Active ingredients: Budesonide
Budesonide 64 micrograms/actuation, Aqueous Nasal Spray.
Nasal spray, suspension.
White homogeneous suspension.
The delivered (metered) dose of 0.05 ml nasal spray, suspension contains 64 micrograms of budesonide.
Excipient (s) with known effect: 0.06 mg of potassium sorbate/0.05 ml nasal spray, suspension
For the full list of excipients, see section 6.1.
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.
Dispersible cellulose (Microcrystalline cellulose and carboxymethylcellulose sodium, (89:11, w/w))
Potassium sorbate E202
Hydrochloric acid, concentrated
Ascorbic acid E300
Amber type III glass bottle fitted with a plastic nasal spray pump and polypropylene nasal applicator: pack size of 1 x120 (1 × 10 ml) doses, 3 × 120 (3 × 10 ml) doses, 10 × 120 (10 × 10 ml) doses
Not all pack sizes may be marketed.
Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom
30th July 2009