FLUDEOXYGLUCOSE F18- fludeoxyglucose f-18 injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Wisconsin Medical Cyclotron LLC

INN (Διεθνής Όνομα):

Fludeoxyglucose F-18

Σύνθεση:

Fludeoxyglucose F-18 500 mCi in 1 mL

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Fludeoxyglucose F18 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 F18 Injection, USP. It is also not known whether Fludeoxyglucose F18 Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Consider alternative diagnost

Περίληψη προϊόντος:

Fludeoxyglucose F18 Injection, USP is supplied in a multi-dose, capped 30 mL glass vial containing between 0.740 – 18.5 GBq/mL (20 - 500 mCi/mL), of no carrier added 2-deoxy-2-[F18] fluoro-D-glucose, at end of synthesis, in approximately 13 - 30 mL. The contents of each vial are sterile, pyrogen-free and preservative-free. NDC 44338-001-30 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15-30°C (59 - 86°F) [See USP Controlled Room Temperature]. Store and dispose of Fludeoxyglucose F18 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 F18 Injection, USP within 12 hours from the EOS time.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

FLUDEOXYGLUCOSE F18- FLUDEOXYGLUCOSE F-18 INJECTION, SOLUTION
WISCONSIN MEDICAL CYCLOTRON LLC
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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 F18 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 F18 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 F18 Injection, USP from its
container and administer by intravenous injection (2).
The recommended dose:
for adults is 5 – 10 mCi (185 –