- Approval Id
- 7266f2852d776580
- Drug Name
- ALBUNORM SOLUTION FOR INFUSION 20%
- Product Name
- ALBUNORM SOLUTION FOR INFUSION 20%
- Approval Number
- SIN15160P
- Approval Date
- 2017-01-19
- Registrant
- WELLCHEM PHARMACEUTICALS PTE LTD
- Licence Holder
- WELLCHEM PHARMACEUTICALS PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INFUSION, SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>The concentration of the albumin preparation, dosage and the infusion-rate should be adjusted to the patient’s individual requirements.</p>
<p><u>Posology</u></p>
<p>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.</p>
<p>If human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include:</p>
<ul class="dash">
<li><p>arterial blood pressure and pulse rate</p></li>
<li><p>central venous pressure</p></li>
<li><p>pulmonary artery wedge pressure</p></li>
<li><p>urine output</p></li>
<li><p>electrolyte</p></li>
<li><p>haematocrit/haemoglobin</p></li>
</ul>
<p><em>Paediatric population</em></p>
<p>Data on the use of Albunorm 20% in children are limited; therefore, the product should only be administered to these individuals if the benefits clearly outweigh potential risks.</p>
<p><u>Method of administration</u></p>
<p>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).</p>
<p>The infusion rate should be adjusted according to the individual circumstances and the indication.</p>
<p>In plasma exchange the infusion-rate should be adjusted to the rate of removal.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate.</p>
<p>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>4.3 Contraindications</strong></p>
<p>Hypersensitivity to albumin preparations or to any of the excipients.</p>
- Atc Code
- B05AA01
- Atc Item Name
- albumin
- Pharma Manufacturer Name
- WELLCHEM PHARMACEUTICALS PTE LTD
