Balance 4.25% glucose 1.25 mmol/l calcium

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BALANCE 4.25% GLUCOSE, 1.25 mmol/L CALCIUM

Composition:

Active substances:

calcium chloride dihydrate; sodium chloride; sodium (S)-lactate solution (sodium (S)-lactate); magnesium chloride hexahydrate; glucose monohydrate (anhydrous glucose).

"Balance 4.25% glucose, 1.25 mmol/l calcium" is supplied in a two-chamber bag. One chamber contains an alkaline lactate solution, and the other chamber contains a glucose-based electrolyte solution. Mixing of the solutions from both chambers occurs by opening the middle seal between the two chambers, resulting in a neutral ready-to-use solution.

Before mixing

1 litre of acidic glucose-based electrolyte solution contains:

Calcium chloride dihydrate	0.3675 g
Sodium chloride	11.279 g
Magnesium chloride hexahydrate	0.2033 g
Glucose monohydrate (anhydrous glucose)	93.5 g (85.0 g)

1 liter of alkaline lactate solution contains:

sodium (S)-lactate solution 15.69 g
(sodium (S)-lactate 7.85 g)

After mixing

1 liter of neutral, ready-to-use solution contains:

Calcium chloride dihydrate	0.1838 g
Sodium chloride	5.640 g
Sodium (S)-lactate solution (sodium (S)-lactate)	7.85 g (3.925 g)
Magnesium chloride hexahydrate	0.1017 g
Glucose monohydrate (anhydrous glucose)	46.75 g (42.5 g)

Ca2+	1.25 mmol
Na+	134 mmol
Mg2+	0.5 mmol
Cl-	100.5 mmol
(S)-lactate	35 mmol
Glucose	235.8 mmol

Excipients: water for injections, hydrochloric acid, sodium hydroxide, sodium bicarbonate.

Dosage form. Solution for peritoneal dialysis.

Main physicochemical properties: a two-chamber bag containing a clear, colorless aqueous solution.

Ready-to-use solution:

Theoretical osmolarity	509 mOsm/L
pH ≈	7.0

Pharmacotherapeutic group.

Dialysis solution for peritoneal dialysis. Hyperosmolar solutions.

ATC code B05D B.

Pharmacological properties.

Pharmacodynamics.

"Balance 4.25% glucose 1.25 mmol/l calcium" is an electrolyte solution containing glucose and a lactate buffer, intended for intraperitoneal administration in the treatment of end-stage renal failure of various etiologies by continuous ambulatory peritoneal dialysis (CAPD).

A characteristic feature of CAPD is the more or less constant presence of approximately 2 liters of dialysis solution in the peritoneal cavity, which is replaced with fresh solution 3 to 5 times daily.

The fundamental principle of any peritoneal dialysis method is the use of the peritoneum as a semipermeable membrane, allowing exchange of dissolved substances and water between blood and dialysis solution by diffusion and convection according to their physicochemical properties.

The electrolyte profile of the solution is essentially similar to that of physiological serum, although it has been adapted (e.g., potassium content) for use in patients with uremia, aiming at replacement therapy of renal function through exchange between the contents of the peritoneal cavity and fluid.

The calcium concentration in this dialysis solution is 1.25 mmol/l, which reduces the risk of hypercalcemia when used concomitantly with calcium-containing phosphate binders and/or vitamin D.

Substances normally excreted in urine, such as urea, creatinine, inorganic phosphates, uric acid, other dissolved substances, and water, are removed from the body into the dialysis solution. Fluid balance can be maintained by using solutions with different glucose concentrations, influencing fluid removal (ultrafiltration).

Secondary metabolic acidosis due to end-stage renal failure is compensated by the presence of lactate in the dialysis solution. Lactate is completely metabolized to bicarbonate.

Pharmacokinetics.

Uremic substances (e.g., urea, creatinine, and uric acid), inorganic phosphates, and electrolytes such as sodium, potassium, calcium, and magnesium are removed from the body into the dialysis solution by diffusion and/or convection.

Glucose in the dialysate is used as an osmotic agent in the "Balance 4.25% glucose 1.25 mmol/l calcium" solution. It is slowly absorbed, reducing the diffusion gradient between the dialysis solution and extracellular fluid. Ultrafiltration is greatest at the beginning of the dwell time and reaches its maximum approximately 2–3 hours after instillation. Subsequently, progressive loss of ultrafiltrate occurs as absorption begins.

After 4 hours, the volume of ultrafiltrate averages 100 ml for the 1.5% glucose solution, 400 ml for the 2.3% glucose solution, and 800 ml for the 4.25% glucose solution. During six hours of dialysis, 60 to 80% of the dialysate glucose is absorbed.

Lactate, used as a buffer agent, is almost completely absorbed within 6 hours of dwell time. In patients with normal liver function, rapid metabolism of lactate is confirmed by normal levels of intermediate metabolites.

Calcium transfer depends on the glucose concentration in the dialysis solution, the volume of drained dialysate, and the serum ionized calcium concentration and calcium concentration in the dialysis solution. The higher the glucose concentration, the volume of drained dialysate, and the serum calcium concentration, and the lower the calcium concentration in the dialysis solution, the greater the calcium removal from the patient's body into the dialysate.

In a typical CAPD regimen, it is expected that 3 exchanges with 1.5% glucose and 1 exchange with 4.25% glucose containing calcium at a concentration of 1.25 mmol/l are used daily. Thus, up to 160 mg of calcium is removed per day, allowing for higher oral intake of calcium-containing medications and vitamin D without risk of hypercalcemia.

Preclinical safety data.

Preclinical studies on the toxicity of "Balance 4.25% glucose 1.25 mmol/l calcium" solution have not been conducted. The electrolytes and glucose contained in the medicinal product are physiological components of human blood plasma. Therefore, toxic effects are not expected when dosage and administration recommendations are followed according to the indications and contraindications.

Clinical characteristics.

Indications.

Terminal (decompensated) stage of chronic renal failure of various etiologies, requiring treatment with peritoneal dialysis.

Contraindications.

For use of this peritoneal dialysis solution

"Balance 4.25% glucose 1.25 mmol/l calcium" must not be used in patients with lactic acidosis, severe hypokalemia, severe hypocalcemia, hypovolemia, and arterial hypotension.

For peritoneal dialysis in general

Peritoneal dialysis must not be used in the following cases:

• Recent surgery or trauma to the abdominal cavity, history of abdominal surgery with development of fibrous adhesions, severe abdominal burns, perforation of the peritoneum;
• Extensive inflammatory skin lesions of the abdominal area (dermatitis);
• Inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticulitis);
• Peritonitis;
• Internal or external abdominal fistula;
• Umbilical, inguinal, or other abdominal wall hernia;
• Intraperitoneal tumors;
• Ileus;
• Lung diseases (particularly pneumonia);
• Sepsis;
• Severe hyperlipidemia;
• Specific cases of uremia unresponsive to peritoneal dialysis;
• Cachexia and significant weight loss, especially if adequate dietary protein intake cannot be ensured;
• Physical or mental inability of the patient to undergo peritoneal dialysis treatment and comply with physician instructions.

If any of the above conditions develop during peritoneal dialysis treatment, the physician must make a decision regarding further management.

Special precautions.

Before using the peritoneal dialysis solution "Balance 4.25% glucose 1.25 mmol/l calcium", it is mandatory to read the medical instruction leaflet.

• The patient should keep this medical instruction leaflet for the medicinal product to be able to reread it as needed.
• If the patient has any questions, they should consult their physician or pharmacist.
• This medicinal product is prescribed for a specific individual patient only and must not be transferred to another patient with similar symptoms to avoid causing harm.
• If any adverse reaction becomes serious or if the patient notices any adverse reactions not listed in this leaflet, they must immediately inform their physician or pharmacist.

Special precautions for handling unused medicinal product

No special requirements for disposal.

For single use only. Any unused solution remaining must be discarded.

Interaction with other medicinal products and other types of interactions.

The use of this peritoneal dialysis solution may reduce the efficacy of other medicinal products, as they may diffuse into the dialysate and be removed from the body along with it. In such cases, dose adjustment may be required.

Significant reduction in serum potassium levels may increase the frequency of digoxin-related adverse reactions. Potassium levels must be monitored particularly carefully when concomitant therapy with cardiac glycosides is administered (see section "Special precautions for use").

The use of diuretics may be beneficial in maintaining residual diuresis; however, it may simultaneously lead to disturbances in water-electrolyte balance.

For patients with diabetes mellitus, daily insulin or oral hypoglycemic agent dosage must be adjusted to account for the increased glucose load.

Special precautions for use.

The peritoneal dialysis solution must not be administered intravenously.

The "Balance 4.25% glucose 1.25 mmol/l calcium" solution may be used after careful assessment of the benefit/risk ratio in the following cases:

• in hyperparathyroidism: therapy should include administration of calcium-containing phosphate binders and/or vitamin D to ensure adequate enteral calcium intake;
• in hypocalcemia: use of a peritoneal dialysis solution with a higher calcium concentration may be necessary, temporarily or permanently, if administration of calcium-containing phosphate binders and/or vitamin D to ensure adequate enteral calcium intake is not feasible;
• in electrolyte loss due to vomiting and/or diarrhea: temporary substitution with a peritoneal dialysis solution containing potassium may be required;
• in patients receiving cardiac glycoside therapy: continuous monitoring of serum potassium levels is mandatory (see section "Interaction with other medicinal products and other forms of interaction"). In case of severe hypokalemia, use of a dialysis solution containing potassium and consultation with a dietitian may be necessary;
• in extensive renal polycystic disease.

During peritoneal dialysis, loss of proteins, amino acids, and water-soluble vitamins occurs. To prevent their deficiency, appropriate dietary intake or nutritional supplements should be ensured.

During prolonged peritoneal dialysis, transport characteristics of the peritoneal membrane may change, primarily indicated by absence of ultrafiltration. In severe cases, peritoneal dialysis should be discontinued and hemodialysis initiated.

The following parameters should be continuously monitored:

• body weight – to detect early signs of hyperhydration or dehydration;
• serum concentrations of sodium, potassium, calcium, magnesium, phosphates, acid-base balance, blood gases, and blood proteins;
• serum concentrations of creatinine and urea;
• parathyroid hormone levels and other indicators of bone metabolism;
• blood glucose levels;
• residual kidney function – to adapt peritoneal dialysis treatment.

Effluent fluid clarity and volume should be monitored. Cloudiness of the fluid and/or abdominal pain may indicate development of peritonitis.

Encapsulating peritoneal sclerosis is considered a known rare complication of peritoneal dialysis therapy, which may rarely lead to fatal outcomes.

Elderly patients

Consideration should be given to the frequent occurrence of hernias in elderly patients before initiating peritoneal dialysis.

Use during pregnancy or breastfeeding.

Pregnancy

Data on the use of "Balance" solutions in pregnant women are limited. Data from animal studies are insufficient (see section "Preclinical safety data"). The peritoneanl dialysis solution should be used during pregnancy only after careful evaluation of the potential benefit versus potential risks and complications for both mother and fetus.

Breastfeeding

Components of the "Balance" solution are excreted in human milk. However, with adequate therapy, no adverse effects in the infant are expected. The necessity of temporarily discontinuing breastfeeding should be considered, taking into account the benefit of breastfeeding for the infant and the therapeutic benefit for the mother.

Reproductive function

There are no clinical data on the effect on reproductive function. However, during therapeutic use, no effect on reproductive function is expected.

Ability to influence the speed of reactions when driving or operating machinery.

"Balance 4.25% glucose 1.25 mmol/l calcium" has no effect or has a negligible effect on the ability to drive or operate machinery.

Method of Administration and Dosage

This solution is intended exclusively for intraperitoneal use.

The treatment regimen, frequency of exchanges, and dwell time are determined by the physician.

Continuous Ambulatory Peritoneal Dialysis (CAPD)

• Adults: In the absence of other prescriptions, patients are usually prescribed 2000 mL of solution per exchange, performed four times daily. After the dwell time of 2 to 10 hours, the solution is drained.

The dosage, volume of solution, and number of exchanges must be individually adjusted for each patient.

If pain occurs at the initiation of peritoneal dialysis, temporarily reduce the volume per exchange to 500–1500 mL.

In patients with excess body weight or those with lost residual renal function, the dialysis solution volume should be increased. For such patients, or those who tolerate large fill volumes well, the volume per exchange may be increased to 2500–3000 mL.

• Children: For pediatric patients, the volume per exchange should be based on age and body surface area (BSA).

The initial volume per exchange should not exceed 600–800 mL/m² BSA, with 4 (sometimes 3 or 5) exchanges per day. The volume may be increased up to 1000–1200 mL/m² BSA depending on tolerance, age, and residual renal function.

Automated Peritoneal Dialysis (APD)

When performing intermittent or continuous cyclic peritoneal dialysis using a machine (Sleep•Safe – cycler), it is recommended to use larger-volume bags to allow multiple solution exchanges. Solution exchanges are performed according to the medical prescription stored in the cycler.

• Adults: Patients typically spend 8–10 hours on the nighttime cycle. Fill volumes range from 1500 to 3000 mL, with 3 to 10 cycles per night. The total volume used is usually 10–18 L, but may range from 6 to 30 L. Cyclic therapy at night is generally combined with 1 or 2 daytime exchanges.
• Children: The volume per exchange should be 800–1000 mL/m² BSA with 5–10 exchanges per night. This may be increased up to 1400 mL/m² BSA depending on tolerance, age, and residual renal function.
• Elderly patients: No specific dosage recommendations exist for elderly patients.

Peritoneal dialysis solutions with high glucose concentration (2.3% or 4.25%) are used when the patient's body weight exceeds the desired dry weight. Fluid removal from the body increases with higher glucose concentration in the dialysis solution. These solutions should be used with caution to protect the peritoneal membrane, prevent dehydration, and maintain glucose load at the lowest possible level.

Peritoneal dialysis is a long-term therapy requiring regular use of individual solution bags.

«Balance 4.25% glucose 1.25 mmol/L calcium» contains 42.5 g of glucose per 1000 mL of solution.

Method and Duration of Procedure

Before performing peritoneal dialysis at home, the patient must undergo appropriate training, practice the technique, and achieve adequate proficiency. Training must be conducted by qualified personnel. Before discharging a patient for home peritoneal dialysis, the physician must ensure that the patient has mastered the procedure. In case of any problems or uncertainties, consult the physician.

Dialysis using prescribed doses should be performed daily and continued as long as renal replacement therapy is considered necessary.

Continuous Ambulatory Peritoneal Dialysis (CAPD): Stay•Safe bag

The solution bag should be warmed in advance to body temperature. The prescribed dose is infused through the peritoneal catheter into the abdominal cavity over 5–20 minutes. According to the physician's recommendations, the solution should remain in the abdominal cavity for 2–10 hours (dwell time), after which it is drained.

Automated Peritoneal Dialysis (APD): Sleep•Safe bag

To initiate the treatment procedure, insert the Sleep•Safe connectors of the system with the prescribed solution into the empty ports of the cycler tray; they will then automatically connect to the Sleep•Safe tubing sets of the cycler system. The cycler checks the solution bag barcodes and sounds an alarm if there is a discrepancy with the prescription stored in the cycler's memory. After this verification, connect the system tubing to the patient's catheter extension set to begin the procedure. The cycler automatically heats the Sleep•Safe solution to body temperature throughout the infusion period. The dwell time and glucose concentration selection are determined according to the medical prescriptions stored in the cycler's memory (details are provided in the Sleep•Safe cycler user manual).

Depending on the required osmotic pressure, «Balance 4.25% glucose 1.25 mmol/L calcium» may be used sequentially with other peritoneal dialysis solutions with lower glucose content (i.e., lower osmolarity).

Stay•Safe system for Continuous Ambulatory Peritoneal Dialysis (CAPD)

The solution bag is warmed in advance to body temperature. Bags with a volume up to 3000 mL should be warmed using an appropriate heater. The warming time for a 2000 mL bag with an initial temperature of 22°C is approximately 120 minutes. Automatic temperature control is set at 39°C ± 1°C. More detailed information can be found in the heater's user manual. Avoid using a microwave oven to prevent local overheating.

1. Solution Preparation

Inspect the appearance of the warmed solution bag (label, expiry date, solution clarity, integrity of the bag, absence of damage to the outer protective bag and integrity of the seal). Place the bag on a firm surface.

Open the outer protective bag and the disinfectant cap packaging. Wash hands using an antimicrobial cleansing agent. Twist the bag, lying on the foil of the outer packaging, at one of the side corners until the central seal opens. The solutions from the two chambers will then mix automatically. Next, twist the bag from the upper edge of the chamber containing the ready solution until the lower triangular seal is fully opened. Ensure all seals are completely open.

Verify that the solution is clear and the bag is not leaking.

1. Bag Replacement Preparation

Secure the bag in the upper ring of the infusion stand, unroll the main line of the solution bag and place the DISC into the organizer. Then unroll the main line of the drainage bag and secure the drainage bag in the lower ring of the infusion stand. Place the catheter connector into one of the two openings of the organizer. Place a new disinfection cap into the other free opening of the organizer. Disinfect hands and then remove the protective cap from the DISC. Connect the catheter connector to the DISC.

1. Drainage.

Open the catheter extension clamp. The drainage procedure has started. Switch position «●»

1. Rinsing.

After completion of the drainage procedure, flush the line by draining a small amount of fresh solution into the drainage bag (approximately for 5 seconds). Switch position «●●»

1. Fill.

The fill procedure begins after setting the control switch to position «○ ●»

1. Safety measures.

After inserting the PIN into the catheter connector, the lumen of the catheter extension automatically closes. Switch position «●●●●»

1. Disconnection.

Remove the protective cap from the new disinfection cap and screw it onto the old cap. Disconnect the catheter connector from the DISC, then screw the catheter connector onto the new disinfection cap.

1. Closing the DISC.

Close the DISC using the open end of the previously used protective cap, which remained in the right opening of the organizer.

1. Check the spent dialysate for clarity and weight. If the drained solution is clear, it should be disposed of properly.

Close•safe system for automated peritoneal dialysis (APD)

(for instructions on setting up the close•safe system, see the user manual)

3000 ml close•safe system:

1. Solution preparation: see stay•safe system.
2. Unroll the bag tubing.
3. Remove the protective cap.
4. Insert the bag connector into the free port of the close•safe cycler tray.
5. The bag is ready for use with the close•safe cycler system.

5000 ml close•safe system:

1. Solution preparation.

Check the appearance of the solution bag (label, expiry date, solution clarity, bag integrity, absence of damage to the outer protective bag and integrity of the seal). Place the bag on a firm surface. Open the outer wrapping of the bag. Wash hands using an antimicrobial cleaning agent. Unroll the central seal and the bag connector. Roll up the bag lying on the wrapping, starting from the end opposite the connector located diagonally, until the central seal opens. Continue rolling until the seal on the small chamber opens.

Ensure that all seals are fully open. Confirm that the solution is clear and the bag is not leaking.

1. Unroll the bag tubing.
2. Remove the protective cap.
3. Insert the bag connector into the free port of the close•safe cycler tray.
4. The bag is ready for use with the close•safe set.

Handling (method of use)

The prepared solution must be used immediately. If this is not possible, use no later than 24 hours after mixing (see also section «Expiry date»).

The plastic packaging may occasionally be damaged during transport or storage, which may lead to contamination and increased microbial growth in the dialysis solution. Therefore, the entire packaging must be carefully inspected for damage before connecting the bag and using the solution for peritoneal dialysis. Pay attention to any damage, even minor, to connectors, body, seams, or corners of the bag to prevent contamination.

Never use damaged bags or bags containing cloudy solution.

The peritoneal dialysis solution may be used only if it is clear and the container is undamaged.

The outer protective bag should be opened immediately before use. Do not use two-chamber solutions without mixing.

To reduce the risk of infection during dialysate exchange, maintain sterile conditions.

Addition of drugs to peritoneal dialysis solution

The medicinal product «Balance 4.25% glucose 1.25 mmol/l calcium» due to the risk of incompatibility and contamination may be mixed only with the following medicinal products in appropriate concentrations and as prescribed by a physician: heparin 1000 IU/l, insulin 20 IU/l, vancomycin 1000 mg/l, teicoplanin 400 mg/l, cefazolin 500 mg/l, ceftazidime 250 mg/l, gentamicin 8 mg/l. Medicinal products must be added under sterile conditions and only as prescribed by a physician. After thorough mixing and checking for absence of cloudiness and foreign particles, the peritoneal dialysis solution must be used immediately (do not store).

Children.

For children, the exchange solution volume should be prescribed according to age and body surface area (BSA).

Overdose.

No incidents related to overdose have been reported.

Excess dialysis solution introduced into the abdominal cavity can be easily drained into the drainage bag. However, if bag exchanges were performed very frequently, dehydration and/or electrolyte imbalance may develop, requiring immediate medical intervention. If an exchange was missed, contact a physician or the appropriate dialysis center.

Incorrect dosing may lead to hyper- or dehydration and electrolyte imbalances.

The most likely consequence of overdose with «Balance 4.25% glucose 1.25 mmol/l calcium» is dehydration.

Insufficient dosage, interruption, or discontinuation of treatment may lead to life-threatening hyperhydration with peripheral edema and cardiac decompensation and/or other symptoms of uremia, which may be life-threatening.

Standard emergency care and intensive therapy protocols must be applied. The patient may require immediate hemodialysis.

Adverse reactions

"Balance 4.25% glucose 1.25 mmol/l calcium" is an electrolyte solution with a composition similar to the electrolyte composition of blood. The solution also has a neutral pH, similar to the physiological pH value.

Adverse reactions may result from the peritoneal dialysis procedure as a method or may be caused by this specific solution.

The frequency of adverse reactions is defined as follows:

very common	(≥ 1/10)
common	(≥ 1/100 to < 1/10)
uncommon	(≥ 1/1000 to < 1/100)
rare	(≥ 1/10 000 to < 1/1000)
very rare	(< 1/10 000)
not known	(cannot be estimated from available data)

Potential adverse reactions associated with peritoneal dialysis solution

Endocrine system disorders:

• Secondary hyperparathyroidism with possible disturbances in bone metabolism (unknown frequency).

Metabolism and nutrition disorders:

• Increased blood sugar levels (common);
• Hyperlipidemia (common);
• Weight gain due to prolonged glucose absorption from the peritoneal dialysis solution (common).

Cardiac disorders:

• Tachycardia (uncommon);
• Hypotension (uncommon);
• Hypertension (uncommon).

Respiratory, thoracic and mediastinal disorders:

• Dyspnea (uncommon).

Renal and urinary system disorders:

• Electrolyte imbalance, e.g., hypokalemia (very common);
• Hypocalcemia (uncommon).

General disorders:

• Dizziness (uncommon);
• Edema (uncommon);
• Fluid imbalance (uncommon), indicated by rapid weight loss (dehydration) or weight gain (hyperhydration). Severe dehydration may occur when using solutions with high glucose concentration.

Potential adverse reactions associated with the peritoneal dialysis procedure

Infections and infestations:

• Peritonitis (very common), indicated by cloudy effluent dialysate. Abdominal pain, fever, and general malaise may subsequently develop, or, in very rare cases, sepsis. The patient must seek immediate medical attention. The bag containing the cloudy dialysate should be sealed with a sterile cap and submitted for microbiological examination and leukocyte count in blood;
• Skin infections and tunnel infections (very common).

In case of skin infection, prompt consultation with the treating physician is required;

• Sepsis (very rare).

Respiratory, thoracic and mediastinal disorders:

• Shoulder pain (common);
• Dyspnea caused by diaphragmatic elevation (unknown frequency).

Gastrointestinal disorders:

• Hernias (very common);
• Abdominal distension and sensation of fullness (common);
• Diarrhea (uncommon);
• Constipation (uncommon);
• Encapsulating peritoneal sclerosis (unknown frequency).

General disorders and catheter exit-site reactions:

• Redness, swelling, discharge, crust formation, and pain at the catheter exit site (very common);
• Procedure-related complications during dialysis solution infusion and drainage (common);
• General weakness (unknown frequency).

Reporting suspected adverse reactions

Reporting suspected adverse reactions after marketing authorization is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and their legal representatives should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

Shelf life of the product in the original retail packaging – 2 years.

Ready-to-use solution without addition of other medicinal products: chemical and physical stability is maintained for 24 hours after opening the package when stored at 20 °C.

Storage conditions.

Store at temperatures not below 4 °C.

Keep out of reach of children.

Incompatibilities.

The medicinal product should be used only as prescribed by a physician to avoid risks of incompatibility and contamination.

The medicinal product must not be mixed with other medicinal products except those specified in this medical instruction.

Packaging.

2000 ml or 2500 ml in a dual-chamber stay•safe bag system; 4 bags per cardboard box with a label in Ukrainian or labeled in Ukrainian and other languages;

3000 ml in a dual-chamber sleep•safe bag system; 4 bags per cardboard box with a label in Ukrainian or labeled in Ukrainian and other languages;

5000 ml in a dual-chamber sleep•safe bag system; 2 bags per cardboard box with a label in Ukrainian or labeled in Ukrainian and other languages.

Prescription status.

Prescription only.

Manufacturer.

Fresenius Medical Care Deutschland GmbH / Fresenius Medical Care Deutschland GmbH.

Manufacturer's address and place of business.

Frankfurter Strasse 6-8, 66606 St. Wendel, Germany / Frankfurter Strasse 6-8, 66606 St. Wendel, Germany.

Marketing Authorization Holder.

Fresenius Medical Care Deutschland GmbH / Fresenius Medical Care Deutschland GmbH.

Address of the Marketing Authorization Holder.

Else-Kroener-Str. 1, 61352 Bad Homburg v.d.H., Germany / Else-Kroener-Str. 1, 61352 Bad Homburg v.d.H., Germany.

Address of the Marketing Authorization Holder's Representative: LLC "Fresenius Medical Care Ukraine", 9 Borispilska Street, Kyiv, 02099, Ukraine.