FLUDEOXYGLUCOSE F-18 injection, solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Precision Nuclear, LLC

INN (Nama Internasional):

FLUDEOXYGLUCOSE F-18

Komposisi:

FLUDEOXYGLUCOSE F-18 500 mCi in 1 mL

Rute administrasi :

INTRAVENOUS

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 Risk Summary Data from published case series and case reports describe Fludeoxyglucose F 18 Injection crossing the placenta with uptake by the fetus (see Data). All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation d

Ringkasan produk:

Fludeoxyglucose F 18 Injection is supplied in a multi-dose, capped 30-mL or 50-mL glass vial containing between 0.74 to 18.5 GBq/mL (20 to 500 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D-glucose, at end of synthesis, in approximately 23 to 30 mL. The contents of each vial are sterile, pyrogen-free and preservative-free. 30-mL vials: NDC 52768-001-30 50-mL vials: NDC 52768-001-50 This radiopharmaceutical is licensed by the State of Tennessee, Department of Environment and Conservation for distribution to entities licensed pursuant to Chapter 1200-02-07 Division of Radiological Health Regulations or under equivalent licenses of an Agreement State or a Licensing State. Store the Fludeoxyglucose F 18 Injection vial upright in a lead shielded container at 20 to 25℃ (68 to 77°F); excursions permitted to 15 to 30℃ (59 to 86°F) [see USP Controlled Room Temperature ]. 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 otorisasi:

Abbreviated New Drug Application

Karakteristik produk

FLUDEOXYGLUCOSE F-18- FLUDEOXYGLUCOSE F-18 INJECTION, SOLUTION
PRECISION NUCLEAR, LLC
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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 USP, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2005
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. (1.1)
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.
(1.2)
Neurology: For the identification of regions of abnormal glucose
metabolism associated with foci of
epileptic seizures. (1.3)
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 to 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 to 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 to 10 mCi (185 to 370 MBq), in all indicated clinical
settings (2.1).
for pediatric patients is 2.6 mCi