Omniscan Prefill Plus

Omniscan Prefill Plus is a contrast agent that has magnetic properties. It is used with magnetic resonance imaging (MRI) to help show blood vessels, organs, and other non-bony tissues more clearly on the MRI.

Omniscan Prefill Plus is used in adults and children who are at least 2 years old to help diagnose certain disorders of the brain and spine (central nervous system), or the stomach, chest, and pelvic areas.

Omniscan Prefill Plus may also be used for reasons not mentioned in this medication guide.

Omniscan Prefill Plus can cause a serious life-threatening condition in people who have advanced kidney disease. Before you get this medicine, inform your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive this medicine. Also, let your doctor know if you have recently received any contrast agents similar to this medicine.

Omniscan Prefill Plus can cause a life-threatening condition in people with advanced kidney disease. Ask your doctor about your individual risk.

Omniscan Prefill Plus can stay in your body for months or years after you receive Omniscan Prefill Plus. It is not known if this could cause any health problems in people whose kidneys work properly. Tell your doctor if you have had repeated scans with a contrast agent, and provide the date of your last scan.

You should not receive Omniscan Prefill Plus if you are allergic to it.

Tell your doctor if you have ever had:

• any type of reaction to a contrast agent;
• asthma, hay fever, food or drug allergies;
• diabetes;
• high blood pressure; or
• liver or kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Some side effects of gadodiamide may occur up to several days after injection.

Omniscan Prefill Plus can cause a life-threatening condition in people with advanced kidney disease. Call your doctor right away if you have any symptoms of this condition, such as:

• burning, itching, swelling, scaling, and tightening or hardening of your skin;
• skin redness or dark patches;
• tiredness, muscle weakness;
• joint stiffness in your arms, hands, legs, or feet;
• pain; or
• trouble moving.

Also call your doctor at once if you have:

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
• a seizure (convulsions); or
• chest pain or pressure, pain spreading to your jaw or shoulder.

Common side effects of Omniscan Prefill Plus may include:

• headache;
• dizziness; or
• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Omniscan Prefill Plus is given as an infusion into a vein. A healthcare provider will give you this injection.

You will be watched for a short time to make sure you do not have an allergic reaction.

In a medical setting, it is unlikely that you will miss a dose.

In a medical setting, an overdose would be treated promptly.

Follow your doctor's instructions regarding any limits on food, drinks, or activities.

Other drugs may affect Omniscan Prefill Plus, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.