CHOLINE C 11 injection

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

The University of Texas MD Anderson Cancer Center

INN (Tên quốc tế):

CHOLINE C-11

Thành phần:

CHOLINE C-11 33.1 mCi in 1 mL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

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 1,225 MBq (4 mCi to 33.1
mCi) per milliliter of (3)
C-choline at End of Synthesis (EOS) calibration time in aqueou