FLUDEOXYGLUCOSE F18 injection

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

The Regents of the University of Michigan

INN (nemzetközi neve):

FLUDEOXYGLUCOSE F-18

Összetétel:

FLUDEOXYGLUCOSE F-18 300 mCi in 1 mL

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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. Risk Summary - 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. However, published studies that describe Fludeoxyglucose F 18 Injection use in pregnant women have not identified a risk of drug-associated major birth defects, miscarriage, or adverse maternal or fetal outcomes. If considering Fludeoxyglucose F 18 Injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Fludeoxyglucose F 18 Injection and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. Data Human Data Data from published case series and case reports describe Fludeoxyglucose F 18 Injection crossing the placental barrier and visualization of radioactivity throughout the body of the fetus. The estimated fetal absorbed radiation dose from the maximum labeled dose (370 MBq) of Fludeoxyglucose F 18 was 10mGy with first trimester exposure to PET alone and 20mGy with first trimester exposure to PET/CT scan combination. Long-term adverse radiation effects to a child exposed to Fludeoyxglucose F 18 Injection in utero are unknown. No adverse fetal effects or radiation-related risks have been identified for diagnostic procedures involving less than 50mGy, which represents less than 20mGy fetal doses. Risk Summary A published case report and case series show the presence of Fludeoxyglucose F 18 Injection in human milk following administration. There are no data on the effects of Fludeoxyglucose F 18 Injection on the breastfed infant or the effects on milk production. Exposure of Fludeoxyglucose F 18 Injection to a breastfed infant can be minimized by temporary discontinuation of breastfeeding (see Clinical Considerations). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Fludeoxyglucose F 18 Injection, any potential adverse effects on the breastfed child from Fludeoxyglucose F 18 Injection or from the underlying maternal condition. Clinical Considerations To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breastmilk and avoid close (breast) contact with the infant for at least 9 hours after the administration of Fludeoxyglucose F 18 Injection. The safety and effectiveness of Fludeoxyglucose F 18 Injection in pediatric patients with epilepsy is established on the basis of studies in adult and pediatric patients. In pediatric patients with epilepsy, the recommended dose is 2.6 mCi. The optimal dose adjustment on the basis of body size or weight has not been determined. In the oncology or cardiology settings, the safety and effectiveness of Fludeoxyglucose F 18 Injection have not been established in pediatric patients.

Termék összefoglaló:

Fludeoxyglucose F 18 Injection is supplied in a multi-dose, capped glass vial containing between 0.037– 11.1GBq/mL (1- 300 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D-glucose, at end of synthesis, in approximately 24 - 26 mL.  The contents of each vial are sterile, pyrogen-free and preservative-free. NDC: 76326-001-20 Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate. 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.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

FLUDEOXYGLUCOSE F18- FLUDEOXYGLUCOSE F18 INJECTION
THE REGENTS OF THE UNIVERSITY OF MICHIGAN
----------
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 FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2005
INDICATIONS AND USAGE
Fludeoxyglucose F 18 Injection 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 F 18 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 F 18 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 2.6 mCi in the