Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Symbicort Turbohaler 100 micrograms/6 micrograms/inhalation, inhalation powder.
| Pharmaceutical Form |
|---|
|
Inhalation powder. White powder. |
Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide 80 micrograms/inhalation and formoterol fumarate dihydrate 4.5 micrograms/inhalation.
Each metered dose contains: budesonide 100 micrograms/inhalation and formoterol fumarate dihydrate 6 micrograms/inhalation.
Excipient with known effect: Lactose monohydrate 810 micrograms per delivered dose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Budesonide |
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. |
|
| Eformoterol |
Formoterol is a predominantly selective β2-stimulator. Formoterol has bronchodilator activity in patients with reversible obstructive airway diseases. In humans formoterol is effective in the prophylaxis of bronchospasm induced by methacholine challenge. |
| List of Excipients |
|---|
|
Lactose monohydrate (which contains milk proteins). |
Symbicort Turbohaler is an inspiratory flow-driven, multidose powder inhaler. The inhaler is white with a red turning grip. The inhaler is made of different plastic materials (PP, PC, HDPE, LDPE, LLDPE, PBT). In each secondary package there are 1, 2, 3, 10 or 18 inhaler(s) containing 60 (or 120) doses.
Not all pack-sizes may be marketed.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
PA 1019/020/001
Date of first authorisation: 23 February 2001
Date of last renewal: 24th July 2014
| Drug | Countries | |
|---|---|---|
| SYMBICORT | Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States |
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