Polibar 94% powder for rectal suspension

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Barium sulfate

Mevcut itibaren:

Bracco UK Ltd

ATC kodu:

V08BA01

INN (International Adı):

Barium sulfate

Doz:

940mg/1ml

Farmasötik formu:

Enema

Uygulama yolu:

Rectal

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF:

Ürün özellikleri

OBJECT 1
POLIBAR
Summary of Product Characteristics Updated 04-Oct-2016 | Bracco UK
Limited
1. Name of the medicinal product
Polibar 94 % w/w powder for rectal suspension
2. Qualitative and quantitative composition
_Active Constituent: _
Barium sulfate 94.015 % w/w
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for rectal suspension.
White powder.
4. Clinical particulars
4.1 Therapeutic indications
This medicinal product is for diagnostic use only.
Polibar is a diagnostic reagent for radiological examination of the
gastro-intestinal tract.
Polibar is indicated in adults and children.
4.2 Posology and method of administration
Posology
Polibar is for rectal (enema) administration.
The administered dose of Polibar will depend on the patient in
question and the section of the
gastrointestinal tract to be viewed.
ADULTS: Usual Dosage Range 150- 750 g barium sulfate in a suitable
suspension.
Double contrast of the large bowel - Give as required between 60 - 115
% w/v.
Single contrast of the large bowel - Give as required between 20 - 40
% 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 lower gastrointestinal
tract
– lower gastrointestinal haemorrhage
– gastrointestinal ischemia
– megacolon or toxic megacolon
– necrotising entercolitis
– severe ileus
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