MedPath
HSA Approval

ALBUMIN SG INJECTION 20%

SIN16765P

ALBUMIN SG INJECTION 20%

ALBUMIN SG INJECTION 20%

April 20, 2023

THE REG CONSULTANTS PTE. LTD.

THE REG CONSULTANTS PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantTHE REG CONSULTANTS PTE. LTD.
Licence HolderTHE REG CONSULTANTS PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION

**【DOSAGE AND ADMINISTRATION】** Albumin SG Injection 20% 125–375mL, equivalent to human serum albumin 25–75g should be administered by intravenous drip infusion or by slow direct intravenous injection. The recommended infusion rate is 2–4mL/min. It may be diluted with 5% glucose and 0.9% sodium chloride when necessary. The dosage may be adjusted according to body weight, age and symptoms.

INTRAVENOUS

Medical Information

**【INDICATIONS】** Hypoalbuminemia caused by albumin loss (burn, nephrotic syndrome, etc), dysfunction of albumin synthesis (liver cirrhosis, etc) and haemorrhagic shock

**【CONTRAINDICATION】** Patients with history of hypersensitivity to this drug and its ingredients

B05AA01

albumin

Manufacturer Information

THE REG CONSULTANTS PTE. LTD.

SK Plasma Co.,Ltd.

Active Ingredients

Human Serum Albumin

10g/50mL

Albumin human

Documents

Package Inserts

ALBUMIN SG PI.pdf

Approved: April 20, 2023

Download

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

ALBUMIN SG INJECTION 20% - HSA Approval | MedPath