Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
TERBUTALINE SULFATE
Imbat Limited
R03AC; R03AC03
TERBUTALINE SULFATE
500 Mcg/Acutuation
Powder for Inhalation
Product subject to prescription which may be renewed (B)
Selective beta-2-adrenoreceptor agonists; terbutaline
Authorised
2012-08-03
Health Products Regulatory Authority 19 November 2019 CRN009GHC Page 1 of 5 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 terbutaline sulphate. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder _Product imported from United Kingdom_: 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. With each inhalation a fraction of the delivered dose will be deposited in the oral cavity. To minimize unnecessary systemic exposure to terbutaline, the patients should be advised to, when possible, rinse their mouth after each use. If a previously effective dosage regimen no longer gives the same symptomatic relief, the patient should urgently seek further medical advice. Health Products Regulatory Authority 19 November 2019 CRN009GHC Page 2 of 5 Consideration should be given to the requirements for additional therapy (including increased dosage Soma hati kamili