MedPath
HSA Approval

NEPHROSTERIL FOR INTRAVENOUS INFUSION

SIN06299P

NEPHROSTERIL FOR INTRAVENOUS INFUSION

NEPHROSTERIL FOR INTRAVENOUS INFUSION

June 21, 1991

FRESENIUS KABI (SINGAPORE) PTE LTD

FRESENIUS KABI (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantFRESENIUS KABI (SINGAPORE) PTE LTD
Licence HolderFRESENIUS KABI (SINGAPORE) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
General Sale List
HSA Singapore 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

L-TRYPTOPHAN

1.9 g/l

Tryptophan

AMINOACETIC ACID (GLYCINE)

3.2 g/l

Glycine

L-MALIC ACID

1.5 g/l

Hyaluronic acid

L-VALINE

6.2 g/l

Valine

ARGININE

4.9 g/l

Arginine

L-SERINE

4.5 g/l

Serine

L-LYSINE MONOACETATE EQV L-LYSINE

7.1 g/l

Lysine

L-ISOLEUCINE

5.1 g/l

Isoleucine

L-METHIONINE

2.8 g/l

Methionine

L-PHENYLALANINE

3.8 g/l

Phenylalanine

L-HISTIDINE

4.3 g/l

Histidine

L-THREONINE

4.8 g/l

Threonine

GLACIAL ACETIC ACID

1.38 g/l

Acetic acid

ACETYLCYSTEINE EQV L-CYSTEINE

0.37 g/l

Cysteine

L-ALANINE

6.3 g/l

Alanine

L-LEUCINE

10.3 g/l

Leucine

L-PROLINE

4.3 g/l

Proline

Documents

Package Inserts

Nephrosteril for Intravenous Infusion PI.pdf

Approved: June 2, 2011

Download

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

NEPHROSTERIL FOR INTRAVENOUS INFUSION - HSA Approval | MedPath