Albumin GCC

Albumin GCC

human albumin

Manufacturer:

Green Cross

Distributor:

Propharm
Full Prescribing Info
Contents
Human serum albumin.
Description
Each 50 ml vial contains Normal Human Serum Albumin (active ingredient) 10 g, Sodium caprylate (as stabilizer) 0.13295 g, Acetyl tryptophan (as stabilizer) 0.197 g, Distilled water for injection q.s.
ALBUMIN-GCC (20%) is a sterile, aqueous solution containing 20% purified human serum albumin (weight/volume).
ALBUMIN-GCC (20%) is prepared by the Cohn ethanol blood fractionation method from pooled human plasma with a poor salt content obtained from healthy blood donors.
The product is stabilized with Sodium caprylate and Acetyl tryptophan. ALBUMIN-GCC (20%) is osmotically equivalent to four times its volume of normal citrated plasma. A liter of ALBUMIN-GCC (20%) solution contains 113.5-138.7 mM of sodium ion. The product contains no preservatives.
ALBUMIN-GCC (20%) is heated at 60°C for ten hours. This heat treatment completely destroys the causative agents of viral hepatitis (HBV, HCV) and HIV-1 and -2. This product is prepared from units of human plasma that have been tested and found nonreactive for HBsAg and antibodies to HIV-1 and -2 and HCV.
Action
Pharmacotherapeutic Group: Blood fractions.
Pharmacology: Pharmacodynamics: Action and Mode or Mechanism of Action: The primary function of albumin is that of providing colloidal osmotic pressure within the circulation. The intravenous administration of Albumin-GCC results, therefore, in drawing extravascular fluid into the vascular system. Serum albumin which contributes to the buffer capacity of the plasma, has transport function. Although Albumin contains some amino acids, it provides only moderate nutritive effect.
Indications/Uses
Hypoalbuminemia caused by albumin deficiency (Burn, Nephrose syndrome) and dysfunction of albumin synthesis; Hemorrhagic shock.
Dosage/Direction for Use
Albumin-GCC (20%) is administered intravenously.
Hypoalbuminemia caused by albumin deficiency (burn, Nephrose Syndrome) and dysfunction of albumin synthesis.
Inject intravenously.
The total dosage will vary with clinical condition and size of the individual.
In adults: An initial dose of 100 ml infusion is suggested.
Additional amount may be administered as clinically indicated.
In children: A dose one quarter to one half the adult dose or dosage may be calculated on the basis of 1.25-2.5 ml per kilogram of body weight.
Hemorrhagic Shock: In the treatment of patient in shock with greatly reduced blood volume. Albumin-GCC may be administered intravenously 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 is not more than 1 ml per minute. The usual rate of administration in children should be calculated on one quarter to one half the adult rate.
Overdosage
Toxicity and treatment of overdosage: Administration of large quantities of albumin should be supplemented with red cell concentrates or replaced by whole blood to combat the relative anaemia which would follow such use.
If circulatory embarrassment or pulmonary edema should develop, the infusion must be stopped immediately and specific treatment given.
Contraindications
ALBUMIN-GCC (20%) is contraindicated in patients with severe anemia or cardiac failure in the presence of normal or increased intravascular volume, and with known hypersensitivity to commercially available albumin solutions.
Warnings
Although this blood product is made from plasma which has been screened or tested for some known transmissible agents including HIV (AIDS), hepatitis B and hepatitis C, the limited sensitivity and reliability of such tests and screening procedures and possible contamination with other or unknown agents must be borne in mind.
Chemical processing and virus inactivation stages included in the manufacture of this product are believed to render it safe from the risk of infection. Nevertheless, this possibility must always be considered, and should be conveyed, whenever possible, to patients who may receive the product.
Special Precautions
ALBUMIN-GCC (20%) should be administered with caution to patients with low cardiac reserve.
Rapid infusion may cause vascular overload with resultant pulmonary edema.
Patients should be closely monitored for signs of increased venous pressure.
Dehydrated patients may require additional fluids.
Rapid administration to injured patients may result in vascular overload or bleeding from previously undetected sites.
Use in pregnancy: There is very little experience of the use of albumin in the early stages of pregnancy.
Use In Pregnancy & Lactation
Use in pregnancy: There is very little experience of the use of albumin in the early stages of pregnancy.
Adverse Reactions
Allergic or pyrogenic reactions are characterized primarily by fever and chills; rash, nausea, vomiting, tachycardia and hypotension have also been reported. ALBUMIN-GCC (20%), particularly if administered rapidly, may result in vascular overload with resultant pulmonary edema.
Caution For Usage
Spillage or Breakage: Do not use if a break of the container or spillage occur. Precautions should be taken to avoid contamination of cuts and abrasions, as well as to avoid inhalation or swallowing of the spillage.
Adequate disinfection can be obtained with the application of 1% sodium hypochlorite solution for 15 minutes. Commercial bleaches may be diluted appropriately to obtain this concentration.
Instruction:
Cleanse exposed rubber stopper with a suitable germicidal solution and prepare the administration equipment as follows: a. Close clamp on infusion set.
b. With bottle upright, thrust piercing pin straight through stopper center. Do not twist or angle.
c. Immediately invert bottle to automatically establish proper fluid level in drip chamber (half full).
d. Attach infusion set, open clamp and solution to expel air from tubing and needle, then close clamp.
e. Make venipuncture and adjust flow.
f. Discard all administration equipment after use.
Should not be used if it appears turbid or if there is sediment in the bottle, or more than 4 hours after the container has been penetrated. Any remaining contents should be discarded.
Storage
Store below 30°C. Do not freeze.
Shelf-Life: 39 months from the manufacturing date.
ATC Classification
B05AA01 - albumin ; Belongs to the class of blood substitutes and plasma protein fractions. Used as blood substitutes.
Presentation/Packing
Inj (vial) 20% x 50 mL.
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