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

Ingredients		amount, g / l
A ctive and 1 you and her you	Formula 13	Formula 15	Formula 14
Glucose (dextrose) monohydrate [that	15.0	25,0	42,50
corresponds to glucose (dextrose) anhydrous \|	13,6	22,7	38,6
Sodium chloride	5,67	5.67	5,67
1 (atrium lactate	3,92	3,92	3,92
Calcium chloride dihydrate	0,18	0,18	0,18
Magnesium chloride hexahydrate	0,15	0,15	0.15
Auxiliary Ingredients
Water for injections	up to 1 liter

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

	Formula 13	Formula 15	Formula 14
1 'of the lyukose	1,36%	2,27 %	3,86 %
Sodium ion (meq / L)	132,0	132,0	132.0
Calcium ion (meq / L)	2,50	2,50	2,50
Magnesium ion (meq / L)	1.50	1,50	1,50
Chloride ion (meq / L)	101,0	101,0	101,0
Lactate ion (meq / L)	35,0	35,0	35,0

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

	Formula 13	Formula 15	Formula 14
1 lyukose	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)	1,25	1,25	1,25

Magnesium ion (mmol / L)	0,75	0,75	0,75
Chloride ion (mmol / L)	101,0	101,0	101,0
Lactate ion (mmol / L)	35,0	35,0	35.0

Osmolarity:

"1,36 %"- 345,68 mOsmol / l ± 5%;

"2,27 %" - 396,1 mOsmol / l ± 5 %;

"3,86 %" - 484,4 mOsmol / l ± 5%.

Description:

Transparent, colorless or from 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, ai-yerogine 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 medicinal preparation "Solution for peritoneal dialysis with glucose and low calcium content" 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 and low calcium content" 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: The gipokalismii perforations of hollow organs of the abdominal cavity and peritoneal integrity violations peritoneum or diaphragm due to recent surgery until complete healing not diagnose diseases of the abdominal cavity, abdominal tumors, localized or diffuse peritonitis, closed trauma of abdominal organs (except cases where the likely benefits of treatment exceed the risk of the drug),inflammatory or ischemic diseases of the intestine, intestinal obstruction, hernia, severe lung diseases (especially with pneumonia), infectious skin diseases, II and III trimester of pregnancy, cachexia, hypoproteinemia.

Carefully:

The procedure for peritoneal dialysis should be performed with caution in tetraplegia, 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 and low calcium" 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, so the risk for newborns and infants can not be ruled out.

The decision to terminate breast-feeding or discontinuation of therapy nursing mother drug "solution for peritoneal dialysis with glucose and low calcium content" should be made by the attending physician taking into account the benefits of breastfeeding for the child and the benefit 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 leakproofness of the package has been 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. "Solution for peritoneal dialysis with glucose and low calcium", containing 3.86% glucose, is a liquid with high osmotic pressure, and the use of this solution alone can cause dehydration (See section "Special instructions").

To prevent the risk of severe dehydration, hypovolemia 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 and low calcium" with a glucose concentration of 1.36% or 2.27%. If additional volume of fluid is required, a solution for peritoneal dialysis with glucose and low calcium content 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 (carer's dialysate) should be checked for fibrin or turbidity, which may indicate the presence of peritonitis.

Doses

Type of therapy (intermittent peritoneal dialysis [SDI |. continuous ambulatory peritoneal dialysis [CAPD] or permanent cyclic peritoneal dialysis [CCPD]), the frequency of sessions, the solution volume for a single session

exchange, the residence time of the solution in the abdominal cavity and the duration of dialysis depend on from individual needs of the patient and should be appointed and monitored by the attending physician.

Adults

Patients on continuous outpatient peritoneal dialysis (PAND) usually perform 4 cycles per day (24 h). Patients on automatic peritoneal dialysis usually spend 4-5 cycles of night and up to 2 cycles during the day. The volume of 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 of age, 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 ns should be heated in the microwave oven due to the potential damage to the container, as well as causing harm or discomfort to the patient.

Side effects:

The adverse reactions presented in this section,either with the use of the drug "Solution for peritoneal dialysis with glucose and low calcium", or with the procedure of peritoneal dialysis. Unwanted drug reactions (PLR) recorded during the post-registration use of the drug are grouped according to systems and organs in accordance with 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 frequency data (can not be determined based on available data).

System-Organ Class	Unwanted reaction	Frequency
Disorders from the metabolism and nutrition	Hypokalismia Fluid retention (hyperhydration) Ginsrvosmia Hypovolemia Hyponatremia Dehydration Gynohloremia Hypoproteinemia Violation of acid-base balance	no data on the frequency
Vascular disorders	Increased blood pressure Lowering blood pressure	no frequency data
Disturbances from the respiratory system, chest and mediastinal organs	Dyspnea	no frequency data
Disorders from the gastrointestinal tract	Sclerosing encapsulating peritonitis Peritonitis Mutnye ieritoneal effluent (outflowing dialysate) Vomiting Diarrhea Nausea Constipation Abdominal pain	no frequency data

System-Organ Class	Unwanted reaction	Frequency
	Bloating Abdom Inal discomfort
Disturbances 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 Muscular spasms Osteo-muscular pain Seizures	no frequency data
General disorders and disorders at the site of administration	Generalized edema Temperature increase Malaise Pain at the injection site	no frequency data

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 improperly performed procedure of 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 listed in the manual are aggravated, or if you notice any other side effects not listed 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 and low calcium", containing 3.86% glucose, can cause severe dehydration.

Treatment of overdose

Measures in the case of hypervolemia 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 gynokalemia. 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 when used with peritoneal dialysis drug "Solution for peritoneal dialysis, containing glucose and low calcium" should monitor the glucose concentration in the blood plasma and to adjust the dose of insulin or other drugs for the treatment of hyperglycemia, if necessary.

Interaction:

Some drugs may not be compatible with the drug "Solution for peritoneal dialysis, containing glucose and low calcium content." Before adding medications, you should read the instructions for usea 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 and low calcium" 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 conduct careful monitoring of the potassium concentration, calcium and magnesium in blood plasma in patients receiving cardiac glycosides. in connection with the existing risk of intoxication with cardiac glycosides. You may need to administer potassium. For example, rapid removal of potassium can cause arrhythmias in patients receiving cardiac glycoside preparations; manifestations of digitalis intoxication may be masked by elevated potassium or magnesium levels or by giocalciemia.Correction of electrolyte balance by dialysis can exacerbate signs and symptoms of intoxication with cardiac glycosides. Conversely, 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. At a normal concentration of kachpy in the blood serum or with hypokalemia, 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 on the interaction with heparin and antibiotics were 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-infectious drugs with the drug "Solution forperitoneal dialysis with glucose and low calcium ": amphotericin B. ampicillin, azlocillin, cefapyrine, cefazolin, cefepime. cefotaxime. ceftazidime. ceftriaxone, ciprofloxacip, clnndamycin, co-trimoxazole, deferoxamine, erythromycin, gentamicin, linezolid, mezlocillin, miconazole, moxifloxacin, nafcillin. ofloxacin. penicillin G. Piperacillin, teicoplapine, ticarcillin, gobramycin and vancomycin. However, aminoglycosides 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 body weight of the patient in order to avoid the development of hyper- or hypohydration, 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 and low calcium content." There are rare reports of fatal outcomes of IPS in patients who used the "Solution for peritoneal dialysis with glucose and low calcium content."

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 maize 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 "Contraindications") In patients with conditions known to increase the risk of developing lactate acidosis (eg, severe hypotension, or sepsis, associated with acute renal failure, congenital metabolic disorders, treatment with such drugs as metformin and nucleoside / nucleotide reverse transcriptase inhibitors (NRTIs)), 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 and low calcium" with a high glucose content

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 hyperkalemia.

With a normal concentration of potassium in the blood serum or with hypokalemia, it may be necessary to add a solution of potassium chloride 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.

The drug "Solution for peritoneal dialysis with glucose and low calcium content" 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 gynecalcemia, the use of solutions for peritoneal dialysis with a low calcium content should be considered. In patients receiving such a solution, it is necessary to monitor the level of calcium in the blood for the timely detection of piukalcismia or worsening of gynecalcemia.In these circumstances, the physician should consider the possibility of correcting doses of drugs that bind phosphate, analogues of vitamin A D and / or calcimimetics.

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

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

Therapy of a significant excess of the amount of the injected drug "Solution for peritoneal dialysis with glucose and low calcium content" is to remove the solution from the abdominal cavity.

If the effluent is clouding (the guarding 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:

Patients with terminal stage of renal failure (PSS) who are on peritoneal dialysis may experience undesirable effects that may to influence the ability to manage vehicles and mechanisms.

Form release / dosage:

Solution for peritoneal dialysis with glucose, 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 "Lyuer" 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. By 2. 4. 5 or 6 packets, together with instructions for use, are placed in a cardboard box.

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

Storage conditions:

At a temperature of 4 to 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the packaging.

Terms of leave from pharmacies:On prescription

Registration number:П N013325 / 01

Date of registration:17.03.2008

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: & nbsp15.04.2015

Illustrated instructions

Instructions

Solution for peritoneal dialysis with glucose and low calcium content (Peritoneal dialysis solution low calcium with glucose)