Brand Name

    US Brand Name

    Choletec


    Description

    Technetium Tc 99m mebrofenin injection 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.

    Technetium Tc 99m mebrofenin injection is used to help your doctor see an image of your liver, gallbladder, and bile duct to see how well they are working.

    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:

    • Kit

    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 technetium Tc 99m mebrofenin 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 technetium Tc 99m mebrofenin 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.

    Other Medical Problems

    The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

    • Gallstones or
    • Liver disease (including hepatitis) or
    • Pancreatitis (inflammation of the pancreas)—The image quality of the gallbladder may be affected in patients with these conditions.

    Proper Use

    A doctor or other health professional will give you this medicine. This medicine is given through a needle placed in a vein.

    It is best to receive this medicine without food, at least 4 hours before or after a meal.


    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 serious allergic reactions. Check with your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you get the injection.

    You will be exposed to radiation when you are given this medicine. Talk with your doctor if you have concerns about this.


    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:

    Rare

    • Chills
    • hives or welts, itching, or skin rash
    • nausea
    • redness of the skin

    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.






    CON-XXXXXXXX

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