A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Fdg Warnings, Precautions, Pregnancy, Nursing, Abuse - Fluorodeoxyglucose F18 Inj
Fdg Warnings, Precautions, Pregnancy, Nursing, Abuse - Fluorodeoxyglucose F18 Inj
WARNINGS
None known
PRECAUTIONS
General
[18F]FDG uptake may be changed by fasting or by blood sugar changes associated
with diabetic mellitus. Blood glucose levels should be stabilized in non-diabetic
patients by fasting before [18F]FDG injection. Diabetic patients may need stabilization
of blood glucose on the day preceding, and on the day of the [18F]FDG scan.
Patients should be monitored for arrhythmias and other manifestations of ischemia.
[18F]FDG, ClDG and their metabolites theoretically could inhibit glucose metabolism.
Their ability to potentiate the arrhythmogenic effects of ischemia has not been
studied.
The contents of each vial are sterile and non-pyrogenic. To maintain sterility,
aseptic technique must be used during all operations involved in the manipulation
and administration of [18F]FDG.
[18F]FDG should be used within 12 hours of the end of synthesis (EOS).
As with any other radioactive material, appropriate shielding should be used
to avoid unnecessary radiation exposure to the patient, occupational workers,
and other persons.
Radiopharmaceuticals should be used only by physicians who are qualified by
specific training in the safe use and handling of radionuclides.
Carcinogenesis, Mutagenesis,
Impairment of Fertility
Studies with [18F]FDG have not been performed to evaluate carcinogenic potential,
mutagenic potential or effects on fertility.
Teratogenic Effects: Pregnancy
Category C
Animal reproduction studies have not been conducted with [18F]FDG. It is not
known whether [18F]FDG can cause fetal harm when administered to a pregnant
woman or can affect reproduction capacity. Therefore, [18F]FDG should not be
administered to a pregnant woman unless the potential benefit justifies the
potential risk to the fetus.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs
are excreted in human milk, caution should be exercised when [18F]FDG is administered
to a nursing woman.
Pediatric Use
See Clinical Trials Section.
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