Alveofakt - instructions for use, dose, side effects, contraindications

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Dosage form: & nbsplIofilizate for the preparation of a suspension for endotracheal administration

Composition:

1 bottle contains:

Surfactant SF-RI1 (phospholipid fraction isolated from the lung tissue of the bull) - 50,76-60,00 mg (in terms of total phospholipids - 66 μmol or 50 mg).

Solvent 1.2 ml contains:

Sodium chloride 5.44 mg

Sodium hydrogen carbonate - 0.12 mg

Water for injection - 1196.28 mg.

Description:

Lyophilizate: lyophilized mass of white or almost white with a characteristic odor.

Solvent: clear, colorless solution.

Reduced suspension: Milk suspension white or white with a yellowish hue, with a characteristic odor.

Pharmacotherapeutic group:Surfactant

ATX: & nbsp

Phospholipids, natural

Pharmacodynamics:

Pulmonary surfactant replenishes the lack of endogenous pulmonary surfactant exogenous. It covers the inner surface of the alveoli; reduces the surface tension in the lungs, stabilizes the alveoli, preventing their clumping at the end of the expiratory phase, promotes adequate gas exchange maintained throughout the entire respiratory cycle. Evenly distributed in the lungs and spreads to the surface of the alveoli. In premature newborns, the level of oxygenation is restored, which requires a reduction in the concentration of inspired oxygen in the gas mixture; reduces mortality and respiratory diseases.

The use of surfactant significantly reduces the severity of the course of respiratory distress syndrome (RDS).

Pharmacokinetics:In experimental studies, the half-life is about 30 hours. The metabolism of the Alveofakt preparation is the same as the metabolism of the natural surfactant. However, the path and speed of metabolism, as well as the degradation of organic molecules, is affected by the degree of immaturity of the lung. The drug is almost completely utilized in the lungs and does not accumulate in the body.

Indications:

1. Prevention of respiratory distress syndrome in preterm infants with a gestation period of less than 27-28 weeks.

2. Treatment of RDS. Preterm neonates with signs of RDS (clinical manifestations: the Silverman score is more than 7 points; X-ray manifestations: "milk lungs"). The degree of oxygen dependence is more than 40%.

3. Asphyxia of newborns. The Apgar score is less than 3 points.

As a rule, premature infants (gestation period 32-34 weeks) (clinical manifestations: instability of blood pressure, oxygen dependence more than 40%, X-ray manifestations: "shock lung").

4. Massive meconial aspiration.After a thorough sanitation of the tracheobronchial tree, if the degree of oxygen dependence is more than 65%.

Contraindications:

Multiple malformations, malformations of life incompatible with life, intestinal atresia, severe birth trauma of the central nervous system, hypothermia less than 36 FROM.

Dosing and Administration:

Endotracheal administration in intubated children on artificial ventilation (IVL) with constant monitoring of the heart rate (HR), oxygen concentration in the arterial bed or saturation with oxygen. Treatment begins as early as possible, after diagnosis of RDS.

Preparation of the reconstituted suspension

Method 1 - using a bottle adapter

Warning: the syringe and adapter remain in the vial throughout the entire procedure for preparing the reconstituted suspension.

1. Open the vial adapter package and attach the syringe to the adapter.

2. Insert the tip of the adapter into the vial cap.

3. Enter the solvent into the vial.

4. Stir immediately for 5 seconds.

5. Insert the suspension into the syringe, and then enter the contents of the syringe back into the vial. Repeat the procedure 5 times!

6. Soak the bottle for about 1 minute with the holder until the foam separates.

7. Slowly draw the suspension into the syringe, while leaving the foam in the vial.

Method 2 - using a needle for the preparation of a suspension

A warning: the syringe and the needle should remain in the vial throughout the entire procedure for preparing the reconstituted suspension. After completion of the suspension preparation process, the needle should not be used any more.

1. Open the bag with the needle to prepare the suspension and attach the needle to the syringe.

2. Insert the needle to prepare the suspension in the vial.

3. Enter the solvent into the vial.

4. Stir immediately for 5 seconds.

5. The contents of the vial are taken into the syringe (the bottle is located at a small angle), and then enter the contents of the syringe back into the vial. Repeat the procedure 5 times! After this, remove the needle from the suspension (but not from the vial), so that the suspension does not enter the syringe.

6. Soak the bottle for about 1 minute with the holder until the foam separates.

7. Slowly draw the suspension into the syringe, while leaving the foam in the vial.

The reconstituted suspension should be stored for 6 hours at a temperature of no higher than 25 ° C or 24 hours at a temperature of 2 ° -8 ° C. Before use, the reconstituted suspension should be shaken gently.

Dosage

Prevention. We recommend a single dose of 1.2 ml of Alveofakt ® for 1 kg of body weight, which is administered the first hour after birth. If necessary, repeat the administration three more times at intervals of 12-24 hours - only 4 single doses.

If the ventilation parameters deteriorate and life-threatening indications arise, the time interval between doses can be reduced under the supervision of the doctor.

Emergency therapy. We recommend a single dose of 1.2 ml of Alveofakt® preparation per 1 kg of body weight immediately if there are clinical symptoms and / or radiological changes that correspond to the development of RDS, or when the respiratory fraction of required oxygen exceeds 40% (FiO₂>0,4).

If necessary, repeat the administration three more times at intervals of 12-24 hours - only 4 single doses. If life-threatening conditions continue, the time interval between doses may be reduced under medical supervision, however, the second dose should be administered no earlier than 30-60 minutes after the first administration.

Treatment with Alveofakt ® is carried out only by intratracheal instillation.

The technique of introduction

1. The correct standing of the endotracheal tube (1 cm above the bifurcation), the correct size of the intubation tube.

2. Control suction from LDP.

3. In the endotracheal tube, insert the catheter into the depth, which determines its exit from the intubation tube by 1 cm.

4. Position of the patient on his left side !!!

5. Introduce the drug into the bolus catheter at a dose of 1.2 ml / kg, then draw air into the syringe and insert it into the catheter, ensuring that the drug reaches the TBD completely.

6. Manual method (bag Penlon, Cardiff etc.) to make 5 respiratory movements and start ALV - the respiratory rate is higher than 60 per minute and the exit time is not less than 0.6 seconds.

7. For an even distribution of the patient's Alveofakt®, the patient can be gently turned to the right-left side for several minutes.

8. If possible, do not perform routine suction from the tubing for 6-8 hours.

9. Constant monitoring of blood gases. Prevent hyperoxia (RO₂ not more than 60 mm Hg, SaO₂ not more than 95%, the best effect if FiO₂0,25 SaO₂ not more than 95-96%).

10. When the stabilization of blood gases is achieved FiO₂0,4 choose the parameters of ventilation (Pin, Tin, Those, Flow) are sufficient for a particular situation.

11. If within the next 4-6 hours the condition starts to deteriorate, i.e. the patient will need FiO₂more than 0.4 it is necessary to solve the problem of repeated administration of the surfactant, based on the data of the radiograph and blood gas parameters.

12. Manipulation should be performed strictly in aseptic conditions.

Side effects:

- Anaphylactoid reaction;

- short-term tracheal or bronchial obstruction, which is eliminated by increasing the respiratory pressure for 30-60 seconds;

- In children with intranatal respiratory tract infection, sputum separation may increase due to activation of mucociliary clearance.

Overdose:

So far, there have been no cases of overdose. However, in case of an overdose and only if there are clear clinical manifestations (from the side of breathing, ventilation or oxygenation), the maximum possible aspiration of suspended contents from the lungs and therapy aimed at maintaining the water electrolyte balance should be performed.

Interaction:

Not installed.

Special instructions:

The drug should be used only in hospital settings by doctors who have experience in the treatment and resuscitation of premature infants.

Before the beginning of treatment it is necessary to carry out correction of acidosis, hypotension, anemia, hypoglycemia and hypothermia.

Form release / dosage:

Lyophilizate for the preparation of a suspension for endotracheal administration, 50 mg (complete with a solvent).

Packaging:

Lyophilizate for the preparation of a suspension for endotracheal administration, 50 mg.

Lyophilizate (in an amount corresponding to 50 mg in terms of total phospholipids) in a vial of colorless hydrolytic glass (type I) sealed with a rubber stopper and crimped with an aluminum cap with a plastic lid type flip-off.

Solvent 1.2 ml in a syringe.

1 vial with lyophilizate, 1 syringe with solvent, 1 needle for suspension, 1 syringe adapter and 1 bottle holder are placed in a transparent blister.

Blister together with instructions for use are placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LSR-005994/10

Date of registration:25.06.2010