Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
Barium Sulfate (UNII: 25BB7EKE2E) (Barium Sulfate - UNII:25BB7EKE2E)
E-Z-EM Canada Inc
Barium Sulfate
Barium Sulfate 960 mg in 1 g
ORAL
PRESCRIPTION DRUG
E-Z-PAQUE is indicated for use in single contrast radiographic examinations of the esophagus, stomach, duodenum and small bowel to visualize the gastrointestinal tract (GI) in adult and pediatric patients. E-Z-PAQUE 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 prior 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 prior aspiration, tracheo-esophageal fistula, or obtundation - With known severe hypersensitivity to barium sulfate or any of the excipients of E-Z-PAQUE Risk Summary E-Z-PAQUE is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology (12.3)] . Risk Summary E-Z-PAQUE is not absorb
How Supplied E-Z-PAQUE (barium sulfate) is supplied as a fine white to lightly colored powder (96 % w/w) in a single dose HDPE plastic bottle containing 169 g of barium sulfate. Provided as: 24 bottles per pack (NDC 32909-750-03) Storage and Handling Store at USP controlled room temperature 20 to 25°C (68 to 77° F).
New Drug Application
E-Z-PAQUE- BARIUM SULFATE POWDER, FOR SUSPENSION E-Z-EM CANADA INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE E-Z-PAQUE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR E-Z-PAQUE. E-Z-PAQUE (BARIUM SULFATE) FOR ORAL SUSPENSION INITIAL U.S. APPROVAL: 2016 INDICATIONS AND USAGE E-Z-PAQUE is a radiographic contrast agent indicated for use in single contrast radiographic examinations of the esophagus, stomach, duodenum and small bowel to visualize the gastrointestinal (GI) tract in adult and pediatric patients (1) DOSAGE AND ADMINISTRATION Adults: Recommended reconstituted oral dose is between 150 – 750 mL (2.1) Pediatric patients: adjust reconstituted dose based on relative GI volume (2.1) Must reconstitute supplied powder with water prior to use. See Full Prescribing Information for reconstitution instructions (2.2) DOSAGE FORMS AND STRENGTHS For oral suspension: 169 grams of barium sulfate (96% w/w) in a single-dose bottle for reconstitution (3) CONTRAINDICATIONS Known or suspected perforation of the GI tract (4) Known obstruction of the GI tract (4) Conditions associated to high risk of GI aspiration (4) Conditions associated to high risk of GI perforation (4) Known hypersensitivity to barium sulfate or any of the excipients of E-Z-PAQUE (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 or 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 a barium sulfate procedure to avoid obstruction or impaction caused by baroliths (5.3) Aspiration pneumonitis: Patients with history of food aspiration or with swallowing disorders are at increased risk. (5.4) ADVERSE REACTIONS Common adverse reactions include naus Pročitajte cijeli dokument