Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
SALBUTAMOL SULFATE
Norton Waterford
100 Mcg/Acutuation
Pressurised Inhalation Suspension
2002-03-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Airomir Autohaler 100 micrograms per metered dose, pressurised inhalation suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each actuation of Airomir Autohaler delivers Salbutamol Sulphate Ph. Eur. equivalent to Salbutamol 100 micrograms into the mouthpiece of the adapter. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation, suspension Pressurised aluminium container fitted with a 25 microlitre valve and supplied with a plastic breath-actuated actuator. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Airomir Autohaler is indicated for the treatment of acute attacks or exacerbations of bronchial asthma and for the treatment of reversible airways obstruction. Airomir Autohaler may also be taken prophylactically before exertion to prevent exercise-induced asthma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral inhalation use. ADULTS AND CHILDREN: For the relief of acute bronchospasm and for managing intermittent episodes of asthma, one inhalation, increasing to two inhalations if necessary. For prevention of exercise-induced bronchospasm, one inhalation before exertion, increasing to two inhalations if necessary. ELDERLY: No special dosage recommendations are made for elderly patients. For all patients, the maximum recommended dose should not exceed eight inhalations in 24 hours. With repetitive dosing, inhalations should not usually be repeated more often than every 4 hours. 4.3 CONTRAINDICATIONS Hypersensitivity to salbutamol or any of the inactive ingredients in Airomir Autohaler. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Salbutamol causes peripheral vasodilation which may result in reflex tachycardia and increased cardiac output. Caution should be used in patients suffering f Belgenin tamamını okuyun