Zenalb-4,5 - instructions for use, dose, side effects, contraindications

Composition:1 liter of solution for infusion contains active substance: human albumin 45 g; Excipients: sodium chloride 100-160 mmol, octanoic acid 4-10 mmol, water for injection up to 1 liter.

Description:Transparent or slightly opalescent liquid from light yellow to green.

Pharmacotherapeutic group:Plasmasuberant

ATX: & nbsp

B.05.A.A.01 Albumen

Pharmacodynamics:

Zenalb-4,5 is 4,5 % solution for infusion of highly purified and virusinactivated human albumin, which is a necessary natural component of blood obtained from a human plasma tested for viral safety. This drug, containing albumin in an amount corresponding to the level of normal human plasma, is a plasma substitute used for blood loss due to bleeding, surgery and hemodialysis.

Zenalb-4,5 is a weakly hypo-colonic protein solution with respect to normal plasma. The most important physiological functions of albumin are due to its effect on oncotic blood pressure and transport function.Albumin stabilizes the volume of circulating blood and is a carrier of hormones, enzymes, toxins and medicines.

Pharmacokinetics:

Normally, the total exchange fraction of albumin is 4-5 g / kg of body weight; Of this amount, 40 to 45% of albumin is in the vascular bed, and 55 to 60% of albumin is in the extravascular space.

The increased permeability of capillaries affects the kinetics of albumin and can lead to a disruption of the normal distribution of albumin in pathological conditions such as severe burns or septic shock.

In healthy people, less than 10% of the administered albumin leaves intravascular space within the first 2 hours after administration. As a result, the circulating volume of blood increases within 1-3 hours after administration of the albumin preparation. Such an effect on the volume of plasma is of an individual character. In some patients, the plasma volume may remain elevated for several hours. However, in patients in critical condition, a significant amount of albumin can be eliminated at an unpredictable rate.

Normally, the half-life of albumin is about 19 days.The excretion of albumin from the body mainly occurs intracellularly under the action of lysosomal proteases.

Indications:

Restoring and maintaining the volume of circulating blood in the presence of its deficiency caused by bleeding or surgical intervention.

Contraindications:

Hypersensitivity to any of the components of the drug.

Carefully:

In case of special risk of hypervolemia and its consequences or hemodilution (decompensated heart failure, arterial hypertension, varicose veins of the esophagus, pulmonary edema, hemorrhagic diathesis, severe anemia, renal and postrenal anuria); with increased vascular permeability.

Pregnancy and lactation:

The preparation Zinalb-4,5 should be administered with caution to women during pregnancy and lactation, since controlled clinical studies of the drug in this group of patients have not been performed. However, the experience of clinical practice of using albumin preparations does not give grounds to expect any adverse effect on the course of pregnancy, fetus or newborn, since human albumin is a normal component of human blood plasma.

Dosing and Administration:

The drug is intended only for intravenous administration without prior dilution.

Before administration, it is necessary to warm the preparation to room temperature or body temperature. Make sure that the appearance of the solution corresponds to the description, the solution is transparent, does not contain mechanical inclusions, and does not change the color. Do not use if the solution is cloudy or contains sediment.

Depending on the volume, the drug is administered immediately or within 3 hours after the puncture of the vial plug with the drug.

The dose and speed of infusion should be selected individually in each case.

The necessary dose of the drug depends on the weight of the body, the severity of the injury or disease, as well as on the duration of fluid and protein loss. For determining the necessary dose should be assessed the sufficiency of the volume of circulating blood, in addition to the amount of albumin in the plasma.

When the patient is prescribed Zenalb-4.5, the following parameters:

- arterial pressure (BP) and pulse;

- central venous pressure;

- pressure with pulmonary hypertension;

- diuresis;

- electrolyte balance;

- the concentration of hematocrit and hemoglobin.

Patients with a critically low blood volume and / or posthemorrhagic shock The drug should be injected at a rate of up to 1 l / h. As the clinical condition of the patient improves and the circulating blood volume returns to normal, it is necessary to reduce the rate of administration to the recommended level of 5 ml / min (300 ml / h). The rate of administration should be adjusted according to individual needs and indications, but usually it should not exceed 5 ml / min.

The dose of the drug for children depends on age, as the plasma volume varies with age. The required dose is calculated as follows:

dose = volume of plasma (L) * 2 [required increase in albumin (g / l)].

The total dose of the replacement fluid, including albumin, corresponds to the volume of the substituted plasma.

For patients who are prescribed plasmapheresis, the total dose of the replacement fluid, including albumin, is equal to the volume of the removed plasma. In this case, the rate of administration should not exceed 30 ml / min (1800 ml / h).

Side effects:

With the introduction of the drug, side effects are minimal and are rare.These include general malaise, "hot flashes", itching, tremors, arterial hypertension, arterial hypotension, chills, j tachycardia, tremor, dyspnea, chest tightness, wheezing, stridor, dizziness. These manifestations usually disappear when the rate of infusion decreases or when the drug is discontinued.

Very rarely, allergic reactions can develop from skin rashes to anaphylactic shock. Symptoms of shock are: lowering blood pressure, dizziness, increased sweating, cold, sticky skin. When allergic reactions occur, it is necessary to stop the administration of the drug and to prescribe the appropriate treatment.

All the side effects of the patient must be reported to the doctor in charge.

Overdose:

In cases where the dose and speed of infusion are excessively high or do not correspond to the circulatory parameters of the patient, hypervolemia and characteristic symptoms of cardiovascular overload (shortness of breath, swelling of the jugular veins, headache), an increase in arterial and / or central venous pressure , development of pulmonary edema.At the first manifestations of the symptoms of cardiovascular overload, the drug should be discontinued immediately and a constant control of the circulatory parameters should be established.

Interaction:The interaction of human albumin with other drugs has not been established. Nevertheless, the patient must inform the treating doctor of other medications used.

Special instructions:

In connection with the very low content of aluminum in the preparation, it is possible to use Zenalb-4.5 in premature infants and during hemodialysis.

If replacement of a sufficiently large volume of plasma is required, monitoring of coagulation and hematocrit values is necessary. It is necessary to ensure adequate replacement of other blood components (clotting factors, electrolytes, platelets and erythrocytes).

Viral safety:

Production of drugs from human blood plasma includes a set of measures to prevent infection and viruses from entering the patient's blood. Such measures include careful selection of healthy donors, testing of each donor for the presence of traces of viruses and infection in his blood, the stage of viral inactivation / removal of viruses in the production process and subsequent monitoring,confirming the absence of antibodies to the human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus and the surface antigen of the hepatitis B virus.

Despite compliance with these measures, the use of human blood products does not completely exclude the possibility of viral agents entering the patient's blood, including unknown viruses or other types of infections. These measures are effective for known viruses, such as HIV-1, HIV-2, hepatitis A, hepatitis B and hepatitis C viruses.

It is recommended to register a series of injected drug.

Effect on the ability to drive transp. cf. and fur:

Does not affect the ability to drive a vehicle, machinery and other activities that require high concentration.

Form release / dosage:Solution for infusion 4.5%.

Packaging:

50 ml, 100 ml, 250 ml or 500 ml in a bottle of clear neutral glass of hydrolytic class II, sealed with a halobutyl stopper and a rolled aluminum cap with a protective plastic cover with the control of the first opening. 1 bottle with the drug, a plastic bottle holder and instructions for the medical use of the drug in cardboard pack.

Storage conditions:

In the dark place at a temperature of 2 to 25 ° C. Do not freeze. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-000461

Date of registration:01.03.2011

Expiration Date:01.03.2016

The owner of the registration certificate:Bio Products Laboratories LimitedBio Products Laboratories Limited United Kingdom

Manufacturer: & nbsp

BIO PRODUCTS Laboratory Limited United Kingdom

Representation: & nbspVITYS A LLCVITYS A LLCRussia

Information update date: & nbsp11.10.2017

Illustrated instructions

Instructions

Zenalb-4,5 (Zenalb-4,5)