CUROSURF instructions for use, description of the medicinal product CUROSURF: contraindications, side effects, dosages, composition - suspension for intratracheal administration in the drug reference book

Instructions for use CUROSURF

Before starting treatment with Curosurf, it is necessary to stabilize the general condition of the child. It is recommended to correct acidosis, hypotension, anemia, hypoglycemia and hypothermia.

In case of reflux, the administration of Kurosurf should be suspended and, if necessary, the peak inspiratory pressure on the ventilator should be increased to the level necessary to clear the endotracheal tube.

In the event of blockage of the endotracheal tube due to the accumulation of mucus in children, ventilation may noticeably deteriorate during the administration of the drug or immediately after its administration, which happens if there is pulmonary secretion in the child before the administration of the drug. Suctioning off mucus before administering the drug may reduce the likelihood of endotracheal tube obstruction. If the obstruction cannot be removed, the endotracheal tube should be replaced immediately.

Aspiration of tracheobronchial secretions is not recommended for at least 6 hours after drug administration, except under life-threatening conditions.

In the event of bradycardia, arterial hypotension and a decrease in blood oxygen saturation, the administration of Kurosurf must be suspended and the necessary measures must be taken to normalize heart rate, after which treatment can be continued. Once the child is stabilized, monitoring of vital signs is necessary.

After using Curosurf, pulmonary compliance (increase in chest volume) and oxygenation can quickly improve, so rapid correction of the ventilator parameters is required.

Improving gas exchange in the alveoli can lead to a rapid increase in oxygen concentration in the arterial bed:

therefore, rapid adjustment of inspired oxygen concentration is required to avoid hyperoxia. Long-term monitoring of PaO2 or oxygen saturation is recommended in addition to periodic blood gas testing to maintain adequate blood oxygenation levels.

Continuous nasal positive pressure (nCPAP) may be used for further treatment in departments equipped with such equipment. Children receiving surfactant should be closely monitored for signs of infection. If early signs of infection appear, the child should be given appropriate antibiotic therapy.

In case of an unsatisfactory response to treatment with Curosurf, or a rapid return of the condition, it is recommended to pay attention to complications of immaturity such as patent ductus arteriosus or other lung diseases such as pneumonia before using the next dose of the drug. Infants born after prolonged membrane rupture (more than 3 weeks) may respond poorly to drug replacement therapy, which may be associated with pulmonary hypoplasia, and may not respond optimally to exogenous surfactant.

Administration of the drug can be expected to reduce the severity of RDS or the risk of its occurrence, but the therapy cannot be expected to completely eliminate the mortality and morbidity associated with preterm birth, since premature babies may be subject to other complications due to their immaturity. After using Kurosurf, cases of transient depression of electrical activity of the brain, lasting from 2 to 10 minutes, were noted. This was observed in only one study and its impact is unclear.

The use of the drug for the purpose of prophylaxis should be carried out only if there is adequate equipment in the delivery room and in accordance with the following recommendations:

prophylaxis is recommended (within 15 minutes after birth) in almost all neonates less than 27 weeks' gestational age;
prophylaxis is recommended in neonates greater than 26 and <30 weeks' gestational age if intubation in the delivery room is necessary and if the mother has not received corticosteroids prenatally;
If corticosteroids are used prenatally, surfactant should only be used if RDS develops.

Taking into account the risk factors in preterm infants, prophylaxis is also recommended in the presence of the following factors:

perinatal asphyxia, presence of diabetes mellitus in the mother, male gender of the child, family predisposition to RDS, cesarean section. In all other cases of preterm birth, selective use of surfactant is recommended in life-saving cases.

There is no information on the effects of initial doses other than 100-200 mg/kg, more frequent use than every 12 hours, or use of Curosurf 15 hours after diagnosis of RDS.

The use of Curosurf in prematurely born infants with severe hypotension has not been studied.

Curosurf®

Before starting treatment with the drug, it is necessary to correct acidosis, arterial hypotension, anemia, hypoglycemia and hypothermia.

In case of reflux of the drug, the administration should be suspended and, if necessary, the peak inspiratory pressure on the ventilator should be increased to the level necessary to clear the endotracheal tube.

Aspiration of tracheobronchial secretions is not recommended for at least 6 hours after drug administration, except under life-threatening conditions.

In the event of bradycardia, arterial hypotension and a decrease in blood oxygen saturation, the administration of the drug must be suspended and the necessary measures must be taken to normalize heart rate, after which treatment can be continued.

Children born after a long anhydrous period (more than 3 weeks) may respond poorly to drug replacement therapy, which may be associated with pulmonary hypoplasia.

The use of the drug for prophylactic purposes must be carried out in accordance with the following recommendations:

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

- Premature newborns with a gestational age of 26 to 28 weeks: prophylaxis is recommended in the absence of antenatal use of corticosteroid drugs.

Taking into account the risk factors in preterm infants less than 28 weeks' gestational age, prophylaxis is also recommended in the presence of the following risk factors for the development of RDS: perinatal asphyxia, need for intubation at birth, maternal diabetes mellitus, male gender of the child, family history of RDS, cesarean delivery section.

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

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

Vials that have been warmed before use should not be returned to the refrigerator.

Do not reuse the drug remaining in the bottle.

Kurosurf instructions for use

Pharmacological action The phospholipid fraction of animal origin, poractant Alpha, almost entirely consists of polar lipids and a small amount of hydrophobic low molecular weight specific proteins. The therapeutic effect of Kurosurf is based on the drug replenishing the lack of endogenous pulmonary surfactant. The medication covers the alveoli from the inside, reduces tension in the lungs and prevents the alveoli from sticking together at the end of the expiratory phase. Kurosurf promotes stable gas exchange during the breathing cycle. After administration, the suspension is evenly distributed in the alveoli of the lungs of a premature baby. With the help of the drug, oxygenation in premature infants is stabilized and the need for inhaled oxygen in the mixture for mechanical ventilation is reduced. When using Kurosurf, mortality and the risk of severe complications of respiratory tract diseases are reduced. Indications for use Kurosurf is recommended for use in premature infants weighing over 700 grams and suffering from respiratory distress syndrome (RDS). A suspension for administration through the trachea is indicated for premature infants in the presence of factors contributing to the development of respiratory disorders.

Directions for use Kurosurf should be used in a medical facility under the guidance of a physician with experience in the resuscitation of premature infants and the use of the drug. Endotracheal administration should be carried out in intubated children who are mechanically ventilated with constant monitoring of heart function. When treating with the drug, the level of oxygen saturation in the blood and its concentration in the arterial bed should be monitored. The drug should be administered immediately after diagnosis of RDS in the neonatal period. Before using Kurosurf, the bottle is heated to +37 degrees Celsius and carefully turned upside down without shaking the contents. The drug is drawn up using sterile needles and injected into the lower trachea using an endotracheal tube. After the administration of Kurosurf, to ensure its uniform distribution, manual ventilation should be performed for 1–2 minutes, consisting of the initial concentration of oxygen on the ventilator. The drug can be administered with the ventilator disconnected or without disconnection using a catheter. The catheter for administering Curosurf should be 0.5 cm above the lower edge of the intubation tube. In an emergency situation, the initial dose of Kurosurf is 1.25–2.5 ml/kg. An additional 2 doses of 1.25 ml/kg can be administered at intervals of 12 hours. To prevent the development of RDS, 1.25–2.5 ml/kg should be administered in the first 15 minutes of life of a premature baby. A repeat dose of 100 mg/kg Curosurf can be used after 6–12 hours. If a diagnosis of RDS is established in a child, a suspension of 1.25 ml/kg should be administered at intervals of 12 hours. The total dose of the suspension should not exceed 300–400 mg/kg.

Side effects Treatment with Kurosurf can cause pulmonary hemorrhage and allergies in the child. Rarely, during treatment with a suspension, arterial hypotension, a decrease in the level of oxygen in the blood, a short-term decrease in the bioelectrical activity of the brain, and a slowdown in heart rate develop. When treated with Curosurf, there may be an increase in mucus secretion, as a result of which the endotracheal tube becomes clogged.

Contraindications Kurosurf should not be used by children who are allergic to the components of the suspension.

Pregnancy Kurosurf is not intended for the treatment of adults, incl. pregnant women and mothers during the lactation period.

Drug interactions No significant interactions have been described in clinical practice.

Overdose Exceeding the dose of Kurosurf has not been described in clinical practice. An overdose of a medication can manifest itself as pronounced disturbances in the functioning of the respiratory system.

Release form Kurosurf is available in the form of a white or slightly yellowish suspension for endotracheal administration. 1 ml contains 80 mg of poractant alpha. The solution is packaged in 1.5 or 3 ml (120 or 240 mg of active ingredient) in transparent glass bottles. The package may contain 1 or 2 bottles of suspension.

Storage conditions Kurosurf suspension should be transported and stored in moderate cold conditions at a temperature of +2–+8 degrees Celsius. Children should be prevented from accessing the storage area of the drug. After heating and a partially used bottle of the drug cannot be stored further.

Composition Curosurf suspension is made on the basis of alpha poractant using auxiliary components - sodium chloride and water for injection.

Pharmacological group Medicines used for the treatment of bronchi and lungs Medicines used for the prevention and treatment of respiratory distress syndrome in newborns

Nosological classification (ICD-10) Respiratory distress in the newborn [distress] (P22)

Active ingredient: poractant alpha

ATX: R07AA02

Manufacturer: Chiesi Pharmaceuticals

Additional information about the manufacturer Country of origin – Austria.

Additionally, before carrying out therapy, if possible, hypoglycemia, acidosis, arterial hypotension, hypothermia and anemia should be corrected. If drug reflux occurs, the inspiratory peak pressure of the ventilator should be increased to clear the tube.