- Approval Id
- 3e3220a26ad09b7a
- Drug Name
- HUMAN ALBUMIN GRIFOLS INJECTION 5%
- Product Name
- HUMAN ALBUMIN GRIFOLS INJECTION 5%
- Approval Number
- SIN11285P
- Approval Date
- 2000-02-15
- Registrant
- GRIFOLS ASIA PACIFIC PTE. LTD.
- Licence Holder
- GRIFOLS ASIA PACIFIC PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION
- Dosage
- <p><strong>Posology</strong><br>
In general, the dosage and the infusion-rate should be adjusted to the patient's individual requirements.<br>
When human albumin is used in replacement therapy, the dosage required is guided by the usual circulatory parameters. The lowest limit for the colloidal osmotic pressure is 20 mm Hg (2.7 kPa).<br>
If human albumin is to be administered, the dose in grams required can be estimated using the following calculation:</p>
<p class="tab">[required total protein (g/l) - actual total protein (g/l)] x plasma volume (l) x 2</p>
<p>The physiological plasma volume may be calculated as approximately 0.04 l/kg body weight.<br>
As the formula in any case is only approximate, laboratory monitoring of achieved protein concentration is recommended.<br>
In cases of extensive substitution and in cases with haematocrit below 30% see "Precautions" – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.<br>
Paediatric use:<br>
In children the physiological plasma volume is age-dependent, this fact must be taken into account.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>Therapeutic indications</strong><br>
Human Albumin Grifols® 5% is indicated for:</p>
<ul class="dash">
<li>Albumin replacement in patients with albumin and blood volume deficiency.</li>
</ul>
<p>Suitable for premature born babies and dialysis patients.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<ul class="dash">
<li>A history of allergic reaction to albumin preparations.</li>
<li>Allergic reaction to this preparation.</li>
<li>All conditions in which hypervolaemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a special risk for the patient.<br>
Examples of such conditions are:
<ul class="bullet">
<li>Decompensated cardiac insufficiency</li>
<li>Hypertension</li>
<li>Oesophageal varices</li>
<li>Pulmonary edema</li>
<li>Haemorrhagic diathesis</li>
<li>Renal and post-renal anuria</li>
<li>Severe anaemia</li>
</ul></li>
</ul>
- Atc Code
- B05AA01
- Atc Item Name
- albumin
- Pharma Manufacturer Name
- GRIFOLS ASIA PACIFIC PTE. LTD.
