FLUDEOXYGLUCOSE F 18 injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Decatur Memorial Hospital

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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 dose. Howeve

Product summary:

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 2‑deoxy-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 73410-003-01 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUDEOXYGLUCOSE F 18- FLUDEOXYGLUCOSE F 18 INJECTION
DECATUR MEMORIAL HOSPITAL
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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
INDICATIONS AND USAGE
Fludeoxyglucose F18 Injection, USP is indicated for positron emission
tomography (PET) imaging in the following settings:
•
•
•
DOSAGE AND ADMINISTRATION
Fludeoxyglucose F18 Injection emits radiation. Use procedures to
minimize radiation exposure. Screen for blood glucose
abnormalitie s.
•
•
Aseptically withdraw Fludeoxyglucose F 18 Injection from its container
and administer by intravenous injection (2).The
recommended dose:
•
•
Initiate imaging within 40 minutes following drug injection; acquire
static emission images 30–100 minutes from time of
injection (2).
DOSAGE FORMS AND STRENGTHS
Multiple-dose glass vial containing 0.74 GBq –11.1 GBq (20
mCi/mL–300 mCi/mL) of Fludeoxyglucose F18 Injection and
4.5 mg of sodium chloride in citrate buffer (approximately 20 mL
volume), for intravenous administration (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
Hypersensitivity reactions have occurred; have emergency resuscitation
equipment and personnel immediately available
(6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT DECATUR MEMORIAL
HOSPITAL AT 800-826-2827 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
•
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
cance r.
Cardiology: For the identification of left ventricular myocardium with
residual glucose metabolism and reversible loss
of systolic function in patients with coronary ar