Albiomin 20%, 20% 100 ml

Human albumin

Indications

– Hypovolemic shock;

– burns;

– hypoproteinemia with or without concomitant tissue edema (after extensive surgery, in sepsis);

– acute respiratory distress syndrome in adults (with volume overload combined with the use of diuretics);

– acute liver failure (to maintain oncotic pressure and bind excess plasma bilirubin);

– hemolytic disease of newborns (in order to bind free bilirubin);

– when removing biological fluids rich in protein (ascites, peritonitis, mediastinitis);

– resuspension of red blood cells;

– acute nephrosis (together with diuretics in the absence of effect from steroid therapy);

– hemodialysis (with the development of hypovolemic shock and hypotension during the session)

Pharmacological effect

Pharmacotherapeutic group

Plasma replacement agent

ATX code: B05AA01

Pharmacodynamics:

Human albumin Biotest is a 20% sterile aqueous solution of albumin and is produced from human blood plasma.

Human albumin Biotest replenishes plasma albumin deficiency, increases circulating blood volume, helps reduce hematocrit and viscosity of whole blood, and also maintains colloid osmotic (oncotic) blood pressure. The drug is involved in the elimination of hormones, enzymes, drugs, toxins, etc.

Pharmacokinetics:

Under normal conditions, the average half-life is 19 days. The balance between synthesis and elimination is usually achieved by regulating the response.

If albumin is replenished externally, equilibrium is established within approximately 48 hours of drug administration. After 1-3 hours of infusion, an increase in circulating blood volume is established due to the diffusion of fluid from the interstitial space.

Special instructions

If allergic or anaphylactic reactions occur, the infusion should be interrupted immediately and appropriate therapy should be administered. If anaphylactic shock occurs, antishock therapy should be administered.

The colloid osmotic pressure of a 20% solution of human Albumin Biotest is four times higher than that of blood plasma. Therefore, when prescribing concentrated plasmatic solutions, it is necessary to ensure that the patient is sufficiently hydrated. It is necessary to constantly monitor the patient’s condition to avoid overload of the circulatory system or overhydration.

20% albumin solutions compared to 4-5% albumin solutions have a relatively low electrolyte content. Therefore, when administering 20% ​​Human Albumin Biotest, blood serum electrolytes should be monitored and, if necessary, measures should be taken to restore or maintain water-electrolyte balance.

If it is necessary to replace large volumes, it is necessary to monitor blood coagulation and hematocrit. The sufficiency of replacement of other blood components (clotting factors, electrolytes, platelets, red blood cells) should be monitored.

Incorrect selection of the dosage regimen and infusion rate without taking into account the state of the patient’s circulatory system can lead to hypervolemia. At the first clinical signs of overload of the cardiovascular system (headache, dyspnea, swelling of the neck veins, increased arterial or venous pressure, pulmonary edema), the infusion should be stopped immediately.

When using medicinal products from human blood or plasma, it is impossible to completely eliminate the risk of transmission of known and as yet unknown viral infections. To reduce the risk of pathogen transmission, donors are screened using strict criteria, donated plasma is tested and collected, and the plasma pool is monitored. In addition, virus removal and inactivation steps are included in the manufacturing process.

To date, there have been no reports of transmission of any viral infections through the drug Human Albumin Biotest, manufactured in accordance with the European Pharmacopoeia and using proven production methods.

Impact on the ability to drive vehicles and machinery:

There is no indication that Human Albumin Biotest may affect the ability to drive a car or operate machinery.

Active ingredient

Human albumin

Composition

1000 ml of solution contains:

Active ingredient:

human plasma proteins 200 g

of which albumin is at least 96%

Excipients:

Sodium caprylate* 2.66 g (16 mmol)

N-acetyl-DL-tryptophan* 3.94 g (16 mmol)

Sodium chloride 3.69 g (63 mmol)

Water for injections up to 1000 ml

* as a stabilizer.

The total amount of sodium ions in the preparation is 122 mmol/l

Pregnancy

Controlled studies on the use of human Albumin Biotest during pregnancy have not been conducted. However, experience in clinical use indicates that the drug does not have a negative effect on the course of pregnancy, the fetus or the newborn.

Contraindications

Chronic heart failure II-III degree; severe anemia; hypervolemia; pulmonary edema; hypersensitivity to albumin or any components of the drug.

With caution:

Human Albumin Biotest should be prescribed with caution in clinical situations where hypervolemia and its consequences (eg, increased stroke volume, increased blood pressure) or hemodilution pose a particular risk to the patient. Thus, Human Albumin Biotest should be used with caution in patients with heart failure, arterial hypertension, esophageal varicose veins, pulmonary edema, acute anemia, bleeding, renal and postrenal anuria.

Side Effects

Rare: mild reactions such as flushing of the face and feeling of heat, urticaria, fever and nausea. In some cases, chills, vomiting, erythema, a drop in blood pressure with tachycardia and dyspnea may occur.

These reactions usually resolve quickly when the infusion rate is reduced or stopped. In very rare cases, very severe reactions, including anaphylactic shock, may occur. In these cases, the infusion should be stopped and the necessary therapy should be started immediately.

Interaction

Human albumin Biotest cannot be mixed with other medications or blood components (for example, red blood cells). To prepare a solution of the drug with a lower concentration, only isotonic solutions should be used (for example, 0.9% sodium chloride solution). Human albumin Biotest cannot be diluted with water for injection, as this can lead to hemolysis.

The specific interaction of Human Albumin Biotest with other drugs is unknown.

Overdose

It is necessary to constantly monitor hemodynamic parameters, since hypervolemia may occur if the dose or infusion rate is too high.

At the first clinical signs of overload of the cardiovascular system (headache, dyspnea, swelling of the jugular veins or increased arterial or central venous pressure, pulmonary edema), the infusion of Human Albumin Biotest should be stopped immediately.

Storage conditions

In a place protected from light at a temperature not exceeding 25°C.

Do not freeze!

Keep out of the reach of children!

Shelf life

3 years. Do not use the drug after the expiration date.

Manufacturer

Biotest AG, Germany