E-Z-HD

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

BARIUM SULFATE

Disponible depuis:

PROMEDICO LTD

Code ATC:

V08BA02

forme pharmaceutique:

POWDER FOR SUSPENSION

Composition:

BARIUM SULFATE 98.3845 %W/W

Mode d'administration:

PER OS

Type d'ordonnance:

Required

Fabriqué par:

E-Z-EM INC., USA

Groupe thérapeutique:

BARIUM SULFATE WITHOUT SUSPENDING AGENTS

Domaine thérapeutique:

BARIUM SULFATE WITHOUT SUSPENDING AGENTS

indications thérapeutiques:

For double contrast radiography of the oesophagus, stomach and duodenum.

Date de l'autorisation:

2010-09-30

Résumé des caractéristiques du produit

E-Z-HD 98 % W/W POWDER FOR ORAL SUSPENSION
1
NAME OF THE MEDICINAL PRODUCT
E-Z-HD 98 % w/w powder for oral suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_Active Constituent: _
_ _
_ _
_ _
_ _
_ _
Barium sulfate 98.45 % w/w
_Excipients include: _
Sorbitol (E420), 2 g per 340 g dose.
Approximately 310 mg sodium per 340 g dose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for oral suspension.
White powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
E-Z-HD is a high density suspension for use as a radiopaque agent
during X-ray visualisation of the upper gastro-intestinal tract
(oesophagus,
stomach and duodenum). It is designed for optimal use in double
contrast X-ray examinations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
E-Z-HD must be administered orally. The powder must be reconstituted
prior to administration (see section 6.6).
The administered dose of E-Z-HD will depend on the patient in question
and the section of the gastrointestinal tract to be viewed.
ADULTS: The contents of one prefilled bottle (340 g) are dispersed in
65 mL of water to produce a 250 % w/v suspension which is swallowed by
the
patient after a suitable gas producing agent has been administered.
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.
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 in any part
of the
gastrointestinal tract
–
gastrointestinal haemorrhage
–
gastrointestinal ischemia
–
megacolon or toxic megacolon
–
necrotising entercolitis
–
severe constipation
–