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

1000 ml of the preparation contain: human plasma proteins of 100 g, of which human albumin is not less than 97%; sodium caprylate 3 g; sodium chloride to a sodium ion content of 125 mmol; sodium hydroxide to pH 7.0; water for injection - up to 1000 ml.

Description:Transparent liquid is yellow, a greenish shade is allowed.

Pharmacotherapeutic group:Plasmasuberant

ATX: & nbsp

B.05.A.A.01 Albumen

Pharmacodynamics:

Albumin is an integral part of the protein fraction of human blood plasma. The albumin drug replenishes the albumin deficiency in plasma, is a means of restoring colloid-oncotic pressure, impaired central and peripheral hemodynamics (rapidly increases blood pressure and circulating blood volume, increasing the passage of tissue fluid into the bloodstream and promoting its retention), water-electrolyte equilibrium; due to the performance of the transport function, albumin promotes better assimilation of medicines and possesses detoxification properties.

Pharmacokinetics:

Normally, the total exchange pool of albumin is 4-5 g / kg of body weight, with 40-45% being intravascular, and 55-60% in tissues.With such body conditions as severe burns or septic shock, increased permeability of capillaries changes the kinetics of albumin and can cause it anomalous distribution. The albumin solution, introduced into the vascular bed, moves to the interstitial space. Within the first 3 minutes from the moment of administration, a higher concentration of albumin in the spleen, liver and heart is determined. The full distribution of albumin occurs in 10-15 minutes. The half-life of albumin averages 19 days, but patients in critical condition can lose significant amounts of albumin; the rate of its exit from the vascular bed varies with the individual characteristics and the patient's condition. Elimination occurs intracellularly with the participation of lysosomal proteases. Splitting albumin to amino acids with their subsequent use for the synthesis of the body's own proteins is 50-60 days, so it is inappropriate to use it for parenteral nutrition.

Indications:

Hypovolemic shock, burn disease, surgical operations using the apparatus of artificial circulation, purulent-septic conditions (incl.peritonitis, pancreatitis, mediastinitis or severe phlegmon), acute liver failure.

Contraindications:

Hypersensitivity to the components of the drug, severe anemia, chronic heart failure II-IV functional class for NYHA, hypervolemia.

Carefully:

Patients with hypertension, renal insufficiency, thrombosis, ongoing internal bleeding, chronic heart failure drug should be used with caution.

Pregnancy and lactation:

Albumin is a normal component of human blood plasma, and the harmful effect of the drug on the course of pregnancy, fetus or newborn is unlikely. However, given that experimental studies of the effect of the drug on the reproductive function of animals, as well as clinical studies on the use of the drug in pregnant women and women during lactation were not conducted, albumin should be used during pregnancy and during breastfeeding only if the potential benefit for the mother exceeds the possible risk to the fetus or child.

The drug can be used in children.

Dosing and Administration:

Individual, depending on the indications and the clinical situation. Usually, adult albumin is given in a dose of 2-4 ml (0.2-0.4 g) per kg of body weight daily or every other day until a therapeutic effect is achieved; for children, the usual single dose is not more than 3 ml / kg.

The drug can be used in premature infants.

With therapy hypovolemic shock the amount and speed of albumin infusion must be adapted to the individual patient's response. It is necessary to follow the hemodynamic parameters and observe the usual precautions to prevent the volatile overload of the circulatory system. The initial dose may be 25 g, (0.3-0.4 g albumin or 3-4 ml preparation per kg body weight); Enter no more than 250 g for 48 hours. The total dose should not exceed the albumin level of a healthy person, i.e. approximately 2 g per kg of body weight in the absence of active bleeding. In children, a single dose can reach 0.5-1 g per kg of body weight.

In the treatment burn disease introduction of albumin begin not earlier than 24 hours after thermal damage, since by this time the capillary permeability.Conducted therapy should maintain a concentration of plasma albumins at a level of 20-30 g / l and an oncotic pressure of 20 mm Hg. (which is equivalent to a total protein concentration of 52 g / l). The duration of therapy is determined by the dynamics of protein loss from the burned areas and with urine. At all stages of treatment of burn disease, it is necessary to carefully monitor the condition of hemodynamics and the water-electrolyte balance of the patient.

For filling devices of artificial circulation Albumin and crystalloid solutions are used to achieve a hematocrit 20% and an albumin concentration of 25 g / l.

When purulent-septic states depending on the severity of intoxication and the degree of hemodynamic disorders, a single dose can be increased to 7 ml of the drug (0.7 g albumin) per kg of body weight.

The use of albumin in the therapy of patients with acute hepatic impairment has the purpose of maintaining the oncotic pressure and the removal of intoxication caused, among other things, by a high level of bilirubin. Therapy starts with a single dose of 25 g, (0.3-0.4 g albumin or 3-4 ml of the drug per kg of body weight) and continues until the serum albumin value reaches 25 g / l, taking into account the general condition of the patient.

Mode of administration: intravenously.The rate of administration should not exceed 40 drops per minute. Bolus albumin solution is permissible shocks of various origins for the rapid increase in blood pressure.

Side effects:In rare cases, it is possible to develop allergic reactions, which may include hives, chills, fever, dyspnea, tachycardia, lowering blood pressure, pain in the lumbar region.

Overdose:

Symptoms: in cases when the dose and speed of infusion of the drug are high or do not correspond to the individual parameters of the patient's blood circulation, it is possible to develop hypervolemia and characteristic symptoms of cardiovascular overload (dyspnea, swelling of the jugular veins, headache). It is also possible to increase arterial and / or central venous pressure, the development of pulmonary edema.

Measures to assist: at the first manifestations of symptoms of cardiovascular system overload should immediately stop the introduction of the drug and establish a constant monitoring of blood circulation parameters. According to the indications - the conduct of symptomatic therapy. Specific antidotes are absent.

Interaction:With the simultaneous use of albumin with ACE inhibitors, the risk of developing arterial hypotension increases. Albumin should not be mixed with amino acid solutions, protein hydrolysates and solutions containing ethyl alcohol.

Special instructions:

The administration of the drug should be accompanied by the control of hemodynamic parameters. It should avoid the rapid introduction of elderly patients, since this can lead to an overload of the cardiovascular system.

Introduction with dehydration is possible only after preliminary ensuring sufficient intake of fluid (by mouth, parenterally).

When the albumin solution is administered, the concentration of sodium and potassium in the patient's blood plasma should be monitored and appropriate measures taken to restore or maintain the balance of these electrolytes.

With the introduction of relatively large volumes of the drug, it is necessary to monitor the parameters of the clotting system, electrolyte balance, platelet and erythrocyte level, hematocrit, and their adequate correction.

Since the albumin preparation is able to effectively increase the colloid osmotic pressure,in the course of its introduction it is necessary to monitor the patient's condition in order to prevent the development of vollemic overload of blood circulation.

The introduction of albumin can affect the blood coagulation system, so in patients with shock, if it is impossible to exclude the hemorrhagic nature of the shock, it is necessary to monitor the indicators of the hemostasis system.

A rapid increase in blood pressure, which may follow the transfusion of the drug, may be accompanied by increased bleeding from those vessels that did not bleed at a lower arterial pressure, which requires control of surgical hemostasis.

With conditions accompanied by a marked violation of capillary permeability, use with caution.

If necessary, the albumin solution can be diluted with saline or 5% dextrose (glucose) solution. For this purpose, water for injection can not be used.

Before use, the drug should be warmed to room temperature or to body temperature.

The preparation is not suitable for use in containers with broken integrity and marking, with turbidity of the solution, presence of a slurry or sediment.

The drug should be administered immediately after opening the vial. Unused residue should be disposed of.

When using drugs obtained from human blood plasma, it is impossible to completely exclude the risk of transmission of viral infections.

Effect on the ability to drive transp. cf. and fur:There was no evidence of the effect of the drug on the ability to drive vehicles and other potentially dangerous mechanisms.

Form release / dosage:Solution for infusions 10%.

Packaging:For 100 ml in bottles of glass for blood, transfusion and infusion preparations with a capacity of 100 ml. Each bottle together with instructions for use in a pack of cardboard.

Storage conditions:At a temperature of 2 to 10 ° C.

Shelf life:5 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-002362

Date of registration:08.10.2012

Expiration Date:Unlimited

The owner of the registration certificate:Kirov Research Institute of Hematology and Blood Transfusion, Federal State Institution Kirov Research Institute of Hematology and Blood Transfusion, Federal State Institution Russia

Manufacturer: & nbsp

Kirov Research Institute of Hematology and Blood Transfusion, Federal State Institution Russia

Information update date: & nbsp14.07.2017

Illustrated instructions

Instructions

Albumen (Albumin)