Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
TERBUTALINE SULFATE
Profind Wholesale Ltd.
500 Mcg/Acutuation
Powder for Inhalation
2010-08-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bricanyl Turbohaler 500 micrograms per metered dose, Inhalation powder. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose contains 500 micrograms of Terbutaline Sulphate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder _Product imported from the UK and from Hungary:_ Multi-dose breath-actuated metered dose powder inhaler. White to off white spherical particles which break into a fine powder on inhalation 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Terbutaline is a selective beta 2 -adrenergic agonist recommended for the relief and prevention of bronchospasm in bronchial asthma and in chronic bronchitis and other bronchopulmonary disorders in which bronchospasm is a complicating factor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and Children: One inhalation (500 micrograms) (metered dose) as required. Not more than 4 inhalations should be necessary in any 24 hour period. ELDERLY: Dosage as for adults. Instructions for use and cleaning are provided in the Patient Information Leaflet, which can be found in each pack. 4.3 CONTRAINDICATIONS Bricanyl preparations are contra-indicated in patients with a history of sensitivity to terbutaline sulphate. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients should be instructed in proper use and their inhalation technique checked regularly. If a previously effective dosage regimen no longer gives the same symptomatic relief, the patient should urgently seek further medical advice. Consideration should be given to the requirements for additional therapy (including increased dosages of anti- inflammatory medication). IRISH MEDICINES BOARD ________________________________________________________________________________________________________ Les hele dokumentet