Pharmacological properties
Pharmacodynamics. Human albumin quantitatively accounts for more than half of all blood plasma protein and about 10% of the total amount of protein synthesized by the liver.
Albumin has a corresponding hyperoncotic effect.
The most important physiological function of albumin is participation in the regulation of blood oncotic pressure and its transport functions. Albumin stabilizes the BCC and is a carrier of hormones, enzymes, drugs and toxins.
Pharmacokinetics. Normally, the total metabolic volume of albumin is 4-5 g/kg of body weight, with 40-45% intravascular and 55-60% in the tissues. In such conditions of the body as severe burns or septic shock, increased capillary permeability changes the kinetics of albumin and can cause its abnormal distribution. Normally, the average T ½ of albumin is about 19 days. The balance between albumin synthesis and breakdown is usually achieved by a feedback mechanism. The elimination process is carried out mainly intracellularly under the action of lysosomal proteases.
In healthy individuals, less than 10% of intravenous albumin leaves the intravascular space within the first 2 hours after administration. There is individual variation in the effect of albumin infusion on plasma volume. In some patients, plasma volume may remain elevated for several hours. However, in critically ill patients, albumin may leave the vascular bed in significant amounts and at an unpredictable rate.
Preclinical safety data: Human albumin is a natural component of human blood plasma and acts similarly to physiological albumin.
To date, there have been no reports of an association between human albumin and embryo-fetal toxicity, oncogenic or mutagenic potential.
No signs of acute toxicity were observed in experimental animal models.
Indication
Restoration and maintenance of BCC in the presence of signs of volume depletion and the need for the use of 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, dose, and infusion rate should be selected based 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 fluid and protein loss.
When administering human albumin, it is necessary to regularly check hemodynamic parameters, which include:
Blood pressure and pulse rate; central venous pressure; pulmonary artery occlusion pressure; urine output; electrolyte concentration; hematocrit/hemoglobin level; clinical manifestations of cardiac/respiratory failure (e.g., dyspnea); clinical manifestations of increased intracranial pressure (e.g., headache).
Human albumin 10% / human albumin 20% can be administered directly i.v. or diluted with an isotonic solution (e.g. 5% glucose solution or 0.9% sodium chloride solution).
Albumin solution should not be diluted with water for injection as this may cause hemolysis in the patient.
The infusion rate should be adjusted according to individual circumstances and indications.
During plasmapheresis, the infusion rate must be adjusted according to the rate of excretion.
When administering large volumes, the drug should be warmed to room temperature or body temperature before use.
Do not use the product if the solution is cloudy or contains a precipitate. This may indicate protein instability or contamination of the solution.
Do not use the product if the packaging is damaged. Destroy if leakage is detected.
After opening the vial, the drug should be used immediately! Any unused solution should be disposed of in accordance with local requirements.
Contraindication
Hypersensitivity to blood protein products or any of the excipients.
Side effects
Criteria for assessing the frequency of adverse drug reactions: very common (1/10); common (1/100 to 1/10); uncommon (1/1000 to 1/100); rare (1/10,000 to 1/1000); very rare (1/10,000). In case of serious reactions, the administration should be discontinued and appropriate treatment should be initiated.
Very rare:
from the immune system: anaphylactic reactions, hypersensitivity, allergic reactions;
Respiratory, thoracic and mediastinal disorders: pulmonary edema, shortness of breath.
rare:
from the nervous system: headache;
Cardiac: tachycardia;
Vascular: arterial hypotension;
from the digestive system: vomiting;
Skin and subcutaneous tissue disorders: urticaria, itching;
general disorders and administration site conditions: chills.
Special instructions
Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the drug. In case of shock, standard anti-shock therapy should be carried out.
The colloid-osmotic effect of albumin 10% / albumin 20% is approximately twice that of blood plasma. Therefore, when administering concentrated albumin, care must be taken to ensure adequate hydration of the patient. The patient's condition must be carefully monitored to protect him from circulatory overload and hyperhydration.
Albumin solution 100-125 g/l contains relatively low amounts of electrolytes. When administering albumin, the patient's electrolyte status should be regularly checked and appropriate measures taken to restore and maintain electrolyte balance.
Albumin solutions should not be diluted with water for injection as this may cause hemolysis in recipients.
If relatively large volumes of blood need to be replaced, coagulation and hematocrit should be monitored. Care should be taken to ensure adequate replacement of other blood components (coagulation factors, electrolytes, platelets and red blood cells).
If the dosage and rate of infusion do not correspond to the patient's circulatory status, hypervolemia may develop. At the first clinical manifestations of cardiovascular overload (headache, shortness of breath, jugular vein occlusion) or with increased blood pressure, increased central venous pressure and pulmonary edema, the 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 should only be used after careful assessment of the risks and benefits.
Standard measures to prevent the transmission of infections when medicinal products prepared from human blood or plasma are used include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be totally excluded. This includes unknown or emerging viruses and other pathogens.
There is no evidence to support the transmission of viruses with albumin properly manufactured according to European Pharmacopoeia specifications.
It is recommended that the name and batch number of the product are recorded every time Albumin 10% / Albumin 20% is administered to a patient in order to maintain a link between the patient's condition and the use of a particular batch.
Use during pregnancy and breastfeeding.
The safety of the use of the drug Albumin-Biopharma 10% / Albumin-Biopharma 20% in pregnant women has not been established in controlled clinical studies. However, clinical experience with the use of albumin has not revealed any harmful effects 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 insufficient to assess safety with respect to reproductive function, embryonic or fetal development, pregnancy, and peri- and postnatal development.
However, human albumin is a normal component of human blood.
Children.
Data is missing.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
No effect on the ability to drive or use machines was observed.
Interactions
Concomitant use of albumin with ACE inhibitors (angiotensin-converting enzyme) increases the risk of developing arterial hypotension.
Incompatibility. Human albumin should not be mixed with other drugs (except recommended diluents - 5% glucose solution or 0.9% sodium chloride solution), whole blood and red blood cell mass.
Overdose
If the dose or infusion rate is too high, hypervolemia may develop. At the first clinical manifestations of symptoms of cardiovascular overload (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 drug should be immediately discontinued and the patient's hemodynamic parameters should be carefully monitored.
Storage conditions
In the original packaging to protect from light at a temperature not exceeding 25 °C.
