Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product 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
Documents
Package Inserts
Zenalb 4.5 Human Albumin Solution PI.pdf
Approved: May 25, 2021
