Human albumin - instructions for use, dose, side effects, contraindications

Plasma-reducing agent obtained by fractionating human plasma. A 5% solution of albumin is an isononic plasma. A 20% albumin solution is hyperoncotic, and its colloidal osmotic effect exceeds that of plasma by about 4 times. With intravenous administration of the drug, the oncotic pressure in the intravascular space increases, which leads to an increase and maintenance of the volume of the circulating plasma. The duration of this effect varies from patient to patient.In some patients, an increase in plasma volume may persist for several hours. Albumin is also a transport protein that binds and carries hormones, enzymes, and drugs in the vascular bed.

Pharmacokinetics:

- Distribution

Normally, the total exchange fraction of albumin is 4-5 g / kg of body weight; Of this amount, 40-45% are in the vascular bed, and 55-60% are in the extravascular space. With such pathological conditions as severe burns or septic shock, the normal distribution of albumin is disrupted, which is associated with a significant increase in the permeability of capillaries.

- Metabolism and elimination

The half-life of albumin is an average of 19 days. Elimination occurs intracellularly with the participation of lysosomal proteases.

In healthy volunteers, less than 10% of intravenously injected albumin is excreted from the vascular bed during the first 2 hours after infusion. However, patients in critical condition can lose significant amounts of albumin, and the rate of its release from the vascular bed is unpredictable.

Indications:

- Replenishment and maintenance of the volume of circulating blood in cases when there is a deficiency and the use of colloidal solutions, in particular, with hypovolemic and hemorrhagic shock;

- Medical plasmapheresis (exchange replacement of plasma);

- As an aid in performing operations with the use of artificial circulation;

- Conducting pre-operative hemodilution and preparing components of autoblood;

- Cerebral edema (hyperoncotic solution).

Contraindications:

- Hypersensitivity to albumin or other components of the drug;

- Chronic heart failure in the phase of decompensation;

- Pulmonary edema;

- Severe anemia;

- Hypervolaemia.

Carefully:

Albumin solution should be used with caution in patients with chronic renal failure, chronic heart failure in the phase of compensation, chronic compensated anemia, hypertension; varicose veins of the esophagus; hemorrhagic diathesis, vascular thrombosis, and continuing internal bleeding.

In elderly patients, in order to avoid overloading the cardiovascular system, it is recommended to avoid the introduction of 20%solution, and with the introduction of a 5% solution, a high rate of administration should be avoided.

Pregnancy and lactation:

The safety of Octampar albumin when used in pregnant women in controlled clinical trials has not been studied. The experience of clinical application of the albumin solution does not give grounds for expecting any harmful effect on the course of pregnancy, on the fetus or newborn, since human albumin is a normal component of human blood plasma.

The effect of Octapharm's albumin on reproductive function in animals has not been studied.

Dosing and Administration:

Concentration of the drug, dose and speed of infusion should be selected individually in each case.

The dose required for administration depends on the body weight, the severity of the injury or disease and the continued loss of fluid and protein. To determine the required dose, the sufficiency of the volume of circulating blood should be assessed, and not the level of albumin in the plasma. A solution of human albumin is administered intravenously drip. The rate of infusion should be selected depending on the patient's condition and indications.

For the 5% albumin solution average single dose of 200-300 ml, maximum dose of 500-800 ml. The recommended rate of administration is not more than 60 cap / min.

For a 20% solution of albumin, a single dose is 100 ml. The recommended rate of administration is not more than 40 cap / min.

With exchange replacement of plasma, the infusion rate can be higher and should correspond to the rate of removal.

Pediatric practice.

The dose is determined individually, based on evidence, clinical status and body weight. The recommended single dose is from 0.5 to 1.0 g / kg.

The drug can be used in premature infants.

Special categories of patients

The drug can be used in patients on hemodialysis.

Recommendations for handling the drug

Before use, the drug solution should be carefully examined. If the solution is turbid or contains inclusions, it can not be used, since such changes may indicate a protein decomposition or microbial contamination.

Before administration, the drug should be kept at room temperature. The drug should be administered immediately after opening the vial.Unused residue should be disposed of.

A solution of albumin 20%, if necessary, can be diluted with saline or 5% glucose solution. For this purpose, water for injection can not be used.

Side effects:

During the period of post-marketing use of the drug, the undesirable reactions listed below were noted.

Frequency of occurrence of undesirable reactions is classified as follows: very often (> 1/10); often (> 1/100, <1/10); not often (> 1 / 1,000, <1/100); rarely (> 1 / 10,000, <1 / 1,000); very rarely (<1 / 10,000), including single messages.

When the drug is used, undesirable reactions are rarely observed. They usually pass on their own with decreasing speed or stopping the administration of the drug. If a severe reaction occurs, the administration should be discontinued and appropriate treatment initiated.

From the immune system: rarely an anaphylactic reaction; very rarely anaphylactic shock.

From the nervous system and psyche: very rarely - headache, confusion. From the cardiovascular system: rarely - hypotension; very rarely - tachycardia, bradycardia, arterial hypertension, flushes of blood to the face.

From the respiratory system: very rarely - dyspnea.

From the gastrointestinal tract: very rarely - nausea.

From the skin and subcutaneous tissue: very rarely - hives, angioedema, erythematous rash, excessive sweating.

General disorders: very rarely - a fever, a shiver.

Other: pain in the lumbar region.

Overdose:

- Overdose Symptoms

In cases where the dose and speed of infusion are excessively high or do not correspond to the patient's blood circulation parameters, it is possible to develop hypervolemia and its symptoms of cardiovascular overload (dyspnea, jugular venous swelling, headache). It is also possible to increase arterial and / or central venous pressure, the development of pulmonary edema.

- Treatment for overdose

At the first manifestations of the symptoms of cardiovascular overload, the drug should be stopped immediately and the blood flow parameters should be constantly monitored. According to the indications - the conduct of symptomatic therapy. Specific antidotes are absent.

Interaction:

Specific interactions of human albumin with other drugs are unknown.

Special instructions:

If allergic or anaphylactic reactions occur, the drug should be discontinued immediately and appropriate treatment started. In the event of shock, anti-shock treatment should be initiated in accordance with current treatment standards.

When carrying out the infusion of the drug, it is necessary to ensure thorough and regular monitoring of blood circulation parameters, including blood pressure, heart rate, central venous pressure, pulmonary wedge pressure, diuresis, electrolyte concentration in plasma, hematocrit / hemoglobin.

When the albumin solution is administered, the concentration of sodium and potassium in the patient's blood plasma should be monitored and appropriate measures taken to restore or maintain the balance of these electrolytes. It should be noted that the concentration of sodium in 5% and 20% solutions is the same.

If it is necessary to replace relatively large volumes, control of blood coagulation and hematocrit values is required. It is necessary to ensure appropriate replacement of other blood components (clotting factors, electrolytes, platelets and red blood cells).

Administration of the albumin solution during dehydration is possible only after preliminary ensuring sufficient fluid intake (inside, parenterally).

Since a 20% albumin solution is able to effectively increase colloid osmotic pressure, during its administration it is necessary to monitor the patient's condition in order to timely detect the overload of blood circulation and hyperhydration.

Solutions of albumin can not be diluted with water for injection, since the introduction of such a solution to the patient can cause hemolysis of red blood cells.

Standard measures to prevent infections caused by the use of drugs derived from human blood or plasma include selection of donors, testing of individual portions and pools of plasma for specific markers of infection, and the inclusion of effective measures to inactivate / eliminate viruses in the production process. However, when using drugs produced from human blood or plasma, the probability of transmission of infectious agents can not be completely ruled out. This also applies to unknown or newly identified viruses and other pathogenic microorganisms.

There were no reports of transmission of viruses with albumin solutions produced by conventional methods in accordance with the specifications of the European Pharmacopoeia.

Each time a patient is administered a drug, it is recommended that the name of the drug and the series number be recorded in the patient's history or medical record so that the relationship between the patient's condition and the administration of the drug of a particular series can be traced.

Effect on the ability to drive transp. cf. and fur:

There was no evidence of the effect of the drug on the ability to drive vehicles and work with mechanisms.

Form release / dosage:Solution for infusions 5%, 20%.

Packaging:

Solution for infusions 5%: 100 ml, 250 ml and 500 ml in a bottle of hydrolytic class II glass, sealed with a rubber stopper, rolled in with an aluminum cap covered with a plastic lid (the plastic cover can be scrolled), 1 bottle with holder and instruction for use put in a cardboard box.

Solution for infusions of 20%: 50 ml and 100 ml in a bottle of glass of hydrolytic class II, sealed with a rubber stopper, rolled under running-in with an aluminum cap,covered with a plastic lid (a plastic lid is allowed to scroll), 1 bottle with a holder and instructions for use are placed in a cardboard box.

Storage conditions:

Store at a temperature of 2 ° C to 25 ° C in a dark place. Do not freeze. Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-000878/09

Date of registration:09.02.2009

The owner of the registration certificate:Octapharma Pharmaceuticals Productionsgesb.H.Octapharma Pharmaceuticals Productionsgesb.H. Austria

Manufacturer: & nbsp

OCTAPHARMA Pharmazeutika Produktionsges, m.b.H. Austria

Representation: & nbspOKTAPHARMA NORDIC AB OKTAPHARMA NORDIC AB Sweden

Information update date: & nbsp29.08.2015

Illustrated instructions

Instructions

Human albumin (Albumin human)