Albumin

Brand Name

Albumin GCC-20%

Generic name

Normal Human Serum Albumin 20%

Dosage Form

Solution for Injection: 50 & 100 ml

Brand Name

Albumin GCC-20%

Generic name

Normal Human Serum Albumin 20%

Dosage Form

Solution for Injection: 50 & 100 ml

Indication & Usage

A 20% solution of purified human serum albumin derived from blood plasma.

The primary function of Albumin is providing colloidal osmotic pressure within the circulation. The intravenous administration of Albumin, result, therefore, in drawing extravascular fluid into the vascular system.

Albumin GCC-20% is indicated for:

  • The prevention or treatment of hypovolemic syndrome and the aversion of cardiovascular collapses.
  • Emergency treatment of shock
  • Hemorrhagic, traumatic, or due to the loss of plasma.
  • Toxiaemic collapse
  • Toxic infective syndromes
  • Shock in acute hemorrhagic pancreatitis
  • Burns
  • In the initial treatment and during the following conditions.
  • Hypoproteinemia and edemas
  • Liver cirrhosis or hepatitis B
  • Nephrotic syndromes
  • Post-operative treatment and nutritional re-equilibration
  • Treatment of chronic deficiencies in esophageal, gastric or intestinal disorders
  • Cerebral edema
  • Neonatal hyperbilirubinemia

Dosage & Administration

Inject intravenously.

The total dosage will vary with clinical condition and size of the individual.

 In adults:

The initial dose of 100ml is suggested.

Additional amount may be injected as clinically indicated.

 In Children:

A dose one-quarter or one-half of the dose in adults.

Adverse reactions

Adverse reactions to albumin are rare. Such reactions may be allergic in nature or due to high plasma protein levels from excessive albumin administration. Allergic manifestations include urticaria, chills, fever, and changes in respiration, pulse and blood pressure.

Contraindications

Patients with severe anemia or cardiac failure in the presence of normal or increased intravascular volume.

Drug interactions

In the absence of compatibility studies, this medicinal product must not mixed with other medicinal products.

Warnings & Precautions

  • Should not be used if turbid, or more than 4 hours after the contents have been exposed.
  • Any remained contents should be discarded.
  • Should be administered carefully to patients with low cardiac reserve.
  • Should not be infused rapidly, because it causes vascular overload with resultant pulmonary edema. Patients should be closely monitored for signs of increased venous pressure.
  • Should be administered fluids to patients with marked dehydration.
  • Allergic or pyrogenic reactions are categorized primarily by fever and chills.
  • Rash, nausea, vomiting, tachycardia and hypotension have also been reported.
  • Albumin, particularly, if administered rapidly, may result in vascular overload with resultant pulmonary edema.
  • The selection and screening of blood donors, and pasteurization of this product at 60°C for 10 hours, have virtually eliminated the possibility of infection by blood-borne viruses. However, freedom from the possibility of blood-borne viruses’ infection cannot be excluded.

Pregnancy & Lactation

Safety for pregnant women is not established. The possibility of Parvovirus B-19 infection cannot be excluded from administration of this product. In case of being infected by Parvovirus B-19, fetal disturbances (abortion, hydrops fetalis, and fetal death) may occur. This product should be given to a pregnant woman only if expected benefit justifies the possible risk.

Storage condition

Room temperature (below 25°C)

Do not freeze

Keep out of reach of children.

Packaging

1 glass vial in each box contains 50 or 100 ml human Albumin 20%.

License Holder

Green Cross/ South Korea

Marketing Authorization Holder in IRAN

Koushan Pharmed

 

    • 1stFloor,No.15,Padidar Alley,Africa Blvd.
    • Tel: +98 2188197145
    • Fax:+98 2188197153
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