Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
CICLESONIDE
AstraZeneca UK Limited
R03BA08
CICLESONIDE
160 Microgram
Pressurised Inhalation Soln
Product subject to prescription which may be renewed (B)
ciclesonide
Marketed
2005-02-18
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alvesco 160 micrograms pressurised inhalation, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 actuation (delivered dose from the mouthpiece) contains 160 micrograms of ciclesonide. _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Pressurised inhalation, solution Clear and colourless. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment to control persistent asthma in adults and adolescents (12 years and older). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The medicinal product is for inhalation use only. Posology Dosing recommendation for adults and adolescents: The recommended dose of Alvesco is 160 micrograms once daily, which leads to asthma control in the majority of patients. In patients with severe asthma and while reducing or discontinuing oral corticosteroids, a higher dose of up to 640mcg/day (given as 320mcg twice daily) may be used (see section 5.1). Patients should be given a dose of inhaled ciclesonide which is appropriate to the severity of their disease. Symptoms start to improve with Alvesco within 24 hours of treatment. Once control is achieved, the dose of Alvesco should be individualised and titrated to the minimum dose needed to maintain good asthma control. Dose reduction to 80 micrograms once daily may be an effective maintenance dose for some patients. Alvesco should preferably be administered in the evening although morning dosing of Alvesco has also been shown to be effective. The final decision on evening or morning dosing should be left to the discretion of the physician. Patients with severe asthma are at risk of acute attacks and should have regular assessments of their asthma control including pulmonary function tests. Increasing use of short-acting bronchodilators to relieve asthma symptoms indicates deterioration of asthma control. If patients find that short-acting relief bronchodilator treatment becomes less effective, or they need more inhalations than usual, medical attention m Прочитать полный документ