Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Zimbus Breezhaler 114 micrograms/46 micrograms/136 micrograms inhalation powder, hard capsules.
| Pharmaceutical Form |
|---|
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Inhalation powder, hard capsule (inhalation powder). Capsules with green transparent cap and uncoloured transparent body containing a white powder, with the product code “IGM150-50-160” printed in black above two black bars on the body and with the product logo printed in black and surrounded by a black bar on the cap. |
Each capsule contains 150 mcg of indacaterol (as acetate), 63 mcg of glycopyrronium bromide equivalent to 50 mcg of glycopyrronium and 160 mcg of mometasone furoate.
Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 114 mcg of indacaterol (as acetate), 58 mcg of glycopyrronium bromide equivalent to 46 mcg of glycopyrronium and 136 mcg of mometasone furoate.
Excipient(s) with known effect: Each capsule contains 25 mg of lactose 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. |
|
| 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. |
|
| Mometasone |
Mometasone is a topical glucocorticoid with local anti-inflammatory properties. It is likely that much of the mechanism for the effects of mometasone lies in its ability to inhibit the release of mediators of the inflammatory cascade. |
| List of Excipients |
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Capsule contents: Lactose monohydrate Capsule shell: Hypromellose |
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 10 hard capsules.
Single pack containing 10 × 1, 30 × 1 or 90 × 1 hard capsules, together with 1 inhaler.
Pack containing 30 × 1 hard capsules, together with 1 inhaler and 1 sensor.
Multipacks containing 150 (15 packs of 10 × 1) hard capsules and 15 inhalers.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/20/1440/001-005
03 July 2020
| Drug | Countries | |
|---|---|---|
| ZIMBUS | Austria, Estonia, Spain, Croatia, Ireland, Italy, Lithuania, Poland, South Africa |
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