Physioneal 40 glucose (Solution) Instructions for Use

Marketing Authorization Holder

Baxter Healthcare, S.A. (Ireland)

ATC Code

B05D (Peritoneal dialysis solutions)

Dosage Forms

	Physioneal 40 glucose	Peritoneal dialysis solution with glucose 1.36%: 1500 ml, 2000 ml, 2500 ml, 3000 ml, or 5000 ml dual-chamber containers, 2, 3, 4, or 5 pcs.
		Peritoneal dialysis solution with glucose 2.27%: 1500 ml, 2000 ml, 2500 ml, 3000 ml, or 5000 ml dual-chamber containers, 2, 3, 4, or 5 pcs.
		Peritoneal dialysis solution with glucose 3.86%: 1500 ml, 2000 ml, 2500 ml, 3000 ml, or 5000 ml dual-chamber containers, 2, 3, 4, or 5 pcs.

Dosage Form, Packaging, and Composition

Peritoneal dialysis solution from light yellow to yellow, clear (small chamber “A”).

	1 L
Dextrose (as monohydrate)	37.5 g
Calcium chloride dihydrate	0.507 g
Magnesium chloride hexahydrate	0.14 g

Excipients: water for injections up to 1000 ml.

Peritoneal dialysis solution from light yellow to yellow, clear (large chamber “B”).

	1 L
Sodium chloride	8.43 g
Sodium bicarbonate	3.29 g
Sodium lactate	2.63 g

Excipients: water for injections up to 1000 ml.
Composition per 1000 ml of mixed solution (“A” and “B”):

	1 L
Dextrose (as monohydrate)	13.6 g
Sodium chloride	5.38 g
Calcium chloride dihydrate	0.184 g
Magnesium chloride hexahydrate	0.051 g
Sodium bicarbonate	2.1 g
Sodium lactate	1.68 g

Ionic composition of the mixed solution (“A” and “B”):

	1 L
Anhydrous glucose	75.5 mmol/L
Sodium	132 mmol/L
Calcium	1.25 mmol/L
Magnesium	0.25 mmol/L
Chloride	95 mmol/L
Bicarbonate	25 mmol/L
Lactate	15 mmol/L

Osmolarity of the final solution 344 mOsm/L.

1500 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (2) – cardboard boxes.
1500 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (3) – cardboard boxes.
1500 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (4) – cardboard boxes.
1500 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (5) – cardboard boxes.
2000 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (2) – cardboard boxes.
2000 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (3) – cardboard boxes.
2000 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (4) – cardboard boxes.
2000 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (5) – cardboard boxes.
2500 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (2) – cardboard boxes.
2500 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (3) – cardboard boxes.
2500 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (4) – cardboard boxes.
2500 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (5) – cardboard boxes.
3000 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (2) – cardboard boxes.
3000 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (3) – cardboard boxes.
3000 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (4) – cardboard boxes.
3000 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (5) – cardboard boxes.
5000 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (2) – cardboard boxes.
5000 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (3) – cardboard boxes.
5000 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (4) – cardboard boxes.
5000 ml – containers (1) dual-chamber PVC type “Single Bag” – PVC bags (5) – cardboard boxes.
1500 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (2) – cardboard boxes.
1500 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (3) – cardboard boxes.
1500 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (4) – cardboard boxes.
1500 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (5) – cardboard boxes.
2000 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (2) – cardboard boxes.
2000 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (3) – cardboard boxes.
2000 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (4) – cardboard boxes.
2000 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (5) – cardboard boxes.
2500 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (2) – cardboard boxes.
2500 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (3) – cardboard boxes.
2500 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (4) – cardboard boxes.
2500 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (5) – cardboard boxes.
3000 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (2) – cardboard boxes.
3000 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (3) – cardboard boxes.
3000 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (4) – cardboard boxes.
3000 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (5) – cardboard boxes.
5000 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (2) – cardboard boxes.
5000 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (3) – cardboard boxes.
5000 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (4) – cardboard boxes.
5000 ml – containers (1) dual-chamber PVC type “Twin Bag” – PVC bags (5) – cardboard boxes.

Peritoneal dialysis solution from light yellow to yellow, clear (small chamber “A”).

	1 L
Dextrose (as monohydrate)	62.6 g
Calcium chloride dihydrate	0.507 g
Magnesium chloride hexahydrate	0.14 g

Excipients: water for injections up to 1000 ml.

Peritoneal dialysis solution from light yellow to yellow, clear (large chamber “B”).

	1 L
Sodium chloride	8.43 g
Sodium bicarbonate	3.29 g
Sodium lactate	2.63 g

Excipients: water for injections up to 1000 ml.
Composition per 1000 ml of mixed solution (“A” and “B”):

	1 L
Dextrose (as monohydrate)	13.6 g
Sodium chloride	5.38 g
Calcium chloride dihydrate	0.184 g
Magnesium chloride hexahydrate	0.051 g
Sodium bicarbonate	2.1 g
Sodium lactate	1.68 g

Ionic composition of the mixed solution (“A” and “B”):

	1 L
Anhydrous glucose	126 mmol/L
Sodium	132 mmol/L
Calcium	1.25 mmol/L
Magnesium	0.25 mmol/L
Chloride	95 mmol/L
Bicarbonate	25 mmol/L
Lactate	15 mmol/L

Osmolarity of the final solution 395 mOsm/L.

Peritoneal dialysis solution from light yellow to yellow, clear (small chamber “A”).

	1 L
Dextrose (as monohydrate)	106.5 g
Calcium chloride dihydrate	0.507 g
Magnesium chloride hexahydrate	0.14 g

Excipients: water for injections up to 1000 ml.

Peritoneal dialysis solution from light yellow to yellow, clear (large chamber “B”).

	1 L
Sodium chloride	8.43 g
Sodium bicarbonate	3.29 g
Sodium lactate	2.63 g

Excipients: water for injections up to 1000 ml.
Composition per 1000 ml of mixed solution (“A” and “B”):

	1 L
Dextrose (as monohydrate)	38.6 g
Sodium chloride	5.38 g
Calcium chloride dihydrate	0.184 g
Magnesium chloride hexahydrate	0.051 g
Sodium bicarbonate	2.1 g
Sodium lactate	1.68 g

Ionic composition of the mixed solution (“A” and “B”):

	1 L
Anhydrous glucose	214 mmol/L
Sodium	132 mmol/L
Calcium	1.25 mmol/L
Magnesium	0.25 mmol/L
Chloride	95 mmol/L
Bicarbonate	25 mmol/L
Lactate	15 mmol/L

Osmolarity of the final solution 483 mOsm/L.

Clinical-Pharmacological Group

Solution for peritoneal dialysis

Pharmacotherapeutic Group

Solution for peritoneal dialysis

Pharmacological Action

Physioneal 40 glucose (hereinafter Physioneal 40) is a solution used for the procedure of peritoneal dialysis, which is necessary for patients with renal failure to remove toxic substances from the body that are formed during the metabolism of nitrogen-containing compounds and are normally excreted by the kidneys.

In addition, peritoneal dialysis maintains an adequate level of water, electrolyte and acid-base balance in these patients.

The peritoneal dialysis procedure is performed by introducing a dialysis solution through a catheter into the abdominal cavity. The glucose included in the solution makes it hyperosmolar relative to plasma, which creates an osmotic gradient that promotes the movement of toxic substances from the patient’s peritoneal capillaries into the dialysis solution.

After a certain exposure time, the solution becomes saturated with toxic substances, is then removed and replaced with a new one.

To maintain water-electrolyte and acid-base balance, the concentrations of electrolytes in the Physioneal 40 solution (with the exception of lactate, which is a precursor to bicarbonate) are selected in such a way as to bring the patient’s plasma electrolyte composition to normal values.

In vitro and ex vivo studies have demonstrated that the Physioneal 40 solution has higher biocompatibility compared to a standard lactate-buffered solution.

Furthermore, clinical studies conducted in a limited group of patients with abdominal pain occurring during the administration of dialysis solutions demonstrated some symptomatic advantages of Physioneal 40.

However, to date, there is no data indicating a reduction in the frequency of clinical complications or significant benefits during long-term use of such solutions.

Pharmacokinetics

Pharmacokinetic studies of the drug have not been conducted.

The glucose, electrolytes and water that are part of the Physioneal 40 solution are absorbed into the bloodstream and metabolized in the usual way, as they are normal components of the human body’s internal environment.

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

Indications

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

Acute or chronic renal failure;
Severe fluid retention;
Severe electrolyte balance disorders;
Poisoning by dialyzable drugs, if other therapeutic methods are unavailable.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
E87	Other disorders of fluid, electrolyte and acid-base balance
N17	Acute renal failure
N18	Chronic kidney disease
R60.9	Edema, unspecified
T36-T50	Poisoning by drugs, medicaments and biological substances (T36-T50)

ICD-11 code	Indication
5C7Z	Other disorders of fluid, electrolyte and acid-base balance
EF02.2	Lipedema
GB60.Z	Acute renal failure, unspecified stage
GB61.Z	Chronic kidney disease, unspecified stage
GB6Z	Renal failure, unspecified
MG29.Z	Edema, unspecified
NE60	Poisoning by drugs, medicaments or biological substances, not elsewhere classified
NE6Z	Harmful effect of unspecified substance

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

For intraperitoneal administration only.

Before use, the solution in the outer packaging can be heated to 37°C (98.6°F), which will make the dialysis procedure more comfortable for the patient.

Only dry heat (for example, a heating pad, mattress, heating plate) should be used for heating.

Solutions should not be heated in water or a microwave oven, as they may cause discomfort to the patient or lead to damage.

Do not use if the solution has changed color, become cloudy, contains mechanical inclusions, shows signs of leakage, or if the integrity of the packaging is compromised.

During the peritoneal dialysis procedure, aseptic rules must be observed.

To mix the solutions from chambers “A” and “B”, remove the outer packaging and immediately break the fragile inter-chamber plug.

Wait for the complete transfer of the solution from the upper chamber to the lower one.

Gently mix by pressing with both hands on the walls of the lower chamber.

The solution should be administered intraperitoneally no later than 24 hours after mixing.

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

For single use only.

Any unused solution residue should be destroyed.

Necessary medications should be administered through the medical port in the upper chamber before the inter-chamber plug is broken.

The compatibility of the drugs should be checked before mixing, taking into account the pH level and salt composition of the Physioneal 40 solution.

The solution should be used immediately after the administration of any medication.

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

Shortness of breath is possible.

Treatment: if an excessive volume of solution is administered, it is removed from the abdominal cavity at any time.

Dosing

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

Before starting continuous peritoneal dialysis at home, patients must undergo training in specialized dialysis centers.

Adult patients on continuous ambulatory peritoneal dialysis (CAPD) usually perform 4 cycles per day (24 hours).

Patients on automated peritoneal dialysis (APD) usually perform 4-5 cycles at 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 is usually from 2.0 to 2.5 liters.

Elderly patients the same as for adults.

During clinical trials, more than 30% of patients were over 65 years old.

Evaluation of the results obtained for these patient groups did not reveal any differences compared to the results for other age groups.

Pediatric patients (from newborns to 18 years of age). The efficacy and safety of Physioneal 40 in clinical studies in pediatric patients have not yet been studied.

In this regard, for this category of patients, it is necessary to compare the expected clinical benefit of using the drug and the risk of adverse reactions.

The recommended solution volume is from 800 to 1400 ml/m² per cycle, the maximum volume with good drug tolerance is 2000 ml/m².

For children under 2 years of age, a volume from 500 to 1000 ml/m² is recommended.

Adverse Reactions

This section presents adverse reactions that were considered to be associated either with the use of Physioneal 40 or with the peritoneal dialysis procedure.

Adverse reactions recorded during clinical trials are presented in the table.

Alkalosis was the most common (in approximately 10% of patients).

System-Organ Class	Preferred Term	Frequency
Benign, malignant and unspecified neoplasms (including cysts and polyps)	Benign neoplasms	Infrequent
Metabolism and nutrition disorders	Alkalosis Hypokalemia Fluid retention Hypercalcemia Hypervolemia Anorexia Dehydration Hyperglycemia Hyperphosphatemia Lactic acidosis	Frequent Frequent Frequent Frequent Infrequent Infrequent Infrequent Infrequent Infrequent Infrequent
Psychiatric disorders	Insomnia	Infrequent
Nervous system disorders	Dizziness Headache Muscle hypertonia	Infrequent Infrequent Infrequent
Cardiac disorders	Arrhythmia Cardiomegaly	Infrequent Infrequent
Vascular disorders	Increased blood pressure Decreased blood pressure	Frequent Infrequent
Respiratory, thoracic and mediastinal disorders	Dyspnea Cough Respiratory acidosis	Infrequent Infrequent Infrequent
Gastrointestinal disorders	Peritonitis Peritoneal injury Abdominal pain Dyspepsia Flatulence Nausea	Frequent Infrequent Infrequent Infrequent Infrequent Infrequent
Skin and subcutaneous tissue disorders	Pruritus	Frequent
General disorders and administration site conditions	Edema Asthenia Chills Facial edema Abdominal wall hernia Malaise Thirst	Frequent Frequent Infrequent Infrequent Infrequent Infrequent Infrequent
Injury, poisoning and procedural complications	Procedure-related complication	Infrequent
Investigations	Increased body weight Increased blood LDH activity Abnormal laboratory test results Increased PCO2 Increased ALT activity Increased C-reactive protein concentration Decreased renal creatinine clearance Increased GGT activity	Frequent Infrequent Infrequent Infrequent Infrequent Infrequent Infrequent Infrequent

* The frequency of adverse drug reactions was assessed using the following scale: very common (≥ 1/10), common (≥ 1/100 – <1/10), infrequent (≥ 1/1000 - <1/100), rare (≥ 1/10,000 - <1/1000) and very rare (< 1/10,000).

If any of the side effects mentioned in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Adverse reactions identified during post-marketing use

Infections and infestations bacterial peritonitis, catheter site infection.

Disorders of the blood and lymphatic system eosinophilia.

Gastrointestinal disorders sclerosing encapsulating peritonitis, cloudy peritoneal dialysate, abdominal discomfort.

Skin and subcutaneous tissue disorders angioedema, rash.

Musculoskeletal and connective tissue disorders musculoskeletal pain.

General disorders and administration site conditions catheter-related complications, hyperthermia.

Contraindications

There are no absolute contraindications to peritoneal dialysis, but special precautions should be taken in some conditions. These are the following conditions and diseases:

Hypersensitivity to the components of the drug;
Hypokalemia;
Cachexia;
Perforation of hollow organs of the abdominal cavity;
Conditions with possible impairment of the integrity of the peritoneum and/or diaphragm due to recent abdominal surgery, trauma, congenital anomaly;
Abdominal tumor;
Abdominal wall hernia;
Fecal fistula or colostomy;
Massive polycystic kidney disease;
Localized and diffuse peritonitis;
Closed trauma of the abdominal organs (except in cases where the risk outweighs the likely benefits of treatment), extensive adhesions in the abdominal cavity, as well as other diseases and conditions in which there is impaired integrity of the abdominal wall, abdominal skin or abdominal cavity;
Inflammatory bowel disease;
Abdominal wall infection;
Lung diseases (especially pneumonia);
Aortic segment replacement with a graft.

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

Use in Pregnancy and Lactation

There are no representative data on the use of Physioneal 40 during pregnancy and breastfeeding. Before prescribing the drug, the doctor must carefully assess the benefit-to-risk ratio for the mother and the potential risk to the fetus or child.

Use in Renal Impairment

In patients with renal failure, periodic studies of plasma bicarbonate and electrolyte concentrations (especially potassium, calcium and phosphorus), blood biochemical tests (including parathyroid hormone concentration), and routine hematological tests should be performed.

Pediatric Use

The efficacy and safety of Physioneal 40 in clinical studies in pediatric patients have not yet been studied.

In this regard, for this category of patients, it is necessary to compare the expected clinical benefit of using the drug and the risk of adverse reactions.

The recommended solution volume is from 800 to 1400 ml/m² per cycle, the maximum volume with good drug tolerance is 2000 ml/m².

For children under 2 years of age, a volume from 500 to 1000 ml/m² is recommended.

Geriatric Use

During clinical trials, more than 30% of patients were over 65 years old.

Evaluation of the results obtained for these patient groups did not reveal any differences compared to the results for other age groups.

Special Precautions

The patient’s water balance and weight should be carefully monitored to avoid the development of hyper- or hypohydration, leading to serious consequences in the form of chronic heart failure, decreased circulating blood volume and shock.

During peritoneal dialysis, losses of protein, amino acids, water-soluble vitamins and other substances are possible, which may require their additional administration.

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

In patients with a plasma bicarbonate concentration exceeding 30 mmol/l, the benefit of treatment with Physioneal 40 should be weighed against the possible risk of developing metabolic alkalosis.

Serum bicarbonate concentration should be constantly monitored.

In patients with secondary hyperparathyroidism, the benefits and risks of using dialysis solutions with low calcium content (including Physioneal 40 solution) should be weighed.

Encapsulating peritoneal sclerosis (EPS) is a rare complication of peritoneal dialysis.

There have been reports of EPS in patients using peritoneal dialysis solutions, including Physioneal 40.

In case of peritonitis development, the choice and dose of antibiotics should, if possible, be based on the results of pathogen identification and sensitivity testing.

Broad-spectrum antibiotics may be prescribed prior to the pathogen identification study.

Potential interaction between dialysis treatment and therapy for other existing diseases must be taken into account.

The serum potassium concentration of patients using cardiac glycosides should be carefully monitored.

In patients with diabetes mellitus and azotemia, careful monitoring of insulin requirements during and after dialysis with dextrose-containing solutions is necessary.

When an excessive volume of Physioneal 40 solution is introduced into the abdominal cavity, signs such as abdominal pain and bloating and/or difficulty breathing may occur.

Therapeutic measures in this case involve removing the solution from the abdominal cavity using drainage.

Excessive use of the Physioneal 40 peritoneal dialysis solution with increased dextrose (glucose) content during peritoneal dialysis treatment can lead to excessive removal of water from the patient’s body.

Potassium is excluded from the composition of the Physioneal 40 peritoneal dialysis solution to avoid the development of hyperkalemia.

In situations where there is a normal serum potassium concentration or hypokalemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia.

This should only be done under the guidance of a physician and after accurate determination of serum and total body potassium concentration.

Effect on ability to drive a car or operate machinery

It is not recommended to drive a car or operate machinery, as during peritoneal dialysis, patients with end-stage renal disease (ESRD) may experience adverse effects that negatively affect the ability to drive vehicles and operate machinery.

Overdose

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

The use of an excessive amount of Physioneal 40 peritoneal dialysis solution with a glucose content of 3.86% can lead to significant removal of water from the patient’s body.

Overdose treatment

Treatment of hypervolemia may involve the prescription of hypertonic peritoneal dialysis solutions and fluid restriction.

Treatment of hypovolemia may involve replenishing fluid losses orally or intravenously, depending on the degree of dehydration.

Electrolyte metabolism disorders require specific treatment for each individual case, confirmed by blood tests.

Hypokalemia, which is the most likely disorder, can be treated by oral potassium administration or by adding a potassium chloride solution to the peritoneal dialysis solution as prescribed by the attending physician.

Hyperglycemia (in patients with diabetes mellitus) should be treated by adjusting the insulin dose according to the insulin administration regimen prescribed by the attending physician.

Drug Interactions

Studies on the interaction of Physioneal 40 with other drugs have not been conducted.

During the peritoneal dialysis procedure, the blood concentration of drugs that are dialyzable may decrease.

The possibility of adjusting the dose of prescribed drugs, taking into account their losses during dialysis, should be taken into account.

The plasma potassium concentration of patients receiving cardiac glycoside therapy should be carefully monitored, as there is a risk of glycoside intoxication.

If necessary, potassium-containing drugs should be prescribed.

Pharmaceutical compatibility: insulin is compatible with Physionil 40 solution in a PVC container.

Storage Conditions

Store at a temperature not exceeding 25°C (77°F). Do not freeze. Keep out of reach of children.

Shelf Life

The shelf life is 2 years.

Dispensing Status

For hospital use only.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Medixlife (Author)

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