Nephrosteril

Amino Acids 7% Solution (Nephrosteril) is a sterile solution for intravenous infusion.
Per 1000 mL contains: L-Leucine 10.30 g, L-Lysine monoacetate 10.01 g (= L-Lysine 7.10 g), L-Alanine 6.30 g, L-Valine 6.20 g, L-Isoleucine 5.10 g, L-Arginine 4.90 g, L-Threonine 4.80 g, L-Serine 4.50 g, L-Histidine 4.30 g, L-Proline 4.30 g, L-Phenylalanine 3.80 g, Glycine 3.20 g, L-Methionine 2.80 g, L-Tryptophan 1.90 g, L-Malic acid 1.50 g, Glacial acetic acid 1.38 g, Acetylcysteine 500 mg (= L-Cysteine 370 mg).

B05B A01 - amino acids - solution for parenteral nutrition.
Pharmacology: Pharmacodynamics: The amino acids contained in Amino Acids 7% Solution (Nephrosteril) are all naturally occurring physiological compounds. As with the amino acids derived from the ingestion and assimilation of food proteins, parenterally administered amino acids enter the body pool of free amino acids and all subsequent metabolic pathways.
Pharmacokinetics: Amino Acids 7% Solution (Nephrosteril) is administered by the intravenous route and, therefore, is 100% bioavailable.
Toxicology: Preclinical safety data: Provided the recommended dosing regimen is complied with, toxic reactions to Amino Acids 7 % Solution (Nephrosteril) are not known and are not to be expected.

Balanced supply of protein elements in acute and chronic renal insufficiency as well as during peritoneal and hemodialysis treatment.

For intravenous infusion: If not otherwise prescribed, up to 0.5 g amino acids/kg BW and day (= 500 mL per day at 70 kg body weight in acute and chronic renal insufficiency without dialysis treatment. Up to 1.0 g amino acids/kg BW and day (= 1000 mL per day at 70 kg body weight) in acute and chronic renal insufficiency under dialysis treatment.
Maximum dosage: Up to 1.5 g amino acids/kg BW and day (= 1500 mL per day at 70 kg body weight). The drop rate should not exceed 20 drops/minute. Administer calorie carriers either before or simultaneously by mouth or parenterally.
Duration of application: In acute renal insufficiency, duration of application is from some days to a maximum of two weeks.
In chronic renal insufficiency without dialysis treatment as well as in acute and chronic renal insufficiency under hemodialysis, hemofiltration or peritoneal dialysis treatment of Amino Acids 7% Solution (Nephrosteril) solution can be used until a sufficient oral supply of protein can be given.

Excessive drop rates may lead to nausea, chills, and vomiting.

Impaired amino acid metabolism, advanced functional impairment of the liver, severe cardiac insufficiency, hyperhydration, hypokalemia, hyponatremia.

This solution does not contain electrolytes, observe therefore, the blood electrolyte level. If necessary, supply sufficient potassium to ensure the anabolic utilization of amino acids. Monitor regularly the water-electrolyte metabolism as well as the acid base status and serum urea. A possibly existing reduction of renal function has to be treated at first by supplying sufficient amounts of water and electrolytes. Infusion of the product may lead to increased production of gastric acid and stress ulcer.
Effects on ability to drive and use machines: Not applicable.

Fertility, Pregnancy and Lactation: Studies with this product have not been carried out on pregnant and breastfeeding women.

None known.

The addition of drugs should be avoided, as additives may lead to chemico-physical changes in the amino acid solution and thus to toxic reactions. If drugs have to be given, observe sterility, complete mixture, change in the solution and general compatibility. Solutions with drugs should not be stored.

Incompatibilities: Due to the increased risk of microbiological contamination and incompatibilities, amino acid solutions should not be mixed with other drugs.
Instructions and Special precautions for Handling and Disposal: Do not use if the solution is cloudy or if the container is damaged.

Store at temperatures not exceeding 25°C. Protected from light. Do not freeze.

Parenteral Nutritional Products

B05XB - Amino acids ; Used in I.V. solutions.

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