E-Z-CAT

Страна: Израел

Език: английски

Източник: Ministry of Health

Активна съставка:

BARIUM SULFATE

Предлага се от:

PROMEDICO LTD

АТС код:

V08BA

Лекарствена форма:

SUSPENSION

Композиция:

BARIUM SULFATE 4.9224 %W/V

Начин на приложение:

PER OS

Вид предписание :

Required

Произведено от:

E-Z-EM INC., USA

Терапевтична група:

BARIUM SULFATE CONTAINING X-RAY CONTRAST MEDIA

Терапевтични показания:

For use in x-ray departments.Opacification of the gastro intestinal tract prior to computerized axial tomography.

Дата Оторизация:

2012-02-28

Листовка

PATIENT PACKAGE INSERT ACCORDING TO THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
This medicine can be sold with a physician’s prescription only
E-Z-CAT
ORAL SUSPENSION
EACH 100 ML OF PREPARATION CONTAIN 4.9 G BARIUM SULFATE
EXCIPIENTS AND ALLERGENS IN THE PREPARATION: See section
6 in the leaflet – “Additional information”.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING
THE PREPARATION. This leaflet contains concise information
about the preparation. If you have any further questions,
refer to the physician or pharmacist.
This preparation has been prescribed for you. Do not pass
it on to others. It may harm them, even if you think that their
medical condition is similar to yours.
1. WHAT IS THE PREPARATION INTENDED FOR?
E-Z-CAT is a contrast agent given to a patient for the purpose
of a CT examination of the gastrointestinal tract, in order to
increase the quality of the stimulation.
This preparation is used for diagnostic purposes only.
The active ingredient, barium sulfate, is not absorbed and is
not metabolized by the body and is eliminated unchanged
from the body.
THERAPEUTIC GROUP: This preparation belongs to a group of
preparations used as opaque to x-rays contrasting agents.
2. BEFORE USING THE PREPARATION:

DO NOT USE THE PREPARATION IF
•
You are hypersensitive to barium sulfate or to any of
the additional ingredients this preparation contains )see
section 6 in the leaflet – “Additional information”)
•
You
suffer
from
any
of
the
following
gastrointestinal
disorders:
{
Fistula, perforation or obstruction in any part of the
gastrointestinal tract
{
Gastrointestinal hemorrhage
{
Insufficient blood flow (ischemia) in the gastrointestinal
tract
{
Enlarged colon )megacolon or toxic megacolon(
{
Necrotizing enterocolitis )NEC(
{
Severe constipation
{
severe impaired gastric emptying
•
You suffer from injuries or chemical burns of the gastrointestinal
tract
•
Immediately before or immediately after gastrointestinal
surgery or any surgical procedure in the gastrointest

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
E-Z-CAT 4.9 % w/v oral suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_Active Constituent: _
Barium sulfate 4.9 % w/v (4.6 % w/w)
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral suspension.
White, milky, viscous suspension.
4
CLINICAL PARTICULARS
4. 1
THERAPEUTIC INDICATIONS
For use in X-ray departments. Opacification of the gastro-intestinal
tract prior to
computerized axial tomography 4. 2 POSOLOGY AND METHOD OF ADMINISTRATION
E-Z-CAT is for oral administration.
_ _
The suspension is diluted with water to obtain a desired
concentration.
Recommended dilutions are shown in section 6.6.
ADULTS AND THE ELDERLY:_ _350 - 450 mL of diluted suspension 30
minutes
prior to the scan and the same volume 5 minutes prior to the scan, or,
as directed
by the physician.
_ _
CHILDREN: The dosage will be dependent on the size, age, health state
and
anatomical region to be imaged of the child. Individual requirements
should be determined, from experience, by the radiologist.
4.3
CONTRAINDICATIONS
_Immune System Disorders _
Hypersensitivity to barium sulfate or to any of the excipients.
_Gastrointestinal Disorders _
Patients with any of the following:
-
a known or suspected fistula, perforation or obstruction in any part
of
the gastrointestinal tract
-
gastrointestinal haemorrhage
-
gastrointestinal ischemia
-
megacolon or toxic megacolon
-
necrotising entercolitis
-
severe constipation
-
severe impaired gastric emptying
should not receive E-Z-CAT.
E-Z-CAT should not be used for infants with swallowing disorders.
_Surgical and Medical Procedures _
Barium sulfate should not be administered immediately before or
immediately
after gastrointestinal surgery, including snare polypectomy or
‘hot’ colonic
biopsy. If post procedural leakage is expected the product must not be
used.
Do not use during and up to four weeks after radiotherapy to the
rectum or
prostate.
_Injury, Poisoning and Procedural Complications _
Do not use if there