Indicated for the prevention and treatment of complications arising from impaired or insufficient protein metabolism in patients with chronic renal insufficiency. It is used in combination with a restricted protein diet (approximately 40 g/day in adults). This generally applies to patients with a glomerular filtration rate (GFR) of 25 mL/min or lower.

Each film-coated tablet contains:

• (RS)-3-methyl-2-oxovaleric acid (α-ketoanalogue of DL-isoleucine), calcium salt: 67 mg
• 4-methyl-2-oxovaleric acid (α-ketoanalogue of leucine), calcium salt: 101 mg
• 2-oxo-3-phenylpropionic acid (α-ketoanalogue of phenylalanine), calcium salt: 68 mg
• 3-methyl-2-oxobutyric acid (α-ketoanalogue of valine), calcium salt: 86 mg
• (RS)-2-hydroxy-4-methylthio-butyric acid (α-hydroxyanalogue of DL-methionine), calcium salt: 59 mg
• L-lysine acetate equivalent to L-lysine 75 mg: 105 mg
• L-threonine: 53 mg
• L-tryptophan: 23 mg
• L-histidine: 38 mg
• L-tyrosine: 30 mg
• Total nitrogen per tablet: 36 mg
• Calcium per tablet: 50 mg

This preparation enables the intake of essential amino acids while reducing nitrogen intake. After absorption, the keto- and hydroxy-analogues are converted into their corresponding essential amino acids by utilizing nitrogen from non-essential amino acids. This process helps reduce urea formation by recycling amino groups, thereby lowering the accumulation of uremic toxins. Keto and hydroxy acids do not cause hyperfiltration in remaining nephrons. These supplements also help improve conditions such as renal hyperphosphatemia and secondary hyperparathyroidism, and may contribute to the improvement of renal osteodystrophy. When used along with a very low-protein diet, this formulation reduces nitrogen load while preventing the negative effects of protein deficiency and malnutrition.

Adults (70 kg body weight): If not otherwise prescribed, take 4 to 8 tablets three times a day during meals. Swallow whole and must not be chewed. Ingestion during meals facilitates proper absorption and the metabolisation into the corresponding amino acids.

Duration of Application: This tablets are given as long as the glomerular filtration rate (GFR) is between 5 and about 15 mL/minute. Simultaneously food should contain 40 g/day protein or less (adults).

• Simultaneous use of calcium-containing medications may increase or worsen elevated serum calcium levels.
• Drugs that can form poorly soluble complexes with calcium—such as tetracyclines, quinolone antibiotics (e.g., ciprofloxacin, norfloxacin), and medicines containing iron, fluoride, or estramustine—should not be taken together with this tablet, as they may interfere with absorption. A gap of at least 2 hours should be maintained between their intake.
• If serum calcium levels rise due to this tablet, sensitivity to cardioactive glycosides may increase, thereby raising the risk of cardiac arrhythmias.
• With treatment, uraemic symptoms may improve; therefore, when used with aluminum hydroxide, its dose may need adjustment. Serum phosphate levels should also be monitored for reduction.

Hypersensitivity to the active ingredients or any excipients Hypercalcemia Disorders of amino acid metabolism

Hypercalcemia may occur. In such cases, reducing vitamin D intake is recommended. If hypercalcemia persists, the dose of this tablet and other calcium sources should be decreased. Serum calcium levels should be monitored regularly, and adequate calorie intake should be ensured. There is no established experience of use in pediatric patients.

There are no sufficient clinical data regarding the use of this tablet in pregnant women. Animal studies have not shown harmful effects on pregnancy, fetal development, or postnatal growth. However, it should be used with caution during pregnancy. There is no available information regarding its use during lactation. No cases of overdose have been reported.

• Serum calcium levels should be checked regularly
• Ensure adequate calorie intake
• In patients with phenylketonuria, note that this tablet contains phenylalanine
• Monitor serum phosphate levels when used with aluminum hydroxide

Drugs used in chronic kidney dialysis

Store below 30°C. Keep in the original packaging and ensure the blister packs are tightly closed to protect from moisture.