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Eczacıbaşı-Monrol Nuclear Products, an equal share joint venture between Monrol Nuclear Products Inc. and Eczacıbaşı Pharmaceuticals Manufacturing that was established in 2008, leads the development of Turkey's nuclear medicine market through the production of high-quality radiopharmaceuticals for diagnosis and treatment.


MON.FDG (18F) I.V. Injectable Solution

Content

Lead shielded, glass vial contains sterile, non-pyrogenic, colorless or light yellow, clear injectable solution of 2-(18F)-Floro-2-deoxy-D-glucose ((18F) FDG)


Description

MON.FDG (18F) is a radiopharmaceutical product used for diagnostic purposes. Fluorine-18 (18F) is a radionuclide with a half-life of 109.8 minutes, decays to stable Oxygen-18 (18O) by emitting a positron with maximum energy of 634 keV, followed by photonic annihilation radiations of 511 keV.


Calibration Activities

250- 18500 MBq (16 - 500 mCi) / Vial


Production Days

Everyday except Sundays


Shelf Life

10 hours after production time


Storage

At room temperature below 30 0C, in lead shield


Packaging

Type I glass vial with bromobutyl rubber stopper in the lead shield


Disposal of Waste Materials

Any unused product or waste material should be disposed of in accordance with local requirements.

MON.TEK Mo99/ Tc99m Generator

Content

Mother nuclide: Sodium Molibdate (Na99MoO4) 10-40 GBq/ Generator (Mo-99 radioactivity at calibration date)Daughter nuclide: (99mTc) Sodium Pertechnetate (Na99mTcO4) (derived from 99Mo/99mTc generator system)


Description

MON.TEK 99Mo/99mTc generator contains fission Molibdenium-99 (99Mo) adsorbed by aluminum oxide (Al2O3) in a glass column. Technetium-99m (99mTc) formed by the decay of 99Mo, is a radiactive isotope having a half life of 6.007 hours. After eluting by 0.9% NACl solution, 99mTc Sodium Pertechnetate solution which is isotonic, colourless, clear, sterile, non-pyrogenic and suitable for I.V. injection is obtained. (99mTc) Sodium Pertechnetate solution can be administrated to the patients directly as a diagnostic agent or for labeling the kits.


Calibration Activities

10, 15, 20, 25, 30, 35, 40 GBq (Given values are for 99Mo activity on calibration date)


Production Days

Wednesday and Saturday


Calibration Day

Next Thursday (8 a.m.) after production or other days depending on request


Shelf Life

Generator: 21 days from the date of production

Eluate: 12 hours after elution time


Storage

Generator: At room temperature below 25 0C, in lead shield (Do not freeze)

Eluate : At room temperature below 25 0C , protected from light in lead shield


Packaging

Generator set:

1 unit 99Mo/99mTc radionuclide generator

5 vials of 10mL and 5 vials of 5 mL sterile, non-pyrogenic 0.9% NaCl solution in the box,

2 x 5 units sterile, non-pyrogenic evacuated vials in the box,

10 units elution label for vial and 10 units label for lead shield,

10 units of swab with alcohol of 70% isopropyl,

Patient Information Leaflet.


Disposal of Waste Materials

Any unused product or waste material should be disposed of in accordance with local requirements.

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