Quantitatively, the human albumin is more than half of the total plasma protein, accounting for approximately 10% of the protein-synthesizing activity of the liver.
Human albumin is Hyperoncotic effect. The main physiological functions of albumin associated with its contribution to the regulation of blood oncotic pressure and the transport function. Albumin is a carrier of hormones, enzymes, drugs and toxin also leads to normal blood volume.
Normally the total exchange albumin pool is 4-5 g / kg body weight, with 40-45% are intravascularly and 55-60% – in the tissue. Under such conditions of the organism as severe burns or septic shock increased capillary permeability changes albumin kinetics and may cause its abnormal distribution. Normally, the average T 1/2 of albumin is about 19 days. The balance between synthesis and cleavage of the albumin is usually carried out by a feedback mechanism. The process of elimination is carried out mainly intracellularly by the action of lysosomal proteases.
In healthy people, less than 10% of the injected / v albumin leaving the intravascular space during the first 2 hours. There is significant individual variability effect of infusion of albumin to plasma volume. In some patients, blood plasma volume can remain increased for several hours. However, patients in critical conditions albumin may leave the bloodstream in substantial quantities and with unpredictable rate.
Preclinical safety data
Human albumin – a natural component of human plasma and acts like physiological albumin.
Investigation of single dose toxicity in animals has minor significance and does not allow to evaluate the toxic or lethal dose, or dose and effect relationship.
Multiple dose toxicity study in animals is not feasible due to the formation of antibodies to heterogeneous protein.
To date there is no information regarding the fetal and fetal toxicity, carcinogenic and mutagenic effect of human albumin. In animal studies also showed no signs of acute toxicity.
Baxter, United States
water g / u.
To restore and maintain blood volume at a failure of the volume and appropriateness of colloids, including Human albumin may be used in the following clinical conditions:
- shock – if in case of emergency treatment of shock and in other similar conditions that require urgent restoration of circulating blood volume;
- burns – or albumin in an isotonic solution or dextrose solution for preventing pronounced hemoconcentration and maintain the desired balance of electrolytes;
- hypoproteinemia edema with or without edema – in clinical situations commonly associated with low concentrations of plasma proteins and lead to a decrease in blood volume;
- hypoalbuminemia – when albumin deficiency was the result of insufficient synthesis, excessive catabolism loss due to burns or trauma or by redistribution within the body
- allergic reactions to albumin or any of the excipients.
Human albumin solution can not be diluted with water for injection, since this may cause haemolysis in recipients. There is a risk of hemolysis with potentially fatal consequences, and the risk of acute renal failure due to the misuse of sterile water for injection for the breeding of human albumin.
With careful human albumin should be used in conditions where hypervolemia and its consequences or haemodilution could represent a special risk for the patient. Examples of such conditions are: decompensated heart failure, hypertension, varicose veins, pulmonary edema, hemorrhagic diathesis, severe anemia, renal and postrenal failure.
Use in renal function
With ostorzhnostyu human albumin should be used in conditions where hypervolemia and its consequences or haemodilution could represent a special risk for the patient. Examples of such conditions are renal and postrenal failure.
Adverse side effects in clinical trials
Data on adverse reactions in the controlled clinical trials of human albumin absent.
Adverse side reactions noted in the post-marketing period
In the post-marketing period there have been reports of these adverse reactions. These reactions are listed by system organ class (SOC) using the preferred terminology of the Medical dictionary for regulatory activities (MedDRA) in descending order of severity:
On the part of the immune system: anaphylactic shock, anaphylactic reaction, hypersensitivity / allergic reactions.
Cardio-vascular system: If necessary, use during lactation should decide the issue of termination of breastfeeding; tachycardia, decreased blood pressure, flushing.
The respiratory system: dyspnea.
From the digestive system: nausea, vomiting, dysgeusia.
For the skin: hives, rash, itching.
Local reactions: fever, chills.
How to accept, acceptance rate and dosage
The dose of the human albumin solution is determined individually. When administered to human albumin should monitor the hemodynamic parameters and the patient’s breathing to avoid pulmonary edema. In addition, the neurological status of the patient should be monitored to prevent increased intracranial pressure.
Human albumin solution to be introduced into / in. Human albumin solution must not be mixed with other drugs, including whole blood and blood components, but it can be used as co-agent, if appropriate from a medical point of view.
Human albumin solution can not be diluted with water for injection, since it can cause hemolysis in patients. A solution of human albumin can not be mixed with protein hydrolysates or solutions containing alcohol, as Such combinations may lead to precipitation of proteins.
Do not add other drugs.
If the dose and rate of administration is not matched with the concentration of the solution and the patient’s clinical status, administration of human albumin may lead to fluid overload.
In patients receiving human albumin, it is necessary to monitor haemodynamic parameters to prevent fluid overload and overload the cardiovascular system.
Store the drug at a temperature of from 2 ° to 25 ° C.
Do not freeze.
Keep out of the reach of children
Albumin human interaction studies with other drugs have not been conducted (known due to lack of data in clinical studies and medical literature reports of security).
Allergic reactions / anaphylactic shock
Any suspicion of an allergic or anaphylactic reactions require immediate discontinuation of the drug. In the case of shock should apply standard anti shock therapy.
Since this medication is made from human blood plasma, it may carry a risk of transmitting infectious agents, eg viruses and, theoretically, the causative agent of Creutzfeldt-Jakob disease. This also applies to unknown or new viruses and other pathogens.
The risk of transmission of infectious agents is reduced by screening plasma donors for possible infection of certain viruses in the past, by testing for the presence of certain viral infections at the moment, and by inactivating and / or removing certain viruses. The measures taken are considered effective for enveloped viruses such as HIV, hepatitis B virus, hepatitis C virus, as well as non-enveloped viruses such as hepatitis A virus and parvovirus B19. It is strongly recommended that every time administration of albumin chelovecheckogo patient record the name and batch number of the drug in order to establish communication between the patient and a series of drug.
Not administered without careful monitoring of hemodynamic parameters, monitor the development of the symptoms of cardiac or respiratory failure, renal failure or increased intracranial pressure.
Hypervolemia / hemodilution
Human albumin should be used with caution in conditions where hypervolemia and its consequences or haemodilution could represent a special risk for the patient. Examples of such conditions are: decompensated heart failure, hypertension, varicose veins, pulmonary edema, hemorrhagic diathesis, severe anemia, renal and postrenal failure. The rate of administration should be selected according to the concentration of the solution and the hemodynamic parameters of the patient. Rapid administration can lead to circulatory overload and pulmonary edema. In the first clinical signs of overload of the cardiovascular system (headache, dyspnea, jugular venous occlusion) or increased blood pressure, increased pressure in the central vein and pulmonary edema administering the drug should be stopped immediately.
Use in pediatric patients
Safety and efficacy of albumin solution chelovecheckogo in pediatric patients has not been established, but any additional risks of using this drug in children, in addition to the risks existing when it is used in adults are not revealed.
With the substitution of relatively large volumes necessary to control parameters of the coagulation system and the level of hematocrit. It is necessary to ensure adequate substitution of other blood components (coagulation factors, electrolytes, platelets and erythrocytes). It is necessary to strictly monitor the hemodynamic parameters.
When the administration of albumin should be monitored chelovecheckogo electrolyte status of the patient, and to take the necessary measures to restore and maintain the balance of electrolytes.
Increase in blood pressure after the infusion Albumin chelovecheckogo necessitates close monitoring of the patient after injury or after surgical intervention to the detection and treatment of damaged vessels which might bleed at a lower blood pressure.
The use, handling and disposal
Albumin chelovecheckogo solution must not be mixed with other drugs, including whole blood and blood components, but it can be used as co-agent, if appropriate from a medical point of view.
Do not use if the solution becomes cloudy, or violation of the vial seal. Formulations for parenteral administration before use must be examined visually for the presence of inclusions and mechanical color change if the solution and container permit. When detecting leaks drug must be discarded.
There is a risk of hemolysis with potentially lethal consequences, and the risk of acute renal failure when using sterile water for injection for cultivation of human albumin at a concentration of 20% and above. Recommended solvents include 0.9% chloride or 5% dextrose solution, sodium solution in water.
Effects on ability to drive vehicles and management mechanisms
Data on the effect of albumin chelovecheckogo on the ability to drive a car and work with the other cars, and there are no mechanisms.
A significant excess dose and increase the rate of administration can cause fluid overload.
3 years. Do not use beyond the expiration date printed on the package