Varibar Pudding (Page 2 of 2)

11  DESCRIPTION

VARIBAR PUDDING (barium sulfate) is a radiographic contrast agent that is supplied as a 40 % w/v ready to use paste with a vanilla aroma for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol and the following chemical structure:

barium-sulfate-structure
(click image for full-size original)

VARIBAR PUDDING has a viscosity of 5000 cPs and contains the following excipients: artificial vanilla flavor, carboxymethylcellulose sodium, citric acid, ethyl vanillin, glycerin, maltodextrin, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, xanthan gum, and xylitol.

12  CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Due to its high atomic number, barium (the active ingredient in VARIBAR PUDDING) 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.

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.

16  HOW SUPPLIED/STORAGE AND HANDLING

VARIBAR PUDDING is supplied as a paste in a multiple-dose polyethylene tube containing 230 mL of barium sulfate (40 % w/v).

Provided as: 12 X 230 mL tubes (NDC 32909-125-22)

Store at USP Controlled Room Temperature 20 to 25°C (68 to 77° F). Protect from freezing.

Once opened, VARIBAR PUDDING may be used for up to 21 days when stored at USP Controlled Room Temperature, 20 to 25°C (68 to 77° F).

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.

Rx only

Manufactured for
Bracco Diagnostics Inc.
Monroe Township, NJ 08831
by EZEM Canada Inc
Anjou (Quebec) Canada H1J 2Z4

VARIBAR® is a registered trademark of E-Z-EM, Inc.

Varibar Pudding Label

varibar-pudding-label
(click image for full-size original)

Varibar Pudding Tube

varibar-pudding-tube
(click image for full-size original)

varibar-pudding-labelvaribar-pudding-tube

Varibar Pudding Carton
NDC: 32909­125­22

varibar-pudding-carton
(click image for full-size original)
VARIBAR PUDDING
barium sulfate paste
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:32909-125
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Barium Sulfate (Barium Sulfate) Barium Sulfate 400 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
DIMETHICONE 350
DIMETHICONE 1000
ETHYL VANILLIN
GLYCERIN
MALTODEXTRIN
POLYSORBATE 80
POTASSIUM SORBATE
SACCHARIN SODIUM
SILICON DIOXIDE
SODIUM BENZOATE
WATER
XANTHAN GUM
XYLITOL
Product Characteristics
Color WHITE Score
Shape Size
Flavor VANILLA Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:32909-125-22 1 TUBE in 1 BOX contains a TUBE
1 230 mL in 1 TUBE This package is contained within the BOX (32909-125-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208844 10/14/2016
Labeler — E-Z-EM Canada Inc (204211163)
Registrant — E-Z-EM, INC. (002041226)
Establishment
Name Address ID/FEI Operations
E-Z-EM Canada Inc 204211163 MANUFACTURE (32909-125), PACK (32909-125), LABEL (32909-125), ANALYSIS (32909-125)

Revised: 10/2018 E-Z-EM Canada Inc

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