Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION
**DOSAGE AND ADMINISTRATION** Albutein® 5% is administered intravenously. The total dosage will vary with the individual. In adults, an inital infusion of 500 mL is suggested. Additional amounts may be administered as clinically indicated. 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 inital 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. **Pediatric Use:** 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 administraion in children should be one-quarter the adult rate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
INTRAVENOUS
Medical Information
**INDICATIONS AND USAGE:** Albutein® 5% is indicated: 1. For treatment of hypovolemic shock.2,4 2. 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. 3. As an adjunct in hemodialysis and in cardiopulmonary bypass procedures. In those conditions in which the colloid requirement is high and there is need for fluid, albumin should be administered as a 25% solution. **Pediatric Use:** 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. * * * **REFERENCES:** 2\. Finlayson, J.S., Albumin Products, _Semin Thromb Hemo_, 6:85–120, 1980. 4\. Hauser, C.J., et. al., Oxygen Transport Responses to Colloids and Crystalloids in Critically Ill Surgical Patients, _Surg Gyn Obs_, 150:811, June 1980.
**CONTRAINDICATIONS:** Albutein® 5% is contraindicated in patients with severe anemia or cardiac failure in the presence of normal or increased intravascular volume. The use of Albutein® 5% is contraindicated in patients with a history of allergic reactions to albumin.
B05AA01
albumin
Manufacturer Information
GRIFOLS ASIA PACIFIC PTE. LTD.
GRIFOLS BIOLOGICALS LLC.
Active Ingredients
Documents
Package Inserts
1.4.3 Albutein PI.pdf
Approved: March 15, 2019