RENO- ALB

Reno-ALB 20% is a nonpyrogenic, sterile aqueous solution of Human Albumin I.P. for intravenous administration and is purified from pooled human venous plasma using a series of chromatography steps.

COMPOSITION:

Each 100 mL RENO-ALB 20 % vial contains.

Total protein- 200g/L

N- Acetyl tryptophan - (0.016 M)

sodium caprylate - (0.016 M)

Na+ -145 ± 15 mEq/L

K+ - ≤ 2m Eq/

aluminium content - ≤ 200 µg/L

RENO-ALB 20% is produced from pooled human plasma for fractionation conforming to the highest standards set forth by regulatory authorities. In addition, the plasma donor units and the production plasma pool are tested negative using NAT approved by regulatory authorities for HIV1& 2, HCV and HBV.

CLINICAL PHARMACOLOGY:

Albumin accounts for 70-80% of the colloid osmotic pressure of plasma involved in regulating the circulating blood volume and this is the primary reason for its clinical use. In addition, it also functions as a carrier protein for several hydrophobic steroid hormones and fatty acids.Human Albumin is a highly stable and globular protein of molecular weight 66,500. The total body albumin in a 70 kg man is approximately 320 g. It is distributed throughout the extracellular compartments and more than 60% of the body albumin pool is located in the extravascular fluid compartment. Albumin has a circulating life span of 15-20 days, with a turnover of approximately 15 g per day. N-Acetyl tryptophan

DOSAGE AND ADMINISTRATION :

Human Albumin I.P. 20% is administered intravenously. The total dosage will vary with the individual. In adults, an initial infusion of 100 mL is suggested. Additional amounts may be administered as clinically indicated. Intravenous Use Only. Human Albumin I.P. 20%, particularly if administered rapidly, may result in vascular overload with resultant pulmonary edema.

Daily dose should not exceed 2 g per kg body weight. Do not dilute with sterile water for injection as this may cause hemolysis in recipients. Large volumes and rapid infusion may cause signs and symptoms of hypervolaemia. Stop the infusion immediately. Reconstitute with 0.9% Sodium Chloride or 5% Dextrose in Water. Do not use Sterile Water for Injection as a diluent. Do not freeze.

STORAGE

Store Human Albumin I.P. 20% at 2°C to 25 °C.

Do not freeze. Protect from light.

Keep away from children.

SHELF LIFE:

Three years from the date of manufacturing at recommended storage conditions.