- Approval Id
- b6a9356db29323ec
- Drug Name
- ALBURX SOLUTION FOR INFUSION 20%
- Product Name
- ALBURX SOLUTION FOR INFUSION 20%
- Approval Number
- SIN15906P
- Approval Date
- 2020-03-11
- Registrant
- CSL BEHRING PTE. LTD.
- Licence Holder
- CSL BEHRING PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INFUSION, SOLUTION
- Dosage
- <p><strong>Posology/Method of administration</strong><br>
The concentration of the albumin solution used, the dosage and the infusion rate should be adjusted to the patient’s individual requirements.</p>
<p><em><strong>Posology</strong></em><br>
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.</p>
<p>Human albumin should be administered under careful haemodynamic monitoring; the parameters include:</p>
<ul>
<li>arterial blood pressure and heart rate,</li>
<li>central venous pressure,</li>
<li>pulmonary artery wedge pressure,</li>
<li>urine output,</li>
<li>electrolytes,</li>
<li>haematocrit/haemoglobin.</li>
</ul>
<p><u>Paediatric population</u><br>
The posology in children and adolescents (0 – 18 years) should be adjusted to the patient’s individual requirements.</p>
<p><em><strong>Method of administration</strong></em><br>
AlbuRx™ 20 is administered intravenously.</p>
<p>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.<br>
In plasma exchange the infusion rate should be adjusted to the rate of removal.</p>
<p>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.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>Therapeutic indications</strong><br>
Restoration and maintenance of circulating blood volume in cases of volume deficiency where the use of a colloid is indicated.<br>
The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient, based on official recommendations.</p>
- Contraindications
- <p><strong>Contraindications</strong><br>
Hypersensitivity to albumin preparations or to any of the excipients (see section “Composition” – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- B05AA01
- Atc Item Name
- albumin
- Pharma Manufacturer Name
- CSL BEHRING PTE. LTD.
