POLIBAR ACB barium sulfate powder for suspension

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

BARIUM SULFATE (UNII: 25BB7EKE2E) (BARIUM - UNII:24GP945V5T)

Beszerezhető a:

E-Z-EM Canada Inc

INN (nemzetközi neve):

BARIUM SULFATE

Összetétel:

BARIUM SULFATE 965 mg in 1 g

Recept típusa:

PRESCRIPTION DRUG

Engedélyezési státusz:

unapproved drug other

Termékjellemzők

POLIBAR ACB- BARIUM SULFATE POWDER, FOR 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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POLIBAR® ACB
BARIUM SULFATE 96% W/W
PREFILLED DISPOSABLE BARIUM ENEMA KIT
POWDER FOR RECTAL SUSPENSION
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.
INDICATIONS AND USAGE
This product is indicated for single and double contrast radiographic
visualization of the colon.
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. Appro