Zenalb -20 - instructions for use, dose, side effects, contraindications

In quantitative terms human albumin represents more than half of the total plasma protein, it accounts for approximately 10% of the protein - the synthesizing activity of the liver. Human albumin has a corresponding hyperoncotic effect.

The most important physiological functions of albumin are its contribution to oncotic blood pressure and transport functions.

Albumin stabilizes the volume of circulating blood and is a transport protein that carries hormones, enzymes, drugs and toxins.

Pharmacokinetics:

The total exchange fraction of albumin is normally 4-5 g / kiloton of body weight; of which 40-45% are in the vascular bed and 55-60% in the extravascular space.

With such pathological conditions as severe burns or septic shock, a significant increase in the permeability of capillaries disrupts the kinetics of albumin and can lead to its pathological distribution. Normally, the average half-life of albumin is about 19 days.

The balance between synthesis and degradation of albumin is achieved, as a rule, through a feedback mechanism. Elimination occurs mainly intracellularly and is carried out by proteases of lysosomes.

In healthy people, less than 10% of the intravenously administered albumin is excreted from the vascular bed during the first two hours after the infusion. The effect on the volume of blood plasma is subject to substantial individual variation. In some patients, the volume of plasma can remain elevated for several hours. However, patients in critical condition can lose significant amounts of albumin, and the rate of its release from the vascular bed is unpredictable.

Indications:

Restoration and maintenance of the volume of circulating blood in the event of its deficiency with expediency application of colloidal solutions.

The choice in favor of albumin, rather than colloids, will depend on the clinical state of each patient, based on official recommendations.

Contraindications:

Hypersensitivity to albumin or other components of the drug.

Carefully:

Zenalb®-20 should be used with caution in patients with chronic renal failure, chronic heart failure in the phase of compensation, chronic compensated anemia, hypertension, varicose veins of the esophagus, hemorrhagic diathesis, vascular thrombosis, ongoing internal bleeding, senile and infants.

Pregnancy and lactation:

The safety of Zenalb®-20 during pregnancy is not established in controlled clinical trials.

However, the clinical experience of using albumin will not give grounds for expecting any harmful effect on the course of pregnancy, fetus or newborn.

Studies of the reproductive toxicity of Zenalb®-20 in animals have not been conducted.

Experimental animal studies are not sufficient to assess safety of reproduction,embryo-fetal development, the course of pregnancy, peri-and postnatal development. Human albumin is a normal component of human blood.

Dosing and Administration:

Concentration of the drug, dose and speed of infusion should be selected individually in each case.

The choice of albumin, rather than an artificial colloid, is determined on the basis of official recommendations depending on the clinical state of the individual patient.

Dosing regimen

The dose required for administration depends on the from body weight, severity of injury or disease and the duration of loss of fluid and protein. The necessary dose is established on the basis of the sufficiency of the volume of circulating blood, and not in dependence from albumin concentration in the blood plasma.

When introducing human albumin, hemodynamic parameters should be monitored regularly, including:

- blood pressure and heart rate;

- central venous pressure:

- pulmonary artery wedge pressure;

- diuresis;

- the content of electrolytes;

- hematocrit / hemoglobin.

Method applications

The albumin solution is administered intravenously with undiluted or diluted isotonic solution (for example, 0.9% sodium chloride solution or 5% dextrose solution).

The rate of administration should be selected depending on the condition of the papist and the indications.

If it is necessary to replace large volumes, the drug should be kept at room temperature before administration.

Do not use a turbid or inclusive solution. such changes may indicate the breakdown of protein or microbial contamination.

The drug should be used within 3 hours after opening or immediately if it is a small amount. The unused residue must be disposed of in accordance with local regulations.

Side effects:

The frequency of adverse affects was classified as follows:

Rarely (≥1/10 000 to <1/1000)

Very rarely (<1 / 10,000)

Rarely: reactions of mild severity, such as a rush of blood to the face, hives, fever, nausea. These reactions, as a rule, quickly pass with decreasing rate of infusion or its termination.

Rarely: severe adverse reactions up to anaphylactic shock. In these cases, the infusion should be discontinued and immediately begin the necessary therapy.

Post-marketing experience: Additional side effects such as chills, hypertension, hypotension, cold feeling, tachycardia, tremor, bronchospasm, dyspnea, chest tightness, stridor and dizziness have been reported.

To ensure the safety of vector-borne agents.

Overdose:

In cases where the dose and speed of infusion are excessively high or do not correspond to the patient's blood circulation parameters, it is possible to develop hypervolemia and its symptoms of cardiovascular overload (dyspnea, jugular venous swelling, headache). It is also possible to increase arterial and / or central venous pressure, the development of pulmonary edema.

At the first manifestations of the symptoms of cardiovascular overload, the drug should be stopped immediately and the blood flow parameters should be constantly monitored. According to the indications - the conduct of symptomatic therapy. Specific antidotes are absent.

Interaction:

Specific interactions of human albumin with other drugs have not been established.

Zenalb®-20 should not be mixed with other medications (with the exception of isotopic solutions, for example, 5% dextrose solution or 0.9% sodium chloride solution), whole blood and erythrocyte mass.

Special instructions:

If there is a suspicion of an allergic or anaphylactic reaction, the drug should be stopped immediately.

In the event of shock, standard measures should be applied anti-shock therapy.

Carefully human albumin should be used in conditions where hypervolemia and its consequences or hemodilution may pose a particular risk to the patient.

Examples of such states are:

Decompensated heart failure;

- hypertension:

- phlebeurysm;

- oteto the lungs;

- hemorrhagic diathesis;

- severe anemia;

- Renal and postrenal insufficiency.

Colloid-osmotic effect 20% albumin solution is approximately four times larger than that of blood plasma. Therefore, when introducing concentrated solution of albumin, is necessary take care to ensure adequate hydration of the patient. Patients should be under close supervision in case of occurrence of an overload of a circulation and a hyperhydration.Solutions of albumin (200-250 g / l) in comparison with solutions of albumin (40-50 g / l) have a relatively low content of electrolytes. Therefore, when it is administered, the electrolyte content in the blood serum should be monitored and, if necessary, taken to restore or maintain the electrolyte balance.

The solution of human albumin can not be diluted with water for injection, tk. this can cause hemolysis in recipients.

When replacing relatively large volumes, it is necessary to monitor the parameters of the coagulation system and the level of hematocrit. It is necessary to ensure adequate replacement of other blood components (clotting factor, electrolytes, platelets and red blood cells). Hypervolaemia can occur if the dose and speed of infusion do not match the patient's blood circulation parameters. At the first manifestations of symptoms of cardiovascular overload (headache, shortness of breath, swelling of the jugular veins) or with an increase in arterial and / or central venous pressure, the development of pulmonary edema should immediately stop the drug.

Standard measures to prevent infections caused by the use of drugs,derived from human blood or plasma, include selection of donors, verification of individual portions and plasma pools for specific markers of infection, as well as the inclusion in the production process of effective measures to inactivate / eliminate viruses. However, when using drugs produced from human blood or plasma, the probability of transmission of infectious agents can not be completely ruled out. This also applies to unknown or newly identified viruses and other pathogens.

There were no reports of transmission of viruses with albumin solutions produced by conventional methods in accordance with the specifications of the European Pharmacopoeia. Appropriate vaccination of patients (against hepatitis A and B) should be provided with the regular / repeated use of products from human plasma.

With each administration of the drug, it is recommended that the name of the drug be recorded and the series is worn in the patient's medical history or medical record so that to trace the connection of the patient's condition with the administration of the drug of a particular series.

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

The effects of Zenalba®-20 on the ability to drive a car or work with machines have not been revealed.

Form release / dosage:Solution for infusions 20%.

Packaging:

50 ml or 100 ml in a bottle of colorless glass (type I Hebrew F), sealed with halobutyl rubber stopper with aluminum lacquer and a polypropylene protective cap.

The bottle with the preparation together with instructions for use in a cardboard bundle.

Storage conditions:

In the dark place at a temperature of 2 - 25 ° C in the original packaging.

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:P N009282

Date of registration:06.10.2008 / 14.07.2015

Expiration Date:Unlimited

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®-20 (Zenalb®-20)