Human Normal Immunoglobulin
Generic Name:
Human Normal Immunoglobulin
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Description:
Human normal Immunoglobulin is a solvent- and detergent-treated, chromatographically purified immunoglobulin G (IgG) derived from pooled human plasma.
Approved indications include primary immunodeficiency (PGD), Kawasaki disease, idiopathic thrombocytopenic purpura, B-cell chronic lymphocytic leukemia, childhood HIV-1 infection, and hematopoietic stem cell transplantation in the elderly. included.
Clinical experience also shows efficacy in GB syndrome, polymotor neuropathy, CIDP, Lambert-Eaton myasthenic syndrome, myasthenia gravis, neonatal sepsis, polymyositis, and dermatomyositis.
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Composition:
Each bottle contains:
In 10gm injection in 100ml
Source:
Human Plasma as Non reactive for HBsAg, HCV, HIV I and II antibodies and negative for HCV RNA by PCR.
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Indication:
Suitable for patients with Primary immunodeficiency syndrome, Kawasaki Syndrome, Idiopathic Thrombocytopenic Purpura, Allogenic Bone marrow transplantation (BMT) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
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Method of Administration:
Administered through an intravenous route.
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Presentation:
The normal immunoglobulin is meant for intravenous use. It is available in 5% concentrations in 10 ml, 20 ml, 50 ml and 100 ml pack sizes.
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Contraindications:
IVIG is contraindicated in individuals who have had anaphylactic or severe systemic reactions to immunoglobulin or any ingredients in the formulation. Epinephrine should be available for immediate treatment of an anaphylactic reaction if it occurs.
IVIG is contraindicated in individuals with selective IgA deficiency or IgA deficiency with antibodies against IgA, since these individuals may have antibodies to IgA (or develop antibodies following administration of IVIG) or other blood products containing IgA.
Acute hypersensitivity reaction to corn; this product contains maltose derived from corn.
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Possible side effect:
Flushing of the face, tightness in the chest, chills, fever, dizziness, nausea, diaphoresis, hypotension, acute renal failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, anaphylactic reactions.
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Shelf Life:
24 months from the date of manufacture.
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Storage:
Store at +2°C to +8°C. Do not freeze. Any vial that entered should be used completely, partially used components should be discarded.