Solution for peritoneal dialysis with glucose - instructions for use, dose, side effects, contraindications

Ingredients		amount, g / l
Active Ingredients	Formula 55	Formula 91	Formula 62
Glucose (dextrose) monohydrate [that	15,0	25,0	42,50
corresponds to glucose (dextrose) anhydrous \|	13,6	22,7	38,6
I 1 sodium chloride	5,67	5,67	5,67
Sodium lactate	3,92	3,92	3,92
Calcium chloride dihydrase	0.26	0,26	0,26
Magnesium chloride hexahydrate	0,15	0,15	0,15
Auxiliary Ingredients
Water for injections	up to 1 liter

Ionic composition (in meq / l) and glucose content in%

Ionic composition (in meq / liter) and glucose content (in%):

	Formula 55	Formula 91	Formula 62
Glucose	1,36%	2,27 %	3,86 %
Sodium ion (meq / L)	132,0	132,0	132,0
Calcium ion (meq / L)	3,50	3,50	3,50
Magnesium ion (meq / L)	1,50	1,50	1,50
Chloride ion (meq / L)	102,0	102,0	102,0
Lactate ion (meq / L)	35,0	35,0	35,0

Ionic composition (in mmol / l) and glucose content (in% and mmol / L)

Ionic composition (in mmol / l) and glucose content (in% and in mmol / l):

	Formula 55	Formula 91	Formula 62
Glucose	1.36 %	2,27 %	3,86 %
Glucose (mmol / l)	75,68	126,1	214,4
Sodium ion (mmol / L)	132,0	132,0	132,0
Calcium ion (mmol / L)	1,75	1,75	1,75
Magnesium ion (mmol / L)	0.75	0,75	0,75

Chloride ion (mmol / L)	102,0	102,0	102,0
Lactate ion (mmol / L)	35,0	35,0	35,0

Osmolarity:

"1.36%" - 347.18 mOsmol / l ± 5%;

"2.27%" - 397.6 mOsmol / l ± 5 %;

"3.86%" - 485.49 mOsmol / l ± 5%.

Description:

Transparent.Colorless or from a light yellow to yellow solution.

Pharmacotherapeutic group:Solution for peritoneal dialysis.

ATX: & nbsp

B.05.D Solutions for peritoneal dialysis

Pharmacodynamics:

Solutions for peritoneal dialysis are sterile, pyrogen-free solutions of electrolytes in water for injections with a composition as close as possible to the electrolyte composition of the plasma. Solutions differ in the degree of hypertension depending on the glucose content. They also contain lactate as a source of bicarbonate ions. Solutions for peritoneal dialysis operate with osmosis and diffusion through the peritoneal membrane.

Pharmacokinetics:

Absorbed electrolytes are followed by conventional metabolism. Glucose can be metabolized in various ways: glycolysis to pyruvate. decomposition to carbon dioxide and water in the pentose-phosphate cycle.

Indications:

The drug "Solution for peritoneal dialysis with glucose" is used in the treatment of any of the methods of peritoneal dialysis and is indicated in the following cases:

acute and chronic renal failure;
severe hyperhydration;
with changes in electrolyte blood composition;
with intoxication with drugs undergoing dialysis, if other more appropriate therapeutic methods are not available.

Contraindications:

The use of the drug "Solution for peritoneal dialysis with glucose" is contraindicated under the following conditions:

hypersensitivity to the components of the drug;
in patients with a known allergy to corn or corn products;
severe lactic acidosis;
non-correctable mechanical defects that impede the procedure of effective peritoneal dialysis or increase the risk of infection;
documented loss of peritoneal function or extensive adhesions leading to a disruption of peritoneal function.

The drug has relative contraindications for use in: hypokalemia, perforation of the hollow organs of the abdominal cavity and peritoneum, violations of the integrity of the peritoneum or diaphragm due to a recent surgery until complete healing, ns diagnosed abdominal cavity disease, abdominal tumors, localized and diffuse peritonitis,closed trauma of the abdominal cavity organs (with the exception of cases when the possible benefits of treatment exceed the risk of using the drug), inflammatory or ischemic diseases of the intestine, intestinal obstruction, hernia, severe lung diseases (especially pneumonia), infectious skin diseases, in the II and III trimester pregnancy, cachexia, hypoproteinemia.

Carefully:

The procedure for peritoneal dialysis should be carried out with caution in tetrategia, arthritis (severe course), mental retardation, psychosis, blindness, hyperlipidemia, during pregnancy and during breastfeeding, congenital anomalies, fecal fistulas, colostomas or ileostomy, frequent episodes of diverticulitis, infection of the abdominal wall, extensive polycystic kidney, with the recently transferred prosthetics of the aorta, with other conditions associated with violations of the integrity of the peritoneum, abdominal wall or abdominal cavity.

Pregnancy and lactation:

Sufficient clinical data for an unambiguous evaluation of the use of the drug "Solution for peritoneal dialysis with glucose" during pregnancy and during breastfeeding, as well as the effect on fertility, are lacking.Before using the drug during pregnancy and during breastfeeding, the doctor should carefully evaluate the "benefit / risk" ratio for each individual patient individually depending on the clinical situation.

Data on the excretion of metabolites of the drug with mother's milk are absent,

therefore the risk for newborns and infants can not be ruled out.

The decision to stop breastfeeding or stop breastfeeding preparation "Solution for peritoneal dialysis with glucose" should be taken the attending physician taking into account the benefits of breastfeeding for the child and the benefits of therapy for the mother.

Dosing and Administration:

Before using the medication, you should read the instructions carefully and take the precautionary measures into account.

Solutions for peritoneal dialysis are for intraperitoneal administration only. Not for intravenous administration.

Do not use the solution if it is not transparent, has changed color, contains foreign particles, if there are signs of leakage of the solution from the container or the integrity of the package is compromised.

As the body weight of the patient approaches the ideal "dry" body weight, it is recommended that the glucose concentration in the peritoneal dialysis solution be reduced. A "solution for peritoneal dialysis with glucose" containing 3.86% glucose is a liquid with a high osmotic pressure, and the use of this solution alone can cause dehydration (See section "Special instructions").

To prevent the risk of severe dehydration, giovosmia and to minimize the loss of proteins, it is recommended to choose a solution for peritoneal dialysis with the lowest osmolarity, taking into account the requirements for the volume of fluid removal at each exchange procedure.

In most cases, apply "Solution for peritoneal dialysis with glucose" with a glucose concentration of 1.36% or 2.27%. If additional fluid volume is to be removed, a solution for peritoneal dialysis with glucose containing 3.86% glucose should be used. The need to remove excess fluid is judged by the weight of the patient's body.

The effluent (caring dialysate) should be checked for fibrin or turbidity, which may indicate the presence of peritonitis.

Doses

Type of therapy (Itermittic peritoneal dialysis | IPD).Continuous outpatient peritoneal dialysis (CAPD) or continuous cyclic peritoneal dialysis (CVDD), the frequency of sessions, the volume of the solution for one exchange session, the period of residence of the solution in the abdominal cavity and the duration of dialysis depend on the individual needs of the patient and should be appointed and monitored by the attending physician.

Adults

Patients on a permanent outpatient peritoneal dialysis (CAPD) usually spend 4 cycles per day (24 hours). Patients on automatic peritoneal dialysis usually spend 4-5 cycles at night and up to 2 cycles during the day. The volume of the dialysis solution introduced into the abdominal cavity depends on the surface area of the body and usually ranges from 2.0 to 2.5 liters.

Children (from newborns to 18 years)

For children aged 2 years and over, the recommended volume of solution is from 800 to 1400 ml / m² for one cycle, maximum 2 liters with regard to portability. For children under 2 years, the recommended volume of solution is from 200 to 1000 ml / m².

Before starting the peritoneal dialysis procedure, it is necessary to train patients and / or their relatives with the attending physician.

Instructions for the procedure

When carrying out the procedure for peritoneal dialysis, you must follow the rules of asepsis.

After removing the outer bag, make sure that there are no leaks, tightly squeezing the container. If leakage is detected, do not use the solution, as sterility may be impaired.

Only for single use.

The unused solution should be discarded.

To ensure comfort, the solution can be heated to body temperature (37 ° C).

The solution for peritoneal dialysis should be heated in an external bag using only dry heat (for example, mattress warmer, heating plate). Solutions should not be heated in water because of the increased risk of infection.

Solutions should not be heated in a microwave oven due to potential damage to the container, as well as causing harm or discomfort to the patient.

Side effects:

Adverse reactions presented in this section are associated either with the use of the drug "Solution for peritoneal dialysis with glucose" or with the procedure of peritoneal dialysis.Unwanted drug reactions (NLR) recorded during the time of post-istrazopic administration of the drug are grouped into systems and organs according to the dictionary MedDRA and are listed below in order of decreasing frequency.

Adverse reactions occurring more often than in single cases are listed according to the following gradation: very often (> 1/10). often (from> 1/100 to <1/10), infrequently (from> 1/1000 to <1/100). rarely (> 1/10000 to <1/1000). very rarely (<1/10000), there is no data on the frequency (it is impossible to determine from the available data).

System-Organ Class	Unwanted reaction	Frequency
Disorders from the metabolism and nutrition	Hypokalemia Delayed fluids (hyperhydration) Hypervolaemia Hypovolemia Hyionatremia Dehydration Hypochloremia Hyiopoesthesia Violation of acid-base balance	no frequency data
Vascular disorders	Increased blood pressure Lowering blood pressure	no frequency data
Disturbances from the respiratory system, chest and mediastinal organs	Dyspnea	no data !,lx about frequency
Disorders from the gastrointestinal tract	Sclerosing encapsulating peritonitis Peritonitis Mudy peritoneal effluent (outflowing dialysate) Vomiting Diarrhea Nausea Constipation Abdominal pain Bloating Abdominal discomfort	no frequency data

System-Organ Class	Unwanted reaction	Frequency
Hcaving from the skin and subcutaneous tissues	Stevens-Johnson Syndrome Hives Rash (including itching, erythematous and generalized) Itching	no frequency data
Disturbances from the musculoskeletal system and connective tissue	Myalgia Muscle spasms Musculoskeletal pain Seizures	no frequency data
General disorders and disorders at the site of administration	Generalized edema Temperature increase Misalignment Pain at injection site	Frequency information

Other undesirable effects of peritoneal dialysis are associated with the dialysis procedure: fungal peritonitis, bacterial peritonitis, infectious and non-infectious complications associated with the use of a catheter (displacement or occlusion of the catheter, infection of the catheter site).

Due to an incorrect procedure for peritoneal dialysis, there may be: a feeling of stretching in the abdominal cavity,pain in the shoulder girdle, bleeding, intestinal cramps, intestinal obstruction, reduction of ultrafiltration.

When performing peritoneal dialysis, patients with diabetes mellitus may develop hyperglycemia, which may require a change in the dosage of insulin or appropriate therapy.

If any of the side effects indicated in the manual are aggravated, or if you notice any other side effects indicated in the instructions, tell your doctor.

Overdose:

Possible consequences of overdose may be hypervolemia, hypovolemia, electrolyte metabolism disorders or hyperglycemia (in particular, in patients with diabetes mellitus).

Excessive administration of the drug "Solution for peritoneal dialysis with glucose", containing 3.86% glucose, can cause severe dehydration.

Treatment of overdose

Activities in the case of hypervolvemia occur in the introduction of hypertonic solutions for peritoneal dialysis and limiting the introduction of fluid.

Therapy of hypovolemia is carried out by means of a substitutive introduction of the fluid orally or intravenously, depending on the degree of dehydration.

Therapy of electrolyte imbalance is carried out in accordance with the type of electrolyte disturbance established by the results of a blood test. The most likely violation is hypocalysis. Correction of hypokalemia is performed by the attending physician and consists in oral administration of potassium preparations or in the addition of potassium chloride to the solution for peritoneal dialysis.

In patients with diabetes mellitus, when using peritoneal dialysis with the drug "Solution for peritoneal dialysis with glucose," it is necessary to monitor the concentration of glucose in the blood plasma and adjust the dose of insulin or other medications to treat hyperglycemia, if necessary.

Interaction:

Some medications may be incompatible with the drug "Solution for peritoneal dialysis with glucose". Before adding drugs, you should read the instructions for use on this drug.

When mixing different drugs, it is necessary to take into account the presence of salts and the pH of the solution. Before mixing, make sure the solutions are compatible.Before use, check the transparency and color of the solution.

Studies on the interaction of the drug "Solution for peritoneal dialysis with glucose" with other drugs have not been conducted.

With peritoneal dialysis, the concentration of dialyzed drugs in the blood can be reduced.

When administering a solution, a specific patient should consider the possible interaction between dialysis therapy and therapy prescribed for other diseases. It is necessary to carefully monitor the concentration of potassium, calcium and magnesium in the blood plasma in patients receiving cardiac glycosides, in connection with the existing risk of cardiac glycoside intoxication. You may need to administer potassium. For example, rapid removal of potassium can cause arrhythmia in patients receiving preparations of cardiac glycosides; manifestations of digitalis intoxication may be masked by an elevated level of potassium or magnesium or gynocalschemia. Correction of electrolyte balance by dialysis can exacerbate signs and symptoms of intoxication with cardiac glycosides. And vice versa,manifestations of intoxication may occur at moderate doses of cardiac glycosides at low potassium concentrations or high calcium concentrations.

Addition of potassium

In solutions for peritoneal dialysis, there is no potassium because of the risk of hyperkalemia. With a normal concentration of potassium in the blood serum or hypocalysmia, it may be necessary to add a potassium chloride solution to the drug (until a potassium concentration of 4 meq / l is reached) to prevent severe hypokalemia. The addition of potassium chloride can be carried out only after the doctor has prescribed a careful assessment of the potassium concentration in the blood serum and the total potassium concentration in the body.

Special studies to study the interaction with heparin and antibiotics have not been carried out. Research in vitro did not show incompatibility of heparin with the drug.

Addition of antibiotics

Research in vitro showed the stability of the following anti-infective drugs with the drug "Solution for peritoneal dialysis with glucose": amphogericin B, ampicillin, azlocillin. cefapyrine, csphazoline, cefepime, cefotaxime, ceftazidime, ceftriaxone, ciprofloxacin, clindamycn. cotrimoxazole, deferoxamine, erythromycin, gentamicin, linezolid, mezlocillin, miconazole, moxifloxacin, nafcillin, ofloxacin. penicillin G. piperacillin, teicoplanin. ticarcillip, tobramycin and vapcomycin. However, amnpoglycosides should not be mixed with penicillins due to chemical incompatibility.

Special instructions:

It is necessary to carefully monitor the state of the water balance and constantly monitor the patient's body weight in order to avoid the development of hyper- or gynohydration, which can lead to such severe consequences as congestive heart failure, decreased circulating blood volume and shock.

In patients with diabetes mellitus, when using peritoneal dialysis with solutions containing dextrose (glucose), the blood glucose concentration should be monitored and, if necessary, the dose of insulin or drugs used in hyperglycemia should be adjusted.

In the process of peritoneal dialysis, significant losses of protein, amino acids, water-soluble vitamins and medications can occur, which may require replacement therapy.

Encapsulating peritoneal sclerosis (IPS) is a known rare complication of peritoneal dialysis therapy. IPS was noted in patients using solutions for peritoneal dialysis, including "Solution for peritoneal dialysis with glucose". There are rare reports of fatal outcomes of IPS in patients who used the "Solution for peritoneal dialysis with glucose."

In case of development of peritonitis, the choice of antibiotics is carried out taking into account the isolated pathogen and its sensitivity, if possible. Prior to identifying the microorganism or microorganisms, broad-spectrum antibiotics can be prescribed. Solutions containing dextrose (glucose) should not be used in patients with corn allergies or corn processing products, since hypersensitivity reactions similar to allergic reactions to cornstarch, including anaphylactic / anaphylactoid reactions, may develop. If any signs or symptoms of a possible hypersensitivity reaction appear, stop the solution immediately and remove the solution from the abdominal cavity.Appropriate therapeutic measures should be taken in accordance with the clinical indicators of the patient's condition.

Patients with severe lactic acidosis should not be treated with solutions for peritoneal dialysis based on lactate (See section "Contraindications"). In patients with conditions that are known to increase the risk of developing lactate acidosis (eg, severe hypotension, or sepsis associated with acute renal failure, congenital metabolic disorders, treatment with drugs such as megformin and nucleoside / nucleotide reverse transcriptase inhibitors (PIOT )), it is necessary to monitor the occurrence of lactate acidosis before and during therapy with solutions for peritoneal dialysis based on lactate.

Excessive use of the drug "Solution for peritoneal dialysis with glucose" with a high content of glucose in the treatment of peritoneal dialysis can lead to a significant removal of fluid from the body.

In solutions for peritoneal dialysis, there is no potassium because of the risk of hypercalismia.

With a normal concentration of potassium in the blood serum or with hypokalemia,

It is necessary to add a solution of potassium chloride to the drug

(to achieve a potassium concentration of 4 meq / L) to prevent severe hypokalemia. The addition of potassium chloride can be carried out only after the doctor has prescribed a careful assessment of the potassium concentration in the blood serum and the total potassium concentration in the body.

The drug "Solution for peritoneal dialysis with glucose" can be used to control the concentrations of calcium and phosphate ions in the blood serum in patients with impaired renal function receiving calcium or magnesium-containing substances that bind phosphates.

In patients with gynecological incision, the use of solutions for peritoneal dialysis with a low calcium content should be considered. In patients receiving this solution, it is necessary to monitor the level of calcium in the blood for the timely detection of hypocalcemia or worsening of hypercalcemia. In these circumstances, the doctor should consider the possibility of adjusting doses of drugs that bind phosphates, vitamin analogues D and / or caliximetics.

Periodically, the concentration of blood plasma electrolytes (in particular, bicarbonates, potassium, magnesium, calcium and phosphates) should be checked, blood biochemical parameters (including the concentration of thyroid hormone vapor and lipid metabolism), and hematological parameters.

A significant excess of the amount of dialysate administered into the abdominal cavity may be manifested by abdominal swelling / swelling in the abdomen and / or dyspnea.

Therapy of a significant excess of the amount of the injected drug "Solution for peritoneal dialysis with glucose" consists in removing the solution from the abdominal cavity.

If the effluent becomes cloudy (leaky dialysate), if there is pain in the abdomen and when the body temperature rises, the dialysis procedure should be stopped immediately and consulted by the treating doctor.

Effect on the ability to drive transp. cf. and fur:

In patients with terminal stage of renal failure (TSPP). those who are on peritoneal dialysis may experience undesirable effects that may affect the ability to drive vehicles and mechanisms.

Form release / dosage:

The solution for peritoneal dialysis with glucose is 1.36%, 2.27%, 3.86% by 1000. 1500, 2000. 2500. 3000. 3500, 4000, 4500, 5000. 5500. 6000 ml is placed in a container (Clear-Flex), made of polyethylene, polyamide and polypropylene.

The container is equipped with injection and distribution ports, hermetically sealed caps (single container), or
The container is provided with an injection port, a hermetically sealed cap and a distribution port that is connected to an empty drainage bag by means of Y-shaped tube, terminated by the valve connection "Lusr" with a cap, the color of which corresponds to a certain concentration of glucose ("Twin Bag" system).

Single container or "Twin Bag" system is packed in an individual plastic bag. For 2, 4, 5 or 6 packages, together with the instructions for use, are placed in a cardboard box.

Packaging:Single container or "Twin Bag" system is packed in an individual plastic bag. For 2, 4, 5 or 6 packages, together with the instructions for use, are placed in a cardboard box.

Storage conditions:

Pat a temperature of 4 to 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N013324 / 01

Date of registration:19.11.2007

Date of cancellation:2017-07-25

The owner of the registration certificate:Bieffe Medital SpABieffe Medital SpA Italy

Manufacturer: & nbsp

BIEFFE MEDITAL, S.p.A. Italy

Representation: & nbspBaxter Baxter USA

Information update date: & nbsp25.07.2017

Illustrated instructions

Instructions

Solution for peritoneal dialysis with glucose (Peritoneal dialysis solution with glucose)