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PARS‑MDP® Kit

 Sterile, NonPyrogen Lyophilized Powder

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

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

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Applications
  • Diagnosis and follow‑up of bone metastases from various cancers
  • Detection of bone lesions and abnormal bone growth
  • Diagnosis of fractures not visible on radiography
  • Diagnosis of osteomyelitis (inflammation of bone or bone marrow caused by bacteria, fungi, or viruses)
  • Diagnosis of reflex sympathetic dystrophy (a type of regional pain syndrome that causes severe bone pain following trauma)
  • Evaluation of infection in hip joint prostheses
  • Diagnosis of increased osteoclastic activity (Paget’s disease)
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Mechanism of Action

The mechanism of action of 99mTc‑Medronate in bone is primarily governed by blood flow and osteoblastic activity. Bone areas that show increased blood flow and increased osteoblastic activity result in higher uptake of the radiopharmaceutical, providing detailed images of the bone.

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

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Composition

Methylene Diphosphonic Acid (5 mg)

Stannous Chloride Dihydrate

Ascorbic Acid

Sodium Chloride

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