FLUDEOXYGLUCOSE F 18 injection

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

NukeMed, Inc. dba SpectronRx

INN (Международно Name):

FLUDEOXYGLUCOSE F-18

Композиция:

FLUDEOXYGLUCOSE F-18 500 mCi in 1 mL

Начин на приложение:

INTRAVENOUS

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

1 INDICATIONS AND USAGE Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: 1.1 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. 1.2 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. 1.3 Neurology For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. 4 CONTRAINDICATIONS None 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Fludeoxyglucose F 18 Injection. It is also not

Каталог на резюме:

16 HOW SUPPLIED Fludeoxyglucose F 18 Injection is supplied in a multi-dose, capped 10-50 mL glass vial containing between 0.15 – 18.5 GBq/mL (4 - 500 mCi/mL), of no carrier added 2-deoxy-2-[F-18] fluoro-D-glucose, at end of synthesis, in approximately 5 - 50 mL. The contents of each vial are sterile, pyrogen-free and preservative-free. 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.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

FLUDEOXYGLUCOSE F 18- FLUDEOXYGLUCOSE F 18 INJECTION
NUKEMED, INC. DBA SPECTRONRX
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUDEOXYGLUCOSE F18 INJECTION. SEE FULL
PRESCRIBING INFORMATION FOR FLUDEOXYGLUCOSE F18 INJECTION.
INITIAL U.S. APPROVAL 1994
INDICATIONS AND USAGE
(1)
INDICATIONS AND USAGE (1)
(1)
(1)
Fludeoxyglucose F18 Injection is indicated for positron emission
tomography (PET) imaging in the following settings: (1)
• 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).
(1)
(1)
DOSAGE AND ADMINISTRATION
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 indicated
clinical settings(2.1).
• for pediatric patients is 2