E-Z-CAT DRY barium sulfate powder for suspension

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

Barium Sulfate (UNII: 25BB7EKE2E) (Barium Sulfate - UNII:25BB7EKE2E)

Beszerezhető a:

E-Z-EM Canada Inc

INN (nemzetközi neve):

Barium Sulfate

Összetétel:

Barium Sulfate 400 mg in 1 g

Recept típusa:

PRESCRIPTION DRUG

Engedélyezési státusz:

New Drug Application

Termékjellemzők

E-Z-CAT DRY- BARIUM SULFATE POWDER, FOR 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
E-Z-CAT DRY SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR E-Z-CAT DRY.
E-Z-CAT DRY (BARIUM SULFATE) FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2017
INDICATIONS AND USAGE
E-Z-CAT DRY is a radiographic contrast agent indicated for use in
computed tomography (CT) of the abdomen to
delineate the gastrointestinal (GI) tract in adult and pediatric
patients (1)
DOSAGE AND ADMINISTRATION
Recommended reconstituted oral dose for adults and pediatric patients
older than 12 years of age is between 450 mL to
900 mL (9 g to 18 g of barium sulfate, respectively) (2.1)
Pediatric patents younger than 12 years of age adjust reconstituted
oral dose based on relative GI volume (2.1)
Must reconstitute supplied powder with water prior to use. See Full
Prescribing Information for reconstitution
instructions (2.3)
DOSAGE FORMS AND STRENGTHS
For oral suspension: 9 grams of barium sulfate (40% w/w) in a
single-dose pouch for reconstitution (3)
CONTRAINDICATIONS
Known or suspected perforation of the (GI) tract (4)
Known obstruction of the GI tract (4)
Conditions associated with high risk of GI perforation or aspiration
(4)
Known severe hypersensitivity to barium sulfate or any of the
excipients of E-Z-CAT DRY (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions: Emergency equipment and trained personnel
should be immediately available (5.1)
Intra-abdominal 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 (5.3)
Aspiration: Caution is recommended in patients with history of food
aspiration and in patients with known swallowing
disorders (5.4)
ADVERSE REACTIO