POLIBAR ACB

Страна: Ізраїль

мова: англійська

Джерело: Ministry of Health

Активний інгредієнт:

BARIUM SULFATE

Доступна з:

PROMEDICO LTD

Код атс:

V08BA02

Фармацевтична форма:

POWDER FOR SUSPENSION

Склад:

BARIUM SULFATE 96.476 %W/W

Адміністрація маршрут:

RECTAL

Тип рецепту:

Required

Виробник:

E-Z-EM INC., USA

Терапевтична група:

BARIUM SULFATE WITHOUT SUSPENDING AGENTS

Терапевтична области:

BARIUM SULFATE WITHOUT SUSPENDING AGENTS

Терапевтичні свідчення:

For rectal administration (enema) as a radio-opaque agent for x-ray visualisation of the lower gastro-intestinal tract. It is designed for both single contrast barium enema and air-double contrast enema usage.

Дата Авторизація:

2010-10-31

Характеристики продукта

POLIBAR
® ACB
CAT. NO. AP14
NDC32909-804-01
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: Sodium
citrate, Sorbitol, Pectin,
Sodium carrageenan, Tragacanth, Simethicone, and Polyoxyethylene
glyceryl monooleate.
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 rectal administration (enema) as a
radio-opaque agent for x-
ray visualisation of the lower gastro-intestinal tract. It is designed
for both single contrast barium
enema and air-double contrast enema usage.
CONTRAINDICATIONS: This product should not be used in patients with
known or suspected
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
formulation. 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 o