FLUDEOXYGLUCOSE F 18- fludeoxyglucose f-18 injection

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Mayo Clinic

INN (שם בינלאומי):

FLUDEOXYGLUCOSE F-18

הרכב:

FLUDEOXYGLUCOSE F-18 240 mCi in 1 mL

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Fludeoxyglucose F 18 Injection USP 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 USP. It is also not known whether Fludeoxyglucose F 18 Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Consider alternative diagnostic tests in a pregnant woman; administer Fludeoxyglucose F 18 Injection USP only if clearly needed. It is not known whether Fludeoxyglucose F 18 Injection USP is excreted in human milk. Consider alternative diagnostic tests in women who are breast-feeding. Use alternatives to breast feeding (e.g., stored breast milk or infant formula) for at least 10 half-lives of radioactive decay, if Fludeoxyglucose F 18 Injection USP is administered to a woman who is breast-feeding. The safety and effectiveness of Fludeoxyglucose F 18 Injection USP in pediatric patients with epilepsy is established on the basis of studies in adult and pediatric patients. In pediatric patients with epilepsy, the recommended dose is 2.6 mCi. The optimal dose adjustment on the basis of body size or weight has not been determined. In the oncology or cardiology settings, the safety and effectiveness of Fludeoxyglucose F 18 Injection USP have not been established in pediatric patients.

leaflet_short:

Fludeoxyglucose F 18 Injection USP is supplied in a multi-dose, capped 30 mL glass vial containing between 0.740 – 8.88 GBq/mL (20 - 240 mCi/mL), of no carrier added 2­deoxy-2-[F 18] fluoro-D-glucose, at end of synthesis, in approximately 29 mL. The contents of each vial are sterile, pyrogen-free and preservative-free. NDC 52670-551-30 Store the Fludeoxyglucose F 18 Injection USP 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 USP 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 USP within 12 hours from the EOS time.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

FLUDEOXYGLUCOSE F 18- FLUDEOXYGLUCOSE F-18 INJECTION
MAYO CLINIC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUDEOXYGLUCOSE F18
INJECTION USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR FLUDEOXYGLUCOSE
F18 INJECTION USP.
FLUDEOXYGLUCOSE F18 INJECTION USP
INITIAL U.S. APPROVAL: 2005
RECENT MAJOR CHANGES
Warnings and Precautions: ( 5.1, 5.2) 7/2010
Adverse Reactions ( 6) 7/2010
INDICATIONS AND USAGE
Fludeoxyglucose F 18 Injection USP 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 USP 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 setting, 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 USP from its
container and
administer by intravenous injection (2). The recommended dose:
for adults is 5 – 10 mCi (185 – 370 MBq), in all i