Albumen

Pharmacological properties

human albumin quantifies more than half of the total plasma protein and about 10% of the total protein synthesized by the liver.

Albumin has a corresponding hyperoncotic effect.

The most important physiological function of albumin is participation in the regulation of oncotic blood pressure and its transport functions. Albumin stabilizes bcc and is a carrier of hormones, enzymes, drugs and toxins.

Pharmacokinetics Normally, the total metabolic volume of albumin is 4–5 g / kg body weight, while 40–45% is intravascular, and 55–60% are in the tissues. Under conditions such as severe burns or septic shock, increased capillary permeability alters the kinetics of albumin and may cause its abnormal distribution. Normal average T_½ Albumin is about 19 days. The balance between synthesis and cleavage of albumin is usually achieved through a feedback mechanism. The elimination process is carried out mainly intracellularly under the action of lysosomal proteases.

In healthy people, less than 10% of the injected iv albumin leaves the intravascular space within the first 2 hours after administration. Significant individual variability of the effect of albumin infusion on blood plasma volume is observed. In some patients, blood plasma volume may remain increased for several hours. However, in patients in critical conditions, albumin can leave the vascular bed in significant quantities and at an unpredictable rate.

Preclinical safety data. Human albumin is a natural component of human blood plasma and acts similarly to physiological albumin.

Currently, there have been no reports of a relationship between human albumin and toxicity to the embryo and the fetus, oncogenic or mutagenic potential.

In experimental animal models, no evidence of acute toxicity was observed.

Indications

Recovery and maintenance of bcc in the presence of signs of insufficient volume and the need for colloids.

The use of albumin or artificial colloid depends on the individual clinical situation for each patient according to official recommendations.

Application

The concentration of the albumin preparation, the dose and the rate of infusion must be selected depending on the individual needs of the patient.

The required dose depends on the patient’s body weight, the severity of the injury or illness, and the degree of loss of fluid and protein.

With the introduction of human albumin, it is necessary to regularly check hemodynamic parameters, which include:

• Blood pressure and heart rate;
• central venous pressure;
• jamming pressure of the pulmonary artery;
• diuresis;
• electrolyte concentration;
• hematocrit / hemoglobin level;
• clinical manifestations of heart / respiratory failure (eg, dyspnea);
• clinical manifestations of increased intracranial pressure (eg, headache).

Human albumin 10% / Human albumin 20% can be administered directly in / in or diluted with isotonic p-rum (for example 5% p-rum glucose or 0.9% r-rum sodium chloride).

Albumin solution cannot be diluted with water for injection, as this can cause hemolysis in the patient.

The rate of infusion must be selected in accordance with individual circumstances and indications.

With plasmapheresis, the infusion rate must be selected in accordance with the excretion rate.

With the introduction of large volumes, the drug should be warmed to room temperature or to body temperature before use.

Do not use if solution is cloudy or contains sediment. This may indicate protein instability or contamination of the solution.

Do not use if packaging is damaged.Destroy when leakage is detected.

After opening the bottle, the drug should be used immediately! All unused residues should be disposed of in accordance with local regulations.

Contraindications

Hypersensitivity to blood protein preparations or any of the excipients.

Side effects

Criteria for assessing the incidence of adverse drug reactions: very frequent (1/10); frequent (from 1/100 to 1/10); infrequent (from 1/1000 to 1/100); rare (from 1/10 000 to 1/1000); very rare (1/10 000). in case of serious reactions, stop administration and begin appropriate treatment.

Very rare:

from the immune system: anaphylactic reactions, hypersensitivity, allergic reactions;

from the respiratory system, chest and mediastinal organs: pulmonary edema, shortness of breath.

Rare:

from the nervous system: headache;

on the part of the heart: tachycardia;

on the part of the vessels: arterial hypotension;

from the digestive system: vomiting;

on the part of the skin and subcutaneous tissue: urticaria, itching;

general disorders and disorders at the injection site: chills.

special instructions

Suspicion of an allergic or anaphylactic reaction requires an immediate cessation of drug administration. in case of shock, standard anti-shock therapy should be given.

Albumin should be used with caution in case of hypervolemia and its consequences or hemodilution, which may pose a particular risk to the patient, for example:

• 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 albumin 10% / albumin 20% is approximately equal to the double effect of blood plasma. Therefore, care must be taken when administering concentrated albumin to ensure proper hydration of the patient. It is necessary to carefully monitor the patients condition in order to protect him from circulatory overload and hyperhydration.

The albumin solution of 100–125 g / l contains a relatively low amount of electrolytes. With the introduction of albumin, the patient’s electrolyte status should be regularly checked and necessary measures taken to restore and maintain electrolyte balance.

Albumin solutions should not be diluted with water for injection, as this can cause hemolysis in recipients.

If it is necessary to replace relatively large volumes of blood, coagulation and hematocrit should be monitored. Caution should be exercised in ensuring appropriate replacement of other blood components (coagulation factors, electrolytes, platelets, and red blood cells).

If the dosage and rate of infusion does not match the patient’s circulatory state, hypervolemia may develop. At the first clinical manifestations of cardiovascular overload (headache, shortness of breath, blockage of the jugular veins) or with increased blood pressure, increased central venous pressure and pulmonary edema, administration should be stopped immediately.

There is evidence that albumin increases the risk of death in patients with traumatic brain injury and in patients with burns. In patients with severe traumatic brain injury and burns, albumin treatment can only be used after a thorough assessment of the risks and benefits.

Standard measures to prevent the transmission of infections when using drugs of human blood or blood plasma include the selection of donors, the verification of individual portions of donor plasma and plasma pools for specific markers of infections and the use of effective measures to inactivate / remove viruses in production.Despite this, with the introduction of drugs made from human blood plasma or blood plasma, the possibility of transmission of infectious agents cannot be completely ruled out. This also applies to unknown or new viruses and other pathogens.

There is no evidence of the transmission of viruses with albumin, properly produced in accordance with the specifications of the European Pharmacopoeia.

It is recommended that you write down the name and batch number of the drug each time you administer 10% albumin / 20% albumin to the patient in order to track the relationship between the patients condition and the use of a particular series.

Use during pregnancy and lactation.

The safety of the use of the drug Albumin-Biofarma 10% / Albumin-Biofarma 20% in pregnant women in controlled clinical trials has not been established. However, clinical experience with the use of albumin did not reveal a harmful effect on the course of pregnancy, the fetus, and the newborn.

The effects of albumin on fertility have not been studied in controlled clinical trials. Experimental animal studies are not enough to assess safety regarding reproductive function, development of the embryo or fetus, pregnancy, peri- and postnatal development.

However, human albumin is a common component of human blood.

Children.

No data available.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

No effect on the ability to drive vehicles or other mechanisms was observed.

Interactions

With the simultaneous use of albumin with inhibitors of apf (angiotensin-converting enzyme), the risk of developing arterial hypotension increases.

Incompatibility. Human albumin should not be mixed with other drugs (except for the recommended solvents - 5% solution of glucose or 0.9% solution of sodium chloride), whole blood and red blood cell mass.

Overdose

If the dose or rate of infusion is too high, hypervolemia may develop. at the first clinical manifestations of symptoms of an overload of the cardiovascular system (headache, shortness of breath, swelling of the jugular veins) or with an increase in arterial and / or central venous pressure and the development of pulmonary edema, the administration of the drug should be stopped immediately and the hemodynamics of the patient should be carefully monitored.

Storage conditions

In the original packaging to protect from the effects of light at a temperature not exceeding 25 ° c.