Human Albumin Baxter: replacement therapy and plasma protein components

2021-06-08 12:45 AM

Human Albumin Baxter is used to restore and maintain blood volume in cases of hypovolemia and the use of albumin-containing colloids is appropriate.

Producer

Baxalta

Ingredient

Whole protein 200g or 250g, of which Human albumin (human albumin) accounts for at least 95%.

Pharmacodynamic

Treatment group: plasma replacement therapy drugs and plasma protein components.

ATC code: B05AA01

Human albumin makes up more than half of plasma proteins and about 10% of proteins synthesized in the liver.

Physical and chemical properties: Human Albumin Baxter 200g/L or 250g/L has a good effect of increasing glue pressure.
 
The most important physiological function of albumin is to contribute to blood colloidal pressure and its transport function. Albumin contributes to the stabilization of blood volume, the transport of hormones, enzymes, medicinal products, and toxins.

Pharmacokinetics

Under normal conditions, the total amount of exchangeable albumin is 4-5 g/kg body weight, of which about 40-45% is in the blood vessels, 55-60% is outside the blood vessels. Increased capillary permeability may alter albumin kinetics and abnormal distribution in severe burns and septic shock.

Under normal conditions, the half-life of albumin is 19 days. The balance of albumin synthesis and degradation by the feedback mechanism. Excretion is mainly intracellular and by lysosomal proteases.
 
In healthy subjects, less than 10% of albumin is released into the bloodstream during the first 2 hours of infusion. There is a considerable inter-individual variation in the effect on blood volume. In some patients, plasma volume can remain elevated for several hours. However, in critically ill patients, albumin can be released from the bloodstream in significant quantities at an unpredictable rate.

Indications and uses

Used in the case of restoration and maintenance of blood volume in cases of hypovolemia and the use of albumin-containing colloids is appropriate.

The preference for albumin or other synthetic colloids depends on the clinical status of the patient, based on official recommendations.

Dosage and Administration

Selected albumin concentration, dosage, and infusion rate must be appropriate to the patient's treatment needs.

Dosage:

The dosage depends on the individual patient's condition, the severity of the injury or medical condition, and the amount of fluid or protein the body continues to lose. Blood volume and plasma albumin deficiency should be checked to determine the appropriate dose.

Human Albumin Baxter solution 200g/L or 250g/L requires intravenous infusion. Do not dilute the product with distilled water for injection because it can cause hemolysis.

Albumin solutions should not be mixed with other drugs containing blood and blood components but can be used concurrently with other injectable preparations when absolutely necessary.

Albumin solutions should not be mixed with hydrolyzed proteins or alcohol-containing solutions because these substances combined may produce protein precipitates.

Do not add additional drugs to the infusion solution.

An increase in circulating volume may occur if the dose and infusion rate are not adjusted, taking into account the concentration of the solution and the clinical status of the individual patient. Hemodynamic parameters should be monitored when patients receive Human Albumin Baxter 200g/L or 250/L and the risk of increased blood flow and circulatory overload should be checked.

If human albumin is used, continuous monitoring of hemodynamic parameters including:

Arterial blood pressure and heart rate.

Venous pressure.

Pulmonary artery pressure.

Urine volume.

Electrolyte concentrations.

Hematocrit/hemoglobin ratio.

Clinical signs of heart failure and respiratory failure (eg, dyspnea).

Clinical signs of increased cranial pressure (eg, headache).

Using

The preparation can be administered directly by intravenous infusion or pre-diluted with isotonic solutions (e.g. 5% glucose solution, 0.9 % sodium chloride solution).

The infusion rate should be appropriate for the specific condition of the individual patient and as directed.

In the case of plasma exchange, the infusion rate must be adjusted to the rate of elimination.

Use caution

The solution can be administered intravenously or pre-diluted with an isotonic solution (eg, 5% glucose solution or 0.9 % sodium chloride solution).

Do not dilute with distilled water for injection because it may cause hemolysis.

When treating with large volumes of infusion, the solution temperature must be brought to room temperature or body temperature before use.

Do not use cloudy or sedimented preparations, in which case the protein may be unstable or the solution may be contaminated.

Do not use the product if the solder joint is not intact. If the bottle is found to be leaking, throw it away.

Use the medicine immediately after opening the cap. Excess medication must be disposed of.

Warning

If an allergic or anaphylactic reaction is suspected, stop the infusion immediately. In the event of a patient in shock, appropriate medical treatment should be instituted immediately.

Particular caution should be exercised when albumin is used in cases of excess body fluids and the consequences of excess body fluids or when blood-thinning would be dangerous to the patient. For example, in some cases:

Decompensated heart failure

High blood pressure

Esophageal varices

Pulmonary edema

Internal bleeding

Severe anemia

Prerenal and postrenal oliguria.

The colloidal pressure of a 200g/L or 250g/L human albumin solution is about 4 times that of plasma. Therefore, when concentrated albumin is indicated, care must be taken to ensure adequate rehydration of the patient. Patients must be carefully monitored for circulatory overload and excess fluid in the body.

The electrolytes in Human Albumin Baxter 200g/L or 250g/L solutions are relatively low when compared to human albumin solutions with concentrations of 40-50 g/L. During infusion of albumin solutions, the patient's electrolyte levels should be closely monitored, and appropriate measures should be taken to restore and maintain electrolyte balance.

Human Albumin Baxter 200g/L (or 250g/L) contains sodium with a concentration of 100-130 mmol/L (or 130-160 mmol/L), caution should be exercised when treating patients on a low-carbohydrate diet. sodium control.

Do not dilute the product with distilled water for injection because it can cause hemolysis.

In the case of large volume replacements, coagulant and hematocrit should be monitored.

Adequate replacement of other blood components (coagulation factors, electrolytes, platelets, red blood cells) should be ensured.

Hypovolemia may occur if the therapeutic dose and infusion rate are not appropriate for the patient's circulatory status. Stop the infusion at the first clinical signs of circulatory overload (headache, dyspnea, jugular venous obstruction), or hypertension, vena cava pressure, pulmonary edema.

Standard measures to prevent contamination with human blood and plasma-derived products include a selection of volunteers, screening of donated samples, and individual plasma bags for specific signs of infection. sterilization, introducing effective steps in the production process to inactivate or eliminate viruses. However, it is not possible to completely eliminate the possibility of transmission of pathogens from preparations derived from human blood or plasma. The same is true for unknown or new viruses, as well as other pathogens.

There have been no confirmed reports of viral infections with albumin produced according to European Pharmacopoeia standards according to established procedures.

It is particularly important with each use of Human Albumin Baxter 200g/L or 250g/L that the patient's name and batch number be carefully recorded in order to maintain patient-to-lot contact.

Allergic reactions/anaphylaxis: If allergic reactions or anaphylaxis-type reactions are suspected, the infusion should be stopped immediately. In case of shock during infusion, standard shock treatment measures should be applied.

Conservative

Hemodynamics: Do not initiate treatment without close hemodynamic control, and should check for evidence of heart/respiratory failure, renal failure, or increased intracranial pressure.

Increase blood volume/increase circulation

Human Albumin preparations should be used in patients at risk of consequent hypervolemia or hypervolemia. Groups of patients at risk include (and are not limited to): decompensated heart failure, hypertension, esophageal varices, pulmonary edema, patients with possible haemorrhage, severe anemia, renal failure, and after CKD.

Adjust the infusion rate based on the drug concentration and the results of the hemodynamic assessment of the patient. Infusion at too rapid a rate can lead to increased circulation and pulmonary edema. Initial clinical signs of hypervolemia include headache, dyspnea, jugular venous distension, or hypertension, CNS hypertension, and pulmonary edema, requiring immediate discontinuation of the infusion.

Infusion of drugs in large volumes

If the volume of substitution is relatively large, close monitoring of the coagulation index and hematocrit is necessary. Take the necessary care to ensure adequate replacement of other blood components (clotting factors, electrolytes, red blood cells, and platelets). Simultaneously conduct appropriate measures to monitor hemodynamic parameters (anticoagulants, electrolytes, platelets, and red blood cells).

Appropriate hemodynamic monitoring is required during drug infusion.

Electrolyte Status

When prescribing Human Albumin, an examination and measures should be taken to maintain/restore the appropriate electrolyte balance.

Blood pressure: Careful observation of hypertension should be observed after 20% (or 25%) albumin infusion in trauma or postoperative patients to detect and treat severe vascular injury to avoid causing bleeding at lower blood pressure levels.

Drug use in children

The safety and effectiveness of the use of Human Albumin preparations in young children are currently inadequate in clinical trials; however, the use of Albumin preparations in these patient populations has been referenced in the literature.

The use of Human Albumin preparations in neonates is not recommended due to lack of experience and data on these patients.

When operating machinery

It has not been reported that Albumin adversely affects the ability to drive and use machines.

Overdose

Hypovolemia may occur if the dose and infusion rate are too high. Stop infusion at the first clinical signs of circulatory overload (headache, dyspnoea, jugular venous obstruction), or manifestations of hypertension, vena cava pressure, pulmonary edema, monitoring the hemodynamic parameters of the patient.

Contraindications

Hypersensitivity to human albumin preparations or to any of the excipients.

This product is contraindicated in people with a history of allergy to albumin and any of its ingredients.

Human Albumin Baxter 200g/L or 250g/L must not be diluted with distilled water for injection as it may cause hemolysis. When using distilled water for injection to dilute albumin concentrations of 20% or higher, there is a risk of death from hemolysis or acute renal failure.

Use in pregnant and lactating women

The safety of Human Albumin Baxter 200g/L or 250g/L, when used in pregnant women, has not been established in controlled clinical trials. However, according to clinical experience, albumin is not harmful to pregnant women, fetuses, and neonates.

No animal reproduction studies have been performed with Human Albumin Baxter 200g/L or 250g/L. Animal studies are insufficient to evaluate safety with regard to reproduction, embryonic and fetal development, pregnancy, and subsequent development.

However, it should be noted that albumin is a normal component of human blood.

Because there are not enough research data on the use of Albumin (Human) preparation for pregnant and lactating women, special consideration should be given to the risks and benefits when prescribing the drug for these patients. this.

Interactive

No special interactions have been found between Human Albumin and other drugs.

Side effects

Undesirable uses determined by the frequency of occurrence

The frequency index of undesirable effects is based on the following:

Very common: ≥1/10 of users.

Common: <1/10 and >1/100 of users.

Uncommon: <1/100 and >1/1,000 users.

Rare: <1/1,000 and >1/10,000 of users.

Very rare: <1/10,000 users.

Unknown: not determined based on available data.

Immune system disorders: Very rare: anaphylaxis.

Gastrointestinal disorders: Rare: nausea.

Skin and subcutaneous tissue disorders: Rare: rash, flushing.

General disorders at the site of infusion: Rare: fever.

In the event of a severe reaction, the infusion should be stopped immediately and active treatment should be initiated.

Adverse effects classified by organ system

In the post-marketing adverse events report, sort by the MedDRA classification system list by system organ class, followed by Preferred Term to sort by severity.

Immune system disorders: anaphylaxis/hypersensitivity/allergic reactions.

Nervous system disorders: headache, altered taste.

Cardiovascular disorders: tachycardia, atrial fibrillation, tachyarrhythmia.

Vascular disorders: hypotension, flushing.

Respiratory, thoracic, and mediastinal disorders: pulmonary edema, dyspnea.

Digestive disorders: nausea, vomiting.

Skin and subcutaneous tissue disorders: urticaria, pruritus, rash.

General disorders at the infusion site: chills, fever.

There are no data reported on adverse reactions in clinical trials with human albumin.

Preservation

Store the drug below 30oC. Do not freeze.

Keep the medicine bottle in the paper box to protect it from light. The medicine must be used as soon as the vial is opened.

Presentation and packaging

Solution for infusion: box of 1 bottle of 50mL.