What is BiResp Spiromax - budesonide, formoterol and what is it used for?
BiResp Spiromax is a medicine that contains the active substances budesonide and formoterol . It is used in the treatment of asthma in adults when the use of a combination product is appropriate. It can be used in patients whose disease is not adequately controlled by treatment with other anti-asthmatic medicines, called corticosteroids and "short-acting beta2 agonists" taken by inhalation, or in patients whose disease is adequately controlled by therapy with corticosteroids and "long-acting beta2 agonists" taken by inhalation. BiResp Spiromax is also indicated to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults with a history of exacerbations of the disease, despite having been subjected to regular therapy in the past. COPD is a chronic disease in which the airways and pulmonary alveoli are damaged or blocked, resulting in difficulty breathing. BiResp Spiromax is a "hybrid" medicine. This means that BiResp Spiromax is similar to a "reference medicine" that contains the same active ingredients, but is administered with a different inhaler. The reference medicine for BiResp Spiromax is Symbicort Turbohaler.
How is BiResp Spiromax - budesonide, formoterol used?
The medicine can only be obtained with a prescription. It is available as an inhalation powder contained in a portable inhaler; each inhalation provides a fixed dose of medicine. BiResp Spiromax 160 / 4.5 micrograms (160 micrograms of budesonide and 4.5 micrograms of formoterol) can be used for the regular treatment of asthma and, as needed, as a relief inhaler. It can also be used for the treatment of COPD. The highest dosage, BiResp Spiromax 320/9 micrograms (320 micrograms of budesonide and 9 micrograms of formoterol), can only be used for the regular treatment of asthma and for the treatment of COPD. As for the regular treatment of asthma, the recommended dose is 1 to 4 inhalations twice a day, depending on the dose used and the severity of the asthma. As an asthma relief therapy, patients can perform 1 or 2 additional inhalation of BiResp Spiromax 160 / 4.5 micrograms solely to alleviate symptoms. Patients who need to take more than 8 inhalations a day should seek medical attention, which will evaluate whether to change the therapy. Regarding the treatment of COPD, the recommended dose is 1 or 2 inhalations twice a day, depending on the dosage used. For more information, see the package leaflet.
How does BiResp Spiromax - budesonide, formoterol work?
The two active ingredients of BiResp Spiromax are known and are present in various medicines used for the treatment of asthma and COPD, either alone or in combination with other medicines. Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids. It acts in a manner similar to natural corticosteroid hormones: by binding to receptors on different types of immune cells, it reduces the activity of the immune system. This in turn leads to a decrease in the release of substances involved in the inflammatory process (including histamine) which helps to keep the airways free, allowing the patient to breathe more easily. Formoterol is a long-acting beta2 agonist. It works by binding to receptors known as beta2 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.
How has BiResp Spiromax - budesonide, formoterol been studied?
Patient studies have been limited to tests to determine the bioequivalence of BiResp Spiromax compared to the reference medicine, Symbicort Turbohaler. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of BiResp Spiromax - budesonide, formoterol?
Because BiResp 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 BiResp Spiromax - budesonide, formoterol been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that BiResp Spiromax 160 / 4.5 micrograms and BiResp Spiromax 320/9 micrograms have been shown to have comparable quality and to be bioequivalent to the corresponding dosages of Symbicort Turbohaler. Therefore, the CHMP considered that, as in the case of Symbicort Turbohaler, the benefits outweigh the identified risks and recommended the granting of the marketing authorization for BiResp Spiromax.
Initially the company had also submitted an application for a lower dosage of BiResp Spiromax; however, since the bioequivalence with the reference medicine has not been demonstrated, the question related to this dosage has been withdrawn.
What measures are being taken to ensure the safe and effective use of BiResp Spiromax - budesonide, formoterol?
A risk management plan has been developed to ensure that BiResp Spiromax is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for BiResp Spiromax, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
Further information on BiResp Spiromax - budesonide, formoterol
On 28 April 2014, the European Commission issued a marketing authorization for BiResp Spiromax, valid throughout the European Union. For more information on BiResp Spiromax therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 04-2014.
