Zenalb-20 (Solution) Instructions for Use

Marketing Authorization Holder

Bio Products Laboratory (United Kingdom)

Contact Information

Bio Products Laboratory (United Kingdom)

ATC Code

B05AA01 (Albumin)

Active Substance

Human albumin (BP British Pharmacopoeia)

Dosage Form

Zenalb-20

Solution for infusion 20% (20 g/100 ml): bottle 1 pc.

Dosage Form, Packaging, and Composition

Solution for infusion is a transparent, slightly opalescent liquid ranging from light yellow to yellow in color; a greenish tint is allowed.

Excipients: sodium chloride, caprylic acid, acetic acid, sodium hydroxide, hydrochloric acid, sodium acetate trihydrate, ethanol, water for injections.

50 ml – bottles of colorless glass (1) – cardboard packs.
100 ml – bottles of colorless glass (1) – cardboard packs.

Clinical-Pharmacological Group

Plasma substitute. Human albumin preparation

Pharmacotherapeutic Group

Plasma substitute

Pharmacological Action

Plasma-substituting drug. It is a 20% sterile aqueous solution of albumin and is produced from human blood plasma.

All donor plasma is tested by approved methods and does not contain HBsAg and antibodies to HIV-1, HIV-2 and hepatitis C virus.

Zenalb-20 is a hyperoncotic protein solution and, upon intravenous administration, increases the circulating blood volume due to the diffusion of fluid from the interstitial space (provided that its volume is within normal limits or increased). The duration of this effect may vary among patients. In some patients, the increase in plasma volume may persist for several hours.

Albumin is also a transport protein that binds and carries hormones, enzymes, and drugs in the vascular bed.

Pharmacokinetics

Distribution

Normally, the total exchangeable fraction of albumin is 4-5 g/kg of body weight; of this amount, 40-45% is in the vascular bed, and 55-60% is in the extravascular space. In pathological conditions such as severe burns or septic shock, the normal distribution of albumin is disrupted, which is associated with a significant increase in capillary permeability.

Elimination

The average T_1/2 of albumin is 19 days. Elimination occurs intracellularly with the participation of lysosomal proteases. In healthy volunteers, <10% of the intravenously administered albumin is eliminated from the vascular bed within the first 2 hours after infusion. However, critically ill patients may lose significant amounts of albumin, and the rate of its exit from the vascular bed is unpredictable.

Indications

• Complex treatment of hypovolemic shock;
• Treatment and prevention of hypovolemia and hypoproteinemia (including during extensive surgical operations, sepsis, adult acute respiratory distress syndrome; removal of protein-rich fluids from the body /ascites/, exudative pleurisy; transfusion of large volumes of thawed washed red blood cells);
• In the complex therapy of hemolytic disease of the newborn to reduce the level of free bilirubin in the blood (therapeutic plasma exchange);
• In acute liver failure to maintain plasma oncotic pressure and bind excess amounts of free bilirubin in the blood plasma;
• For preoperative hemodilution (obtaining an additional volume of blood to fill the heart-lung machine during coronary artery bypass surgery);
• To increase the therapeutic response in patients with acute nephritis resistant to treatment with cyclophosphamide or steroids;
• In the development of shock or hypotension in patients during hemodialysis.

ICD codes

Dosage Regimen

The concentration of the drug, dose, and infusion rate should be selected individually in each specific case. The dose required for administration depends on body weight, the severity of the injury or disease, and the ongoing loss of fluid and protein. To determine the required dose, the circulating blood volume should be assessed, not the plasma albumin level.

A single dose for adults is 100 ml intravenously by drip. The infusion rate should be selected depending on the patient’s condition and indication.

The recommended administration rate for patients with normal circulating blood volume is 1-2 ml/min (60-120 ml/h). For patients with severe hypovolemia, the drug should be administered at a rate not exceeding 120 ml/h. The solution can be administered by infusion using a suitable intravenous administration set with a filter.

The dose of the drug is set individually, taking into account the indication, clinical condition, and body weight of the patient. The recommended single dose for children is from 0.5 to 1.0 g/kg.

Adverse Reactions

With the usual infusion of 20% albumin, side effects are minimal.

From the digestive system: nausea, vomiting, increased salivation.

Allergic reactions: from mild transient urticaria to severe anaphylactic shock (stop the infusion, carry out a set of therapeutic measures).

Other: chills, hyperthermia, lower back pain. Treatment of patients with hypovolemia may lead to hemodilution, which persists for several hours.

Contraindications

• Chronic heart failure in the decompensation phase;
• Pulmonary edema;
• Severe anemia;
• Hypervolemia;
• Hypersensitivity to albumin or other components of the drug.

Use with caution in chronic renal failure, chronic heart failure in the compensation phase, chronic compensated anemia, arterial hypertension, esophageal varices, hemorrhagic diathesis, vascular thrombosis, ongoing internal bleeding, in elderly and infant patients.

Use in Pregnancy and Lactation

The safety of Zenalb-20 when used in pregnant women has not been studied in controlled clinical trials.

Existing clinical experience with the use of albumin solution does not provide grounds to expect any harmful effects on the course of pregnancy, the fetus, or the newborn, since Human albumin is a normal component of human blood plasma.

The effect of Zenalb-20 on reproductive function in animals has not been studied.

Use in Renal Impairment

The drug should be used with caution in chronic renal failure.

Pediatric Use

The drug should be used with caution in infant patients.

Geriatric Use

The drug should be used with caution in elderly patients.

Special Precautions

Before use, each bottle should be carefully inspected: cloudy, frozen solutions, partially used bottles should be destroyed.

Before infusion, Zenalb-20 should be warmed to room temperature.

After piercing the cap, the required dose should be administered within 3 hours or immediately if the dose volume is small.

During the infusion, the patient’s clinical condition should be carefully monitored to prevent hypervolemia. The function of the circulatory and respiratory systems should be monitored during and after treatment with Zenalb-20. The selection and screening of blood donors, as well as heat treatment of the drug at 60°C (140°F) for 10 hours, practically eliminate the risk of infection by blood-borne viruses. However, the risk of infection by blood-borne viruses cannot be completely excluded.

Other drugs should not be added to Zenalb-20.

Effect on the ability to drive vehicles and mechanisms

No effect of Zenalb-20 on the ability to drive a car or operate machinery has been identified.

Overdose

Symptoms: if the dose and infusion rate do not correspond to the patient’s circulatory parameters, hypervolemia and symptoms characteristic of it, such as overload of the cardiovascular system (including shortness of breath, jugular vein distension, headache), may develop. An increase in blood pressure and/or central venous pressure, as well as the development of pulmonary edema, are also possible.

Treatment: administration of the drug should be stopped immediately and the patient’s circulatory parameters should be constantly monitored. If indicated, symptomatic therapy should be carried out. There are no specific antidotes.

Drug Interactions

Zenalb-20 should not be mixed with other drugs.

Storage Conditions

The drug should be stored in the original packaging out of the reach of children, protected from light, at a temperature from 2°C (35.6°F) to 25°C (77°F); do not freeze.

Shelf Life

The shelf life is 3 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.