Gambrosol Trio - instructions for use, dose, side effects, contraindications

	Component A	Component B
Dextrose (glucose)	500g	500g
Sodium chloride	5.38 g	5.38 g
Hydrochloric acid (as necessary before)	pH 3.1	pH 3.1
Water for injection (as needed before)	1000 ml	1000 ml
	Component C
Sodium chloride	5.38 g
Sodium lactate	4.72 g
Calcium chloride dihydrate	0.209 g
Magnesium chloride hexahydrate	0.054 g
Sodium hydroxide (as needed before)	pH 6.6
Water for injection (as needed before)	1000 ml

After mixing

	A + C	B+ C	A + AT + C
	Low	With an average	With a high
	content	content	content
	glucose (1.5%)	glucose (2.5%)	glucose (3.9%)
Sodium Na ⁺	133 mmol / l	132 mmol / l	131 mmol / l
Calcium Ca ²⁺	1.38 mmol / l	1.35 mmol / l	1.31 mmol / l
Magnesium Mg²⁺	0.26 mmol / l	0.25 mmol / l	0.24 mmol / l
Chlorine C1 '	95.4 mmol / l	95.2 mmol / l	95.2 mmol / l
Lactate	41.0 mmol / l	40.0 mmol / l	39.0 mmol / l
Dextrose (glucose)	85.0 mmol / L	139.0 mmol / l	215.0 mmol / l
Theoretical Osmolarity:	356.0 mOsm / l	408.0 mOsm / l	482.0 mOsm / l

Gambrosol Trio c calcium 1.75 mmol / l]

Before mixing on 1000 ml

	Component A	Component B
Dextrose (glucose)	500g	500g
Sodium chloride	5.38 g	5.38 g
Hydrochloric acid (as necessary before)	pH 3.1	pH 3.1
Water for injection (as needed before)	1000 ml	1000 ml
	Component C
Sodium chloride	5.38 g
Sodium lactate	4.72 g
Calcium chloride dihydrate	0.271 g
Magnesium chloride hexahydrate	0.054 g
Sodium hydroxide (as needed before)	pH 6.6
Water for injection (as needed before)	1000 ml

Description:A clear, colorless or pale yellow solution.

Pharmacotherapeutic group:Solution for peritoneal dialysis

ATX: & nbsp

B.05.D Solutions for peritoneal dialysis

Pharmacodynamics:

Gambrosol Trio is a solution of electrolytes containing dextrose (glucose) and a lactate buffer free of bacterial endotoxins, administered for the treatment of chronic renal failure of various genesis by peritoneal dialysis (PD).

The fluid balance can be maintained by applying solutions with different glucose concentrations that cause liquid removal (ultrafiltration). The osmolality of the prepared solutions is determined by the concentration of glucose.

The level of electrolytes in solution corresponds to the physiological level of electrolytes in blood plasma, except for potassium and lactate. Lactate is used as an alkaline buffer to correct acid-base balance. Isometric configuration of lactate S⁺, which is present in vivo in the plasma of human blood.

Entered intraperitoneally dextrose (glucose), lactate buffer and electrolytes are absorbed into the blood and metabolized in the usual way. When splitting 1 g of dextrose (glucose) to carbon dioxide and water, 4 kcal is released. The level of concentration of ingredients corresponds to their physiological level in blood plasma.

Lactate is completely metabolized to bicarbonate.

Indications:

Solutions for peritoneal dialysis are shown with: acute and chronic renal failure, excessive fluid retention, various types of electrolyte imbalance not responding to other therapy (including hyperkalemia), and intoxication with dialysis substances.

Contraindications:

Contraindications for peritoneal dialysis as a method:

Conditions affecting the integrity of the abdominal wall or abdominal cavity, such as: fresh wound, burns or other extensive inflammatory skin lesions in the area of the exit site of the catheter, peritonitis; Perforation of abdominal cavity organs; abdominal operations with fibrous spikes in the anamnesis, inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticulosis), intra-abdominal tumors, recent surgery on the abdominal cavity, ileus,hernia of the abdominal region; internal or external abdominal fistulas; dermatitis of the anterior abdominal wall;
Pulmonary diseases, especially pneumonia;
Sepsis;
Lactate acidosis;
Cachexia and significant weight loss, especially if adequate nutrition is not possible;
In rare cases, uremia, which can not be treated with peritoneal dialysis;
Expressed hyperlipidemia;
Use in patients who are physically or mentally (psychosis, dementia, etc.) are unable to comply with the doctor's instructions for peritoneal dialysis procedures.

Contraindications for these specific solutions:

Pronounced lactate acidosis and pronounced hypokalemia, marked hypercalcemia.

Pregnancy and lactation:

Studies of the effect of a solution for peritoneal dialysis on reproductive function and on the fetus were not carried out in pregnant women and lactation. The solution for peritoneal dialysis should be used in pregnant women and during lactation only after assessing the benefit / risk ratio.

Dosing and Administration:

Solutions for peritoneal dialysis are for intraperitoneal use only.

Duration of therapy, frequency of procedures, duration and volume of dialysis are determined by the attending physician.

Preparation of the solution is carried out in accordance with the doctor's prescription: after heating to the body temperature (37 ° C), the outer shell of the bags is removed, a septum between chamber C with electrolytes and one or both chambers with dextrose (glucose) A and / or AT. Cameras with dextrose (glucose) are emptied by squeezing them. The finished solution can be used for 18 hours after mixing.

After treatment of the skin and hands with a disinfectant, the solution is injected intraperitoneally through a surgically installed special catheter for peritoneal dialysis, which provides a connection to the plastic bag filled with the solution.

Usually within a day apply 3-5 times the exchange of 2-2.5 liters (depending on body weight), with equal intervals of time between the exchange of solution in the abdominal cavity.

To date, there is no data on the use of Gambrosola Trio in pediatrics. For this category of patients, a solution should be used if the benefits exceed the risk of side effects (at a rate of 20-40 ml / kg of weight a day).

Side effects:

Metabolic disorders: hyperglycemia, hypocalcemia, hypokalemia, reduction of ultrafiltration, lactic acidosis, hypervolemia.

Disorders from the cardiovascular system: increase in blood pressure.

Impaired nervous system: fainting.

Common Effects: abdominal pain, asthenia, headache, peritonitis.

Also possible fever; when the catheter is infected: signs of inflammation, catheter occlusion, ileus; pain in the shoulder joint; Respiratory disorders associated with pulmonary edema, electrolyte imbalance; krampi; diarrhea or constipation; hernia (ventral, diaphragmatic).

Overdose:

Overdose can cause hypovolemia, a violation of the balance of electrolytes and acid-base balance, hyperglycemia. Treatment is symptomatic.

Excess solution for peritoneal dialysis merges into an empty drainage bag.

Interaction:

It should be remembered that the medications taken can be passed into the dialysate and, together with it, can be excreted from the body, therefore, a dose adjustment of these preparations may be required.

The level of potassium should be controlled especially carefully with concomitant therapy with digitalis preparations, since the sensitivity to these drugs increases against a background of hypokalemia

Special instructions:

It is necessary to carefully monitor the state of hemodynamics, water balance, to avoid hyper and hypohydration followed by the development of congestive heart failure or hypovolemia and shock.

It is also necessary to control the acid-base and electrolyte balance throughout the procedure. Particular attention should be paid to the timely correction of the level of bicarbonate, potassium, calcium, magnesium and inorganic phosphates.

It is necessary to carefully monitor the level of glycemia: in patients not suffering from diabetes, sensitivity to hyperglycemia changes as a result of combined the effect of reducing glucose tolerance due to uremia and transperitoneal glucose absorption; in patients with diabetes, the dose of insulin should be adjusted in accordance with the level of hyperglycemia, insulin is injected intraperitoneally into the solution in the container.

In the case of secondary hyperparathyroidism, serum parathyroid hormone and other bone metabolism parameters should also be monitored and therapy should include the appointment of calcium to bind phosphates and / or active metabolites of vitamin D to ensure adequate enteral digestioncalcium.

Mixing of components is carried out immediately before use.

It is necessary to carefully observe the rules of asepsis when mixing, connecting, detaching the package with solution from the mains. Do not use the solution in case of damage to the package, violation of the transparency of the solution.

Care should be taken to warm the solutions to a body temperature of 37 ° C. Regular monitoring of physical parameters, concentrations of electrolytes, creatinine and urea, plasma protein, blood sugar level, in some cases other laboratory parameters (for example: blood gases, acid-base balance) is mandatory.

Guidelines for use.

To prepare and assemble the system, you should carefully read the instructions for use for accessories for peritoneal dialysis.

Before use, it is necessary to warm the bag with peritoneal dialysis solution to body temperature (37 ° C) using dry heat.

Preparation for use.

Wash the hands;
Collect accessories for the procedure in accordance with the instructions;
A bag of solution, sealed in an external transparent plastic bag, warmed to body temperature (37 ° C) using dry heat;
Open the outer transparent plastic bag and remove the three-chamber bag with solutions and the drain bag from the package;
Prepare a solution of the required composition: break the partitions between chamber C with electrolytes and one or both chambers with dextrose (glucose) A and / or AT. Cameras with dextrose (glucose) emptied by squeezing them;
Put the bag with the finished solution on the work surface with the connector upward;
Carefully inspect the mains and the drain bag for the presence of liquid in them (in case of detection of liquid, they must be replaced); Allowed the presence of small drops of solution on the walls.
Before the procedure, it is necessary to carefully inspect the status of the patient's outflow line and the connector.
Check the expiration date, the integrity of the bag with the solution (the presence of leaks or broken plugs leads to a violation of sterilization).

Application.

Wear a mask and wash your hands thoroughly and disinfect them with an alcohol-containing gel;
Put the bag with the finished solution (preheated to a temperature of 37 ° C) on the work surface with the connector upward;
Divide the mains and close the clamps on the flow line of the solution and the outflow line, break the tube with the partition of the empty drain plastic bag;
Prepare the patient's transit line;
Remove the protective caps from the connector and from the patient's transfer line, then connect them, tightly twisting;
Hang a bag with a ready solution at the top, and an empty drainage plastic bag - below the level of the abdominal cavity;
Filling: open the clamp on the flow line of the solution and on the patient's main line, when the solution bag becomes empty, close the clamp on the patient's main line and on the flow line of the solution;
Drain: open the clamp on the patient's main line and on the drain line, when draining is complete, close the clamp on the patient's line;
Rinse: Open the clamp on the flow line of the solution and on the drain line wait for three seconds and close the clamps.
Completion of the procedure: Wash hands thoroughly and disinfect them alcohol-containing gel, open the packing of the protective cap, without touching its inner surface, disconnect the connector of the patient's transfer line and gently close it with a new protective cap, fix the patient's transit line.

Form release / dosage:

Solution for peritoneal dialysis [with calcium 1.35 mmol / l, with calcium 1.75 mmol / l].

Packaging:

Solution for peritoneal dialysis

Primary packaging:

Three components of the solution - A, B, C, are placed in three isolated chambers of a three-chamber PVC plastic bag, cameras A and B have a discharge tube with a partition for mixing solutions, chamber C has an outlet pipe (port) for connection to the line, sealed from the outside.

A three-chamber plastic bag made of PVC with solutions with a total volume of 2 000 ml, 2 500 ml, 3 000 ml or 5 000 ml is additionally sealed in a sealed, transparent plastic bag made of PVC.

Three components of the solution - A, B, C, are placed in three isolated chambers of a three-chamber plastic bag made of PVC, cameras A and B have a discharge tube with a partition for mixing solutions,chamber C has a discharge tube (port) on the outside connected to an empty drain PVC plastic bag, which has an outlet pipe (port) for connection to a line sealed from the outside.

A three-chamber plastic bag made of PVC with solutions with a total volume of 2,000 ml, 2,500 ml, 3,000 ml or 5,000 ml, together with an empty drain PVC plastic bag is additionally sealed in a sealed, transparent plastic bag made of PVC.

The volume of the solution (ml) in each chamber (A, B, C) in plastic bags totaling 2,000 ml, 2,500 ml, 3,000 ml or 5,000 ml.

	2 000 ml	2 500 ml	3 000 ml	5 000 ml
Chamber A (ml)	61-63	76-78	92-94	153-155
Camera B (ml)	102 -104	128-130	153-155	256-260
Camera C (ml)	1 940 - 1 980	2 425-2 475	2 910-2 970	4 850-4 950

Secondary packaging:

4 bags of 2 000 ml, 4 bags of 2 500 ml, 3 bags of 3 000 ml or 2 bags of 5 000 ml, with instructions for use are placed in a cardboard box.
4 bags of 2 000 ml, 4 bags of 2 500 ml, 3 bags of 3 000 ml or 2 bags of 5 000 ml, with instructions for use are placed in a cardboard box.

Storage conditions:

In a place inaccessible to children, at a temperature not lower than + 4 ° C.

Shelf life:1 year 6 months.

Terms of leave from pharmacies:For hospitals

Registration number:LSR-002129/08

Date of registration:27.03.2008 / 26.03.2012

Expiration Date:Unlimited

Date of cancellation:2015-08-13

The owner of the registration certificate:Fresenius Medical Kea Deutschland GmbHFresenius Medical Kea Deutschland GmbH Germany

Information update date: & nbsp15.03.2017

Illustrated instructions

Instructions

Gambrosol Trio (Gambrosol trio)