- Approval Id
- c65a31af2a67ef45
- Drug Name
- ALBUTEIN INFUSION 5%
- Product Name
- ALBUTEIN INFUSION 5%
- Approval Number
- SIN01177P
- Approval Date
- 1988-05-13
- 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>DOSAGE AND ADMINISTRATION:</strong><br>
Albutein® 5% is administered intravenously. The total dosage will vary with the individual. In adults, an initial infusion of 500 mL is suggested. Additional amounts may be administered as clinically indicated. <br>
In the treatment of the patient in shock with greatly reduced blood volume, Albutein® 5% may be administered as rapidly as necessary in order to improve the clinical condition and restore normal blood volume. This may be repeated in 15–30 minutes if the initial dose fails to prove adequate. In the patient with a slightly low or normal blood volume, the rate of administration should be 1–2 mL per minute.<br>
<strong>Pediatric Use:</strong> The pediatric use of Albutein® 5% has not been clinically evaluated. The dosage will vary with the clinical state and body weight of the individual. Typically, a dose one-quarter to one-half the adult dose may be administered, or dosage may be calculated on the basis of 0.6 to 1.0 gram per kilogram of body weight (12 to 20 mL of Albutein® 5%). The usual rate of administration in children should be one-quarter the adult rate.<br>
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>INDICATIONS AND USAGE:</strong><br>
Albutein® 5% is indicated:</p>
<ol type="a">
<li>For treatment of hypovolemic shock.<sup>2,4</sup></li>
<li>In conditions in which there is severe hypoalbuminemia. However, unless the pathologic condition responsible for the hypoalbuminemia can be corrected, administration of albumin can afford only symptomatic or supportive relief.</li>
<li>As an adjunct in hemodialysis and in cardiopulmonary bypass procedures.</li>
</ol>
<p>In those conditions in which the colloid requirement is high and there is less need for fluid, albumin should be administered as a 25% solution.<br>
<strong>Pediatric Use:</strong> The pediatric use of Albutein® 5% has not been clinically evaluated. Therefore, physicians should weigh the risks and benefits of the use of Albutein® 5% in the pediatric population.</p>
<hr>
<p><strong>REFERENCES:</strong><br>
2. Finlayson, J.S., Albumin Products, <em>Semin Thromb Hemo</em>, 6:85–120, 1980.<br>
4. Hauser, C.J., et. al., Oxygen Transport Responses to Colloids and Crystalloids in Critically Ill Surgical Patients, <em>Surg Gyn Obs</em>, 150:811–816, June 1980.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS:</strong><br>
Albutein® 5% is contraindicated in patients with severe anemia or cardiac failure in the presence of normal or increased intravascular volume.<br>
The use of Albutein® 5% is contraindicated in patients with a history of allergic reactions to albumin.</p>
- Atc Code
- B05AA01
- Atc Item Name
- albumin
- Pharma Manufacturer Name
- GRIFOLS ASIA PACIFIC PTE. LTD.
