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Monrol Products
About Compnay
Monrol
Monrol is a CDMO, providing early development support to its customers as well as oering fully
integrated services
for today’s nimble, lean, virtual companies eectively taking new produc concepts into clinical trials,
demonstrating proof of concept and going int rst-in-human studies. Monrol is committed to transform
and improve patient
journey in cancer treatment with its radiopharmaceutical products portfolio
distributing to more than 60 countries around the globe.
MON.FDG (18F)
Content
Lead shielded, glass vial contains sterile, non-pyrogenic, colorless or light yellou clear injectable solution of 2-(18F)-Floro-2-deoxy-D-glucose ((18F) FDG)
Description
MON.FDG (18F) is a radiopharmaceutical product used for diagnostic purpose:
Fluorine-18 (18F) is a radionuclide with a half-life of 109.8 minutes, decays ti stable Oxygen-18 (180) by emitting a positron with maximum energy of 634 kel 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 a 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 99Mo /99MTC GENERATOR
Content
Mother nuclide: Sodium Molibdate (Na99Mo04) 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 (A|203) in a glass column. Technetium-99m (99mTc) formed by the decay of 99Mo, is a radi-active isotope having a half life of 6.007 hours. After eluting by 0.9% NACI 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 OC, in lead shield (Do not freeze)
Eluate: At room temperature below 25 OC, 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 × 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.
