POLIBAR Powder for rectal suspension

Active ingredients: Barium sulfate

Product name and form

Polibar 94% w/w powder for rectal suspension.

Pharmaceutical Form

Powder for rectal suspension.

White powder.

Qualitative and quantitative composition

Active Constituent: Barium sulfate 94.015% w/w.

For a full list of excipients, see section 6.1.

Active Ingredient
Description

Barium sulfate is inert and has no pharmacological action. It serves only as a radiopaque substance to opacify the gastro-intestinal tract during X-ray examinations.

List of Excipients

Gum ghatti
Sorbitol (E420)
Sodium citrate (E331)
Sodium carrageenan (E407)
Simeticone
Polyoxyethylene glyceryl mono-oleate
Citric acid anhydrous (E330)

Pack sizes and marketing

Unit dose prefilled enema bag composed of polyvinylchloride containing 397 g, 567 g or 680 g of product. Not all pack sizes may be marketed.

Marketing authorization holder

Bracco Imaging spa, Via Egidio Folli 50, 20134, Milano, Italy

Marketing authorization dates and numbers

PL 12032/0021

7th May 1993 / 15th January 2004