Zenalbi 20 (Human Albumin) 20% Infusion Solution – 50 mL Glass Vial

Composition:

The active ingredient is Human Albumin.
Zenalbi 20 is a solution containing 200 g/L of total protein, of which not less than 95% is human albumin.
Other excipients include: sodium octanoate, sodium hydroxide (for pH adjustment), acetic acid (for pH adjustment), and water for injection.

Indications for Use:

Zenalbi 20 is a solution containing human albumin, a natural protein found in blood that performs several essential physiological functions.
Human albumin used in this product is derived from screened and selected blood plasma donors in the United States.

Zenalbi 20 is used as a replacement for blood or body fluids lost during:

• bleeding,

• surgery, or

• kidney dialysis ("cleansing" of the blood using a machine).

It contains four times the amount of albumin found in normal blood.

The solution is administered intravenously (IV) either undiluted or diluted in 5% glucose or 0.9% sodium chloride.

Prescription only.

Method of Administration:

Zenalbi 20 is administered as a slow IV infusion. It is only given by a healthcare professional (doctor or nurse).

Instructions:

• Before use, warm the vial to room temperature.

• A fine plastic tube with a connector is inserted into a vein via a needle.

• The needle is removed, and the connector is attached to the tube.

• The vial is then attached to the other end of the tube and hung above the patient.

• The solution drips slowly through a filter and into the vein via the plastic tubing.

Dosage:

The dose and frequency of Zenalbi 20 are determined by a doctor or nurse, based on individual needs.

During and after treatment with Zenalbi 20, your doctor will monitor:

• how the medication is working (via heart rate and pulse),

• your blood pressure,

• pressure in the heart or lungs (via a fine tube inserted into a vein or artery),

• heart and breathing functions – especially in elderly or very young patients,

• blood tests – to monitor protein, sodium, and potassium levels and determine when to stop treatment.

Storage Conditions:

• Keep out of reach of children.

• Do not use after the expiry date on the carton or vial (the expiry is valid until the last day of the stated month).

• Store at 2°C to 25°C.

• Do not freeze.

• Once opened, the vial must be used within 3 hours.

• Do not use if the solution is cloudy or contains visible particles.

• Store in the original carton, protected from light.