Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION
**Application and Dosage** 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 g amino acids/kg BW and day ≙ 1000 ml per day at 70 kg BW in acute and chronic renal insufficiency **under** hemodialysis, hemofiltration or peritoneal dialysis treatment. Max. 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 calory carriers either before or simultaneously by mouth or parenterally. **Duration of Application** In acute renal insufficiency duration of application is from some days up to 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 Nephrosteril can be used until a sufficient **oral** supply of protein can be again given.
INTRAVENOUS
Medical Information
**Indications** Balanced supply of protein elements in acute and chronic renal insufficiency as well as during peritoneal and hemodialysis treatment.
**Contraindications** Impaired amino acid metabolism, advanced functional impairment of the liver, severe cardiac insufficiency, hyperhydration, hypokalemia, hyponatremia.
B05BA01
amino acids
Manufacturer Information
FRESENIUS KABI (SINGAPORE) PTE LTD
FRESENIUS KABI AUSTRIA GMBH
Active Ingredients
Documents
Package Inserts
Nephrosteril for Intravenous Infusion PI.pdf
Approved: June 2, 2011
