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:

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 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