FLUDEOXYGLUCOSE F-18 injection

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:

Cardinal Health 414, LLC

INN (Διεθνής Όνομα):

FLUDEOXYGLUCOSE F-18

Σύνθεση:

FLUDEOXYGLUCOSE F-18 300 mCi in 1 mL

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Fludeoxyglucose F-18 Injection 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 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; admin

Περίληψη προϊόντος:

Fludeoxyglucose F-18 Injection is supplied in a multi-dose, capped 30 mL glass vial containing between 0.74 - 18.5 GBq (20 - 500 mCi/mL), of no carrier added 2-deoxy-2-[F-18] fluoro-D-glucose, at end of synthesis, in approximately 2 - 30 mL. The contents of each vial are sterile, pyrogen-free and preservative-free. NDC 65857-150-30 0.74 - 18.5 GBq (20 - 500 mCi/mL) Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements for the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate. Store the Fludeoxyglucose F-18 Injection vial upright in a lead or tungsten alloy shielded container at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). The expiration date and time are provided on the container label. Use Fludeoxyglucose F-18 Injection within 12 hours from the EOS time.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

FLUDEOXYGLUCOSE F-18- FLUDEOXYGLUCOSE F-18 INJECTION
CARDINAL HEALTH 414, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUDEOXYGLUCOSE F-18 INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUDEOXYGLUCOSE F-18
INJECTION.
FLUDEOXYGLUCOSE F-18 INJECTION, USP
INITIAL U.S. APPROVAL: 2005
INDICATIONS AND USAGE
Fludeoxyglucose F-18 Injection is indicated for positron emission
tomography (PET) imaging in the following settings:
•
•
•
DOSAGE AND ADMINISTRATION
Fludeoxyglucose F-18 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 - 18.5 GBq (20 - 500 mCi/mL)
of Fludeoxyglucose F-18 Injection and 4.5 mg of
sodium chloride in citrate buffer (approximately 2 - 30 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 CARDINAL HEALTH AT
1-800-618-2768 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 cancer
(1).
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 dy