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HSA Approval

ALBURX SOLUTION FOR INFUSION 25%

SIN15907P

ALBURX SOLUTION FOR INFUSION 25%

ALBURX SOLUTION FOR INFUSION 25%

March 11, 2020

CSL BEHRING PTE. LTD.

CSL BEHRING PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantCSL BEHRING PTE. LTD.
Licence HolderCSL BEHRING PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore 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™ 25 is administered intravenously. The product is ready for use and can be administered as supplied, either directly or it can first be diluted to 5% albumin with 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, but should normally not exceed 1 – 2 ml/min. In plasma exchange the infusion rate should be adjusted to the rate of removal. The diluted solution is a clear, slightly viscous and almost colourless, yellow, amber, or green solution. The diluted product is stable for 24 hours at 30°C.

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

Human albumin

250 g/L

Albumin human

Documents

Package Inserts

Alburx 25% PI.pdf

Approved: March 11, 2020

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