E-Z-DOSE WITH LIQUID POLIBAR PLUS 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 1.05 g in 1 mL
Prescription type:
PRESCRIPTION DRUG
Authorization status:
unapproved drug other

E-Z-DOSE WITH LIQUID POLIBAR PLUS- 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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E-Z-DOSE™ WITH LIQUID POLIBAR PLUS®

BARIUM SULFATE SUSPENSION

(105% w/v, 58% w/w)

DESCRIPTION

E-Z-DOSE™ with LIQUID POLIBAR PLUS® is a single dose, disposable barium sulfate retention

enema system which includes the Miller™ Air tip. E-Z-DOSE™ with LIQUID POLIBAR PLUS

contains barium sulfate suspension (105% w/v, 58% w/w) for rectal administration. Each 100 mL

contains 105 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

acacia, citric acid, hydrochloric acid, natural and artificial vanilla flavor, polysorbate 80, potassium

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

sodium carrageenan, 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 unchanged from the body.

INDICATIONS AND USAGE

For radiography of the gastrointestinal tract.

CONTRAINDICATIONS

This product should not be used in patients with known intestinal perforation or hypersensitivity to

barium sulfate products.

Enema System

Do not use a retention cuff in a colostomy stoma. A colostomy stoma requires a special colostomy

catheter. Do not use a retention cuff following recent rectal surgery or low rectal anastomosis, or when

proctitis or other rectal conditions such as inflammatory or neoplastic diseases are suspected. In those

cases use soft pediatric Flexi-Tip

rectal catheters, E-Z-EM Ref. 9504 (24 Fr) or Ref. 9514 (14 Fr).

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.

Barium sulfate should not be used proximal to known or suspected obstruction of the colon, or in those

cases where the use of barium sulfate is contraindicated. Care must be taken to avoid overinflation of

the cuff, since overfilling, or asymmetrical filling with displacement of the tip, may occur. Such

displacement can lead to rectal perforation, barium granulomas or vasovagal reactions, or may cause the

cuff to deflate. Overinflation may cause the inflatable cuff to rupture with possible injury to the patient.

The enema tip should also not be moved unnecessarily once inserted.

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.

After any barium study of the GI tract, it is important to rehydrate the patient as quickly as possible to

prevent impaction of the bowel by barium sulfate. To prevent barium sulfate impaction in the bowel, 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 contraindicated.

Use with caution when obstructive lesions of the colon are suspected. Care should be taken to minimize

the amount of barium sulfate allowed to flow proximal to obstructive lesions of the colon. Care must be

taken during insertion of the enema tip into the patient to prevent application of pressure to the vagus

nerve which can lead to vasovagal reactions and syncopal episodes. Forceful or deep insertion may

also cause tearing or perforation of the rectum.

Inflation of the retention cuff should only be performed by a physician, or qualified personnel under a

physician’s supervision, under fluoroscopic control. Do not inflate cuff with more than 100 cc air. Use

only with the E-Z-EM Retention Cuff Inflator Ref. 9529. Do not unnecessarily move enema tip and

inflated retention cuff once inserted. To ensure maximum rectal visualization, the inflated cuff should be

deflated immediately after completion of the fluoroscopic phase of the exam, or after the colon is

completely filled.

Information for Patients

Before administration of this product patients should be instructed to:

1. Inform their physician if they are pregnant.

2. Inform their physician if they are allergic to any drugs or food, or if they have had any prior

reactions to barium sulfate products or other contrast agents used in x-ray procedures (see

PRECAUTIONS - General).

3. Inform their physician about any other medications they are currently taking.

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, their 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 sulfate 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 allergic-like 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 mL 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.

All E-Z-EM barium contrast and barium contrast delivery systems are latex-free. However, allergic

reactions to enema accessories, in particular to retention catheters (tips) with latex cuffs, can occur.

Such reactions could occur immediately and result in the previously mentioned acute allergic-like

responses or might be delayed in appearance and result in a contact dermatitis. Known atopic patients,

particularly those with a history of asthma or eczema, should be evaluated for alternative methods of

administration in order to avoid these adverse reactions. All plastic/rubber accessories are disposable,

single-use devices that must not be reused or left in the body cavity for an extended period of time.

OVERDOSAGE

On rare occasions following repeated administration, severe stomach cramps, nausea, vomiting,

diarrhea or constipation may occur. 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

General

The volume and concentration of LIQUID POLIBAR PLUS 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. See below for typical adult doses.

Patient Preparation for Colon Examinations

In order to achieve optimum results, the colon must be cleansed prior to the use of a barium enema. This

is usually accomplished by placing the patient on a low fat, low residue diet, combined with the use of

laxatives and/or cathartics. A cleansing enema may also be used unless contraindicated.

Double-Contrast Colon Examination (if other enema tips, inflators or insufflators are used refer

to their labeling for directions for use)

The following procedure is intended only as a guide. The quantity of contrast to use will depend on the

patient’s body habits and the radiographic procedures being preferred (typical adult dose: 500 mL to

1500 mL).

Attach the Retention Cuff Inflator (E-Z-EM Ref. 9529) to the clear tube on the retention cuff.

Attach the blue air-bulb insufflator (E-Z-EM Ref. 9525) to the blue tube.

Inspect the tubing system to ensure that it is free of obstructions.

Shake bottle VIGOROUSLY prior to use. Close off the large-bore tubing with the clamp and attach

it securely to the bottle.

Suspend the bottle and bleed air from the tubing. Reclamp.

Lubricate the enema tip with desired lubricant and carefully insert. Carefully insert the tip until the

base of the retention cuff is just beyond the anorectal junction. The base of the cuff should be at the

level of anal sphincter for best retention and maximum safety. If necessary, the cuff should be gently

pulled back until its proximal end rests on the anal sphincter.

Note: A retention cuff is not necessary or desirable in patients with normal sphincter tone. This can

be determined by preliminary rectal digital examination.

Prior to inflating the retention cuff, fluoroscopy may be used to visualize the rectum with contrast

medium to ensure the absence of contraindications. (See CONTRAINDICATIONS).

Inflate the cuff under fluoroscopic control. Use only the Retention Cuff Inflator (E-Z-EM Ref.

9529) to inflate retention cuff with approximately 100 cc air. To inflate the cuff, squeeze inflator

once only and clamp off the tubing to retain inflation. (See PRECAUTIONS).

Start with patient in the prone position. Fill the rectum with LIQUID POLIBAR PLUS

Rotate the patient (left side down and 10° to 15° Trendelenberg) and introduce enough LIQUID

POLIBAR PLUS to reach the splenic flexure. Clamp tubing shut.

Rotate the patient to the prone position, with the bottle on the floor, drain the rectum. Clamp the

tubing and introduce air to inflate ascending colon and cecum.

Turn the patient slowly to the right side and introduce more air. (Evacuate rectum again if

necessary).

Turn the patient slowly on his/her back. This maneuver will cause barium to pass through the hepatic

flexure into the ascending colon.

Slowly turn the patient to the prone position and raise the table slightly. Doing this will fill the

cecum. If necessary, drain the rectum and introduce additional air.

To remove the enema tip, deflate the cuff by releasing the clamp on the Retention Cuff Inflator.

Gently remove and discard the tip and the entire E-Z-DOSE™ system.

STORAGE

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

HOW SUPPLIED

E-Z-DOSE™ is supplied as follows:

As a kit, Cat. No. P650PPS, NDC 32909-652-02, which includes 650 mL bottle Cat. No. P650PPS,

NDC 32909-651-01 and tubing with a Miller™ Air Tip.

Rx Only (USA)

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. 08/14 TX1739

E-Z-Dose with Liquid Polibar Plus - Package

NDC: 32909-652-02

E-Z-DOSE WITH LIQUID POLIBAR PLUS

barium sulfate suspension

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:329 0 9 -6 52

Route of Administration

RECTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ba rium sulfa te (UNII: 25BB7EKE2E) (barium sulfate - UNII:25BB7EKE2E)

barium sulfate

1.0 5 g in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

a ca cia (UNII: 5C540 3N26 O)

a nhydro us citric a cid (UNII: XF417D3PSL)

E-Z-EM Canada Inc

dimethico ne 3 50 (UNII: 2Y53S6 ATLU)

dimethico ne 10 0 0 (UNII: MCU2324216 )

hydro chlo ric a cid (UNII: QTT1758 2CB)

po lyso rba te 8 0 (UNII: 6 OZP39 ZG8 H)

po ta ssium chlo ride (UNII: 6 6 0 YQ9 8 I10 )

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

wa ter (UNII: 0 59 QF0 KO0 R)

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

silico n dio xide (UNII: ETJ7Z6 XBU4)

so dium benzo a te (UNII: OJ245FE5EU)

ca rra g eena n (UNII: 5C6 9 YCD2YJ)

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

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

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 -

6 52-0 2

6 in 1 PACKAGE

1

6 50 mL in 1 BOTTLE, DISPENSING; Type 2: Prefilled Drug Delivery

Device/System (syringe, patch, etc.)

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 1/19 8 4

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

E-Z-EM Canada

20 421116 3

ANALYSIS(329 0 9 -6 52) , PACK(329 0 9 -6 52) , LABEL(329 0 9 -6 52) , MANUFACTURE(329 0 9 -

6 52)

Revised: 2/2015

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