human normal immunoglobulin


SK Plasma


International Apex
Full Prescribing Info
Human natural immunoglobulin.
Each mL contains: Human Immunoglobulin 50 mg.
Immunoglobulins are produced by B lymphocytes as part of the humoral response to foreign antigens. Immunoglobulins used in clinical practice are preparations containing antibodies, usually prepared from human plasma or serum, and mainly comprise IgG. Normal immunoglobulin, prepared from material from blood donors, contains several antibodies against infectious diseases prevalent in the general population, whereas specific immunoglobulins contain minimum specified levels of one antibody. Antibodies may also be prepared by genetic engineering techniques. Immunoglobulins are used for passive immunization, thus conferring immediate protection against some infectious diseases. They are preferred to antisera of animal origin as the incidence of adverse reaction is lower.
It is also used for agammaglobulinemia, hypogammaglobulinemia, and combination therapy with antibiotics for severe infections, idiopathic thrombocytopenic purpura (in case that distinguished hemorrhage tendency occur and transient hemostasis care is needed such as surgical treatment or delivery, when other drugs are not available), Kawasaki disease (for the prevention of complication in coronary artery), Guillain-Barre syndrome (subacute demyelinating polyneuritis).
Dosage/Direction for Use
Agammaglobulinemia, hypogammaglobulinemia, and combination therapy with antibiotics for severe infections after reconstitution: 2,500-5,000 mg (human immunoglobulin) as single dose for adult, 100-150 mg/kg as single dose for children by intravenous instillation or injection. In case of intravenous infusion, administer very slowly.
Idiopathic thrombocytopenic purpura: the dosage is 200-400 mg/kg daily. If the improvement in symptom is not shown after consecutive 5 days, administration should be discontinued.
Kawasaki disease (for the prevention of complication in coronary artery): the dosage is 400 mg/kg once a day for consecutive 5 days.
Guillain-Barre syndrome (subacute demyelinating polyneuritis): the dosage is 400 mg/kg once a day for consecutive 5 days.
Special Precautions
Strenuous efforts are made to screen human donor material used in the preparation of immunoglobulins; the transmission of infections, including hepatitis B and HIV, which has been associated with the use of certain blood products, does not appear to be a problem with the immunoglobulins currently in use. IgA, present in some immunoglobulin preparations, may give rise to the production of anti-IgA antibodies in patients with IgA deficiencies, with the consequent risk of anaphylactic reactions.
Adverse Reactions
Local reactions with pain and tenderness at the site of intramuscular injection may follow the use of immunoglobulins. Hypersensitivity reactions, including, rarely, anaphylactic reactions, have also been reported; such reactions, though, are far less frequent than after the use of antisera of animal origin. Some immunoglobulins are available as intravenous preparations. Systemic reactions with fever, chills, facial flushing, headache, and nausea may occur, particularly at high rates of infusion.
Drug Interactions
Immunoglobulins may interfere with the ability of live vaccines to induce an immune response and a suitable interval should be considered during co-administration. The ability of vaccines to induce an immune response can be influenced by the recent use of other vaccines or immunoglobulins. Live vaccines should either be given simultaneously (but at different sites) or an interval of at least 3 weeks allowed between administration. Live vaccines should normally he given at least 3 weeks before or at least 3 months after the use of immunoglobulin.
However, travelers should receive appropriate vaccines regardless of these limitations if time is short. Intravenous immunoglobulin preparations should be used with caution in patients with renal impairment. Immunoglobulin products containing sucrose may be associated with an increased risk of inducing acute renal failure. The incidence of renal failure appears to be greatest with immunoglobulin products containing sucrose.
Store at temperatures between 2°-8°C. Protect from light.
ATC Classification
J06BA - Immunoglobulins, normal human ; Used in passive immunizations.
Soln for inj (vial) 50 mg/mL x 50 mL, 100 mL x 1's.
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