READI-CAT2 barium sulfate suspension

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Barium Sulfate (UNII: 25BB7EKE2E) (Barium Sulfate - UNII:25BB7EKE2E)
Available from:
E-Z-EM Canada Inc
INN (International Name):
Barium Sulfate
Composition:
Barium Sulfate 21 mg in 1 mL
Prescription type:
PRESCRIPTION DRUG
Authorization status:
unapproved drug other

READI-CAT2- barium sulfate suspension

READI-CAT2 BANANA SMOOTHIE- barium sulfate suspension

READI-CAT2 BERRY SMOOTHIE- barium sulfate suspension

READI-CAT2 MOCHACCINO SMOOTHIE- barium sulfate suspension

READI-CAT2 VANILLA SMOOTHIE- barium sulfate suspension

E-Z-EM Canada Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been

approved by FDA. For further information about unapproved drugs, click here.

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NDC 32909-723-01

READI-CAT

2

BARIUM SULFATE SUSPENSION

(2.1% w/v, 2.0% w/w)

NDC 32909-725-03

BANANA SMOOTHIE

READI-CAT

2

NDC 32909-755-03

CREAMY VANILLA SMOOTHIE

READI-CAT

2

NDC 32909-715-03

BERRY SMOOTHIE

READI-CAT

2

NDC 32909-775-03

MOCHACCINO SMOOTHIE

READI-CAT

2

DESCRIPTION

READI-CAT 2 is a barium sulfate suspension 2.1% w/v, 2.0% w/w for oral administration. Each 100

mL contains 2.1 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 BaSO . 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

Citric acid, natural and artificial orange flavor, natural and artificial vanilla flavor, potassium sorbate,

purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sorbitol solution and xanthan

gum.

BANANA SMOOTHIE READI-CAT 2 is a barium sulfate suspension 2.1% w/v, 2.0% w/w for oral

administration. Each 100 mL contains 2.1 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 BaSO . 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

®

®

®

®

®

®

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Artificial vanilla flavor, benzoic acid, citric acid, natural banana flavor (with other natural flavors),

potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium

citrate, sorbitol solution and xanthan gum.

CREAMY VANILLA SMOOTHIE READI-CAT 2 is a barium sulfate suspension 2.1% w/v, 2.0%

w/w for oral administration. Each 100 mL contains 2.1 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 BaSO . 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

Artificial vanilla flavor, benzoic acid, citric acid, potassium sorbate, purified water, saccharin sodium,

simethicone emulsion, sodium benzoate, sodium citrate, sorbitol solution and xanthan gum.

BERRY SMOOTHIE READI-CAT 2 is a barium sulfate suspension 2.1% w/v, 2.0% w/w for oral

administration. Each 100 mL contains 2.1 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 BaSO . 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

Benzoic acid, citric acid, natural and artificial blueberry flavor, potassium sorbate, purified water,

saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, sorbitol solution and xanthan

gum.

MOCHACCINO SMOOTHIE READI-CAT 2 is a barium sulfate suspension 2.1% w/v, 2.0% w/w

for oral administration. Each 100 mL contains 2.1 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 BaSO . 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

Benzoic acid, citric acid, natural and artificial bavarian chocolate flavor, natural and artificial coffee

cappuccino flavor, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium

benzoate, sodium citrate, sorbitol solution and xanthan gum.

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 from the GI tract unchanged.

INDICATIONS AND USAGE

For use in Computed Tomography to opacify the GI tract.

CONTRAINDICATIONS

This product should not be used in patients with known or suspected gastric or intestinal perforation, or

hypersensitivity to barium sulfate or any component of this barium sulfate formulation.

®

®

®

WARNINGS

Rarely, severe allergic reactions of an anaphylactoid nature, have been reported following

administration of barium sulfate contrast agents. Appropriately trained personnel and facilities 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.

PRECAUTIONS

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. Ingestion of barium is not recommended in patients with a

history of food aspiration. If barium studies are required in these patients or in patients in whom

integrity of the swallowing mechanism is unknown, proceed with caution. If barium is aspirated into the

larynx, further administration should be immediately discontinued. After any barium study of the GI tract,

it is important to rehydrate the patient as quickly as possible to prevent impaction of the barium. To

prevent barium impaction in the colon, the use of mild laxatives such as milk of magnesia or lactulose

following completion of the examination may also be required. These mild laxatives are recommended

on a routine basis and in patients with a history of constipation unless clinically contraindicated.

Information for Patients

Before using this product patients should be instructed to tell the physician ordering the procedure and

the imaging technologist:

1. if they are pregnant.

2. if they are allergic to any foods or medication, or if they have had any prior reactions to barium

sulfate products or other x-ray contrast agents.

3. if they are currently taking any medications, have any serious medical condition for which they are

being treated or followed, or had any recent surgery.

4. seek immediate medical attention if they experience an allergic reaction after using this product.

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, its 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. EKG changes have been reported following or during barium enema procedures. 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 allergiclike 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 cc 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 indicated responses can be present in both fluoroscopic and

CT procedures. These are transitory in nature and are not considered serious. Symptoms may be treated

according to currently accepted standards of medical care.

DOSAGE AND ADMINISTRATION

The volume and concentration of the CT barium sulfate suspension 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.

Suggested 30 Minute Barium Administration Protocol for Abdomen Studies:

Administer 300 mL CT barium suspension 30 minutes before scan and 150 mL immediately prior to

scan; or use as directed by physician.

Suggested 90 Minute Barium Administration Protocol for Abdomen/Pelvis Studies: Administer

450 mL CT barium suspension 90 minutes before scan, another 300 mL 30 minutes before scan, and

finally 150 mL immediately prior to scan; or use as directed by physician.

Other dosing regimens may be followed as applicable.

STORAGE

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

HOW SUPPLIED

READI-CAT 2 is supplied in the following quantities:

450 mL bottles, Cat. No. 723, NDC 32909-723-01.

BANANA SMOOTHIE READI-CAT 2 is supplied in the following quantities:

450 mL bottles, Cat. No. 7450, NDC 32909-725-03.

CREAMY VANILLA SMOOTHIE READI-CAT 2 is supplied in the following quantities:

450 mL bottles, Cat. No. 7550, NDC 32909-755-03.

BERRY SMOOTHIE READI-CAT 2 is supplied in the following quantities:

450 mL bottles, Cat. No. 7150, NDC 32909-715-03.

MOCHACCINO SMOOTHIE READI-CAT 2 is supplied in the following quantities:

450 mL bottles, Cat. No. 450307, NDC 32909-775-03.

SHAKE WELL PRIOR TO USE

Manufactured by E-Z-EM Canada Inc.

for E-Z-EM, Inc., a subsidiary of Bracco Diagnostics Inc.

Monroe Township, NJ 08831

Tel. 1-516-333-8230 1-800 544-4624

rev. 11/13 TX1665-1

Readi–Cat

2 Barium Sulfate Suspension

CAT. NO. 723

NDC: 32909–723–01

®

®

®

®

®

Readi–Cat

2 Barium Sulfate Suspension

CAT. NO. 7150

NDC: 32909–715–03

Readi–Cat

2 Barium Sulfate Suspension

CAT. NO. 7450

NDC: 32909–725–03

Readi–Cat

2 Barium Sulfate Suspension

CAT. NO. 7550

NDC: 32909–755–03

Readi–Cat

2 Barium Sulfate Suspension

CAT NO. 450307

NDC: 32909–775–03

READI-CAT2

barium sulfate suspension

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:329 0 9 -723

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Ba rium Sulfa te (UNII: 25BB7EKE2E) (Barium Sulfate - UNII:25BB7EKE2E)

Barium Sulfate

21 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

a nhydro us citric a cid (UNII: XF417D3PSL)

dimethico ne 3 50 (UNII: 2Y53S6 ATLU)

dimethico ne 10 0 0 (UNII: MCU2324216 )

po ta ssium so rba te (UNII: 1VPU26 JZZ4)

sa ccha rin so dium (UNII: SB8 ZUX40 TY)

silico n dio xide (UNII: ETJ7Z6 XBU4)

so dium benzo a te (UNII: OJ245FE5EU)

so rbito l (UNII: 50 6 T6 0 A25R)

wa ter (UNII: 0 59 QF0 KO0 R)

xa ntha n g um (UNII: TTV12P4NEE)

Product Characteristics

Color

WHITE

S core

S hap e

S iz e

Flavor

ORANGE

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:329 0 9 -723-

450 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 6 /0 1/19 8 5

11/30 /20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Unappro ved drug o ther

0 6 /0 1/19 8 5

11/30 /20 18

READI-CAT2 BANANA SMOOTHIE

barium sulfate suspension

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:329 0 9 -725

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Ba rium Sulfa te (UNII: 25BB7EKE2E) (Barium Sulfate - UNII:25BB7EKE2E)

Barium Sulfate

21 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

a nhydro us citric a cid (UNII: XF417D3PSL)

benzo ic a cid (UNII: 8 SKN0 B0 MIM)

dimethico ne 3 50 (UNII: 2Y53S6 ATLU)

dimethico ne 10 0 0 (UNII: MCU2324216 )

po ta ssium so rba te (UNII: 1VPU26 JZZ4)

sa ccha rin so dium (UNII: SB8 ZUX40 TY)

silico n dio xide (UNII: ETJ7Z6 XBU4)

so dium benzo a te (UNII: OJ245FE5EU)

triso dium citra te dihydra te (UNII: B22547B9 5K)

so rbito l (UNII: 50 6 T6 0 A25R)

wa ter (UNII: 0 59 QF0 KO0 R)

xa ntha n g um (UNII: TTV12P4NEE)

Product Characteristics

Color

WHITE

S core

S hap e

S iz e

Flavor

BANANA, VANILLA

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:329 0 9 -725-

450 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /0 1/19 9 8

11/30 /20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Unappro ved drug o ther

0 8 /0 1/19 9 8

11/30 /20 18

READI-CAT2 BERRY SMOOTHIE

barium sulfate suspension

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:329 0 9 -715

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Ba rium Sulfa te (UNII: 25BB7EKE2E) (Barium Sulfate - UNII:25BB7EKE2E)

Barium Sulfate

21 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

a nhydro us citric a cid (UNII: XF417D3PSL)

benzo ic a cid (UNII: 8 SKN0 B0 MIM)

dimethico ne 3 50 (UNII: 2Y53S6 ATLU)

dimethico ne 10 0 0 (UNII: MCU2324216 )

po ta ssium so rba te (UNII: 1VPU26 JZZ4)

sa ccha rin so dium (UNII: SB8 ZUX40 TY)

silico n dio xide (UNII: ETJ7Z6 XBU4)

so dium benzo a te (UNII: OJ245FE5EU)

triso dium citra te dihydra te (UNII: B22547B9 5K)

wa ter (UNII: 0 59 QF0 KO0 R)

xa ntha n g um (UNII: TTV12P4NEE)

Product Characteristics

Color

WHITE

S core

S hap e

S iz e

Flavor

BLUEBERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:329 0 9 -715-

450 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 2/0 1/20 0 2

12/31/20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Unappro ved drug o ther

0 2/0 1/20 0 2

12/31/20 18

READI-CAT2 MOCHACCINO SMOOTHIE

barium sulfate suspension

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:329 0 9 -775

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Ba rium Sulfa te (UNII: 25BB7EKE2E) (Barium Sulfate - UNII:25BB7EKE2E)

Barium Sulfate

21 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

a nhydro us citric a cid (UNII: XF417D3PSL)

benzo ic a cid (UNII: 8 SKN0 B0 MIM)

dimethico ne 3 50 (UNII: 2Y53S6 ATLU)

dimethico ne 10 0 0 (UNII: MCU2324216 )

po ta ssium so rba te (UNII: 1VPU26 JZZ4)

sa ccha rin so dium (UNII: SB8 ZUX40 TY)

silico n dio xide (UNII: ETJ7Z6 XBU4)

so dium benzo a te (UNII: OJ245FE5EU)

triso dium citra te dihydra te (UNII: B22547B9 5K)

so rbito l (UNII: 50 6 T6 0 A25R)

wa ter (UNII: 0 59 QF0 KO0 R)

xa ntha n g um (UNII: TTV12P4NEE)

Product Characteristics

Color

WHITE

S core

S hap e

S iz e

Flavor

COFFEE, CHOCOLATE

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:329 0 9 -775-

450 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 3/31/20 0 9

10 /31/20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Unappro ved drug o ther

0 3/31/20 0 9

10 /31/20 18

READI-CAT2 VANILLA SMOOTHIE

barium sulfate suspension

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:329 0 9 -755

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Ba rium Sulfa te (UNII: 25BB7EKE2E) (Barium Sulfate - UNII:25BB7EKE2E)

Barium Sulfate

21 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

a nhydro us citric a cid (UNII: XF417D3PSL)

benzo ic a cid (UNII: 8 SKN0 B0 MIM)

dimethico ne 3 50 (UNII: 2Y53S6 ATLU)

dimethico ne 10 0 0 (UNII: MCU2324216 )

po ta ssium so rba te (UNII: 1VPU26 JZZ4)

sa ccha rin so dium (UNII: SB8 ZUX40 TY)

E-Z-EM Canada Inc

silico n dio xide (UNII: ETJ7Z6 XBU4)

so dium benzo a te (UNII: OJ245FE5EU)

triso dium citra te dihydra te (UNII: B22547B9 5K)

so rbito l (UNII: 50 6 T6 0 A25R)

wa ter (UNII: 0 59 QF0 KO0 R)

xa ntha n g um (UNII: TTV12P4NEE)

Product Characteristics

Color

WHITE

S core

S hap e

S iz e

Flavor

VANILLA

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:329 0 9 -755-

450 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

11/0 1/20 0 5

12/31/20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Unappro ved drug o ther

11/0 1/20 0 5

12/31/20 18

Labeler -

E-Z-EM Canada Inc (204211163)

Registrant -

E-Z-EM, INC. (002041226)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Cimbar Perfo rmance Minerals,

Inc .

9 6 38 0 56 71

API MANUFACTURE(329 0 9 -755, 329 0 9 -715, 329 0 9 -775, 329 0 9 -725, 329 0 9 -

723)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

E-Z-EM

Ca na da

20 421116 3

LABEL(329 0 9 -723, 329 0 9 -725, 329 0 9 -715, 329 0 9 -775, 329 0 9 -755) , ANALYSIS(329 0 9 -725, 329 0 9 -

723, 329 0 9 -755, 329 0 9 -775, 329 0 9 -715) , MANUFACTURE(329 0 9 -723, 329 0 9 -755, 329 0 9 -715, 329 0 9 -

775, 329 0 9 -725) , PACK(329 0 9 -723, 329 0 9 -715, 329 0 9 -775, 329 0 9 -755, 329 0 9 -725)

Revised: 5/2017

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