E-Z-HD (Page 2 of 2)

8.5 Geriatric Use

Clinical studies of E-Z-HD 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.

11  DESCRIPTION

E-Z-HD (barium sulfate) is a radiographic contrast agent that is supplied as a fine, white to lightly colored powder for suspension (98 % w/w) for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.43 g/mol, a density of 4.5 g/cm3 , and the following chemical structure:

barium-sulfate-structure

E-Z-HD contains excipients including: acacia, artificial cherry flavor, artificial strawberry flavor, carrageenan, citric acid, ethyl maltol, polysorbate 80, saccharin sodium, simethicone, sodium citrate, and sorbitol.

12  CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Due to its high atomic number, barium (the active ingredient in E-Z-HD) 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  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

16.1 How Supplied
E-Z-HD (barium sulfate) for suspension, is supplied as a fine, white to lightly colored powder (98 % w/w) in a single-dose HDPE plastic bottle containing 334 grams of barium sulfate.

Provided as: 24 bottles per pack (NDC 32909-764-01)

16.2 Storage and Handling
Store 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

Manufactured by
EZEM Canada Inc
Anjou (Quebec) Canada H1J 2Z4
For
Bracco Diagnostics Inc.
Monroe Township, NJ 08831
Revised February 2017

EZ-HD Labels
NDC: 32909-764-01

e-z-hd-unit-label
(click image for full-size original)
e-z-hd-external-label
(click image for full-size original)
E-Z-HD
barium sulfate powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:32909-764
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Barium Sulfate (Barium Sulfate) Barium Sulfate 980 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
acacia
anhydrous citric acid
dimethicone 1000
ethyl maltol
polysorbate 80
saccharin sodium
silicon dioxide
trisodium citrate dihydrate
sorbitol
carrageenan sodium
Product Characteristics
Color WHITE Score
Shape Size
Flavor STRAWBERRY, CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:32909-764-01 24 BOTTLE in 1 CARTON contains a BOTTLE
1 340 g in 1 BOTTLE This package is contained within the CARTON (32909-764-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208036 01/11/2016
Labeler — E-Z-EM Canada Inc (204211163)
Registrant — BRACCO DIAGNOSTICS INC (849234661)
Establishment
Name Address ID/FEI Operations
CIMBAR PERFORMANCE MINERALS, INC. 963805671 API MANUFACTURE (32909-764)
Establishment
Name Address ID/FEI Operations
E-Z-EM Canada Inc 204211163 ANALYSIS (32909-764), MANUFACTURE (32909-764), PACK (32909-764), LABEL (32909-764)

Revised: 02/2017 E-Z-EM Canada Inc

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