Surfactant - what is it? Surfactant-bl: side effects. Indications for use Surfactant-BL

Surfactant is a special substance that lines the inside of the alveoli of the lungs. Its main function is considered to maintain surface tension and the ability of the lungs to inflate and collapse during breathing. Its role is especially important during the first breath of a newborn. This substance has bactericidal properties, therefore, various medications.

What is surfactant

Surfactant is located in the pulmonary alveoli. It helps the lungs receive and absorb oxygen. The substance consists of proteins, polysaccharides and phospholipids. It is produced in lung tissue.

The functions of surfactant are that it ensures normal breathing. In addition, it promotes better oxygen absorption by participating in immune reactions. It is worth noting that pulmonary surfactant is poorly produced in premature babies, which leads to the development respiratory failure. In an adult, a deficiency of this substance can occur due to burns of the respiratory system, lung injuries, or insufficient intake of fats into the body.

Basic properties

Surfactant is a substance that is complex in its structure and composition. All its components are produced by the lung tissues of a full-term baby, shortly before his birth. It is an insufficiently well-developed surfactant system that often causes breathing problems or congestion of the lungs of newborns, which can ultimately lead to the death of the child.

Immaturity can also be observed in a full-term baby in the presence of provoking factors, such as smoking during pregnancy. It is worth noting that this substance additionally has protective qualities, preventing the formation of inflammatory processes. This substance is characterized by the fact that it:

reduces surface tension in the alveoli;
ensures breathing stability;
normalizes gas exchange;
performs an anti-edematous function.

In addition, surfactant is a substance involved in the antibacterial protection of the alveoli and eliminates the inflammatory process in acute lung damage. Recently, therapy with the introduction of this drug has been widely used in departments. Numerous trials have confirmed the effectiveness of the use of such drugs in treatment critical conditions and other respiratory diseases.

Drugs

Surfactant preparations temporarily replace the natural substance when its formation is impaired. They are used in the treatment of distress syndrome in newborns. Among the main drugs are the following:

"Exosurf";
"Kurosurf";
"ACC";
"Bromhexine."

The drug "Curosurf" contains a surfactant isolated from the lungs of pigs. It helps restore normal breathing, but its use is only permitted in clinical settings.

The drug "Exosurf" facilitates the process of stretching the lungs. The surfactant is administered as a solution through a special tube. If necessary, it is reintroduced.

When inflammatory processes occur in the respiratory system, the drugs “ACC” and “Bromhexine” are used in accordance with the instructions.

For what diseases is it prescribed?

The main purpose of surfactant preparations is determined by their effectiveness in the presence of severe respiratory diseases. These include the following diseases and syndromes:

distress syndrome;
acute lung injury;
tuberculosis;
pneumonia.

Distress syndrome is formed as a result of immaturity of the lungs. A disturbance in the pulmonary circulatory system provokes damage to all components, swelling and infection.

Acute lesion lungs occurs when pathological process in patients who are in It occurs as a result of acute or systemic damage to the lungs with subsequent development inflammatory process. Lack of surfactant leads to pulmonary edema, as well as respiratory failure.

Pneumonia is accompanied by tissue damage and pulmonary edema, which leads to collapse of the alveoli. Surfactant preparations help normalize gas exchange, promoting the expansion of the alveoli.

Pulmonary tuberculosis provokes very serious disorders in the pulmonary system, as well as extensive changes in certain areas. The use of surfactant preparations during complex treatment of tuberculosis can significantly reduce the frequency of changes in lung tissue, which helps reduce the inflammatory process.

Contraindications and precautions

Such drugs are quite well tolerated. However, the administration of surfactant should be carried out by doctors with appropriate training. In some cases, the tracheal tube may become blocked with mucus. Rapid administration of medication may cause bronchial obstruction or reflux. In some cases, bleeding may occur, which is mainly observed when the lungs are immature in newborns.

There are practically no contraindications, but it is worth remembering that sensitivity to individual components of the drug may occur.

The drug "Surfactant-BL"

The drug "Surfactant-BL" is intended for treatment dangerous conditions newborns. The drug is administered by inhalation. Phospholipids of the drug involve the alveoli in respiratory process, which increases blood oxygen saturation and promotes sputum discharge.

The drug helps improve immunity, as well as reduce the risk of pneumonia, which can be very dangerous, especially in the first days of a child’s life. Inhalation administration of the drug helps reduce the severity of distress syndrome by normalizing gas exchange in the lungs. Literally after 2 hours, the level of oxygen in the blood increases noticeably.

At inhalation use medicines active substance has absolutely no noticeable effect on the functioning internal organs.

Instructions for the drug Surfactant-BL, contraindications and methods of use, side effects and reviews about this drug. Doctors' opinions and the opportunity to discuss on the forum.

Medicine

Instructions for use

Shape selection
release and
dosages

Name of the drug on English language

Composition of Surfactant-BL

SURFACTANT-BL

lyophilisate for preparation. emulsions for inhalation. administration 25 mg: vial. 10 pieces.

SURFACTANT-BL

lyophilisate for preparation. emulsions for endotracheal administration 75 mg: fl. 2 or 10 pcs.

Release form Surfactant-BL

SURFACTANT-BL Lyophilisate for the preparation of emulsion for inhalation administration

Bottles (2) - cardboard packs (5) - cardboard boxes.

SURFACTANT-BL Lyophilisate for the preparation of emulsion for endotracheal administration

bottles (2) - cardboard packs.
bottles (10) - cardboard packs.

pharmachologic effect

SURFACTANT-BL

Highly purified natural surfactant obtained from large cattle.

A complex of substances from a mixture of phospholipids and surfactant-associated proteins; reduces the surface tension of the pulmonary alveoli, preventing their collapse and the development of atelectasis. Restores the content of phospholipids on the surface of the alveolar epithelium, stimulates the involvement of additional areas of the pulmonary parenchyma in breathing; promotes the removal of toxic substances from the alveolar space along with sputum. Increases the activity of alveolar macrophages and inhibits the expression and excretion of cytokines by polymorphonuclear leukocytes; stimulates the synthesis of endogenous surfactant by type II alveolocytes and protects the alveolar epithelium from damage by chemical and physical agents.

When administered by inhalation, it has no effect on the cardiovascular system, does not have a local irritating effect, does not affect blood composition and hematopoiesis, with the exception of short-term (1 day after stopping the administration of the drug in doses of 200 and 400 mg/kg) lymphopenia and granulocytosis due to an increase in the number of rod- and segmented neutrophils. Subsequently, the composition of the peripheral blood is completely normalized. Does not affect the biochemical parameters of blood, urine and blood coagulation system, does not cause pathological changes functions and structure of internal organs.

In premature newborns with respiratory distress syndrome, endotracheal administration of the drug during mechanical ventilation improves gas exchange in the lung tissue. 30-120 minutes after administration, signs of hypoxemia decrease, the partial pressure of oxygen in the arterial blood and saturation of Hb with oxygen, and also decreases hypercapnia (partial pressure carbon dioxide), which allows you to switch to more physiological parameters of mechanical ventilation (reduce toxic oxygen concentrations in the inhaled gas mixture to 40%, as well as reduce the total duration of mechanical breathing). Significantly reduces mortality and the incidence of complications in newborns with respiratory distress syndrome.

Pharmacokinetics

SURFACTANT-BL

6-8 hours after a single intratracheal injection, the concentration of surfactant in the lungs decreases and reaches its original value after 12 hours.

The drug is completely utilized in the lungs and does not accumulate in the body.

Describes how the drug enters the body and passes through the tissues; can it accumulate in them and in what quantities, how is it removed from the body.

Indications for use Surfactant-BL

Information on what Surfactant-BL helps with:

SURFACTANT-BL

- respiratory distress syndrome of newborns.

— acute lung injury syndrome and respiratory distress syndrome in adults (including against the background multiple trauma, sepsis, aspiration of gastric contents, endogenous intoxication, massive blood loss and multiple blood transfusions, use of artificial blood pressure pumps during cardiac surgery, severe pneumonia).

Attention! You should not choose your drug using the information in this section. The effect of medications is very individual, and only a specialist should prescribe them.

Contraindications Surfactant-BL

SURFACTANT-BL

— intraventricular hemorrhages of the III-IV stage. in newborns;

- pneumothorax;

- pneumomediastinum;

- interstitial emphysema;

- gas exchange disorders associated with LV insufficiency and bronchial obstruction.

Method of application and dosage Surfactant-BL

SURFACTANT-BL

Respiratory distress syndrome newborns on mechanical ventilation: endotracheal (microjet spraying through the endotracheal tube and side adapter) and inhalation (in the form of an aerosol using a bronchoalveolar nebulizer). The microjet is administered slowly - a dose of 75 mg in a volume of 2.5 ml over 60-90 minutes, in the form of an aerosol through an alveolar nebulizer - in the same dose for 2-3 hours. The drug is administered 1-2 times at a dose of 75 mg/kg in the form 3% emulsion (30 mg in 1 ml of 0.9% sodium chloride solution). When severe respiratory distress syndrome(type 2, due to mixed etiology - immaturity of the lungs and the presence of infections) - 100 mg/kg. The drug is re-administered at intervals of 6-10 hours, if necessary - after several days.

Immediately before administration, 75 mg of lyophilized powder is diluted with 2.5 ml of 0.9% sodium chloride solution for injection. To do this, add 2.5 ml of warm (36°C) 0.9% sodium chloride solution into the bottle and let the bottle stand for 2-3 minutes, then carefully mix the suspension in the bottle without shaking, draw the emulsion into a syringe with a thin needle, pour it back into the bottle along the wall several times (4-5) until completely uniform emulsification, avoiding the formation of foam. The bottle must not be shaken. After dilution, a milky emulsion is formed, devoid of flakes or particulate matter.

Administration of the drug

The newborn is pre-intubated and immediately before the administration of Surfactant-BL, sputum is aspirated from respiratory tract and endotracheal tube. Through an adapter with an additional lateral entrance into the trachea using a syringe pump or drip, the prepared drug is infused over 60-90 minutes. For uniform distribution surfactant various departments lungs, during the infusion of the drug to the child, if the severity of the condition allows, carefully change the position of the body for a few minutes: turning to the right or left side, raising the head end. The procedure is completed with several forced breaths of the patient. It is advisable not to debride the trachea for several hours after the administration of surfactant.

Aerosol administration is carried out using a nebulizer included in the circuit of the ventilator as close as possible to the endotracheal tube to reduce drug losses. It is advisable to use devices that allow the delivery of a surfactant aerosol synchronously with inhalation. To obtain an aerosol and administer the drug, it is necessary to use only non-ultrasonic bronchoalveolar nebulizers, because the surfactant is destroyed when the emulsion is treated with ultrasound.

Acute lung injury and respiratory distress syndrome adults: endobronchially, using a fibrobronchoscope, at a dose of 12 mg/kg body weight per day, divided into 2 injections of 6 mg/kg, performed after 12-16 hours. The drug is administered in the form of a 1.5% emulsion (15 mg in 1 ml of 0.9% sodium chloride solution). Repeated administration of the drug (4-6 injections) may be required until there is a sustained improvement in gas exchange (up to an increase in the oxygenation index of more than 300 mm Hg), an x-ray picture and the possibility of mechanical ventilation with FiO2 less than 40%.

In most cases, the duration of the course of using Surfactant-BL does not exceed two days. In 10-20% of patients, the administration of the drug is not accompanied by normalization of gas exchange (especially patients with severe multiple organ failure). If oxygenation does not improve within 2 days, the drug is discontinued.

Rules for preparing emulsion

75 mg of lyophilized powder is diluted in the same way as for newborns, in 2.5 ml of 0.9% sodium chloride solution. The resulting emulsion is diluted with an additional 0.9% sodium chloride solution to 5 ml, obtaining a 1.5% emulsion of the drug (15 mg in 1 ml of 0.9% sodium chloride solution).

Administration of the drug

Endobronchial administration of the drug is preceded by a thorough sanitation bronchoscopy, carried out according to standard techniques, at the end of which an equal amount of the drug emulsion is injected into each lung. Best effect is achieved by introducing the emulsion into each segmental bronchus. The volume of the injected emulsion is determined by the dose of the drug.

Intratracheal instillation is indicated if bronchoscopy is not possible. The emulsion is prepared according to the method described above. Before administering the drug, it is necessary to thoroughly sanitize the tracheobronchial tree, having previously taken measures to improve sputum drainage (vibromassage, postural therapy, mucolytics in the absence of contraindications to their use). The emulsion is injected through a catheter installed into the endotracheal tube so that the end of the catheter is located below the opening of the endotracheal tube, but always above the carina of the trachea. The emulsion must be administered in 2 doses (dividing the dose in half), with an interval of 10 minutes.

At tuberculosis(after selecting multicomponent antimycobacterial therapy) - inhalation before or 1.5-2 hours after meals at a dose of 25 mg 5 times a week for the first 2 weeks, then 3 times a week for the next 6 weeks. Course duration: 8 weeks, 28 inhalations.

Side effects of Surfactant-BL

SURFACTANT-BL

Newborns: short-term reflux (retrograde release of the drug emulsion), which is eliminated by several forced breaths of air or an oxygen-air mixture (when using the aerosol method of administration, such phenomena are not observed); bleeding in the lungs 1-2 days after administration in premature infants with low birth weight; retinopathy - with a rapid and significant increase in the partial oxygen tension in the blood; short-term hyperemia skin(requires assessment of the adequacy of mechanical ventilation parameters to exclude hypoventilation due to transient airway obstruction).

Adults: specific side effects not found. With endobronchial administration, there is a deterioration in gas exchange lasting 10-60 minutes, associated with the bronchoscopy procedure itself.

Almost all drugs have side effects. As a rule, this occurs when taking drugs in maximum doses, when using the medicine for a long time, when taking several medications at once. Individual intolerance to a particular substance is also possible. This can have serious consequences, so if medicine causes side effects for you, you need to stop taking it and consult a specialist.

special instructions

SURFACTANT-BL

The use of Surfactant-BL is possible only in a specialized intensive care unit.

Newborns

An important factor in the effectiveness of the use of Surfactant-BL in complex treatment respiratory distress syndrome of newborns is the timely initiation of therapy, within the first day ( better than the first hours) after birth. The use of high-frequency oscillatory ventilation significantly increases efficiency and reduces the frequency adverse reactions.

Before administering Surfactant-BL, it is necessary to stabilize central hemodynamics and maintain adequate diuresis. Spontaneous breathing of the child is unacceptable. If spontaneous breathing is present or occurs during drug administration, ventilation parameters should be corrected or drug synchronization with the ventilator should be used. It is necessary to check the correct position (depth of position) of the endotracheal tube.

After administration of the drug it is possible rapid rise partial tension of oxygen and reduction of partial tension of carbon dioxide, as well as blood CBS. In this regard, it is necessary to regularly monitor these indicators. You should simultaneously change the parameters of mechanical ventilation in accordance with the degree of blood oxygenation to reduce the risk of developing hyperoxia. Before administering the drug, it is necessary to carry out a correction metabolic acidosis(reduces the effectiveness of the drug). In the first minutes after microjet administration of Surfactant-BL, large bubble rales may be heard in the lungs during inspiration. For 4-6 hours after administration, you should refrain from draining the contents of the bronchi. In children with intrapartum respiratory tract infection, administration of the drug may increase sputum production due to activation of mucociliary clearance, which requires their sanitation at an earlier date.

Drug for the treatment of respiratory distress syndrome of newborns

Active substance

Surfactant

Release form, composition and packaging

Lyophilisate for the preparation of emulsion for endotracheal, endobronchial and inhalation administration in the form of a white or white with a yellowish tint pressed into a tablet mass or powder, a prepared emulsion of white with a creamy or white with a yellowish tint, homogeneous, in which flakes or solid particles should not be observed.

75 mg - Glass bottles with a capacity of 10 ml (2) - cardboard packs (5) - cardboard boxes.

pharmachologic effect

Surfactant-BL, a highly purified natural surfactant from the lungs of cattle, is a complex of substances from a mixture of phospholipids and surfactant-associated proteins, has the ability to reduce surface tension on the surface of the pulmonary alveoli, preventing their collapse and the development of atelectasis.

Surfactant-BL restores the content of phospholipids on the surface of the alveolar epithelium, stimulates the involvement of additional areas of the pulmonary parenchyma in breathing and promotes the removal of toxic substances and infectious agents from the alveolar space along with sputum. The drug increases the activity of alveolar macrophages and inhibits the expression of cytokines by polymorphonuclear leukocytes (including eosinophils); improves mucociliary clearance and stimulates the synthesis of endogenous surfactant by type II alveolocytes, and also protects the alveolar epithelium from damage by chemical and physical agents, restores the functions of local innate and acquired immunity.

The experiment established that with daily inhalation administration for 10 days or 6 months and additional observation for one month, the drug has no effect on cardiovascular system, does not have a local irritating effect, does not affect the composition of the blood and hematopoiesis, does not affect the biochemical parameters of blood, urine and the blood coagulation system, does not cause pathological changes in the functions and structure of internal organs, does not have teratogenic, allergenic and mutagenic properties.

It has been established that in premature newborns with respiratory distress syndrome (RDS) who are on artificial pulmonary ventilation (ALV), endotracheal, microjet or bolus administration of surfactant-BL can significantly improve gas exchange in the lung tissue. With a microjet injection after 30-120 minutes, and with a bolus after 10-15 minutes, signs of hypoxemia decrease, the partial tension of oxygen in arterial blood (PaO 2) and saturation of hemoglobin (Hb) with oxygen increases, and hypercapnia decreases (the partial tension of carbon dioxide decreases ). Restoring the function of the lung tissue allows you to switch to more physiological parameters of mechanical ventilation and reduce its duration. When using surfactant-BL, mortality and the incidence of complications in newborns with RDS are significantly reduced. It has also been established that in adults with acute lung injury syndrome (ALI) and acute respiratory distress syndrome (ARDS), early, on the first day of development of ARDS, endobronchial administration of the drug halves the time patients spend on mechanical ventilation and in the intensive care unit and intensive care(ICU), prevents the development of purulent-septic complications associated with prolonged mechanical ventilation (purulent and ventilator-associated pneumonia), and significantly reduces mortality in direct and indirect lung damage. A more pronounced and earlier effect of therapy is observed with the combined use of endobronchial administration of surfactant-BL and the lung “opening” maneuver.

The clinic has established that in patients with lungs who have not responded positively to treatment with anti-tuberculosis drugs (ATDs) for 2-6 months, when adding a two-month course of inhalation of the drug to the treatment regimen, abacillation is achieved in 80.0% of patients, a decrease or disappearance of infiltrative and focal changes lung tissue in 100% and closure of the cavity(s) in 70% of patients. Thus, complex anti-tuberculosis treatment with the addition of a course of surfactant-BL inhalations makes it possible to receive positive result from treatment significantly faster and in a significantly larger percentage of patients.

Pharmacokinetics

It has been experimentally shown that after a single intratracheal administration of surfactant-BL to rats, its content in the lungs drops after 6-8 hours and reaches the initial value after 12 hours. The drug is completely metabolized in the lungs by type II alveolocytes and alveolar macrophages and does not accumulate in the body.

Indications

— respiratory distress syndrome (RDS) in newborns with a birth weight of more than 800 g;

- V complex therapy acute lung injury syndrome (ALI) and acute respiratory distress syndrome (ARDS) in adults, developing as a result of direct or indirect lung injury;

- in complex therapy of pulmonary tuberculosis, both in newly diagnosed patients and in case of relapse of the disease, with infiltrative (with and without decay) or cavernous clinical form, including in the presence of drug resistance of Mycobacterium tuberculosis, up to multidrug resistance.

Contraindications

For respiratory distress syndrome (RDS) of newborns:

— intraventricular hemorrhages of III-IV degrees;

- air leak syndrome (pneumomediastinum, interstitial emphysema);

- developmental defects incompatible with life;

— DIC syndrome with symptoms of pulmonary hemorrhage;

For ARDS and SOPL in adults:

- gas exchange disorders associated with left ventricular heart failure;

- gas exchange disorders caused by broncho-obstruction;

- air leak syndrome.

For pulmonary tuberculosis:

- tendency to hemoptysis and pulmonary hemorrhages;

- children under 18 years of age, since clinical trials in this age group have not been carried out and doses have not been determined;

- air leak syndrome.

Dosage

Before starting treatment, it is necessary to correct acidosis, arterial hypotension, anemia, hypoglycemia and hypothermia. Radiological confirmation of RDS is desirable.

The drug is administered micro-jet, in the form of an aerosol through a nebulizer or bolus. With microjet administration, the surfactant-BL emulsion is administered slowly using a syringe dispenser (a dose of 75 mg in a volume of 2.5 ml) over 30 minutes, and in the form of an aerosol through an alveolar nebulizer - the same dose over 60 minutes. Surfactant-BL can be administered as a bolus at a dose of 50 mg/kg body weight (in a volume of 1.7 ml/kg). The second and, if necessary, third time, the drug is administered after 8-12 hours in the same doses, if the child continues to need increased concentration oxygen in the supplied gas mixture (FiO 2 >0.4). It should be remembered that repeated administrations of surfactant-BL are less effective if the first administration was delayed (late).

In the case of severe RDS (type 2 RDS, which often develops in full-term infants due to meconium aspiration, intrauterine pneumonia, sepsis) it is necessary to use a large dose of surfactant-BL - 100 mg/kg. The drug is also re-administered at intervals of 8-12 hours, and, if necessary, for several days.

An important factor in the effectiveness of the use of surfactant-BL in the complex treatment of RDS in newborns is the early start of surfactant-BL therapy, within two hours after birth when established diagnosis RDS, but not later than the first day after birth.

The use of high-frequency oscillatory ventilation significantly increases the effectiveness of surfactant-BL therapy and reduces the incidence of adverse reactions.

Preparation of the emulsion:

Immediately before administration, surfactant-BL (75 mg in a vial) is diluted with 2.5 ml of a 0.9% solution for injection. To do this, add 2.5 ml of warm (37°C) 0.9% sodium chloride solution into the bottle and let the bottle stand for 2-3 minutes, then carefully mix the suspension in the bottle without shaking, draw the emulsion into a syringe with a thin needle, pour it back into the bottle along the wall several (4-5) times until completely uniform emulsification, avoiding the formation of foam. The bottle must not be shaken. After dilution, a milky emulsion is formed; there should be no flakes or solid particles in it.

Administration of the drug.

Microjet injection. The child is first intubated and sputum is aspirated from the airway and endotracheal tube (ET). Important It has correct location and compliance of the size of the ET with the diameter of the trachea, since with a large leakage of the emulsion past the ET (more than 25% on a respiratory monitor or auscultation), as well as with selective intubation into the right bronchus or a high standing ET, the effectiveness of surfactant-BL therapy is significantly reduced or devalued. Next, the breathing cycle of the newborn is synchronized with the operating mode of the ventilator using sedatives- or diazepam, and in cases of severe hypoxia - narcotic analgesics. The prepared surfactant-BL emulsion is administered through a catheter inserted through an adapter with an additional side entrance into the ET so that the lower end of the catheter does not reach the lower edge of the endotracheal tube by 0.5 cm. Administration is carried out using a syringe dispenser for 30 minutes, without interrupting mechanical ventilation, without depressurization of the breathing circuit. To distribute the surfactant evenly throughout the various parts of the lungs during drug administration, if the severity of the child’s condition allows, the first half of the dose is administered with the child positioned on the left side, and the second half of the dose with the child positioned on the right side. At the end of the administration, 0.5 ml of 0.9% sodium chloride solution is drawn into the syringe and the administration is continued to displace the remaining drug from the catheter. It is advisable not to carry out sanitation of the trachea for 2-3 hours after the administration of surfactant-BL.

Aerosol administration surfactant-BL carried out using an alveolar nebulizer included in the circuit of a ventilator synchronized with inhalation, as close as possible to the endotracheal tube to reduce drug losses. If this is not possible, it is preferable to use a micro-jet or bolus route of administration. Ultrasonic nebulizers cannot be used to obtain an aerosol and administer the drug, since surfactant-BL is destroyed when the emulsion is treated with ultrasound. It is necessary to use compressor-type nebulizers.

Bolus administration of surfactant-BL. Before administering the drug, as with microjet administration, stabilization of central hemodynamics, correction of hypoglycemia, hypothermia and metabolic acidosis are carried out. Radiological confirmation of RDS is desirable. The child is intubated and sputum from the respiratory tract and ET are aspirated. Immediately before the administration of surfactant-BL, the child can be temporarily transferred to manual ventilation using a self-expanding Ambu-type bag. If necessary, the child is sedated with sodium hydroxybutyrate or diazepam. The prepared surfactant-BL emulsion (30 mg/ml) is used at a dose of 50 mg/kg in a volume of 1.7 ml/kg. For example, a child weighing 1500 g is administered 75 mg (50 mg/kg) in a volume of 2.5 ml. The drug is administered as a bolus over 1-2 minutes through a catheter placed in the endotracheal tube, while the child is carefully turned on the left side and the first half of the dose is administered, then turned on the right side and the second half of the dose is administered. The introduction is completed with forced manual ventilation for 1-2 minutes with a concentration of inhaled oxygen equal to the initial value on the ventilator or manual ventilation using a self-expanding Ambu-type bag. Monitoring the saturation of hemoglobin with oxygen is mandatory; monitoring the content of blood gases before and after the administration of surfactant-BL is desirable.

Next, the child is transferred to assisted ventilation or forced mechanical ventilation and the ventilation parameters are adjusted. Bolus administration of the drug allows you to quickly deliver a therapeutic dose into the alveolar space and avoid the inconvenience and adverse reactions of microjet administration.

For full-term newborns weighing more than 2.5 kg with a severe form of type 2 RDS, due to the large volume of the emulsion, half the dose is administered as a bolus, and the other half of the dose as a micro-jet.

Bolus administration can also be used for prophylactic administration of surfactant-BL. Subsequently, depending on the initial condition and the effectiveness of therapy, the child can be extubated with a possible transfer to a non-invasive method of ventilation with the maintenance of continuous positive airway pressure (CP AR).

2. Treatment of acute lung injury syndrome and acute respiratory distress syndrome in adults.

Treatment with surfactant-BL is carried out by endobronchial bolus administration using a fiberoptic bronchoscope. The drug is administered at a dose of 12 mg/kg/day. The dose is divided into two injections of 6 mg/kg every 12-16 hours. Repeated administration of the drug (4-6 injections) may be required until there is a sustained improvement in gas exchange (an increase in the oxygenation index of more than 300 mmHg) and an increase in the airiness of the lungs on chest x-ray and the possibility of performing mechanical ventilation with FiO 2< 0.4.

In most cases, the duration of the course of using surfactant-BL does not exceed two days. In 10-20% of patients, the use of the drug is not accompanied by normalization of gas exchange, primarily in those patients to whom the drug is administered against the background of advanced multiple organ failure (MOF). If there is no improvement in oxygenation within two days, the administration of the drug is stopped.

The most important factor in the effectiveness of the use of surfactant-BL in the complex treatment of SOPL/ARDS is the time of initiation of drug administration. It must be started within the first 24 hours (preferably the first hours) from the moment the oxygenation index drops below 250 mmHg.

The drug can also be administered prophylactically if there is a threat of development of SOPL/ARDS in patients with chronic diseases lungs, including those with chronic obstructive pulmonary disease (COPD), as well as before extensive operations on chest at a dose of 6 mg/kg per day, 3 mg/kg every 12 hours.

Preparation of the emulsion. Before administration, surfactant-BL (75 mg in a bottle) is diluted in the same way as for newborns in 2.5 ml of 0.9% sodium chloride solution. The resulting emulsion, which should not contain flakes or solid particles, is diluted with an additional 0.9% sodium chloride solution to 5 ml (15 mg per 1 ml).

Endobronchial administration is the optimal method of drug delivery. The administration of surfactant-BL is preceded by a thorough sanitation bronchoscopy, carried out according to standard methods. At the end of this procedure, an equal amount of the drug emulsion is injected into each lung. The best effect is achieved by introducing the emulsion into each segmental bronchus. The volume of the injected emulsion is determined by the dose of the drug.

Most effective way The use of surfactant-BL in the treatment of SOPL/ARDS is a combination of endobronchial administration of the drug and the “opening” of the lungs maneuver, and the segment-by-segment administration of the drug is carried out immediately before the “opening” of the lungs maneuver.

After administration of the drug, for 2-3 hours it is necessary to refrain from sanitation of the bronchi and not to use drugs that increase sputum secretion. The use of intratracheal instillation is indicated if bronchoscopy is impossible. The emulsion is prepared according to the method described above. Before administering the drug, it is necessary to thoroughly sanitize the tracheobronchial tree, having previously taken measures to improve sputum drainage (vibromassage, postural therapy). The emulsion is injected through a catheter installed into the endotracheal tube so that the end of the catheter is located below the opening of the endotracheal tube, but always above the carina of the trachea. The emulsion must be administered in two doses, dividing the dose in half, with an interval of 10 minutes. In this case, also after instillation, a lung “opening” maneuver can be performed.

Treatment of pulmonary tuberculosis is carried out by repeated inhalations of the drug surfactant-BL as part of complex therapy against the background of fully developed therapy with anti-tuberculosis drugs (ATDs), that is, when the patient is empirically or based on data on the drug sensitivity of the pathogen, 4-6 ADTs are selected, which in the prescribed dose and combination are well tolerated by patients. Only then is the patient prescribed surfactant-BL emulsion in inhalation at a dose of 25 mg per administration:

- the first 2 weeks - 5 times a week;

- the next 6 weeks - 3 times a week (every 1-2 days). The duration of the course is 8 weeks - 28 inhalations, the total dose of surfactant-BL is 700 mg. During the course of treatment with surfactant-BL, anti-tuberculosis drugs can be discontinued (replaced) according to indications. Chemotherapy continues after completion of the course of treatment with surfactant-BL.

Preparation of the emulsion: before use, surfactant-BL (75 mg in a bottle) is diluted in the same way as for newborns in 2.5 ml of 0.9% sodium chloride solution. The resulting emulsion, which should not contain flakes or solid particles, is diluted with an additional 0.9% sodium chloride solution to 6 ml (12.5 mg per 1 ml). Next, 2.0 ml of the resulting emulsion is transferred to the nebulizer chamber and another 3.0 ml of 0.9% sodium chloride solution is added to it, stirring carefully. Thus, the nebulizer chamber contains 25 mg of surfactant-BL in 5.0 ml of emulsion. This is the dose for one inhalation to one patient. Thus, 1 bottle of surfactant-BL contains three doses for inhalation in three patients. The emulsion prepared for inhalation must be used within 12 hours when stored at a temperature of +4°C - +8°C (do not freeze the emulsion). Before use, the emulsion must be carefully mixed and warmed to 36°C-37°C.

Inhalation administration: 5.0 ml of the resulting emulsion (25 mg) located in the nebulizer chamber is used for inhalation. Inhalations are carried out 1.5-2 hours before or 1.5-2 hours after meals. For inhalation, compressor-type inhalers are used, for example, "Boreal" from Flaem Nuova, Italy or "Pari Boy SX" from Pari GmbH, Germany or their analogues, which allow spraying small volumes of drugs and are equipped with an economizer device that allows you to stop the supply of the drug during exhalation time, which significantly reduces drug loss. The use of an economizer is extremely important so that the patient receives a therapeutic dose of the drug without loss (25 mg). If, due to the severity of the condition, the patient cannot use the entire volume of the emulsion, breaks should be taken for 15-20 minutes and then continue inhalation. In the presence of large quantity sputum should be coughed up thoroughly before inhalation. If there is evidence of bronchial obstruction, 30 minutes before inhalation of the surfactant-BL emulsion, it is necessary to first inhale a beta 2-adrenergic agonist (at the doctor's choice) that reduces bronchial obstruction. It is necessary to use only compressor and not ultrasonic nebulizers, since surfactant-BL is destroyed when the emulsion is treated with ultrasound. Before administering the drug, it is necessary to carry out a thorough sanitation of the tracheobronchial tree, having previously taken measures to improve sputum drainage: vibration massage, postural therapy and mucolytics, which must be prescribed 3-5 days before the start of surfactant-BL therapy in the absence of contraindications to their use.

Side effects

1. For respiratory distress syndrome (RDS) of newborns:

With microjet and bolus administration of surfactant-BL, obstruction with the ET drug or regurgitation of the emulsion may occur. This can occur if the section of the instructions “preparation of the emulsion” is not followed (use of 0.9% sodium chloride solution with a temperature below 37°C, non-uniform emulsion), with a rigid chest, high activity of the child, accompanied by coughing, crying, discrepancy between the size of the ET and the internal diameter of the trachea, selective intubation, administration of surfactant-BL into one bronchus, or a combination of these factors. If all these factors are excluded or eliminated, then in this case it is necessary to briefly increase the peak inspiratory pressure (P peak) for a child on mechanical ventilation. If a child shows signs of airway obstruction when he is not on mechanical breathing, it is necessary to give several respiratory cycles using manual ventilation with high blood pressure to move the drug deeper. When using the aerosol method of administering the drug, such phenomena are not observed. Physical and instrumental monitoring of hemodynamics and hemoglobin oxygen saturation (SaO 2) is required. Bleeding in the lungs may occur, usually within 1-2 days after administration of the drug in premature infants with low or extremely low birth weight. Prevention of pulmonary hemorrhage consists of early diagnosis and adequate treatment functioning ductus arteriosus. With a rapid and significant increase in the partial oxygen tension in the blood, retinopathy can develop. The oxygen concentration in the inhaled mixture should be reduced as quickly as possible to a safe value, maintaining the target hemoglobin oxygen saturation within 86-93%. Some newborns experience short-term hyperemia of the skin, requiring assessment of the adequacy of mechanical ventilation parameters to exclude hypoventilation due to transient airway obstruction. In the first minutes after microjet and bolus administration of surfactant-BL, large bubble rales may be heard in the lungs during inspiration. For 2-3 hours after using surfactant-BL, you should refrain from sanitation of the bronchi. In children with intrapartum respiratory tract infection, administration of the drug may increase sputum production due to activation of mucociliary clearance, which may require their sanitation at an earlier date.

2. For ARDS and nozzle in adults:

To date, there have been no specific adverse reactions in the treatment of surfactant-BL for nostrils and ARDS. of various origins was not observed. If the endobronchial route of administration is used, a deterioration in gas exchange lasting from 10 to 60 minutes is possible, associated with the bronchoscopy procedure itself. When arterial blood hemoglobin saturation with oxygen (SaO2) decreases below 90%, it is necessary to temporarily increase positive end-expiratory pressure (PEEP) and the oxygen concentration in the gas mixture supplied to the patient (FiO2). In the case of a combination of endobronchial administration of surfactant-BL and the maneuver of “opening” the lungs, no deterioration in gas exchange was observed.

3. For pulmonary tuberculosis:

When treating pulmonary tuberculosis, in 60-70% of patients after 3-5 inhalations there is a significant increase in the volume of sputum discharge or sputum appears that was not there before the start of inhalations. The effect of “easy sputum discharge” is also noted, while the intensity and pain of cough is significantly reduced, and exercise tolerance is improved. These objective changes and subjective feelings are a manifestation direct action surfactant-BL and are not adverse reactions.

Overdose

Surfactant-BL for intravenous, intraperitoneal and subcutaneous methods administration to mice at a dose of 600 mg/kg and inhalation administration to rats at a dose of 400 mg/kg does not cause changes in the behavior and condition of the animals. In no case was there any death of animals. During clinical use, no cases of overdose were observed.

Drug interactions

Surfactant-BL cannot be used in conjunction with expectorants, since the latter will remove the administered drug along with sputum.

special instructions

The use of surfactant-BL for the treatment of critical conditions of newborns and adults is possible only in a specialized intensive care unit, and for the treatment of pulmonary tuberculosis - in a hospital and a specialized anti-tuberculosis dispensary.

1. Treatment of respiratory distress syndrome (RDS) in newborns.

Before administering surfactant-BL, mandatory stabilization of central hemodynamics and correction of metabolic acidosis, hypoglycemia and hypothermia, which negatively affect the effectiveness of the drug, are necessary. Radiological confirmation of RDS is desirable.

2. Treatment of nozzle and ARDS.

The drug should be used as part of a comprehensive treatment of acute respiratory failure and ARDS, including rational respiratory support, antibiotic therapy, maintenance of adequate hemodynamics and water-electrolyte balance.

The question of the use of surfactant-BL for POPL combined with severe multiple organ failure (MOF) should be decided individually, depending on the possibility of correcting other components of MOF.

3. Treatment of pulmonary tuberculosis.

In rare cases, after 2-3 inhalations, hemoptysis may occur. In this case, it is necessary to interrupt the course of treatment with surfactant-BL and continue it after 3-5 days.

Surfactant-BL has not been observed to be incompatible with any anti-tuberculosis drug. There are no data on interactions with anti-tuberculosis drugs administered in aerosols, so this combination should be avoided.

Impact on the ability to drive vehicles and operate machinery

Surfactant-BL therapy does not affect the ability to drive vehicles.

Pregnancy and lactation

It is used for health reasons in the treatment of ARDS.

Use in childhood

The drug is used for the treatment of respiratory distress syndrome (RDS) in newborns with a birth weight of more than 800 g. Contraindicated in:

Intraventricular hemorrhages of III-IV degrees;

— air leak syndrome (pneumothorax, pneumomediastinum, interstitial emphysema);

- developmental defects incompatible with life;

— DIC syndrome with symptoms of pulmonary hemorrhage;

Contraindicated in children under 18 years of age for the treatment of ARDS, SOPL and pulmonary tuberculosis, since clinical trials have not been conducted in this age group and doses have not been determined.

Conditions for dispensing from pharmacies

By doctor's prescription. Used in hospital settings.

Storage conditions and periods

In a place protected from light, at a temperature not exceeding minus 5°C. Keep out of the reach of children. Shelf life - 1 year.

Before using SURFACTANT-BL, you should consult your doctor. These instructions for use are for informational purposes only. To get more complete information Please refer to the manufacturer's instructions.

Clinical and pharmacological group

12.062 (Drug for the treatment of respiratory distress syndrome of newborns)

pharmachologic effect

Highly purified natural surfactant obtained from cattle.

When administered by inhalation, it has no effect on the cardiovascular system, does not have a local irritating effect, does not affect blood composition and hematopoiesis, with the exception of short-term (1 day after stopping the administration of the drug in doses of 200 and 400 mg/kg) lymphopenia and granulocytosis due to an increase in the number of rod- and segmented neutrophils. Subsequently, the composition of the peripheral blood is completely normalized. Does not affect the biochemical parameters of blood, urine and the blood coagulation system, does not cause pathological changes in the functions and structure of internal organs.

In premature newborns with respiratory distress syndrome, endotracheal administration of the drug during mechanical ventilation improves gas exchange in the lung tissue. 30-120 minutes after administration, signs of hypoxemia decrease, the partial pressure of oxygen in arterial blood and Hb oxygen saturation increase, and hypercapnia (partial pressure of carbon dioxide) decreases, which makes it possible to switch to more physiological parameters of mechanical ventilation (reduce toxic oxygen concentrations in the inhaled gas mixture up to 40%, and also reduce the total duration of mechanical breathing). Significantly reduces mortality and the incidence of complications in newborns with respiratory distress syndrome.

Pharmacokinetics

6-8 hours after a single intratracheal injection, the concentration of surfactant in the lungs decreases and reaches its original value after 12 hours.

The drug is completely utilized in the lungs and does not accumulate in the body.

SURFACTANT-BL: DOSAGE

Respiratory distress syndrome of newborns on mechanical ventilation: endotracheal (microjet spraying through the endotracheal tube and side adapter) and inhalation (in the form of an aerosol using a bronchoalveolar nebulizer). The microjet is administered slowly - a dose of 75 mg in a volume of 2.5 ml over 60-90 minutes, in the form of an aerosol through an alveolar nebulizer - in the same dose for 2-3 hours. The drug is administered 1-2 times at a dose of 75 mg/kg in the form 3% emulsion (30 mg in 1 ml of 0.9% solution). In the case of severe respiratory distress syndrome (type 2, caused by mixed etiology - immaturity of the lungs and the presence of infections) - 100 mg/kg. The drug is re-administered at intervals of 6-10 hours, if necessary - after several days.

Administration of the drug

The newborn is pre-intubated and immediately before the administration of Surfactant-BL, sputum is aspirated from the respiratory tract and endotracheal tube. Through an adapter with an additional lateral entrance into the trachea using a syringe pump or drip, the prepared drug is infused over 60-90 minutes. To distribute the surfactant evenly throughout the various parts of the lungs, during the infusion of the drug to the child, if the severity of the condition allows, carefully change the position of the body for several minutes: turning to the right or left side, raising the head end. The procedure is completed with several forced breaths of the patient. It is advisable not to debride the trachea for several hours after the administration of surfactant.

Acute lung injury syndrome and respiratory distress syndrome in adults: endobronchially, using a fiberoptic bronchoscope, at a dose of 12 mg/kg body weight per day, divided into 2 injections of 6 mg/kg, performed every 12-16 hours. The drug is administered as 1.5 % emulsion (15 mg in 1 ml of 0.9% sodium chloride solution). Repeated administration of the drug (4-6 injections) may be required until there is a sustained improvement in gas exchange (up to an increase in the oxygenation index of more than 300 mm Hg), x-ray picture and the possibility of mechanical ventilation with FiO2 less than 40%.

Rules for preparing emulsion

Administration of the drug

Endobronchial administration of the drug is preceded by a thorough sanitation bronchoscopy, carried out according to standard techniques, at the end of which an equal amount of the drug emulsion is injected into each lung. The best effect is achieved by introducing the emulsion into each segmental bronchus. The volume of the injected emulsion is determined by the dose of the drug.

For tuberculosis (after selecting multicomponent antimycobacterial therapy) - inhalation before or 1.5-2 hours after meals at a dose of 25 mg 5 times a week for the first 2 weeks, then 3 times a week for the next 6 weeks. Course duration: 8 weeks, 28 inhalations.

SURFACTANT-BL: SIDE EFFECTS

Newborns: short-term reflux (retrograde release of the drug emulsion), which is eliminated by several forced breaths of air or an oxygen-air mixture (when using the aerosol method of administration, such phenomena are not observed); bleeding in the lungs 1-2 days after administration in premature infants with low birth weight; retinopathy - with a rapid and significant increase in the partial oxygen tension in the blood; short-term hyperemia of the skin (requires assessment of the adequacy of mechanical ventilation parameters to exclude hypoventilation due to transient airway obstruction).

Adults: no specific side effects have been identified. With endobronchial administration, there is a deterioration in gas exchange lasting 10-60 minutes, associated with the bronchoscopy procedure itself.

Indications

respiratory distress syndrome of newborns.
acute lung injury syndrome and respiratory distress syndrome in adults (incl.
against the background of multiple trauma,
sepsis,
aspiration of gastric contents,
endogenous intoxication,
massive blood loss and multiple blood transfusions,
use of AIK during cardiac surgery,
severe pneumonia).

Contraindications

intraventricular hemorrhages grade III-IV.
in newborns;
pneumothorax;
pneumomediastinum;
interstitial emphysema;
gas exchange disorders,
associated with LV failure and bronchial obstruction.

special instructions

The use of Surfactant-BL is possible only in a specialized intensive care unit.

Newborns

An important factor in the effectiveness of the use of Surfactant-BL in the complex treatment of respiratory distress syndrome in newborns is the timely initiation of therapy, within the first day (preferably the first hours) after birth. The use of high-frequency oscillatory ventilation significantly increases efficiency and reduces the incidence of adverse reactions.

After administration of the drug, a rapid increase in the partial tension of oxygen and a decrease in the partial tension of carbon dioxide, as well as blood CBS, are possible. In this regard, it is necessary to regularly monitor these indicators. You should simultaneously change the parameters of mechanical ventilation in accordance with the degree of blood oxygenation to reduce the risk of developing hyperoxia. Before administering the drug, it is necessary to correct metabolic acidosis (reduces the effectiveness of the drug). In the first minutes after microjet administration of Surfactant-BL, large bubble rales may be heard in the lungs during inspiration. For 4-6 hours after administration, you should refrain from draining the contents of the bronchi. In children with intrapartum respiratory tract infection, administration of the drug may increase sputum production due to activation of mucociliary clearance, which requires their sanitation at an earlier date.

Prevention of pulmonary hemorrhage during drug administration consists of early diagnosis and adequate treatment of a functioning ductus arteriosus.

Adults

Therapy should be started within the first day (preferably the first hours) from the moment the oxygenation index drops below 200 mm Hg. The issue of using Surfactant-BL for acute lung injury syndrome, combined with severe multiple organ failure, should be decided individually, depending on the possibility of correcting other components of multiple organ failure.

If the level of Hb oxygenation decreases after drug administration by more than 10%, it is necessary to temporarily increase the level of positive end-expiratory pressure and FiO2.

lyophilisate for preparation. emulsions for inhalation. administration 25 mg: vial. 10 pieces. Reg. No.: LSR-010019/08

Clinical and pharmacological group:

Drug for the treatment of respiratory distress syndrome of newborns

Release form, composition and packaging

25 mg - bottles (2) - cardboard packs (5) - cardboard boxes.

Description of the active components of the drug " Surfactant-bl»

pharmachologic effect

Highly purified natural surfactant obtained from cattle.

When administered by inhalation, it has no effect on the cardiovascular system, does not have a local irritating effect, does not affect blood composition and hematopoiesis, with the exception of short-term (1 day after stopping the administration of the drug in doses of 200 and 400 mg/kg) lymphopenia and granulocytosis due to an increase in the number of rod- and segmented neutrophils. Subsequently, the composition of the peripheral blood is completely normalized. Does not affect the biochemical parameters of blood, urine and the blood coagulation system, does not cause pathological changes in the functions and structure of internal organs.

In premature newborns with respiratory distress syndrome, endotracheal administration of the drug during mechanical ventilation improves gas exchange in the lung tissue. 30-120 minutes after administration, signs of hypoxemia decrease, the partial pressure of oxygen in arterial blood and Hb oxygen saturation increase, and hypercapnia (partial pressure of carbon dioxide) decreases, which makes it possible to switch to more physiological parameters of mechanical ventilation (reduce toxic oxygen concentrations in the inhaled gas mixture up to 40%, and also reduce the total duration of mechanical breathing). Significantly reduces mortality and the incidence of complications in newborns with respiratory distress syndrome.

Indications

- respiratory distress syndrome of newborns.

— acute lung injury syndrome and respiratory distress syndrome in adults (including against the background of multiple trauma, sepsis, aspiration of gastric contents, endogenous intoxication, massive blood loss and multiple blood transfusions, use of artificial blood pressure during cardiac surgery, severe pneumonia).

Dosage regimen

Administration of the drug

Rules for preparing emulsion

Administration of the drug

Endobronchial administration of the drug is preceded by a thorough sanitation bronchoscopy, carried out according to standard techniques, at the end of which an equal amount of the drug emulsion is injected into each lung. The best effect is achieved by introducing the emulsion into each segmental bronchus. The volume of the injected emulsion is determined by the dose of the drug.

Side effect

Newborns: short-term reflux (retrograde release of the drug emulsion), which is eliminated by several forced breaths of air or an oxygen-air mixture (when using the aerosol method of administration, such phenomena are not observed); bleeding in the lungs 1-2 days after administration in premature infants with low birth weight; retinopathy - with a rapid and significant increase in the partial oxygen tension in the blood; short-term hyperemia of the skin (requires assessment of the adequacy of mechanical ventilation parameters to exclude hypoventilation due to transient airway obstruction).

Contraindications

— intraventricular hemorrhages of the III-IV stage. in newborns;

- pneumothorax;

- pneumomediastinum;

- interstitial emphysema;

- gas exchange disorders associated with LV insufficiency and bronchial obstruction.

Application for children

Used according to indications in newborns.

special instructions

The use of Surfactant-BL is possible only in a specialized intensive care unit.

Newborns

Prevention of pulmonary hemorrhage during drug administration consists of early diagnosis and adequate treatment of a functioning ductus arteriosus.

Adults

If the level of Hb oxygenation decreases after drug administration by more than 10%, it is necessary to temporarily increase the level of positive end-expiratory pressure and FiO2.