ENTERO VU 24%- barium sulfate suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BARIUM SULFATE (UNII: 25BB7EKE2E) (BARIUM SULFATE - UNII:25BB7EKE2E)

Available from:

E-Z-EM Canada Inc

INN (International Name):

BARIUM SULFATE

Composition:

BARIUM SULFATE 240 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ENTERO VU 24% is indicated for use in small bowel radiographic examinations to visualize the gastrointestinal (GI) tract in adult patients. ENTERO VU 24% is contraindicated in patients with the following conditions: - known or suspected perforation of the GI tract - known obstruction of the GI tract - high risk of GI perforation such as those with a recent GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, post GI surgery or biopsy, acute GI injury or burn, or recent radiotherapy to the pelvis - high risk of aspiration such as those with known or suspected tracheo-esophageal fistula or obtundation - known severe hypersensitivity to barium sulfate or any of the excipients of ENTERO VU 24% Risk Summary ENTERO VU 24% is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. Risk Summary ENTERO VU 24% is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to

Product summary:

16.1  How Supplied ENTERO VU 24% (barium sulfate) is supplied as a suspension (24% w/v) in a single-dose HDPE plastic bottle containing 600 mL of barium sulfate suspension (24% w/v). Provided as: 6 x 600 mL bottles (NDC 32909-146-06) 16.2  Storage and Handling Store at USP controlled room temperature 20°C to 25°C (68°F to 77° F). Protect from freezing.

Authorization status:

New Drug Application

Summary of Product characteristics

ENTERO VU 24%- BARIUM SULFATE SUSPENSION
E-Z-EM CANADA INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ENTERO VU 24% SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ENTERO VU 24%.
ENTERO VU 24% (BARIUM SULFATE) ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
ENTERO VU 24% is a radiographic contrast agent indicated for use in
small bowel radiographic
examinations to visualize the gastrointestinal (GI) tract in adult
patients (1)
DOSAGE AND ADMINISTRATION
For oral use only:
Adults: Recommended dose is 600 mL (2.1)
DOSAGE FORMS AND STRENGTHS
Oral Suspension: barium sulfate (24% w/v) supplied in single dose
bottle (3)
CONTRAINDICATIONS
Known or suspected perforation of the gastrointestinal (GI) tract (4)
Known obstruction of the GI tract (4)
Conditions associated with high risk of GI perforation or aspiration
(4)
Known hypersensitivity to barium sulfate or any of the excipients of
ENTERO VU 24% (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions: Emergency equipment and trained personnel
should be immediately
available (5.1)
Intra-abdominal barium leakage: May occur in conditions such as GI
fistula, ulcer, inflammatory bowel
disease, appendicitis, diverticulitis, severe stenosis or obstructing
lesions of the GI tract (5.2)
Delayed GI transit and obstruction: Patients should maintain adequate
hydration in days following
barium sulfate procedure to avoid obstruction or impaction (5.3)
Aspiration Pneumonitis: Patients with a history of food aspiration or
with swallowing disorders are at
increased risk. Monitor patients for aspiration (5.4)
ADVERSE REACTIONS
Common adverse reactions include nausea, vomiting, diarrhea and
abdominal cramping (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BRACCO DIAGNOSTICS INC
AT 1-800-257-
5181 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1  INDICATIONS AND USAGE
2  DOSAG