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HSA Approval

ALBUTEIN INFUSION 5%

SIN01177P

ALBUTEIN INFUSION 5%

ALBUTEIN INFUSION 5%

May 13, 1988

GRIFOLS ASIA PACIFIC PTE. LTD.

GRIFOLS ASIA PACIFIC PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantGRIFOLS ASIA PACIFIC PTE. LTD.
Licence HolderGRIFOLS ASIA PACIFIC PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore 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

ALBUMIN (HUMAN)

12.5 g/250 ml

Albumin human

Documents

Package Inserts

1.4.3 Albutein PI.pdf

Approved: March 15, 2019

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