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HSA Approval

ZENALB 4.5 HUMAN ALBUMIN SOLUTION 4.5% w/v

SIN07170P

ZENALB 4.5 HUMAN ALBUMIN SOLUTION 4.5% w/v

ZENALB 4.5 HUMAN ALBUMIN SOLUTION 4.5% w/v

October 9, 1992

EURO ASIA MEDICO PTE. LTD.

EURO ASIA MEDICO PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantEURO ASIA MEDICO PTE. LTD.
Licence HolderEURO ASIA MEDICO PTE. LTD.

Product Classification

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

Formulation Information

INJECTION

**4.2 Posology and method of administration** The concentration of the albumin preparation, dosage and the 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 **Method of administration** Human albumin can be directly administered by the intravenous route. The infusion rate should be adjusted according to the individual circumstances and the indication. The recommended rate of administration for patients with normal blood volume should be 1–2ml/minute (60–120ml/hour). In patients with greatly reduced blood volume and/or shock, infusion of Zenalb® 4.5 may be as rapid as necessary, e.g. up to 1L/hour. In plasma exchange the infusion 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 patient, based on official recommendations.

**4.3 Contraindications** Hypersensitivity to albumin preparations or to any of the excipients. Patients with severe anaemia and patients with cardiac failure.

B05AA01

albumin

Manufacturer Information

EURO ASIA MEDICO PTE. LTD.

BIO PRODUCTS LABORATORY LIMITED

Active Ingredients

ALBUMIN (HUMAN)

4.5% w/v

Albumin human

Documents

Package Inserts

Zenalb 4.5 Human Albumin Solution PI.pdf

Approved: May 25, 2021

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