Index of drugs

Supplementing and maintaining the volume of circulating blood in the states of its volume loss and when the use of colloidal fluid is indicated. The decision to use albumin instead of artificial colloidal fluid is made only on the basis of current recommendations and depends on the clinical situation of the patient.

1 ml of solution contains 200 mg of total protein, including at least 95% of human albumin.

The preparation has a hyperonkotic effect. The most important physiological effect of albumin is its effect on the oncotic pressure of the blood and its transport functions. Albumin stabilizes the volume of circulating blood and is a carrier of hormones, enzymes, drugs and toxins. Under normal conditions, the total exchangeable amount of albumin is 4-5 g / kg, of which 40-45% is in the intravascular space, and 55-60% in the extravascular space. In conditions such as severe burns or septic shock, increased capillary permeability leads to a change in albumin kinetics and may result in its improper distribution. Under normal conditions, average T_0,5 albumin is about 19 days. The balance between synthesis and decomposition is properly achieved due to regulation in the feedback mechanism. The elimination takes place mainly intracellularly thanks to the action of lysosomal proteases. In healthy people, less than 10% of infused albumin leaves the intracellular compartment within the first 2 hours of infusion. There is considerable variability in the range of effects on the volume of plasma. In some patients, increased plasma volume may persist for several hours. However, in critically ill patients, albumin can escape from the intravascular space in considerable amounts and with unpredictable speed.

Hypersensitivity to albumin preparations or to any of the excipients.

If you suspect an allergic or anaphylactic type of reaction, the infusion should be stopped immediately. In case of shock, anti-shock treatment should be applied in accordance with current medical standards. Caution should be exercised when administering albumin in hypervolaemic states and its consequences or hemodilution, which could pose particular risks for the patient. Examples of such conditions are: decompensated heart failure, hypertension, esophageal varices, pulmonary edema, haemorrhagic diathesis, severe anemia, renal and non-renal anuria. The colloid -osmotic effect of human albumin at a concentration of 200 g / I is about 4-fold greater than that of blood plasma. Therefore, proper hydration of the patient should be ensured when administering a concentrated solution of albumin. Patients should be closely monitored to avoid overloading the circulatory system and conduction. Human solutions of human albumin at a concentration of 200-250 g / 1 contain relatively few electrolytes compared to human albumin solutions at a concentration of 40-50 g / l. When administering albumin, monitor the electrolyte concentration of the patient and take appropriate measures to restore or maintain the electrolyte balance. Albumin solutions must not be diluted with water for injections, as this may cause hemolysis in patients receiving the solution. In the case of supplementation of large circulating blood deficiencies, it is necessary to check the coagulation parameters and hematocrit. Sufficient substitution of other blood components (coagulation factors, electrolytes, platelets and erythrocytes) should be ensured. If the dose and rate of infusion have not been adjusted to the patient's cardiovascular system, hypervolaemia may occur. At the first clinical signs of cardiovascular overload (headache, shortness of breath, widening of the jugular veins) or if the blood pressure increases, increase in venous pressure and pulmonary edema, the infusion should be stopped immediately.Despite the use of standard measures to prevent transmission of infectious agents associated with the use of preparations obtained from human blood or plasma, when medicines prepared from human blood or plasma are administered, the risk of transmission of infectious agents can not be totally excluded. This also applies to unknown and newly discovered viruses and other pathogens. No cases of virus transmission have so far been reported with albumin preparations produced according to an approved trial and in compliance with the requirements set out in the European Pharmacopoeia. In the case of a diet deprived of sodium, the sodium in the preparation should be taken into account - 280 mg in a vial of 100 ml; 140 mg in a 50 ml vial.

Human albumin is a natural component of human blood. Clinical experience with albumin shows that it has no harmful effects on the course of pregnancy, fetus and newborn. No clinical studies have been conducted to determine the safety of the preparation in pregnant and breast-feeding women.

After the marketing of an analogue preparation manufactured by the same manufacturer, the following side effects occurred: tachycardia, nausea, vomiting, burning and tingling sensations at the injection site, chills, fever, weakness, hypersensitivity, local or generalized allergic reactions, anaphylactic shock, drowsiness, headache, paresthesia, anxiety, tightness in the chest, shortness of breath, bronchospasm, Quincke's edema, redness, pruritus, generalized or local urticaria, shock, drop in blood pressure, flushing. When medicines prepared from human blood or plasma are administered, the risk of transmission of infectious agents can not be completely ruled out. This also applies to unknown and newly discovered viruses and other pathogens. No cases of virus transmission have so far been reported with albumin preparations produced according to an approved trial and in compliance with the requirements set out in the European Pharmacopoeia.

Intravenous infusion. The concentration, dosage and infusion rate should be adjusted to the individual needs of the patient. The dose required depends on the patient's weight, the severity of the injury or illness, and the loss of fluid and protein. The required dose should be determined based on the assessment of circulating blood deficiency and not on the basis of plasma albumin. If human albumin is to be administered, the haemodynamic status should be monitored regularly, including: arterial blood pressure and heart rate, central venous pressure, pulmonary wedge pressure, urinary excretion, electrolyte concentration, hematocrit / hemoglobin. It should be taken into account that in children the physiological volume of plasma depends on age. The preparation can be used in the treatment of premature infants. The preparation can be administered directly intravenously or by dilution with an isotonic solution, e.g. 50 mg / ml Glucose solution. i.e. 5% or sodium chloride 9 mg / ml solution. i.e. 0.9%. The speed of infusion should be adapted to the specific circumstances and indications. In the case of plasma exchange (plasmapheresis), the infusion rate should be adapted to the rate of removal. Do not dilute albumin solution with water for injections, as it may cause haemolysis in patients. Do not mix human albumin with other drugs, whole blood and concentrate of red blood cells.