Balance 1.5% glucose 1.25 mmol/l calcium

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Balance 1.5% 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 1.5% glucose, 1.25 mmol/l calcium" is supplied in a dual-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.

Prior to 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)	33.0 g (30.0 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)	16.5 g (15.0 g)

Ca2+	1.25 mmol
Na+	134 mmol
Mg2+	0.5 mmol
Cl-	100.5 mmol
(S)-lactate	35 mmol
Glucose	83.2 mmol

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

Dosage form. Solution for peritoneal dialysis.

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

Ready-to-use solution:

Theoretical osmolarity	356 mOsm/L
pH ≈	7.0

Pharmacotherapeutic group.

Peritoneal dialysis solution. Hypertonic solutions.

ATC code B05D B.

Pharmacological Properties

Pharmacodynamics

"Balance 1.5% 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 exchanged 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 via 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 uremic patients to perform 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, which influence fluid removal (ultrafiltration).

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

Pharmacokinetics

Uremic waste products (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 via diffusion and/or convection.

The glucose in the dialysate is used as an osmotic agent in the "Balance 1.5% 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 exposure and reaches its maximum after approximately 2–3 hours. Subsequently, progressive loss of ultrafiltrate occurs during the absorption phase.

After 4 hours, the average ultrafiltrate volume is 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 practically completely absorbed within 6 hours of dwell time. In patients with normal liver function, rapid lactate metabolism is confirmed by normal levels of intermediate metabolites.

Calcium transfer depends on the glucose concentration in the dialysis solution, the volume of dialysate drained, and the ionized calcium in serum and the 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.

With a typical CAPD regimen using 3 exchanges of 1.5% glucose and 1 exchange of 4.25% glucose with calcium at a concentration of 1.25 mmol/l, up to 160 mg of calcium is removed per day. This allows for higher oral intake of calcium-containing medications and vitamin D without risk of hypercalcemia.

Preclinical Safety Data

Preclinical toxicity studies of the "Balance 1.5% 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, taking into account 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 1.5% glucose 1.25 mmol/l calcium" must not be used in patients with lactic acidosis, severe hypokalemia, and severe hypocalcemia.

For peritoneal dialysis in general

Peritoneal dialysis must not be used in the following cases:

• recent abdominal surgery or trauma, history of abdominal operations 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;
• intra-abdominal tumors;
• ileus;
• lung diseases (particularly pneumonia);
• sepsis;
• severe hyperlipidemia;
• specific cases of uremia unresponsive to peritoneal dialysis treatment;
• cachexia and significant weight loss, especially if adequate dietary protein intake cannot be ensured;
• physical or mental inability of the patient to undergo treatment with peritoneal dialysis and to follow physician's instructions.

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

Special precautions.

Before using the peritoneal dialysis solution "Balance 1.5% glucose 1.25 mmol/l calcium", the medical instructions must be carefully read.

• The patient should keep this medical instruction leaflet for the medicinal product to be able to review it again.
• If the patient has any questions, he or she should consult his or her physician or pharmacist.
• This medicinal product is prescribed for a specific patient only and should 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 instruction, he or she must immediately inform his or her physician or pharmacist.

Special handling precautions for unused medicinal product

No special requirements for disposal.

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

Interaction with other medicinal products and other forms of interaction.

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.

A significant decrease in serum potassium levels may increase the frequency of adverse reactions associated with digitalis. Serum potassium levels must be monitored particularly carefully during concomitant treatment with cardiac glycosides (see section "Special precautions for use").

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

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

Special precautions for use.

The peritoneal dialysis solution must not be administered intravenously.

The solution "Balance 1.5% glucose 1.25 mmol/l calcium" 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 potassium-containing dialysis solution and consultation with a dietitian may be necessary;
• in extensive polycystic kidney disease.

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

During long-term peritoneal dialysis, transport characteristics of the peritoneal membrane may change, primarily indicated by lack 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 markers of bone metabolism;
• blood glucose levels;
• residual kidney function – to adapt peritoneal dialysis treatment accordingly.

Effluent fluid clarity and volume should be monitored. Cloudy effluent and/or abdominal pain 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 higher incidence 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 peritoneal dialysis solution should be used during pregnancy only after careful evaluation of the potential benefits and risks, as well as possible complications for both mother and child.

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, no effect on reproductive function is expected during therapeutic use.

Ability to affect reaction speed when driving or operating machinery.

"Balance 1.5% glucose 1.25 mmol/l calcium" has no effect or only a negligible effect on the ability to drive or operate machinery.

Method of Administration and Dosage

This solution is intended for intraperitoneal use only.

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 typically administered 2000 mL of solution per exchange, four times daily. After a dwell time of 2 to 10 hours in the peritoneal cavity, the solution is drained.

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

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

In patients with excess body weight or those with significant residual renal function loss, 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: The volume per exchange for pediatric patients 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 to 1000–1200 mL/m² BSA depending on tolerance, age, and residual kidney function.

Automated Peritoneal Dialysis (APD)

When an automated device (slip•safe – cycler) is used for intermittent or continuous cycling peritoneal dialysis, larger-volume bags are recommended to allow multiple solution exchanges. Solution exchanges are performed according to the prescription stored in the cycler.

• Adults: Typically, patients undergo 8–10 hours of nocturnal cycling. 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. Nocturnal cycling is generally combined with 1 or 2 daytime exchanges.
• Children: The volume per exchange should be 800–1000 mL/m² BSA with 5–10 nocturnal exchanges. This may be increased to 1400 mL/m² BSA depending on tolerance, age, and residual renal function.
• Elderly patients: No specific dosage recommendations are available for elderly patients.

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

«Balance 1.5% glucose 1.25 mmol/L calcium» contains 15 g of glucose in 1000 mL of solution.

Method and Duration of Procedure

Before performing peritoneal dialysis at home, the patient must receive appropriate training, including practical experience and mastery of the technique. Training must be conducted by qualified personnel. Before discharging a patient for home-based peritoneal dialysis, the physician must confirm that the patient has adequately learned the procedure. In case of any problems or uncertainties, the patient must 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 pre-warmed to body temperature. The required dose is infused through the peritoneal catheter into the peritoneal cavity over 5–20 minutes. According to the physician’s recommendations, the solution should remain in the peritoneal 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 cycler’s empty ports. The connectors will then automatically link to the sleep•safe tubing sets of the cycler system. The cycler reads the barcodes on the solution bags and triggers an alarm if there is a mismatch with the prescription stored in the cycler’s memory. After this verification, connect the tubing set to the patient’s catheter extension set to begin the procedure. The cycler automatically warms the sleep•safe solution to body temperature throughout the infusion phase. The dwell time and choice of glucose concentration are determined according to the medical prescription stored in the cycler’s memory (details are provided in the sleep•safe cycler user manual).

Depending on the required osmotic pressure, «Balance 1.5% glucose 1.25 mmol/L calcium» may be used sequentially with other peritoneal dialysis solutions containing higher glucose concentrations (i.e., higher osmolarity).

stay•safe system for Continuous Ambulatory Peritoneal Dialysis (CAPD)

The solution bag should be pre-warmed 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 starting at 22°C is approximately 120 minutes. The automatic temperature control is set at 39°C ± 1°C. Refer to the heater’s user manual for further details. Avoid using microwave ovens 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 seam integrity). Place the bag on a firm surface.

Open the outer protective bag and the disinfection cap packaging. Wash hands using an antimicrobial cleanser. Twist the bag, lying on the foil of the outer packaging, at one of the side corners until the central seam opens. The solutions from the two chambers will then mix automatically. Next, twist the bag from the top edge of the chamber containing the ready-to-use solution until the lower triangular seam is fully opened. Ensure all seams are completely open.

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

1. Preparation for bag exchange.

Secure the bag in the upper ring of the IV pole, unroll the tubing of the solution bag and place the DISC into the organizer. Then unroll the tubing of the drainage bag and secure the drainage bag in the lower ring of the IV pole. Place the catheter connector into one of the two openings of the organizer. Place a new disinfection cap into the other available 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 line clamp. The drainage procedure has started. Switch position «●»

1. Rinsing.

After completion of the drainage procedure, flush the tubing 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 line 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 with 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.

Cl•safe system for automated peritoneal dialysis (APD)

(for questions regarding setup of the cl•safe system, see the instruction for its use)

3000 ml cl•safe system:

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

5000 ml cl•safe system:

1. Solution preparation.

Check the appearance of the solution bag (label, expiration 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. Unfold the middle seam and the bag connector. Roll the bag lying on the wrapping, starting from the end opposite the connector located diagonally, until the middle seam opens. Continue rolling until the seam on the small chamber opens.

Ensure that all seams are fully opened. 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 cl•safe cycler tray.
4. The bag is ready for use with the cl•safe set.

Handling (method of use)

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

The plastic packaging may occasionally be damaged during transportation or storage, which may lead to contamination and an increase in the number of microorganisms 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 contents.

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, sterile conditions must be maintained.

Addition of medications to the peritoneal dialysis solution

The medicinal product «Balance 1.5% glucose 1.25 mmol/l calcium» due to the risk of incompatibility and contamination may be mixed only with the following medicinal products at the 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 volume of solution per exchange 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 peritoneal cavity can be easily drained into the drainage bag. However, if exchanges were performed too 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 of «Balance 1.5% glucose 1.25 mmol/l calcium» is dehydration.

Insufficient dose, interruption, or discontinuation of treatment may lead to life-threatening hyperhydration with peripheral edema and decompensated cardiac function 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 1.5% 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 be consequences of the peritoneal dialysis procedure itself 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 based on 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 glucose (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 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 peritoneal dialysis procedure

Infections and infestations:

• peritonitis (very common), indicated by clouding of the drained dialysate. Abdominal pain, fever, and general malaise may develop later, or, in very rare cases, sepsis. The patient must seek immediate medical attention. The bag containing the cloudy dialysate should be capped with a sterile cap and submitted for microbiological testing and leukocyte count;
• 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 due to 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, crusts, and pain at the catheter exit site (very common);
• complications related to dialysis solution infusion and drainage procedures (common);
• general weakness (unknown frequency).

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after marketing authorization is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life.

Shelf life in 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 instructions for use.

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 multilingual labeling including Ukrainian;

3000 ml in a dual-chamber slide•safe bag system; 4 bags per cardboard box with a label in Ukrainian or multilingual labeling including Ukrainian;

5000 ml in a dual-chamber slide•safe bag system; 2 bags per cardboard box with a label in Ukrainian or multilingual labeling including Ukrainian.

Prescription status.

Prescription only.

Manufacturer.

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

Manufacturer's address and location.

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 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.

Local representative of the marketing authorization holder: LLC "Fresenius Medical Care Ukraine", 9 Boryspylska St., Kyiv, 02099, Ukraine.