Finished product reference

Superparamagnetic Dextran Nanoparticles

Injection, Suspension · Parenteral · 13 %/87 % · 10 mL

List code
51720
Pharmacologic class
Diagnostic agent (superparamagnetic iron oxide nanoparticles, dextran-coated)

What it is and how it works

These are nanoparticles of iron oxide coated with dextran or carboxydextran that exhibit superparamagnetism. After injection they are taken up by macrophages of the reticuloendothelial system, including lymph nodes, liver and spleen, where they alter local magnetic properties so that tissue can be detected with a handheld magnetometer probe or visualised as signal loss on MRI.

Indications

Localisation of sentinel lymph nodes (e.g. in breast cancer and melanoma surgery) using a magnetic detection probe, and as a contrast or tracer agent in MRI, according to the product licence.

Dosage and administration (summary)

Dosing is individualised according to product-specific protocol by the specialist (e.g. interstitial or subcutaneous injection near the tumour for sentinel node detection).

Contraindications

Hypersensitivity to iron oxide or dextran compounds; iron overload disorders.

Warnings and precautions

Hypersensitivity reactions may occur. Residual particles can cause persistent skin discolouration at the injection site and MRI artefacts or signal voids in the injected region for months, which should be considered in follow-up imaging.

Pregnancy

Use in pregnancy only if clearly necessary; data are limited.

Storage and supply

Store according to the manufacturer, typically at room temperature; do not freeze.

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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