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PARS‑MIBI® Kit

 Sterile, NonPyrogen Lyophilized Powder

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KIT FOR THE PREPARTION OF Tc-99m-SestaMIBI INJECTION
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SPECT Imaging
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Diagnostic
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About the Product

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

radiopharmaceutical kits , Diagnostic/SPECT - mibi
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Applications
  • Evaluation of cardiac function (myocardial perfusion scan)
  • Detection of possible abnormalities in breast tissue
  • Imaging and diagnosis of parathyroid hyperfunction (hyperparathyroidism)
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Mechanism of Action

The active substance MIBI, which belongs to the isonitrile family, is a lipophilic cationic molecule with affinity for tissues that exhibit both high mitochondrial content and negative plasma membrane potential. Diagnosis with the radiopharmaceutical 99mTc‑SestaMIBI, also known as myocardial perfusion scan, is used to produce images that demonstrate blood flow to the heart muscle. Cardiac uptake of the 99mTc‑SestaMIBI complex is proportional to local myocardial blood flow, reaching a maximum of approximately 1.5% under stress conditions and about 1% at rest.

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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‑MIBI® 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 MIBI kit vials, along with five labels specifically for the radiolabeling procedure.

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Composition

Copper (I) Tetramibi Tetrafluoroborate (0.5 mg)

Stannous Chloride Dihydrate

Glycine

Sodium Pyrophosphate

L‑Cysteine Hydrochloride Monohydrate

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Storage Conditions
  • Store the PARS‑MIBI® 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‑SestaMIBI remains stable for up to 6 hours at 15°C to 25°
  • The PARS‑MIBI® kit should not be used after the expiration date.
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