E-Z-PAQUE

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

BARIUM SULFATE

Disponibil de la:

PROMEDICO LTD

Codul ATC:

V08BA01

Forma farmaceutică:

POWDER FOR SUSPENSION

Compoziție:

BARIUM SULFATE 96 %W/W

Calea de administrare:

PER OS, RECTAL

Tip de prescriptie medicala:

Required

Produs de:

E-Z-EM INC., USA

Grupul Terapeutică:

BARIUM SULFATE WITH SUSPENDING AGENTS

Zonă Terapeutică:

BARIUM SULFATE WITH SUSPENDING AGENTS

Indicații terapeutice:

Single - contrast radiography of the oesophagus stomach duodenum and small bowel. For use only in x-ray departments.

Data de autorizare:

2012-02-28

Caracteristicilor produsului

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
E-Z-Paque 96 % w/w powder for oral/rectal suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_Active Constituent: _
Barium sulfate 96.2983 % w/w
_Excipients include: _
Sorbitol (E420), 2 g per 100 g powder.
Approximately 224 mg sodium per 100 g powder.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for oral/rectal suspension.
White powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For use only in x-ray departments.
Single – contrast radio graphy of the oesophagus stomach duodenum
and small bowel.
Radiographic visualization of the gastro-intestinal tract by oral or
rectal (enema) administration (bulk
pack presentation)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
E-Z-Paque is primarily intended for use in the upper gastro-intestinal
tract but may also be
administered by enema. The powder must be reconstituted prior to
administration (see section 6.6).
The administered dose of E-Z-Paque will depend on the patient in
question, the route of
administration and the section of the gastrointestinal tract to be
viewed.
ADULTS: Single contrast of the oesophagus, stomach and duodenum - give
orally 175 to 300 mL of
suspension at 100 % w/v.
Small bowel - give orally 250 to 300 mL of suspension at 60 % w/v.
The actual administered dose should be determined from experience, by
the radiologist.
CHILDREN: The dosage will be dependent on the size, age, health state
and anatomic region to be
imaged of the child. Individual requirements should be determined,
from experience, by the
Page 2 of 10
radiologist.
ELDERLY: There are no special dosage recommendations. The dosage
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 any part of
the gastrointestinal tract
-
gas