Prepcat Suspension
Name: Prepcat Suspension
Prepcat Suspension - Clinical Pharmacology
Barium sulfate is an insoluble material which, because of its density, provides a positive contrast during x-ray examination. Barium sulfate is an inert radiopaque material which is not absorbed or metabolized and is eliminated intact from the body in a manner similar to other non-absorbed inorganic materials. Excretion rate is a function of gastrointestinal transit time.
Indications and Usage for Prepcat Suspension
Prepcat is indicated for use as a diagnostic aid (contrast medium) for computed tomography of the gastrointestinal tract.
Prepcat Suspension Dosage and Administration
Individual technique will determine the suspension quantity and specific procedure used. The following are suggested for Prepcat use as an aid for computed tomography.
Upper G.I. Opacification
The patient should drink 300 mL of ready-to-use Prepcat approximately 2 hours before the CT scan and an additional 300 mL approximately 15 minutes prior to examination.
If rapid upper gastrointestinal tract transit is desired, administer the product chilled.
Total Bowel Opacification
The patient should drink 300 mL the night preceding the examination, 300 mL two hours prior to the examination and 300 mL approximately 15 minutes prior to examination.
Rectal/Colon Administration
Rectally administered Prepcat should be at room temperature to body temperature. Transfer the desired quantity of ready-to-use Prepcat into an enema administration unit, such as Empty Enema Kit. Close the slide clamp. Lubricate the tip and carefully insert. If Empty Enema Kit is used, invert and squeeze the red ball into the bag. Return the bag to upright and with the patient in the left lateral position, open the slide clamp to administer the suspension. Coating of the entire colon may be achieved by rotating the patient 360°. For increased patient comfort, excess suspension may be drained back into the enema bag.
Pediatric Use
The quantity of suspension used and the barium sulfate concentration will depend upon patient size, technique used and clinical need.
For single patient use only. Properly discard unused portion.
How is Prepcat Suspension Supplied
Catalog No. 169415. NDC 68240-126-45. 450 mL (15 fl. oz.) bottle; twenty-four (24) bottles with straws per case.
Store at 25°C (77°F); excursions permitted to 15º to 30ºC (59 to 86ºF). Protect from freezing.
Shake well before using.
DIN: 00794260
Distributed in Canada by:
tyco Healthcare
Pointe-Claire, QC, Canada H9R 5H8
Establishment License # 100689-A
Made in Mexico
Manufactured by:
Mallinckrodt Inc.
St. Louis, MO 63042 USA
www.Mallinckrodt.com
MID 1304678 Rev 04/2009
G.I. EXAMS
- Pre-mixed
- Ready-to-use
- Flavored
tyco
Healthcare
Mallinckrodt
Package Label - Principal Display Panel - 450 mL Bottle
L A F A Y E T T E
PREPCAT™
BARIUM SULFATE SUSPENSION
Catalog No. 169415
O3™ ANTIMICROBIAL TECHNOLOGY
CT CONTRAST / G.I. EXAMS
Rx only
450 mL
PREPCAT
Barium Sulfate Suspension USP
NDC 68240-126-45
Catalog No. 169415
A strawberry flavored, ready-to-use, 1.5% w/w (w/v), barium sulfate USP suspension for use as an aid for computed tomography of the gastrointestinal tract.
Contents: Barium sulfate USP, sorbitol, simethicone, suspending agent, potassium sorbate, flavoring, citric acid, saccharin sodium and water.
Contraindications: Do not use in patients with suspected gastrointestinal tract perforation or known hypersensitivity to barium sulfate formulations.
Dosage and Administration: See package insert for complete instructions.
For single patient use only. Properly discard unused portion.
Shake well before using.
Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from freezing.
Net Contents: 450 mL (15 fl. oz.)
DIN: 00794260
Distributed in Canada by:
tyco Healthcare
Pointe-Claire, QC, Canada H9R 5H8
Establishment License # 100689-A
Made in Mexico
Manufactured by:
Mallinckrodt Inc.
St. Louis, MO 63042 USA
www.Mallinckrodt.com
MID 1170010
Rev 04/2009
tyco
Healthcare
Mallinckrodt
PREPCAT barium sulfate suspension | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
|
Labeler - Mallinckrodt Inc. (810407189) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Mallinckrodt Medical, S.A. de C.V. | 810407189 | analysis, manufacture |