Budesonide/Formoterol Teva Pharma B.V. is a medicine used for the treatment of asthma in adults for whom a combination product is considered appropriate. It can be used in patients: - whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists’ taken by inhalation; - whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists’ taken by inhalation. Budesonide/Formoterol Teva Pharma B.V. is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare–ups) of the disease in the past despite regular treatment. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing. Budesonide/Formoterol Teva Pharma B.V. is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substances, but Budesonide/Formoterol Teva Pharma B.V. is given using a different inhaler. The reference medicine for Budesonide/Formoterol Teva Pharma B.V. is Symbicort Turbohaler. Budesonide/Formoterol Teva Pharma B.V. contains the active substances budesonide and formoterol.
Therapeutic Indication
### Therapeutic indication Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only. Asthma Budesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: -in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists. or -in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. COPD Symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1) < 70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Therapeutic Area (MeSH)
ATC Code
R03AK07
ATC Item
formoterol and budesonide
Pharmacotherapeutic Group
Drugs for obstructive airway diseases
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Budesonide | N/A | 布地奈德 |
| formoterol fumarate dihydrate | N/A | Aluminum sulfate |
EMA Name
GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.)
Medicine Name
GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.)
Aliases
N/ANo risk management plan link.
