Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules.
| Pharmaceutical Form |
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Inhalation powder, hard capsule (inhalation powder). Capsules with transparent yellow cap and natural transparent body containing a white to almost white powder, with the product code “IGP110.50” printed in blue under two blue bars on the body and the company logo ( |
Each capsule contains 143 micrograms of indacaterol maleate equivalent to 110 micrograms of indacaterol and 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of glycopyrronium.
Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 110 micrograms of indacaterol maleate equivalent to 85 micrograms of indacaterol and 54 micrograms of glycopyrronium bromide equivalent to 43 micrograms of glycopyrronium.
Excipient(s) with known effect: Each capsule contains 23.5 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Glycopyrronium |
Glycopyrronium is an inhaled long-acting muscarinic receptor antagonist (anticholinergic) for once-daily maintenance bronchodilator treatment of COPD. Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways. |
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| Indacaterol |
Indacaterol is a partial agonist at the human beta2-adrenergic receptor with nanomolar potency. When inhaled, indacaterol acts locally in the lung as a bronchodilator. In isolated human bronchus, indacaterol has a rapid onset of action and a long duration of action. |
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| Indacaterol and Glycopyrronium bromide |
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| List of Excipients |
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Capsule content: Lactose monohydrate |
Inhaler body and cap are made from acrylonitrile butadiene styrene, push buttons are made from methyl metacrylate acrylonitrile butadiene styrene. Needles and springs are made from stainless steel.
PA/Alu/PVC – Alu perforated unit-dose blister. Each blister contains either 6 or 10 hard capsules.
Single pack containing 6x1, 10x1, 12x1, 30x1 or 90x1 hard capsules, together with 1 inhaler.
Multipacks containing 96 (4 packs of 24x1) hard capsules and 4 inhalers.
Multipacks containing 150 (15 packs of 10x1) hard capsules and 15 inhalers.
Multipacks containing 150 (25 packs of 6x1) hard capsules and 25 inhalers.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/13/863/001-008
Date of first authorisation: 19 September 2013
Date of latest renewal: 22 May 2018
| Drug | Countries | |
|---|---|---|
| XOTERNA | Austria, Estonia, Spain, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, South Africa |
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) printed in black on the cap.