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PARS‑HEDP® Kit

 Sterile, NonPyrogen Lyophilized Powder

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Theranostic
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About the Product

PARS-HEDP is a sterile, nonpyrogen lyophilized kit that, after radiolabeling with Re188, is used for pain palliation and treatment of bone metastases. The HEDP kit is intended solely for palliative and therapeutic use and is used for the preparation of 188Re-HEDP.

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Applications
  •  Palliation of bone pain caused by metastases from cancers such as prostate and breast cancer that have spread to the bone.
  •  Suitable for patients requiring relief from acute and sudden bone metastasis pain.
  •  Possibility of postinjection imaging to evaluate drug distribution.
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Mechanism of Action

188Re-HEDP is a phosphonate radiopharmaceutical that binds to bone areas with high metabolic activity, particularly bone metastases arising from various cancers. After uptake, Rhenium188 emits beta radiation, which destroys cancer cells and reduces pain caused by metastases. In addition, Rhenium188 also emits gamma radiation, allowing imaging and precise evaluation of drug distribution in the body. This mechanism provides rapid and localized pain relief.

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Preparation and Administration

Note: This pharmaceutical product is intended solely for use in nuclear medicine facilities by personnel experienced in handling radiopharmaceuticals.

The PARS-HEDP kit is manufactured under aseptic conditions. After a multistep radiolabeling process with sterile, non-pyrogen sodium perrhenate injection (Na188ReO₄) — eluted from a 188W/188Re generator — the preparation is ready for intravenous administration. The dose to be used will be prescribed by the physician.

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Box Contents

Each box contains one instruction leaflet, one HEDP kit vial, one buffer solution vial, one perrhenate solution vial, one saline solution vial, and one vacuum vial, along with one label specifically for the radiolabeling procedure.

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Composition

Hydroxyethylidene Diphosphonic Acid (40 mg)

Ascorbic Acid

Stannous Chloride Dihydrate

Acetate Buffer Solution

Potassium Perrhenate Solution

0.9% Saline Solution

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Storage Conditions
  • Store the PARS-HEDP kit in a refrigerator (2°C to 8°C) and protected from light. The cold chain must be maintained under all circumstances.
  • After radiolabeling, 188Re-HEDP remains stable for up to 48 hours at 15°C to 25°C.
  • The PARS-HEDP kit should not be used after the expiration date.
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