FLUDEOXYGLUCOSE F 18- fludeoxyglucose f-18 injection

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

Fludeoxyglucose F-18 (UNII: 0Z5B2CJX4D) (Fludeoxyglucose F-18 - UNII:0Z5B2CJX4D)

متاح من:

Kettering Medical Center

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures None. Pregnancy Category C Animal reproduction studies have not been conducted with Fludeoxyglucose F 18 Injection. It is also not known whether Fludeoxyglucose F 18 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Consider alternative diagnostic tests in a p

ملخص المنتج:

Fludeoxyglucose F 18 Injection is supplied in a multi-dose form, capped glass vial containing between 0.148 - 1,480 MBq (4 - 40 mCi/mL), of no carrier added 2-deoxy-2-[18 F]fluoro-D-glucose, at end of synthesis, in approximately 20 mL. The contents of each vial are sterile, pyrogen-free and preservative-free. Store the Fludeoxyglucose F 18 Injection vial upright in a lead shielded container at 25°C (77°F); excursions permitted to 15- 30°C (59-86°F). Store and dispose of Fludeoxyglucose F 18 Injection in accordance with the regulations and a general license, or its equivalent, of an Agreement State or a Licensing State. The expiration date and time are provided on the container label. Use Fludeoxyglucose F 18 Injection within 12 hours from the EOS time.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

FLUDEOXYGLUCOSE F 18- FLUDEOXYGLUCOSE F-18 INJECTION
KETTERING MEDICAL CENTER
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUDEOXYGLUCOSE F 18
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FLUDEOXYGLUCOSE F 18
INJECTION.
FLUDEOXYGLUCOSE F 18 INJECTION FOR INTRAVENOUS USEINITIAL U.S.
APPROVAL: 1994
RECENT MAJOR CHANGES
Warnings and Precautions: (5.1, 5.2) 7/2010
Adverse Reactions (6) 7/2010
INDICATIONS AND USAGE
Fludeoxyglucose F 18 Injection is indicated for positron emission
tomography (PET) imaging in the following
settings:
Oncology: For assessment of abnormal glucose metabolism to assist in
the evaluation of malignancy in
patients with known or suspected abnormalities found by other testing
modalities, or in patients with an
existing diagnosis of cancer.
Cardiology: For the identification of left ventricular myocardium with
residual glucose metabolism and
reversible loss of systolic function in patients with coronary artery
disease and left ventricular
dysfunction, when used together with myocardial perfusion imaging.
Neurology: For the identification of regions of abnormal glucose
metabolism associated with foci of
epileptic seizures (1).
DOSAGE AND ADMINISTRATION
Fludeoxyglucose F 18 Injection emits radiation. Use procedures to
minimize radiation exposure. Screen for
blood glucose abnormalities.
In the oncology and neurology settings, instruct patients to fast for
4 - 6 hours prior to the drug's
injection. Consider medical therapy and laboratory testing to assure
at least two days of
normoglycemia prior to the drug's administration (5.2).
In the cardiology settings, administration of glucose-containing food
or liquids (e.g., 50 - 75 grams) prior
to the drug's injection facilitates localization of cardiac ischemia
(2.3).
Aseptically withdraw Fludeoxyglucose F 18 Injection from its container
and administer by intravenous
injection (2). The recommended dose:
For adults is 5 - 10 mCi (185 - 370 MBq), in all indicated