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

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Applications
  • Treatment of neuroendocrine tumors (NETs) such as those of the gastrointestinal tract, pancreas, small intestine, and stomach
  • Treatment of metastatic tumors of neuroendocrine origin that are uncontrolled and have progressed
  • Treatment of tumors in patients who have not responded to hormone therapy and chemotherapy
  • Helping to reduce tumor growth and alleviate symptoms of carcinoid syndrome
  • A suitable and reliable choice for physicians as a personalized therapy
  • Reduction of tumor size, pain relief, and improvement in the patient’s quality of life
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Mechanism of Action

177Lu‑DOTATATE binds specifically to neuroendocrine tumor cell receptors. 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 TATE® 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 TATE kit vial, along with one label specifically for the radiolabeling procedure.

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Composition

Dotatate (140 µg)

Sodium Ascorbate

Sodium Acetate

Mannitol

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Storage Conditions
  • Store the PARS‑LUTO TATE® 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‑DOTATATE immediately; otherwise, the radiolabeled solution remains stable for up to 7 days in a freezer (-8°C to -20°C).
  • The PARS‑LUTO TATE® kit should not be used after the expiration date.
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