Preclinical safety data Human albumin is a natural component of human plasma and acts similarly to physiological albumin.
The study of the toxicity of a single dose in animals is of low significance and does not allow assessing the toxic or lethal dose or the relationship between dose and effect.The toxicity of multiple doses in animals is not feasible due to the formation of antibodies to a heterogeneous protein.
To date, there is no information on embryonic and fetal toxicity, carcinogenic and mutagenic effects of human albumin.
In animal studies, there were also no signs of acute toxicity. Allergic reactions / anaphylactic shock
Any suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the drug. In the case of shock, standard anti-shock therapy should be used.
Since this drug is made from human blood plasma, it can carry the risk of transmission of infectious agents, for example, viruses and, theoretically, the causative agent of Creutzfeldt-Jakob disease. This also applies to unknown or new viruses and other pathogens.
The risk of transmitting infectious agents is reduced by screening plasma donors for possible infection by certain viruses in the past, by testing for the presence of certain viral infections, and by inactivating and / or removing certain viruses.The measures taken are considered effective for envelope viruses, such as HIV, hepatitis B virus, hepatitis C virus, as well as for non-enveloped viruses such as hepatitis A virus and parvovirus B19. It is strongly recommended that each time an ALBUMINE HUMAN is administered, the patient should write down the name and number of the drug series in order to establish the connection between the patient and the drug series.
Hemodynamics
Do not administer without careful monitoring of hemodynamic indicators, monitor the development of symptoms of cardiac or respiratory failure, renal failure, or increased intracranial pressure.
Hypervolaemia / hemodilution
ALBUMIN HUMAN should be used with caution under conditions in which hypervolemia and its consequences or hemodilution can pose a particular risk to the patient. Examples of such conditions are: decompensated heart failure, hypertension, varicose veins, pulmonary edema, hemorrhagic diathesis, severe anemia, renal and post-renal insufficiency.
The rate of administration should be selected in accordance with the concentration of the solution and the hemodynamic parameters of the patient.Rapid administration can lead to circulatory congestion and pulmonary edema. At the first clinical signs of cardiovascular overload (headache, dyspnea, blockage of the jugular veins) or increased blood pressure, increased pressure in the central vein and pulmonary edema, the drug should be discontinued immediately.
Application in pediatric practice
Safety and effectiveness of the solution ALBUMINA HUMAN in children are not established, however, no additional risks of using this drug in children, except for the risks that exist when it is used in adults, have not been identified.
Large volumes
When replacing relatively large volumes, it is necessary to monitor the parameters of the coagulation system and the level of hematocrit. It is necessary to ensure adequate replacement of other blood components (clotting factors, electrolytes, platelets and red blood cells). It is necessary to strictly monitor hemodynamic parameters.
Electrolyte status
When the ALBUMINE of the HUMAN is introduced, the electrolyte status of the patient should be monitored, as well as taking the necessary measures to restore and maintain the electrolyte balance.
Blood pressure
The rise in blood pressure after the ALBUMINUM OF THE HUMAN infusion necessitates careful follow-up of the patient after trauma or after surgery to detect and treat damaged vessels that might not bleed at a lower blood pressure.
Application, handling and disposal
A solution of ALBUMIN HUMAN should not be mixed with other drugs, including whole blood and blood components, but it can be used as a concomitant if it is medically appropriate.
Do not use if the solution is clouding or the bottle is not sealed. Preparations for parenteral administration before use should be visually inspected for mechanical inclusions and discoloration if the solution and container permit this. If a leak is found, the product must be discarded.
There is a risk of hemolysis with potentially fatal consequences, as well as a risk of acute renal failure when using sterile water for injection to dilute human albumin at a concentration of 20% or higher.Recommended solvents include 0.9% sodium chloride solution or 5% dextrose solution in water.