Haemo plasma balance
Producer: Fresenius Kabi Gmbh (Frezenius Kabi) Germany
Code of automatic telephone exchange: B05AA06
Release form: Liquid dosage forms. Solution for infusions.
General characteristics. Structure:
Acting substances: 30 g of gelatin (in the form of the gelatin modified liquid *).
Ionic structure: sodium 150 ¼Ý¬ó/l (there correspond 150 mmol/l), potassium 5 ¼Ý¬ó/l (there correspond 5 mmol/l), magnesium 3 ¼Ý¬ó/l (there correspond 1.5 mmol/l), chloride 100 ¼Ý¬ó/l (there correspond 100 mmol/l), a lactate 30 ¼Ý¬ó/l (there correspond 30 mmol/l), osmolality 295 ¼Äß¼/kg.
* partially hydrolyzed and suktsinirovanny gelatin.
Excipients: sodium chloride, chloride magnesium hexahydrate, potassium chloride, lactate sodium solution (in terms of sodium a lactate anhydrous), water for an injection.
Pharmacological properties:
Pharmacodynamics. Geloplazma Balans - 3% solution of suktsinirovanny gelatin or the modified liquid gelatin for in/in introductions with an average molecular weight of 45 000 Yes. It has colloid pressure of 34 mm/Bar.
The isoelectric point is reached at рН =4.5. The negative charges arising in a molecule as a result of a suktsinirovaniye lead to increase in a molecule in sizes and, thus, more volume proteinaceous chains, than nesuktsinirovanny form, at preservation of molecular weight. As a result of Geloplazm Balans renders sufficient volemichesky effect during 3-4 h.
Geloplazma Balans replaces a lack of the intravascular liquid caused krovo-or plazmopotery. Thus, the ABP average, ventricular diastolic pressure, cardiac systolic volume, cardiac index, delivery of oxygen and a diuresis increase.
Increases the volume of the circulating blood that leads to increase in venous return and minute volume of blood circulation, increase in the ABP and improvement of perfusion of peripheral fabrics. Causing an osmotic diuresis, provides maintenance of function of kidneys at shock. Reduces viscosity of blood, improves microcirculation. Thanks to the colloid and osmotic properties prevents or reduces probability of development of intersticial hypostasis.
Pharmacokinetics. Colloid osmotic pressure of solution defines degree of manifestation of initial effect. Duration of action depends on the speed of degradation and excretion of a colloid.
The Volemichesky effect of Geloplazma Balans is equivalent to amount of the entered solution. Geloplazma Balans quickly leaves a blood channel that is explained by existence of a large number of low-molecular fractions (in 2 h in blood there are about 20% of the administered drug). T1/2 is 9 h. It is removed by kidneys - 75%, through intestines - 15% (10% are split in fabrics by means of proteolysis and joins in protein metabolism). Does not kumulirut.
Indications to use:
— hypovolemia (prevention and treatment): hemorrhagic, traumatic, burn and toxic shock;
— prevention and treatment of arterial hypotension at spinal or epidural anesthesia;
— extracorporal blood circulation;
— hemodilution.
Route of administration and doses:
In/in kapelno, duration of infusion and volume of the entered solution korrigirut taking into account ChSS, ABP loudspeakers, a diuresis, a condition of perfusion of peripheral fabrics.
At medium-weight blood loss and with the preventive purpose in the preoperative period or during operation enter in a dose 0.5-1 l during 1-3 h.
At treatment of a heavy hypovolemia - 1-2 l. In the emergency, life-threatening situations enter 500 ml in the form of bystry infusion (under pressure), then after improvement of indicators of blood circulation infusion is carried out in the quantity equivalent to volume deficit.
For maintenance of OTsK at shock - to 10-15 l during 24 h.
Extracorporal blood circulation: 0.5-1.5 l (depending on the used system).
Features of use:
Use at pregnancy and feeding by a breast. Cases of embriotoksichesky action of Geloplazma Balans were not noted, however possibility of allergic reactions cannot be excluded completely. At pregnancy it is necessary to appoint drug when the possible advantage for mother exceeds potential risk for a fruit. There are no data on Geloplazma Balans's penetration into maternal milk.
Use at abnormal liver functions. With care to use at chronic diseases of a liver.
Use at renal failures. With care: chronic renal failure.
Use for children. Any information on Geloplazma's use the balance aged till 1 year is not available for children.
Use for elderly patients. Extent of decrease in a hematocrit should not exceed 25% at elderly patients.
Special instructions. Geloplazma Balans can change indicators of diagnostic tests to glucose, fructose, cholesterol, fatty acids, and also SOE, specific weight of urine, protein indicators in urine (including a biuretic method). Muddy solutions do not use. Before gelatin transfusion the doctor has to make visual survey of the bags intended for infusion. Drug is considered suitable for use on condition of preservation of tightness of packaging. Drug has to be transparent.
Extent of decrease in a hematocrit should not exceed 25% (at elderly, and also at cardiovascular and pulmonary insufficiency - 30%). At chronic heart failure infusion is carried out slowly because of a possible circulator overload. At introduction during operation more than 2-3 l in the postoperative period it is necessary to control concentration of protein in blood serum, especially in the presence of hypostasis of fabrics (if necessary for further plasma substituting therapy administration of human albumine is reasonable).
At disturbances of coagulability of blood and chronic diseases of a liver control of parameters of coagulability of blood and seralbumin is necessary. When using in the form of infusion under pressure (a tonometer cuff, the pump for infusions) solution needs to be warmed up to body temperature. At administration of drug under pressure all air has to be previously removed from a bag.
Side effects:
As a result of Geloplazma Balans's infusion reactions, as are possible allergic (anaphylactoid or anaphylactic) at administration of any other plasma substituting solutions, at massive introduction - the hypocoagulation (caused by effect of cultivation).
Interaction with other medicines:
Pharmaceutical it is incompatible with fatty emulsions, barbiturates, muscle relaxants, antibiotics, GKS.
Let's combine with solutions of electrolytes, carbohydrates, a whole blood.
Contraindications:
— hypersensitivity;
— hypervolemia;
— heavy heart failure;
— serious violation of coagulability of blood;
— overhydratation.
With care: the chronic renal failure, hemorrhagic diathesis, a fluid lungs, a hypopotassemia, a hypernatremia, a condition of dehydration (in this case first of all correction of water and electrolytic balance is required), chronic diseases of a liver at which synthesis of albumine and factors of coagulation is broken and will lead introduction of colloidal solution to their further dilution.
Overdose:
The main risk of overdose is connected with a possibility of a circulator overload that further can negatively influence function of heart and lungs. At emergence of symptoms of a circulator overload as a result of overdose immediately to stop injection.
Storage conditions:
To store at a temperature not above 25 °C. Not to freeze! To store in the place, unavailable to children. A period of validity - 2 years. Not to use after the termination of a period of validity.
Issue conditions:
According to the recipe
Packaging:
500 ml - bags plastic polyvinyl chloride two-layer (15) - boxes cardboard.