Kurosurf

General characteristics. Structure:

1 bottle of 1.5 ml contains:
Active component: The Poraktant the Alpha - 120 mg.

Excipients: sodium chloride, water for injections.

1 bottle of 3 ml contains:
Active component: The Poraktant the Alpha - 240 mg.

Excipients: sodium chloride, water for injections.

Structure on 1 ml of suspension:
Active component: The Poraktant the Alpha – 80 mg (there correspond about 74 mg of total quantity of phospholipids).

Excipients: sodium chloride, water for injections.

Pharmacological properties:

Pharmacodynamics. The Poraktant the Alpha is the natural surfactant emitted from lungs of a pig which contains almost exclusively polar lipids, first of all, phosphatidylsincaline (about 70% of the general content of phospholipids) and about 1% of specific hydrophobic low-molecular proteins of SP-B and SP-C.
Compensates for the deficiency of endogenous pulmonary surfactant. Covers an internal surface of alveoluses, reduces surface intention in lungs, stabilizes alveoluses, preventing their adhesion at the end of an expiratory phase, promotes the adequate gas exchange supported during all respiratory cycle. It is evenly distributed in lungs and extends to surfaces of alveoluses. At premature newborn children recovers oxygenation level that demands decrease in concentration of the inhaled oxygen in gas mix. Reduces death rate and complications from respiratory diseases. Surfactant use considerably reduces weight of course of the respiratory distress syndrome (RDS).

Pharmacokinetics. In pilot studies the elimination half-life makes 67 h. However out of lungs (in blood serum and in other bodies) in 48 h after introduction only trace quantities of lipids of surfactant are found.

Indications to use:

- treatment of RDS at premature children with body weight more than 700 g;
- prevention of RDS at premature newborns at suspicion on possible development of a syndrome.

Route of administration and doses:

Endotracheal introduction at the intubated children who are on the artificial ventilation of the lungs (AVL) with continuous monitoring of the heart rate (HR), concentration of oxygen in an arterial bed or saturability of blood oxygen. Drug has to be used only in the conditions of a hospital by the doctors having experience of treatment and resuscitation of premature children. Treatment is begun as soon as possible after diagnosis of RDS.

Drug use technique
Before the use the bottle is heated to 37 °C, carefully overturned upside down, avoiding stirring. Suspension is gathered from a bottle with use of sterile needles and syringes and entered through an endotracheal tube into a lower part of a trachea. After introduction manual ventilation within 1 - 2 min. with the concentration of the inhaled oxygen equal to an initial indicator on the device IVL, for drug hypodispersion is carried out.
The drug can be administered or with the child's detachment from the device IVL, or without detachment (with use of a catheter).
The end of a catheter through which the drug is administered has to be cut off 0,5 cm above the lower end of an endotracheal tube.

Dosage

Emergency therapy
Initial single dose of 100 - 200 mg/kg (1,25 - 2,5 ml/kg). If necessary apply one or two additional doses on 100 mg/kg with an interval of 12 h. Maximum general dose of 300 - 400 mg/kg.

Prevention
Drug in a single dose of 100 - 200 mg/kg (1,25 - 2,5 ml/kg) needs to be entered within the first 15 minutes after the child's birth with suspicion on possible development of RDS.
The repeated dose of drug of 100 mg/kg is entered in 6-12 hours. In case of establishment of the diagnosis of RDS and need of carrying out IVL administration of drug (on 100 mg/kg) is continued with 12 - an hour interval. Maximum general dose of 300 - 400 mg/kg.

Features of use:

Before an initiation of treatment drug it is necessary to carry out correction of acidosis, arterial hypotension, anemia, a hypoglycemia and hypothermia.
In case of a drug reflux introduction needs to be suspended and, if necessary, to increase peak inspiratory pressure on the device IVL to the level which is necessary for clarification of an endotracheal tube.
In case of obstruction of an endotracheal tube owing to accumulation of slime at children ventilation at administration of drug or right after its introduction can worsen considerably that happens in the presence of pulmonary secretion at the child before administration of drug. Suction of slime before administration of drug can reduce probability of obstruction of an endotracheal tube. In case of impossibility of removal of obstruction эндотрахеальнуто the tube needs to be replaced immediately.
It is not recommended to carry out aspiration of a tracheobronchial secret within, at least, 6 hours after administration of drug, except for conditions, life-threatening.
In case of developing of bradycardia, arterial hypotension and decrease in saturability of blood oxygen administration of drug needs to be suspended and carried out necessary measures for normalization of ChSS then treatment can be continued.
The children born after the long anhydrous period (more than 3 weeks) can badly react to replacement therapy by drug that can be connected with a hypoplasia of lungs.
It is possible to expect that administration of drug will reduce weight of RDS or risk of its emergence, however it is impossible to assume that therapy completely will eliminate the mortality and incidence connected with premature births as prematurely born children can be exposed to other complications owing to their immaturity.
Use of drug for the purpose of prevention needs to be carried out according to the following recommendations:
- premature newborns with gestational age from 24 to 25 weeks: prevention is recommended;
- premature newborns with gestational age from 26 to 28 weeks: prevention in case of lack of antenatal use of corticosteroid drugs is recommended.
In view of risk factors at premature newborns with gestational age less than 28 weeks, prevention is also recommended with the following risk factors of development of RDS: perinatal asphyxia, need of an intubation at the birth, existence of a diabetes mellitus of an umatera, a male of the child, family predisposition to RDS, Cesarean section.
- premature newborns with gestational age of 29 weeks and more: the drug has to be administered only in case of development of RDS.
Recovery of gas exchange in alveoluses can lead to bystry increase in concentration of oxygen in an arterial bed that will demand immediate reorganization of indicators of IVL to avoid a hyperoxia. In this regard it is recommended to carry out long monitoring of gas structure of an arterial blood and fabric content of oxygen.
The bottles which are warmed up before the use should not be placed back in the refrigerator. Do not use the drug which remained in a bottle for the second time.

Side effects:

- pulmonary bleeding;
- allergic reactions

Are seldom observed:

- bradycardia;
- arterial hypotension;
- decrease in saturability of blood oxygen;
- obstruction of an endotracheal tube owing to slime accumulation;
- temporary (2-10 min.) decrease in electric activity of a brain.

Interaction with other medicines:

It is not established.

Contraindications:

Hypersensitivity to drug components.

Use during pregnancy and during breastfeeding
It is not applied.

Overdose:

So far the overdose phenomena at use of the drug Kurosurf® were not noted. Nevertheless, in case of overdose and only in the presence of accurate clinical manifestations (from breath, ventilation or oxygenation) the greatest possible aspiration of the weighed contents from lungs and the therapy directed to maintenance of water and electrolytic balance has to be carried out.

Storage conditions:

In the dark place at a temperature from 2 to 8 °C. List B. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Suspension for endotracheal introduction of 80 mg/ml.
On 1,5 ml or 3 ml of drug in the bottle from colourless glass closed by a stopper from chlorbutyl, which is pressed out by an aluminum cap and closed by a plastic cover. One or two bottles in a case from polyfoam together with the application instruction place in a cardboard pack.