Readi-Cat 2

6 ADVERSE REACTIONS The following adverse reactions have been identified from spontaneous reporting or clinical studies of barium sulfate administered orally. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure: Nausea, vomiting, diarrhea and abdominal cramping Serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes Common adverse reactions include nausea, vomiting, diarrhea and abdominal cramping ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

4 CONTRAINDICATIONS READI-CAT 2 products are contraindicated in patients: with known or suspected perforation of the GI tract with known obstruction of the GI tract at high risk of GI perforation such as those with a recent prior GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, post GI surgery or biopsy, acute GI injury or burn, or recent radiotherapy to pelvis at high risk of aspiration such as those with prior aspiration, tracheo-esophageal fistula, or obtundation known severe hypersensitivity to barium sulfate or any of the excipients of READI-CAT 2 or READI-CAT 2 SMOOTHIES Known or suspected perforation of the GI tract ( 4 ) Known obstruction of the GI tract ( 4 ) Conditions associated with high risk of GI perforation or aspiration ( 4 ) Known hypersensitivity to barium sulfate or any of the excipients of READI-CAT 2 products ( 4 )

11 DESCRIPTION READI-CAT 2 and READI-CAT 2 SMOOTHIE (barium sulfate) are radiographic contrast agents supplied as a suspension (2% w/v) for oral administration. The active ingredient barium sulfate is designated chemically as BaSO 4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm 3 , and the following chemical structure: READI-CAT 2 products contain excipients including: benzoic acid, citric acid, potassium sorbate, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, sorbitol solution, xanthan gum, and purified water. READI-CAT 2 products also contain natural and artificial flavorings including: banana, blueberry, orange, vanilla, chocolate, and coffee flavors. barium-sulfate-suspensions-structure

2 DOSAGE AND ADMINISTRATION For oral use only: Adults and pediatric patients 12 years and older: 450 mL to 900 mL (9 g to 18 g of barium sulfate, respectively) ( 2.1 ) Patients younger than 12 years of age: scale down dose based on relative GI volume ( 2.1 ) 2.1 Recommended Dosage Base dosing on individual needs and procedure to be performed. Adult and pediatric patients 12 years and older: 450 mL to 900 mL (9 g to 18 g of barium sulfate) Patients younger than 12 years of age: adjust dose based on relative GI volume 2.2 Administration Instructions For oral use only Shake bottle vigorously for 30 seconds prior to oral administration Administer undiluted prior to scan Discard any unused suspension Advise patients to hydrate following the barium sulfate procedure

1 INDICATIONS AND USAGE READI-CAT 2 and READI-CAT 2 SMOOTHIES are indicated for use in computed tomography (CT) of the abdomen to delineate the gastrointestinal (GI) tract in adult and pediatric patients. READI-CAT 2 and READI-CAT 2 SMOOTHIE are radiographic contrast agents, indicated for use in computed tomography (CT) of the abdomen to delineate the gastrointestinal (GI) tract in adult and pediatric patients ( 1 )

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Due to its high atomic number, barium (the active ingredient in READI-CAT 2 products) 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.

20201009

3

3 DOSAGE FORMS AND STRENGTHS Oral suspension: 9 grams of barium sulfate supplied as a suspension (2% w/v) in a single-dose HDPE plastic bottle. Oral Suspension: 9 grams barium sulfate (2% w/v) supplied in a single dose HDPE plastic bottle ( 3 )

Readi-Cat 2 Barium Sulfate Barium Sulfate Barium Sulfate anhydrous citric acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate sorbitol water xanthan gum saccharin sodium Readi-Cat 2 Banana Smoothie Barium Sulfate Barium Sulfate Barium Sulfate anhydrous citric acid benzoic acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate sorbitol water xanthan gum saccharin sodium Readi-Cat 2 Berry Smoothie Barium Sulfate Barium Sulfate Barium Sulfate anhydrous citric acid benzoic acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate sorbitol water xanthan gum saccharin sodium Readi-Cat 2 Mochaccino Smoothie Barium Sulfate Barium Sulfate Barium Sulfate anhydrous citric acid benzoic acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate sorbitol water xanthan gum saccharin sodium Readi-Cat 2 Creamy Vanilla Smoothie Barium Sulfate Barium Sulfate Barium Sulfate anhydrous citric acid benzoic acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate sorbitol water xanthan gum saccharin sodium Readi-Cat 2 Barium Sulfate Barium Sulfate Barium Sulfate anhydrous citric acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate sorbitol water xanthan gum saccharin sodium Readi-Cat 2 Banana Smoothie Barium Sulfate Barium Sulfate Barium Sulfate anhydrous citric acid benzoic acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate sorbitol water xanthan gum saccharin sodium Readi-Cat 2 Berry Smoothie Barium Sulfate Barium Sulfate Barium Sulfate anhydrous citric acid benzoic acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate sorbitol water xanthan gum saccharin sodium Readi-Cat 2 Mochaccino Smoothie Barium Sulfate Barium Sulfate Barium Sulfate anhydrous citric acid benzoic acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate sorbitol water xanthan gum saccharin sodium Readi-Cat 2 Creamy Vanilla Smoothie Barium Sulfate Barium Sulfate Barium Sulfate anhydrous citric acid benzoic acid dimethicone 350 dimethicone 1000 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate sorbitol water xanthan gum saccharin sodium

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.

NDA208143

Readi-Cat 2

Barium Sulfate

32909-744

HUMAN PRESCRIPTION DRUG

ORAL

Readi–Cat ® 2 Barium Sulfate Suspension Labels NDC: 32909-744-03 Readi-cat 2 external label Readi-cat 2 internal label

Warning and Precautions ( 5.6 ) 2/2017

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 January 2020 CL10E801

8 USES IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary READI-CAT 2 products are not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. 8.2 Lactation Risk Summary READI-CAT 2 products are not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the infant to READI-CAT 2. 8.4 Pediatric Use The efficacy of READI-CAT 2 in pediatric patients of all groups is based on successful opacification of the GI tract during radiographic procedures [see Clinical Pharmacology ( 12.1 )] . READI-CAT 2 is contraindicated in pediatric patients with tracheo-esophageal fistula [see Contraindications ( 4 )] . Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] . Pediatric patients with cystic fibrosis or Hirschsprung disease should be monitored for bowel obstruction after use [see Warnings and Precautions ( 5.3 )] . 8.5 Geriatric Use Clinical studies of READI-CAT 2 products do 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.

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied READI-CAT 2 and READI-CAT 2 SMOOTHIES (barium sulfate) are supplied as suspensions (2 % w/v) in a unit dose in a single-dose HDPE plastic bottle containing 9 grams of barium sulfate in 450 mL. READI-CAT 2 products are provided in the following flavors as: READI-CAT 2: (Orange): 12 x 450 mL bottles (NDC 32909-744-03) READI-CAT 2 SMOOTHIE (Banana): 12 x 450 mL bottles (NDC 32909-742-03) READI-CAT 2 SMOOTHIE (Berry): 12 x 450 mL bottles (NDC 32909-741-03) READI-CAT 2 SMOOTHIE (Creamy Vanilla): 12 x 450 mL bottles (NDC 32909-746-03) READI-CAT 2 SMOOTHIE (Mochaccino): 12 x 450 mL bottles (NDC 32909-747-03) 16.2 Storage and Handling Store at USP controlled room temperature, 20 to 25°C (68 to 77° F)