Entero VU

In the U.S.

• Bar-Test
• Entero VU
• E-Z-Cat Dry
• E-Z-Disk
• E-Z-HD
• Readi-Cat 2
• Readi-Cat 2 Smoothie
• Tagitol V
• Varibar
• Varibar Pudding
• Volumen

In Canada

• Acb
• Baro-Cat
• Colobar-100
• Epi-C
• Epi-Stat
• Esobar
• Esopho-Cat Esophageal Cream
• E-Z-Cat
• E-Z-Hd
• E-Z-Jug
• E-Z-Paque
• Gel-Unix 10

Available Dosage Forms:

• Cream
• Tablet
• Paste
• Suspension
• Powder for Suspension
• Liquid

Therapeutic Class: Diagnostic Agent, Radiological Contrast Media

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of barium sulfate oral suspension in children 12 years of age and older. However, safety and efficacy of this medicine have not been established in children younger than 12 years of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of barium sulfate oral paste in children 6 months of age and older. However, safety and efficacy of this medicine have not been established in children younger than 6 months of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of barium sulfate oral suspension or paste in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Interactions with Medicines

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.

Interactions with Food/Tobacco/Alcohol

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:

• Allergy to other contrast agents, recent or
• Asthma, hay fever, or other allergies, history of—May increase risk for allergic reaction to occur again.

• Appendicitis (inflammation of the appendix) or
• Cancer or
• Inflammatory bowel disease or
• Stomach or bowel problems (eg, diverticulitis, fistula, stenosis, ulcer)—May cause barium to leak in the stomach in patients with these conditions.

• Cystic fibrosis or
• Dehydration or
• Electrolyte imbalance or
• Stomach or bowel problems (eg, Hirschsprung disease, severe stenosis)—May increase risk for more serious side effects.

• Fructose intolerance (genetic disease), history of—The oral suspension contains sorbitol, which can make this condition worse.

• Radiation treatment on the pelvis (hip area), recent or
• Stomach or bowel blockage, known or suspected or
• Stomach or bowel perforation, known or suspected or
• Stomach or bowel problems (eg, bleeding, injury, ischemia, severe ileus, toxic megacolon) or
• Stomach or bowel surgery or
• Trouble swallowing—Should not be used in patients with these conditions.

Your doctor will check your or your child's progress 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 or your child should continue to receive it.

Serious allergic reactions may occur while you are receiving this medicine. Tell your doctor right away if you have a rash, itching, noisy breathing, trouble breathing, lightheadedness, dizziness, or fainting after receiving this medicine.

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.

• If you have an allergy to barium or any other part of Entero VU (barium suspension).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have had any of these health problems: Blockage, hole, bleeding, injury, burn, or blood flow problems in the GI (gastrointestinal) tract; slow-moving GI (gastrointestinal) tract; or a problem called toxic megacolon.
• If you have had a recent hole in the GI (gastrointestinal) tract, GI surgery, or radiation to the pelvic area.
• If you have trouble swallowing or have inhaled food, liquids, saliva, or vomit into your lungs.
• If you are not able to break down fructose.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Entero VU with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Most of the time, Entero VU (barium suspension) will be given in a hospital or doctor's office. If stored at home, follow how to store as you were told by the doctor.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Entero VU or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Entero VU. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

This product should not be used in patients with known gastric or intestinal perforation or hypersensitivity to barium sulfate products.

Due to the increased likelihood of allergic reactions in atopic patients, it is important that a complete history of known and suspected allergies as well as allergic-like symptoms, e.g., rhinitis, bronchial asthma, eczema and urticaria, must be obtained prior to any medical procedure utilizing these products. A mild allergic reaction would most likely include generalized pruritus, erythema or urticaria (approximately 1 in 250,000). Such reactions will generally respond to an antihistamine such as 50 mg of diphenhydramine or its equivalent. In the rarer, more serious reactions (approximately 1 in 1,000,000) laryngeal edema, bronchospasm or hypotension could develop. Severe reactions which may require emergency measures are often characterized by peripheral vasodilation, hypotension, reflex tachycardia, dyspnea, agitation, confusion and cyanosis progressing to unconsciousness. Treatment should be initiated immediately with 0.3 to 0.5 mL of 1:1000 epinephrine subcutaneously. If bronchospasm predominates, 0.25 to 0.50 grams of intravenous aminophylline should be given slowly. Appropriate vasopressors might be required.

Adrenocorticosteroids, even if given intravenously, exert no significant effect on the acute allergic reactions for a few hours. The administration of these agents should not be regarded as emergency measures for the treatment of allergic reactions.

Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardia following the administration of any diagnostic agent. Such reactions are usually non-allergic in nature and are best treated by having the patient lie flat for an additional 10 to 30 minutes under observation.

Entero VU™ 24% is supplied in the following quantity:
600 mL jug, Cat. No. L145, NDC 32909-145-06.

Rx Only (USA)

Manufactured by E-Z-EM Canada Inc., for E-Z-EM, Inc.
a subsidiary of Bracco Diagnostics Inc.
Monroe Township, NJ 08831
Tel: 1-516-333-8230 1-800 544-4624

rev. 05/14 TX1219-2 ©2006 E-Z-EM, Inc.

Entero VU™ 24% - 600 ml
Barium Sulfate Suspension
NDC: 32909-145-06