Composition, form of production and packaging
Solution for infusions 5% slightly viscous, clear, light yellow color.
1 ml of 1 fl.
human albumin 50 mg 12.5 g
Excipients: sodium chloride, sodium caprylate, acetyltryptophan, water d / u.
250 ml - bottles made of transparent glass (1) - cardboard boxes.
Solution for infusions of 20% is slightly viscous, transparent, light yellow in color.
1 ml of 1 fl.
human albumin 200 mg 10 g
Excipients: sodium chloride, sodium caprylate, acetyltryptophan, water d / u.
50 ml - bottles made of transparent glass (1) - cardboard boxes.
Solution for infusions of 20% is slightly viscous, transparent, light yellow in color.
1 ml of 1 fl.
human albumin 200 mg 20 g
Excipients: sodium chloride, sodium caprylate, acetyltryptophan, water d / u.
100 ml - bottles made of transparent glass (1) - cardboard boxes.
Solution for infusions 25% slightly viscous, clear, light yellow color.
1 ml of 1 fl.
human albumin 250 mg 12.5 g
Excipients: sodium chloride, sodium caprylate, acetyltryptophan, water d / u.
50 ml - bottles made of transparent glass (1) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Plasma-replacing drug obtained by fractionation of blood and plasma of healthy donors. Albumin is a protein with a molecular weight of 69,000 daltons, which is an integral part of the protein fraction of human blood.
It replenishes the deficiency of blood plasma albumin, supports the colloid-osmotic (oncotic) blood pressure, quickly increases blood pressure and general bcc, promotes the passage of fluid from the tissue into the bloodstream, and has detoxification properties.
PHARMACOKINETICS
Data on the pharmacokinetics of Uman albumin are not available.
INDICATIONS
- Substitution therapy with albumin deficiency and blood loss (Uman Albumin 5%);
- Substitution therapy with a severe degree of albumin deficiency (Uman Albumin 20% and 25%).
DOSING MODE
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. Art. (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)]? volume of plasma (L)? 2.
The physiological volume of plasma can be calculated as corresponding to 40 ml / kg of body weight.
Because as 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.
The drug is administered only in / in the drip.
The rate of infusion is determined in accordance with individual characteristics and indications; as a rule for 5% solution - 5 ml / min, for 20% and 25% solutions - 1-2 ml / min. 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.
SIDE EFFECT
Rarely observed reactions of moderate severity: hot flushes, urticaria, febrile condition, nausea. Usually, these reactions stop after slowing or stopping the administration of the drug.
In very rare cases, the administration of the drug may cause shock. In this case, the drug should be discontinued and the necessary treatment should be carried out.
CONTRAINDICATIONS
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;
- arterial 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).
Increased individual sensitivity to the components of the drug.
With caution should prescribe the drug for kidney failure, thrombosis, ongoing internal bleeding, chronic heart failure.
PREGNANCY AND LACTATION
The drug Uman Albumin 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.
APPLICATION FOR FUNCTIONS OF THE LIVER
Caution should be given in case of kidney failure.
APPLICATION FOR CHILDREN
It is necessary to take into account the fact that in children the physiological volume of plasma depends on age.
SPECIAL INSTRUCTIONS
The colloid-osmotic pressure of 20% albumin solution 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 can be continued with a 5% solution of human albumin.
With the introduction of significant volumes, monitoring of clotting time and hematocrit 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.
If the shock develops, stop the infusion and prescribe an anti-shock therapy.
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 the absence of HBsAg, HIV 1, HIV 2. In addition, testing for the presence of hepatitis C virus RNA is performed by gene amplification. In production, only antigen-negative samples of 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 cumulation of aluminum and the resulting toxicity is significantly reduced.
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).
Use in Pediatrics
It is necessary to take into account the fact that in children the physiological volume of plasma depends on age.
OVERDOSE
With frequent administration of the drug in high doses, hypervolemia can develop.
At the first clinical manifestations of heart failure (headache, choking), increased blood pressure, increased central venous pressure, pulmonary edema, the infusion should be immediately discontinued, 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.
DRUG INTERACTION
Until now, no interactions of human albumin with other drugs have been reported.
The drug should not be mixed with other drugs, blood or erythrocyte mass, as this can lead to protein precipitation.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a place protected from light, inaccessible to children at a temperature of no higher than 30 В° C. Do not freeze. Shelf life - 3 years (provided the integrity of the packaging is preserved and the storage conditions are fully observed).
The prepared solution should be used immediately.
