Finished product reference

Anti-d Immunoglobulin

Injection, Solution · Intramuscular · 300 µg/2mL

List code
52345
Pharmacologic class
Blood product; specific human immunoglobulin (anti-D (Rh0) immunoglobulin)

What it is and how it works

Plasma-derived IgG containing high titres of antibodies against the RhD antigen. It binds RhD-positive fetal red cells in the maternal circulation, leading to their clearance before the mother's immune system becomes sensitised, thereby preventing formation of maternal anti-D antibodies.

Indications

Prevention of RhD sensitisation in RhD-negative women during pregnancy (routine antenatal prophylaxis and after potentially sensitising events), after delivery of an RhD-positive infant, and after miscarriage, termination or ectopic pregnancy; after incompatible transfusion of RhD-positive blood.

Dosage and administration (summary)

Dosing is individualised according to protocol, gestational age and the estimated volume of fetomaternal haemorrhage (Kleihauer test); given by intramuscular injection, usually within 72 hours of the sensitising event.

Contraindications

RhD-positive individuals; RhD-negative women already sensitised with anti-D antibodies; hypersensitivity to human immunoglobulins; intramuscular route in severe thrombocytopenia or coagulation disorders.

Warnings and precautions

Hypersensitivity reactions including anaphylaxis may occur, particularly in IgA-deficient patients with anti-IgA antibodies. As a plasma-derived product, transmission of infectious agents cannot be totally excluded. May interfere with live viral vaccines (e.g. measles, rubella) for up to 3 months.

Pregnancy

Intended for use in pregnancy; no adverse effects on the fetus are expected.

Storage and supply

Store at 2–8 °C refrigerated; 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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