Main physical and chemical characteristics: inodorous transparent aqueous solution and colors;
Structure. Gambrosol of a trio 10 is in a bag with three departments. Everyone from two smaller departments (And yes In) contain 50% solution of glucose and sodium chloride (NaCl), and rub, more department (C), includes solution of electrolytes.
On each 1000 ml of solution:
Department And yes In (with glucose) together is contained
(in the form of glucose monohydrate)
5, 38 g
Department With with electrolytes includes
5, 38 g
sodium S-lactate (+) anhydrous
(in the form of 60% of m/m of solution)
4, 72 g
(7, 87 g)
Calcii chloridum dihydrate
0, 271 g
magnesium chloride hexahydrate
When mixing contents of departments And yes/or In with solution of electrolytes department With the following solutions are formed:
mixing of contents of departments And yes About educated solution 10L (Light)
mixing of contents of departments In and About educated solution 10M (Medium)
mixing of contents of departments And, In and About educated solution 10H (High)
Electrolytic structure on each 1000 ml of divorced solution:
Divorced solution mmol/l
Na sodium ++
Ca calcium ++
1, 70 mmol/l
Mg magnesium ++
0, 24 mmol/l
Cl chlorine -
96, 0 mmol/l
Settlement osmolarity mosm/l
5, 5-6, 5
5, 5-6, 5
5, 5-6, 5
Divorced solution mekv/l
Na sodium ++
Ca calcium ++
3, 40 mekv/l
Mg magnesium ++
0, 48 mekv/l
Cl chlorine -
96, 0 mekv/l
other components: department And yes In: hydrochloric acid (37%), water for injections
department With: sodium hydroxide, water for injections.
Form of production of medicine. Solution for a peritoneal dialysis.
Farmakoterapevtichesky group. Solutions for a peritoneal dialysis. Code of automatic telephone exchange B05D.
Effect of the medicine.
Pharmacodynamics. Sterile solution, free from bacterial endotoxins, for intraperitoneal use by the peritoneal dialysis (PD). Level of electrolytes in divorced solutions similar with physiological level in plasma, except for potassium, a lactate and magnesium. Osmolarity of divorced solution depends on concentration of glucose. The lactate is used as the alkaline buffer for correction and/or support of acid-base balance. The isomeric form of a lactate in Gambrosol trio10 - S (+) is physiological for people.
Pharmacokinetics. Glucose, the buffer, electrolytes and water which are entered intraperitoneally are absorbed in blood and metabolized in the natural way.
Indications for use. Acute and chronic renal failure. Correction of a delay of liquid and some types of heavy electrolytic imbalances (for example, hyperpotassemias) that are not subject to other therapy. Treatment of intoxication, caused by agents that can be removed by a dialysis.
Way of use and dose. For intraperitoneal use. After a partition break between departments And yes With and mixing of two solutions solution with concentration of glucose of 1,5% is formed. Also when mixing contents of departments In and With solution with concentration of glucose 2, 5 of % is formed. At last, having broken shaky partitions and having mixed contents of all three departments, solution with concentration of glucose 3, 9 of % is formed.
From therapy, the quantity of exchanges, volume is defined on one exchange, hour of exposure and duration of a dialysis in each separate case of a state and the patient's weight. Average quantity of exchanges from 3 to 5 times a day. The volume of filling depends on the body sizes, is more often than from 2 to 2, 5 liters for adults. In pediatric practice volumes of solution are used are reduced respectively to age, the size of a body and the child's weight.
Concentration of glucose in solution is chosen according to needs of the patient for ultrafiltration, but it is desirable not to abuse use of solutions with its high quantity.
Intraperitoneal use demands use of a special catheter and a corresponding set which provides association of a bag with solution with the patient's catheter.
Side effect. Side effects of a peritoneal dialysis include problems that connected with procedure of a dialysis and solution for a dialysis.
The problems connected with procedure of a dialysis include: abdominal pain, bleeding, peritonitis (that is followed by cavity pain, to opacifications to dialyzate and sometimes fever), infections together with a dialysis catheter (signs an inflammation: reddening and secretion), blockings of a catheter, Ilheus, joint pain, Kyla of an abdominal cavity.
Problems that as a rule, connected with peritoneal dialysis solution, meet not so often as what connected with procedure of a dialysis, and is included by the weakness, dizziness, fatigue, myotonia, a headache, respiratory symptoms connected with a fluid lungs and electrolytic disturbances (for example; gipokalemiya, gipomagniyamiya), diarrhea and lock.
In the course of a dialysis concentration of drugs in blood of patients can be reduced. If it is necessary, it is necessary to apply the adjusting therapy.
Contraindications. Solution should not be used at patients who have lactoacidosis and a heavy hyperpotassemia.
The general contraindications for peritoneal dialysis treatment. The peritoneal dialysis should not is carried out for following circumstances:
early stage after abdominal surgery or an injury of a front abdominal wall; the expressed spaykovy process in the anamnesis, burns, perforation and an inflammation of skin of an abdominal wall;
inflammatory diseases in intestines (an illness Krone, ulcer colitis, a diverticulitis);
dokumentovana loss of function of a peritoneal membrane; cachexia and essential loss of weight;
patients who are incapable mentally or physically to carry out PD as it is reported by the doctor.
Do not recommend to carry out a peritoneal dialysis in the second half of pregnancy at all.
Do not recommend to apply a peritoneal dialysis in a case existence of accompanying states which influence an obryushinny wall (for example, infections of skin or burns, recent surgeries, Kyla) or an obryushinny cavity (for example, intestinal impassability, commissures, intestinal perforation, defects of a diaphragm, a tumor and pregnancy in late terms) and at heavy respiratory insufficiency, dystrophy or heavy frustration of a lipidic exchange.
Overdose. Excess of dialysis liquid which got to a peritoneal cavity can be easily vyvedeny in a drainage bag. Effects overdose are possible include a hypovolemia, electrolytic disturbances or (at patients who have diabetes) a hyperglycemia. Therapy is symptomatic.
Features of use. Solutions for a peritoneal dialysis Gambrosol are intended to a trio 10 only for intraperitoneal use.
It is necessary to bring closer solution temperature to body temperature before use. Before preparation to performance it is necessary to be convinced that all solutions transparent, and seals unimpaired, to wash up hands and to be convinced that the place carrying out procedure pure. For preparation of solution, ready to use, it is necessary to remove external packaging. According to information from the doctor it is necessary to break gentle (and) a partition (i) between the main electrolytic bag (department C) and one or both departments with glucose solution (department And or/and In). Solution of glucose has to get to the main electrolytic bag. It is necessary to wash out department with glucose by expression of divorced solution to empty department back. To give the chance of solution to turn ostatochno in the main department again. Now PD solution ready for use also has to be is used within 18 hours after cultivation.
It is necessary to keep exact records of liquid balance of the patient and to attentively control the body weight of the patient to avoid hyper - or hydropenias with serious consequences which include congestive heart failure, decrease in volume and shock.
At patients with a renal failure it is necessary to measure periodically concentration of electrolytes of serum (especially bicarbonate, potassium, calcium, magnesium and phosphate), chemical composition of blood and hematologic parameters.
There can be necessary a replenishment of proteins of amino acids and vitamins which are dissolved in water as during a dialysis their considerable losses can take place.
At patients who not patients with diabetes, the sensitivity threshold to a hyperglycemia can be a miscellaneous as a result of joint effects of reaction to glucose against uraemia and transperitoneal absorption of glucose.
At the patients sick with a diabetes mellitus, it is necessary to control glucose level in blood, and the dose of insulin or other hyper glycemic drug needs often to be entered dobavochno for support of glycemic control. Insulin can be entered intraperitoneally through a bag with solution.
Dehydration and hyperglycemia can arise if the patient does not adhere to instructions and will break all strizhn in the period of a solution exchange. The delay of solution can arise if it was not succeeded to break a midstream and mixing of volumes of solutions not really happened.
When carrying out procedure it is necessary to follow the rules of an asepsis.
there are no these clinical trials in pediatric practice now. At this category of patients of advantage Gambrosol trios 10 have to be defined taking into account side effects.
Interaction with other medicines. there are no these researches about incompatibility of solution for a peritoneal dialysis with other medicines now.
Any medicines which are added to solution for a peritoneal dialysis can be incompatible.
At simultaneous use with drugs of a digitalis there is a danger of development of digitalis intoxication.
Terms and storage conditions. To store at a temperature not below +4 °C. In original packaging to keep 18 months. After mixing to components of particles to keep 18 hours before opening. After opening to use immediately for once.