Survant - instructions for use, doses, side effects, contraindications

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Dosage form: & nbspsuspension for endotracheal administration

Composition:

1 ml of the suspension contains:

Active substances: bovine lung extract containing bovine lung lipids in terms of:

- the total content of phospholipids is 25.0 mg;

- diluted phosphatidylcholine - 11.0-15.5 mg;

- free fatty acids - 1,4-3,5 mg;

- triglycerides - 0.50-1.75 mg.

Excipients: sodium chloride - q.s. up to 9.0 mg; sodium hydroxide - q.s. to a pH of 6.2-7.6; hydrochloric acid - q.s. to a pH of 6.2-7.6; water for injection - up to 1.0 ml.

Description:

Milky white liquid from almost white to light brown color.

Pharmacotherapeutic group:surfactant

ATX: & nbsp

Phospholipids, natural

Pharmacodynamics:

The mechanism of action of the attack is based on a decrease in the surface tension of the alveolar walls during breathing and prevention of the alveolar decay at the end of expiration (expiratory phase). Deficiency of pulmonary surfactant causes respiratory distress syndrome (RDS) in premature newborns.

The attacker replenishes the amount of surfactant and restores the superficial activity of the lungs in premature newborns.

After endotracheal administration, the attackant rapidly spreads through the alveolar space, which leads to the stabilization of the alveoli and their increased resistance to decay during respiration, which ultimately improves alveolar breathing.

In clinical studies involving preterm infants with respiratory distress syndrome, after the administration of a single dose of the attacker, an improvement in oxygenation was observed.

Also, these children had a decrease in the need for oxygen, as well as an increase in the arterial-alveolar oxygenation factor (a / ArO₂). In addition, there was a significant decrease in the need for respiratory support, which was confirmed by lower mean airway resistance. In most cases, these phenomena persisted for at least 72 hours after the administration of a single dose of the attackant.

Pharmacokinetics:Since the preparation of Survant® is introduced directly into the lungs, the classical clinical pharmacokinetic parameters (plasma concentrations, half-life, etc.) have not been studied.

Indications:

Prophylaxis and treatment of Respiratory Distress Syndrome (RDS, hyaline membrane disease) in premature newborns.

Prophilactics

Premature newborns with a birth weight of 700 g or signs of a surfactant deficiency. The use of Survant® should be started as soon as possible, preferably within 15 minutes of birth.

Treatment

For the treatment of preterm infants with RDS, confirmed by radiography and requiring artificial ventilation, the preparation of Survant® should be administered as soon as possible, preferably within 8 hours from the moment of birth.

Contraindications:

Not identified.

Dosing and Administration:

Only for endotracheal administration.

The drug Survanta® should be used by a doctor who has experience of intubation, artificial ventilation and care for premature neonates, or under his supervision.

Significant improvement in oxygenation can be achieved within a few minutes after drug administration, in order to prevent hyperoxia, careful medical monitoring and monitoring of systemic oxygenation is necessary.

Dose of the drug is calculated as 100 mg of the drug per 1 kg of body weight, based on the weight at birth. Table 1 shows the total doses of the drug, depending on the weight of the child at birth.

Table 1

Doses of Survant®
Body weight (grams)	Total dose (ml)	Body weight (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
1 101-1150	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 7	1951-2000	8,0

During the first 48 hours of the child's life, 4 doses of the attackant can be prescribed.

The drug should be administered no more often than once a day. 6 hours.

Directions for use

Before using the drug Survant®, the bottle should be inspected to avoid discoloration.

If sedimentation occurs during storage, rotate the bottle gently to dissolve it (DO NOT INSERT!). A small amount of foam can form on the surface, this is a natural property of the Survant® preparation.

Before the introduction of the preparation, Survant® should be warmed at room temperature for at least 20 minutes or in hands for at least 8 minutes. FOR THE HYGIENE OF SURVANTA® PREPARATION, DO NOT USE OTHER METHODS.

A closed, unused bottle of Survant® preparation that was warmed to room temperature can be re-placed in the refrigerator for 24 hours, cooled and stored for later use. The preparation of Survant® should not be heated and re-cooled more than once. Each vial of the preparation SURVANTA® is intended for single use. The used vial with drug residues should no longer be used. SURVANTA® PREPARATION DOES NOT NEED DILUTION OR ULTRASOUND PROCESSING BEFORE USING.

Administration of the drug

general information

The Survant® preparation is administered endotracheally by instillation through a French probe No. 5 with an opening at the end in one of the following ways:

- insertion of the probe into the child's endotracheal tube, detaching it for a short time from the ventilator;

- insertion of the probe through the suction valve without disconnecting the endotracheal tube from the ventilator;

- instillation through the second lumen of a double-lumen endotracheal tube.

If the drug is inserted through a probe with an opening at the end, the length of the probe should be reduced so that the end of the probe is a short distance from the endotracheal tube above the bifurcation of the child's trachea. Introduction of the drug into the main bronchi is unacceptable.

In order that the drug SURVANTA® is distributed evenly 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 Survant® into 2 equal parts it is recommended to enter it in the following positions

- The head and body are rotated about 45 ° to the right.

- The head and body are rotated about 45 ° to the left. When dividing the dose of Survant® in 4 parts, it is recommended to enter it in the following positions

1. The head and trunk are inclined 5-10 ° down, the head is turned to the right.

2. The head and trunk are inclined 5-10 ° downward, the head is turned to the left.

3. The head and trunk are bent 5-10 ° upwards, the head is turned to the right.

4. The head and trunk are raised 5-10 ° upward, the head is turned to the left.

The procedure of administration is facilitated if one medical worker enters the dose of the drug and the other changes the position of the child's body and monitors his condition.

The first dose

Instillation through a probe with an opening 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 put in the plastic syringe all the contents of the bottle, using a large needle (at least number 20). PREPARATION OF SURVANTA® DOES NOT REQUIRE FILTERING. DO NOT PREVENT THE PREPARATION;

- attach a pre-measured French probe No. 5 with an opening at the end to the syringe;

- fill the probe with the drug;

- 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 Survant® preparation, make sure that the endotracheal tube is properly positioned and patchy.At the physician's discretion, the content of the endotracheal tube can be drawn before the administration of the drug. The condition of the child should be stabilized before the administration of the drug.

In the case of using the drug Survant® for prevention of RDS The child must be weighed, intubated and stabilized. The drug should be administered as soon as possible, preferably within 15 minutes of birth. Lay the baby properly, then gently insert 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 manual ventilation using a hand bag with sufficient oxygen at a rate of 60 breaths per minute and sufficient positive pressure to ensure adequate gas exchange and chest movement.

When using the drug Survant® for treatment of RDS The first dose should be administered as soon as possible after the child is connected to the ventilator. Lay the baby properly, then gently enter 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 ventilation. In both cases, ventilatory ventilation should be continued for at least 30 seconds or until the condition stabilizes. Then change the position of the child for the next fractional dose.

Similarly install the remaining fractional doses. After the administration of each fractional dose, remove the probe and perform mechanical ventilation for at least 30 seconds or until the child's condition is stabilized. After instillation of the last fractional dose, remove the probe without rinsing it. Within an hour after the administration of the drug, do not suction the contents of the airway, except in cases of signs of significant obstruction of the airways.

AFTER THE END OF THE INTRODUCTION OF SURVANTA®, CONTINUE ARTIFICIAL VENTILATION OF LUNGS IN CONVENTIONAL REGIME AND CONDUCT CONVENIENT NECESSARY TREATMENT MANIPULATIONS.

Instillation through the second lumen of a double-lumen endotracheal tube

- Ensure that the child is intubated using a two-lumen endotracheal tube of suitable size;

- based on the weight of the child and using the table of doses, determine the total dose of the drug Survant®;

- slowly put a total dose of the drug into the plastic syringe, using a large needle (at least No. 20). SURVANTA® PREPARATION DOES NOT REQUIRE FILMING. DO NOT PREVENT THE PREPARATION;

- Before the introduction of the Survant® drug, make sure that the endotracheal tube is installed correctly. At the physician's discretion, the content of the endotracheal tube can be drawn before the administration of the drug. The condition of the child should be stabilized before the administration of the drug.

In the case of using the drug Survant® for prevention of RDS development The child must be weighed, intubated and stabilized. The drug should be administered as soon as possible, preferably within 15 minutes of birth.

Attach the syringe containing the Survant® preparation to the second tube clearance.

Lay the baby properly, then gently enter the first fractional dose through the second lumen of the endotracheal tube for 2-3 seconds, without interrupting the artificial ventilation of the lungs. When manually ventilating the lungs to prevent cyanosis, perform artificial ventilation using a hand bag,with sufficient oxygen content at a rate of 60 breaths per minute and sufficient positive pressure to ensure adequate gas exchange and chest movement.

When using the drug Survant® for treatment of RDS The first dose should be administered as soon as possible after the child is connected to the ventilator. Immediately before the instillation of the first fractional dose, the parameters of the artificial ventilation mode should be changed: speed up to 60 / min, inspiration time 0.5 seconds, FiABOUT₂ - 1.0. Lay the baby properly, then gently enter the first fractional dose through the probe for 2-3 seconds through the second lumen of the endotracheal tube, without interrupting the artificial ventilation of the lungs.

In both cases, ventilatory ventilation should be continued for at least 30 seconds or until the condition stabilizes. Then change the position of the child for the next fractional dose.

Similarly, instill the remaining fractional doses. After the administration of each fractional dose, remove the probe and perform mechanical ventilation for at least 30 seconds or until the child's condition stabilizes. After instillation of the last dose, disconnect the syringe from the second lumen of the endotracheal tube.ENTER 0.5 ML AIR TO SOLD THE SECOND LINK OF THE ENDOTRACHEAL TUBE, AND CLOSE IT.

AFTER THE END OF THE INTRODUCTION OF SURVANTA®, CONTINUE ARTIFICIAL VENTILATION OF LUNGS IN CONVENTIONAL REGIME AND CONDUCT CONVENIENT NECESSARY TREATMENT MANIPULATIONS.

Repeated doses

The need to assign repeated doses of the attacker is determined by the presence of signs of a persistent RDS. The dose is also calculated using Table 1.

Repeated administration of the drug should be carried out no earlier than 6 hours after the introduction of the previous dose in the event that the child is still intubated and requires the inhalation of a gas mixture containing at least 30% oxygen to maintain PA₂ below or equal to 80 mm Hg.

Before prescribing repeated doses for prophylaxis, radiographic confirmation of the presence of RDS should be obtained.

Prepare the attack and place the child properly to administer each fractional dose, as described previously. After the administration of each fractional dose, remove the probe from the endotracheal tube and perform mechanical ventilation for at least 30 seconds or until the child's condition stabilizes.

When introducing repeated doses, do not use lung ventilation with a hand bag. DURING THE INTRODUCTION OF SURVANT ® PREPARATION, THE MODES OF ARTIFICIAL VENTILATION OF THE LUNGS MAY BE MODIFIED BY THE DOCTOR'S ATTENTION TO SUPPORT ADEQUATE OXYGENATION AND VENTILATION.

AFTER THE END OF THE INTRODUCTION OF SURVANTA®, CONTINUE ARTIFICIAL VENTILATION OF LUNGS IN CONVENTIONAL REGIME AND CONDUCT CONVENIENT NECESSARY TREATMENT MANIPULATIONS.

Precautionary measures

If during the introduction of the drug in the child develops a bradycardia or a decrease in oxygen saturation, the procedure should be discontinued and take appropriate measures to improve the condition of the child. After stabilization of the child's condition, resume the procedure.

After the introduction of the attack in the lungs, transient, wet rales can be heard. Absorption of endotracheal contents or any other therapeutic manipulation is not required, except in cases of obvious signs of airway obstruction.

Side effects:

The most common adverse events were noted during the administration of the drug.

In controlled clinical trials with repeated administration of the drug, each dose of the attack was divided into 4 parts.Each fractional dose was inserted through a probe inserted into the endotracheal tube with a short-term detachment from the ventilator.

Transitional bradycardia was observed in 11.9% of cases with the introduction of the drug Survant®.

Decrease in oxygen saturation was observed in 9.8% of cases with the introduction of the drug Survant®.

Other phenomena during the introduction of the drug appeared in less than 1% of the cases with the introduction of the drug Survant® and included: the reflux of the Survant® preparation in the endotracheal tube, pallor, vasoconstriction, lowering of blood pressure, occlusion of the endotracheal tube, increased arterial pressure, hypocapnia, hypercapnia and apnea. During the procedure for the administration of the drug, no lethal outcomes were noted, and all the resulting side effects were stopped with the help of symptomatic therapy.

In controlled clinical trials, the prevalence of concomitant diseases that are common among preterm infants has been studied. The data obtained in all controlled trials are presented in Table 2.

table 2

All controlled clinical trials
Concomitant disease	The attacker (%)	Control (%)	The value of P *
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 associated with air leakage from the lungs	10,9	24,7	<0,001
Interstitial emphysema	20,2	38,4	<0,001
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 haemorrhage	7,2	5,3	0,166

* Significance of P when comparing groups in controlled studies

In the analysis of all controlled clinical studies, there was no difference in the incidence of intracranial hemorrhages. However, in one study in which the attack was administered once for treatment, and in another study of prophylactic repeated administration of the drug, the prevalence of intracranial hemorrhage was significantly higher among patients receiving the attack (63.3% vs. 30.8%, P = 0.001, and 48 , 8% versus 34.2%, P = 0.047, respectively).

In controlled clinical trials, there was no evidence of the effect of the use of the attack on laboratory test results: the level of leukocytes, sodium and potassium, bilirubin and serum creatinine.

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. Class antibodies IgG or IgM were not identified.

There are several other complications that occur in premature infants. 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 the attacker.

Violations of the blood and lymphatic system

Coagulopathy, thrombocytopenia, disseminated intravascular coagulation.

Disorders from the endocrine system

Hemorrhage in the adrenal glands, inadequate secretion of antidiuretic hormone.

Disorders of nutrition and metabolism

Hyperphosphatemia, intolerance to food.

Disturbances from the nervous system

Convulsions.

Cardiological disorders

Tachycardia, ventricular tachycardia, heart failure, cardiac and respiratory arrest, strengthening apical shock, persistent fetal circulation, complete abnormal flow of the pulmonary veins.

Disorders from 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, subglottic stenosis, diaphragm paralysis, respiratory failure.

Disorders from the digestive system

Bloating, gastrointestinal bleeding, intestinal perforation, gut flushes, intestinal infarction, stress ulcer, inguinal hernia.

Disorders from the hepatobiliary system

Liver failure.

Disorders from the urinary system

Renal failure, hematuria.

Systemic disorders and complications at the site of administration

Fever, worsening of general condition.

Follow-up care of patients

At the moment of the remote in time complications of treatment by the attack was not noted.

Overdose:

No cases of an overdose of Survant® were reported. Based on data from animal studies, overdose can lead to acute airway obstruction.In case of an overdose, symptomatic and supportive treatment should be given.

After the administration of the SURVANT® preparation in the lungs, transient, wet rales can be heard. Absorption of endotracheal contents or any other therapeutic manipulation is not required, except in cases of obvious signs of airway obstruction.

Interaction:

Not known.

Special instructions:

The drug SURVANTA® MAY QUICKLY PROMOTE OXYGENATION AND SURFACE ACTIVITY OF LUNGS. In this regard, the drug should be used only in highly specialized departments where specialists with experience of intubation, artificial ventilation and care for premature newborns work. When prescribing a drug, frequent monitoring of systemic indices of oxygen and carbon dioxide in the arterial blood or percutaneous measurement is necessary.

In the course of the introduction of the drug, the cases of transderic brodicardia and reduction of oxygen saturation were noted. If these unwanted reactions develop, the procedure should be discontinued and appropriate measures taken to improve the child's condition.After stabilization of the child's condition, the procedure should be resumed.

General information

There is no experience of using the Survant® drug in patients weighing less than 600 g and more than 1,750 grams, and also in combination with other methods of treatment of RDS (eg, high-frequency artificial ventilation or extracorporeal membrane oxygenation).

In controlled clinical trials in neonates treated with Survant®, an increased risk of nosocomial sepsis was noted. The increased risk of sepsis in children treated with Survant® was not associated with an increase in mortality among these children. The causative agents were similar in the group of children treated and in the control group. Po prevalence of other infectious diseases, there were no significant differences between the groups.

Form release / dosage:Suspension for endotracheal administration, 25 mg / ml.

Packaging:

For 4 ml or 8 ml of the drug in a bottle of clear colorless glass type I (Hept. F.) with a capacity of 10 ml or 21 ml respectively.

Each bottle is sealed with a halobutyl plug with Teflon coating and crimped with an aluminum cap with a plasticcover.

One bottle together with instructions for use in a cardboard pack.

Storage conditions:

At a temperature of 2 to 8 ° C, in a dark place. Do not freeze.

Keep out of the reach of children.

Shelf life:

18 months.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription