Varibar Thin Honey

Barium Sulfate


E-z-em Canada Inc
Human Prescription Drug
NDC 32909-121
Varibar Thin Honey also known as Barium Sulfate is a human prescription drug labeled by 'E-z-em Canada Inc'. National Drug Code (NDC) number for Varibar Thin Honey is 32909-121. This drug is available in dosage form of Suspension. The names of the active, medicinal ingredients in Varibar Thin Honey drug includes Barium Sulfate - 400 mg/mL . The currest status of Varibar Thin Honey drug is Active.

Drug Information:

Drug NDC: 32909-121
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: Varibar Thin Honey
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 - 400 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: 03 Jan, 2018
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
32909-121-071 BOTTLE, PLASTIC in 1 BOX (32909-121-07) / 250 mL in 1 BOTTLE, PLASTIC03 Jan, 2018N/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:

Varibar thin honey barium sulfate barium sulfate barium sulfate anhydrous citric acid carboxymethylcellulose sodium dimethicone 350 dimethicone 1000 glycerin modified corn starch (1-octenyl succinic anhydride) polysorbate 80 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate water xanthan gum xylitol saccharin sodium

Indications and Usage:

1 indications and usage varibar thin honey is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. varibar thin honey is a radiopaque contrast agent indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology 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 barium sulfate procedure to avoid obstruction or impaction ( 5.3 ) aspiration pneumonitis: aspiration may occur during the modified barium swallow examination, monitor the patient for aspiration ( 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, and dermal reactions including rashes, urticaria and itching. a history of bronchial asthma,
atopy, food allergies, 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 varibar thin honey is contraindicated in patients at high risk of perforation of the gi tract [see contraindications ( 4 )] . administration of varibar thin honey 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, 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 after the barium sulfate procedure. 5.4 aspiration pneumonitis the use of varibar thin honey is contraindicated in patients with trachea-esophageal fistula [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 varibar thin honey. monitor the patient closely for aspiration, discontinue administration of varibar thin honey if aspiration is suspected, and monitor for development of aspiration pneumonitis. 5.5 systemic embolization barium sulfate products may occasionally intravasate into the venous drainage of the gi tract 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 a barium sulfate suspension, monitor patients for potential intravasation when administering barium sulfate.

Dosage and Administration:

2 dosage and administration for oral use only – administer by syringe, spoon, or cup. the recommended dose is: adults: 5 ml pediatric patients: 1 to 3 ml during a single modified barium swallow examination, multiple doses may be administered maximum cumulative dose: 30 ml ( 2 ) 2.1 recommended dosing the recommended dose of varibar thin honey administered orally by syringe, spoon, or cup is: adults 5 ml pediatric patients 1 to 3 ml during a single modified barium swallow examination, multiple doses of varibar thin honey may be administered, to assess the patient during multiple swallows and different radiographic views. the maximum cumulative dose is 30 ml. once opened, write the discard after date on the immediate container label. discard any unused product after 21 days. 2.2 important administration instructions for oral use only advise patients to hydrate following the barium sulfate procedure.

Dosage Forms and Strength:

3 dosage forms and strengths oral suspension: barium sulfate (40% w/v) supplied in a multiple-dose plastic bottle as a ready-to-use suspension for oral administration. each bottle contains 250 ml of suspension. oral suspension: barium sulfate (40% w/v) supplied in a multiple-dose bottle for oral administration ( 3 )

Contraindications:

4 contraindications varibar thin honey is contraindicated in patients with: known or suspected perforation of the gastrointestinal (gi) tract known obstruction of the gi tract high risk of gi perforation such as those with a recent 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 the pelvis high risk of aspiration such as those with known or suspected tracheo-esophageal fistula or obtundation known severe hypersensitivity to barium sulfate or any of the excipients of varibar thin honey known or suspected perforation of the gastrointestinal (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 varibar thin honey ( 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 cramp ( 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

Use in Specific Population:

8 use in specific populations 8.1 pregnancy risk summary varibar thin honey is 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 varibar thin honey is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the infant to the drug. 8.4 pediatric use the efficacy of varibar thin honey in pediatric patients is based on successful opacification of the pharynx during modified barium swallow examinations [see clinical pharmacology ( 12.1 )] . safety and dosing recommendations in pediatric patients are based on clinical experience. varibar thin honey is contraindicated in pediatric patients with trachea-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 )]. monitor patients with cystic fibrosis or hirschsprung disease for bowel obstruction after use [see warnings and precautions ( 5.3 )] . 8.5 geriatric use clinical studies of varibar thin honey did 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 varibar thin honey (barium sulfate) is a radiographic contrast agent that is supplied as an off-white to lightly colored suspension (40% w/v) with an apple aroma 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: varibar thin honey has a viscosity of 1500 cps and contains the following excipients: carboxymethylcellulose sodium, citric acid, glycerin, natural and artificial apple flavor, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, starch modified (from corn), xanthan gum, and xylitol. barium-sulfate-structure

Clinical Pharmacology:

12 clinical pharmacology 12.1 mechanism of action due to its high atomic number, barium (the active ingredient in varibar thin honey) is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies. 12.2 pharmacodynamics barium sulfate is biologically inert and has no known pharmacological effects. 12.3 pharmacokinetics under physiological conditions, barium sulfate passes through the gastrointestinal tract in an unchanged form and is absorbed only in small, 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 varibar thin honey is supplied as a suspension in a multiple-dose polyethylene bottle containing 250 ml of barium sulfate (40 % w/v). provided as: 12 x 250 ml bottles (ndc 32909-121-07) 16.2 storage and handling store at usp controlled room temperature 20 to 25°c (68 to 77° f). protect from freezing. once opened, varibar thin honey may be used for up to 21 days when stored 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 [see dosage and administration ( 2.2 ) and warnings and precautions ( 5.3 )] . seek medical attention for worsening of constipation or slow gastrointestinal passage [see warnings and precautions ( 5.3 )] . seek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory difficulty [see warnings and precautions ( 5.1 )] . rx only manufactured by ezem canada inc anjou (quebec) canada h1j 2z4 for bracco diagnostics inc. monroe township, nj 08831 varibar is a registered trademark of e-z-em, inc. january 2018

Package Label Principal Display Panel:

Varibar thin honey box varibar-thin-honey-box

Varibar thin honey unit label varibar-thin-honey-internal-label


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.