Polibar ACB

E-Z-EM Canada Inc

POLIBAR® ACB Barium Sulfate 96% w/w Prefilled Disposable Barium Enema Kit Powder for rectal suspension

FULL PRESCRIBING INFORMATION: CONTENTS*

• POLIBAR ACB DESCRIPTION
• CLINICAL PHARMACOLOGY
• POLIBAR ACB INDICATIONS AND USAGE
• POLIBAR ACB CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Precautions for Enema System
  • Information for Patients
  • Drug Interactions
  • Usage in Pregnancy
• POLIBAR ACB ADVERSE REACTIONS
• ALLERGIC REACTIONS
• OVERDOSAGE
• POLIBAR ACB DOSAGE AND ADMINISTRATION
  • Instructions for Mixing:
  • Instructions for Use:
• STORAGE
• HOW SUPPLIED:

FULL PRESCRIBING INFORMATION

POLIBAR ACB DESCRIPTION

Polibar® ACB is a barium sulfate for suspension (96% w/w) for rectal administration. Each 100 g contains 96 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 BaSO4. 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, acidic or alkaline solutions, and organic solvents. Excipients: citric acid, pectin, polysorbate 80, simethicone, sodium citrate, sorbitol, tragacanth.

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.

POLIBAR ACB INDICATIONS AND USAGE

This product is indicated for single and double contrast radiographic visualization of the colon.

POLIBAR ACB CONTRAINDICATIONS

This product should not be used in patients with known or suspect-ed colonic perforation, toxic megacolon, recent rectal surgery or radiotherapy to the rectum or prostate, or hypersensitivity to barium sulfate or any component of this barium sulfate formu-lation. It should also not be used within six days of large forceps or “hot” colonic biopsy or a snare polypectomy.

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, warrants 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.

This product contains sorbitol. Patients with hereditary fructose intolerance should not take this product without first consulting their physician.

This medicine contains approximately1.462 mg of sodium for each gram of powdered product. This should be taken into consideration by patients on a controlled sodium diet.

After any barium study of the GI tract, it is important to re-hydrate the patient as quickly as possible, in order 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 rec-ommended on a routine basis in patients with a history of constipation unless contraindicated.

Precautions for Enema System

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 not to exert undue pressure to the neuromuscular plexus, which can lead to vasovagal reactions and syncopal episodes. Forceful or deep insertion may also cause tearing or perforation of the rectum. The enema tip should not be moved unnecessarily once inserted.

Information for Patients

Before administration of this product patients should be instructed to:

• Inform their physician if they are pregnant.
• 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 ).
• Inform their physician about any other medications they are currently taking.

Drug Interactions

Barium sulphate is biologically inert and there are no known interactions with other medicinal products, however, 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 medicinal agents from that of barium sulfate should be considered.

Usage in Pregnancy

While this product is not contraindicated in pregnancy, it should be noted that radiographic procedures may be harmful to the fetus. Barium sulfate is not absorbed systemically and is therefore not contraindicated during lactation and breast-feeding.

POLIBAR ACB 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, appendicitis, 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 be obtained prior to any medical procedure utilizing these products. A mild allergic reaction would most likely include generalized pruritis, erythema or urticaria (approximately 1 in 250,000). Such reac¬tions will generally respond to an antihistamine such as diphenhydramine or its equivalent. In the rarer, more serious reactions (approximately 1 in 1,000,000) laryngeal edema, bron¬chospasm 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 and in accordance with facility Allergic Reaction treatment procedures. Use of epinephrine subcutaneously may be recommended. If bronchospasm predominates, 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 agents and barium contrast delivery systems are latex-free, howev-er, allergic reactions to enema accessories, in particular other manufacturers’ retention catheters (tips) with latex cuffs, can occur. Such reactions could occur immediately or might be delayed in appearance and appropriate medical intervention must be available.

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.

POLIBAR ACB DOSAGE AND ADMINISTRATION

Use diluted for either single or double contrast radiography of the colon. The volume and concentration of Polibar ACB 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.

Instructions for Mixing:

• Prior to mixing, choose the desired density (% w/v, % w/w) from the chart below, depending on procedure type. Remove and discard white seal.
• Add the required amount of lukewarm water to obtain the desired concentration. Close cap and hold bag by the finger holes and shake vigorously until powder is completely suspended (about 20 to 30 seconds). Wait 10 minutes, then re-shake for 30 seconds.
  

NOTE: When adding more than 800 mL of water, add the water in two equal portions, shaking vigorously each time.

• 3.Close tubing clamp. Then, with thumb and forefinger, pop red ball from tubing into the bag. NOTE: Do not store suspension after mixing.

NOTE: Do not store suspension after mixing.

Instructions for Use:

NOTE:

• Due to reported anaphylactoid reactions to latex, it is strongly suggest that vinyl or non-latex gloves be used during the procedure.
• 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.
• Fluoroscopy may be used to visualize rectum with contrast medium to ensure absence of contraindications. (See CONTRAINDICATIONS. )
• For double contrast studies, use an enema tip for air contrast (not included) and follow the stated instructions for use.

• Connect enema tip to tubing of enema bag.
• Lubricate enema tip with desired lubricant and carefully insert into the patient’s anus. Care must be taken during insertion of the enema tip not to exert undue pressure to the neuromuscular plexus, which can lead to vasovagal reactions and syncopal episodes. Forceful or deep insertion may also cause tearing or perforation of the rectum.
• Release the clamp on enema tubing and administer the desired quantity of the barium suspension.
• Discard entire enema kit with tip (these are intended for single use only.)

STORAGE

Store product to protect from excessive heat (above 40°C).

SHAKE WELL PRIOR TO USE

HOW SUPPLIED:

Polibar® ACB Disposable Barium Enema Kit with Rigid Tip is supplied in the following quantity:
397 g Bag; Cat. No. AP14, NDC 32909-804-01
454 g Bag; Cat No. AP16, NDC 32909-804-02

Manufactured by
E-Z-EM Canada Inc.
a subsidiary of E-Z-EM, Inc.
Lake Success, NY 11042
Tel : 1-516-333-8230    1-800 544-4624

POLIBAR® ACB Barium Sulfate 96% w/w
Prefilled Disposable Barium Enema Kit
NDC:32909-804-02