FLUDEOXYGLUCOSE F-18 injection

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Pharmalogic South Carolina, LLC

INN:

FLUDEOXYGLUCOSE F-18

composition:

FLUDEOXYGLUCOSE F-18 300 mCi in 1 mL

administration_route:

INTRAVENOUS

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 diagnoses 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 ventriclar 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 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 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 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 or multi-dose capped 10 mL glass vial containing between 0.740 GBq/mL - 11.1 GBq/mL (20 mCi/mL - 300 mCi/mL), of no carrier added 2-deoxy-2-[18F]fluoro-D-glucose, at end of synthesis, in approximately 23 mL - 30mL or 2 mL - 10mL respectively. The contents of each vial are sterile, pyrogen-free and preservative-free. NDC 16129-001-30 and NDC 16129-001-10 This radiopharmaceutical is licensed by the Nuclear Regulatory Commission, for distribution to entities licensed pursuant to 10 CFR 35.200 or under the equivalent licenses of an Agreement State or Licensing State. Store the Fludeoxyglucose F 18 Injection, USP vial upright in a lead shielded container at 20ºC - 25ºC (68ºF - 77ºF); excursions permitted to 15ºC - 30ºC (59ºF - 86ºF)[See USP Controlled Room Temperature]. 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.

authorization_status:

Abbreviated New Drug Application

SPC

FLUDEOXYGLUCOSE F-18- FLUDEOXYGLUCOSE F-18 INJECTION
PHARMALOGIC SOUTH CAROLINA, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUDEOXYGLUCOSE F 18
INJECTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR FLUDEOXYGLUCOSE F
18 INJECTION, USP.
FLUDEOXYGLUCOSE F 18 INJECTION, USP FOR INTRAVENEOUS USE.
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 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 hours - 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 grams - 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 a