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PARS‑LUTO PSMA® Kit

Sterile, NonPyrogen Lyophilized Powder

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SPECT Imaging
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Diagnostic
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About the Product

PARS‑LUTO PSMA is a sterile, non‑pyrogen lyophilized radiopharmaceutical kit for the treatment of prostate cancer, which, after radiolabeling with Lu‑177, is used for this purpose. The LUTO PSMA kit is intended solely for therapeutic use and for the preparation of 177Lu‑PSMA.

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Applications
  • Treatment of metastatic castration‑resistant prostate cancer (mCRPC)
  • Treatment of prostate cancer in patients who have not responded to hormone therapy and chemotherapy
  • Treatment of metastatic lesions (bone, lymph nodes, and visceral) with pain reduction and disease progression delay
  • A suitable and reliable choice for physicians as a personalized therapy
  • Reduction of PSA levels and improvement in patients’ daily functioning
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Mechanism of Action

177Lu‑PSMA binds specifically to prostate cancer cell receptors (PSMA). After binding, the Lutetium‑177 isotope, through its beta‑emitting properties, causes DNA damage in the cancer cells.

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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‑LUTO PSMA® 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 one LUTO PSMA kit vial, along with one label specifically for the radiolabeling procedure.

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Composition

PSMA‑617 (135 µg)

Sodium Ascorbate

Sodium Acetate

Mannitol

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Storage Conditions
  • Store the PARS‑LUTO PSMA® kit in a freezer (-8°C to -20°C) and protected from light. The cold chain must be maintained under all circumstances.
  • After radiolabeling, administer 177Lu‑PSMA immediately; otherwise, theradiolabeled solution remains stable for up to 7 days in a freezer (-8°C to -20°C).
  • The PARS‑LUTO PSMA® kit should not be used after the expiration date.
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