Uman albumin - instructions for use, dose, side effects, contraindications

Active substance	5% / 250 ml	20% / 50 ml	20% / 100 ml	25% / 50 ml
Human albumin	50 g / l	200 g / l	200 g / l	250 g / l
Auxiliary matter
Sodium chloride	8.39 g / l	4.52 g / l	4.52 g / l	3.52 g / l
Sodium caprylate	0.665 g / l	2,660 g / l	2,660 g / l	3,325 g / l
Acetyltryptophan	0.985 g / l	3.940 g / l	3.940 g / l	4.925 g / l
Water for injections	Not less than 1000 ml	Not less than 1000 ml	Not less than 1000 ml	Not less than 1000 ml

Description:Slightly viscous transparent liquid from almost colorless to yellow, amber or greenish.

Pharmacotherapeutic group:Plasmasuberant

ATX: & nbsp

B.05.A.A.01 Albumen

Pharmacodynamics:

Plasma-replacing agent obtained by fractionating blood and plasma of healthy donors. It replenishes the deficiency of blood plasma albumin, supports the colloid-osmotic (oncotic) blood pressure, rapidly increases blood pressure and circulating blood volume (BCC), facilitates the passage of fluid from tissue into the bloodstream, possesses detoxification properties.

Indications:

1. Substitution therapy with albumin deficiency and blood loss (Uman Albumin 5%).

1. Substitution therapy with a severe degree of albumin deficiency (Uman Albumin 20% and 25%).

Contraindications:

Increased individual sensitivity to the drug or its components.Allergic reactions to the drug.

All conditions in which hypervolemia or its consequences (increased stroke volume, high blood pressure) or hemodilution may pose a risk to the patient:

- Decompensated heart failure

- hypertension

- varicose veins of the esophagus pulmonary edema

- hemorrhagic diathesis

- severe anemia

- Renal and postrenal anuria

- dehydration (if the fluid is not replenished at the same time)

Carefully:Renal failure, thrombosis, ongoing internal bleeding, chronic heart failure.

Pregnancy and lactation:

Albumin solution should be used during pregnancy and during breastfeeding only if the potential benefit to the mother exceeds the possible risk to the fetus or child.

Dosing and Administration:

The dosage regimen and the rate of administration of the drug are calculated on the basis of individual patient parameters.

The minimum value of the colloid-osmotic pressure is 20 mm Hg (2.7 kPa). With the appointment of human albumin, the required dose in grams can be calculated by the following formula:

[required total protein (g / l) - available total protein (g / l)] x volume of plasma (L) x 2

The physiological volume of plasma can be calculated as corresponding to 40 ml / kg of body weight.

Since this formula is approximate in some cases, laboratory monitoring of protein concentration is recommended. In the case of extensive replacement therapy and a decrease in hematocrit below 30%, transfusion of erythrocyte mass is necessary to maintain oxygen transport by blood.

Human albumin is ready for use and should only be injected intravenously.

The rate of infusion is determined in accordance with individual characteristics and indications; usually 5 ml / min (for 5% solution) and 1 - 2 ml / min (for 2G % and 25% solutions). The maximum time of administration is 3 hours. During plasmapheresis, the infusion rate should not exceed 30 ml / min.

When large volumes are introduced, the preparation should be warmed to room temperature or body temperature before use.

Pediatric Use

It is necessary to take into account the fact that in children the physiological volume of plasma depends on age.

Side effects:

Rarely, such moderate reactions as blood rashes, urticaria, febrile condition and nausea are observed.Usually, these reactions cease, as soon as the drug is slowed and stopped. In very rare cases, the administration of the drug may cause shock. In this case, the drug should be discontinued and treated accordingly.

Information about the virus security is provided in the section "Special instructions".

Any other effects not listed above should be reported to the treating physician.

Overdose:

With the frequent administration of high doses of the drug, hypervolemia may develop. At the first clinical manifestations of heart failure (headache, choking), increased blood pressure, increased central venous pressure, pulmonary edema, the infusion should be stopped immediately, and the blood parameters (hemoglobin, hematocrit) of the patient should be clearly monitored.

It is suggested that diuresis and cardiac output may increase depending on the severity of the clinical picture.

Interaction:

To date, no interactions of human albumin with other substances have been reported. The drug should not be mixed with other drugs, blood or erythrocyte mass, as this can lead to protein precipitation.

Special instructions:

The colloid-osmotic pressure of 20% albumin is 4 times higher than that of blood plasma. Therefore, when concentrated albumin is introduced, special attention should be given to adequate hydration of the patient. It is necessary to conduct careful monitoring of patients for circulatory disorders and hyperhydration. If the volume of 20% or 25% of the albumin solution is more than 200 ml, electrolyte solutions must be introduced to maintain a normal fluid balance. Alternatively, therapy may be continued 5 % solution of human albumin.

With the introduction of significant volumes, coagulation and hematocrit control is necessary. Particular attention should be paid to ensuring that blood components such as clotting factors, electrolytes, platelets, red blood cells are within normal limits.

In the event of a shock reaction, it is necessary to stop the infusion and prescribe anti-shock therapy.

The drug can be used within the time limits indicated on the package.

Before use, it is necessary to carry out a visual inspection of the preparation and packaging: the solution must be transparent, not containing any inclusions, the glass packaging must be hermetic, without cracks.In the case history, it is necessary to register the label data (name of the preparation, manufacturer, serial number, production date).

When injecting drugs derived from human blood or plasma, infectious diseases caused by transmission of infectious agents can not be completely excluded. To reduce the risk of transmission of infectious agents, donors and the preparations received are carefully checked. Each unit of plasma used to produce human albumin is tested for lack of HBsAg, HIV 1, HIV 2.

In addition, testing for the presence of hepatitis C virus RNA is performed using gene amplification. In production, only antigen-negative samples of the donor plasma are used. The production schedule of the drug includes the stage of virus removal and inactivation. When ultrafiltration and diafiltration, metal ions are removed; thus, the risk of accumulation of aluminum and accumulation-induced toxicity is significantly reduced.

Form release / dosage:A solution of 5%, 20%, 25%.

Packaging:

Solution 5% / 250 ml - a bottle of clear glass with a solution and instructions for use in a cardboard box.

A solution of 20% / 50 ml - a bottle of clear glass with a solution and instructions for use in a cardboard box.

A solution of 20% / 100 ml - a bottle of clear glass with a solution and instructions for use in a cardboard box.

A solution of 25% / 50 ml - a bottle of clear glass with a solution and instructions for use in a cardboard box.

Storage conditions:

In the dark place at a temperature of no higher than 30 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

If the packaging has not been broken and the storage conditions have been fully complied with, the shelf life is 3 years from the date of manufacture.

The prepared solution should be used immediately.

Do not use a turbid solution or if there is a flocculent residue in it!

Do not freeze!

Terms of leave from pharmacies:On prescription

Registration number:LS-000150

Date of registration:30.03.2010

The owner of the registration certificate:Kedrion SpAKedrion SpA Italy

Manufacturer: & nbsp

KEDRION, S.p.A. Italy

Representation: & nbspCEDRION SpA CEDRION SpA Italy

Information update date: & nbsp29.08.2015

Illustrated instructions

Instructions

Uman albumin (Uman albumin)