Alburex 20% 100 ml Solution

ALBUREX, solution for 20% intravenous infusion

ALBUREX composition

Active substance: In 1 liter of solution there are 200 g (200 g/L) of human plasma protein, of which at least 96% is human albumin. It is hyperoncotic compared to normal plasma. Each ml of Alburex 20 solution contains approximately 3.2 mg sodium (140 mmol/L).

Indications for use

Restoration and maintenance of circulating blood volume in cases of volume deficit where the use of colloids is indicated. Selection of albumin rather than a synthetic colloid is based on official recommendations and will depend on the clinical condition of individual patients.

Contraindications

Hypersensitivity to albumin preparations or to any of the excipients.

Use during pregnancy and lactation

Controlled clinical studies on the use of Alburex 20 in women during pregnancy have not been conducted. However, in clinical practice regarding the use of albumin, no evidence has been found of any harmful effect on the course of pregnancy, the fetus, or the newborn. Studies on reproductive capacity in animals with Alburex 20 have not been conducted. It is not known whether Alburex 20 is excreted in breast milk.

Since human albumin is a normal constituent of human blood, risk to the breastfed infant from the mother’s treatment with Alburex 20 during lactation is not expected.

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

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

ALBUREX dosage and method of administration

The concentration of the albumin solution used, the dose, and the infusion rate should be adjusted according to the patient’s individual needs. Dosage The required dose depends on the patient’s body weight, the severity of the injury and/or disease, and ongoing fluid and/or protein losses. To determine the required dose, not only the albumin level in plasma but also the measurement of the circulating blood volume should be used. Human albumin should be administered under strict hemodynamic monitoring; these parameters include: • arterial blood pressure and pulse rate, • central venous pressure, • pulmonary artery wedge pressure, • urine output, • electrolytes, • hematocrit/hemoglobin.

In the pediatric patient group, in children and adolescents (0–18 years), the dose of the product should be adjusted based on the patient’s individual needs. Method of administration Alburex 20 is administered intravenously. The product is ready for use; the solution may be administered either directly or after dissolving first in an isotonic solution (e.g., 5% glucose or 0.9% sodium chloride). The infusion rate should be adjusted according to individual characteristics and indications, but should not exceed 1–2 ml per minute.

During plasma exchange, the infusion rate should be adjusted to the rate of removal of plasma. Instructions for use Alburex 20 is administered intravenously. The solution may be administered either directly or after dissolving first in an isotonic solution (e.g., 5% glucose or 0.9% sodium chloride). Albumin solutions should not be diluted with water for injection, as this may cause hemolysis in patients.

When administering large volumes, the product should be warmed until it reaches room temperature or body temperature. The solution should be clear and slightly viscous. Do not use infusion solutions that are cloudy or contain precipitates. This may indicate that the protein is unstable or that the solution has been contaminated.

After opening the container, the solution inside should be used immediately. Any unused product or waste should be disposed of in accordance with local regulations.