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

Human albumin is more than half the protein fraction of human blood and about 10% of the protein synthesized by the liver. The most important physiological functions of albumin are its contribution to oncotic 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 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. The average half-life of albumin is normally 19 days.The balance between synthesis and degradation, as a rule, is achieved through a feedback mechanism. Elimination predominantly occurs intracellularly with the participation of lysosomal proteases. In healthy subjects, less than 10% of intravenously injected albumin is excreted from the vascular bed during the first 2 hours after infusion. The effect on the volume of plasma is subject to substantial individual variation. In some patients, the plasma volume 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:

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

Contraindications:

Hypersensitivity, severe anemia, chronic heart failure II-III stage, hypervolemia, pulmonary edema.

Carefully:Arterial hypertension, renal failure, thrombosis, ongoing internal bleeding, bronchial asthma, allergic rhinitis, Quincke's edema.

Pregnancy and lactation:

Safety of the use of Albumin in pregnancy in controlled clinical trials is not established. However, clinical experience with the use of albumin does not give grounds for expecting any harmful effect on the course of pregnancy, fetus or newborn. Studies of reproductive toxicity in animals Albumin were not performed. 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. Albumin is a normal component of human blood.

Dosing and Administration:

The albumin concentration, dosage regimen and rate of administration should be tailored to the needs of each patient.

Dosing regimen

The dose required depends on the patient's body weight, the severity of the injury or illness, and the duration of loss of fluid and protein. To determine the necessary dose, a measure of the sufficiency of the volume of circulating blood should be used, and not the albumin content in the plasma.

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

- blood pressure and heart rate;

- central venous pressure;

- pulmonary artery wedge pressure;

- diuresis;

- the content of electrolytes;

- hematocrit / hemoglobin.

Method of administration

The solution is allowed to enter without prior dilution or dilute in isotonic solution (for example, 5% dextrose solution or 0.9% sodium chloride solution).

Solutions of albumin are not allowed to dilute with water for injection, as this can lead to hemolysis in the recipient.

When introducing large volumes, it is necessary to preheat the solution to room temperature or body temperature.

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

After opening the container, the drug should be injected immediately. Unused remnants of the drug must be disposed of in accordance with local requirements.

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

Side effects:

In rare cases, there may be "hot flashes" of blood, urticaria, fever and nausea, which quickly disappear with a decrease in speed or discontinuation of the drug.Very rarely, severe reactions can occur, for example shock. In these cases, the drug should be discontinued and immediately begin appropriate treatment. The questions of infection with blood-borne diseases are covered in the section "Special instructions".

Overdose:

With a high dose or speed of administration, hypervolemia may develop. At the first signs of cardiovascular system overload (headache, shortness of breath, swelling of the jugular veins) or increased arterial and central venous pressure and pulmonary edema, the drug should be discontinued immediately and constant monitoring of the circulatory parameters should be established.

Interaction:

The interaction of human albumin with other drugs has not been established. Albumin 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), blood or erythrocyte mass.

Special instructions:

If there is a suspicion of an allergic or anaphylactic reaction, the drug must be discontinued immediately.In case of shock, standard anti-shock therapy should be taken.

Albumin should be used with caution if hypervolemia and its consequences or hemodilution can be dangerous 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.

With the introduction of albumin, it is necessary to monitor the electrolyte status of the patient (see section "Method of administration and dose") and take appropriate measures to restore or maintain electrolyte balance.

Solutions of albumin are not allowed to dilute with water for injection, as this can lead to hemolysis in the recipient.

With extensive replacement therapy, blood clotting and hematocrit control are necessary. Particular attention should be given to the proper replacement of other blood components (clotting factors, electrolytes, platelets and red blood cells).

If there is a discrepancy between the dose and the rate of administration of the drug to the patient's circulatory state, hypervolemia may develop.At the first signs of cardiovascular overload (headache, shortness of breath, swelling of the jugular veins) or increased arterial and central venous pressure and pulmonary edema should be stopped immediately.

The production of drugs from human blood or plasma includes a set of measures that prevent the transmission of infections to patients. Such measures include the careful selection of blood and plasma donors to prevent the donation of people at risk, testing each unit of blood or plasma and the pool of plasma for viruses / infections. Manufacturers of such medicines also take measures to process blood or plasma, which allow inactivating or removing viruses. Despite the observance of these measures, it is impossible to completely eliminate the risk of transmission of infection, including unknown or newly discovered viruses or other types of infection, when manufacturing medicinal products from human blood or plasma. With the administration of each dose of drug Albumin It is strongly recommended that its name and series be recorded in order to retain information about it.

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

Does not affect.

Form release / dosage:

Solution for infusions 10%.

Packaging:

50 ml or 100 ml in glass bottles for blood, transfusion and infusion preparations.

Each bottle, together with instructions for use, is placed in a pack of cardboard.

Storage conditions:

In dry, dark place at a temperature of 2 to 10 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-002141

Date of registration:12.07.2013

Expiration Date:12.07.2018

The owner of the registration certificate:STATION OF BLOOD TRANSFUSION OF KALININGRAD OBLAST, HBUZ STATION OF BLOOD TRANSFUSION OF KALININGRAD OBLAST, HBUZ Russia

Manufacturer: & nbsp

STATION OF BLOOD TRANSFUSION OF KALININGRAD OBLAST, HBUZ Russia

Information update date: & nbsp14.07.2017

Illustrated instructions

Instructions

Albumen (Albumin)