Hemolactol - instructions for use, dose, side effects, contraindications

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Dosage form: & nbsp

solution for hemodialysis [potassium 2 mmol / l, potassium 4 mmol / l]

Composition:Per 1000 ml

	potassium 2 mmol / l	potassium 4 mmol / l
Sodium chloride	5.961 grams	5.844 g
Calcium chloride dihydrate	0.257 g	0.257 g
Magnesium chloride hexahydrate	0.152 g	0.152 g
Potassium chloride	0.149 g	0.298 g
Sodium lactate solution	7.471 g	7.471 g
acc. Sodium lactate anhydrous	4,483 g	4,483 g
Anhydrous Dextrose (glucose)	1,100 grams	1,100 grams
acc. Dextrose (glucose) monohydrate	1.210 g	1.210 g
Water for injection (as needed)	up to 1000 ml
Hydrochloric acid
(as needed)	to pH 4.5-6.5

Content of electrolytes:

	potassium 2 mmol / l	potassium 4 mmol / l
Sodium Na ⁺	142 mmol / l	131 mmol / l
Potassium To ⁺	2.0 mmol / L	4.0 mmol / l
Calcium Ca ²⁺	1.75 mmol / l	1.70 mmol / l
21 Magnesium Mg	0.75 mmol / l	0.75 mmol / l
Chlorine C1 '	109.0 mmol / L	109.0 mmol / L
Lactate	40.0 mmol / l	40.0 mmol / l
Theoretical Osmolarity:	301.6 mOsm / l	301.6 mOsm / l

Description:

A clear, colorless or pale yellow solution.

Pharmacotherapeutic group:Solution for hemodialysis

ATX: & nbsp

Hemodialysates (concentrates)

Pharmacodynamics:

HEMOLACTOL is a solution of electrolytes containing potassium ions in two concentrations (2 mmol / L, 4 mmol / L), dextrose (glucose) and lactate buffer, free of bacterial endotoxins. The solution is pharmacologically inactive. During the procedure of hemodialysis,hemofiltration and hemodiafiltration plasma fluid and substances dissolved in it, including toxins, are removed through a semipermeable hemofiltration membrane (dialyzer). Since large volumes of liquid are removed during these procedures, pre-or post-dilution of a sterile solution that replenishes the volume of blood circulating in the outline of the hemodialysis apparatus is required.

HEMOLACTOL contains sodium, calcium, magnesium, chlorine and glucose ions in physiological concentrations, which makes it possible to use it as a replenishing solution. Lactate is metabolized in the Corey cycle (the stage of gluconeogenesis) with the formation of an equimolar amount of glucose, which allows you to correct metabolic acidosis.

Indications:

Hemolactol is used to treat acute renal failure of various genesis by hemodialysis, haemofiltration and hemodiafiltration; in case of poisoning by filtering or dialyzing drugs and substances with normokaliemia for the prevention of hyperkalemia.

Contraindications:

Absolute contraindications to application are not revealed. Do not use with severe decompensated metabolic acidosis, or with a marked violation of lactate metabolism.

Pregnancy and lactation:Studies of the effect of the solution for hemodialysis on reproductive function and on the fetus when used in pregnant women and during lactation were not conducted. The solution for hemodialysis should be used in pregnant women and during lactation only after evaluating the potential benefits for the mother and the risk of the fetus (child).

Dosing and Administration:

HEMOLACTOL is injected into the extracorporeal circuit to the hemofiltration (predilution) or after the hemofiltration (post-dilution). The volume of the replenishing solution depends on the intensity of the therapy and the required replacement volume and is in the competence of the attending physician. With continuous hemofiltration procedures or with hemodialysis, the clearance of the removed substances depends on the blood flow rate, the rate of administration of hemolactol, the area and characteristics of the haemofilter membrane

As a rule, the rate of intake of the replenishing solution in the hemodialysis apparatus during hemofiltration and hemodiafiltration is:

For adults, 500-1500 ml / hour;

For children 20 ml / kg / hour.

As a rule, the rate of dialysis solution entering the contour of the hemodialysis apparatus with continuous hemodialysis is:

For adults, 500-2000 ml / h;

For children 20 ml / kg / hour

The procedure continues for as long as it is clinically necessary.

Solutions with different potassium concentrations are used depending on the initial level of potassium in the blood.

Side effects:

During hemodialysis, hemofiltration and hemodiafiltration procedures, nausea and vomiting can occur, due to increased blood pressure, chills and hypotension.

Possible electrolyte imbalance: the development of hypokalemia in the long-term uncontrolled administration of HEMOLACTOL with a concentration of potassium 2 mmol / l in the extracorporeal contour of the hemodialysis apparatus.

Overdose:

Symptoms: Overdose can cause hypervolemia in patients with renal insufficiency.

Treatment: Continuation of the procedure will remove excess fluid.

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 dosage correction of these preparations may be required.

The potassium level should be monitored especially carefully with concomitant therapy with cardiac glycosides, as the sensitivity to these drugs increases with hypokalemia.

Changes in the concentration of electrolytes can lead to overdose events with cardiac glycosides.

Special instructions:

Care should be taken to monitor hemodynamics, water balance, acid-base and electrolyte balance throughout the procedure. Particular attention should be paid to the timely correction of the level of potassium. The pronounced decompensated metabolic acidosis should be corrected by infusion of the sodium bicarbonate solution into the extracorporeal circuit of the apparatus before the application of HEMOLACTOL. It is permissible to use only devices for continuous renal replacement therapy. It is necessary to carefully monitor the level of glycemia, especially in diabetes mellitus. Particular attention is needed for patients with severe hepatic insufficiency, heart failure with a lactate replenishment solution.

It is necessary to carefully follow the rules of asepsis, both when connecting, and when detaching the packet from the solution from the mains. Do not use the solution in case of damage to the package, violation of the transparency of the solution. Empty unused solution immediately after use.The temperature of the solutions (37 ° C) should be closely monitored during the procedure.

Do not mix with solutions containing bicarbonate, to avoid the formation and precipitation of calcium and magnesium carbonates.

Do not reuse partially used bags with solution.

Guidelines for use

Remove the outer shell of the PVC plastic bag with the solution, having first ascertained its integrity, absence of foreign inclusions, cloudiness of the solution and its leakage. In any of these cases, do not use the solution.

Hang a plastic bag of PVC with a solution on the hooks of the scales built into the unit. Strictly observe the rules of asepsis, connect the hemodialysis solution line to the bag.

During the procedure, the solution is consumed from a plastic bag. When it is completely emptied, replace the empty bag with a full one, strictly observe the above instructions.

Form release / dosage:

Solution for hemodialysis [potassium 2 mmol / l, potassium 4 mmol / l].

Packaging:

By 5000 ml of the drug in a transparent plastic bag of PVC, which is equipped with an outflow tube,injection port with a plug and a Lueur-Lock connector for connection to the replenishment or dialysis line.

A plastic bag with a solution, additionally sealed in a sealed, transparent plastic bag made of PVC.

2 bags of PVC for 5 000 ml with two instructions for use are placed in a cardboard box (For hospitals).

Storage conditions:

At a temperature not lower than + 4 ° С. Keep out of the reach of children.

Shelf life:

2 years. Do not use after expiration date indicated on the package.

Terms of leave from pharmacies:For hospitals

Registration number:LSR-009339/09

Date of registration:19.11.2009

Expiration Date:Unlimited

The owner of the registration certificate:Gambro Lundia ABGambro Lundia AB Italy

Manufacturer: & nbsp

GAMBRO DASCO, S.p.A. Italy

Information update date: & nbsp21.03.2017

Illustrated instructions

Instructions

Hemolactol (Hemolactol)