Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
CHOLINE C-11 (UNII: M4AS4XGD4Q) (CHOLINE C-11 - UNII:M4AS4XGD4Q)
Global Isotopes, LLC d/b/a Zevacor Molecular
CHOLINE C-11
CHOLINE C-11 4 mCi in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Choline C11 Injection is indicated for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI). In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limitation of Use : 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer. None. There are no adequate and well controlled studies with Choline C11 Injection in pregnant women and the fetal radiation dose from a 11 C-choline PET imaging study is unknown. It is not known whether Choline C11 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capa
Choline C 11 Injection is packaged in a multi-dose glass vial containing between 148 MBq to 1225 MBq (4 mCi to 33.1 mCi) of 11 C- choline at EOS calibration time in aqueous 0.9% sodium chloride solution (approximately 10 mL volume). Store Choline C 11 Injection at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) (see USP Controlled Room Temperature). Use the solution within 120 minutes of EOS calibration.
Abbreviated New Drug Application
CHOLINE C 11- CHOLINE C11 INJECTION GLOBAL ISOTOPES, LLC D/B/A ZEVACOR MOLECULAR ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CHOLINE C11 INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CHOLINE C11 INJECTION. CHOLINE C11 INJECTION FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2012 INDICATIONS AND USAGE These highlights do not include all the information needed to use Choline C11 Injection safely and effectively. See full prescribing information for Choline C11 Injection. CHOLINE C11 Injection for intravenous use Initial U.S. Approval: 2012 Choline C 11 Injection is a radioactive diagnostic agent for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging. In these patients, C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limitation of Use: C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer ( 1). DOSAGE AND ADMINISTRATION Aseptically withdraw Choline C 11 Injection from its container and administer 370 to 740 MBq (10 to 20 mCi) as a bolus intravenous injection. The radioactivity dose (370 to 740 MBq, 10 to 20 mCi) is chosen based on patient body dimensions and the characteristics of the image acquisition system ( 2.1). Initiate imaging immediately after administration of Choline C 11 Injection and acquire static emission images 0 to 15 minutes from the time of injection ( 2.5). The effective radiation absorbed dose from 740 MBq (20 mCi) dose of Choline C 11 Injection is approximately 3.22 mSv (0.32 rem) in an adult ( 2.4). Image interpretation: Refer to full prescribing inf Läs hela dokumentet