Finished product reference

Igm-enriched Human (Immune Globulin)

Injection · Parenteral · 50 mg/1mL · 100 mL

List code
52092
Pharmacologic class
Blood product: IgM-enriched human immunoglobulin (intravenous)

What it is and how it works

A preparation of human plasma immunoglobulins enriched in IgM (with IgA and IgG). IgM is a potent activator of complement and an effective agglutinating and opsonising antibody, and the preparation provides antibodies that neutralise bacterial toxins and enhance clearance of pathogens.

Indications

Adjunctive treatment, with antibiotics, of severe bacterial infections and sepsis; replacement therapy in immunocompromised patients and severe secondary antibody deficiency.

Dosage and administration (summary)

Dosing is individualised by the specialist, given as an intravenous infusion over several days according to the product protocol and clinical response.

Contraindications

Hypersensitivity to human immunoglobulins, especially in IgA-deficient patients with antibodies against IgA; hereditary fructose intolerance if the product contains sorbitol or fructose.

Warnings and precautions

Infuse slowly initially and monitor for infusion and anaphylactic reactions. As with other intravenous immunoglobulins, thromboembolism, acute renal dysfunction, haemolysis and aseptic meningitis may occur; ensure adequate hydration. Derived from human plasma, so transmission of infectious agents cannot be totally excluded.

Pregnancy

Clinical experience with immunoglobulins suggests no harmful effects, but use only when clearly needed.

Storage and supply

Store at 2–8 °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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