NDC 32909-741 Readi-cat 2 Berry Smoothie

Barium Sulfate

NDC Product Code 32909-741

NDC 32909-741-03

Package Description: 12 BOTTLE, PLASTIC in 1 CARTON > 450 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Readi-cat 2 Berry Smoothie with NDC 32909-741 is a a human prescription drug product labeled by E-z-em Canada Inc. The generic name of Readi-cat 2 Berry Smoothie is barium sulfate. The product's dosage form is suspension and is administered via oral form.

Labeler Name: E-z-em Canada Inc

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Readi-cat 2 Berry Smoothie Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BARIUM SULFATE 20 mg/mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Radiographic Contrast Agent - [EPC] (Established Pharmacologic Class)
  • X-Ray Contrast Activity - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: E-z-em Canada Inc
Labeler Code: 32909
FDA Application Number: NDA208143 What is the FDA Application Number?
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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 11-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Readi-cat 2 Berry Smoothie Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

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 onlyShake bottle vigorously for 30 seconds prior to oral administrationAdminister undiluted prior to scanDiscard any unused suspensionAdvise patients to hydrate following the barium sulfate
  • Procedure

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.

4  Contraindications

  • READI-CAT 2 products are contraindicated
  • In 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 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 pelvisat high risk of aspiration such as those with prior aspiration,
  • Tracheo-esophageal fistula, or obtundationknown severe hypersensitivity to barium sulfate or any of
  • The excipients of READI-CAT 2 or READI-CAT 2 SMOOTHIES

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.

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 crampingSerious adverse reactions and fatalities include aspiration
  • Pneumonitis, barium sulfate impaction, intestinal perforation with
  • Consequent peritonitis and granuloma formation, vasovagal and syncopal
  • Episodes

8.1 Pregnancy

Risk SummaryREADI-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 SummaryREADI-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.

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: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.

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.

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.

16  How Supplied/Storage And Handling

16.1 How SuppliedREADI-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 HandlingStore at USP controlled
room temperature, 20 to 25°C (68 to 77° F)

17  Patient Counseling Information

  • After administration advise patients to:Maintain adequate hydrationSeek medical attention for worsening of constipation or
  • Slow gastrointestinal passageSeek medical attention for any delayed onset of hypersensitivity:
  • Rash, urticaria, or respiratory difficulty.Manufactured byEZEM Canada IncAnjou (Quebec) Canada H1J 2Z4ForBracco Diagnostics
  • Inc.Monroe Township, NJ 08831Revised February 2017

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