MedPath
HSA Approval

Uman Albumin Solution for Infusion 200 g/l

SIN14044P

Uman Albumin Solution for Infusion 200 g/l

Uman Albumin Solution for Infusion 200 g/l

November 3, 2011

DUO MEDICAL PTE. LTD.

DUO MEDICAL PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantDUO MEDICAL PTE. LTD.
Licence HolderDUO MEDICAL PTE. LTD.

Product Classification

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

Formulation Information

INFUSION, SOLUTION

**4.2 Posology and method of administration** The concentration of the albumin preparation, dosage and infusion rate should be adjusted to the patient’s individual requirements. **Posology** The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required. If human albumin is to be administered, haemodynamic performance should be monitored regularly. This may include: - arterial blood pressure and pulse rate - central venous pressure - pulmonary artery wedge pressure - urine output - electrolyte - haematocrit/haemoglobin. UMAN ALBUMIN can be administered to premature infants and dialysis patients as the aluminium content of the finished product is not more than 200 mcg/l. **Method of administration** Human albumin can be directly administered by the intravenous route, or it can also be diluted in an isotonic solution (e.g. 5% glucose or 0.9% sodium chloride). The infusion rate should be adjusted according to the individual circumstances and the indication. In plasma exchange, the infusion rate should be adjusted to the rate of removal.

INTRAVENOUS

Medical Information

**4.1 Therapeutic indications** Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate. The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient, based on official recommendations.

**4.3 Contraindications** Hypersensitivity to albumin preparations or to any of the excipients.

B05AA01

albumin

Manufacturer Information

DUO MEDICAL PTE. LTD.

Kedrion S.p.A.

Active Ingredients

Human Albumin (Human Plasma Protein containing at least 95% Albumin)

200 g/l

Albumin human

Documents

Package Inserts

Uman PI.pdf

Approved: November 3, 2011

Download

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Uman Albumin Solution for Infusion 200 g/l - HSA Approval | MedPath