Description

      Choline C 11 injection is used to help diagnose recurrent prostate cancer. It is used for a procedure called positron emission tomography (PET) scan to detect tumors that are not detectable by other scanning procedures, such as bone scan, computed tomography (CT), or magnetic resonance imaging (MRI).

      Choline C 11 is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents, which may be used to find and treat certain diseases or to study the function of the body's organs.

      This medicine is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine.

      This product is available in the following dosage forms:

      • Solution

      Before Using

      In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

      Allergies

      Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

      Pediatric

      Appropriate studies have not been performed on the relationship of age to the effects of choline C 11 injection in the pediatric population. Safety and efficacy have not been established.

      Geriatric

      No information is available on the relationship of age to the effects of choline C 11 injection in geriatric patients.

      Breastfeeding

      There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

      Drug Interactions

      Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

      Other Interactions

      Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


      Proper Use

      A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins just before you have a PET scan.

      Your doctor will have you drink plenty of water or other fluids (as tolerated) during the four hours before you have the PET/CT scan.

      You will need to urinate right away and as often as possible for at least one hour after the PET/CT scan.


      Precautions

      It is very important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

      This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, tell your doctor right away.

      While receiving this medicine, you will be exposed to radiation. If you have any questions about this, talk to your doctor.

      Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


      Side Effects

      Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

      Check with your doctor or nurse immediately if any of the following side effects occur:

      Incidence not known

      • Cough
      • difficulty swallowing
      • dizziness
      • fast heartbeat
      • hives, itching, or skin rash
      • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
      • shortness of breath
      • tightness in the chest
      • unusual tiredness or weakness

      Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

      Incidence not known

      • Burning, pain, or stinging at the injection site
      • Coldness or numbness at the injection site
      • Inflammation, redness, swelling, or warmth at the injection site

      Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

      Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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