Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
BUDESONIDE
Breath Limited
BUDESONIDE
0.5mg/2ml
Nebuliser Suspension
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Budesitan 0.5mg/2ml Nebuliser Suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of suspension contains 0.25mg budesonide. One ampoule of 2ml suspension contains 0.5mg budesonide. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Nebuliser suspension White to off-white suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of persistent bronchial asthma in patients where use of a pressurised inhaler or dry powder formulation is unsatisfactory or inappropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: For inhalation use only. The dose should be given twice daily. Administration once daily may be considered in cases of mild to moderate stable asthma. INITIAL DOSAGE: The initial dose should be tailored to the severity of the disease and thereafter should be adjusted on an individual basis. The following doses are recommended but the minimum effective dose should always be sought: Children aged 6 months and above: 0.25 – 1.0mg daily. For patients in maintenance therapy with oral steroids a higher initial dosage up to 2.0 mg daily should be considered. Adults (including the elderly) and children/adolescents over 12 years of age: 0.5 - 2 mg daily. In very severe cases the dosage may be increased further. MAINTENANCE DOSE: The maintenance dose should be adjusted to meet the requirements of the individual patient taking account of the severity of the disease and the clinical response of the patient. When the desired clinical effect has been obtained, the maintenance dose should be reduced to the minimum required for control of the symptoms. Children aged 6 months and above: 0.25 - 1.0mg daily. Adults (including the elderly) and children/adole Citiți documentul complet