Index of drugs

Treatment of respiratory distress syndrome (RDS) in premature babies. Prophylactic treatment in premature babies at risk of RDS.

1 vial (1.5 ml) contains 120 mg surfactant (fraction of phospholipids from pig lungs).

A pulmonary surfactant (surfactant) is a mixture of substances, mainly phospholipids and specific proteins that cover the inner surface of the alveoli. It reduces the surface tension in the alveoli, which stabilizes the alveoli, prevents them from collapsing after exhalation and enables proper gas exchange during the respiratory cycle. The preparation is used for substitutional treatment of deficiency of endogenous surfactant, by administering it directly to the airways. After intratracheal administration, the surfactant remains mostly in the lungs.

Hypersensitivity to the active substance or any of the excipients. No particular contraindications are known to date.

Before the preparation is administered, the general condition of the newborn should be stable. Equalization of biochemical parameters is required for acidosis, hypotension, anemia, hypoglycaemia and hypothermia. In the case of reflux, discontinue administration, and if necessary, increase the peak inspiratory pressure to completely clean the tracheal tube. In neonates whose ventilation is severely impaired during or immediately after administration of the drug, the mucosa endotracheal tube may become blocked, especially if a significant amount of secretion has been observed in the lungs prior to dosing. Sustaining the secretion before administration of the drug may reduce the likelihood of blockage of the endotracheal tube with mucus. If there is a suspicion that the endotracheal tube is clogged and the secretion does not work, then the endotracheal tube should be replaced immediately. Nevertheless, aspiration of tracheal secretions is not recommended for at least 6 h after drug administration, except in life-threatening situations. If episodes of bradycardia, hypotension or oxygen saturation occur, the administration should be discontinued and appropriate measures should be taken to normalize the heart. Once stabilized, the newborn can be re-treated, while monitoring its vital functions. In order to maintain adequate blood oxygenation, in addition to regular gasometric tests, it is also recommended to constantly monitor percutaneously the partial oxygen pressure (PaO₂) or saturation of arterial blood with oxygen. Continuing treatment, you can use nCPAP (nasal continuous positive airway pressure), but only on wards suitably equipped for this. Newborns treated with surfactant should be closely monitored for signs of infection. At the first signs of infection, appropriate antibiotic therapy should be given immediately. In cases where the use does not improve, or in the event of a sudden relapse, other possible complications of premature birth, such as persistent ductus arteriosus or other lung disease, eg pneumonia, should be considered before the Next dose. In newborns born long after the rupture of the membranes of the fetus (longer than 3 weeks), lung hypoplasia may occur and they may not respond optimally to the administration of surfactant. There was a short-term inhibition of the electrical activity of the brain after the treatment, lasting from 2 to 10 min (observed in one clinical trial and there is no agreement on their clinical significance). No data are available on the effects of starting doses other than 100 or 200 mg / kg, doses administered more frequently than every 12 h or initiation of administration more than 15 hours after RDS diagnosis. There are no studies on the use of the drug in premature infants with severe hypotension.

Not applicable.

Uncommon: sepsis, intracranial haemorrhage, pneumothorax. Rare: bradycardia, hypotension, bronchopulmonary dysplasia, pulmonary haemorrhage, reduced arterial oxygen saturation.Not known: hyperoxia, newborn cyanosis, apnea, atypical EEG, complications of endotracheal intubation. Apnea or sepsis may be the result of the immaturity of the newborn. Intracranial haemorrhage occurring after administration of the preparation was accompanied by a decrease in mean arterial blood pressure and a rapid increase to the maximum partial oxygen pressure (PaO₂). There was a slight increase in the incidence of persistent ductus arteriosus in neonates treated with the preparation (this is associated with haemodynamic changes induced by rapid lung development after surfactant administration). Antibody formation has been observed against the proteins in the preparation, but so far without any evidence of clinical relevance. Despite the use of intensive care, preterm infants have a relatively frequent cerebral hemorrhage and cerebral ischemia, recognized as periventricular white matter softening or haemodynamic disorders, such as persistent ductus arteriosus and persistent fetal circulation. These children also have a high risk of infection, such as pneumonia and bacteraemia (or sepsis). Seizures may also occur in the perinatal period. Premature infants often have blood and electrolyte imbalance, which may be intensified by severe diseases and mechanical ventilation. Other complications associated with prematurity (associated with the severity of the disease and using mechanical ventilation): pneumothorax, interstitial pulmonary emphysema and pulmonary haemorrhage. In addition, long-term use of high oxygen concentrations and mechanical ventilation may be associated with the occurrence of bronchopulmonary dysplasia and retinopathy of premature babies.

The preparation should only be used by properly trained medical staff who have experience in the care, resuscitation and maintenance of stable condition of premature babies. The product is administered endotracheally and intrabronchially in newborns who are constantly monitored for heart rate and oxygen concentration or oxygen saturation of arterial blood, as is the case in neonatal wards.Healing. One 100-200 mg / kg dose is recommended. (1.25-2.5 ml / kg) as soon as possible after diagnosis of RDS. In children in whom RDS is considered to be a cause of persisting or worsening respiratory conditions, additional doses of 100 mg / kg may be required. each (1.25 ml / kg) at intervals of at least 12 h (the maximum total dose is 300-400 mg / kg).prophylactically. A single dose of 100-200 mg / kg should be given as soon as possible after birth (preferably within 15 min). Subsequent doses of 100 mg / kg can be given 6-12 h after the first dose and then at 12 h intervals if RDS requiring mechanical ventilation (maximal total dose: 300-400 mg / kg) occurs.
1. Administration of the preparation by disconnecting the infant from the ventilator: disconnect the infant for a while from the ventilator and deliver 1.25-2.5 ml / kg (100-200 mg / kg) of suspension in a single rapid injection through the tracheal tube directly to the lower trachea. For about 1 minute, manual ventilation should be carried out using a self-expanding bag, and then the child should be reconnected to the respirator whose parameters are set the same as before the suspension. If necessary, further doses (1.25 ml / kg) should be administered in the same way. 2. Administration without the need to detach the infant from the ventilator: 1.25-2.5 ml / kg (100-200 mg / kg) suspension should be administered as a single rapid injection directly into the lower trachea, bypassing the catheter, through the suction port into the tube intubation. If necessary, further doses (1.25 ml / kg) should be administered in the same way. 3. Administration of the product through the tracheal tube in the delivery room before mechanical ventilation begins: in this case manual ventilation using a self-expanding bag is used, and its interruption and use of CPAP (Continuous Positive Airway Pressure) is possible in the delivery room as well as later, after moving to the neonatal unit (INtubation SURfactant Extubation - INSURE).
After administration of the drug, lung compliance (chest extension), can be rapidly improved, which requires rapid adjustment of the ventilator parameter settings. Improved gas exchange in alveoli can lead to a sharp increase in arterial oxygen levels: therefore, to prevent hyperoxia, the concentration of inhaled oxygen should be adjusted quickly.In order to maintain adequate blood oxygenation, in addition to regular gasometric tests, it is also recommended to permanently monitor percutaneously the oxygen partial pressure (PaO₂) or saturation of arterial blood with oxygen.