What is Budesonide / Formoterol Teva Pharma BV and what is it used for?
Budesonide / Formoterol Teva Pharma BV is a medicine containing the active substances budesonide and formoterol . It is used for the treatment of asthma in adults when the use of an association 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. Budesonide / Formoterol Teva Pharma BV is a "hybrid" medicine. This means that Budesonide / Formoterol Teva Pharma BV is similar to a "reference medicine" that contains the same active ingredients, but is administered with a different inhaler. The reference medicine for Budesonide / Formoterol Teva Pharma BV is Symbicort Turbohaler.
How is Budesonide / Formoterol Teva Pharma BV 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. Budesonide / Formoterol Teva Pharma BV can be used for the regular treatment of asthma.
As for the regular treatment of asthma, the recommended dose is one to four inhalations twice a day, depending on the dose used and the severity of the asthma. As an asthma relief therapy, patients should use a distinct "relief inhaler" to relieve symptoms. Patients who need to take more than eight inhalations a day should seek medical attention, which will evaluate the need to change therapy. For more information, see the package leaflet.
How does Budesonide / Formoterol Teva Pharma BV -?
The two active ingredients of Budesonide / Formoterol Teva Pharma BV are known and are present in various medicines used to treat asthma, either alone or in combination with other medicines. Budesonide belongs to a group of anti-inflammatory medicines called 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 in turn leads to a decrease in the release of substances involved in the inflammatory process (including histamine), thus helping to keep the airways free and allowing the patient to breathe more easily. Formoterol is a long-acting beta2 agonist. It works by binding to beta2 receptors in the musculature. Once inhaled, it binds mostly to these receptors in the airways, inducing muscle relaxation, which in turn helps keep the airways wide and promotes patient breathing.
What are the benefits and risks of Budesonide / Formoterol Teva Pharma BV -?
Studies have been conducted to show that Budesonide / Formoterol Teva Pharma BV is bioequivalent to the reference medicine (ie it produces the same level of active substance in the body) and that the two medicines have the same mechanism of action. It is therefore believed that the benefits and risks of Budesonide / Formoterol Teva Pharma BV are the same as those of the reference medicine.
Why has Budesonide / Formoterol Teva Pharma BV been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) has decided that Budesonide / Formoterol Teva Pharma BV 160 / 4.5 micrograms and 320/9 micrograms has been shown to have a comparable quality profile and to be bioequivalent to the corresponding dosages by 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 Budesonide / Formoterol Teva Pharma BV
What measures are being taken to ensure the safe and effective use of Budesonide / Formoterol Teva Pharma BV -?
A risk management plan has been developed to ensure that Budesonide / Formoterol Teva Pharma BV 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 Budesonide / Formoterol Teva Pharma BV, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Budesonide / Formoterol Teva Pharma BV -
On 19 November 2014, the European Commission issued a marketing authorization for Budesonide / Formoterol Teva Pharma BV, valid throughout the European Union. For more information about treatment with Budesonide / Formoterol Teva Pharma BV, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 11-2014.
