What is Airexar Spiromax - Salmeterol - Fluticasone and what is it used for?
Airexar Spiromax is a medicine used for the regular treatment of adults with severe asthma and to relieve the symptoms of chronic obstructive pulmonary disease (COPD, a long-term illness in which the airways and pulmonary alveoli are progressively damaged or blocked, with consequent difficulty in breathing). It contains the active substances salmeterol (a long-acting beta-2 agonist) and fluticasone propionate (a corticosteroid).
In the treatment of asthma, Airexar Spiromax can be used in patients whose disease is not adequately controlled by treatment with a combination of a beta-2 agonist and a lower dose of inhaled corticosteroid or in patients whose asthma is already adequately controlled with a long-acting beta-2 agonist and a high dose of inhaled corticosteroid.
In COPD, Airexar Spiromax is used in adults who have had exacerbations (exacerbations) of the disease in the past and who show significant symptoms despite regular treatment.
Airexar Spiromax is a "hybrid" medicine. This means that Airexar Spiromax is similar to a 'reference medicine' called Seretide Diskus (also known as Seretide Accuhaler), which contains the same active ingredients. However, Airexar Spiromax is available only in a single high dose, while the reference medicine is available in three dosages, ie the same dosage
How is Airexar Spiromax - Salmeterol - Fluticasone used?
Airexar Spiromax is available as an inhalation powder contained in a portable inhaler. Each inhalation provides a fixed dose of medicine.
The recommended dose is an inhalation twice a day. Patients should be periodically evaluated by a doctor to make sure they are given the lowest dose sufficient to control symptoms. Since Airexar Spiromax is only available in a single high dose (containing 50 micrograms of salmeterol and 500 micrograms of fluticasone propionate), if a lower dosage turns out to be adequate, patients should switch to an alternative combination of salmeterol and fluticasone propionate containing one more dose low fluticasone propionate.
Airexar Spiromax can only be obtained with a prescription. For more information, see the package leaflet.
How does Airexar Spiromax - Salmeterol - Fluticasone work?
The two active ingredients of Airexar Spiromax are well known and are present in various medicines used for the treatment of asthma and COPD, either alone or in combination with other medicines.
Salmeterol is a long-acting beta-2 agonist. It works by binding to receptors known as beta-2 receptors and found in the musculature of the airways. By binding to these receptors, it induces muscle relaxation, which in turn helps to keep the airways wide and promotes the patient's breathing.
Fluticasone propionate belongs to a group of anti-inflammatory medicines known as corticosteroids. It acts in a similar way to natural corticosteroid hormones: by binding to receptors on different types of immune cells, it reduces the activity of the immune system. This action in turn determines a reduction in the release of substances that participate in the inflammatory process (including histamine), thus helping to keep the airways free and allowing the patient to breathe more easily.
What benefit has Airexar Spiromax - Salmeterol - Fluticasone shown during the studies?
Patient studies have been limited to tests to determine the bioequivalence of Airexar Spiromax compared to the reference medicine, Seretide Diskus. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
Because Airexar Spiromax is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
What are the risks associated with Airexar Spiromax - Salmeterol - Fluticasone?
Because Airexar Spiromax is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Airexar Spiromax - Salmeterol - Fluticasone been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Airexar Spiromax has been shown to have comparable quality and to be bioequivalent to Seretide Diskus. Therefore, the CHMP considered that, as in the case of Seretide Diskus, the benefits outweigh the identified risks and recommended to approve the use of Airexar Spiromax in the EU.
What measures are being taken to ensure the safe and effective use of Airexar Spiromax - Salmeterol - Fluticasone?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Airexar Spiromax have been included in the summary of product characteristics and the package leaflet.
Other information about Airexar Spiromax - Salmeterol - Fluticasone
The full EPAR for Airexar Spiromax can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Airexar Spiromax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
