Similar drugsTo uncover Dosage form: & nbspA solution for hemofiltration. Composition:Per 1000 ml: 2 mmol / L potassium 4 mmol / L potassium Sodium chloride 5.9610 g 5.9610 g Potassium chloride 0.1491 g 0.2982 g Calcium chloride dihydrate 0.2205 g 0.2205 g Magnesium chloride hexahydrate 0.1017 g 0.1017 g Sodium lactate (50% solution) 8,5200 g 8,5200 g Glucose Monohydrate 1.1000 g 1.1000 g (corresponding to anhydrous glucose) (1.0000 g) (1.0000 g) Water for injections up to 1000 ml up to 1000 ml To correct the pH, 25% hydrochloric acid and sodium hydroxide are used. Ionic composition per 1000 ml: 2 mmol / L potassium 4 mmol / L potassium Sodium 140,0 140,0 Potassium 2,0 4,0 Calcium 1,5 1,5 Magnesium 0,5 0,5 Chloride 108,0 110,0 Glucose 5,5 5,5 Lactate 38,0 38,0 Theoretical osmolality 296 mOsml / L 300 mOsml / L Description:Transparent, colorless or slightly yellowish solution. Pharmacotherapeutic group:Solutions for hemodialysis. Hemofiltrates. Pharmacodynamics:Basic principles of hemofiltration, hemodialysis and hemodiafiltration.During hemofiltration water and dissolved substances, such as uremic toxins, electrolytes, and also bicarbonate, are removed from the blood by ultrafiltration. The ultrafiltrate is replaced by a replacement solution (a solution for hemofiltration) containing in the composition balanced electrolytes and a buffer composition.During hemodialysis, water and dissolved substances, such as uremic toxins, electrolytes, as well as bicarbonate and other small molecules,are exchanged between the patient's blood and the dialysate by diffusion; the direction and magnitude (magnitude) of the diffusion process is dependent on the relevant concentration gradients between the blood and the dialysate. Solutions for hemofiltration can also be used as dialysis solutions.In hemodiafiltration, the basic principles of hemofiltration and hemodialysis are combined.MultiLak is a lactate-buffered replacement solution for intravenous use or for use as a dialysis solution to balance the fluid and remove electrolytes during continuous renal replacement therapy, for example, treatment of acute renal failure.The introduced lactate is converted by metabolism, resulting in the formation of an equimolar amount of bicarbonate.Electrolytes of Na+, K+, Mg2+, Ca2+, Cl- , as well as bicarbonate are the main elements for maintaining and correcting the homeostasis of fluid and electrolytes (volume of circulating blood, osmotic balance, KHS). Pharmacokinetics:MultiLaq active substances are not metabolized, except for glucose and lactate.The introduced lactate is converted by metabolism, resulting in the formation of an equimolar amount of bicarbonate.The distribution of electrolytes and bicarbonate is regulated in accordance with the requirements and the metabolic status and residual renal function. Elimination of water and electrolytes depends on cellular needs, metabolic status, residual renal function and other pathways of fluid loss (eg, intestines, lungs, skin). Indications:- For use in patients with acute renal failure requiring prolonged hemofiltration or other form of continuous renal replacement therapy;- For use in patients with chronic renal failure, which shows transient treatment with a solution for hemofiltration, for example, during stay in the intensive care unit and intensive care- Continuous renal replacement therapy, shown as part of the treatment of intoxication with water-soluble toxins that can be filtered / dialyzed. Contraindications:- Hypersensitivity to active substances or to any of the excipients,- Hypokalemia (only for Multilak 2 mmol / L potassium),- Metabolic alkalosis,- Hyperlactatemia, lactic acidosis, hepatic insufficiency and decreased lactate metabolism for other reasons,- Severe diseases of the cardiovascular system,- Concomitant treatment with metformin. Pregnancy and lactation:There are no data on the use of the drug during pregnancy and during breastfeeding.The use of the drug MultiLak during pregnancy and during breastfeeding is possible only if the positive effect for the mother justifies the possible risk to the fetus and the baby. Dosing and Administration:Continuous renal replacement therapy (haemofiltration, hemodialysis and haemofiltration), including prescription of solutions for hemofiltration should be under the guidance of a physician with experience in such treatment.MultiLak is intended for intravenous use and use as a dialysis solution. With hemofiltration, the infusion of ready-to-use solution is made into the extracorporeal circuit of the blood flow. When hemodialysis, a solution for hemodialysis should be used through the dialysis compartment of the dialyzer. With hemodiafiltration, hemodialysis and haemofiltration are combined.Multilak must be introduced by means of metering pumps.Taking into account the clinical status and body weight of the patient, the attending physician prescribes the required amount of hemofiltration solution, treatment regimen (hemodialysis, haemofiltration or hemodiafiltration), as well as the frequency and duration of treatment. The flow of the effluent must exceed the total flow of the hemofiltration solution by clinically necessary removal of liquid from the patient's body (net ultrafiltration).In acute renal failure to remove metabolic products, depending on the patient's metabolic status, and also if not otherwise prescribed, continuous treatment with a dose of 2000 ml / h is adequate for adult patients with a body weight of 70 kg. The intensity of GF-treatment should not exceed 6 l / h of plasma-water exchange. The maximum recommended amount is 75 l / day.In patients with chronic renal failure, the MultiLaqua dose should be at least one third of the body weight per treatment session - three sessions per week.The dose and duration of hemofiltration, hemodialysis or hemodiafiltration,necessary for acute intoxication, depend on the toxin and its concentration, as well as the severity of clinical symptoms, the body weight of the patient and should be clinically conditioned by the individual condition of the patient.The marked increase in the systemic lactate concentration or the development of lactic acidosis may indicate an inadequate metabolism of lactate. In this case, you should switch to a GF-solution based on another buffer, for example bicarbonate, (see also section "Special instructions").Pediatric Patients:There is no clinical experience in the use and dosing of this drug in children. Multilak is not recommended for use in children until the data of the results of further studies become available.MultiLac should be assigned in accordance with the following steps:1. Remove the outer packaging and carefully inspect the bag for hemofiltration. The outer packaging must be removed immediately before the procedure. Plastic containers can be accidentally damaged during transportation from the manufacturer to the site of dialysis.This can lead to a violation of sterility and the growth of microorganisms or fungi in the solution for hemofiltration.It is necessary to carry out a careful visual inspection of the container before connecting it to the system, and also the solution before use. Special care should be taken even for minor damage to the closure cap, the seams and corners of the container, in order to detect possible contamination.This solution should be used only if it is clean and transparent, and only in the case of the integrity of the container and connectors.In doubtful cases, the question of the application of this solution for hemofiltration should be decided by the doctor in charge.2. Application of the solutionIf any other medicinal product is to be added to Multilak, the solution must be prepared immediately before use and mixed thoroughly.Unless otherwise prescribed, MultiLak should be heated immediately before use until 36.5 ° C - 38.0 ° C. The exact temperature should be chosen depending on the clinical requirements and the technical equipment used.Multilak is designed for single use.Partially used and damaged containers must be disposed of in waste.In acute renal failure, treatment is performed for a limited period of time and stops when the renal function is fully restored or becomes sufficient to allow switching to other treatments. The use of hemofiltration solutions for the treatment of patients with chronic renal insufficiency should be discontinued when the patient can be transferred to standard treatment for chronic renal failure, for example, intermittent hemodialysis. Continuous renal replacement therapy, used as part of the treatment of intoxication, ceases when the degree of detoxification becomes sufficient. Side effects:Adverse reactions, such as nausea, vomiting, muscle cramps, hypotension and hypertension, can be the result of applying a solution for hemofiltration.The following potential side effects of treatment may be expected: nausea, vomiting, muscle cramps, hypotension and hypertension, hyperhydration or hypohydration, electrolyte disorders (eg, hypokalemia),hypophosphatemia, hyperglycemia, metabolic alkalosis and hyperlactatemia.The exact frequency of such events is not defined. Overdose:After using the recommended doses, no reports of extreme situations occurred; in addition, the administration of the solution can be stopped at any time. If the fluid balance is not accurately calculated and not monitored, hyperhydration or dehydration may result, leading to concomitant circulatory reactions. These reactions can manifest themselves through changes in arterial pressure, central venous pressure, heart rate and pulmonary arterial pressure. In case of hyperhydration, congestive heart failure and / or pulmonary congestion (small circle overload) may develop.If too much volume is used, this can lead to abnormal electrolyte and acid-base concentrations, for example, an overdose of lactate (buffer base) may occur if an appropriately large volume of the GF solution is not administered. This can lead to metabolic alkalosis, a decrease in ionized calcium or tetany.Treatment: correction of the rate of ultrafiltration and the volume of the solution administered, symptomatic therapy. In the case of hyperhydration, ultrafiltration should be increased, and the speed and volume of the solution administered are reduced. In cases of severe dehydration, ultrafiltration should be reduced or discontinued, and the volume of the injected EF solution should be increased accordingly. Interaction:Correct dosing of multilak and strict control of parameters of clinical chemistry and important vital indicators allows to avoid undesirable reactions at interaction with other medical products. The following interactions are assumed:- Electrolyte solutions, parenteral nutrition and other infusions, usually prescribed in intensive care, can change the composition of the serum and the fluid balance. This should be taken into account in hemofiltration, hemodialysis or hemodiafiltration.- Hemofiltration, hemodialysis or hemodiafiltration may reduce the concentration of the concentration of drugs in the blood, especially drugs with a low ability to bind to protein, with a small amount of distribution,with a molecular mass below the hemofiltration threshold and drugs absorbed by the hemofiltrator. A certain revision of the dose of such drugs may be required.- The toxic effect of digitalis can be masked by hyperkalemia, hypermagnesia and hypocalcemia. Correction of these electrolyte disorders by haemofiltration, dialysis or hemodiafiltration can force the appearance of signs of digitalis intoxication, for example, cardiac arrhythmia.- Antiretroviral drugs (i.e., reverse transcriptase inhibitors) are associated with some risk of increased lactate and lactic acidosis. Although clinical data are not sufficient, additive effects on lactate levels with the concomitant use of Multilak and reverse transcriptase inhibitors are considered possible. Appropriate control is required (including monitoring of pH and serum lactate concentration).- The concomitant use of metformin with Multilak may be associated with an increased risk for a clinically significant increase in serum lactate levels and for the development of lactic acidosis. Thus, the combined use of metformin and MultiLaq is contraindicated. Special instructions:Lactate is administered by infusion, as part of MultiLac's needs, to be metabolized to bicarbonate, thus achieving the functions of the buffer base. The marked increase in the systemic lactate concentration or the development of lactic acidosis may indicate an inadequate metabolism of lactate. In this case, you should switch to a GF-solution based on another buffer, for example bicarbonate, as prescribed.The concomitant use of multilak and reverse transcriptase inhibitors may be associated with an increased risk of increased serum lactate and / or lactic acidosis. Appropriate control is required (including monitoring of pH and serum lactate concentration).Systemic lactate infusion can increase the ratio between lactate and pyruvate in the blood of patients, which is related to the state of the cellular oxidation-reduction potential (redox status). This can lead to negative effects in the heart, especially in patients with serious cardiac diseases (eg, cardiac insufficiency).Thus, the use of multilak in patients with serious diseases of the cardiovascular system is contraindicated.Serum potassium concentrations should be monitored regularly before and during hemofiltration, hemodialysis and hemodiafiltration. The status of the patient's potassium and its trends during treatment should be taken into account.If hypokalemia is established or there is a tendency to develop it, it may be necessary to add potassium and / or change the GF solution to a solution with a higher potassium concentration.If hyperkalaemia is diagnosed or tends to develop, a change in the GF solution to a solution with a lower potassium concentration and / or augmentation of the dose may be indicated along with conventional intensive care measures.In addition, the following parameters should be monitored before and during hemofiltration, hemodialysis and hemodiafiltration: serum sodium, serum calcium, serum magnesium, serum phosphate, serum glucose, acid-base state, serum lactate, urea and creatinine levels, body weight and fluid balance (for early recognition of hyper- and dehydration).Clinically important substances can be removed during the treatment of hemofiltration, hemodialysis and hemodiafiltration, and may not be replenished by MultiLak.These losses must be compensated for by an adequate diet, nutritional supplements or adapted parenteral nutrition.It is not recommended to use the drug in children under 18 years of age (due to the lack of data from clinical studies on the efficacy and safety of children).Before use, the solution bag must be thoroughly inspected for damage or leakage.Multilak should be heated before infusion to the recommended temperature and should not be administered with a solution temperature below room temperature under any circumstances. Effect on the ability to drive transp. cf. and fur:Not applicable. Form release / dosage:A solution for hemofiltration (potassium 2 mmol / l), (potassium 4 mmol / l). Packaging:In a transparent plastic bag "Biofine®" with a volume of 5000 ml, which has a discharge tube, a port with a plug sealed from the outside. The bag containing the solution, the tube and the port are sealed in a sealed transparent plastic bag.2 bags in a carton box along with instructions for medical use. Storage conditions:Store at a temperature of at least 4 ° C. Do not freeze.Keep out of the reach of children. Shelf life:2 years.The drug should be used before the date indicated on the package.After the expiration date, the drug should not be used. Terms of leave from pharmacies:On prescription Registration number:PL-000706 Date of registration:28.09.2011 / 18.10.2016 Expiration Date:Unlimited The owner of the registration certificate:Fresenius Medical Kea Deutschland GmbHFresenius Medical Kea Deutschland GmbH Germany Manufacturer: & nbspFRESENIUS MEDICAL CARE DEUTSCHLAND, GmbH Germany Information update date: & nbsp2016-12-12 Illustrated instructions × Illustrated instructions Instructions