ULTIBRO BREEZHALER 110/50 MCG 30 CAP + INHALER

** Ultibro™ breezhaler® (indacaterol and glycopyrronium) 110/50 microgram Inhalation Powder hard capsule 30 capsules and 1 inhaler.

** Each capsule contains:
143 micrograms indacaterol maleate, equivalent to 110 micrograms indacaterol
and 63 micrograms glycopyrronium bromide, equivalent to 50 micrograms glycopyrronium
Excipients: Lactose monohydrate, magnesium stearate

** Therapeutic indications:
Ultibro Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

** Posology:
The recommended dose is the inhalation of the content of one capsule once daily using the Ultibro Breezhaler inhaler.
Ultibro Breezhaler is recommended to be administered at the same time of the day each day. If a dose is missed, it should be taken as soon as possible on the same day. Patients should be instructed not to take more than one dose in a day.

** Method of administration:
For inhalation use only. The capsules must not be swallowed.
The capsules must be administered only using the Ultibro Breezhaler inhaler.

** Pharmacotherapeutic group:
Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics, ATC code: R03AL04

** Mechanism of action:

– Ultibro Breezhaler:
When indacaterol and glycopyrronium are administered together in Ultibro Breezhaler, they provide additive efficacy due to their different mode of action targeting different receptors and pathways to achieve smooth muscle relaxation. Due to the differential density of beta2-adrenoceptors and M3-receptors in central versus peripheral airways, beta2-agonists should be more effective in relaxing peripheral airways, whilst an anticholinergic compound may be more effective in central airways. Thus for bronchodilation in both peripheral and central airways of the human lung a combination of a beta2-adrenergic agonist and a muscarinic antagonist may be beneficial.

– Indacaterol:
Indacaterol is a long-acting beta2-adrenergic agonist for once-daily administration. The pharmacological effects of beta2-adrenoceptor agonists, including indacaterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic-3′, 5′-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle. In vitro studies have shown that indacaterol has multi-fold greater agonist activity at beta2-receptors compared to beta1 and beta3-receptors.
When inhaled, indacaterol acts locally in the lung as a bronchodilator. Indacaterol is a partial agonist at the human beta2-adrenergic receptor with nanomolar potency.
Although beta2-adrenergic receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-adrenergic receptors are the predominant receptors in the human heart, there are also beta2-adrenergic receptors in the human heart comprising 10% to 50% of the total adrenergic receptors. Their presence in the heart raises the possibility that even highly selective beta2-adrenergic agonists may have cardiac effects.

– Glycopyrronium:
Glycopyrronium is an inhaled long-acting muscarinic receptor antagonist (anticholinergic) for once-daily maintenance bronchodilator treatment of COPD. Parasympathetic nerves are the major bronchoconstrictive neural pathway in airways, and cholinergic tone is the key reversible component of airflow obstruction in COPD. Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways.
Glycopyrronium bromide is a high affinity muscarinic receptor antagonist. A greater than 4-fold selectivity for the human M3 receptors over the human M2 receptor has been demonstrated using radioligand binding studies.

** Ultibro Breezhaler capsules must be administered only by the oral inhalation route and only using the Ultibro Breezhaler inhaler.

** Ultibro Breezhaler capsules must not be swallowed.

** Do not store above 30 degrees C. Store in the original package in order to protect from moisture.
Keep out of the reach and sight of children.

** Ultibro Breezhaler capsules must always be stored in the blister, and only removed immediately before use.

** Discard the Ultibro Breezhaler inhaler after 30 days of use.

** Medicinal product subject to medical prescription.

* Manufactured by: NOVARTIS Pharma Stein AG, Stein – Switzerland
For: Novartis Pharma AG, Basle – Switzerland
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