Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
TERBUTALINE SULFATE
McDowell Pharmaceuticals
TERBUTALINE SULFATE
500 Mcg/Dose
Powder for Inhalation
Product subject to prescription which may be renewed (B)
Withdrawn
2014-03-25
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:_ White to off white spherical particles which break into a fine powder on inhalation, contained in a plastic multi-dose breath-actuated metered dose powder inhaler. 4 CLINICAL PARTICULARS Terbutaline is a selective 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. Care should be taken in patients suffering from myocardial insufficiency or thyrotoxicosis. Due to the hyperglycaemic effects of 2-stimulants, additional blood glucose measurements are initially recommended when Bricanyl therapy is commenced in diabetic patients. Cardiovascular effects may be seen with sympathomimetic drugs, including Bricanyl. There is some evidence from post-marketing data and published literatur Přečtěte si celý dokument