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2. Qualitative and Quantitative Composition

Page 1 of 8 NEW ZEALAND DATA SHEET BUTACORT 1. Product Name BUTACORT, 50 micrograms or 100 micrograms per actuation, aqueous nasal suspension. 2. Qualitative and Quantitative Composition BUTACORT 50: Each actuation contains 50 micrograms of budesonide. BUTACORT 100: Each actuation contains 100 micrograms of budesonide. For the full list of excipients, see section 3. Pharmaceutical Form 50 micrograms/actuation: An almost white opaque suspension, almost odourless. Amber glass bottle fitted with a metered pump device delivering 50 micrograms budesonide per actuation. Delivery of valve: 50 microliters (each 50 microliter contains 50 micrograms of budesonide). 100 micrograms/actuation: An almost white opaque suspension, almost odourless. Amber glass bottle fitted with a metered pump device delivering 100 micrograms budesonide per actuation.

Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may

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