Buy Survanta® suspension 25 mg/ml 4 ml bottle 1pc. packaging
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Survanta® [Beractant]

EbbVi Ltd.
1583 Items
2019-09-19
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Clinical Pharmacology

The mechanism of action of Beractant is based on reducing the surface tension of the alveolar walls during breathing and preventing the alveoli from falling off at the end of expiration (expiratory phase). A deficiency of pulmonary surfactant causes respiratory distress syndrome (RDS) in preterm infants.

Beractant replenishes the amount of surfactant and restores the surface activity of the lungs in preterm infants.
After endotracheal administration, Beractant is quickly distributed throughout the alveolar space, which leads to stabilization of the alveoli and increase their resistance to decay during breathing, which ultimately improves alveolar respiration. In clinical studies involving premature infants with respiratory distress syndrome, after a single dose of bearactant was administered, there was an improvement in oxygenation.
Also, these children showed a decrease in oxygen demand, as well as an increase in arterial-alveolar oxygenation coefficient (a / AES2). In addition, there was a significant decrease in the need for respiratory support, which was confirmed by lower values ​​of the average airway resistance. In most cases, these phenomena persisted for at least 72 hours after administration of a single dose of Beractant.

Pharmacokinetics
Since the drug Survant® administered directly into the lungs; classical clinical pharmacokinetic parameters (plasma concentrations, half-life, etc.) have not been studied.

Indications

Prevention and treatment of Respiratory Distress Syndrome (RDS, hyaline membrane disease) in preterm infants.
Prevention
Premature newborns with a birth weight of 700 g or signs of surfactant deficiency. Use of the drug Survanta® should be started as soon as possible, preferably within 15 minutes from the moment of birth.
Treatment
For the treatment of premature infants with RDS, confirmed by radiography and requiring mechanical ventilation, the drug Survant® should be appointed as soon as possible, preferably within 8 hours from the moment of birth.

Composition

1 ml
phospholipid fraction, isolated from the lung tissue of the bull in terms of:
total phospholipid content 25 mg
dinaturated phosphatidylcholine 11-15.5 mg
free fatty acids 1.4-3.5 mg
triglycerides 0.5-1.75 mg

Excipients: sodium chloride - q.s. up to 9 mg, sodium hydroxide - q.s. to pH 6.2-7.6, hydrochloric acid - q.s. to pH 6.2-7.6, water d / and - to 1 ml.

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Survanta® [Beractant]

Dosage and Administration

Only for endotracheal administration.
Drug survant® should be used by a doctor with experience in intubation, mechanical ventilation and care for premature infants, or under his supervision.
A significant improvement in oxygenation can be achieved within a few minutes after administration of the drug, to prevent hyperoxia, careful medical monitoring and monitoring of systemic oxygenation is necessary.
The dose of the drug is calculated as 100 mg of the drug per 1 kg of body weight, based on the weight at the time of birth. Table 1 shows the total dose of the drug, depending on the weight of the child at birth.
Table 1. Doses of Survant®

Body mass
(grams)
Total dose
(ml)
Body mass
(grams)
Total dose
(ml)
600-650 2,6 1301-1350 5,4
651-700 2,8 1351-1400 5,6
701-750 3,0 1401-1450 5,8
751-800 3,2 1451-1500 6,0
801-850 3,4 1501-1550 6,2
851-900 3,6 1551-1600 6,4
901-950 3,8 1601-1650 6,6
951-1000 4,0 1651-1700 6,8
1001-1050 4,2 1701-1750 7,0
1051-1100 4.4 1751-1800 7,2
1101-1150 4,6 1801-1850 7,4
1151-1200 4,8 1851-1900 7,6
1201-1250 5,0 1901-1950 7,8
1251-1300 5,2 1951-2000 8,0

During the first 48 hours of a child's life, 4 doses of Beractant may be administered. The drug should be administered no more than once every 6 hours.

Directions for use
Before using the drug Survant® the vial should be inspected to prevent discoloration of the drug.
If a precipitate has formed during storage, gently rotate the vial (DO NOT SHAKE!) To dissolve it. In this case, a small amount of foam may form on the surface; this is a natural property of Survant.® . 
Before the introduction of the drug Survant® warm it at room temperature for at least 20 minutes or in hands for at least 8 minutes. FOR WARMING PREPARATION OF THE SURVANT® DO NOT USE OTHER METHODS.
Closed, unused vial of the drug Survant®which has been warmed to room temperature, can be re-placed in a refrigerator for 24 hours, cooled and stored for later use. Drug survant® do not warm and re-cool more than once. Each bottle of drug Survant® designed for single use. Used vial with the remnants of the drug should not be applied. PREPARATION OF SURVANT® DOES NOT REQUIRE BREEDING OR ULTRASOUND BEFORE USE.
Drug administration
general information
Drug survant® is introduced endotracheally by means of installations through the French probe No. 5 with a hole at the end in one of the following ways:

  • insertion of the probe into the baby’s endotracheal tube, disconnecting it from the ventilator for a short time;
  • insertion of the probe through the suction valve without disconnecting the endotracheal tube from the ventilator;
  • installation through the second lumen of the double-lumen endotracheal tube.

If the drug is installed through a probe with a hole at the end, the probe length should be reduced so that the end of the probe is a short distance from the endotracheal tube above the bifurcation of the trachea of ​​the child. The introduction of the drug in the main bronchi is unacceptable.
In order for the drug Survant® evenly distributed over the lungs, each dose is divided into equal fractional doses. Each dose can be divided into 2 or 4 equal parts. Each fractional dose is administered at different positions of the child.
When dividing the dose of the drug Survant® 2 equal parts are recommended to enter it in the following positions

  • Head and torso rotated approximately 45 ° to the right.
  • Head and torso rotated about 45 ° to the left. When dividing the dose of the drug Survant® PA 4 parts, it is recommended to enter it in the following positions


1. Head and torso tilted 5-10 ° down; head turned to the right.

2. The head and torso are inclined by 5-10 ° down, the head is turned to the left.

3. Head and torso raised 5-10 ° up, head turned to the right.

4. Head and torso raised 5-10 ° up, head turned to the left

The introduction procedure is facilitated if one medical professional injects a dose of the drug, and the other changes the position of the child’s body and monitors its condition.

First dose
Instillation through a probe with a hole at the end

  • Based on the weight of the child and using the table of doses, determine the total dose of the drug Survant®;
  • Slowly draw the entire contents of the bottle into a plastic syringe, using a large needle (at least # 20). PREPARATION OF SURVANT® DOES NOT REQUIRE FILTERING. DO NOT SHAKE THE PREPARATION;
  • Attach the pre-measured French probe number 5 with a hole at the end to the syringe;
  • fill the probe with the preparation;
  • through the probe, remove excess drug from the syringe so that only the total dose of the drug remains in it;
  • before the introduction of the drug Survant® make sure that the endotracheal tube is properly positioned and passable. At the discretion of the physician, before the administration of the drug, the endotracheal tube can be sucked out. The condition of the child should be stabilized before the introduction of the drug.

In case of using the drug Survant® for the prevention of RDS, the child must be weighed, intubated and stabilized. The drug should be administered as soon as possible, preferably within 15 minutes from the moment of birth. Lay the baby properly, then gently inject the first part of the dose through the probe for 2-3 seconds.
After the introduction of the first fractional dose, remove the probe from the endotracheal tube. To prevent cyanosis, perform a manual ventilation of the lungs using a hand bag with sufficient oxygen content at a speed of 60 breaths per minute and sufficient positive pressure to ensure adequate gas exchange and chest movement.
When using the drug Survant® for the treatment of RDS, the first dose should be administered as soon as possible after the child has been connected to the ventilator. Lay the child properly, then gently inject the first fractional dose through the probe for 2-3 seconds. After the introduction of the first fractional dose, remove the probe from the endotracheal tube. Resume artificial respiration. In both cases, artificial respiration must be continued for at least 30 seconds or until the state stabilizes. Then change the position of the child for the next fractional dose.
Similarly install the remaining fractional doses. After the introduction of each fractional dose, remove the probe and perform artificial respiration for at least 30 seconds or until the child’s condition has stabilized. After installing the last fractional dose, remove the probe without flushing it. Within an hour after the injection, do not suck off the contents of the respiratory tract, unless there are signs of significant obstruction of the airways.
AFTER THE END OF THE INTRODUCTION OF THE SURVANT PREPARATION® CONTINUE ARTIFICIAL VENTILATION OF THE LUNGS IN THE REGULAR REGIME AND CONDUCT THE REGULAR NECESSARY HEALING MANIPULATIONS.
Instillation through the second lumen of the double-lumen endotracheal tube

  • Ensure that the child is intubated using a suitable sized, double lumen endotracheal tube;
  • based on the weight of the child and using the table of doses, determine the total dose of the drug Survant®;
  • Slowly draw the total dose of the drug into the plastic syringe using a large needle (at least # 20). PREPARATION OF SURVANT® DOES NOT REQUIRE FILTERING. DO NOT SHAKE THE PREPARATION;
  • before the introduction of the drug Survant® make sure the endotracheal tube is installed correctly. At the discretion of the physician, before the administration of the drug, the endotracheal tube can be sucked out. The condition of the child should be stabilized before the introduction of the drug.

In case of using the drug Survant® for the prevention of the development of RDS, the child must be weighed, intubated and stabilized. The drug should be administered as soon as possible, preferably within 15 minutes from the moment of birth.Attach a syringe containing Survant® to the second lumen of the tube. Lay the child properly, then gently enter the first fractional dose through the second lumen of the endotracheal tube for 2-3 seconds without interrupting mechanical ventilation. For manual ventilation to prevent cyanosis, perform artificial ventilation using a hand bag with sufficient oxygen at a speed of 60 breaths per minute and sufficient positive pressure to ensure adequate gas exchange and chest movement.
When using the drug Survant® for the treatment of RDS, the first dose should be administered as soon as possible after the child has been connected to the ventilator. Immediately before the installation of the first fractional dose, the parameters of the artificial respiration mode should be changed: speed up to 60 / min, inhalation time 0.5 second, FiC2 - 1.0. Lay the child properly, then gently inject the first fractional dose through a probe for 2-3 seconds through the second lumen of the endotracheal tube, without interrupting mechanical ventilation.
In both cases, artificial respiration must be continued for at least 30 seconds or until the state stabilizes. Then change the position of the child for the next fractional dose.
Similarly install the remaining fractional doses. After the introduction of each fractional dose, remove the probe and perform artificial respiration for at least 30 seconds or until the child’s condition has stabilized. After the last dose has been installed, disconnect the syringe from the second lumen of the endotracheal tube, INPUT 0.5 ML OF AIR TO SEVE THE SECOND CLEARANCE OF THE ENDOTRACHEAL TUBE AND CLOSE IT.
AFTER THE END OF THE ADMINISTRATION OF THE SURVANT® DRUG, CONTINUE THE ARTIFICIAL VENTILATION OF THE LUNGS IN THE REGULAR REGIME AND CONDUCT THE REGULAR NECESSARY HEALING MANIPULATIONS.
Repeated doses
The need for the appointment of repeated doses of Beractant determined by the presence of signs of persistent RDS. The dose is also calculated using table number 1.
Repeated administration of the drug should be carried out no earlier than 6 hours after the previous dose, if the child is still intubated and requires inhalation of a gas mixture containing at least 30% oxygen, to maintain Pa02 below or equal to 80 mm Hg.
Before prescribing repeated doses for prophylaxis, radiographic confirmation of the presence of RDS should be obtained.
Prepare Beractant and place the child properly for the introduction of each fractional dose, as described earlier. After the introduction of each fractional dose, remove the probe from the endotracheal tube and perform artificial respiration for at least 30 seconds or until the child’s condition has stabilized.
With the introduction of repeated doses, do not use the ventilation of the lungs hand bag. DURING THE INTRODUCTION OF THE SURVANT PREPARATION® THE PARAMETERS OF THE MODE OF ARTIFICIAL VENTILATION OF THE LUNGS CAN BE CHANGED BY THE MEANS OF THE DOCTOR TO MAINTAIN ADEQUATE OXYGENATION AND VENTILATION.
AFTER THE END OF THE INTRODUCTION OF THE SURVANT PREPARATION® CONTINUE ARTIFICIAL VENTILATION OF THE LUNGS IN THE REGULAR REGIME AND CONDUCT THE REGULAR NECESSARY HEALING MANIPULATIONS.
Precautionary measures
If during the administration of the drug a child develops bradycardia or a decrease in oxygen saturation, the procedure should be stopped and appropriate measures taken to improve the child’s condition. After stabilization of the child's condition, resume the procedure.
After the introduction of Beractant in the lungs transient moist rales can be heard. Suction of the endotracheal contents or any other therapeutic manipulations are not required, except for the cases of obvious signs of airway obstruction.

Adverse reactions

The most frequent side effects were observed in the process of drug administration. In controlled clinical trials with repeated administration of the drug, each dose of Beractant was divided into 4 parts. Each fractional dose was installed through a probe inserted into the endotracheal tube when it was briefly disconnected from a ventilator. Transient bradycardia was observed in 1.9% of cases with the introduction of the drug Survant®. A decrease in oxygen saturation was observed in 9.8% of cases with the administration of the drug Survant® . 
Other phenomena during the procedure of drug administration occurred in less than 1% of cases with the administration of the drug Survant® and included: Survant's reflux of the drug® endotracheal tube, pallor, vasoconstriction, lower blood pressure, blockage of the endotracheal tube, high blood pressure, hypocapnia, hypercapnia and apnea. During the procedure for administering the drug, no lethal outcomes were noted, and all the side effects that occurred were cropped by symptomatic therapy.
In controlled clinical trials, the incidence of comorbidities that are common among premature babies has been studied. The data obtained in all controlled studies are presented in Table 2.
Table 2. All controlled clinical studies

Concomitant disease Beractant (%) Control(%) P value *
Open arterial duct 46,9 47,1 0,814
Intracranial Hemorrhage 48,1 45,2 0,241
Severe intracranial hemorrhage 24,1 23,3 0,693
Complications of leakage of air from the lungs 10,9 24,7  
Interstitial emphysema 20,2 38,4  
Necrotizing enterocolitis 6,1 5,3 0,427
Apnea 65,4 59,6 0,283
Severe apnea 46,1 42,5 0,114
Sepsis developed after treatment 20,7 16,1 0,019
Infection developed after treatment 10,2 9,1 0,345
Pulmonary hemorrhage 7,2 5,3 0,166

* P value when comparing groups in controlled studies

In the analysis of all controlled clinical studies, no differences in the frequency of intracranial hemorrhages were identified. However, in one study in which Beractant was administered once for medical purposes, and in another study of prophylactic repeated administration of the drug, the incidence of intracranial hemorrhage was significantly higher among patients who received Beractant (63.3% versus 30.8%, P = 0.001; and 48.8% vs. 34.2%, P = 0.047, respectively).
In controlled clinical trials, no effect of the use of beractant on laboratory test results was observed: leukocyte levels, sodium and potassium, bilirubin and creatine, and blood serum.
More than 4,300 serum samples obtained before and after treatment from approximately 1,500 patients were examined by immunoblotting for the presence of antibodies to surfactant-associated proteins, SP-B and SP-C. No IgG or IgM antibodies have been identified.
There are several more complications that occur in premature babies. The occurrence of these complications has been reported in controlled clinical trials. The incidence of these complications did not differ in the main and control groups; none of the complications were associated with treatment with beractant. Violations of the blood and lymphatic system
Coagulopathy, thrombocytopenia, disseminated intravascular coagulation.
Endocrine Disorders
Adrenal hemorrhage, inadequate secretion of antidiuretic hormone.
Nutrition and Metabolism Disorders
Hyperphosphatemia, food intolerance.
Nervous system disorders
Cramps.
Cardiac disorders
Tachycardia, ventricular tachycardia, heart failure, cardiac and respiratory arrest, increased apical impulse, persistent fetal circulation, complete anomalous confluence of the pulmonary veins.
Violations of the vascular system
Reduced blood pressure, increased blood pressure, aortic thrombosis, air embolism.
Respiratory, thoracic and mediastinal disorders
Pulmonary consolidation, bleeding through the endotracheal tube, deterioration in children after weaning, decompensation of respiratory activity, subglossal stenosis, paralysis of the diaphragm, respiratory failure.
Disorders of the digestive system
Abdominal distention, gastrointestinal bleeding, intestinal perforation, volvulus, intestinal infarction, stress ulcer, inguinal hernia.
Violations of the hepatobiliary system
Liver failure.
Violations of the urinary system
Renal failure, hematuria.
Systemic abnormalities and complications at the site of administration
Fever, worsening general condition.
Follow-up patient care
At the moment, there are no delayed complications of treatment with a bacterial extract.

Not identified.

Drug interactions

Not known

Special instructions

Drug survant® CAN FASTLY IMPACT ON OXYGENATION AND SURFACE LUNG ACTIVITY. In this regard, the drug should be used only in highly specialized departments, where there are specialists with experience in conducting intubation, mechanical ventilation and care for premature infants. In the appointment of the drug requires frequent monitoring of system indicators of oxygen and carbon dioxide in arterial blood or percutaneous measurement.
DURING THE ADMINISTRATION OF THE PREPARATION, THE OCCASIONS OF TRANSITOR BRADICARDS AND A REDUCTION OF OXYGEN SATURATION HAD BEEN NOTED. If these adverse reactions develop, the procedure should be terminated and appropriate measures taken to improve the condition of the child. After stabilization of the child’s condition, the procedure should be resumed.
General information
No experience with the drug Survant® in patients with a body weight less than 600 g and more than 1750 g, as well as in combination with other methods of treatment of RDS (for example, high-frequency artificial lung ventilation or extracorporeal membrane oxygenation).
In controlled clinical trials in newborns treated with Survant®, there was an increased risk of developing nosocomial sepsis. Increased risk of sepsis in children treated with Survant®, was not associated with an increase in mortality among these children. The pathogens were similar in the group of children treated and in the control group. There were no significant differences between the groups in the incidence of other infectious diseases.

Overdosage

About cases of drug overdose Survant® not reported. Based on data from animal studies, overdose can lead to acute airway obstruction. In case of overdose, symptomatic and maintenance treatment should be carried out.
After the introduction of the drug Survant® in the lungs transient moist rales may be heard. Suction of the endotracheal contents or any other therapeutic manipulations are not required, except for the cases of obvious signs of airway obstruction.

  • Brand name: Survant
  • Active ingredient: Beractant
  • Dosage form: Suspension for endotracheal administration of 25 mg / ml.
    On 4 ml of a preparation in a bottle from transparent colorless glass like I (Evr. F.) with a capacity of 10 ml. Each bottle is capped with a halobutyl stopper with a teflon coating, and compressed with an aluminum cap with a plastic cap.
    One bottle together with instructions for use in a carton box.
  • Manufacturer: EbbVi Ltd.
  • Country of Origin: Russia

Studies and clinical trials of Beractant (Click to expand)

  1. Characterization of Surfactant Subtypes of Beractant and a Synthetic Peptide Containing Surfactant KL4following Surface Area Cycling and Addition of Fibrinogen
  2. PP-107. Comparison of beractant and poractant rescue treatment in neonatal respiratory distress syndrome
  3. Early administration of the second dose of surfactant (beractant) in the treatment of severe hyaline membrane disease
  4. A randomized trial comparing beractant and poractant treatment in neonatal respiratory distress syndrome
  5. Surfactant (beractant) therapy for infants with congenital diaphragmatic hernia on ECMO: Evidence of persistent surfactant deficiency
  6. Multicenter study of surfactant (beractant) use in the treatment of term infants with severe respiratory failure
  7. Beractant less costly than calfactant in neonatal ICUs
  8. Calfactant and beractant equally effective in neonatal respiratory distress syndrome
  9. Beractant beneficial in bronchiolitis?
  10. Beractant vs colfosceril palmitate for neonatal RDS
  11. Poractant alfa versus beractant in the treatment of preterm infants with respiratory distress syndrome
  12. Comparison of Infasurf (Calfactant) and Survanta (Beractant) in the Prevention and Treatment of Respiratory Distress Syndrome
  13. Beractant for neonatal respiratory distress syndrome
  14. Beractant less costly than calfactant in neonatal ICUs
  15. Cost Effectiveness of Beractant in the Prevention of Respiratory Distress Syndrome
  16. Beractant/colfosceril palmitate
  17. Beractant therapy improves survival of extremely premature infants
  18. Beractant OK in long term
  19. Poractant alfa versus beractant for respiratory distress syndrome in preterm infants: A retrospective cohort study
  20. Mortality in preterm infants with respiratory distress syndrome treated with poractant alfa, calfactant or beractant: a retrospective study
  21. In response to mortality in preterm infants with respiratory distress syndrome treated with poractant alfa, calfactant or beractant: a retrospective study
  22. Comparison of Infasurf (Calf Lung Surfactant Extract) to Survanta (Beractant) in the Treatment and Prevention of Respiratory Distress Syndrome
  23. Early administration of the second dose of surfactant (beractant) in the treatment of severe hyaline membrane disease
  24. A randomized trial comparing beractant and poractant treatment in neonatal respiratory distress syndrome

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