Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
CHOLINE C-11 (UNII: M4AS4XGD4Q) (CHOLINE C-11 - UNII:M4AS4XGD4Q)
The University of Texas MD Anderson Cancer Center
INTRAVENOUS
PRESCRIPTION DRUG
Choline C 11 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 Pregnancy Category C. There are no adequate and well controlled studies with Choline C 11 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 C 11 Injection can cause fetal harm when administered
Choline C 11 Injection is packaged in a glass vial containing between 148 MBq to 3,700 MBq (4 mCi to 100 mCi) of 11 C-choline at EOS calibration time in aqueous 0.9% sodium chloride solution (approximately 10 mL volume).
Abbreviated New Drug Application
CHOLINE C 11- CHOLINE C 11 INJECTION THE UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CHOLINE C 11 INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CHOLINE C 11 INJECTION. CHOLINE C 11 INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2012 INDICATIONS AND USAGE Choline C 11 Injection is a radioactive diagnostic agent for positron emission tomography (PET) imaging of patients with (1) suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic (1) resonance imaging. In these patients, C-choline PET imaging may help identify potential sites of prostate cancer (1) recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate (1) specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. (1) (1) Limitation of Use: C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer (1). (1) (1) DOSAGE AND ADMINISTRATION Aseptically withdraw Choline C 11 Injection from its container and administer 370 – 740 MBq (10 – 20 mCi) as a bolus intravenous injection. The radioactivity dose (370 – 740 MBq, 10 – 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 C11 Injection and acquire static emission images 0 – 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 information (2.5). DOSAGE FORMS AND STRENGTHS Choline C 11 Injection contains 148 MBq to 3,700 MBq (4 mCi to 100 mCi) per milliliter of (3) C-choline at End of Synthesis (EOS) calibration time in aqueous Lugege kogu dokumenti