BRICANYL TURBOHALER Inhalation powder (2023)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Bricanyl Turbohaler, 0.5 mg/dose, inhalation powder.
Qualitative and quantitative composition
<u>Each delivered dose contains:</u> Terbutaline sulfate 0.4 mg (which corresponds to 0.5 mg metered dose). Excipients with known effect: Bricanyl Turbohaler 0.5mg/dose: each delivered dose contains approximately ...
Pharmaceutical form
Inhalation powder. A white inhaler comprising a blue turning grip, an integral dose indicator and a white cover.
Therapeutic indications
Terbutaline is a selective beta<sub>2</sub>-adrenergic agonist recommended for the relief and prevention of bronchospasm in bronchial asthma and other bronchopulmonary disorders in which bronchospasm or ...
Posology and method of administration
Posology Adults and Children One inhalation (0.5 mg) as required. Not more than 4 inhalations should be required in any 24-hour period. The duration of action of a single dose is up to 6 hours. Elderly ...
Contraindications
Hypersensitivity to the active substance (terbutaline) or to any of the excipients listed in section 6.1.
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 ...
Interaction with other medicinal products and other forms of interaction
Beta-blocking agents (including eye drops), especially the non-selective ones such as propranolol, may partially or totally inhibit the effect of beta-stimulants. Therefore, Bricanyl preparations and non-selective ...
Pregnancy and lactation
Pregnancy Although no teratogenic effects have been observed in animals or in patients, Bricanyl should only be administered with caution during the first trimester of pregnancy. Breast-feeding Terbutaline ...
Effects on ability to drive and use machines
Bricanyl Turbohaler has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The frequency of adverse reactions is low at the recommended dose. Terbutaline given by inhalation is unlikely to produce significant systemic effects when given in recommended ...
Overdose
There is a potential for progressive accumulation of dry powder in the mouthpiece of the Bricanyl Turbuhaler that could be released if dropped (for example, from a table) towards the end of inhaler life. ...
Pharmacodynamic properties
<b>Pharmaco-therapeutic group:</b> selective beta<sub>2</sub>-adrenoreceptor agonist, terbutaline <b>ATC code:</b> R03AC03 Terbutaline sulfate is a selective beta<sub>2</sub>-adrenoceptor agonist, thus ...
Pharmacokinetic properties
After inhalation via Turbohaler, the absolute pulmonary bioavailability is about 16% of the delivered dose at a normal inhalation flow rate. Following administration of a single 1.5 mg dose (3 inhalations ...
Preclinical safety data
The major toxic effect of terbutaline, observed in toxicological studies in rats and dogs at exposures in excess of maximum human exposure, is focal myocardial necrosis. This type of cardiotoxicity is ...
List of excipients
Lactose monohydrate (which may contain milk protein residue)
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Bricanyl Turbohaler consists of a number of assembled plastic details, the main parts being the dosing mechanism, the drug substance store, the desiccant store and the mouthpiece. The inhaler is protected ...
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
AstraZeneca UK Limited, 1 Francis Crick Avenue, Cambridge, CB2 0AA, UK
Marketing authorization number(s)
PL 17901/0117
Date of first authorization / renewal of the authorization
Date of first authorisation: 2<sup>nd</sup> November 1987 Date of latest renewal: 12<sup>th</sup> May 2007
Date of revision of the text
4<sup>th</sup> May 2023
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