Baritop Plus
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Baritop Plus
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Barium Sulphate 94.6%w/w
3. PHARMACEUTICAL FORM
Granules to prepare an aqueous suspension for oral or rectal use as a radiopaque.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
Baritop Plus is an X-ray contrast medium for use in the radiological examination of the gastrointestinal tract.
4.2. Posology and Method of Administration
After reconstitution with water to make a suspension, Baritop Plus is either taken by mouth as a barium meal or given rectally as an enema.
Adult:
|
Part of GI Tract |
Method |
Volume (ml) |
Concentration % w/v |
|
Oesophagus |
Oral |
10-150 |
50-200 |
|
Stomach & Duodenum |
Oral, Double-Contrast, Distension Filling & Relief |
10-300 |
30-200 |
|
Small Intestine |
Oral |
100-300 |
30-150 |
|
Colon |
Enema |
200-2000 |
20-130 |
Children and infants:
As for adults but in proportion to body weight.
4.3. Contra-Indications
|
Oral use: |
Suspected perforation of intestinal organs. digestive organs. |
Haemorrhage in |
|
Enema use: |
Suspected perforation of intestinal organs. digestive organs: Extreme exhaustion. |
Haemorrhage in |
4.4. Special Warnings and Special Precautions For Use
Baritop Plus should be used with great caution in:
Oral use: Suspected or known fistula in digestive organs.
Stricture or signs suggesting obstruction.
Enema use: Suspected or known fistula in digestive organs.
Stricture or signs suggesting obstruction: Diseases of internal organs that could lead to perforation (e.g. appendicitis, diverticulitis, ulcerative colitis, invagination tumour, parasitic disease etc).
Water and laxatives should be given to patients to prevent constipation.
4.5. Interaction with other Medicinal Products and other Forms of Interaction
None stated.
4.6. Pregnancy and Lactation
At the discretion of the physician.
4.7. Effects on Ability to Drive and Use Machines
None stated.
4.8. Undesirable Effects
May cause constipation, transient diarrhoea, abdominal pain, anal pain and bleeding.
4.9 Overdose
Treat symptomatically.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Not applicable - barium sulphate is not absorbed from the gastrointestinal tract.
5.2. Pharmacokinetic Properties
Not applicable - barium sulphate is not absorbed from the gastrointestinal tract.
5.3. Pre-clinical Safety Data
No formal preclinical studies have been undertaken. Barium sulphate is a well established pharmaceutical substance that has been available for many years. It is also the subject of a recognised pharmacopoeial monograph.
6. PHARMACEUTICAL PARTICULARS 6.1. List of Excipients
Potato starch, soluble Acacia
Silicon resin emulsion Sodium benzoate Green apple oil Carmellose sodium
Hydrogenated maltose starch syrup, powdered Purified water
6.2. Incompatibilities
None stated.
6.3. Shelf Life
36 months.
6.4. Special Precautions for Storage
Store in a dry place.
6.5 Nature and contents of container
Polyethylene - cellulose bags 200 g pack.
6.6. Instructions for Use, Handling and Disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Sanochemia Diagnostics UK Ltd.
1 Friary Temple Quay Bristol BS16EA United Kingdom
MARKETING AUTHORISATION NUMBER(S)
8.
19088/0007
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30/01/2009
10 DATE OF REVISION OF THE TEXT
25/07/2013