CHOLINE C 11 injection

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

CHOLINE C-11 (UNII: M4AS4XGD4Q) (CHOLINE C-11 - UNII:M4AS4XGD4Q)

から入手可能:

The University of Texas MD Anderson Cancer Center

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

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

製品概要:

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).

認証ステータス:

Abbreviated New Drug Application

製品の特徴

CHOLINE C 11- CHOLINE C 11 INJECTION
THE UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER
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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