BRICANYL Tablet (2022)
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Περιεχόμενα
Name of the medicinal product
Bricanyl Tablets 5mg.
Qualitative and quantitative composition
Each tablet contains 5mg terbutaline sulfate. Excipient(s) with known effect: Each Bricanyl Tablet contains 104 mg lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. Off white, circular, biconvex tablet, engraved A/BT and scored on one side, symbol 5 on the reverse.
Therapeutic indications
<u>For bronchodilation:</u> 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 ...
Posology and method of administration
Posology When used as maintenance therapy the patient should also receive optimal anti-inflammatory therapy, e.g. inhaled corticosteroids, leukotriene receptor antagonists. Bricanyl Tablets have a duration ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
As for all beta<sub>2</sub>-agonists caution should be observed in patients with thyrotoxicosis. Cardiovascular effects may be seen with sympathomimetic drugs, including Bricanyl. There is some evidence ...
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. Maintenance treatment ...
Effects on ability to drive and use machines
Bricanyl Tablets has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of safety profile The intensity of the adverse reactions depends on dosage and route of administration. Most of the adverse reactions are characteristic of sympathomimetic amines. The majority ...
Overdose
Possible symptoms and signs Headache, anxiety, tremor, nausea, tonic cramp, palpitations, tachycardia, arrhythmia. A fall in blood pressure sometimes occurs. Laboratory findings: hypokalaemia, hyperglycaemia ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> selective beta<sub>2</sub>-agonist, terbutaline <b>ATC code:</b> R03CC03 Terbutaline is a selective beta<sub>2</sub>-adrenergic stimulant having the following pharmacological ...
Pharmacokinetic properties
Basic parameters have been evaluated in man after i.v and oral administration of therapeutic doses, e.g. <u>i.v single dose:</u> Volume distribution (vss): 114 L Total body clearance (cl): 213 ml/min ...
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 Maize starch Povidone Microcrystalline cellulose Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
36 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Glass bottles and Securitainers of 100 and 500 tablets. Not all pack sizes may be marketed.
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 17901/0116
Date of first authorization / renewal of the authorization
Date of first authorisation: 28<sup>th</sup> May 2002 Date of latest renewal: 15<sup>th</sup> May 2007
Date of revision of the text
9<sup>th</sup> November 2022
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