Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INFUSION, SOLUTION
**Posology** The concentration of the albumin preparation, dosage and the infusion-rate should be adjusted to the patient’s individual requirements. 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 This product is suitable for premature infants and dialysis patients.
INTRAVENOUS
Medical Information
**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.
**Contraindications** Hypersensitivity to albumin preparations or to any of the excipients.
B05AA01
albumin
Manufacturer Information
GRIFOLS ASIA PACIFIC PTE. LTD.
INSTITUTO GRIFOLS SA
Grifols Biologicals LLC (Optional manufacturer of Fraction V)
Active Ingredients
Documents
Package Inserts
Human Albumin Grifols PI.pdf
Approved: March 10, 2005