FLUDEOXYGLUCOSE F18 injection

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH

INN (Nama Antarabangsa):

FLUDEOXYGLUCOSE F-18

Komposisi:

FLUDEOXYGLUCOSE F-18 300 mCi in 1 mL

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 pregnant woman; administer Fludeoxyglucose F 18 Injection only if clearly needed. It is not known whether Fludeoxyglucose F 18 Injection 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 is administered to a woman who is breast-feeding. The safety and effectiveness of Fludeoxyglucose F 18 Injection in pediatric patients with epilepsy is established on the basis of studies in adult and

Ringkasan produk:

Fludeoxyglucose F 18 Injection is supplied in a multi-dose, capped 20 mL glass vial containing between 0.740 – 11.1GBq/mL (20 - 300 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D-glucose, at end of synthesis, in approximately 16 - 17 mL.  The contents of each vial are sterile, pyrogen-free and preservative-free. NDC 13267-123 -23 This radiopharmaceutical is licensed by the State of New York, Department Of Health, Bureau of Environmental Radiation Protection, for distribution to persons licensed pursuant to New York's Regulatory Code for Radioactive material specified in Chapter 1-Part 16 of the State Sanitary Code, as appropriate, or under equivalent licenses of an Agreement State or Licensing State. 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.

Status kebenaran:

New Drug Application

Ciri produk

FLUDEOXYGLUCOSE F18 - FLUDEOXYGLUCOSE F18 INJECTION
THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUDEOXYGLUCOSE F18 INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUDEOXYGLUCOSE F18
INJECTION. FLUDEOXYGLUCOSE F18
INJECTION 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 F18 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 F18 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 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 F18 Injection from its container
and administer by intravenous injection (2). The
recommended dose:
for adults is 5 – 10 mCi (185 – 370 MBq), in all