Readi-cat 2 Banana Smoothie

Barium Sulfate


E-z-em Canada Inc
Human Prescription Drug
NDC 32909-742
Readi-cat 2 Banana Smoothie also known as Barium Sulfate is a human prescription drug labeled by 'E-z-em Canada Inc'. National Drug Code (NDC) number for Readi-cat 2 Banana Smoothie is 32909-742. This drug is available in dosage form of Suspension. The names of the active, medicinal ingredients in Readi-cat 2 Banana Smoothie drug includes Barium Sulfate - 20 mg/mL . The currest status of Readi-cat 2 Banana Smoothie drug is Active.

Drug Information:

Drug NDC: 32909-742
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Readi-cat 2 Banana Smoothie
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Barium Sulfate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: E-z-em Canada Inc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Suspension
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:BARIUM SULFATE - 20 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: NDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 01 Nov, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 22 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: NDA208143
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:E-Z-EM Canada Inc
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
NUI:N0000180185
N0000010258
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:25BB7EKE2E
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:X-Ray Contrast Activity [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:Radiographic Contrast Agent [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class:Radiographic Contrast Agent [EPC]
X-Ray Contrast Activity [MoA]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
32909-742-0312 BOTTLE, PLASTIC in 1 CARTON (32909-742-03) / 450 mL in 1 BOTTLE, PLASTIC01 Nov, 2020N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Readi-cat 2 barium sulfate barium sulfate barium sulfate anhydrous citric acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate sorbitol water xanthan gum saccharin sodium readi-cat 2 banana smoothie barium sulfate barium sulfate barium sulfate anhydrous citric acid benzoic acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate sorbitol water xanthan gum saccharin sodium readi-cat 2 berry smoothie barium sulfate barium sulfate barium sulfate anhydrous citric acid benzoic acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate sorbitol water xanthan gum saccharin sodium readi-cat 2 mochaccino smoothie barium sulfate barium sulfate barium sulfate anhydrous citric acid benzoic acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate sorbitol water xanthan gum saccharin sodium readi-cat 2 creamy vanilla smoothie barium sulfate barium sulfate barium sulfate anhydrous citric acid benzoic acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate sorbitol water xanthan gum saccharin sodium readi-cat 2 barium sulfate barium sulfate barium sulfate anhydrous citric acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate sorbitol water xanthan gum saccharin sodium readi-cat 2 banana smoothie barium sulfate barium sulfate barium sulfate anhydrous citric acid benzoic acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate sorbitol water xanthan gum saccharin sodium readi-cat 2 berry smoothie barium sulfate barium sulfate barium sulfate anhydrous citric acid benzoic acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate sorbitol water xanthan gum saccharin sodium readi-cat 2 mochaccino smoothie barium sulfate barium sulfate barium sulfate anhydrous citric acid benzoic acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate sorbitol water xanthan gum saccharin sodium readi-cat 2 creamy vanilla smoothie barium sulfate barium sulfate barium sulfate anhydrous citric acid benzoic acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate sorbitol water xanthan gum saccharin sodium

Indications and Usage:

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. 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 )

Warnings and Cautions:

5 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 ) 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, a
topy, 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.

Dosage and Administration:

2 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 ) 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

Dosage Forms and Strength:

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. oral suspension: 9 grams barium sulfate (2% w/v) supplied in a single dose hdpe plastic bottle ( 3 )

Contraindications:

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 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 )

Adverse Reactions:

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 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.

Use in Specific Population:

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 monitor
ed 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.

Description:

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 baso 4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm 3 , and the following chemical 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. barium-sulfate-suspensions-structure

Clinical Pharmacology:

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.

Nonclinical Toxicology:

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.

How Supplied:

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): 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)

Information for Patients:

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 january 2020 cl10e801

Package Label Principal Display Panel:

Readi–cat ® 2 barium sulfate suspension labels ndc: 32909-744-03 readi-cat 2 external label readi-cat 2 internal label

Readi–cat ® 2 barium sulfate suspension labels — banana smoothie ndc: 32909-742-03 readi-cat 2 banana external label readi-cat 2 banana internal label

Readi–cat ® 2 barium sulfate suspension labels ndc: 32909-741-03 readi-cat 2 berry external label readi-cat 2 berry internal label

Readi–cat ® 2 barium sulfate suspension labels ndc: 32909-747-03 readi-cat 2 mochaccino external label readi-cat 2 mochaccino internal label

Readi–cat ® 2 barium sulfate suspension labels ndc: 32909-746-03 readi-cat 2 creamy vanilla external label readi-cat 2 creamy vanilla internal label


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