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PARS‑PYP® Kit

 Sterile, NonPyrogen Lyophilized Powder

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KIT FOR THE PREPARATION OF PYROPHOSPHATE (Sn) 99mTc INJECTION
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SPECT Imaging
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Diagnostic
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About the Product

PARS‑PYP is a sterile, non‑pyrogen lyophilized radiopharmaceutical kit for the diagnosis of cardiac amyloidosis, which, after radiolabeling with Tc‑99m, is used for evaluation of this condition via SPECT imaging. The PYP kit is intended solely for diagnostic use and for the preparation of 99mTc‑Pyrophosphate.

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Applications
  • Diagnosis and management of cardiac amyloidosis
  • Diagnosis of ATTR (Transthyretin Amyloidosis) without the need for cardiac biopsy
  • Differentiation between types of amyloidosis, i.e., ATTR and AL (Amyloid Light), aiding in therapeutic decision‑making
  • Evaluation of unexplained ventricular wall thickening
  • Early diagnosis of cardiac amyloidosis in elderly patients with unexplained cardiomyopathy
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Mechanism of Action

After intravenous administration, 99mTc‑Pyrophosphate predominantly binds to microcalcifications and mineral changes associated with amyloid deposits formed in the heart wall. This binding, particularly in the ATTR type, leads to accumulation of the radiopharmaceutical in the affected areas, enabling imaging, whereas in the AL type, this accumulation is less pronounced.

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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‑PYP® kit is manufactured under aseptic conditions. After radiolabeling with a specified amount of sterile, non‑pyrogen sodium pertechnetate injection (Na99mTcO₄) — eluted from a 99Mo/99mTc 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 and five PYP kit vials, along with five labels specifically for the radiolabeling procedure.

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Composition

Sodium Pyrophosphate Decahydrate (14 mg)

Stannous Chloride Dihydrate

Ascorbic Acid

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Storage Conditions
  • Store the PARS‑PYP® kit in a refrigerator (2°C to 8°C) and protected from light. The cold chain must be maintained under all circumstances.
  • After radiolabeling, 99mTc‑Pyrophosphate remains stable for up to 6 hours at 15°C to 25°
  • The PARS‑PYP® kit should not be used after the expiration date.
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