CHOLINE C 11 injection

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Decatur Memorial Hospital

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Choline C11 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. There are no adequate and well controlled studies with Choline C11 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 C11 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capa

পণ্য সারাংশ:

Choline C 11 Injection is packaged in a multi-dose glass vial containing between 148 MBq to 1225 MBq (4 mCi to 33.1 mCi) of 11 C- choline at EOS calibration time in aqueous 0.9% sodium chloride solution (approximately 10 mL volume). NDC 73410-004-01 Store Choline C 11 Injection at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) (see USP Controlled Room Temperature). Use the solution within 120 minutes of EOS calibration.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

CHOLINE C 11- CHOLINE C 11 INJECTION
DECATUR MEMORIAL HOSPITAL
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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 C11 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
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Choline C11 injection contains 148 MBq to 1225 MBq (4 mCi to 33.1 mCi)
per milliliter of
C-choline at EOS (End of
Synthesis) calibration time in aqueous 0.9% sodium chloride solution
(approximately 10 mL volume) (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
Imaging errors have been reported; blood PSA levels < 2 ng/mL have
been associated with poor imaging performance
(5.1).
•
•
ADVERSE REACTIONS
Exclusive of an uncommon, mild injection site reaction, no other
adverse reactions have been reported (6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT DECATUR MEMORIAL
HOSPITAL AT 800-826-2827 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Colchicine and androgen-deprivation therapeutic drugs may interfere
with
C-choline PET/CT imaging performance (5.1).
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 11/2019
FULL PRESCRIBING INFORMAT