CHOLINE C 11- choline c-11 injection

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

UCSF Radiopharmaceutical Facility

DCI (Dénomination commune internationale):

CHOLINE C-11

Composition:

CHOLINE C-11 33.1 mCi in 1 mL

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 fetal harm when administered to a pregnant w

Descriptif du produit:

Choline C 11 Injection is packaged in a multiple-dose glass 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 120 minutes of EOS calibration.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

CHOLINE C 11- CHOLINE C-11 INJECTION
UCSF RADIOPHARMACEUTICAL FACILITY
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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.
CHOLINEC 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).
CONTRAINDICATIONS
None (4).