Albumin infusion solution 10% 100ml
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Active ingredients
Human albumin
Release form
Solution
Composition
1 ml solution for infusion contains: Human albumin 200 mg. Excipients: sodium caprylic acid, sodium chloride, water for injection
Pharmacological effect
Plasma-substituting (hydrating) Albumin is an integral part of the protein fraction of human blood. The drug is produced from donor plasma tested for the absence of antibodies to human immunodeficiency viruses (HIV-1, HIV-2), hepatitis C virus and hepatitis B surface antigen. Albumin in the body performs the following main functions: hemodynamic (maintaining colloid-oncotic blood pressure ), sorption-transport and function of the main protein reserve of the body. Albumin 10% solution is a weak hyperoncotic solution that maintains the oncotic pressure of the circulating blood. When applied to the bloodstream, fluid from the interstitial space is attracted and retained in it, which increases and stabilizes blood pressure. Albumin binds and inactivates toxins, transports pigments (bilirubin) inside the body, fatty acids, ions of some metals, medicinal substances, improves tissue perfusion in diseases involving hypoproteinemia, and has a positive effect on the protein-synthesizing function of the liver
Pharmacokinetics
Normal blood plasma contains 40-50 g / l of albumin, which accounts for 55-60% of the total protein content. After the internal administration of albumin, it takes 10-15 minutes for complete intravascular distribution. During the first 3 minutes from the moment of administration, a higher concentration of albumin in the spleen, liver and heart is determined. The albumin solution introduced into the vascular bed in large quantities moves into the interstitial space. The biological half-life of serum albumin ranges from 7 to 20 days. From 10 to 16 g of albumin is consumed daily in the body. Albumin is the main reserve protein of the body, its disintegration makes it possible to synthesize globulins and structural proteins of tissues and organs. The use of albumin preparations for parenteral nutrition is impractical, since its half-life in the body can reach 60 days
Indications
Shock (traumatic, operative and toxic), burns accompanied by dehydration and thickening of the blood, hypoproteinemia and hypoalbuminemia, gastrointestinal lesions with digestive disorders (peptic ulcer, tumors, obstructed gastrointestinal anastomosis, etc.)
Contraindications
Hypersensitivity to human albumin. Severe forms of heart failure (due to the possible occurrence of acute heart failure). Thrombosis. Severe hypertension. Continuing internal bleeding. Hypervolemia. Pulmonary edema. Severe anemia. Cerebral edema. Pregnancy. Lactation. Caution is prescribed for: Renal failure. Bronchial asthma. Allergic rhinitis. Edema Quincke
Precautionary measures
Before using the drug, the doctor registers these labels (product name, manufacturer, serial number) in the patient's history. In old age, the quick introduction of a 10% albumin solution should be avoided, as this can lead to an overload of the cardiovascular system. Before starting the infusion, albumin solutions should be warmed to room temperature. The drug is not suitable for use in containers with compromised integrity or labeling, with a change in physical properties (discoloration, cloudiness of the solution, suspended matter, sediment), with expired shelf life, improper storage
Use during pregnancy and lactation
During pregnancy, the use of human albumin is possible only in cases of extreme necessity. Data on the safety of human albumin during lactation are not available.
Dosage and administration
Dosage regimen Individual, depending on the evidence and the clinical situation. Albumin solution 10% is administered intravenously drip or spray. A single dose of the drug depends on the concentration of albumin solution, the initial state and the age of the patient. Albumin solution 10% is administered at a dose of 200-300 ml. The rate of introduction of 10% albumin solution is not more than 40 drops per minute. The jet injection of albumin solutions is permissible in case of shocks of various genesis for a rapid increase in blood pressure. In pediatric practice, the dosage of albumin solutions is calculated based on the concentration in milliliters per kilogram of body weight (not more than 3 ml / kg of body weight of the child)
Side effects
On the part of the digestive system: nausea, vomiting hypersalivation are possible. Since the cardiovascular system: arterial hypotension, tachycardia. Allergic reactions: possible urticaria. Rarely - anaphylactic shock. Other: possible increase in body temperature, pain in the lumbar region
Overdose
Symptoms: in cases where the dose and infusion rate are excessively high or do not correspond to the patient’s blood circulation parameters, hypervolemia and its characteristic symptoms of cardiovascular overload (dyspnea, jugular vein swelling, headache) may develop. It is also possible to increase arterial and / or central venous pressure, the development of pulmonary edema. Treatment: at the first manifestations of symptoms of overload of the cardiovascular system, it is necessary to immediately stop the introduction of the drug and establish a constant monitoring of the parameters of blood circulation. According to indications - conducting symptomatic therapy. No specific antidotes
Interaction with other drugs
With the simultaneous use of human albumin with ACE inhibitors increases the risk of arterial hypotension
special instructions
Allergic reactions / anaphylactic shock Any suspicion of allergic or anaphylactic reactions requires the immediate cessation of drug administration. If shock develops, standard anti-shock therapy should be used. Since this drug is made from human blood plasma, it may carry the risk of transmitting pathogens, such as 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 with certain viruses in the past, by testing for the presence of certain viral infections now, 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 for shellless viruses, such as hepatitis A virus and parvovirus B19. It is highly recommended that, with each administration of Albumen to a human patient, the name and serial number of the drug be recorded in order to establish a connection between the patient and the drug series.Hemodynamics Do not enter without careful monitoring of hemodynamic parameters, monitor the development of symptoms of cardiac or respiratory failure, renal failure or increased intracranial pressure. Hypervolemia / hemodilution Human albumin should be used with caution in conditions in which hypervolemia and its consequences or hemodilution may be 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 failure. The rate of administration should be chosen according to the concentration of the solution and the hemodynamic parameters of the patient. Rapid administration may cause circulatory overload and pulmonary edema. At the first clinical signs of an overload of the cardiovascular system (headache, shortness of breath, blockage of the jugular veins) or an increase in blood pressure, an increase in pressure in the central vein and pulmonary edema, administration of the drug should be stopped immediately. Application in pediatric practice The safety and efficacy of human albumin solution in pediatric patients has not been established, however, no additional risks of using this drug in children, other than the risks associated with its use in adults, have not been identified. Large volumes When replacing relatively large volumes, it is necessary to monitor the indicators of the coagulation system and the hematocrit level. It is necessary to ensure adequate replacement of other blood components (coagulation factors, electrolytes, platelets and red blood cells). It is necessary to strictly monitor hemodynamic parameters. Electrolyte status When human albumin is administered, the patient’s electrolyte status should be monitored, and the necessary measures should be taken to restore and maintain electrolyte balance. Blood pressure Increasing blood pressure after infusion of human albumin necessitates careful monitoring of the patient after injury or after surgery to detect and treat damaged vessels that might not bleed at lower blood pressure.Application, handling and disposal Albumen human solution should not be mixed with other drugs, including with whole blood and blood components, however, it can be used as a co-agent if it is medically appropriate. Do not use if the solution is cloudy or the bottle is tight. Preparations for parenteral administration before use should be visually examined for the presence of mechanical impurities and discoloration, if the solution and container allow it. If leakage is detected, the drug must be discarded. There is a risk of hemolysis with potentially lethal consequences, as well as the risk of acute renal failure when using sterile water for injection to dilute human albumin with a concentration of 20% or higher. Recommended solvents include 0.9% sodium chloride solution or 5% dextrose in water. Impact on the ability to drive motor vehicles and control mechanisms Data on the effect of human albumin on the ability to drive a car and work with other machines and mechanisms are not available.