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

The preparation contains: human albumin - 200 g, Excipients: sodium acetyltryptophan (Hebrew F.) 16 mmol, sodium caprylate (Hebrew F.) 16 mmol and sodium chloride (Hebrew F.) to a sodium content of 140 mmol, water for injection (Hebrew F.) to 1 l.

Description:

Transparent slightly viscous liquid yellow, a greenish shade is allowed.

Pharmacotherapeutic group:Plasmasuberant

ATX: & nbsp

B.05.A.A.01 Albumen

Pharmacodynamics:

Human albumin is more than half the protein fraction of human plasma and about 10% of the protein synthesized by the liver.

Physicochemical characteristics: human albumin with a dosage of 200 g / l has a hyperoncotic effect. The most important physiological functions of albumin are its contribution to oncotic blood pressure and transport functions. Albumin stabilizes the volume of circulating blood and is a transport protein that carries hormones, enzymes, drugs and toxins.

Pharmacokinetics:

The total exchange fraction of albumin is normally 4-5 g / kg of body weight, of which 40-45% are in the vascular bed and 55-60% in the extravascular space.With such pathological conditions as severe burns or septic shock, a significant increase in the permeability of capillaries disrupts the kinetics of albumin, and can lead to its pathological distribution.

Normally, the average half-life of albumin is about 19 days. The balance between synthesis and degradation is achieved, as a rule, through a feedback mechanism. Elimination occurs mainly intracellularly and is carried out by proteases of lysosomes.

In healthy people, less than 10% of the albumin introduced by infusion is removed from the vascular bed within the first two hours after infusion. The effect on the volume of blood plasma is subject to substantial individual variation. In some patients, the volume of blood plasma may remain elevated for several hours. However, patients in critical condition can lose significant amounts of albumin, and the rate of its release from the vascular bed is unpredictable.

Indications:

Restoring and maintaining the volume of circulating blood in the event of its deficiency with the advisability of using colloidal solutions.

Contraindications:

Hypersensitivity to the active substance or any other component included in the preparation.

Pregnancy and lactation:

Safety of Albuirex^® during pregnancy in controlled clinical trials have not been established. However, the clinical experience of using albumin does not give grounds for expecting any harmful effect on the course of pregnancy, fetus or newborn.

Studies of reproductive toxicity in animals with Albuirex® have not been conducted.

Experimental data on animals are insufficient for assessing safety with respect to reproduction, embryo-fetal development, the course of pregnancy of peri- and postnatal development.

Human albumin is a normal component of human blood.

Dosing and Administration:

The concentration of albumin, dosing regimen and the rate of infusion solution administration should be selected individually for each patient.

Dosing regimen

Calculation of the dose depends on the patient's body weight, the severity of the injury or disease, and also on the duration of fluid and protein loss.The required dose should be determined on the basis of the adequacy of the volume of circulating blood, and not depending on the concentration of albumin in the blood plasma.

If it is necessary to introduce albumin, hemodynamic parameters should be monitored regularly, including:

- blood pressure and heart rate;

- central venous pressure;

- pressure of wedging of the pulmonary artery;

- diuresis;

- the content of electrolytes;

- hematocrit and / or hemoglobin.

Mode of application

Human albumin should be administered only intravenously. You can enter directly the finished solution or pre-dilute it with an isotonic solution (for example, 5% dextrose solution or 0.9% sodium chloride solution).

Solutions of albumin can not be diluted with water for injection, as this can lead to hemolysis in recipients.

The rate of administration should be determined depending on the patient's condition and indications, but, as a rule, should not exceed 1-2 ml / min.

With plasmapheresis, the rate of administration of the drug should correspond to the rate of plasma removal.

In the case of storage of the drug in the refrigerator before the introduction of the temperature of the solution should be brought to roomtemperature.

Do not use turbid solutions or solutions containing mechanical inclusions. This may indicate the instability of the protein or contamination of the solution.

The solution should be used immediately after opening the vial. Unused residues should be disposed of in accordance with local regulations.

Side effects:

The undesirable reactions presented below are listed in accordance with the damage to organs and organ systems (classification MedDRA) and frequency of occurrence. Frequency of occurrence is defined as follows: Often (≥ 1/10), often (≥ 1/100 and <1/10), infrequently (≥ 1/1 000 and <1/100), rarely (≥ 1/10 000 and <1/1 000), rarely (<1/10 000, including individual cases). Frequency categories were formed on the basis of clinical studies of the drug and post-registration surveillance.

Reactions of mild severity, such as "hot flashes" of blood, urticaria, fever and nausea are rare. These reactions, as a rule, quickly disappear when the rate decreases or the drug is stopped. Very rarely, severe reactions can occur, such as shock. In these cases, the drug should be discontinued immediately and appropriate treatment initiated.

Overdose:

With a high dose or speed of administration, hypervolemia can develop.

At the first clinical signs of cardiovascular overload (headache, dyspnea, swelling of the jugular veins) or with increased blood pressure, central venous pressure and pulmonary edema, stop the infusion immediately and monitor hemodynamics continuously.

Interaction:

The interaction of human albumin with other drugs has not been established.

Alburex® should not be mixed with other medicinal products (with the exception of isotonic solutions, for example, 5% dextrose solution or 0.9% sodium chloride solution), whole blood and erythrocyte mass.

Special instructions:

Solutions of albumin can not be diluted with water for injection, as this can cause hemolysis in recipients.

If there is a suspicion of an allergic or anaphylactic reaction, you must immediately stop the infusion. In the event of shock, standard anti-shock therapy should be taken.

Albumin should be administered with caution under conditions,when hypervolemia and its consequences or hemodilution may pose a particular risk to the patient. Examples of such states are:

- Decompensated heart failure;

- arterial hypertension;

- varicose veins of the esophagus;

- pulmonary edema;

- hemorrhagic diathesis;

- severe anemia;

- Renal and postrenal anuria.

The colloidal osmotic effect of human albumin is 200 g / L approximately 4 times higher than that of blood plasma. Therefore, with the introduction of concentrated albumin, measures should be taken to ensure adequate hydration of the patient. It is necessary to constantly monitor the patient's condition in order to prevent circulatory overload and hyperhydration.

Solutions of human albumin with a concentration of 200-250 g / l contain fewer electrolytes than human albumen solutions at a concentration of 40-50 g / l. When administering albumin, the patient should monitor the electrolyte content (see the section "Method of administration and dose") and take appropriate measures to restore and maintain the electrolyte balance.

With extensive replacement therapy, it is necessary to monitor the parameters of the blood coagulation system and hematocrit.Measures should be taken to ensure adequate replacement of other blood components (clotting factors, electrolytes, platelets and red blood cells).

Hypervolaemia can develop if the dose and rate of administration of the infusion solution are not adjusted relative to the patient's hemodynamic state. At the first clinical signs of cardiovascular overload (headache, dyspnea, swelling of the jugular veins) or with increasing blood pressure, central venous pressure and pulmonary edema, immediately stop the infusion and conduct constant monitoring of the patient's hemodynamics.

Standard measures to prevent the transmission of infections resulting from the use of drugs derived from human blood or plasma include selection of donors, screening of individual donations and plasma pools for the presence of specific infection markers, and the inclusion of effective production steps aimed at inactivation and / or removal viruses. Despite this, with the use of drugs derived from human blood or plasma, the possibility of transmitting infectious agents, including unknown or new viruses and other infectious agents, can not be completely ruled out.

Cases of transfer of viruses in the use of albumin, produced in accordance with the requirements of the European Pharmacopoeia, are not established.

Every time the Albureex® drug is administered to a patient, it is strongly recommended that the name and serial number of the drug be recorded in order to maintain the connection between the patient and the drug series.

Effect on the ability to drive transp. cf. and fur:

Does not affect the ability to manage vehicles and mechanisms.

Form release / dosage:

Solution for infusions 20%.

Packaging:

For 50 ml or 100 ml in a vial of clear, colorless glass, corked with a rubber stopper and rolled in aluminum caps with a plastic disc.

For 1 bottle with instructions for use in a cardboard bundle.

Storage conditions:

At a temperature of no higher than 30 ° C in a dark place. Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-002608

Date of registration:03.09.2014

Expiration Date:03.09.2019

The owner of the registration certificate:CESEL Behring AGCESEL Behring AG Switzerland

Manufacturer: & nbsp

CSL BEHRING, AG Switzerland

Information update date: & nbsp16.07.2017

Illustrated instructions

Instructions

Alburex® (Alburex®)