Ketoalfa

N/A

Prevention and treatment of damages due to faulty or deficient protein metabolism in chronic kidney disease in connection with a limited dietary protein intake of 40 g/day or less (adult). Usually, this applies to patients whose glomerular filtration rate (GFR) is less than 25 mL/min.

N/A

Hypersensitivity to the active substances or to any of the excipients, Hypercalcaemia, Disturbed amino acid metabolism.

Amino Acid Keto Analogues tablets are administered for nutrition therapy in chronic kidney disease. Amino Acid Keto Analogues allow the intake of essential amino acids while minimizing the amino-nitrogen intake. The use of Amino Acid Keto Analogues in combination with a very low protein diet allows reducing nitrogen intake while preventing the deleterious consequences of inadequate dietary protein intake and malnutrition.

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, quinolines such as ciprofloxacin and norfloxacin as well as drugs containing iron, fluoride or estramustine) should not be taken at the same time with Amino Acid Keto Analogues to avoid disturbed absorption of the active substances. An interval of at least two hours should elapse between the ingestion of Amino Acid Keto Analogues and these drugs.

Hypercalcaemia (Very Rare), If hypercalcaemia occurs, the intake of vitamin D should be reduced. In case of persisting hypercalcaemia, the dose of Amino Acid Keto Analogues as well as the intake of any other calcium sources has to be reduced.

There are no adequate data from the use of Amino Acid Keto Analogues in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women. No experience has been made so far with the use during lactation.

The serum calcium level should be monitored regularly Ensure sufficient calorie intake In the presence of hereditary phenylketonuria, attention should be given to the fact that Amino Acid Keto Analogues contains phenylalanine Monitoring of the serum phosphate levels is needed in case of concomitant administration of aluminium hydroxide