FLUDEOXYGLUCOSE F 18- fludeoxyglucose f 18 injection

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Global Isotopes, LLC d/b/a Zevacor Molecular

INN (Kansainvälinen yleisnimi):

FLUDEOXYGLUCOSE F-18

Koostumus:

FLUDEOXYGLUCOSE F-18 20 mCi in 1 mL

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 abnormality 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. ( 4) Pregnancy Category C Animal reproduction studies have not been conducted with Fludeoxyglucose F18 Injection. It is also not known whether Fludeoxyglucose F18 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  Consider alternative diagnostic te

Tuoteyhteenveto:

Fludeoxyglucose F18 Injection, USP is supplied in a multi-dose, capped 30 mL glass vial containing between 0.740 GBq/mL–11.1 GBq/mL (20 mCi/mL—300 mCi/mL), of no carrier added 2­deoxy-2-[F 18] fluoro-D-glucose, at end of synthesis, in approximately 20 mL.  The contents of each vial are sterile, pyrogen-free and preservative-free. NDC 69126-003-01 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.  Storage Store the Fludeoxyglucose F18 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 F18 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 F18 Injection within 12 hours from the EOS time. 

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

FLUDEOXYGLUCOSE F 18- FLUDEOXYGLUCOSE F 18 INJECTION
GLOBAL ISOTOPES, LLC D/B/A ZEVACOR MOLECULAR
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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 F 18
INJECTION, USP. FLUDEOXYGLUCOSE F 18
INJECTION, USP, FOR INTRAVENOUS 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 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 emits radiation. Use procedures to
minimize radiation exposure. Screen for blood glucose
abnormalitie s.
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 F 18 Injection from its container
and administer by intravenous injection ( 2).The
recommended dose:
For adults