, prevention is also recommended if there are the following risk factors for RDS development: perinatal asphyxia, the need for intubation at birth, the presence of diabetes maternal, the male gender of the child, family predisposition to RDS, cesarean section.

    - premature newborns with a gestational age of 29 weeks or more: the drug should be administered only if RDS develops.

    Restoration of gas exchange in the alveoli can lead to a rapid increase in the oxygen concentration in the arterial channel, which will require an immediate adjustment of the ventilator indices in order to avoid hyperoxia. In this regard, it is recommended to carry out long-term monitoring of the gas composition of arterial blood and tissue oxygen content.

    Pre-heated bottles should not be placed back in the refrigerator.

    Do not use the remnant in the vial again.

    Form release / dosage:

    Suspension for endotracheal administration, 80 mg / ml.

    Packaging:

    For 1.5 ml or 3 ml of the drug in a bottle of colorless glass, closed with a stopper of chlorobutyl, crimped with an aluminum cap and closed with a plastic lid.

    One or two bottles in a foamed plastic case together with the instructions for use are placed in a cardboard box.

    Storage conditions:

    In a dark place at a temperature of 2 to 8 ° C.

    Keep out of the reach of children.

    Shelf life:

    18 months.

    The drug can not be used after the expiration date.
    Terms of leave from pharmacies:For hospitals
    Registration number:П N015827 / 01
    Date of registration:14.05.2009 / 02.08.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:Torrex Chiesi Pharma GmbHTorrex Chiesi Pharma GmbH Austria
    Manufacturer: & nbsp
    Representation: & nbspChiesi Pharmaceuticals Ltd.Chiesi Pharmaceuticals Ltd.
    Information update date: & nbsp07.02.2018
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