Fizionil 40 with glucose - instructions for use, dose, side effects, contraindications

Components	Physionyl 40 with glucose, g
	1,36%	2,27%	3,86%
Active components
Dextrose (glucose) monohydrate	41,25	68,85	117,14
[equivalent to dextrose (glucose)
anhydrous]	(37,5)	(62,6)	(106,5)
Calcium chloride dihydrate	0,507	0,507	0,507
Magnesium chloride hexahydrate	0,140	0,140	0,140
Auxiliary components
Water for injections	up to 1000 ml

1000 ml of buffer solution (large chamber "B") contain:

Components	Physionyl 40 with glucose, g
Components	1,36%	2,27%	3,86%
Active components
Sodium chloride	8,43	8,43	8,43
Sodium bicarbonate	3,29	3,29	3,29
Sodium lactate	2,63	2,63	2,63
Auxiliary components

1000 ml of a mixed solution ("L" and "B") contain:

Components	Physionyl 40 with glucose, g
	1,36%	2,27%	3,86%
Active components
Dextrose (glucose) monohydrate	15,0	25,0	42,5
[equivalent to dextrose (glucose)
anhydrous]	(13,6)	(22,7)	(38,6)
11 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 bicarbonate	2,10	2,10	2,10
Sodium lactate	1.68	1,68	1,68
Auxiliary components
Water for injections	up to 1000 ml

Water for injections up to 1000 ml

1000 ml of the final solution obtained after mixing the contents of chambers "L" and "B" contain 362.5 ml of solution "A" and 637.5 ml of solution "B". The pH of the final solution is 7.4.

Ionic composition of the final solution after mixing:

	Physionyl 40 with glucose, mmol / L
	1,36%	2,27%	3,86%
Glucose anhydrous	75,5	126	214
(C6H1206)
Sodium	132	132	132
Calcium	1,25	1,25	1,25
Magnesium	0,25	0,25	0,25
Chloride	95	95	95
Hydrogen carbonate	25	25	25
Lactate	15	15	15

Osmolarity of the final solution Physiopolil 40 with glucose after mixing:

1,36%	2,27%	3,86%
344 mOsm / l	395 mOsm / l	483 mOsm / l

Description:

Transparent solution from light yellow to yellow.

Pharmacotherapeutic group:Solution for peritoneal dialysis.

ATX: & nbsp

B.05.D Solutions for peritoneal dialysis

Pharmacodynamics:

Physionyl 40 with glucose (hereinafter, "Physionyl 40") is a solution used for the procedure of peritoneal dialysis, which is necessary for patients with renal insufficiency to remove from the body toxic substances that are formed in the process of metabolism of nitrogen-containing compounds and released under normal kidney conditions. In addition, peritoneal dialysis maintains in these patients at an adequate level of water, electrolyte and acid-base balance.

The procedure for peritoneal dialysis is performed by injecting a dialysis solution through a catheter into the abdominal cavity. The glucose in the solution makes it hyperosmolar with respect to the plasma, thereby creating an osmotic gradient that facilitates the movement of toxic substances from the capillaries of the peritoneum of the patient to the dialysis solution.After a certain exposure time, the solution is saturated with toxic substances, then removed and replaced with a new one.

In order to maintain the electrolyte electrolyte and acid-base balance of the electrolytes in the solution, Physionyl 40 (with the exception of lactate, which is a precursor of bicarbonate) was selected in such a way as to bring the electrolyte composition of the patient's plasma to normal values.

Research in vitro and ex vivo demonstrated that the Physionyl 40 solution had a higher attainability in comparison with the standard lactate buffer solution. In addition, clinical studies performed in a limited group of patients with abdominal pains arising during the administration of dialysis solutions demonstrated some symptomatic benefits of Physionyl 40. However, to date, there is no evidence that a reduction in the incidence of clinical complications or significant benefits in the process prolonged use of such solutions.

Pharmacokinetics:

Pharmacokinetic studies of the drug were not conducted.Included in the solution of Fiznonil 40 glucose, electrolytes and water are absorbed into the bloodstream and metabolite from the usual way, as they are normal components

internal environment of the human body.

Glucose is metabolized (1 g glucose = 4 kcal or 17 kJ) to carbon dioxide and water.

Indications:

For peritoneal dialysis (especially those patients in whom administration of solutions with lactate buffer and low pH causes discomfort or abdominal pain) with:

acute or chronic renal failure;
heavy fluid retention;
pronounced violations of the electrolyte balance;
poisoning with drugs undergoing dialysis, if other therapeutic methods are not available.

Contraindications:

Hypersensitivity to the components of the drug, indicated in the section "Composition"; hypokalemia; cachexia; perforation of the hollow organs of the abdominal cavity; condition with possible violation of the integrity of the peritoneum and / or diaphragm due to a recent surgery on the abdominal cavity, trauma, congenital anomaly; swelling of the abdominal cavity; a hernia of the abdominal wall; fecal fistula or colostomy; massive polycystic lesionskidney; localized and diffuse peritonitis; closed trauma of the abdominal organs (except when the risk exceeds the likely benefits of treatment), extensive adhesion in the abdominal cavity, as well as other diseases and conditions in which there is a broken integrity of the abdominal wall, abdominal skin or abdominal cavity: inflammatory bowel diseases; infection of the abdominal wall; lung disease (especially pneumonia); replacement of aorta by graft; use in patients with a history of severe severe allergies to cornstarch or cornstarch products.

Carefully:

Care should be taken when using the drug in patients suffering from blindness, tetraplegia, arthritis (severe course), mental retardation, psychosis, hyperlipidemia.

Pregnancy and lactation:

Application during pregnancy and during breastfeeding

Representative data on the use of the preparation Physionyl 40 during pregnancy and during breastfeeding are absent. Prior to prescribing, the physician should carefully evaluate the ratio of benefit to the mother and the potential risk to the fetus or child individually, depending on the clinical situation.

Breastfeeding period

It is not known whether the preparation Physionyl 40 penetrates into breast milk. Risk for newborns and infants can not be ruled out. It is necessary to assess the need to stop breastfeeding or stop using Physionyl 40. Considering the benefits of breastfeeding for a child and the benefits of therapy for the mother.

Dosing and Administration:

Subscription

The type of therapy, the frequency of therapy sessions, the volume of the solution administered, the duration of exposure and the duration of dialysis are determined by the physician.

Prior to the initiation of permanent peritoneal dialysis at home, patients should be trained in specialized dialysis centers.

Adult patients on a permanent outpatient peritoneal dialysis (PAND), usually 4 cycles per day (24 hours). Patients on automatic peritoneal dialysis (APD) 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 body surface area and, as a rule, is from 2.0 to 2.5 liters.

Elderly patients: the same as in adults.In clinical trials, more than 30% of patients were older than 65 years. Evaluation of the results obtained for these groups of patients did not reveal any differences compared to the results for other age groups.

Patients of childhood (from newborns to 18 years of age). The efficacy and safety of the preparation Physionyl 40 in clinical studies in pediatric patients has not yet been studied. In this regard, in this category of patients it is necessary to compare the expected clinical benefit of the drug and

risk of unwanted reactions. For children over 2 years of age, the recommended solution is 800 to 1400 ml / m 2² per cycle, the maximum volume with good tolerability of the drug - 2000 ml / m². Children under the age of 2 recommended the volume of 200 to 1000 ml / m².

Introduction

Precautions to be taken before applying the drug Only for intraperitoneal administration

Before use, the solution in the outer packaging can be heated to 37 ° C. which will make the procedure of dialysis more comfortable for the patient. Use only dry heat for heating (for example.mattress, heating plate). Solutions should not be heated in water or a microwave oven, as they can cause discomfort or damage to the patient.
Do not use if the solution has changed color, clouded, contains mechanical inclusions, shows signs of leakage between cameras or to external medium or if the integrity of the package is compromised.
During the procedure, peritoneal dialysis should follow the rules of asepsis.
In order to mix solutions from chambers "A" and "B", it is necessary to remove the outer packaging and immediately break the fragile inter-chamber plug. Wait until the solution flows from the upper chamber to the lower one. Gently mix by pressing both hands against the walls of the lower chamber. The solution should be administered intraperitoneal not later than 24 hours after mixing.
Dialysate should be checked for fibrin or turbidity, which may indicate the presence of peritonitis.
Only for single use.
The unused solution should be discarded.
The necessary medications should be injected through the medical port in the upper chamber before the inter-chamber plug is broken.It is necessary to check the compatibility of the preparations before mixing, taking into account the pH level and salt composition of the solution Physionyl 40. The solution should be used immediately after administration of any drug.
To prevent the risk of severe dehydration, hypovolemia and to minimize protein loss, 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.

- Possible shortness of breath. Treatment: when an excess volume of solution is administered, ci'o removal from the abdomen at any time.

Side effects:

This section presents unwanted reactions that were regarded as associated with either the use of Physionyl 40. or with peritoneal dialysis. Unwanted reactions recorded during clinical studies are given in the table. The most common alkalosis (about 10% of patients).

System-Organ Class	Preferred term	Frequency
Benign,	Benign	Infrequent
malignant	neoplasms
unspecified
neoplasms (including
cysts and polyps)
1 (crooks from the side	Eosnophilia	No frequency information
blood and lymphatic
systems
Infringements from	Alkalosis	Frequent
metabolism and nutrition	Hypokalemia	Frequent
	Hyperhydration	Frequent
	Hypercalcemia	Frequent
	Hypervolaemia	Frequent
	Anorexia	Infrequent
	Dehydration	Infrequent
	Hyperglycaemia	Infrequent
	Hnperphosphates	Infrequent
	Lactoacndosis	Infrequent
		Infrequent
Disorders of the psyche	Insomnia	Infrequent
Infringements from	Dizziness	Infrequent

nervous system	Headache Muscle hypertension	Infrequent Infrequent
Infringements from	Arrhythmia	Infrequent
hearts	Cardiomegaly	Infrequent
Infringements from	Increased blood pressure	Frequent
vessels	pressures
	Reduction of blood pressure	Infrequent
Infringements from	Dyspnea	Infrequent
respiratory system.	Cough	Infrequent
organs of the chest and with pleasure	Respiratory acidosis	Infrequent
Infringements from	Peritonitis	Frequent
gastrointestinalintestinal	Peritoneal injury	Infrequent
tract	Abdominal pain	Infrequent
	Dyspepsia	Infrequent
	Flatulence	Infrequent
	Nausea	Infrequent
	Sclerotic encapsulating peritonitis	No frequency information
	Mutated peritoneal exudate	No frequency information
Infringements from	Itching	Frequent
skin and subcutaneous tissue	Edema Quincke	No frequency data is available
	Rash	frequency information
Disturbances from musculoskeletal and connective tissue	Musculoskeletal pain	No frequency information
General disorders and	Edema	Frequent
violations at the site of administration	Asthenia	Frequent
	Chills	Infrequent
	Edema of the face	Nechayetis
	Herniated abdominal wall	Infrequent

	Malaise	Infrequent
	Thirst	Infrequent
	Fever	11et information about the frequency
Injuries, intoxications and	Complication caused by	11th
complications of manipulation	procedure
Laboratory and	Weight gain	Frequent
instrumental data	Increased activity
	lactate dehydrogenase	Infrequent
	Deviation from the norm of laboratory resultsth researches	Infrequent
	Increase in PCA	Infrequent
	Increased activity
	alannna.minotransfsrazy	Infrequent
	Increase in concentration
	C-reactive protein	Inaccuracy
	Decreased renal function
	creatinine clearance	Infrequent
	Increased activity
	gamma glutamyl transferase	Infrequent

* The frequency of adverse drug reactions was assessed using the following scale: very frequent (> 1/10), frequent (> 1/100 - <1/10), infrequent (> 1/1000 - <1/100). rare (> 1/10 000 - <1/1000), very rare (<1/10 000) and no frequency data (can not be determined from available data).

If any of the side effects indicated in the manual are aggravated or you notice any other side effects not listed in the instructions, inform your doctor.

Undesirable reactions identified during the post-gland application Infections and invasions: bacterial peritonitis, infection at the site of the catheter. Disorders from the circulatory and lymphatic systems: eosinophilia.

Disorders from the digestive system: sclerosing encapsulating peritonitis, turbid peritoneal dialysate, abdominal discomfort.

Disturbances from the skin and subcutaneous tissues: Quincke's edema, rashes.

Disorders from the musculoskeletal system and connective tissue: musculoskeletal pain.

General disorders and disorders and site of administration: complications associated with catheter, hyperthermia.

Overdose:

Consequences of a possible overdose may be hypervolemia, gppovolemia, electrolyte metabolism disorders or hyperglycemia (in patients with diabetes mellitus).Using an excess amount of peritoneal dialysis solution Physiospil 40 with a glucose content of 3.86% can lead to significant removal of water from the patient's body.

Treatment of overdose

Treatment of hypervosmia can consist in the appointment of hypertonic solutions for peritoneal dialysis and the restriction of fluid intake. Treatment of hypovolemia can consist in the compensation of fluid loss orally or intravenously, depending on the degree of dehydration. Disorders of electrolyte metabolism require specific treatment for each individual case, confirmed by blood analysis. Giookalemia, which is the most likely disorder, can be treated by administration to potassium or by adding a solution of potassium chloride to the solution for peritoneal dialysis in accordance with the prescription of the attending physician.

Hyperglycemia (in diabetic patients) should be treated by adjusting the dose of insulin in accordance with the prescribed insulin delivery schedule.

Interaction:

Studies on the interaction of the preparation Physionyl 40 with other drugs have not been conducted.During the peritoneal dialysis procedure, it is possible to reduce the concentration in the blood of drugs undergoing dialysis. It is necessary to take into account the possibility of correcting the dose of prescription drugs taking into account their losses during dialysis. It is necessary to carefully monitor the concentration of potassium in the blood plasma of patients receiving cardiac glycosides, since there is a risk of developing glkokozidnon intoxication. If necessary, calneous preparations should be prescribed.

Pharmaceutical Compatibility: Insulin is compatible with a solution of Physionyl 40 in a PVC container.

Special instructions:

Care should be taken to monitor the water balance and body weight of the patient in order to avoid the development of hyperhidrosis, leading to severe consequences in the form of chronic heart failure, a decrease in the volume of circulating blood and shock.

When carrying out peritoneal dialysis, protein, amino acid, water-soluble vitamins and other substances may be lost, which may require additional administration.

In patients with renal insufficiency, the concentration of plasma electrolytes (especially, hydrocarbonates, potassium, magnesium, calcium and phosphates) should be periodically monitored;biochemical blood test (including parathyroid hormone concentration and lipid content), as well as routine hematological studies. 11The correct fixation or sequence of actions during the procedure can lead to air entering the peritoneal cavity and, as a result, to pain in the abdominal area and / or peritonitis.

In patients with diabetes mellitus, the concentration of blood glucose should be monitored and the dose of insulin or other hypoglycemic agents should be adjusted accordingly.

In patients with plasma concentrations of hydroxy carboiate in excess of 30 mmol / L, the benefits of treatment with Fionion 40 should be compared and the possible risk of developing metabolic alkalosis. It is necessary to constantly monitor the concentration of hydrocortic acid in the blood serum.

In patients with secondary hypernarathyroidism, the benefit and risk of dialysis solutions with a low calcium content (1.25 mmol / l), including the solution of Fsionyl 40, should be weighed, since the use of the drug may exacerbate the disease.

Encapsulating peritoneal sclerosis (IPS) is a rare complication of peritoneal dialysis.There have been reports of IPS cases in patients who used solutions for peritoneal dialysis, including Fsionyl 40.

14 In case of development of peritonitis, the choice and dose of antibiotics should, if possible, be based on the results of identification of the pathogen and the study of its sensitivity. Before carrying out the investigation but identifying the causative agent, antibiotics of a wide spectrum of action may be prescribed.

Solutions containing glucose should not be used in patients with a history of severe allergies to cornstarch or cornstarch products. Hypersensitivity reactions associated with allergy tocorn starch, including anaphylactoid reactions / anaphylactoid shock. If a suspected development of a hypersensitivity reaction is suspected, the solution should be immediately discontinued and the solution removed from the abdominal cavity and the necessary countermeasures should be taken according to the clinical indications.

Patients with increased lactate concentration should be cautiously administered lactate-containing solutions for peritoneal dialysis.

In patients with conditions associated with an increased risk of lactacidosis (e.g., severe hypotension or sepsis, which can be associated with acute renal insufficiency, congenital anomalies matabolizma treatment drugs, such as metformnn and nucleoside / nucleotide reverse transcriptase inhibitors), Before or during the treatment with lactate-containing solutions for peritoneal dialysis, careful monitoring is required for the occurrence of lactate acidosis.

It is necessary to take into account the potential interaction between dialysis treatment and therapy directed at other available diseases. It is necessary to carefully monitor the potassium concentration in the blood serum of patients using cardiac glycosides.

In patients with diabetes and azotemia should be closely monitored in the need for insulin during and after dialysis, held dextrose-soderzhattsimi solutions.

When administered into the abdominal cavity of an excessive volume Fizionil 40 possible features such solution as abdominal pain and bloating and / or difficulty in breathing.

Therapeutic measures in this case consist in removing the solution from the abdominal cavity by means of drainage.

Excessive use of a solution for peritoneal dialysis Physionyl 40 with a high content of dextrose (glucose) during treatment with peritoneal dialysis can lead to excessive removal of water from the patient's body.

Potassium is excluded from the solution for peritoneal dialysis Physionyl 40 in order to avoid the development of hypercalcemia. In situations in which there is a normal concentration of potassium in the blood serum or gynocalpemnia. can be shown the addition of potassium chloride (up to a concentration of 4 meq / L) to prevent severe hypokalemia. This should be done only under the guidance of a doctor and after an accurate determination of the potassium concentration in the blood serum and in the body as a whole. The efficacy and safety of the drug in children is not studied. Clinical data on the effect on fertility are not available.

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

It is not recommended to operate the car or other mechanisms, since during peritoneal dialysis in patients with terminal stage of renal failure (TSPN), undesirable effects may occur,negatively affecting the ability to drive vehicles and perform other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:Solution for peritoneal dialysis.

Packaging:

A solution for peritoneal dialysis [with glucose 1.36%, 2.27%, 3.86%] with a total volume of 1500 ml, 2000 ml, 2500 ml, 3000 ml or 5000 ml is placed in a small and large chamber of a two-chamber container made of PVC , interconnected by a tube-partition, which is destroyed at the moment of mixing the contents of the chambers.

The container is equipped with two tubes, one of which is the injection port, is located in the upper part of the small chamber: the other - the straight tube is located in the lower part of the large chamber and has a connection "Lyuer" (single "Single Yog" container) or
The container is equipped with a tube-injection port located in the upper part of the small chamber and a system of supply pipes connected to an empty drainage package through Y-shaped tube that has a Lueur or Spike connection (the "Twin Bag" system).

Single container "Single Bag" or "Twin Bag" system is hermetically packed in an individual package of G1VX.For 2, 3, 4 or 5 packs, together with the instructions for use are placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiration date

Terms of leave from pharmacies:For hospitals

Registration number:LS-002443

Date of registration:22.02.2012

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: & nbsp22.02.2012

Illustrated instructions

Instructions

Physionyl 40 with glucose (Physioneal 40 Glucose)