FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
This product is indicated for single and double contrast radiographic visualization of the colon.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Polibar Acb Manufacturers
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E-z-em Canada Inc
Polibar Acb | E-z-em Canada Inc
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.
Water to be added (mL) BaSO4 (% w/v) BaSO4 (% w/w) Total Volume (mL) Procedure 200 139.6 67.0 314 Double
contrast 300 107.2 58.1 409 400 86.1 51.3 509 500 71.9 45.9 609 700 54.1 38.0 809 Single
contrast 1000 39.5 30.1 1110 1500 27.2 22.4 1611 2000 20.7 17.8 2111 2200 19.0 16.5 2311 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.) -
E-z-em Canada Inc
Polibar Acb | Amerisourcebergen Drug Corporation
Do not use more unless directed by a doctor. See Warnings.
adults & children 12 years and over
one bottle once daily
children 2 to under 12 years
½ bottle once daily
Discard Unused portion
children under 2 years
do not use
Caution:
REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING; HOLD BOTTLE UPRIGHT, GRASPING BOTTLE CAP WITH FINGERS. GRASP PROTECTIVE SHIELD WITH OTHER HAND AND PULL GENTLY TO REMOVE.
Positioning:
Left-side position: Lie on left side with knee bent and arms at rest.
Knee-chest position:
Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.
Administering enema:
• With steady pressure, gently insert enema with tip pointing toward navel • squeeze bottle until recommended dose is expelled (it is not necessary to empty until completely. Bottle contains more liquid than needed for effective use. A small amount of liquid will remain in bottle after squeezing). • Remove tip from rectum. • stop using if tip is hard to insert. Forcing the tip into rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care. • maintain position until urge to evacuate is strong (usually 1 to 5 minutes) • if no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.
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