Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
SALBUTAMOL SULFATE
Norton Waterford
100 Microgram
Pressurised Inhalation Suspension
2003-07-27
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Salbutamol CFC-Free 100 micrograms, pressurised inhalation, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each actuation delivers Salbutamol Sulphate equivalent to Salbutamol 100 micrograms per metered (ex valve) dose. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation suspension A homogenous creamy white to greyish white suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Salbutamol CFC-Free is indicated for the treatment of acute attacks or exacerbations of bronchial asthma and for the treatment of reversible airways obstruction. Salbutamol CFC-Free may also be taken prophylactically before exertion to prevent exercise-induced asthma. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION 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. For patients requiring a spacer device the Aerochamber has been shown to be compatible with Salbutamol CFC-Free. 4.3 CONTRAINDICATIONS Hypersensitivity to salbutamol or any of the inactive ingredients in Salbutamol CFC-Free. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Salbutamol causes peripheral vasodilation which may result in reflex tachycardia and increased cardiac output. Caution should be used in patients suffering from angina, severe tachycardia or thyrotoxicosis. IRISH MEDICINES BO Lesen Sie das vollständige Dokument