E-Z-PAQUE- barium sulfate powder, for suspension

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

E-Z-EM Canada Inc

INN (Διεθνής Όνομα):

Barium Sulfate

Σύνθεση:

Barium Sulfate 960 mg in 1 g

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

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).

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

E-Z-PAQUE- 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-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