Ketoanalogue, amino acids.
Each film-coated tablet contains: Calcium-4-methyl-2-oxo-valerate 101 mg (α-ketoanalogue to leucine, calcium salt), Calcium-3-methyl-2-oxo-butyrate 86 mg (α-ketoanalogue to valine, calcium salt), Calcium-2-oxo-3-phenylpropionate 68 mg (α-ketoanalogue to phenylalanine, calcium salt), Calcium-3-methyl-2-oxo-valerate 67 mg (α-ketoanalogue to isoleucine, calcium salt), Calcium-DL-2-hydroxy-4-(methylthio) butyrate 59 mg (α-hydroxynalogue to methionine, calcium salt), L-Lysine Acetate 105 mg, L-Threonine 53 mg, L-Histidine 38 mg, L-Tyrosine 30 mg, L-Tryptophan 23 mg, Total Nitrogen Content 36 mg, Calcium (1.25 mmol) = 0.05 g.
Colour: Quinoline Yellow & Titanium Dioxide.
For prevention and therapy of damages due to faulty or deficient protein metabolism in chronic renal insufficiency in connection with limited protein food of 40 gram per day (for adults) and less.
If not otherwise prescribed the dose for adults (70 kg body weight) is 4 to 8 tablets three times daily during meals. The tablets must not chewed. Ingestion during meals facilities proper absorption and the metabolization into the corresponding amino acids. There is no experience in children.
For oral use.
Or as prescribed by the physician.
Duration of Application: The product administered as long as the glomerular filtration rate (GFR) is below 25 mL/min, and concomitantly, dietary protein is restricted to 40 g/day or less (adult).
Hypersensitivity to the active substances or to any of the excipients.
Hypercalcaemia.
Disturbed amino acid metabolism.
Metabolism and nutrition disorders: Very rare: hypercalcaemia.
If hypercalcaemia occurs, the intake of vitamin D should be reduced. In case of persisting hypercalcaemia, the dose of the product as well as the intake of any other calcium sources has to be reduced.
Concomitant administration of calcium-containing drugs may cause or aggravate elevated serum calcium levels.
Drugs that form hardly soluble compounds with calcium (e.g. tetracyclines, quinolones such as ciprofloxacin and norfloxacin as well as drugs containing iron, fluoride or estramustine) should not be taken at the same time with the products to avoid disturbed absorption of the active substances. An interval of at least two hours should elapse between the ingestion of the product and other drugs.
The susceptibility to cardioactive glycosides, and hence the risk for arrhythmia will increase if the product produces elevated serum calcium levels.
Uraemic symptoms improve under therapy with the product. Thus, in case of aluminum hydrochloride administration, the dose of these drugs has to be reduced if necessary. Serum phosphate levels should be monitored for a decrease.
Store at temperatures not exceeding 30°C. Keep in a cool dry place.
G04BX - Other urologicals ; Used in the treatment of urological problems.
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