Index of drugs

Prevention and treatment of suspected or confirmed relative or complete hypovolaemia and shock.

500 ml of the solution contains: 2.775 g of sodium chloride, 1.635 g of sodium acetate trihydrate, 0.15 g of potassium chloride, ca. 0.075 g of Calcium chloride dihydrate, 0.1 g of Magnesium chloride hexahydrate and 20 g of gelatine (in the form of a modified liquid gelatin) ). Theoretical osmolarity: 284 mOsmol / l.

A 4% solution of succinylated gelatin (also called liquid modified gelatin) with an average molecular weight of 26,500 daltons (medium mass) in a plasma adapted, balanced, isotonic electrolyte solution. The negative charge introduced into the molecule in the succinylation process causes the molecules to unfold. As a result, the molecular volume is greater than for non-succinylated gelatin of the same molecular weight. The initial volume effect of the preparation measured is almost 100% of the infusion volume, and a sufficient volume effect is maintained for 4-5 h. The preparation does not interfere with the blood group determination and does not affect the coagulation mechanisms. The product complements intra- and extravascular deficits caused by blood, plasma and interstitial fluid loss. As a result, mean arterial pressure, left ventricular end-diastolic pressure, ejection volume, cardiac index, oxygen supply, microcirculation and diuresis increase without dehydration of the extravascular space. The product contributes to restoring electrolyte balance and correcting acidosis. It does not contain lactates, so it can be administered to patients with liver disease. As a source of bicarbonates, the solution contains acetates, metabolized by all organs and muscles. After administration in the form of an infusion, the preparation is rapidly distributed in the intravascular space. Most of the preparation after administration in the form of an infusion is eliminated by the kidneys. Only a small amount is excreted in the faeces, and no more than 1% is metabolised. Smaller molecules are eliminated directly by glomerular filtration, while larger ones are subject to proteolytic degradation followed by excretion through the kidneys. Metabolism by proteolysis is so flexible that no accumulation of the preparation was found even in patients with renal insufficiency. T_0,5 in plasma may be prolonged in patients undergoing hemodialysis (GFR <0.5 ml / min).

Hypersensitivity to gelatin solutions or to any of the other ingredients. Hypervolemia. Overhydration. Hyperkalemia.

Caution should be exercised in patients with a history of a history of allergy, eg asthma, severe renal impairment, edema associated with water / salt congestion, severe blood clotting disorder and in cases of cardiovascular overload, eg in patients with congestive heart failure, heart failure right- or left-chamber, hypertension, pulmonary edema or renal failure with oligo- or anuria. Gelatin solutions administered to supplement blood volume may in rare cases lead to allergic (anaphylactic / anaphylactoid) reactions of varying degrees of severity. In order to detect this type of reaction at the earliest stage, the first 20-30 ml of the preparation should be administered slowly, while closely monitoring the patient, especially at the initial stage of infusion. If anaphylactic / anaphylactoid reactions occur, the infusion should be stopped immediately and appropriate treatment initiated. It must not be administered with transfused blood or blood products (platelet concentrate, plasma or plasma fractions) through the same infusion set. It is necessary to monitor the concentration of electrolytes and water balance, especially in patients with hypernatremia, hyperkalemia or impaired renal function and monitoring hemodynamics, hematology and coagulation system. When supplementing significant blood losses by infusing large volumes of the product, hematocrit and electrolytes should be monitored (hematocrit values ​​should not fall below 25%, and in the elderly or patients in critical condition below 30%).In these cases, the dilution effect and coagulation factors should be monitored, especially in patients with hemostatic disorders. Because this preparation does not replace lost plasma proteins, it is recommended to monitor the plasma protein concentration. The preparation can be used in children only when the expected benefits are significantly greater than the potential risks (there is insufficient experience). After the infusion of the preparation can be performed laboratory blood tests (blood type or atypical antigens). Nevertheless, it is recommended to take blood samples before commencing the infusion of the preparation, in order to avoid impeding interpretation of the results.

Due to the possibility of anaphylactoid reactions causing unfavorable effects on the fetus or newborn baby due to the reduced maternal blood pressure, the preparation should be avoided in pregnant women, unless the patient's clinical condition requires the use of this preparation. Taking into account the benefits of breastfeeding and the benefits for the mother associated with the administration of the preparation, a decision should be made whether to interrupt breastfeeding or to stop / stop the preparation.

Uncommon: moderate transient increase in body temperature. Rare: anaphylactoid reactions with varying degrees of severity, allergic skin reactions. Very rare: severe anaphylactoid reactions, tachycardia, low blood pressure, breathing problems, fever, chills. Mild anaphylactoid reactions include: generalized edema, urticaria, periosteum edema or angioneurotic edema. Moderate anaphylactoid reactions include: dyspnea, larynx, wheezing, urticaria, nausea, vomiting, dizziness (fainting state), diaphragm, chest or throat tightness, abdominal pain. Severe anaphylactoid reactions include cyanosis or SaO₂ ≤92% at each stage, lowering of blood pressure (systolic blood pressure <90 mmHg in adults), confusion, collapse / collapse, loss of consciousness or incontinence.

Intravenously. Adults. The dose and infusion rate are selected depending on the degree of blood loss and individual needs in terms of restoring and maintaining a stable hemodynamic situation. Normally, the starting doses are between 500 and 1,000 ml. In the case of high blood loss, higher doses can be used. If you lose more than 20% of your blood volume, usually the blood or blood components should be given as a supplement. The maximum daily dose depends on the degree of hemodilution. Be careful and do not allow the hematocrit to fall below critical values. If necessary, you can additionally carry out a transfusion of the red blood cell concentrate. Attention should also be paid to the dilution of plasma proteins (eg albumin and clotting factors), which should be supplemented if necessary. In the state of shock, the preparation can be given quickly by means of a 500 ml pressure infusion in 5-10 min.