Label: 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

  • NDC Code(s): 32909-711-03, 32909-722-03, 32909-724-03, 32909-756-03, view more
    32909-777-03
  • Packager: E-Z-EM Canada Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 15, 2018

If you are a consumer or patient please visit this version.

  • 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 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 REACTIONS

    Common adverse reactions include nausea, 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.

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 2/2017

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  • FULL PRESCRIBING INFORMATION: CONTENTS*
  • 1  INDICATIONS AND USAGE

    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.

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  • 2  DOSAGE AND ADMINISTRATION

    2.1 Recommended Dosage

    Base dosing on individual needs and procedure to be performed.

    • Adult and pediatric patients 12 years and older: 450 mL to 900 mL (9 g to 18 g of barium sulfate)
    • Patients younger than 12 years of age: adjust dose based on relative GI volume

    2.2 Administration Instructions

    • 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 sulfate procedure
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  • 3  DOSAGE FORMS AND STRENGTHS

    Oral suspension: 9 grams of barium sulfate supplied as a suspension (2% w/v) in a single-dose HDPE plastic bottle.

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  • 4  CONTRAINDICATIONS

    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
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  • 5  WARNINGS AND PRECAUTIONS

    5.1 Hypersensitivity Reactions

    Barium sulfate preparations contain a number of excipients, including natural and artificial flavors and may induce serious hypersensitivity reactions. The manifestations include hypotension, bronchospasm and other respiratory impairments, dermal reactions including rashes, urticaria, and itching. A history of bronchial asthma, atopy, or a previous reaction to a contrast agent may increase the risk for hypersensitivity reactions. Emergency equipment and trained personnel should be immediately available for treatment of a hypersensitivity reaction.

    5.2 Intra-abdominal Barium Leakage

    The use of READI-CAT 2 products is contraindicated in patients at high risk of perforation of the GI tract [see Contraindications (4)]. Administration of READI-CAT 2 products may result in leakage of barium from the GI tract in the presence of conditions such as carcinomas, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, or diverticulitis, and in patients with a severe stenosis at any level of the GI tract, especially if it is distal to the stomach. The barium leakage has been associated with peritonitis and granuloma formation.

    5.3 Delayed Gastrointestinal Transit and Obstruction

    Orally administered barium sulfate may accumulate proximal to a constricting lesion of the colon, causing obstruction or impaction with development of baroliths (inspissated barium associated with feces) and may lead to abdominal pain, appendicitis, bowel obstruction, or rarely perforation. Patients with the following conditions are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired GI motility, electrolyte imbalance, dehydration, on a low residue diet, taking medications that delay GI motility, and constipation, pediatric patients with cystic fibrosis or Hirschsprung disease, and the 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 a barium sulfate procedure.

    5.4 Aspiration Pneumonitis

    The use of READI-CAT 2 products is contraindicated in patients at high risk of aspiration [see Contraindications (4)]. Oral administration of barium is associated with aspiration pneumonitis, especially in patients with a history of food aspiration or with compromised swallowing mechanism. Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. In patients at risk for aspiration, begin the procedure with a small ingested volume of READI-CAT 2 products. Discontinue administration of READI-CAT 2 products immediately if aspiration is suspected.

    5.5 Systemic Embolization

    Barium sulfate products may occasionally intravasate into the venous drainage of the large bowel and enter the circulation as a "barium embolus" leading to potentially fatal complications which include systemic and pulmonary embolism, disseminated intravascular coagulation, septicemia and prolonged severe hypotension. Although this complication is exceedingly uncommon after oral administration of barium sulfate suspension, monitor patients for potential intravasation when administering barium sulfate.

    5.6 Risk with Hereditary Fructose Intolerance

    READI-CAT 2 contains sorbitol which may cause severe reactions if ingested by patients with hereditary fructose intolerance, such as: vomiting, hypoglycemia, jaundice, hemorrhage, hepatomegaly, hyperuricemia, and kidney failure. Before administration of READI-CAT 2 assess patients for a history of hereditary fructose intolerance and avoid use in these patients.

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  • 6  ADVERSE REACTIONS

    The following adverse reactions have been identified from spontaneous reporting or clinical studies of barium sulfate administered orally. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure:

    • Nausea, vomiting, diarrhea and abdominal cramping
    • Serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes
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  • 8  USES IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    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.

    8.2 Lactation

    Risk Summary
    READI-CAT 2 products are not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the infant to READI-CAT 2.

    8.4 Pediatric Use

    The efficacy of READI-CAT 2 in pediatric patients of all groups is based on successful opacification of the GI tract during radiographic procedures [see Clinical Pharmacology (12.1)].

    READI-CAT 2 is contraindicated in pediatric patients with tracheo-esophageal fistula [see Contraindications (4)].

    Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions [see Warnings and Precautions (5.1)]. Pediatric patients with cystic fibrosis or Hirschsprung disease should be monitored for bowel obstruction after use [see Warnings and Precautions (5.3)].

    8.5 Geriatric Use

    Clinical studies of READI-CAT 2 products do not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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  • 11  DESCRIPTION

    READI-CAT 2 and READI-CAT 2 SMOOTHIE (barium sulfate) are radiographic contrast agents supplied as a suspension (2% w/v) for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm3, and the following chemical structure:

    barium-sulfate-suspensions-structure

    READI-CAT 2 products contain excipients including: benzoic acid, citric acid, potassium sorbate, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, sorbitol solution, xanthan gum, and purified water.

    READI-CAT 2 products also contain natural and artificial flavorings including: banana, blueberry, orange, vanilla, chocolate, and coffee flavors.

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  • 12  CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Due to its high atomic number, barium (the active ingredient in READI-CAT 2 products) is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies.

    12.3 Pharmacokinetics

    Under physiological conditions, barium sulfate passes through the GI tract in an unchanged form and is absorbed only in pharmacologically insignificant amounts.

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  • 13  NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    No animal studies have been performed to evaluate the carcinogenic potential of barium sulfate or potential effects on fertility.

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  • 16  HOW SUPPLIED/STORAGE AND HANDLING

    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): 24 x 450 mL bottles (NDC 32909-724-03)
    READI-CAT 2 SMOOTHIE (Banana): 24 x 450 mL bottles (NDC 32909-722-03)
    READI-CAT 2 SMOOTHIE (Berry): 24 x 450 mL bottles (NDC 32909-711-03)
    READI-CAT 2 SMOOTHIE (Creamy Vanilla): 24 x 450 mL bottles (NDC 32909-756-03)
    READI-CAT 2 SMOOTHIE (Mochaccino): 24 x 450 mL bottles (NDC 32909-777-03)

    16.2 Storage and Handling

    Store at USP controlled room temperature, 20 to 25°C (68 to 77° F)

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  • 17  PATIENT COUNSELING INFORMATION

    After administration advise patients to:

    • Maintain adequate hydration
    • Seek medical attention for worsening of constipation or slow gastrointestinal passage
    • Seek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory difficulty.

    Manufactured by
    EZEM Canada Inc
    Anjou (Quebec) Canada H1J 2Z4

    For
    Bracco Diagnostics Inc.
    Monroe Township, NJ 08831

    Revised February 2017

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  • PRINCIPAL DISPLAY PANEL

    Readi–Cat® 2 Barium Sulfate Suspension Labels
    NDC: 32909-724-03

    readi-cat-2-external-label-32909-724-03
    readi-cat-2-internal-label-32909-724-03
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  • PRINCIPAL DISPLAY PANEL

    Readi–Cat® 2 Barium Sulfate Suspension Labels
    NDC: 32909-722-03

    readi-cat-2-banana-external-label-32909-722-03
    readi-cat-2-banana-internal-label-32909-722-03
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  • PRINCIPAL DISPLAY PANEL

    Readi–Cat® 2 Barium Sulfate Suspension Labels
    NDC: 32909-711-03

    readi-cat-2-berry-external-label-32909-711-03
    readi-cat-2-berry-internal-label-32909-711-03
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  • PRINCIPAL DISPLAY PANEL

    Readi–Cat® 2 Barium Sulfate Suspension Labels
    NDC: 32909-777-03

    readi-cat-2-mochaccino-external-label-32909-777-03
    readi-cat-2-mochaccino-internal-label-32909-777-03
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  • PRINCIPAL DISPLAY PANEL

    Readi–Cat® 2 Barium Sulfate Suspension Labels
    NDC: 32909-756-03

    readi-cat-2-creamy-vanilla-external-label-32909-756-03
    readi-cat-2-creamy-vanilla-internal-label-32909-756-03
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  • INGREDIENTS AND APPEARANCE
    READI-CAT 2 
    barium sulfate suspension
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:32909-724
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Barium Sulfate (UNII: 25BB7EKE2E) (Barium Sulfate - UNII:25BB7EKE2E) Barium Sulfate 20 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid (UNII: XF417D3PSL)  
    dimethicone 350 (UNII: 2Y53S6ATLU)  
    dimethicone 1000 (UNII: MCU2324216)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    water (UNII: 059QF0KO0R)  
    xanthan gum (UNII: TTV12P4NEE)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor ORANGE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:32909-724-03 24 in 1 CARTON 03/27/2017
    1 450 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA208143 03/27/2017
    READI-CAT 2 BANANA SMOOTHIE 
    barium sulfate suspension
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:32909-722
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Barium Sulfate (UNII: 25BB7EKE2E) (Barium Sulfate - UNII:25BB7EKE2E) Barium Sulfate 20 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid (UNII: XF417D3PSL)  
    benzoic acid (UNII: 8SKN0B0MIM)  
    dimethicone 350 (UNII: 2Y53S6ATLU)  
    dimethicone 1000 (UNII: MCU2324216)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sodium benzoate (UNII: OJ245FE5EU)  
    trisodium citrate dihydrate (UNII: B22547B95K)  
    sorbitol (UNII: 506T60A25R)  
    water (UNII: 059QF0KO0R)  
    xanthan gum (UNII: TTV12P4NEE)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor BANANA, VANILLA Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:32909-722-03 24 in 1 CARTON 03/27/2017
    1 450 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA208143 03/27/2017
    READI-CAT 2 BERRY SMOOTHIE 
    barium sulfate suspension
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:32909-711
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Barium Sulfate (UNII: 25BB7EKE2E) (Barium Sulfate - UNII:25BB7EKE2E) Barium Sulfate 20 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid (UNII: XF417D3PSL)  
    benzoic acid (UNII: 8SKN0B0MIM)  
    dimethicone 350 (UNII: 2Y53S6ATLU)  
    dimethicone 1000 (UNII: MCU2324216)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sodium benzoate (UNII: OJ245FE5EU)  
    trisodium citrate dihydrate (UNII: B22547B95K)  
    sorbitol (UNII: 506T60A25R)  
    water (UNII: 059QF0KO0R)  
    xanthan gum (UNII: TTV12P4NEE)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor BLUEBERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:32909-711-03 24 in 1 CARTON 03/27/2017
    1 450 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA208143 03/27/2017
    READI-CAT 2 MOCHACCINO SMOOTHIE 
    barium sulfate suspension
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:32909-777
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Barium Sulfate (UNII: 25BB7EKE2E) (Barium Sulfate - UNII:25BB7EKE2E) Barium Sulfate 20 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid (UNII: XF417D3PSL)  
    benzoic acid (UNII: 8SKN0B0MIM)  
    dimethicone 350 (UNII: 2Y53S6ATLU)  
    dimethicone 1000 (UNII: MCU2324216)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sodium benzoate (UNII: OJ245FE5EU)  
    trisodium citrate dihydrate (UNII: B22547B95K)  
    sorbitol (UNII: 506T60A25R)  
    water (UNII: 059QF0KO0R)  
    xanthan gum (UNII: TTV12P4NEE)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor COFFEE, CHOCOLATE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:32909-777-03 24 in 1 CARTON 03/27/2017
    1 450 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA208143 03/27/2017
    READI-CAT 2 CREAMY VANILLA SMOOTHIE 
    barium sulfate suspension
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:32909-756
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Barium Sulfate (UNII: 25BB7EKE2E) (Barium Sulfate - UNII:25BB7EKE2E) Barium Sulfate 20 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid (UNII: XF417D3PSL)  
    benzoic acid (UNII: 8SKN0B0MIM)  
    dimethicone 350 (UNII: 2Y53S6ATLU)  
    dimethicone 1000 (UNII: MCU2324216)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sodium benzoate (UNII: OJ245FE5EU)  
    trisodium citrate dihydrate (UNII: B22547B95K)  
    sorbitol (UNII: 506T60A25R)  
    water (UNII: 059QF0KO0R)  
    xanthan gum (UNII: TTV12P4NEE)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor VANILLA Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:32909-756-03 24 in 1 CARTON 03/27/2017
    1 450 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA208143 03/27/2017
    Labeler - E-Z-EM Canada Inc (204211163)
    Registrant - BRACCO DIAGNOSTICS INC (849234661)
    Establishment
    Name Address ID/FEI Business Operations
    E-Z-EM Canada Inc 204211163 ANALYSIS(32909-777, 32909-711, 32909-722, 32909-756, 32909-724) , MANUFACTURE(32909-711, 32909-777, 32909-722, 32909-756, 32909-724)
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