Mangafodipir (Intravenous)

Mangafodipir is an MRI (magnetic resonance imaging) contrast agent (also known as paramagnetic agents). MRI agents are used to help create clear images during MRI. MRI is a specific type of diagnostic procedure. It uses magnets and computers to produce images or “pictures” of certain areas inside the body. Unlike x-rays, it does not use ionizing radiation.

Mangafodipir is given by injection before an MRI to help identify issues in the liver.

Mangafodipir is injected into a vein. The dose of this agent will vary for different patients based on their body weight.

This medicine is to be used only by or under the supervision of a doctor.

In deciding to use a diagnostic test, any risks of the test must be weighed against the benefits. This is a decision you and your doctor will make together. Additionally, other factors may influence test results. For this test, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know 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

Studies on this medicine have only been conducted in adult patients, and there is no specific information comparing the use of mangafodipir in children under 12 years of age with its use in other age groups.

Mangafodipir is not expected to cause different side effects or problems in teenagers than it does in adults.

Geriatric

Many medicines have not been specifically studied in older people. Therefore, it may not be known whether they work the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of mangafodipir in the elderly with its use in other age groups.

Breast Feeding

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

Interactions with Medicines

While some medicines should not be used together at all, in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with specific medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this diagnostic test. Make sure to inform your doctor if you have any other medical problems, especially:

• Allergies (history of) or
• Immune system problems (history of)—Possible increased risk of having an allergic reaction to mangafodipir

• Nausea or vomiting or
• Other stomach issues such as reflux (acid backing up from the stomach)—This medicine commonly causes nausea and vomiting, which could lead to more problems.

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 as soon as possible if any of the following side effects occur:

Rare

• Chest pain
• irregular heartbeat
• itching
• shortness of breath
• skin rash or hives
• swelling of face

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:

More common

• Nausea and/or vomiting
• redness at place of injection
• warmth at place of injection

Less common

• Abdominal or stomach pain
• coldness at place of injection
• feeling of pressure at place of injection
• dizziness
• headache
• pain at place of injection

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.

In the U.S.

• Teslascan

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.