CHOLINE C 11- choline c-11 injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Washington University School of Medicine

INN (International Name):

CHOLINE C-11

Composition:

CHOLINE C-11 33.1 mCi in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 U se: 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 f

Product summary:

Choline C 11 Injection is packaged in a glass 30 mL vial containing between 148 MBq to 1,225 MBq (4 mCi to 33.1 mCi) per milliliter of 11 C-choline at EOS calibration time in aqueous 0.9% sodium chloride solution.  Store Choline C 11 Injection at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) (see USP Controlled Room Temperature).  Use the solution within 60 minutes of EOS calibration.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHOLINE C 11- CHOLINE C-11 INJECTION
WASHINGTON UNIVERSITY SCHOOL OF MEDICINE
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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 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 – 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 C 11
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 – 1,225 MBq (4 – 33.1 mCi) per
milliliter of
C-choline at end of
synthesis calibration time in aqueous 0.9% sodium chloride solution (
3).
CONTRAINDICATIO