Source: Health Sciences Authority (SG) Revision Year: 2018 Publisher: Chiesi Farmaceutici SpA, Via Palermo, 26/A, 43122 Parma, Italy
Foster NEXThaler 100 micrograms/6 micrograms per dose inhalation powder.
| Pharmaceutical Form |
|---|
|
Inhalation powder. The multidose inhaler contains a white or almost white powder. |
Each metered dose of 10 mg inhalation powder contains:
100 micrograms of beclometasone dipropionate anhydrous and 6 micrograms of formoterol fumarate dihydrate.
This is equivalent to a delivered dose (the dose leaving the mouthpiece) of 81.9 micrograms of beclometasone dipropionate anhydrous and 5.0 micrograms of formoterol fumarate dihydrate.
Excipients with known effect:
Each inhalation contains 9.9 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Beclometasone is a pro-drug with weak glucocorticoid receptor binding affinity. It is extensively hydrolysed via esterase enzymes to the active metabolite beclometasone-17-monopropionate (B-17-MP), which has potent topical anti-inflammatory activity. |
|
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 small amounts of milk proteins) |
Each carton contains 1 Nexthaler inhaler which contains 1.50 g inhalation powder and provides 120 inhalations. Each inhaler is contained in a heat sealed protective pouch (foil package) made of PET/Al/PE (Polyethylene Terephtalate/Aluminium/Polyethylene) or PA/Al/PE (Polyamide/Aluminium/Polyethylene).
Foster NEXThaler is a multi-dose inhalation device. The device consists of a casework comprising a lower shell with window to display number of doses left and an integral cover. When opened, the cover, which also drives the dose counter mechanism, reveals a mouthpiece through which the drug is inhaled. The lower shell and mouthpiece are made from acrylonitrile butadiene styrene and the cover is made from polypropylene.
Chiesi Farmaceutici SpA, Via Palermo, 26/A, 43122 Parma, Italy
| Drug | Countries | |
|---|---|---|
| FOSTER | Austria, Cyprus, Germany, Estonia, Spain, Hong Kong, Croatia, Israel, Italy, Lithuania, Malta, Netherlands, Romania, Singapore, Tunisia, Turkey |
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