DESCRIPTION SECTION.

11 DESCRIPTION. READI-CAT and READI-CAT SMOOTHIE (barium sulfate) are radiographiccontrast agents supplied as suspension (2% w/v) for oral administration. The active ingredient barium sulfate is designated chemically asBaSO4 with molecular weight of 233.4 g/mol,a density of 4.5 g/cm3, and the followingchemical structure:READI-CAT products contain excipientsincluding: benzoic acid, citric acid, potassium sorbate, saccharinsodium, simethicone emulsion, sodium benzoate, sodium citrate, sorbitolsolution, xanthan gum, and purified water.READI-CAT products also contain naturaland artificial flavorings including: banana, blueberry, orange, vanilla,chocolate, and coffee flavors.. barium-sulfate-suspensions-structure.

ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. The following adverse reactionshave been identified from spontaneous reporting or clinical studiesof barium sulfate administered orally. Because the reactions are reportedvoluntarily from population of uncertain size, it is not alwayspossible to reliably estimate their frequency or to establish causalrelationship to drug exposure:Nausea, vomiting, diarrhea and abdominal crampingSerious adverse reactions and fatalities include aspirationpneumonitis, barium sulfate impaction, intestinal perforation withconsequent peritonitis and granuloma formation, vasovagal and syncopalepisodes. Nausea, vomiting, diarrhea and abdominal cramping. Serious adverse reactions and fatalities include aspirationpneumonitis, barium sulfate impaction, intestinal perforation withconsequent peritonitis and granuloma formation, vasovagal and syncopalepisodes. Common adverse reactions includenausea, 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.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY. 12.1 Mechanismof Action. Due to its high atomic number, barium (the active ingredient in READI-CAT2 products) is opaque to x-rays and therefore acts as positive contrastagent for radiographic studies.. 12.3 Pharmacokinetics. Under physiological conditions, barium sulfatepasses through the GI tract in an unchanged form and is absorbed onlyin pharmacologically insignificant amounts.

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS. READI-CAT products are contraindicatedin patients:with known or suspected perforation of the GI tractwith known obstruction of the GI tractat high risk of GI perforation such as those with recentprior 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 pelvisat high risk of aspiration such as those with prior aspiration,tracheo-esophageal fistula, or obtundationknown severe hypersensitivity to barium sulfate or any ofthe excipients of READI-CAT or READI-CAT SMOOTHIES. 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 recentprior 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 ofthe excipients of READI-CAT or READI-CAT SMOOTHIES. Known or suspected perforation of the GI tract (4)Known obstruction of the GI tract (4)Conditions associated with high risk of GI perforation oraspiration (4)Known hypersensitivity to barium sulfate or any of the excipientsof READI-CAT products (4). Known or suspected perforation of the GI tract (4). Known obstruction of the GI tract (4). Conditions associated with high risk of GI perforation oraspiration (4). Known hypersensitivity to barium sulfate or any of the excipientsof READI-CAT products (4).

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. For oral use only:Adults and pediatric patients 12 years and older: 450 mLto 900 mL (9 to 18 of barium sulfate, respectively) (2.1)Patients younger than 12 years of age: scale down dose basedon relative GI volume (2.1). Adults and pediatric patients 12 years and older: 450 mLto 900 mL (9 to 18 of barium sulfate, respectively) (2.1). Patients younger than 12 years of age: scale down dose basedon relative GI volume (2.1). 2.1 Recommended Dosage. Base dosing on individual needs and procedureto be performed.Adult and pediatric patients 12 years and older: 450 mLto 900 mL (9 to 18 of barium sulfate)Patients younger than 12 years of age: adjust dose basedon relative GI volume. Adult and pediatric patients 12 years and older: 450 mLto 900 mL (9 to 18 of barium sulfate). Patients younger than 12 years of age: adjust dose basedon relative GI volume. 2.2 Administration Instructions. For oral use onlyShake bottle vigorously for 30 seconds prior to oral administrationAdminister undiluted prior to scanDiscard any unused suspensionAdvise patients to hydrate following the barium sulfateprocedure. For oral use only. Shake bottle vigorously for 30 seconds prior to oral administration. Administer undiluted prior to scan. Discard any unused suspension. Advise patients to hydrate following the barium sulfateprocedure.

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS. Oral suspension: grams of bariumsulfate supplied as suspension (2% w/v) in single-dose HDPE plasticbottle.. Oral Suspension: grams barium sulfate (2% w/v) suppliedin single dose HDPE plastic bottle (3). Oral Suspension: grams barium sulfate (2% w/v) suppliedin single dose HDPE plastic bottle (3).

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGEAND HANDLING. 16.1 How SuppliedREADI-CAT and READI-CAT SMOOTHIES (bariumsulfate) are supplied as suspensions (2 w/v) in unit dose in asingle-dose HDPE plastic bottle containing grams of barium sulfatein 450 mL.READI-CAT2 products are provided in the following flavors as:READI-CAT 2: (Orange): 12 450 mL bottles(NDC 32909-744-03)READI-CAT SMOOTHIE (Banana): 12 x450 mL bottles (NDC 32909-742-03)READI-CAT SMOOTHIE(Berry): 12 450 mL bottles (NDC 32909-741-03)READI-CAT2 SMOOTHIE (Creamy Vanilla): 12 450 mL bottles (NDC 32909-746-03)READI-CAT SMOOTHIE (Mochaccino): 12 450 mL bottles (NDC 32909-747-03)16.2 Storage and HandlingStore at USP controlledroom temperature, 20 to 25C (68 to 77 F).

INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE. READI-CAT and READI-CAT SMOOTHIES are indicatedfor use in computed tomography (CT) of the abdomen to delineate thegastrointestinal (GI) tract in adult and pediatric patients.. READI-CAT and READI-CAT SMOOTHIEare radiographic contrast agents, indicated for use in computed tomography(CT) of the abdomen to delineate the gastrointestinal (GI) tract inadult and pediatric patients (1).

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING INFORMATION. After administration advise patients to:Maintain adequate hydrationSeek medical attention for worsening of constipation orslow gastrointestinal passageSeek medical attention for any delayed onset of hypersensitivity:rash, urticaria, or respiratory difficulty.Manufactured byEZEM Canada IncAnjou (Quebec) Canada H1J 2Z4ForBracco DiagnosticsInc.Monroe Township, NJ 08831 Revised January 2020CL10E801. Maintain adequate hydration. Seek medical attention for worsening of constipation orslow gastrointestinal passage. Seek medical attention for any delayed onset of hypersensitivity:rash, urticaria, or respiratory difficulty.

NONCLINICAL TOXICOLOGY SECTION.

13 NONCLINICAL TOXICOLOGY. 13.1 Carcinogenesis,Mutagenesis, Impairment of Fertility. No animal studies have been performed toevaluate the carcinogenic potential of barium sulfate or potentialeffects on fertility.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Readi-Cat(R) Barium Sulfate Suspension LabelsNDC:32909-744-03. Readi-cat external label. Readi-cat internal label.

RECENT MAJOR CHANGES SECTION.

Warning and Precautions (5.6)2/2017.

SPL UNCLASSIFIED SECTION.

2.1 Recommended Dosage. Base dosing on individual needs and procedureto be performed.Adult and pediatric patients 12 years and older: 450 mLto 900 mL (9 to 18 of barium sulfate)Patients younger than 12 years of age: adjust dose basedon relative GI volume. Adult and pediatric patients 12 years and older: 450 mLto 900 mL (9 to 18 of barium sulfate). Patients younger than 12 years of age: adjust dose basedon relative GI volume.

USE IN SPECIFIC POPULATIONS SECTION.

8 USES IN SPECIFIC POPULATIONS. 8.1 Pregnancy. Risk SummaryREADI-CAT2 products are not absorbed systemically following oral administration,and maternal use is not expected to result in fetal exposure to thedrug.. 8.2 Lactation. Risk SummaryREADI-CAT2 products are not absorbed systemically by the mother following oraladministration, and breastfeeding is not expected to result in exposureof the infant to READI-CAT 2.. 8.4 Pediatric Use. The efficacy of READI-CAT2 in pediatric patients of all groups is based on successful opacificationof the GI tract during radiographic procedures [see ClinicalPharmacology (12.1)].READI-CAT is contraindicated in pediatric patients with tracheo-esophagealfistula [see Contraindications (4)].Pediatric patients witha history of asthma or food allergies may be at increased risk fordevelopment of hypersensitivity reactions [see Warnings andPrecautions (5.1)]. Pediatricpatients with cystic fibrosis or Hirschsprung disease should be monitoredfor bowel obstruction after use [see Warnings and Precautions(5.3)].. 8.5 GeriatricUse. Clinicalstudies of READI-CAT products do not include sufficient numbersof subjects aged 65 and over to determine whether they respond differentlyfrom younger subjects. Other reported clinical experience has notidentified differences in responses between the elderly and youngerpatients. In general, dose selection for an elderly patient shouldbe cautious, usually starting at the low end of the dosing range,reflecting the greater frequency of decreased hepatic, renal, or cardiacfunction, and of concomitant disease or other drug therapy.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS. Hypersensitivity reactions: Emergency equipment and trainedpersonnel should be immediately available (5.1)Intra-abdominal leakage: May occur in conditions such asGI 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 maintainadequate hydration in days following barium sulfate procedure toavoid obstruction or impaction (5.3)Aspiration: Caution is recommended in patients with historyof food aspiration and in patients with known swallowing disorders(5.4). Hypersensitivity reactions: Emergency equipment and trainedpersonnel should be immediately available (5.1). Intra-abdominal leakage: May occur in conditions such asGI 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 maintainadequate hydration in days following barium sulfate procedure toavoid obstruction or impaction (5.3). Aspiration: Caution is recommended in patients with historyof food aspiration and in patients with known swallowing disorders(5.4). 5.1 Hypersensitivity Reactions. Barium sulfate preparations contain numberof excipients, including natural and artificial flavors and may induceserious hypersensitivity reactions. The manifestations include hypotension,bronchospasm and other respiratory impairments, dermal reactions includingrashes, urticaria, and itching. history of bronchial asthma, atopy,or previous reaction to contrast agent may increase the risk forhypersensitivity reactions. Emergency equipment and trained personnelshould be immediately available for treatment of hypersensitivityreaction.. 5.2 Intra-abdominal Barium Leakage. The use of READI-CAT products is contraindicatedin patients at high risk of perforation of the GI tract [seeContraindications (4)]. Administrationof READI-CAT products may result in leakage of barium from the GItract in the presence of conditions such as carcinomas, GI fistula,inflammatory bowel disease, gastric or duodenal ulcer, appendicitis,or diverticulitis, and in patients with severe stenosis at any levelof the GI tract, especially if it is distal to the stomach. The bariumleakage has been associated with peritonitis and granuloma formation.. 5.3 Delayed Gastrointestinal Transit and Obstruction. Orally administeredbarium sulfate may accumulate proximal to constricting lesion ofthe colon, causing obstruction or impaction with development of baroliths(inspissated barium associated with feces) and may lead to abdominalpain, appendicitis, bowel obstruction, or rarely perforation. Patientswith the following conditions are at higher risk for developing obstructionor baroliths: severe stenosis at any level of the GI tract, impairedGI motility, electrolyte imbalance, dehydration, on low residuediet, taking medications that delay GI motility, and constipation,pediatric patients with cystic fibrosis or Hirschsprung disease, andthe elderly [see Use in Specific Populations (8.4, 8.5)]. To reduce the risk of delayed GI transit and obstruction,patients should maintain adequate hydration following barium sulfateprocedure.. 5.4 Aspiration Pneumonitis. The use of READI-CAT products is contraindicatedin patients at high risk of aspiration [see Contraindications(4)]. Oral administrationof barium is associated with aspiration pneumonitis, especially inpatients with history of food aspiration or with compromised swallowingmechanism. Vomiting following oral administration of barium sulfatemay lead to aspiration pneumonitis. In patients at risk for aspiration,begin the procedure with small ingested volume of READI-CAT products.Discontinue administration of READI-CAT products immediately ifaspiration is suspected.. 5.5 SystemicEmbolization. Barium sulfate products may occasionally intravasate into the venousdrainage of the large bowel and enter the circulation as bariumembolus leading to potentially fatal complications which includesystemic and pulmonary embolism, disseminated intravascular coagulation,septicemia and prolonged severe hypotension. Although this complicationis exceedingly uncommon after oral administration of barium sulfatesuspension, monitor patients for potential intravasation when administeringbarium sulfate.. 5.6 Risk with Hereditary Fructose Intolerance. READI-CAT2 contains sorbitol which may cause severe reactions if ingested bypatients with hereditary fructose intolerance, such as: vomiting,hypoglycemia, jaundice, hemorrhage, hepatomegaly, hyperuricemia, andkidney failure. Before administration of READI-CAT assess patientsfor history of hereditary fructose intolerance and avoid use inthese patients.