BRICANYL TURBOHALER 500 Mcg/Dose Powder for Inhalation
Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Charakterystyka produktu
(SPC)
23-04-2024
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Składnik aktywny:
TERBUTALINE SULFATE
Dostępny od:
McDowell Pharmaceuticals
INN (International Nazwa):
TERBUTALINE SULFATE
Dawkowanie:
500 Mcg/Dose
Forma farmaceutyczna:
Powder for Inhalation
Typ recepty:
Product subject to prescription which may be renewed (B)
Status autoryzacji:
Withdrawn
Data autoryzacji:
2014-03-25
Charakterystyka produktu
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
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