Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
IPRATROPIUM BROMIDE MONOHYDRATE SALBUTAMOL SULFATE
PCO Manufacturing
IPRATROPIUM BROMIDE MONOHYDRATE SALBUTAMOL SULFATE
0.5/2.5 Base mg/unit
Nebuliser Solution
Product subject to prescription which may be renewed (B)
Withdrawn
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Combivent UDVs 500 micrograms/2.5mg per 2.5ml Nebuliser Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.5 ml single dose unit contains: 500 micrograms ipratropium bromide (as the monohydrate) and 2.5 mg salbutamol (as the sulphate) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nebuliser solution. A clear, colourless solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Combivent UDVs are indicated for the management of bronchospasm in patients suffering from chronic obstructive pulmonary disease who require regular treatment with both ipratropium and salbutamol 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose is: _Adults (including elderly patients and children over 12 years):_ 1 vial three or four times daily. Children: There is no experience of the use of COMBIVENT UDVs in children under 12 years. COMBIVENT UDVs are intended for inhalation only and may be administered from a suitable nebuliser or an intermittent positive pressure ventilator. The single dose units should not be taken orally or administered parenterally. The dose of nebuliser solution may need to be diluted in order to obtain a final volume suitable for the particular nebuliser being used; if dilution is necessary use only sterile sodium chloride 0.9% solution. Instructions for Use: 1. Prepare the nebuliser by following the manufacturer's instructions and the advice of your doctor. 2. Carefully separate a new vial from the strip. NEVER use one that has been opened already. 3. Open the vial by simply twisting off the top, always taking care to hold it in an upright position. 4. Unless otherwise instructed by your doctor squeeze all the contents of the plastic vial into the nebuliser c Přečtěte si celý dokument