Finished product reference

Immune Globulin

Injection · Intravenous · 50 mg/1mL · 200 mL

List code
50893
Pharmacologic class
Blood product: normal human immunoglobulin (IgG)

What it is and how it works

A preparation of polyclonal IgG antibodies pooled from the plasma of many healthy donors. It provides passive immunity by replacing deficient antibodies and, at high doses, exerts immunomodulatory effects including Fc-receptor blockade, complement inhibition and modulation of autoantibodies.

Indications

Replacement therapy in primary and secondary immunodeficiency; immunomodulation in immune thrombocytopenia, Guillain–Barré syndrome, Kawasaki disease, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy; intramuscular preparations for pre- and post-exposure prophylaxis of certain infections such as hepatitis A and measles.

Dosage and administration (summary)

Dosing is individualised by the specialist according to indication, body weight and response (replacement versus immunomodulatory regimens), following the product protocol and infusion-rate guidance.

Contraindications

Hypersensitivity to human immunoglobulins, particularly in IgA-deficient patients with anti-IgA antibodies; intramuscular products must not be given intravenously, and are avoided in severe thrombocytopenia or coagulation disorders.

Warnings and precautions

Infusion reactions and anaphylaxis may occur, especially with the first infusion or a high infusion rate. Thromboembolic events, acute renal failure (particularly with sucrose-containing products), haemolytic anaemia and aseptic meningitis have been reported; ensure adequate hydration and use the minimum practicable rate in at-risk patients. Passively transferred antibodies may interfere with serological tests and with live attenuated virus vaccines.

Pregnancy

Long clinical experience suggests no harmful effects on pregnancy, the fetus or neonate, but use only when clearly needed.

Storage and supply

Store at 2–8 °C (some products permit storage below 25 °C); do not freeze; protect from light.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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