Instructions for use Albuven 20% solution 100 ml
Composition
active ingredient: human albumin;
1 ml of the drug contains 200 mg of human albumin;
excipients: sodium caprylate, sodium chloride, sodium hydroxide, water for injection.
Dosage form
Solution for infusion.
Main physicochemical properties: transparent viscous liquid from yellowish to light brown in color, a greenish tint is allowed.
Pharmacotherapeutic group
Blood and related products. Blood substitutes and blood plasma protein fractions. Albumin.
Code ATXV05A 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.
Albumin exhibits a corresponding hyperoncotic 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 volume of albumin is 4–5 g/kg of body weight, of which
40–45% in the intravascular space and 55–60% in the extravascular space. In conditions such as severe burns or septic shock, anomalous distribution may occur, which is associated with increased capillary permeability and altered albumin kinetics.
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 leak 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.
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.
The use of albumin or artificial colloid depends on the individual clinical situation for each patient according to official recommendations.
Contraindication
Hypersensitivity to blood protein products or any of the excipients.
Interaction with other medicinal products and other types of interactions
Concomitant use of albumin with ACE inhibitors (angiotensin-converting enzyme) increases the risk of developing arterial hypotension, especially in patients receiving therapeutic plasmapheresis.
Specific interactions of human albumin with other drugs are unknown.
Application features
Tracking
To improve the traceability of biological medicinal products, it is recommended that the name and batch number of the product be recorded in the primary medical record every time it is administered to a patient.
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.
The colloid-osmotic effect of albumin 20% is approximately four times that of blood plasma. Therefore, when administering concentrated albumin, care must be taken to ensure adequate hydration of the patient. The patient's condition must be closely monitored to prevent circulatory overload and hyperhydration.
A 100–200 g/L human albumin solution has a relatively low electrolyte content compared to a 40–50 g/L human albumin solution. When administering albumin, the patient's electrolyte status should be regularly checked and appropriate measures taken to restore and maintain electrolyte balance.
Albumin solutions should not be diluted with water for injection because this may cause hemolysis in recipients.
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.
There is evidence that albumin increases the risk of death in patients with traumatic brain injury and in patients with burns. In patients with severe traumatic brain injury and burns, albumin treatment should only be used after careful assessment of the risks and benefits.
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.
It is recommended that the name and batch number of the product are recorded every time albumin 20% is administered to a patient in order to maintain a link between the patient's condition and the use of a particular batch.
Total sodium (Na+) in the product does not exceed 160 mmol/L. This should be taken into account when treating patients on a controlled sodium diet.
Use during pregnancy or breastfeeding
The safety of ALBUVEN 20% 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.
The effect of albumin on fertility has not been studied in controlled clinical trials.
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.
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;
- clinical manifestations of cardiac/respiratory failure (e.g., shortness of breath);
- clinical manifestations of increased intracranial pressure (e.g., headache).
Human albumin 20% 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.
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 vial, the drug should be used immediately! Any unused solution should be disposed of in accordance with local requirements.
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.
In addition, it is necessary to resolve the issue of forced diuresis or sympathomimetic support after additional examination of the patient.
Adverse reactions
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).
In case of serious reactions such as anaphylactic shock, pulmonary edema, angioedema, etc., the administration should be discontinued and appropriate treatment should be initiated.
| Organ systems | Reactions | Frequency |
| On the part of the immune system | Anaphylactic shock | Rare |
Anaphylactic reaction | Rare | | Hypersensitivity | Rare |
| Allergic reactions, including skin reactions, angioedema, fever | Rare |
| From the nervous system | Headache | Single |
| From the heart | Tachycardia | Single |
| Bradycardia | Single |
| From the vascular side | Arterial hypertension | Single |
| Arterial hypotension | Single |
| Facial redness (hot flashes) | Single |
| Respiratory, thoracic and mediastinal disorders | Dyspnea | Rare |
| Pulmonary edema | Rare |
| Increased respiratory rate | Rare |
| Gastrointestinal tract | Nausea | Single |
| Vomiting | Single |
| Skin and subcutaneous tissue disorders | Urticaria | Single |
| Erythematous rash | Single |
| Itch | Single |
| Injection site reactions including swelling, pain, skin rash, redness, burning sensation | Single |
| General disorders and administration site conditions | Hyperthermia | Single |
| Chills | Single |
| Fever | Single |
| Feeling hot, cold | Single |
| Numbness | Single |
| Tremor of limbs | Single |
| Swelling | Single |
| Weakness | Single |
| Pain in the lower back, muscles, abdomen, chest | Single |
| Cold sweat | Single |
Usually, general disorders and reactions at the injection site disappear quickly after slowing the rate of drug administration or stopping the infusion.
For prevention of 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.
Keep out of reach of children.
Incompatibility.
Concomitant use of albumin with ACE inhibitors increases the risk of developing arterial hypotension.
Human albumin should not be mixed with other medicinal products (except the recommended diluents - 5% glucose solution or 0.9% sodium chloride solution), whole blood and packed red blood cells. 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
