Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product 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
Documents
Package Inserts
Uman PI.pdf
Approved: November 3, 2011