Liquid Polibar Plus

Barium Sulfate

E-z-em Canada Inc
Human Prescription Drug
NDC 32909-167

Liquid Polibar Plus also known as Barium Sulfate is a human prescription drug labeled by 'E-z-em Canada Inc'. National Drug Code (NDC) number for Liquid Polibar Plus is 32909-167. This drug is available in dosage form of Suspension. The names of the active, medicinal ingredients in Liquid Polibar Plus drug includes Barium Sulfate - 1.05 g/mL . The currest status of Liquid Polibar Plus drug is Active.

Drug Information:

Drug NDC:	32909-167
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:	Liquid Polibar Plus
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 - 1.05 g/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL RECTAL
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:	UNAPPROVED DRUG OTHER
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 Feb, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	21 Jun, 2026
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.
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 NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
32909-167-55	750 mL in 1 BOTTLE, PLASTIC (32909-167-55)	01 Feb, 2021	N/A	No
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.

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Product Elements:

Liquid polibar plus barium sulfate barium sulfate barium sulfate acacia anhydrous citric acid dimethicone 350 dimethicone 1000 hydrochloric acid polysorbate 80 potassium chloride potassium sorbate water saccharin sodium silicon dioxide sodium benzoate carrageenan trisodium citrate dihydrate sorbitol xanthan gum liquid polibar plus barium sulfate barium sulfate barium sulfate acacia anhydrous citric acid dimethicone 350 dimethicone 1000 hydrochloric acid polysorbate 80 potassium chloride potassium sorbate water saccharin sodium silicon dioxide sodium benzoate carrageenan trisodium citrate dihydrate sorbitol xanthan gum

Indications and Usage:

Indications and usage for radiography of the gastrointestinal tract.

Warnings:

Warnings rarely, severe allergic reactions of an anaphylactoid nature, have been reported following administration of barium sulfate contrast agents. appropriately trained personnel and facilities should be available for emergency treatment of severe reactions and should remain available for at least 30 to 60 minutes following administration, since delayed reactions can occur.

General Precautions:

General diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. a history of bronchial asthma, atopy, as evidenced by hay fever and eczema, or a previous reaction to a contrast agent, warrant special attention. caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension or advanced cardiac disease. ingestion of this product is not recommended in patients with a history of food aspiration. if barium studies are required in these patients or in patients in whom integrity of the swallowing mechanism is unknown, proceed with caution. if this product is aspirated into the larynx, further administration should be immediately discontinued. after any barium study of the gi tract, it is important to rehydrate the patient as quickly as possible to prev Read more...

ent impaction of the bowel by barium sulfate. to prevent barium sulfate impaction in the bowel, the use of mild laxatives such as milk of magnesia or lactulose, following completion of the examination may also be required. these mild laxatives are recommended on a routine basis and in patients with a history of constipation unless contraindicated.

Dosage and Administration:

Dosage and administration general the volume and concentration of liquid polibar plus Â® to be administered will depend on the degree and extent of contrast required in the area(s) under examination and on the equipment and technique employed. see applicable system below for typical adult dose. patient preparation for colon examinations in order to achieve optimum results, the colon must be cleansed prior to the use of a barium enema. this is usually accomplished by placing the patient on a low fat, low residue diet, combined with the use of laxatives and/or cathartics. a cleansing enema may also be used unless contraindicated.

Contraindications:

Contraindications oral administration this product should not be used in patients with known gastric or intestinal perforation or hypersensitivity to barium sulfate products. rectal administration this product should not be used in patients with known intestinal perforation or hypersensitivity to barium sulfate products.

Adverse Reactions:

Adverse reactions adverse reactions, such as nausea, vomiting, diarrhea and abdominal cramping, accompanying the use of barium sulfate formulations are infrequent and usually mild. severe reactions (approximately 1 in 1,000,000) and fatalities (approximately 1 in 10,000,000) have occurred. procedural complications are rare, but may include aspiration pneumonitis, barium sulfate impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities. ekg changes have been reported following or during barium enema procedures. it is of the utmost importance to be completely prepared to treat any such occurrence.

Use in Pregnancy:

Usage in pregnancy radiation is known to cause harm to the unborn fetus exposed in utero . therefore, radiographic procedures should only be used when, in the judgement of the physician, their use is deemed essential to the welfare of the pregnant patient.

Overdosage:

Overdosage on rare occasions following repeated administration, severe stomach cramps, nausea, vomiting, diarrhea or constipation may occur. these are transitory in nature and are not considered serious. symptoms may be treated according to currently accepted standards of medical care.

Description:

Description liquid polibar plus Â® barium sulfate suspension (105% w/v, 58% w/w) is a barium sulfate suspension for oral and rectal administration. each 100 ml contains 105 g barium sulfate. barium sulfate, due to its high molecular density is opaque to x-rays and, therefore, acts as a positive contrast agent for radiographic studies. the active ingredient is barium sulfate and its structural formula is baso 4 . barium sulfate occurs as a fine, white, odorless, tasteless, bulky powder which is free from grittiness. its aqueous suspensions are neutral to litmus. it is practically insoluble in water, solutions of acids and alkalies, and organic solvents. inactive ingredients acacia, citric acid, hydrochloric acid, natural and artificial vanilla flavor, polysorbate 80, potassium chloride, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium carrageenan, sodium citrate, sorbitol solution and xanthan gum.

Clinical Pharmacology:

Clinical pharmacology barium sulfate, due to its high molecular density is opaque to x-rays and, therefore, acts as a positive contrast agent for radiographic studies. barium sulfate is biologically inert and, therefore, is not absorbed or metabolized by the body, and is eliminated unchanged from the body.

How Supplied:

How supplied liquid polibar plus Â® is supplied as follows: 750 ml jugs, ndc 32909-167-55. rx only shake well prior to use

Information for Patients:

Information for patients before administration of this product patients should be instructed to: inform their physician if they are pregnant. inform their physician if they are allergic to any drugs or food, or if they have had any prior reactions to barium sulfate products or other contrast agents used in x-ray procedures (see precautions - general ). inform their physician about any other medications they are currently taking.

Package Label Principal Display Panel:

Liquid polibar plus carton ndc:32909-168-02 liquid polibar plus bottle ndc:32909-167-55 liquid-polibar-plus-carton liquid-polibar-plus-bottle

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.