Gelofusin solution for infusion in 500 ml bottles, 10 pcs.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Gelofusin solution is a 4% solution of modified gelatin. It has a 100% volemic effect, which lasts 3-4 hours and depends on the rate of removal of the colloid. The maximum daily dose when administered is 200 ml per kg, and in case of massive bleeding, up to 10-15 liters per day are administered.

The drug replaces the volume of lost intravascular fluid, which causes an increase in blood pressure , systolic volume, and increased diuresis . The volemic effect is equivalent to the amount of solution administered. The drug reduces blood viscosity, which leads to improved microcirculation; its use eliminates interstitial edema . It also has a pronounced detoxifying effect. Does not have a negative effect on hemostasis , can be used in renal failure . The loss of proteins is not compensated by the use of this drug.

Pharmacokinetics

After administration, it is quickly distributed in the intravascular space, with a small amount released into the interstitial space. It is not deposited in the reticuloendothelial system. 95% is excreted by the kidneys and 5% by the intestines and only 1% is metabolized. Small molecules are excreted by filtration in the kidneys, while large molecules are degraded in the liver and then excreted by the kidneys. Proteolytic metabolism occurs easily, and even in cases of renal failure, gelatin accumulation is not observed. The half-life of elimination from the vascular bed is 4 - 5 hours. It is somewhat prolonged in patients who are on hemodialysis .

Pharmacological properties of the drug Gelofusin

Gelofusin is a 4% solution of succinate gelatin (also known as modified liquid gelatin) in a 0.9% solution of sodium chloride with an average molecular weight of 30,000 Da. The relative viscosity of the solution is 1.9 at a temperature of 37 °C, colloid osmotic pressure is 34 mm Hg. Art. Due to succination, the gelatin molecules become more negatively charged and therefore more extractable. Due to the shape of its molecules, gelatin produces a greater volumetric effect than non-succinated protein chains of the same molecular weight. The volumetric effect of Gelofusin is equivalent to the amount of administered solution, that is, it is 100%, and lasts for 3-4 hours. Thus, Gelofusin is a substitute for blood plasma, but does not have a plasma-expanding effect. After infusion, Gelofusin quickly distributes in the intravascular space and partially, due to its low molecular weight, in the interstitial space. The volume-dependent effect of Gelofusin persists for at least 3–4 hours. It is excreted mainly in the urine, only a small amount is excreted in feces, and only about 1% of the administered solution is metabolized. Small molecules are eliminated directly by glomerular filtration.

Gelofusin, instructions for use (Method and dosage)

It is administered intravenously. The daily dose and duration of administration depend on the patient’s condition and circulatory disorders that need to be corrected. To detect allergic reactions, 20 ml of solution is administered slowly and under supervision.

For moderate blood and plasma loss - Gelofusin 500 ml-1000 ml.

For severe hypovolemia - 1000-2000 ml.

For extracorporeal circulation - 500-1000 ml.

The maximum daily dose depends on the degree of hemodilution . In case of massive blood loss, transfusion of up to 10 liters per day is possible. A decrease in hematocrit of less than 25% requires a whole blood transfusion, and then the administration of Gelofusin is continued.

Use of the drug Gelofusin

IV total dose, duration and rate of infusion depend on the amount of blood or plasma loss, as well as on the patient's condition; if necessary, they are adjusted taking into account controlled circulatory parameters, such as blood pressure. Be aware of the danger of circulatory overload due to too rapid infusion or administration of too large a volume of the drug. The infusion should begin immediately after attaching the package with the solution to the system. To identify possible anaphylactic/anaphylactoid reactions, the first 20–30 ml of the drug is administered slowly under medical supervision. Adults are prescribed in the following doses:

Maximum daily dose: The therapeutic limit depends on the dilution effect. When the hematocrit decreases to a level below 25% (for patients with cardiovascular or pulmonary insufficiency - 30%), red blood cells or whole blood must be administered (Gelofusin can be used in parallel with a blood product, the rate and volume of infusion depend on the clinical condition of the patient). The maximum daily dose depends on the volume of blood or plasma lost, as well as on the patient's condition. For example, with massive blood loss, if necessary, it is possible to transfuse up to 10–15 liters of solution over 24 hours. The maximum infusion rate depends on the state of the coronary blood flow. The rate of administration can be increased by applying pressure to the container or using an infusion pump. Before administration, Gelofusin should be warmed to a temperature of 37 °C. When infusing under pressure (eg with a cuff or infusion pump), all air should be removed or evacuated from the container with an air space inside, as well as from the device, as there is a risk of air embolism during the infusion. Further information: it is necessary to monitor the water and electrolyte balance of the body; Replace electrolytes if necessary. Administration of the drug can affect a number of laboratory parameters: ESR, specific gravity of urine, results of nonspecific determination of protein (for example, using the biuret method). Particular care should be taken when administering the drug to patients with bleeding disorders, renal failure and chronic liver disease.

Analogs

Level 4 ATC code matches:
Perftoran

Poliglyukin

Albumen

Stabizol

Ceruloplasmin

Refortan

Gemodez-N

Reopoliglyukin

Geloplasma , Gelatinol , Modelel .

Reviews about Gelofusin

It is believed that in case of massive blood loss, it is more rational to use drugs that have minimal hemostasiological effects - these are drugs based on hydroxyethyl starch ( Refortan , Infucol , Stabizol ) and Gelofusin based on gelatin. The latter has advantages: it has pronounced volemic activity and does not negatively affect hemostasis and liver and kidney function. In addition, it has a pronounced detoxifying effect and is safe from the point of view of allergic reactions. However, an allergic reaction is potentially possible.

It has been proven that the use of Gelofusin improves microcirculation more effectively than hydroxyethyl starch . That is why it is the drug of choice for significant blood loss and is often used in emergency situations. There are few reviews about this drug, apparently due to the fact that many patients do not even know what infusion therapy they received in the postoperative period in the intensive care unit.

• “... My brother had a severe head injury and significant blood loss. We bought him Gelofusin. Despite the fact that they dripped a lot, there was no reaction. Everything turned out well - he recovered."
• “... There was a complex operation and during the operations 1000 ml of this drug was dripped, plus a glucose solution and saline solution. In the intensive care unit, I also received this solution up to 1 liter for the first two days. Relatives bought it, so I know. She tolerated it well, there were no reactions.”
• “... During obstetric hemorrhage during a long operation, I received a lot of drippings - up to 7 liters. Fortunately, everything worked out.”

Special instructions for the use of the drug Gelofusin

There are no data on the use of Gelofusin in children. Gelofusin should be used with extreme caution in case of hypernatremia, since additional sodium is administered along with Gelofusin; states of dehydration, since in these cases correction of water balance is first required; blood clotting disorders, since the administration of the drug affects coagulation factors; renal failure, since drug elimination may be impaired; chronic liver diseases, as this may affect the synthesis of albumin and blood clotting factors. Despite the lack of data on the embryotoxic effect of Gelofusin, it can be prescribed during pregnancy only when the expected beneficial effect for the mother outweighs the potential risk for the fetus. There is no data on the use of Gelofusin during breastfeeding. Like all other colloidal plasma replacement drugs, Gelofusin can cause the development of anaphylactoid/anaphylactic reactions of varying severity - from skin manifestations (urticaria, flushing of the skin of the face and neck) to systemic ones: decreased blood pressure, anaphylactic shock, bronchospasm, cardiac or respiratory arrest. Such reactions can occur in both conscious and anesthetized patients. However, in the acute phase of shock caused by insufficiency of blood volume, anaphylactoid/anaphylactic reactions were not observed. Patients receiving Gelofusin should be closely monitored for possible anaphylactoid/anaphylactic reactions. General principles for the prevention and treatment of anaphylactoid/anaphylactic reactions: There is no known test to preliminarily identify patients susceptible to anaphylactoid/anaphylactic reactions; It is also impossible to predict the course of these reactions. They can be both histamine-dependent and histamine-independent. Histamine release can be prevented by the use of antihistamines and combined H1 and H2 receptor blockers. The feasibility of prophylactic use of GCS has not been proven. When using colloidal preparations, the following principles should be adhered to:

• doctors and junior medical personnel must have adequate information regarding the severity of reactions that may be caused by colloidal plasma replacement drugs;
• careful monitoring of patients is required during the administration of the first 20–30 ml of Gelofusin;
• you should have equipment and drugs ready to carry out resuscitation measures;
• If anaphylactoid/anaphylactic reactions occur, stop the infusion immediately.

Gelofusin price, where to buy

You can buy Gelofusin at any pharmacy. The cost of one bottle of solution is 211-230 rubles.

• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

Pharmacy24

• Gelofusin 500 ml No. 10 solution for infusion B. Brown Medical SA, Switzerland
  1892 UAH. order

PaniPharmacy

• Gelofusin infusion Gelofusin solution inf. 500ml No. 10 Switzerland, B. Braun

  1743 UAH. order

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Gelofusin solution for infusion in 500 ml bottles, 10 pcs.

Gelofusin should be used with caution in patients with allergic diseases, including patients with bronchial asthma.

Gelatin volume replacement preparations may rarely cause anaphylactoid reactions of varying severity. In order to determine the development of an anaphylactoid reaction as early as possible, the first 20-30 ml should be administered slowly and with careful monitoring of the patient. .

Gelofusin should be used with caution and only with careful monitoring of the patient’s hemodynamic condition in the following cases:

• elderly patients;
• patients who are at risk of circulatory overload, including patients with congestive heart failure, right or left ventricular failure, hypertension, pulmonary edema or renal failure with oligo- or anuria.

Serum electrolyte concentrations and fluid balance should be monitored, especially in patients with hypernatremia, hypokalemia, dehydration, or impaired renal function. Particular attention should be paid to the appearance of symptoms of hypocalcemia (including signs of tetany, paresthesia), and appropriate measures should be taken.

In a state of dehydration, the fluid deficit must first be corrected. Electrolytes should be properly replaced.

When compensating for severe blood losses by infusion of large volumes of Gelofusin, it is necessary to check the hematocrit under any circumstances. The hematocrit should not fall below the critical values ​​​​specified in the section "Method of administration and dosage".

Likewise, in such situations, the effect of dilution on coagulation factors should be monitored, especially in patients with existing hemostatic disorders.

Since the drug does not replace the loss of plasma proteins, it is recommended to check the concentrations of the latter.

General guidelines for the prevention of adverse reactions

Carefully monitor the patient during the infusion, especially when administering the first 20-30 ml of solution.

Sufficient informing of doctors and nursing staff about the types and severity of possible adverse reactions that may develop after the administration of colloidal volume substitutes.

Immediate access to all equipment and medications for cardiopulmonary resuscitation. Immediately stop the infusion if any signs of an adverse reaction occur.

Emergency treatment of anaphylactic reactions is carried out according to generally accepted regimens, depending on the severity of the reaction.

One procedure cannot predict which patients are prone to developing anaphylactic reactions, nor can it predict the course and severity of any such reaction.

Anaphylactoid reactions caused by gelatin solutions can be histamine-mediated or histamine-independent. Histamine release can be prevented by using a combination of H1 and H2 receptor blockers. Prophylactic administration of corticosteroids has not been found to be effective.

Adverse reactions can develop in both conscious and anesthetized patients. To date, anaphylactoid reactions have not been reported in the acute phase of volume depletion and shock.

Effect on laboratory test results

Gelofusin may interfere with the results of such clinical chemical tests, resulting in high error values:

• erythrocyte sedimentation rate;
• specific gravity of urine;
• determination of nonspecific proteins, including the biuret method.

Unused contents of an open container must be disposed of.

Use the solution only if it is clear and free of sediment and the container is not damaged. Apply immediately after attaching the container to the system for input.

After mixing or adding additional substances, begin administration immediately.