Summary of medicine characteristics - BARITOP 100
1 NAME OF THE MEDICINAL PRODUCT
Baritop 100
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Barium Sulphate 100 %w/v
3 PHARMACEUTICAL FORM
Barium Sulphate Suspension
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Baritop 100 is an X-ray contrast medium for use in the Radiological examination of the gastrointestinal tract.
4.2 Posology and method of administration
Oral or by enema in accordance with the parts to be examined and
examination methods
Part of GI Tract Method
Volume Concentration
(ml) (% w/v)
Oesophagus
Oral
10–150
50–100
| Stomach & Duodenum | Oral, DoubleContrast, Distension Filling & Relief | 10–300 | 30–100 |
| Small Intestine | Oral | 100–300 | 30–100 |
| Colon | Enema | 200–2000 | 20–100 |
As for adults but in proportion to body weight.
As for adults but in proportion to body weight.
4.3 Contraindications
Oral Use: Suspected perforation of intestinal organs: Haemorrhage in digestive
organs.
Enema Use: Suspected perforation of intestinal organs: Haemorrhage in digestive organs: Extreme exhaustion.
4.4 Special warnings and precautions for use
4.4 Special warnings and precautions for useBaritop 100 should be used with great caution in:
| Oral use: | Suspected or known fistula in digestive organs: Stricture or signs suggesting obstruction. Suffering from extreme exhaustion. |
| 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 Fertility, 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 PHARMACOLOGICAL PROPERTIES5.1 Pharmacodynamic properties
Not applicable.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
5.3 Preclinical safety dataNo 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
Carmellose sodium
Tragacanth
Sodium saccharin
Glycine
Sodium ascorbate
Silicon resin emulsion
Sodium benzoate
Sodium dehydroacetate Cream soda essence flavour Purified water
6.2 Incompatibilities
None known
6.3 Shelf life
36 months.
6.4 Special precautions for storage
None stated.
6.5 Nature and contents of container
300ml sealed can
Steel body and bottom with an aluminium top. The top is coated internally with polyester film laminate and the body and bottom with epoxy resin.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNone stated.
7 MARKETING AUTHORISATION HOLDER
Red Knights Pharma Ltd.
5300 Lakeside
Cheadle Royal Business Park,
Cheadle SK8 3GP
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 55644/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION
09/12/2010