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:

Precision Nuclear LLC

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:

unapproved drug other

Đặc tính sản phẩm

CHOLINE C 11 - CHOLINE C 11 INJECTION
PRECISION NUCLEAR LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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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
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 information (2.5).
DOSAGE FORMS AND STRENGTHS
Choline C 11 injection contains 14