Albuven 10% solution 100 ml

Instructions for use Albuven 10% solution 100 ml

Composition

active ingredient: human albumin;

1 liter of solution contains 100 g of total protein, at least 96% of which is human albumin;

excipients: sodium caprylate, sodium chloride, sodium hydroxide, water for injection.

The sodium content does not exceed 160 mmol/l.

Dosage form

Solution for infusion.

Main physicochemical properties: transparent, slightly viscous, almost colorless, yellowish, amber or green liquid.

Pharmacotherapeutic group

Blood and related products. Blood substitutes and blood plasma protein fractions. Albumin.

ATX code B05A A01.

Pharmacological properties

Pharmacodynamics

Human albumin quantitatively accounts for more than half of all blood plasma protein and approximately 10% of the total protein synthesized by the liver.

Human albumin, 100 g/L, exhibits a corresponding moderate oncotic effect.

The most important physiological function of albumin is its participation in the oncotic pressure of the blood and its transport functions. Albumin stabilizes the circulating blood volume and is a carrier of hormones, enzymes, drugs, and toxins.

Pharmacokinetics

Under normal conditions, the total metabolic pool of albumin is 4–5 g/kg body weight, 40–45% of which is in the intravascular space and 55–60% in the extravascular space. Increased capillary permeability alters albumin kinetics, and in conditions such as severe burns or septic shock, abnormal distribution is possible.

Under normal conditions, the average half-life of albumin is approximately 19 days. The balance between synthesis and degradation is usually achieved through feedback regulation. Elimination occurs primarily intracellularly with the participation of lysosomal proteases.

In healthy individuals, less than 10% of administered albumin leaves the intravascular space within the first 2 hours after administration. There is considerable individual variation in the effect on plasma volume. In some patients, plasma volume may remain elevated for several hours. However, in critically ill patients, albumin may be removed from the vascular space in significant amounts at an unpredictable rate.

Preclinical safety data.

Human albumin is a normal component of human blood plasma and acts like physiological albumin.

Single-dose toxicity studies in animals are of little value and do not allow for the assessment of toxic or lethal doses or dose/effect relationships. Repeat-dose toxicity studies are not possible due to the development of antibodies to the heterologous protein in animal models.

To date, there have been no reports of an association between human albumin and embryo-fetal toxicity, oncogenic or mutagenic potential.

No signs of acute toxicity were observed in experimental animal models.

Indication

Restoration and maintenance of circulating blood volume in cases of volume depletion and the need for the use of colloids.

Contraindication

Hypersensitivity to albumin preparations or any of the excipients.

Interaction with other medicinal products and other types of interactions

Specific interactions of human albumin with other drugs are unknown.

Application features

Standard measures to prevent the transmission of infections when medicinal products prepared from human blood or plasma are used include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective measures for the inactivation/removal of viruses during manufacturing. Despite these measures, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This includes unknown or emerging viruses and other pathogens.

There is no evidence to support the transmission of viruses with albumin properly manufactured according to European Pharmacopoeia specifications.

Traceability

It is recommended that the name and batch number of the product are recorded in the primary medical record every time ALBUVEN is administered to a patient in order to maintain a link between the patient's condition and the use of a particular batch of this medicinal product.

Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the drug. In the event of shock, standard anti-shock therapy should be administered.

Albumin should be used with caution in cases of hypervolemia and its consequences or hemodilution that may pose a particular risk to the patient, such as:

decompensated heart failure;

arterial hypertension;

varicose veins of the esophagus;

pulmonary edema;

hemorrhagic diathesis;

severe anemia;

renal and postrenal anuria.

Human albumin solution 100 g/l has a relatively low electrolyte content compared to human albumin solution 40–50 g/l. When administering albumin, the patient's electrolyte status should be regularly checked (see section "Method of administration and dosage") and appropriate measures should be taken to restore and maintain electrolyte balance.

If it is necessary to replace relatively large volumes of blood, coagulation and hematocrit should be monitored.

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

If the dosage and rate of infusion do not correspond to the patient's circulatory status, hypervolemia may develop. At the first clinical manifestations of cardiovascular overload (headache, shortness of breath, dilated jugular veins) or in the event of increased blood pressure, increased central venous pressure and pulmonary edema, the administration should be stopped immediately.

The total sodium (Na+) content of the product does not exceed 160 mmol/l. This should be taken into account when treating patients on a controlled sodium diet.

When administering large volumes, the drug should be warmed to room temperature or body temperature before use.

Do not use if the solution is cloudy or contains a precipitate. This may indicate protein instability or contamination of the solution.

Do not use if packaging is damaged. Destroy if leakage is detected.

After opening the bottle, the drug should be used immediately! Any unused solution should be disposed of in accordance with local regulations.

Use during pregnancy or breastfeeding

The safety of ALBUVEN in pregnant women has not been established in controlled clinical studies. However, clinical experience with albumin has not revealed any harmful effects on the course of pregnancy, the fetus or the newborn.

Studies on the effect of ALBUVEN on fertility in animals have not been conducted.

Experimental studies on animals are insufficient to assess safety with respect to reproductive function, embryonic or fetal development, the course of pregnancy, and peri- and postnatal development.

However, human albumin is a normal component of human blood.

Ability to influence reaction speed when driving vehicles or other mechanisms

No effect on the ability to drive or use machines was observed.

Method of administration and doses

The concentration of the albumin preparation, dosage, and infusion rate should be adjusted to the individual needs of the patient.

The required dose depends on the patient's body weight, the severity of the injury or illness, and the degree of fluid and protein loss. Volume adequacy indicators, rather than plasma albumin levels, should be used to determine the required dose.

When administering human albumin, hemodynamic parameters should be regularly monitored, including:

blood pressure and pulse rate;

central venous pressure;

pulmonary artery occlusion pressure;

diuresis;

electrolyte concentration;

hematocrit/hemoglobin.

Human albumin can be administered directly intravenously or diluted with an isotonic solution (e.g. 5% glucose solution or 0.9% sodium chloride solution).

The rate of administration should be adjusted according to the clinical condition of the individual patient.

In plasmapheresis, the infusion rate must be adjusted according to the rate of excretion.

Children

Data on the use of human albumin in children are limited.

Overdose

If the dose or infusion rate is too high, hypervolemia may develop. At the first clinical manifestations of symptoms of cardiovascular overload (headache, shortness of breath, dilated jugular veins) or with an increase in arterial and/or central venous pressure and the development of pulmonary edema, the drug should be immediately discontinued and the patient's hemodynamic parameters should be carefully monitored.

Side effects

Minor reactions such as flushing, urticaria, fever and nausea occur rarely. These reactions usually resolve quickly when the infusion rate is slowed or the drug is stopped. Very rarely, serious reactions such as shock may occur. In case of severe reactions, the infusion should be stopped immediately and appropriate therapy should be initiated.

Criteria for assessing the frequency of adverse drug reactions: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); rare (<1/10,000).

For information on preventing the transmission of infectious agents through the drug, see the section "Special instructions for use".

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit-risk balance of the medicinal product. Physicians are asked to report any suspected adverse reactions to the manufacturer and/or the regulatory authority.

Expiration date

3 years.

Storage conditions

Store in the original packaging to protect from light at a temperature not exceeding 25 °C.

Do not freeze.

Keep out of reach of children.

Incompatibility

Human albumin should not be mixed with other medicinal products (except those mentioned in the section "Method of administration and dosage"), whole blood and red blood cell mass.

Furthermore, human albumin should not be mixed with protein hydrolysates (e.g. parenteral nutrition) or solutions containing alcohol, as such combinations may cause protein precipitation.

Packaging

50 ml, 100 ml of the drug in bottles. 1 bottle in a cardboard pack.

Vacation category

According to the recipe.

Producer

LLC "BIOPHARMA PLASMA", Ukraine.

Location of the manufacturer and its business address

Legal address: Ukraine, 09100, Kyiv region, Bila Tserkva, Kyivska st., 37-V

Address of place of business

Ukraine, 09100, Kyiv region, Bila Tserkva, Kyivska st., 37-V