Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
IPRATROPIUM BROMIDE SALBUTAMOL
Breathe Pharmaceuticals Limited
0.5mg/2.5m Milligrams per Ampule
Nebuliser Solution
2008-10-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Combineb 0.5mg/2.5mg per 2.5ml Nebuliser Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.5 ml single dose ampoule contains 0.5mg of ipratropium bromide (as monohydrate) and 2.5mg of salbutamol (as sulphate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nebuliser Solution A 2.5ml ampoule containing 2.5ml of colourless nebuliser solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Combineb 0.5mg/2.5mg per 2.5ml nebuliser solution is indicated for the management of bronchospasm in patients suffering from chronic obstructive pulmonary disease (COPD) who require regular treatment with both ipratropium bromide and salbutamol. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For inhalation use. The recommended dose is: _Adults (including elderly patients and children over 12 years): _1 ampoule three or four times daily. _Children under 12 years: _There is no experience of the use of Combineb 0.5mg/2.5mg per 2.5ml nebuliser solution in children under 12 years. _Administration:_ Combineb 0.5mg/2.5mg per 2.5ml nebuliser solution may be administered from a suitable nebuliser or an intermittent positive pressure ventilator after the single dose ampoule has been opened and its contents transferred to the nebuliser chamber. Administration should be in accordance with the manufacturer’s instructions for the device. The solution in the single dose ampoules is intended for inhalation use only and should not be taken orally or administered parenterally. 1. Prepare the nebuliser by following the manufacturer's instructions and the advice of your doctor. 2. Carefully separate a new ampoule from the strip. Never use an ampoule that has been opened already. 3. Open the ampoule by simply twisting off Citiți documentul complet