Composition, form of production and packaging
Solution for infusions 3% transparent, colorless or light yellow in color.
1 l
gelatin (in the form of gelatin modified liquid *) 30 g
Ionic composition: sodium 150 meq / l (corresponding to 150 mmol / l) potassium 5 meq / l (corresponding to 5 mmol / l) magnesium 3 meq / l (corresponding to 1.5 mmol / l) chloride 100 meq / l (corresponding to 100 mmol / l ) lactate 30 meq / l (corresponding to 30 mmol / l) Osmolality 295 mOsm / kg
* partially hydrolysed and succinated gelatin.
Auxiliary substances: sodium chloride - 5.382 g, magnesium chloride hexahydrate - 0.305 g, potassium chloride - 0.373 g, sodium lactate solution (in terms of sodium lactate anhydrous) - 3.36 g, water d / and - up to 1 liter.
500 ml - plastic polyvinylchloride bags two-layer (15) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2008.
PHARMACHOLOGIC EFFECT
Geloplasmic Balance - 3% solution of succinated gelatin or modified liquid gelatin for intravenous administration with an average molecular weight of 45,000 Da. It has a colloidal pressure of 34 mm / bar.
The isoelectric point is reached at pH = 4.5. The negative charges that arise in the molecule as a result of succination lead to an increase in the size of the molecule and, thus, more voluminous protein chains are formed than the non-succinic chains, while maintaining the molecular weight. As a result, Geloplasmas Balance has a sufficient volemic effect for 3-4 hours.
Geloplasmic Balance replaces the lack of intravascular fluid caused by blood or plasmomotor. Thus, mean BP, ventricular diastolic pressure, cardiac systolic volume, cardiac index, oxygen delivery and diuresis are increasing.
Increases the volume of circulating blood, which leads to an increase in venous return and a minute volume of circulation, an increase in blood pressure and an improvement in the perfusion of peripheral tissues. Calling osmotic diuresis, it ensures the maintenance of kidney function in shock. Reduces the viscosity of blood, improves microcirculation. Due to its colloid-osmotic properties it prevents or reduces the likelihood of developing interstitial edema.
PHARMACOKINETICS
The colloid-osmotic pressure of the solution determines the degree of manifestation of the initial effect. The duration of action depends on the rate of degradation and excretion of the colloid.
The volemic effect of Geloplasmas The balance is equivalent to the amount of the injected solution. Geloplasma Balance quickly leaves the bloodstream, which is explained by the presence of a large number of low molecular weight fractions (after 2 hours in the blood there are about 20% of the injected drug). T 1/2 - 9 hours. It is excreted by the kidneys - 75%, through the intestine - 15% (10% is cleaved in tissues through proteolysis and included in protein metabolism). Do not cumulate.
INDICATIONS
- Hypovolemia (prevention and treatment): hemorrhagic, traumatic, burn and toxic shock;
- prevention and treatment of arterial hypotension with spinal or epidural anesthesia;
- extracorporeal circulation;
- hemodilution.
DOSING MODE
In / in the drip, the duration of the infusion and the volume of the administered solution is corrected taking into account the dynamics of heart rate, blood pressure, diuresis, perfusion state of peripheral tissues.
With moderate blood loss and with a preventive purpose in the preoperative period or during the operation, administer a dose of 0.5-1 L for 1-3 hours.
In the treatment of severe hypovolemia - 1-2 liters.
In emergency, life-threatening situations, 500 ml is injected in the form of fast infusion (under pressure), then after an improvement in blood circulation, the infusion is performed in an amount equivalent to a volume deficit.
To maintain the BCC in shock - up to 10-15 liters within 24 hours.
Extracorporeal circulation : 0.5-1.5 l (depending on the system used).
SIDE EFFECT
As a result of infusion of Geloplasmas Balance, allergic (anaphylactoid or anaphylactic) reactions are possible, as with any other plasma-substituting solutions, with massive administration - hypocoagulation (caused by the dilution effect).
CONTRAINDICATIONS
hypersensitivity;
- hypervolemia;
- severe heart failure;
- severe bleeding disorder;
hyperhydration.
With caution: chronic renal failure, hemorrhagic diathesis, pulmonary edema, hypokalemia, hypernatremia, a state of dehydration (in this case, first of all correction of the water-electrolyte balance is required), chronic liver diseases, in which albumin synthesis and coagulation factors are disrupted, and colloidal solution will lead to further dilution.
PREGNANCY AND LACTATION
No cases of embryotoxic effect of Geloplasmas Balance were noted, however, the possibility of allergic reactions can not be ruled out completely. In pregnancy, the drug should be administered when the possible benefit to the mother exceeds the potential risk to the fetus. There is no data on the penetration of the Geloplasmas Balance in the mother's milk.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution: chronic renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Use with caution in chronic liver disease.
APPLICATION FOR CHILDREN
No information on the use of Geloplasmas in children under the age of 1 year is not available.
APPLICATION IN ELDERLY PATIENTS
The degree of decrease in hematocrit should not exceed 25% in elderly patients.
SPECIAL INSTRUCTIONS
Geloplasmic Balance can change the indicators of diagnostic tests for glucose, fructose, cholesterol, fatty acids, as well as ESR, specific gravity of urine, indicators of protein in the urine (including biuret method). Turbulent solutions do not use. Before the gelatin transfusion, the physician should perform a visual inspection of the bags intended for infusion. The preparation is considered suitable for use under condition of the tightness of the package. The drug should be transparent.
The degree of decrease in hematocrit should not exceed 25% (in the elderly, as well as in cardiovascular and pulmonary insufficiency - 30%). In chronic heart failure, infusion is slow because of possible circulatory overload. If you administer more than 2-3 liters during the postoperative period, you should monitor the protein concentration in the blood serum, especially if there is tissue swelling (if necessary, human albumin is useful for further plasma replacement therapy).
With violations of blood coagulability and chronic liver diseases, control of the parameters of coagulability of blood and serum albumin is necessary. When used as an infusion under pressure (cuff of the tonometer, infusion pump), the solution must be heated to body temperature. When the preparation is administered under pressure, all air from the bag must be removed beforehand.
OVERDOSE
The main risk of overdose is associated with the possibility of circulatory overload, which in the future can adversely affect the function of the heart and lungs. If there are symptoms of circulatory congestion due to an overdose, stop the infusion immediately.
DRUG INTERACTION
Pharmaceutically incompatible with fat emulsions, barbiturates, muscle relaxants, antibiotics, GCS.
Compatible with solutions of electrolytes, carbohydrates, whole blood.
TERMS AND CONDITIONS OF STORAGE
Store at a temperature not exceeding 25 В° C. Do not freeze! Keep out of the reach of children.
Shelf life - 2 years.
Do not use after expiry date.
