BUDESONIDE Nebuliser Suspension

Active ingredients: Budesonide

Product name and form

Budesonide 0.5mg Nebuliser Suspension.

Pharmaceutical Form

Nebuliser suspension.

White to off-white suspension.

Qualitative and quantitative composition

One ml of suspension contains 0.25mg budesonide.

One ampoule of 2ml suspension contains 0.5mg budesonide.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Budesonide is a glucocorticosteroid with a high local anti-inflammatory effect. At doses clinically equivalent to systemically acting glucocorticosteroids, budesonide gives significantly less HPA axis suppression and has a lower impact on inflammatory markers.

List of Excipients

Disodium edetate
Sodium chloride
Polysorbate 80
Citric acid
Sodium citrate
Water for injection

Pack sizes and marketing

Low density polyethylene ampoule containing 2ml nebuliser suspension.

Pack sizes: Tri-laminate foil sachets containing 5, 20, 24, 40 (2 × 20) and 60 ampoules (in strips of 4, 5, 8, 10 or 12 ampoules).

Not all pack sizes may be marketed.

Marketing authorization holder

Breath Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom

Marketing authorization dates and numbers

PL: 18023/0007

26-10-2005 / 24-02-2009