Index of drugs

Prevention and treatment of respiratory distress syndrome (RDS) in premature babies. Beraktant significantly reduces the incidence of respiratory distress syndrome and mortality due to RDS and reduces the incidence of pulmonary leaks. Prevention: premature babies with birth b. less than 1250 g or with symptoms of surfactant deficiency should be given as soon as possible, preferably within 15 minutes after birth. Treatment: in the treatment of newborns with respiratory distress syndrome confirmed by radiological tests and requiring mechanical ventilation, the preparation should be administered as early as possible, preferably before the 8th hour of life.

1 ml of the preparation contains 25 mg of phospholipids (including 11-15.5 mg of phosphatidylcholine), 0.5-1.75 mg of triglycerides and 1.4-3.5 mg of free fatty acids.

Sterile, pyrogen-free, purified bovine lung extract exhibiting endogenous surfactant properties for endotracheal administration. It lowers the surface tension of the alveoli and stabilizes them, preventing them from collapsing, which ensures proper gas exchange during the respiratory cycle. In the neonatal respiratory distress syndrome (RDS), the preparation complements the deficiency of endogenous surfactant and restores the action of the surface of the alveoli.

Beraktant is intended for intratracheal administration only. Beraktant can quickly affect blood oxygenation and lung compliance, which is why the drug can be used in specialized clinical centers, in which doctors are employed trained in the performance of intubation and artificial ventilation and general care for prematurely born newborns. The condition of newborns receiving beraktant should be frequently monitored by performing the O concentration assays₂ and what₂ in arterial or percutaneous blood samples. There have been reports of transient symptoms of bradycardia and decreased oxygen saturation occurring during the administration of the drug. In the event of these symptoms, discontinue the preparation and take appropriate measures. After the symptoms have resolved, the medicine should be resumed. After administration of the preparation, short-lasting rales and wet breathing noise may occur. There is no need to suck up secretions from the airways through the endotracheal tube or to take other actions unless there are clear signs of airway obstruction. In clinical trials, an increased probability of sepsis caused by hospital bacteria in newborns treated with beraktant was observed. The increased risk of sepsis was not associated with increased mortality in this group. In controlled clinical trials, the use of berathuron in neonates with birth weight below 600 g or above 1750 g has not been evaluated. There have been no controlled clinical studies on the use of beraktant in combination with experimental RDS (eg high frequency ventilation or extracorporeal oxygenation). No data are available on other doses than 100 mg phospholipids / kg, more than 4 doses, more than every 6 hours, or after 48 hours of treatment.

Not applicable.

There have been reports of transient symptoms of bradycardia and decreased oxygen saturation occurring during the administration of the drug. Other reactions that occurred during the administration of less than 1% of the doses are: reflux in the tracheal tube, paleness, vasoconstriction, hypotension, occlusion of the endotracheal tube, hypertension, hypocapnia, hypercapnia and apnea. In any case, during the procedure of drug administration, there was no death and all reactions resolved after symptomatic treatment. A clinical trial was conducted in which the method of administration of each dose was compared in 4 parts (after 1/4 dose) with each dose in two parts (1/2 dose) with intermittent ventilation and uninterrupted ventilation (through a catheter inserted through an additional port in the tracheal tube). At the time of administration of the first dose divided in the group administered after 1/4 of the dose, significantly less reflux in the tracheal tube was observed than in the group with continuous ventilation.During the first dose in two parts there were significantly fewer cases of oxygen desaturation in the uninterrupted ventilation group than in the intermittent ventilation group. There were no differences in the occurrence of these symptoms after the Next divided doses and in the heart rate after any of the doses. After analyzing the results of all clinical trials, there were no differences in the incidence of intracranial haemorrhage. However, in one study in which a single dose of beraktant was used to save life and one of the studies in which prophylactic doses of multiple intracranial hemorrhages were used in infants who received berathantes were statistically significantly greater than in the control groups. In post-marketing clinical trials, involving approximately 8,100 newborns, the percentage of haemorrhage was lower than in controlled studies. It is known that many complications occur in premature infants. So far no complications or consequences of beraktant treatment have been found. Repeated-dose studies in infants who survived were made after 6 months of clinical evaluation. In babies who received beraktant, there were significantly fewer cerebral palsies and the need for additional oxygen use compared to the control. During the study, wheezing was more frequently observed in infants who received a berathurist, although there was no difference in the use of bronchodilator therapy. There are data from the final clinical evaluation obtained after 12 months from the use of multiple doses of beraktant in surviving infants; in contrast to results obtained after 6 months in infants treated with beraktantem there were significantly fewer wheezing cases. After 12 months there were no differences in the incidence of cerebral palsy. In the group of infants who survived, the clinical evaluation was completed 24 months after administration. In the group treated with beraktant we observed a statistically significant reduction in the incidence of wheezing, wheezing and rapid breathing.

The preparation should only be administered by physicians specializing in the use of intubation and artificial ventilation as well as general care for prematurely born babies or under the supervision of such doctors. Within a few minutes of administration of the beraktant, there may be a significant improvement in oxygenation of the blood, therefore, to prevent hyperoxia, frequent and accurate clinical observations and monitoring of oxygen concentration in arterial blood are necessary. The dose of the preparation is 100 mg phospholipids / birth kg body weight. (4 ml / kg). During the first 48 hours of life, 4 doses can be given. Doses should not be administered more frequently than every 6 hours. The product is administered intratracheally through a 1.65 mm diameter catheter. One of the following methods is recommended: delivery through a catheter inserted into the tracheal tube during its disconnection for a short time from the ventilator; passing through a catheter inserted through an additional suction port without disconnecting the tracheal tube from the ventilator; administration by a second light of a double-entry intubation tube. Beraktantu should not be administered to the main bronchi. To ensure even distribution of beraktant in the lungs, the calculated dose is given in divided doses - 2 or 4. During the administration of each of the divided doses, the position of the newborn changes.The first dose. When the drug is administered prophylactically should be weighed, intubate the newborn and stabilize its condition. Give the dose as soon as possible after birth, preferably within the first 15 minutes. Distribute the first divided dose over a period of 2-3 seconds. Carry out manual ventilation, providing enough oxygen to prevent cyanosis, at a rate of 60 breaths / min and at sufficient positive pressure. When a drug is administered curative to save life, the first dose should be given as soon as possible after connecting the newborn to the ventilator as part of the management of the respiratory distress syndrome. Directly before the first dose, modify the parameters of the ventilator: respiration rate - 60 / min., Inspiratory time - 0.5 sec. And FiO₂ - 1.0. Both when the drug is administered prophylactically, and when it is administered therapeutically, the newborn should be ventilated for at least 30 s or until its condition has stabilized. Give the remaining doses divided, following the same pattern.After each dose, administer ventilation for at least 30 seconds or until the newborn has stabilized. After resumption of drug administration resume ventilation and clinical care.Next doses. All subsequent doses of beraktant, when given repeatedly, are also 100 mg of phospholipids / kg. and depend on the birth weight of the newborn baby. The newborn should not be re-weighed before the next dose of beraktant. A dosage table should be used to establish the dose. The need for additional doses of beraktant indicate the symptoms of a persistent respiratory distress syndrome. In clinical studies with multiple doses of beraktant, a significant reduction in mortality due to RDS was observed, taking the following criteria when administering the next doses: give the next dose at the earliest 6 hours after the previous dose if the infant remains intubated and requires at least 30% oxygen inhaled to maintain PaO₂ at 80 mmHg (80 tracks); in a newborn who has received a prophylactic dose before additional doses, radiographs should be radiographically confirmed. After each divided dose, ventilate the newborn for at least 30 seconds or until the condition stabilizes. In clinical trials, the ventilator parameters at the time of dosing were different than during the first dose. During the administration of additional doses of FiO₂ increased by 0.2 or by such a fraction that avoided cyanosis. The ventilator operated at a rate of 30 breaths / min with an inspiratory time of less than 1 second. If the frequency of 30 or more breaths / min was not changed before the beraktant was given, the dose was not changed during the application of the beraktant. When administering additional doses, do not carry out manual ventilation with the help of a respiratory bag. After resumption of drug administration resume ventilation and clinical care. Dose table and details on drug administration are included in the Summary of Product Characteristics.