Lutetium (Lu) Chloride: Radiopharmaceutical Precursor, Solution

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Lutetium (177Lu) Chloride

Radiopharmaceutical Precursor, Solution


Lutetium (177Lu) Chloride
Radiopharmaceutical Precursor, Solution

Manufacturing Date Every Sunday

Packaging 10 ml Type I, Flat Bottle, Glass Vial

Half-life 6,648 days

Chemical Form LuCl3 in 0,05 M HCl

Radiochemical Concentration 37 GBq / mL


≥ 99.9% Lutetium-177
Radionuclide Purity ≤ 0.07% Lutetium-177m
≤ 0.01% Other Impurities
Cu ≤ 1.0 µg/GBq
Fe ≤ 0.5 µg/GBq
Chemical Purity
Pb ≤ 0.5 µg/GBq
Zn ≤  1.0 µg/GBq
Shelf life 8 days after production
Content
35 mg diethylene triamine penta acetic acid calcium trisodium hydrate

Description
10 mL glass vial contains sterile, white colored, 35 mg lyophilized powder. It is not administered
to the patients directly. In nuclear medicine, it is used with Technetium-99m via intravenous,
intrathecal, inhalation or oral routes for diagnostic purposes. 99mTc-DTPA solution is used with
synthigraphic metod as a diagnostic agent in neurology, pulmonary imaging (with a nebulizer)
gastroenterology and nephrology.

Shelf Life
MON.DTPA KIT : 24 months
99m
Tc-DTPA solution : 8 hours

Storage
MON.DTPA KIT : At 2-8 0C in a refrigerator and protected from light
99m
Tc-DTPA solution : At room temperature below 25 0C, in lead shield, protected from light

Packaging
In a cardbord box, type I glass vial with bromobutyl rubber stopper and aluminium flip-off cap
(5 vials/box)

Disposal of Waste Materials


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

Content
10 mg methylenediphosphonic acid(MDP)

Description
10 mL glass vial contains white colored, sterile 10 mg lyophilized powder for I.V. injection. It is
not administered to the patients directly. It is used with technetium-99m via I.V. injection in
nuclear medicine for diagnostic purposes. 99mTc-MDP solution is used as a diagnostic agent for
investigating bone diseases.

Shelf Life
MON.MDP KIT : 24 months
99m
Tc-MDP Solution : 8 hours

Storage
MON.MDP KIT : At 2-8 0C in a refrigerator and protected from light
99m
Tc-MDP solution : At room temperature below 25 0C, in lead shield, protected from light

Packaging
In a cardboard box, type I glass vial with bromobutyl rubber stopper and aluminium flip-off cap
(5 vials/box)

Disposal of Waste Materials


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

Marketing authorisation number: 08.12.2011 - 243 / 77


Revision date: 00 / 2018

ECZACIBAŞI-MONROL NÜKLEER
ÜRÜNLER SAN. VE TİC. A.Ş.
Barbaros Mah. Sütçüyolu Cad.
No:72/A Ataşehir/İstanbul
Phone: +90.216 544 0 544 (pbx)
Fax: +90.216 472 41 48
E-Mail: [email protected]
www.monrol.com.tr
MON.DMSA KIT

Content
1.0 mg dimercaptosuccinic acid (DMSA)

Description
10 mL glass vial contains white colored, sterile 1.0 mg lyophilized powder for I.V. injection. It
is not administered to the patients directly. It is used with technetium-99m via I.V. injection in
nuclear medicine for diagnostic purposes.
99m
Tc-DMSA solution is used as a diagnostic agent for investigating kidney diseases.

Shelf Life
MON.DMSA KIT : 24 months
99m
Tc-DMSA solution : 8 hours

Storage
MON.DMSA KIT : At 2-8 0C in a refrigerator and protected from light
99m
Tc-DMSA solution : At room temperature below 25 0C, in lead shield, protected from light

Packaging
In a cardboard box type I glass vial with bromobutyl rubber stopper and aluminium flip-off cap
(5 vials/box)

Disposal of Waste Materials


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

Marketing authorisation number: 03.08.2010 - 229 / 58


Ruhsat no:Revision date: -00
05.02.2010 223/ 2018
/ 48
Revizyon tarihi: 00 / 2018
ECZACIBAŞI-MONROL NÜKLEER
ÜRÜNLER SAN. VENÜKLEER
ECZACIBAŞI-MONROL TİC. A.Ş.
ÜRÜNLER SAN.
Barbaros Mah. VE TİC. A.Ş.
Sütçüyolu Cad.
Barbaros Mah. Sütçüyolu Cad. No:72/A Ataşehir/İstanbul
Phone: +90.216 544 0 544 (pbx)
Telefon:
Fax: +90.216 472 41 48
Faks:
E-Mail: [email protected]
[email protected]
www.monrol.com.tr
MON.MIBI KIT

Content
1.0 mg tetrakis (2-methoxyisobutylisonitrile) copper (I) tetrafluoroborate (MIBI)

Description
10 mL glass vial contains white colored, sterile 1.0 mg lyophilized powder for I.V. injection. It
is not administered to the patients directly. It is used with technetium-99m via I.V. injection in
nuclear medicine for diagnostic purposes. 99mTc-MIBI solution is used as a diagnostic agent for
investigating cardiac diseases, breast imaging and parathyroid imaging.

Shelf Life
MON.MIBI KIT : 24 months
99m
Tc-MIBI solution : 8 hours

Storage
MON.MIBI KIT : At 2-8 0C in a refrigerator and protected from light
99m
Tc-MIBI solution : At room temperature below 25 0C, in lead shield, protected from light

Packaging
In a cardboard box, type I glass vial with bromobutyl rubber stopper and aluminium flip-off cap
(5 vials/box)

Disposal of Waste Materials


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

Marketing authorisation number: 23.02.2010 - 226 / 52


Revision date: 00 / 2018

ECZACIBAŞI-MONROL NÜKLEER
ÜRÜNLER SAN. VE TİC. A.Ş.
Barbaros Mah. Sütçüyolu Cad.
No:72/A Ataşehir/İstanbul
Phone: +90.216 544 0 544 (pbx)
Fax: +90.216 472 41 48
E-Mail: [email protected]
www.monrol.com.tr

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