READI-CAT 2- barium sulfate suspension READI-CAT 2 BANANA SMOOTHIE- barium sulfate suspension READI-CAT 2 BERRY SMOOTHIE- bari

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 20 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

READI-CAT 2 and READI-CAT 2 SMOOTHIES are indicated for use in computed tomography (CT) of the abdomen to delineate the gastrointestinal (GI) tract in adult and pediatric patients. READI-CAT 2 products are contraindicated in patients: - with known or suspected perforation of the GI tract - with known obstruction of the GI tract - at 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 pelvis - at high risk of aspiration such as those with prior aspiration, tracheo-esophageal fistula, or obtundation - known severe hypersensitivity to barium sulfate or any of the excipients of READI-CAT 2 or READI-CAT 2 SMOOTHIES Risk Summary READI-CAT 2 products are not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. Risk Summary READI-CAT 2 products are not absorbed systemically by

Product summary:

16.1 How Supplied READI-CAT 2 and READI-CAT 2 SMOOTHIES (barium sulfate) are supplied as suspensions (2 % w/v) in a unit dose in a single-dose HDPE plastic bottle containing 9 grams of barium sulfate in 450 mL. READI-CAT 2 products are provided in the following flavors as: READI-CAT 2: (Orange): 12 x 450 mL bottles (NDC 32909-744-03) READI-CAT 2 SMOOTHIE (Banana): 12 x 450 mL bottles (NDC 32909-742-03) READI-CAT 2 SMOOTHIE (Berry): 12 x 450 mL bottles (NDC 32909-741-03) READI-CAT 2 SMOOTHIE (Creamy Vanilla): 12 x 450 mL bottles (NDC 32909-746-03) READI-CAT 2 SMOOTHIE (Mochaccino): 12 x 450 mL bottles (NDC 32909-747-03) 16.2 Storage and Handling Store at USP controlled room temperature, 20 to 25°C (68 to 77° F)

Authorization status:

New Drug Application

Summary of Product characteristics

READI-CAT 2- BARIUM SULFATE SUSPENSION
READI-CAT 2 BANANA SMOOTHIE- BARIUM SULFATE SUSPENSION
READI-CAT 2 BERRY SMOOTHIE- BARIUM SULFATE SUSPENSION
READI-CAT 2 MOCHACCINO SMOOTHIE- BARIUM SULFATE SUSPENSION
READI-CAT 2 CREAMY VANILLA SMOOTHIE- 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
READI-CAT 2 AND READI-CAT 2
SMOOTHIE PRODUCTS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
READI-CAT 2 (BARIUM SULFATE) ORAL SUSPENSION
READI-CAT 2 SMOOTHIE (BARIUM SULFATE) ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2016
RECENT MAJOR CHANGES
Warning and Precautions (5.6)
2/2017
INDICATIONS AND USAGE
READI-CAT 2 and READI-CAT 2 SMOOTHIE are radiographic contrast agents,
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
For oral use only:
Adults and pediatric patients 12 years and older: 450 mL to 900 mL (9
g to 18 g of barium sulfate, respectively) (2.1)
Patients younger than 12 years of age: scale down dose based on
relative GI volume (2.1)
DOSAGE FORMS AND STRENGTHS
Oral Suspension: 9 grams barium sulfate (2% w/v) supplied in a single
dose HDPE plastic bottle (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 hypersensitivity to barium sulfate or any of the excipients of
READI-CAT 2 products (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 o