Dianil PD4 with glucose - instructions for use, doses, side effects, contraindications

Component	Dianil PD4 with glucose, g
Component	1,36%	2,27%	3,86%
Dextrose (glucose) monohydrate	15,0	25,0	42,5
(corresponds to dextrose (glucose) anhydrous)	(13,6)	(22,7)	(38,6)
Sodium chloride	5,38	5,38	5,38
Calcium chloride dihydrate	0,184	0,184	0,184
Magnesium chloride hexahydrate	0,051	0,051	0,051
Sodium lactate	4,48	4,48	4,48
Water for injections	up to 1000 ml

Ion content in mmol / l:

	Dianil PD4 with glucose, mmol / l
	1,36%	2,27%	3,86%
Sodium ion	132	132	132
Calcium ion	1,25	1,25	1,25
Magnesium ion	0,25	0,25	0,25
Chloride ion	95	95	95
Lactate Ion	40	40	40

	Dianil PD4 with glucose, mOsm / l
Osmolarity	1,36%	2,27%	3,86%
Osmolarity	344	395	483

Description:

Transparent liquid from light yellow to yellow.

Pharmacotherapeutic group:Solution for peritoneal dialysis

ATX: & nbsp

B.05.D Solutions for peritoneal dialysis

Pharmacodynamics:

For patients with renal insufficiency, peritoneal dialysis is a procedure that allows to remove from the body toxic substances formed during the metabolism of nitrogen-containing compounds and normally released by the kidneys, and also to maintain adequate regulation of water, electrolyte and acid-base balances.

This procedure is performed by introducing a solution for peritoneal dialysis into the abdominal cavity through a catheter. As a result of osmosis and diffusion through the peritoneum there is an exchange of substances between peritoneal capillaries and dialysis fluid.After a few hours of exposure, the solution is saturated with toxic substances, after which the solution must be replaced. With the exception of lactate, which is a precursor of bicarbonate, the electrolyte concentrations in the solution are chosen in such a way as to normalize the concentrations of electrolytes in the plasma. The nitrogen exchange products present in high concentrations in the blood pass through the peritoneum into the dialysis solution. Glucose makes the solution hyperosmolar with respect to plasma, creating an osmotic gradient that facilitates the passage of liquid from the plasma into a solution necessary to compensate for the excessive hydration encountered in patients with chronic renal insufficiency.

Pharmacokinetics:

Entered intraperitoneally, glucose is absorbed into the blood and metabolized in the usual way.

Indications:

Drug drug Dianil PD4 with glucose is indicated in cases when peritoneal dialysis is used:

acute and chronic renal failure;
heavy fluid retention;
at violations of the electrolyte balance;
when poisoning with drugs undergoing dialysis, if other more appropriate therapeutic methods are not available.

Drug drug Dianil PD4 with glucose can be used to control the concentration of calcium ions and phosphates in the blood serum in patients with impaired renal function receiving calcium or magnesium-containing substances that bind phosphates.

Contraindications:

The use of the drug Dianil PD4 with glucose is contraindicated under the following conditions:

- hypersensitivity to any of the components of the drug;

- in patients with a known allergy to corn or products from corn (dextrose (glucose) monohydrate is produced from hydrolysed corn starch);

- 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.

Carefully:

The procedure for peritoneal dialysis should be carried out with caution when:

violations of the integrity of the peritoneum or diaphragm due to surgery, trauma, congenital anomalies until the moment of complete healing, abdominal tumors,infection of the abdominal wall, hernia, fistula, colostomy or ileostomy, frequent episodes of diverticulitis, inflammatory or ischemic bowel diseases, large polycystic kidneys and other conditions associated with abdominal, abdominal or abdominal integrity disorders;
other conditions, including the recently transferred aortic prosthetics and severe pulmonary diseases.

Pregnancy and lactation:

Sufficient data for an unambiguous evaluation of the use of the drug Dianil PD4 with glucose in pregnancy and during breastfeeding are absent. Before using the drug Dianil PD4 with glucose during pregnancy and during breastfeeding, a thorough evaluation of the "benefit / risk" ratio for each particular patient should be made.

To decide on the appointment of peritoneal dialysis as one of the methods of treatment in late pregnancy, a thorough assessment of the relationship between the expected benefit and possible complications should be made.

Dosing and Administration:

Introduction

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

Do not use the solution if it is not clear, 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.

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

Doses

The type of therapy (intermittent peritoneal dialysis [IPD], continuous outpatient peritoneal dialysis [CAPD] or continuous cyclic peritoneal dialysis [PCPC]), the frequency of sessions, the volume of solution for one exchange session, the period of the solution in the abdominal cavity and the duration of dialysis should be determined by the responsible doctor , the management of each individual patient.

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. Dianil containing 3.86% glucose is a liquid with high osmotic pressure, and the use of this solution alone can cause dehydration.

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, a solution of Dianil with a glucose concentration of 1.36% or 2.27% is used. If additional volume of liquid is required, a solution of Dianil containing 3.86% glucose should be used. The need to remove excess fluid is judged by the weight of the patient's body.

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 500 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.

Contamination of the luer lock-in connector or disruption of the clamp-on sequence can lead to air entering the abdominal cavity and, as a result, pain in the abdominal region and / or peritonitis.

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.

For complete system preparation, refer to the instructions accompanying the accessories.

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 because of potential damage to the container, as well as causing harm or discomfort to the patient.

The container with the solution must be warm to the touch. The temperature above 45 ° C can change the composition of the solution. If a heating method is used that provides heating to temperatures above 45 ° C, the temperature of the container should often be checked by touch. Once the container is warm, it should be removed from the heat source.

Preparation for use

Collect the set.
Narrow out the outer bag longitudinally from the bottom and remove the container with the solution. The plastic may be cloudy due to the absorption of moisture during the sterilization process, which is normal and does not affect the quality and safety of the solution. The turbidity will gradually decrease.
If you need to add some medicine, follow the instructions below in preparation for use.
Place the container on the work surface.
Unscrew the highways.
Examine the patient connector to make sure that the exhaust ring is not attached to the connector.
Examine the mains and the drainage container for the presence of a solution in them.If the solution is found, the parts must be discarded. Note: small drops of solution are allowed.
Depress the container to check for leaks or broken brittle plugs. Pay attention to whether the jet of solution passes through the brittle plug. Do not use the solution if the container or brittle plug is leaking, as sterility may be impaired.

In case of need for additional administration of medicinal products E Inspect the container to make sure that the sealed rubber medical port is in place. Do not use if the rubber injection port is not attached to the container port.

Put on the mask.
Prepare the drug port in accordance with the rules of asepsis.
Using a 2.5 cm syringe, a 19-25 gauge needle, puncture the sealed injection canal and inject the medication.
Arrange the container so that the drug port is at the top. Squeeze and tap on the port to remove the solution. Mix the medicine and solution thoroughly by shaking the container.

Execution of the procedure

Put on the mask and wash your hands.
Make sure the transfer tube is closed.
Break the connector of the brittle plug (blue) by squeezing the tube over the top of the plug, bending it forward-backward until the plug breaks from the base. See Fig. 1 and 2.
Remove the exhaust ring from the patient connector.
Remove the locking cap from the patient's adapter tube and immediately attach the trunk to the patient connector by screwing it to the stop.
Squeeze the flow line of the solution.

Break the brittle plug (green) by squeezing the tube over the top of the plug and bending forward and back until its parts separate from each other.

See Fig. 3 and 4.

Hang a new container with a solution.
Place the drainage container below the abdominal level.
Open the valve of the adapter tube to remove the solution from the abdominal cavity. Caution: during the discharge of the solution, the fibrin strands can attach to the connector of the brittle plug.
Close the transfer tube valve after draining.
Open the current loop clamp and drain the new solution directly into the drain container for 5 seconds.
Squeeze the drain line.
Open the valve of the adapter tube and begin pouring the solution into the abdominal cavity.
Close the transfer tube valve after the solution is finished.
Prepare a new detachable cap.
Disconnect the patient's transfer tube from the container and attach the new cap to the adapter tube.

Side effects:

Adverse reactions presented in this section are associated either with the use of the drug Dianil PD4 with glucose, or with the procedure of peritoneal dialysis.

The undesirable reactions that occurred in patients on the background of the use of the drug Dianil PD4 with glucose during clinical trials and during post-exposure monitoring are presented below.

Adverse reactions occurring more often than in isolated cases are listed in according to the following gradation: very frequent (> 10%); frequent (> 1% and <10%); infrequent (> 0.1% and <1%); rare (> 0.01% and <0.1%); very rare (<0.01%) frequency unknown (the frequency can not be established based on the available data).

System-Organ Class	Unwanted reaction	Frequency
Disorders from the metabolism and nutrition	Hypokalemia Fluid retention Hypervolaemia Hypovolemia Hyponatremia Dehydration Hypochloremia	Frequency unknown
Vascular disorders	Increased blood pressure Lowering blood pressure	Frequency unknown
Disturbances from the respiratory system, chest and mediastinal organs	Dyspnea	Frequency unknown
Disorders from the gastrointestinal tract	Sclerosing encapsulating peritonitis Peritonitis Muddy peritoneal effluent Vomiting Diarrhea Nausea Constipation Abdominal pain Bloating Abdominal discomfort	Frequency unknown
Disturbances from the skin and subcutaneous tissues	Stevens-Johnson Syndrome Hives Rash (including itching, erythematous and generalized) Itching	Frequency unknown

System-Organ Class

Unwanted reaction

Frequency

Disturbances from the musculoskeletal system and connective tissue

Myalgia

Muscle spasms Musculoskeletal pain

Frequency unknown

General disorders and disorders at the site of administration

Generalized edema

Temperature increase

Malaise

Pain at the injection site

Frequency unknown

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.

The physician should instruct the patient about the need to report all cases of aggravation of the side effects indicated in the instructions for use, as well as the occurrence of any undesirable phenomena not listed in the instructions.

Overdose:

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

Excessive administration of a solution of Dianil 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 disorders is carried out in accordance with the type of electrolyte disorder established in the analysis of blood. The most likely violation is hypokalemia. 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 receiving insulin or oral medication, when using peritoneal dialysis with a solution Dianil should monitor the concentration of glucose in the blood plasmaand adjust the dose of insulin or oral medications if necessary.

Interaction:

Some medications may be incompatible with the drug Dianil PD4 with glucose. Before adding drugs, you should read the instructions for use on this drug. Studies on the interaction of a solution for peritoneal dialysis Dianil 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. For example, rapid removal of potassium can cause arrhythmias in patients receiving cardiac glycoside preparations; manifestations of digitalis intoxication may be masked by elevated levels of potassium or magnesium or hypocalcemia.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.

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. 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.

Research in vitro showed the stability of the following anti-infectious drugs with the drug Dianil PD4 with glucose: amphotericin B, ampicillin, azlocillin, cefapyrine, cefazolin, cefepine, cefotaxime, ceftazidime, ceftriaxone, ciprofloxacin, clindamycin, co-trimoxazole, deferoxamine, erythromycin, gentamicin, linezolid, mezlocillin, miconazole, moxifloxacin, nafcillin, ofloxacin, penicillin G, piperacillin, teicoplanin, ticarcillin, tobramycin 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. if necessary, adjust the dose of insulin or medications. used in hyperglycemia.

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 who used solutions for peritoneal dialysis, including Dianil PD4 with glucose. There are rare reports of fatal outcomes of IPS in patients who applied Dianil PD4 solution with glucose.

When the effluent clouding (caring dialysate) becomes cloudy, with the appearance of pain in the abdomen and with an increase in body temperature, the dialysis procedure should be stopped immediately and consult a doctor.

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 depending on 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 Dianil PD4 with glucose solution for peritoneal dialysis 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 the potassium concentration is reached 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.

In patients with hypercalcemia should consider the use of a solution of Dianil PD4 with glucose as a solution for peritoneal dialysis with a low calcium content. In patients receiving such a 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 physician should consider the possibility of correcting doses of drugs that bind phosphates, vitamin D analogues and / or calcimimetics. Periodically, the concentration of plasma electrolytes (in particular, bicarbonates, potassium, magnesium, calcium and phosphates) should be checked, blood biochemical parameters (including thyroid hormone vapor concentration and lipid profile parameters), 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 drug administered Dianil PD4 with glucose is to remove the solution from the abdominal cavity.

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

Patients with end-stage renal failure (PDSS) who are on peritoneal dialysis may experience undesirable effects that may affect the ability to drive vehicles and mechanisms (eg, malaise or hypovolemia).

Form release / dosage:

Solution for peritoneal dialysis with glucose, 1.36%, 2.27%, 3.86%.

Packaging:

Solution for peritoneal dialysis with glucose, 1.36%, 2.27%, 3.86% in plastic bags "Viflex", made from PVC 250 ml, 500 ml, 750 ml, 1000 ml, 1500 ml, 2000 ml, 2500 ml, 3000 ml, 5000 ml. Package "Vifaflex" as an individual container or as part of a unified system "Twin Bag" factory way connected with Y tube and an empty drainage container. Individual package and "Twin Bag" system are hermetically packed in a protective plastic bag.

For 1,2, 3, 4, 5, 6 packages together with instructions for use in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years. Use until the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N013842 / 01

Date of registration:15.07.2008 / 25.04.2013

Expiration Date:Unlimited

The owner of the registration certificate:Baxter Khelskea SABaxter Khelskea SA Ireland

Manufacturer: & nbsp

BAXTER HEALTHCARE, S.A. Ireland

Representation: & nbspBaxter Baxter USA

Information update date: & nbsp26.09.2014

Illustrated instructions

Instructions

Dianil PD4 with glucose (Dianeal PD4 with Glucose)