Contents: Ipratropium bromide, fenoterol hydrobromide.
Description:
BERODUAL Solution for Inhalation: 1 mL (= 20 drops) solution for inhalation contains: (8r)-3?-hydroxy-8-isopropyl-1?H,5?H-tropanium bromide (±)-tropate monohydrate (= ipratropium bromide) corresponding to 250 mcg ipratropium bromide anhydrous 261mcg 1-(3,5-dihydroxy-phenyl)-2-[[1-(4-hydroxy-benzyl)-ethyl]-amino]-ethanol hydrobromide (= fenoterol hydrobromide) 500mcg.
Excipients/Inactive Ingredients: benzalkonium chloride, disodium edetate dihydrate, sodium chloride, hydrochloric acid, water purified.
Indication: BERODUAL is a bronchodilator for the prevention and treatment of symptoms in chronic obstructive airway disorders with reversible airflow limitation such as bronchial asthma and especially chronic bronchitis with or without emphysema. Concomitant anti-inflammatory therapy should be considered for patients with bronchial asthma and steroid responsive chronic obstructive pulmonary disease (COPD).
Dosage:
BERODUAL Solution for Inhalation: (1 mL contains - 261 mcg ipratropium bromide + 500 mcg fenoterol hydrobromide); (20 drops = 1 mL).
Treatment should be initiated and administered under medical supervision, e.g. in the hospital setting. Home based treatment can be recommended in patients when a low dose rapid acting beta-agonist bronchodilator such as BERODUAL-metered dose inhaler has been insufficient in providing relief after consultation with an experienced physician. It can also be recommended in patients who are in need for nebuliser treatment for other reasons e.g. handling issues of metered dose inhaler or requirement of higher doses in experienced patients.
The treatment with the solution for inhalation should always be started with the lowest recommended dose. The dosage should be adapted to the individual requirements and tailored according to the severity of the acute episode.
Administration should be stopped when sufficient symptom relief is achieved.
The following dosages are recommended: Adults (including elderly) and adolescents - >12 years of age: Acute episodes of bronchospasm: Depending on the severity of the acute episode doses ranging between 261 mcg ipratropium bromide/500 mcg fenoterol hydrobromide (i.e. 1 mL = 20 drops) and 652.5 mcg ipratropium bromide/1250 mcg fenoterol hydrobromide (i.e. 2.5 mL = 50 drops) may be used. In exceptional particular severe cases doses up to 1044 mcg ipratropium bromide/2000 mcg fenoterol hydrobromide (i.e. 4 mL = 80 drops) may be used.
Children 6 - 12 years: Acute asthma episodes: Depending on the severity of the acute episode and age doses ranging between 130.5 mcg ipratropium bromide/250 mcg fenoterol hydrobromide (i.e. 0.5 mL= 10 drops) and 522 mcg ipratropium bromide/1000 mcg fenoterol hydrobromide (i.e. 2 mL = 40 drops) may be used.
Children < 6 years (below 22 kg body weight): Because there is limited information in this age group the following dose is recommended to be given under medical supervision only: About 26.1 mcg ipratropium bromide/50 mcg fenoterol hydrobromide (i.e. 0.1 mL = 2 drops) per kg body weight = up to a maximum of 0.5 mL (=10 drops).
Instructions for use: The solution for inhalation is intended only for inhalation with suitable nebulising devices and must not be taken orally.
The recommended dose is to be diluted with physiological saline to a final volume of 3 - 4 mL and nebulised and inhaled until sufficient symptom relief is achieved.
BERODUAL solution for inhalation may, however, not be diluted with distilled water.
The solution should be freshly diluted each time before use; any residual diluted solution should be discarded.
The diluted solution should be inhaled directly after preparation of the solution.
The duration of inhalation can be controlled by the dilution volume.
BERODUAL solution for inhalation can be administered using a range of commercially available nebulising devices. The lung and systemic drug exposure is dependent on the nebuliser used and may be higher than with BERODUAL metered dose aerosol depending on the efficiency of the device.
Where wall oxygen is available the solution is best administered at a flow rate of 6 - 8 litres per minute.
The instructions provided by the manufacturer of the nebulising device for proper care, maintenance and cleaning of the equipment should be followed.
