SEEBRI BREEZHALER 50 MCG 30 CAP + INHALER

** Seebri® breezhaler® (Glycopyrronium) 50 mcg Inhalation Powder, hard capsules 30 capsules and 1 inhaler.

** Composition:

Each capsule contains:

50 micrograms glycopyrronium, Equivalent to 63 micrograms of glycopyrronium bromide.

Excipients: Lactose monohydrate, magnesium stearate

** Dose:

The recommended dose is the inhalation of the content of one capsule once daily using the Seebri Breezhaler inhaler.

** Pharmaceutical Form:

Hard capsule for Inhalation use only.

* Therapeutic indications:

Seebri Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

** Pharmacotherapeutic group:

Drugs for obstructive airway diseases, anticholinergics, ATC code: R03BB06

** Mechanism of action:

– Seebri Breezhaler 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. It has a rapid onset of action as evidenced by observed receptor association/dissociation kinetic parameters and the onset of action after inhalation in clinical studies.

– The long duration of action can be partly attributed to sustained concentrations of active substance in the lung as reflected by the prolonged terminal elimination half-life of glycopyrronium after inhalation via the Seebri Breezhaler inhaler in contrast to the half life after intravenous administration.

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

** Do not swallow capsules

** Do not store above 30 degrees C. Store in the original packaging in order to protect from moisture.

Keep out of the reach and sight of children.

** Store in the original package to protect from moisture and do not remove until immediately before use.

** Dispose each inhaler after 30 days of use.

** Medicinal product subject to medical prescription.

** Box:

Box contains 30 capsules (5 strips of 6 capsules) & Device (Breezhaler).

** Manufactured by: NOVARTIS Pharma Stein AG, Stein – Switzerland

For: Novartis Pharma AG, Basle – Switzerland