BRICANYL TURBOHALER 500 Mcg/Dose Powder for Inhalation
País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Características técnicas
(SPC)
19-04-2024
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Ingredientes ativos:
TERBUTALINE SULFATE
Disponível em:
IMED Healthcare Ltd.
DCI (Denominação Comum Internacional):
TERBUTALINE SULFATE
Dosagem:
500 Mcg/Dose
Forma farmacêutica:
Powder for Inhalation
Tipo de prescrição:
Product subject to prescription which may be renewed (B)
Status de autorização:
Withdrawn
Data de autorização:
2014-05-28
Características técnicas
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:_
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. Consideration should be
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