Similar drugsTo uncover Dosage form: & nbspA solution for hemofiltration. Composition:Per 1000 ml: 2 mmol / L potassium 4 mmol / L potassium Sodium chloride 6.136 g 6.136 g Potassium chloride 0.1491 g 0.2982 g Sodium bicarbonate 2.940 g 2.940 g Calcium chloride dihydrate 0.2205 g 0.2205 g Magnesium chloride hexahydrate 0.1017 g 0.1017 g Glucose Monohydrate 1,100 grams 1,100 grams (in terms of anhydrous) (1,000 g) (1,000 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 and theoretical osmolarity (mmol / l) of the prepared solution: A solution of 2 mmol / L potassium A solution of 4 mmol / L potassium Sodium 140 140 Potassium 2,0 4,0 Calcium 1,5 1,5 Magnesium 0,50 0,50 Chloride 111 113 Glucose 5,55 5,55 Hydrocarbonate 35 35 Theoretical osmolality 296 mOsmol / l 300 mOsmol / l Description:A clear, colorless solution. Pharmacotherapeutic group:Solutions for hemodialysis. Hemofiltrates. Pharmacodynamics:Basic principles of hemofiltration:In the course of continuous 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.The final solution for hemofiltration is a replacement solution containing a bicarbonate buffer,for intravenous use in the treatment of acute renal failure of any type by continuous hemofiltration.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 equilibrium, acid-base state). Pharmacokinetics:A ready-made solution for hemofiltration should be used only intravenously. The distribution of electrolytes and bicarbonate is regulated in accordance with the needs and metabolic status, as well as the residual renal function of the patient. The active substances of the replacement solution are not metabolized, except for glucose. 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 continuous hemofiltration. Contraindications:Metabolic alkalosis. Childhood.Contraindications, depending on the solution:Multibiki 2 mmol / L potassium:Hypokalemia Multibib 4 mmol / L potassium:HyperkalemiaContraindications, depending directly on the technical procedure of hemofiltration:Renal failure with increasing hypercatabolism in cases where uremic symptoms can no longer be alleviated by hemofiltration.Inadequate blood flow of vascular access.High risk of bleeding as a result of systemic anticoagulation. Pregnancy and lactation:Currently, there is no experience of clinical use of the drug in this group of patients. The use of the drug during pregnancy and during breastfeeding is possible only in those cases when the expected benefit for the mother exceeds the potential risk to the fetus and the child. Dosing and Administration:Hemofiltration in patients with acute renal failure, including the prescription of replacement solutions, should be given to a doctor who has experience of such treatment.In acute renal failure, it is performed for a limited period of time and stops when the renal function is restored completely.MultiBeek is intended exclusively for intravenous administration.Administer the infusion of ready-to-use solution into the extracorporeal circulation by means of a dosing pump.As the blood serum is filtered during hemofiltration, the filtered volume, minus the required ultrafiltration liquid, must be replaced with a solution for hemofiltration.The filtration rate is assigned by the attending physician depending on the clinical condition and body weight of the patient. Unless otherwise specified, for adults, a total filtration rate of 800 to 1400 ml / h is acceptable for the output of the final metabolic products, depending on the status of the patient's metabolism. Recommended maximum filtration rate: 75 liters per day.There is no clinical experience in the use and dosing of this drug in children.The hemofiltration solution should be used 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 d if the container and the connectors are in perfect order.In doubtful cases, the question of the application of this solution for hemofiltration should be decided by the doctor in charge.2. Mixing the contents of two sectionsIn a two-section bag, bicarbonate and electrolytes, including glucose compartments, are mixed immediately before use to prepare the final solution. The mixed solution is clear and colorless.After mixing both sections, it is necessary to check that the joint is fully open, that both solutions are clean and transparent, that the container does not leak.A) Expand the smaller section.B) Fold the solution package starting from the corner opposite the smaller section ...C) ... until the seam between the two sections along the entire length opens, and until both solutions are mixed3. Ready-to-use solutionAny addition to the replacement solution should only be done after the replacement solution is completely mixed. After such addition, the replacing solution should be thoroughly mixed again before the infusion begins.The ready solution should be used immediately, within 48 hours after mixing.Unless otherwise specified, the ready-to-replace solution must be heated immediately before infusion to a temperature of 36.5-38.0 ° C. The exact temperature should be selected depending on the clinical recommendations and the technical equipment used.The solution for haemofiltration is intended for single use.Partially used and damaged containers are discarded. Side effects:Adverse reactions, such as nausea, vomiting, muscle cramps, hypotension and hypertension, can occur as a result of the actual treatment or the use of a replacement solution.In general, the tolerability of hemofiltration solutions buffered with bicarbonate is good.However, the following potential adverse effects of treatment may be expected: hyper or hypohydration, electrolyte disorders (eg, hypokalemia), hypophosphatemia, hyperglycemia and metabolic alkalosis. Overdose:After the use of recommended doses, no development of any urgent situations was reported; moreover, the administration of this solution can be stopped at any time. If the water balance is not calculated and not properly monitored, hyperhydration or dehydration may develop, causing appropriate circulatory responses. This can be manifested by changes in blood pressure,central venous pressure, heart rate, and pressure in the pulmonary artery. In cases of hyperhydration, congestive heart failure and / or congestion in the lungs may develop.In cases of hyperhydration, it is necessary to increase the ultrafiltration, as well as to reduce the rate and volume of the replacement solution introduced. In cases of severe dehydration, it is necessary to reduce or stop ultrafiltration, and also to increase the volume of the replacement solution appropriately.An overdose can lead to electrolyte disturbances and a violation of the acid-alkaline state, for example, an overdose of bicarbonate can occur if an inadequately large volume of replacement solution is introduced. This can potentially lead to metabolic alkalosis, decreased ionized calcium or tetany.Treatment is symptomatic. Interaction:Proper dosage of replacement solutions and strict control of biochemical parameters and clinical symptoms allows to avoid undesirable reactions when interacting with other medications.The following interactions are possible:Substitution of electrolytes, parenteral nutrition and other infusions, usually conducted during intensive care, interact with the composition of the serum and the liquid status of the patient. This should be taken into account when appointing a patient with hemofiltration.Treatment with hemofiltration can reduce the concentration of drugs in the blood, especially low-binding drugs with a protein, with a low volume of distribution, a molecular weight below the hemofiltration threshold and hemofiltrated adsorbed drugs.You may need to adjust the dose of such drugs accordingly.The toxic effects of digitalis can be masked by hyperkalemia, hypermagnesia, and hypocalcemia. Correction of these electrolytes by hemofiltration can increase manifestations and symptoms of digitalis toxicity, for example, cardiac arrhythmia. Special instructions:Prior to the infusion, the hemofiltration solution should be heated to approximately body temperature using appropriate equipment, and under any circumstances, a solution with a temperature below room temperature should not be administered.Heating of this solution approximately to body temperature should be carefully controlled: make sure that the solution is clear and contains no particles.During the use of MultiBic in continuous renal replacement therapy (CRRT), white precipitates of calcium carbonate were rarely observed in the system of connecting tubes, especially close to the pumping unit and the heating element that warms the MultiBic.Precipitation can occur especially if the temperature of the MultiBic solution at the inlet of the pumping unit is already higher than 25 ° C.Therefore, the MultiBic solution in the connection pipe system must be visually inspected carefully every 30 minutes during the CRRT to ensure that the solution in the connecting tube system is clear and does not contain a precipitate.Precipitation may also occur with significant delay after initiation of treatment.If there is a precipitate appearance, the MultiBic solution and the tube system for the CRRT should be replaced immediately, and the patient should be carefully monitored.Serum potassium concentrations must be monitored regularly prior to haemofiltration and during the procedure. It should take into account the status of potassium in the patient and the trend in the course of hemofiltration. In the presence of hypokalemia or tendencies to its development, it may be necessary to add potassium and / or replace the replacement solution with a solution with a higher potassium content.In the absence of compatibility studies, this drug should not be confused with other drugs. If an additive is added to the replacement solution, this should only be done after assessing the compatibility with the replacement solution and only after the two replacement solution compartments have been thoroughly mixed.Chemical and physical stability during the use (in-use) of the ready-to-use solution was demonstrated for 48 hours at a temperature of 25 ° C. Other storage times and operating conditions (more than 48 hours, including treatment time, above 25 ° C before entering the pump set) are the responsibility of the user.From the microbiological point of view, once attached to the hemofiltration circuit, and also because of the presence of bicarbonate, the product should be used immediately. Other storage times and operating conditions are the responsibility of the user.In the presence of a tendency to the development of hyperkalemia, an increase in the rate of filtration, as well as the main measures of intensive therapy, can be shown.MulTibic 2 mmol / L potassium: in the presence of a tendency to the development of hyperkalemia, an increase in the rate of filtration and / or substitution of a replacement solution for a solution with a lower potassium concentration, as well as basic intensive care measures, can be shown.Before the beginning of hemofiltration and during the procedure it is necessary to monitor the following parameters: sodium serum, serum calcium, serum magnesium,serum phosphate, serum glucose, acid-base state, urea and creatinine levels, body weight and water balance (for early diagnosis of hyperhydration and dehydration).There is no experience of clinical use and dosing of this drug in children.Thoroughly inspect the packaging before use. Do not use mortars before mixing. Effect on the ability to drive transp. cf. and fur:Not applicable. Form release / dosage:A solution for hemofiltration. Packaging:The preparation is placed in two-chamber plastic bags "Biofine" in a total volume of 5 liters (with a 250 ml chamber for solution A and a 4750 ml chamber for solution B) with connecting tubes made of a polyolefin-synthetic elastomer mixture (chamber A contains one connecting tube with an input device made of polyolefin, chamber B contains two tubes: with a Luer tip made of polycarbonate and a HF connector made of polycarbonate).Each two-chamber package with the devices attached to it is placed in a protective plastic bag.Two 2-chamber packages in a protective plastic bag, along with instructions for medical use, are placed in a cardboard box. Storage conditions:Store at a temperature of at least 4 ° C.Do not freeze.Keep out of the reach of children. Shelf life:1 year.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-000996 Date of registration:18.10.2011 / 07.11.2016 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