NDC 32909-105 Varibar Thin Liquid

Barium Sulfate

NDC Product Code 32909-105

NDC 32909-105-10

Package Description: 24 BOTTLE, PLASTIC in 1 CASE > 148 g in 1 BOTTLE, PLASTIC

NDC Product Information

Varibar Thin Liquid with NDC 32909-105 is a a human prescription drug product labeled by E-z-em Canada Inc. The generic name of Varibar Thin Liquid is barium sulfate. The product's dosage form is powder, for suspension and is administered via oral form.

Labeler Name: E-z-em Canada Inc

Dosage Form: Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the 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.


Varibar Thin Liquid 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 .81 g/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • DIMETHICONE 1000 (UNII: MCU2324216)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SORBITOL (UNII: 506T60A25R)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • XYLITOL (UNII: VCQ006KQ1E)

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.

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: NDA208036 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: 04-30-2019 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: 12-31-2020 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’.

* Please review the disclaimer below.

Varibar Thin Liquid Product Label Images

Varibar Thin Liquid 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

Description

VARIBAR® THIN
LIQUID (Target Viscosity 4 CPS) is a barium sulfate for suspension
(40% w/v After Reconstitution) for oral administration. Each 100 g
contains 81 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 BaSO4. 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: carboxymethylcellulose sodium,
citric acid, maltodextrin, natural and artificial apple flavor, polysorbate
80, saccharin sodium, simethicone, sodium citrate, sorbitol and xylitol.

Indications And Usage

This
product is indicated for use in radiography of the esophagus, pharynx
and hypopharynx.

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.

Contraindications

This product
should not be used in patients with known or suspected gastrointestinal
perforation; or hypersensitivity to barium sulfate or any components
of this barium sulfate formulation.

Warnings

Rarely, severe allergic reactions of an anaphylactoid
nature, have been reported following administration of barium sulfate
contrast agents. Appropriate facilities and trained personnel 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

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.Given that the contrast material is designed
for a procedure that is performed to document the presence and extent
of pathophysiology of the swallowing mechanism as well as to determine
appropriate remediation of such, aspiration of the barium sulfate
is an expected consequence for some patients. When this occurs, it
is recommended that the patient be assisted in attempts to expectorate
the aspirant. The study should be resumed if the clinician is prepared
to assess the patient’s response to specific interventions designed
to eliminate or minimize the recurrence of aspiration (postural changes,
sensory enhancements, swallowing maneuvers and/or dietary changes).
It is recommended that the study begin with the introduction of limited
amounts of material per swallow (3 mL or less).After any barium study of the GI tract, it
is important to rehydrate the patient as quickly as possible to prevent
impaction of the bowel by barium sulfate. To prevent barium sulfate
impaction in the bowel, secondary to administration of large volumes
of this product (i.e. >120 mL) the use of mild laxatives such as milk
of magnesia or lactulose, following completion of the examination
may also be required.Use with caution in patients with complete or nearly complete esophageal
or gastric obstruction.

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.

Drug Interactions

The presence of barium sulfate formulations in
the GI tract may alter the absorption of therapeutic agents taken
concomitantly. In order to minimize any potential change in absorption,
the separate administration of barium sulfate from that of other agents
should be considered.

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.

Nursing Mothers

Barium sulfate
products may be used during lactation.

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
impaction, granuloma formation, intravasation, embolization and peritonitis
following intestinal perforation, vasovagal and syncopal episodes,
and fatalities. It is of the utmost importance to be completely prepared
to treat any such occurrence.

Allergic Reactions

Due to the increased likelihood of allergic reactions
in atopic patients, it is important that a complete history of known
and suspected allergies as well as allergic-like symptoms, e.g., rhinitis,
bronchial asthma, eczema and urticaria, must be obtained prior to
any medical procedure utilizing these products. A mild allergic reaction
would most likely include generalized pruritus, erythema or urticaria
(approximately 1 in 250,000). Such reactions will generally respond
to an antihistamine such as 50 mg of diphenhydramine or its equivalent.
In the rarer, more serious reactions (approximately 1 in 1,000,000)
laryngeal edema, bronchospasm or hypotension could develop. Severe
reactions which may require emergency measures are often characterized
by peripheral vasodilation, hypotension, reflex tachycardia, dyspnea,
agitation, confusion and cyanosis progressing to unconsciousness.
Treatment should be initiated immediately with 0.3 to 0.5 mL of 1:1000
epinephrine subcutaneously. If bronchospasm predominates, 0.25 to
0.50 grams of intravenous aminophylline should be given slowly. Appropriate
vasopressors might be required. Adrenocorticosteroids, even if given
intravenously, exert no significant effect on the acute allergic reactions
for a few hours. The administration of these agents should not be
regarded as emergency measures for the treatment of allergic reactions.Apprehensive patients may develop weakness,
pallor, tinnitus, diaphoresis and bradycardia following the administration
of any diagnostic agent. Such reactions are usually non-allergic
in nature and are best treated by having the patient lie flat for
an additional 10 to 30 minutes under observation.

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.

Other

Mixing Instructions for VARIBAR® THIN LIQUID Cat. No. D105: Add water to the 40% w/v line on the VARIBAR® THIN LIQUID bottle
label and replace the lid securely. Invert the bottle and tap with
fingers to mix the powder into the water. Shake vigorously for 30
seconds. Wait 5 minutes, and refill with water to the 40% w/v line.
Then reshake thoroughly.After reconstitution with water, VARIBAR® THIN LIQUID has been shown
to be stable for up to 72 hours if refrigerated at 2°-8° C. With refrigeration,
notate the information on the label to track usage time. Enter date
opened and use by date.

Mixing
instructions for reconstituting Varibar® Thin Liquid (Cat # D105)

Dosage And Administration

The dose of VARIBAR® THIN LIQUID 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.

Storage

Store VARIBAR® THIN LIQUID to protect from freezing
and excessive heat (above 40°C).

How Supplied

VARIBAR® THIN LIQUID is supplied in the following
quantity: 148 g bottle, Cat. No. D105, NDC 32909-105-10Manufactured byE-Z-EM Canada
Inc., for E-Z-EM, Inc.a subsidiary of Bracco Diagnostics
Inc.Monroe Township, NJ 08831Tel: 1-516-333-8230
1-800 544-4624rev. 05/14 TX1356-3

* Please review the disclaimer below.

Previous Code
32819-1001
Next Code
32909-115