E-Z-Paque 96% powder for suspension

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Barium sulfate

זמין מ:

Bracco UK Ltd

קוד ATC:

V08BA01

INN (שם בינלאומי):

Barium sulfate

כמות:

960mg/1gram

טופס פרצבטיות:

Powder for oral or rectal suspension

מסלול נתינה (של תרופות):

Oral; Rectal

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

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BNF:

מאפייני מוצר

OBJECT 1
E-Z-PAQUE
Summary of Product Characteristics Updated 01-Mar-2018 | Bracco UK
Limited
1. Name of the medicinal product
E-Z-Paque 96 % w/w powder for oral suspension
2. Qualitative and quantitative composition
_Active Constituent:_
Barium sulfate 96% w/w
_Excipients with known effect (per 100 g of powder):_
Sorbitol (E420), 2.2 g.
Propylene glycol : 77 mg
Sodium : 121 mg.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for oral suspension.
White powder with a vanilla and strawberry odour.
4. Clinical particulars
4.1 Therapeutic indications
This medicinal product is for diagnostic use only.
E-Z-Paque is indicated for use as a positive contrast medium for
radiographic visualisation of the gastro-
intestinal tract.
E-Z-Paque is indicated in adults and children.
4.2 Posology and method of administration
Posology
E-Z-Paque is primarily intended for use in the upper gastro-intestinal
tract.
The administered dose of E-Z-Paque will depend on the patient in
question 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 radiologist.
ELDERLY: There are no special dosage recommendations. The dosage
should be determined, from
experience, by the radiologist.
Method of administration
For instructions on reconstitution of the medicinal product before
administration, see section 6.6.
4.3 Contraindications
_Immune System Disorders _
Hypersensitivity to barium sulfate or to any of the excipients listed
in section 6.1.
_Gastrointestinal Disorders _
Patients with any of the following:
- a known or suspected perforation of the gastrointesti