Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INFUSION, SOLUTION
**Posology/Method of administration** The concentration of the albumin solution used, the 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 or protein losses. Measurements of the circulating blood volume, and not just of the plasma albumin level, should be used to determine the dose required. Human albumin should be administered under careful haemodynamic monitoring; the parameters include: - arterial blood pressure and heart rate, - central venous pressure, - pulmonary artery wedge pressure, - urine output, - electrolytes, - haematocrit/haemoglobin. Paediatric population The posology in children and adolescents (0 – 18 years) should be adjusted to the patient’s individual requirements. **_Method of administration_** AlbuRx™ 5 is administered intravenously. The infusion rate should be adjusted according to the individual circumstances and the indication, but should normally not exceed 5 ml/min. In plasma exchange the infusion rate should be adjusted to the rate of removal.
INTRAVENOUS
Medical Information
**Therapeutic indications** Restoration and maintenance of circulating blood volume in cases of volume deficiency where the use of a colloid is indicated. 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 (see section “Composition” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
B05AA01
albumin
Manufacturer Information
CSL BEHRING PTE. LTD.
CSL Behring AG (Bulk Production and Primary Packager)
CSL Behring L.L.C
Active Ingredients
Documents
Package Inserts
Alburx 5% PI.pdf
Approved: March 11, 2020