Formulations: Ketoanalogues + essential amino acids: Ca-3-methyl-2-oxo-valerate (α-ketoanalogue to isoleucine, Ca salt) 67 mg, Ca-4-methyl-2-oxo-valerate (α-ketoanalogue to leucine, Ca salt) 101 mg, Ca-2-oxo-3-phenylpropionate (α-ketoanalogue to phenylalanine, Ca salt) 68 mg, Ca-3-methyl-2-oxo-butyrate (α-ketoanalogue to valine, Ca salt) 86 mg, Ca-DL-2-hydroxy-4-(methylthio) butyrate (α-hydroxyanalogue to methionine, Ca salt) 59 mg, L-lysine acetate (equiv to 75 mg L-lysine) 105 mg, L-threonine 53 mg, L-tryptophan 23 mg, L-histidine 38 mg, L-tyrosine 30 mg. Total nitrogen content/tab: 36 mg, Ca/tab: 1.25 mmol equiv to 0.05 g

Indications or Uses: Prevention and therapy of damage due to faulty or deficient protein metabolism in chronic renal insufficiency in connection with limited protein in food of 40 g per day and less in patients with glomerular filtration rate (GFR) below 25 mL/min.

Dosage and Directions for Use: Adult >70 kg 4-8 tab tid.

Contraindication: Hypersensitivity to ≥1 amino acids or idiosyncratic reaction to ketoanalogues of essential amino acids. Metabolic disorders associated with impaired nitrogen utilization; hypercalcemia, disturbed amino acid metabolism. Severe liver diseases & hepatic coma.

Special Precaution: Patients with severe heart disease. Ensure sufficient supply of calories. Regular evaluation of serum Ca level & laboratory determinations. Parenteral regimens should include non-protein calories adequate for weight maintenance if patient requires extended period of nutritional support. Pregnancy & Lactation.

Adverse Reaction: Hypercalcemia; generalized flushing, fever and nausea. Vomiting, abdominal pain, diarrhea & fatigue may occur at the beginning of therapy.

Interactions: Increase of serum Ca level or intensification w/ Ca-containing medicaments. Interfered absorption w/ sparingly soluble compound w/ Ca (eg, tetracycline).

Presentation/Packaging: Film coated tablet 600 mg x 100's.

For more information on this product please see the product insert