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Uses
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 Use: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer.
History
There is currently no drug history available for this drug.
Other Information
Choline C 11 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with PET imaging. The active ingredient, 11C-choline, has the molecular formula of C411CH14 NOCl with a molecular weight of 138.63 g and has the following chemical structure:
Choline C 11 Injection is provided as a ready to use sterile, pyrogen-free, clear and colorless solution. Each milliliter contains 148 MBq to 1225 MBq (4 mCi to 33.1 mCi) of 11C-choline at EOS calibration time in aqueous 0.9% sodium chloride solution. The pH of the solution is between 4.5 and 7.5.
Carbon 11 is a cyclotron-produced radionuclide that decays to Boron 11 by positron emission and has a physical half life of 20.4 minutes (Table 2).
*Produced by positron annihilation | ||
Radiation/Emission | % Per Disintegration | Energy |
Positron (β+) |
99.76 | 960.2 keV (Max.) |
Gamma (±)* |
199.5 | 511 keV |
The specific gamma ray constant (point source air kerma coefficient) for 11C-choline is 5.8 R/mCi-hr at 1 cm. Selected coefficients of attenuation are listed in Table 3 as a function of lead shield thickness. For example, the use of 39 mm thickness of lead will attenuate the external radiation by a factor of about 1,000.
Shield Thickness (Pb) mm | Coefficient of Attenuation |
4 | 0.5 |
8 | 0.25 |
13 | 0.1 |
26 | 0.01 |
39 | 0.001 |
52 | 0.0001 |
Table 4 lists fractions remaining at selected time intervals from the calibration time. This information may be used to correct for physical decay of the radionuclide.
*Calibration time | |
Minutes | Fraction Remaining |
0* | 1.000 |
5 | 0.844 |
10 | 0.712 |
15 | 0.600 |
20 | 0.507 |
25 | 0.427 |
30 | 0.360 |
Sources
Choline C 11 Manufacturers
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Mayo Clinic
Choline C 11 | Mayo Clinic
2.1 Radiation Safety - Drug HandlingCholine C 11 Injection is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration. Use waterproof gloves and effective shielding when handling Choline C 11 Injection. Radiopharmaceuticals, including Choline C 11 Injection, should only be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radioactive materials, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.
2.2 Recommended Dose and Administration InstructionsThe recommended dose is 370 to 740 MBq (10 to 20 mCi) administered 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
Inspect Choline C 11 Injection visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored. Aseptically withdraw Choline C 11 Injection from its container and administer the drug as a bolus through a peripheral venous catheter. Dispose of any unused drug in a safe manner, in compliance with applicable regulations. 2.3 Patient PreparationPrior to administration of Choline C 11 Injection:
Fasting for at least six hours is recommended to minimize the potential for dietary choline interference with radioactivity uptake in tissue. Ensure that the patient is well hydrated and encourage voiding when imaging is completed. 2.4 Radiation DosimetryThe estimated radiation absorbed doses for adults from intravenous injection of Choline C 11 Injection are shown in Table 1. These estimates are calculated from data in Tolvanen 1 and using OLINDA/EXM (Organ Level Internal Dose Assessment/Exponential Modeling) software from Vanderbilt University.2
Table 1: Estimated Radiation Absorbed Dose Per Unit Activity for Adults, Choline C 11 Injection a Gastrointestinal
b Assumed radiation weighting factor, wr, (formerly defined as quality factor, Q) of 1 for conversion of absorbed dose (Gray or rad) to dose equivalent (Sieverts or rem) for C 11. To obtain radiation absorbed dose in rad/mCi from the above table, multiply the dose in μGy/MBq by 0.0037, (e.g.,3.59 μGy/MBq x 0.0037 = 0.0133 rad/mCi).
c Radiation tissue weighting factors, wT, used in the calculation of effective dose are from 1990 Recommendations of the International Commission on Radiological Protection, ICRP Publication 60 (1991). To obtain radiation absorbed dose in rem/mCi from above table, multiply the dose in μGy/MBq by 0.0037, (e.g., 4.35 μGy/MBq x 0.0037 = 0.0161 rem/mCi). Organ/Tissue Mean Absorbed Dose Per Unit Administered Activity (μGy/MBq)b Adrenals 3.59 Bone - Osteogenic Cells 4.81 Bone - Red Marrow 1.90 Brain 1.16 Breast 1.39 Gallbladder Wall 4.54 GIa - Lower Large Intestine Wall 1.81 GIa - Small Intestine 2.35 GIa - Stomach Wall 6.00 GIa - Upper Large Intestine Wall 6.41 Heart wall 3.43 Kidneys 20.62 Liver 20.11 Lungs 4.59 Muscle 2.54 Ovaries 2.02 Pancreas 29.19 Skin 1.22 Spleen 9.16 Testes 1.36 Thymus 1.69 Thyroid 1.49 Urinary Bladder Wall 3.41 Uterus 1.96 Total body 2.97 Effective Dose (μSv/MBq)c 4.35The effective dose resulting from a 740 MBq (20 mCi) dosage of Choline C 11 Injection is 3.22 mSv in an adult, (740 x 4.35 = 3219 μSv = 3.2 mSv). The use of a CT scan to calculate attenuation correction for reconstruction of 11C-choline images (as done in PET/CT imaging) will add radiation exposure. Based upon current scanning techniques, an effective dose of 5.8 mSv would be added from CT scanning. The actual radiation dose is operator, scanner, and patient dependent. The total radiation exposure from 11C-choline administration and subsequent scan on a PET/CT scanner is estimated to be 9.0 mSv (3.2 mSv + 5.8 mSv).
2.5 Imaging Guidelines Initiate image acquisition immediately after administration of Choline C 11 Injection. Imaging is typically performed from the base of the pelvis to the base of the skull. Acquire static emission images 0 to 15 minutes from the time of injection. Localized uptake of 11C-choline in a site suspicious for prostate cancer recurrence (a positive image) is determined by comparison of the anatomical relationship of concentrated radioactivity to the neighboring tissue background, exclusive of the radioactivity physiologically accumulated within the pancreas, liver, spleen, kidney and colon. -
Precision Nuclear Llc
Choline C 11 | Precision Nuclear Llc
2.1 Radiation Safety - Drug HandlingCholine C 11 Injection is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration. Use waterproof gloves and effective shielding when handling Choline C 11 Injection. Radiopharmaceuticals, including Choline C 11 Injection, should only be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radioactive materials, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.
2.2 Recommended Dose and Administration InstructionsThe recommended dose is 370 to 740 MBq (10 to 20 mCi) administered 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
Inspect Choline C 11 Injection visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored. Aseptically withdraw Choline C 11 Injection from its container and administer the drug as a bolus through a peripheral venous catheter. Dispose of any unused drug in a safe manner, in compliance with applicable regulations. 2.3 Patient PreparationPrior to administration of Choline C 11 Injection:
Fasting for at least six hours is recommended to minimize the potential for dietary choline interference with radioactivity uptake in tissue. Ensure that the patient is well hydrated and encourage voiding when imaging is completed. 2.4 Radiation DosimetryThe estimated radiation absorbed doses for adults from intravenous injection of Choline C 11 Injection are shown in Table 1. These estimates are calculated from data in Tolvanen 1 and using OLINDA/EXM (Organ Level Internal Dose Assessment/Exponential Modeling) software from Vanderbilt University.2
Table 1: Estimated Radiation Absorbed Dose Per Unit Activity for Adults, Choline C 11 Injection a Gastrointestinal
b Assumed radiation weighting factor, wr, (formerly defined as quality factor, Q) of 1 for conversion of absorbed dose (Gray or rad) to dose equivalent (Sieverts or rem) for C 11. To obtain radiation absorbed dose in rad/mCi from the above table, multiply the dose in μGy/MBq by 0.0037, (e.g.,3.59 μGy/MBq x 0.0037 = 0.0133 rad/mCi).
c Radiation tissue weighting factors, wT, used in the calculation of effective dose are from 1990 Recommendations of the International Commission on Radiological Protection, ICRP Publication 60 (1991). To obtain radiation absorbed dose in rem/mCi from above table, multiply the dose in μGy/MBq by 0.0037, (e.g., 4.35 μGy/MBq x 0.0037 = 0.0161 rem/mCi). Organ/Tissue Mean Absorbed Dose Per Unit Administered Activity (μGy/MBq)b Adrenals 3.59 Bone - Osteogenic Cells 4.81 Bone - Red Marrow 1.90 Brain 1.16 Breast 1.39 Gallbladder Wall 4.54 GIa - Lower Large Intestine Wall 1.81 GIa - Small Intestine 2.35 GIa - Stomach Wall 6.00 GIa - Upper Large Intestine Wall 6.41 Heart wall 3.43 Kidneys 20.62 Liver 20.11 Lungs 4.59 Muscle 2.54 Ovaries 2.02 Pancreas 29.19 Skin 1.22 Spleen 9.16 Testes 1.36 Thymus 1.69 Thyroid 1.49 Urinary Bladder Wall 3.41 Uterus 1.96 Total body 2.97 Effective Dose (μSv/MBq)c 4.35The effective dose resulting from a 740 MBq (20 mCi) dosage of Choline C 11 Injection is 3.22 mSv in an adult, (740 x 4.35 = 3219 μSv = 3.2 mSv). The use of a CT scan to calculate attenuation correction for reconstruction of 11C-choline images (as done in PET/CT imaging) will add radiation exposure. Based upon current scanning techniques, an effective dose of 5.8 mSv would be added from CT scanning. The actual radiation dose is operator, scanner, and patient dependent. The total radiation exposure from 11C-choline administration and subsequent scan on a PET/CT scanner is estimated to be 9.0 mSv (3.2 mSv + 5.8 mSv).
2.5 Imaging Guidelines Initiate image acquisition immediately after administration of Choline C 11 Injection. Imaging is typically performed from the base of the pelvis to the base of the skull. Acquire static emission images 0 to 15 minutes from the time of injection. Localized uptake of 11C-choline in a site suspicious for prostate cancer recurrence (a positive image) is determined by comparison of the anatomical relationship of concentrated radioactivity to the neighboring tissue background, exclusive of the radioactivity physiologically accumulated within the pancreas, liver, spleen, kidney and colon. -
Mayo Clinic
Choline C 11 | Boehringer Ingelheim Vetmedica, Inc.
ToMORROW (cephapirin benzathine) is for use in dry cows only. Infuse each quarter at the time of drying off with a single 10 mL syringe. Use no later than 30 days prior to calving.
Completely milk out all four quarters. The udder and teats should be thoroughly washed with warm water containing a suitable dairy antiseptic and dried, preferably using individual paper towels. Carefully scrub the teat end and orifice with 70% alcohol, using a separate swab for each teat. Allow to dry.
ToMORROW is packaged with the Opti-Sert® Protective Cap.
For partial insertion: Twist off upper portion of the Opti-Sert Protective Cap to expose 3–4 mm of the syringe tip.
For full insertion: Remove protective cap to expose the full length of the syringe tip.
Insert syringe tip into the teat canal and expel the entire contents of syringe into the quarter. Withdraw the syringe and gently massage the quarter to distribute the medication.
Do not infuse contents of the mastitis syringe into the teat canal if the Opti-Sert Protective Cap is broken or damaged.
DOSIS E INSTRUCCIONES DE USO
ToMORROW (cefapirina benzatínica) se administra únicamente en vacas secas. Introducir por infusión en cada cuarto al momento del período de secado una sola jeringa de 10 mL. Administrar a más tardar a los 30 días anteriores a la parición.
Ordeñar por completo los cuatro cuartos. La ubre y los pezones deberán lavarse a fondo con agua tibia mezclada con un antiséptico adecuado para ganado lechero y secarse utilizando de preferencia toallas de papel individuales. Con cuidado frotar la punta del pezón y el orifico con una solución de alcohol al 70%, empleando una torunda distinta para cada pezón. Dejar secar.
ToMORROW viene empacada con un Tapón Protector Opti-Sert®.
Para una inserción parcial: Romper torciendo la parte superior del Tapón Protector Opti-Sert para dejar expuestos de 3 a 4 mm de la punta de la jeringa.
Para una inserción completa: Retirar el tapón protector para exponer completamente la punta de la jeringa.
Insertar la punta de la jeringa en el ducto del pezón y expulsar todo el contenido de la jeringa dentro del cuarto. Retirar la jeringa y masajear suavemente el cuarto para distribuir el medicamento.
No introducir por infusión el contenido de la jeringa para tratar la mastitis en el ducto del pezón si el Tapón Protector Opti-Sert está roto o dañado.
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