Albumin Biofarma 100MG 100 ml (4472)

ALBUMIN-BIOFARMA, solution for infusion

ALBUMIN-BIOFARMA composition

Active substance: 100 mg human albumin is contained in 1 ml of solution.

Indications for use

Restoration and support of blood circulation when there is a need arising due to reduced volume and the necessity for the use of colloids. The use of albumin or a colloid depends on the individual clinical situation of each patient in accordance with official recommendations.

Contraindications

High sensitivity to blood protein preparations or to any of the excipients of the product.

Use during pregnancy and lactation

The safety of using the 10% Albumin-Biofarma preparation during pregnancy has not been determined in controlled studies. However, clinical experience with albumin has not revealed any adverse effects of albumin use 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 in animals regarding reproductive function, embryo and fetal development, the course of pregnancy, and pre- and postnatal development are not sufficient to assess safety.

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

Effect on the ability to drive vehicles and operate other potentially dangerous machinery

No effect on the ability to drive vehicles or operate other potentially dangerous machinery has been observed.

ALBUMIN-BIOFARMA dosage and method of use

The concentration of the albumin preparation, the dose, and the infusion rate should be selected based on the patient’s individual requirements. The required dose for administration depends on the patient’s body weight, the severity of the trauma or illness, and the level of fluid and protein loss in the patient. The required dose is determined based on the compatibility of the circulating blood volume with the albumin non-plasma level. When using human albumin, regular monitoring of the hemodynamic parameters listed below is necessary: - arterial blood pressure and pulse rate; - central venous pressure; - pulmonary artery occlusion pressure; - urine output (diuresis); - electrolyte composition; - hematocrit/hemoglobin; - clinical manifestations of cardiovascular/respiratory failure (e.g., shortness of breath); - clinical manifestations of increased intracranial pressure (e.g., headache).

Human albumin 10% can be administered intravenously either directly or diluted with an isotonic solution (e.g., 5% glucose or 0.9% sodium chloride solution). Human albumin solution must not be diluted with water for injection, as this may cause hemolysis in the patient. The infusion rate should be selected according to individual conditions and indications. During plasmapheresis, the infusion rate should be selected in accordance with the rate of extracorporeal removal.

When administering albumin in large volumes, the preparation must be warmed to room temperature or body temperature before use. The solution should not be used if it is cloudy or contains sediment. Such changes indicate instability of proteins or contamination of the solution. Do not use the product if the packaging is damaged. If leakage is detected, the product must be discontinued.

After opening the vial, the product must be used immediately! Any unused residues of the solution must be disposed of in accordance with local requirements.