FDG PUTRA INJECTION

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

2-DEOXY-2-[18F] FLOURO-D-GLUCOSE

Available from:

Fasiliti Penyediaan Radiofarmaseutikal-Siklotron

INN (International Name):

2-DEOXY-2-[18F] FLOURO-D-GLUCOSE

Units in package:

10ml mL

Manufactured by:

Fasiliti Penyediaan Radiofarmaseutikal-Siklotron

Summary of Product characteristics

FDG PUTRA INJECTION
DESCRIPTION
FDG Putra Injection is a radio labeled analog of glucose which is used
for diagnostic
purposes in conjunction with Positron Emission Tomography (PET). It is
administered by
intravenous route.
ACTIVE INGREDIENT
The active ingredient of FDG Putra Injection is 2-deoxy-2-[
18
F] fluoro-D-glucose,
abbreviated [
18
F] FDG, has a molecular weight of C
6
H
11
18
FO
5
with a molecular weight of
181.26 daltons, and has the following chemical structure:
FDG Putra Injection is supplied as a ready to use sterile, pyrogen
free, clear and
colourless solution. The pH of the solution is between 4.5-8.5. This
solution is packed in
a 10 ml sterile glass vial. In each mL of FDG Putra Injection contains
370-9250 MBq
(10-250 mCi).
PHYSICAL CHARACTERISTIC
Fluorine F-18 decays by positron (ß
+
) emission and has a half-life of 109.7 minutes. The
principal photons useful for diagnostic imaging are the 511 keV gamma
photons,
resulting from the interaction of the emitted positron with an
electron (Table 1).
TABLE 1.PRINCIPAL EMISSION DATA FOR FLUORINE F 18
RADIATION/EMISSION
% PER DISINTEGRATION
MEAN ENERGY
Positron (β
+
)
96.73
249.8 keV
Gamma (±)
*
193.46
511.0 keV
*Produced by positron annihilation
From: Kocher, D.C. “Radioactive Decay Tables” DOE/TIC-11062,89
(1981)
TABLE DECAY FACTORS
For use in correcting for physical decay of this radionuclide, the
fractions remaining at
selected intervals after calibration are shown in Table 2.
TABLE 2. PHYSICAL DECAY CHART FOR FLUORINE F 18
MINUTES
FRACTION REMAINING
0*
1.00
15
0.909
30
0.826
60
0.683
110
0.500
220
0.250
440
0.060
* Calibration time
PHARMACODYNAMICS
FDG Putra Injection is rapidly distributed to all organs of the body
after intravenous
administration. After background clearance of FDG Putra Injection,
optimal PET imaging
is generally achieved between 30 to 40 minutes after administration.
In cancer, the cells are generally characterized by enhanced glucose
metabolism partially
due to (1) an increase in activity of glucose transporters, (2) an