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PARS‑HEDP® Kit

 Sterile, NonPyrogen Lyophilized Powder

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SPECT Imaging
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Diagnostic
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About the Product

PARS‑EDTMP is a sterile, non‑pyrogen lyophilized kit that, after radiolabeling with Lu‑177, is used for pain palliation and treatment of bone metastases. The EDTMP kit is intended solely for palliative and therapeutic use and is used for the preparation of 177Lu‑EDTMP.

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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.
  • Prevention of pain progression in growing bone metastases.
  • Sustained and durable efficacy in pain palliation, thereby improving patients’ quality of life.
  • Possibility of follow‑up and imaging to assess treatment response.
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Mechanism of Action

177Lu‑EDTMP is a phosphonate radiopharmaceutical that binds to bone calcium surfaces and bone metastases arising from various cancers. After uptake, Lutetium‑177 emits beta radiation, which destroys cancer cells and reduces pain caused by metastases. Additionally, the gamma radiation emitted by Lutetium‑177 enables treatment follow‑up. This mechanism provides sustained and long‑lasting pain relief and can be used in multi‑dose treatment regimens.

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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‑EDTMP kit is manufactured under aseptic conditions. After radiolabeling with sterile, non‑pyrogen Lutetium chloride injection (177LuCl₃), 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 and five EDTMP kit vials, along with five labels specifically for the radiolabeling procedure.

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Composition

Ethylenediamine Tetramethylene Phosphonic Acid (50 mg)

Sodium Hydroxide

Sodium Chloride

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Storage Conditions
  • Store the PARS‑EDTMP kit in a refrigerator (2°C to 8°C) and protected from light. The cold chain must be maintained under all circumstances.
  • After radiolabeling, administer 177Lu‑EDTMP immediately; otherwise, the labeled solution remains stable for up to 4 days in a freezer (-8°C to -20°C).
  • The PARS‑EDTMP kit should not be used after the expiration date.
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