BUDESONIDE Nebuliser Suspension (2017)
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Περιεχόμενα
Name of the medicinal product
Budesonide 0.5mg Nebuliser Suspension.
Qualitative and quantitative composition
One ml of suspension contains 0.25mg budesonide. One ampoule of 2ml suspension contains 0.5mg budesonide. For the full list of excipients, see section 6.1.
Pharmaceutical form
Nebuliser suspension. White to off-white suspension.
Therapeutic indications
Treatment of persistent bronchial asthma in patients where use of a pressurised inhaler or dry powder formulation is unsatisfactory or inappropriate. Very serious pseudocroup (laryngitis subglottica) in ...
Posology and method of administration
Posology Asthma The dose should be given twice daily. Administration once daily may be considered in cases of mild to moderate stable asthma. Initial dosage The initial dose should be tailored to the severity ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Budesonide is not indicated for the treatment of acute dyspnoea or status asthmaticus. These conditions should be treated with short acting β-sympathomimetics and other bronchodilators. The transfer of ...
Interaction with other medicinal products and other forms of interaction
Budesonide Nebuliser Suspension can increase the efficacy of inhaled beta-2-sympathomimetics. Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk ...
Pregnancy and lactation
Pregnancy Most results from prospective epidemiological studies and world-wide post-marketing data have not been able to detect an increased risk for adverse effects for the foetus and newborn child from ...
Effects on ability to drive and use machines
Inhaled budesonide has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Tabulated list of adverse reactions The following definitions apply to the incidence of undesirable effects: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 ...
Overdose
Symptoms Acute overdose with budesonide usually does not constitute a clinical problem. The only harmful effect after a large amount of sprays during a short period is a suppression of the cortex function. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other drugs for obstructive airways diseases, inhalant, Glucocorticoids ATC code: R03 BA 02 Budesonide is a glucocorticosteroid with a powerful local anti-inflammatory action. ...
Pharmacokinetic properties
Absorption In adults the systemic availability of budesonide following administration of Budesonide Nebuliser Suspension via a jet nebuliser is approximately 15% of the nominal dose and 40% to 70% of the ...
Preclinical safety data
Preclinical data revealed no special hazard for humans in the therapeutic dose range based on studies of chronic toxicity, genotoxicity and carcinogenicity. Glucocorticoids, including budesonide, have ...
List of excipients
Disodium edetate Sodium chloride Polysorbate 80 Citric acid Sodium citrate Water for injection
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life: 3 years. After first opening of the foil sachet, the ampoule may be stored unopened for three months. Use ampoule within 12 hours of opening.
Special precautions for storage
Store in the original package in order to protect from light and moisture.
Nature and contents of container
Low density polyethylene ampoule containing 2ml nebuliser suspension. Pack sizes: Tri-laminate foil sachets containing 5, 20, 24, 40 (2 20) and 60 ampoules (in strips of 4, 5, 8, 10 or 12 ampoules). ...
Special precautions for disposal and other handling
Budesonide nebuliser suspension can be mixed with 0.9% saline and with solutions of terbutaline, salbutamol, sodium chromoglycate, or ipratropium bromide. For single use only. Any unused solution should ...
Marketing authorization holder
Breath Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom
Marketing authorization number(s)
PL: 18023/0007
Date of first authorization / renewal of the authorization
26-10-2005 / 24-02-2009
Date of revision of the text
16.09.2017
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