Albunorm 20% 50 ml Solution for Infusion

Albunorm Albumin, solution

Albunorm Albumin composition

The composition of 1 liter of solution contains 200 g (200 g/liter) human albumin obtained from human plasma (in 50, 100 ml vials). Excipients: sodium ion, potassium ion, N-Acetyl-DL- tryptophan, caprylic acid, before using this medicine carefully read this package leaflet, as it contains important information for you. • Keep this package leaflet; you may need to read it again. If you have any additional questions, ask your doctor or pharmacist.

⚫ This medicinal product has been prescribed for you only; do not give it to others, even if their disease symptoms are the same as yours, because this medicinal product may be harmful to them.

Indications for use

The product is used to restore and support the volume of circulating blood in patients with volume deficiency. 2010651-02

Contraindications

If you are allergic to human albumin preparations or to any of the excipients of this medicine (see: "Composition").

Use during pregnancy and lactation

Human albumin is a normal component of human blood. When this product is used during pregnancy or lactation, harmful effects are not known. Special attention should be paid to the regulation of blood volume in women. Consult your doctor before using any medicine.

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

There is no evidence that human albumin impairs the ability to drive vehicles or operate other potentially dangerous machinery.

Albunorm Albumin dosage and method of use

Albunorm 20% is ready for use for intravenous infusion («drip»), and the infusion rate (how quickly albumin is administered into the vein) will depend on your specific situation. It will be decided which treatment is best for you. Before use, the product should be brought to room or body temperature. ⚫ The solution must be clear and must not contain any sediment; any unused solution must be discarded. • If you have any questions regarding the use of this product, ask your doctor or pharmacist. When receiving albumin, the patient’s hemodynamic performance should be monitored regularly: ⚫ arterial blood pressure, pulse; electrolytes; central venous pressure; pressure in the pulmonary artery; • the amount of urine excreted; hematocrit/hemoglobin; pediatric population.

Side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. After albumin infusion, side effects occur rarely and usually disappear when the infusion rate is reduced or the infusion is stopped (affects 1 to 10 users in 10,000): flushing (redness), hives, fever and nausea. Rare (affects fewer than 1 user in 10,000): hypersensitivity reactions. The frequency is not known (based on available data, it is not possible to estimate the frequency of occurrence): confused state; headache; increased or decreased heart rate; high blood pressure or low blood pressure; feeling of heat; respiratory failure; nausea; hives; swelling around the eyes, nose, and mouth; rash; increased sweating; fever; chills. If any side effects occur during the use of this medicine, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Special warnings and precautions

Before using Albunorm 20%, consult your doctor, pharmacist, or nurse. In certain cases, Albunorm 20% should be used with special caution. If you have been exposed to a special risk due to an increase in blood volume, for example in severe heart disorders, high blood pressure, dilation of the veins of the esophagus, fluid accumulation in the lungs, bleeding disorders, a marked decrease in the number of red blood cells, or absence of urination, signs of increased volume (headache, breathing difficulty, blockage of the jugular vein) or signs of increased blood pressure should be stopped immediately. If signs of reaction occur, stop immediately.

Safety in patients with severe head injury. When medicines are prepared from human blood or plasma, certain measures are taken to prevent infections from being transmitted to patients. These include carefully selecting blood and plasma donors to exclude the risk of infection, testing each donor and plasma pool for signs of virus/infection, and the steps taken by manufacturers during the production process to inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are used, it is not possible to completely rule out the possibility of transmission of infection. This also applies to any unknown or emerging viruses or other infections. There is no information about virus infection related to albumin produced according to the European Pharmacopoeia specifications using methods that have been used. It is strongly recommended to record the name of the product and the batch number each time you receive every dose of 20% in order to keep track of the batches used. Important information about some components of 20%. This medicinal product contains sodium and potassium, and may be harmful to people on a low-sodium or low-potassium diet. If this applies to you, inform your doctor.

Interactions with other medicinal products

Until now, it has not been known that human albumin has any interactions. Albunorm 20% solution should not be mixed in the same infusion with other medicinal products, blood, or packed red blood cells. If you are currently using any other medicinal product, or have used it, or may use it in the near future, inform your doctor or pharmacist. 2010651-02