Composition, form of production and packaging
Solution for infusion 1 liter
human albumin 45 g
Excipients: sodium chloride (100-160 mmol / l), water d / and (up to 1 l), octanoic acid (4-10 mmol / l).
50 ml - bottles of glass (1) - packs of cardboard.
100 ml - glass bottles (1) - packs of cardboard.
250 ml - bottles of glass (1) - packs of cardboard.
500 ml - glass bottles (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Zenalb-4.5 is a 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 preparation, containing albumin in an amount corresponding to level of normal human plasma, is a plasma substitute used for blood loss due to bleeding, surgery and during hemodialysis.
Zenalb-4.5 is a weakly hypo-onocotic 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, 40-45% of albumin is in the vascular bed, and 55-60% of albumin is in the extravascular space.
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, T 1/2 albumin is about 19 days. The excretion of albumin from the body mainly occurs intracellularly under the action of lysosomal proteases.
INDICATIONS
- restoration and maintenance of the volume of circulating blood in the presence of its deficiency caused by bleeding or surgical intervention.
DOSING MODE
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 body weight, the severity of the injury or disease, as well as the duration of loss of fluid and protein. To determine the required dose, the sufficiency of the circulating blood volume should be assessed, in addition to the amount of albumin in the plasma.
When appointing Zenalb-4.5 to a patient, the following parameters should be monitored:
- Blood pressure 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 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 EFFECT
With the introduction of the drug, side effects are minimal and are rare . These include general malaise, hot flashes, itchy skin, tremors, arterial hypertension, arterial hypotension, chills, tachycardia, tremors, dyspnea, chest tightness, wheezing, stridor, dizziness. These manifestations usually disappear when the rate of infusion decreases or when the drug is stopped.
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 prescribe the appropriate treatment.
All the side effects of the patient must be reported to the doctor in charge.
CONTRAINDICATIONS
- Hypersensitivity to any of the components of the drug.
With caution 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
Zenalb-4.5 should be given with caution to women during pregnancy and lactation, as controlled clinical studies of the drug in this group of patients were not 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.
APPLICATION FOR CHILDREN
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)].
SPECIAL INSTRUCTIONS
Due to 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 the careful selection of healthy donors, the 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 hepatitis B surface antigen. Despite the observance of these measures, the use of human blood products does not entirely exclude the possibility of viral agents entering the blood of the patient, incl. 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.
Impact on the ability to drive vehicles and manage mechanisms
Does not affect the ability to drive a vehicle, machinery and other activities that require high concentration.
OVERDOSE
In cases where the dose and rate of infusion are excessively high or do not correspond to the patient's blood circulation parameters, it is possible to develop hypervolemia and symptoms of cardiovascular overload (dyspnea, swelling of jugular veins, headache), 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.
DRUG 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.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Store the drug in a dark place at a temperature of 2 to 25 В° C. Do not freeze. Keep out of the reach of children. Shelf life - 3 years.
Do not use after expiry date.
