FLIXOTIDE EVOHALER Pressurised inhalation, suspension (2018)
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Περιεχόμενα
Name of the medicinal product
Flixotide 50 micrograms Evohaler. Flixotide 125 micrograms Evohaler. Flixotide 250 micrograms Evohaler.
Qualitative and quantitative composition
Flixotide 50 micrograms Evohaler, Flixotide 125 micrograms Evohaler and Flixotide 250 micrograms Evohaler are pressurised inhalation, suspensions, delivering either 50, 125 or 250 micrograms of fluticasone ...
Pharmaceutical form
Pressurised inhalation, suspension. Flixotide Evohaler does not contain any chlorofluorocarbons (CFCs).
Therapeutic indications
Fluticasone propionate given by inhalation offers prophylactic treatment for asthma. Adults Mild asthma Patients requiring intermittent symptomatic bronchodilator asthma medication on a regular daily basis. ...
Posology and method of administration
Patients should be made aware of the prophylactic nature of therapy with inhaled fluticasone propionate and that it should be taken regularly even when they are asymptomatic. If patients find that relief ...
Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Special warnings and precautions for use
The management of asthma should follow a stepwise programme, and patient response should be monitored clinically and by lung function tests. Patients' inhaler technique should be checked regularly to make ...
Interaction with other medicinal products and other forms of interaction
Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after inhaled dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome ...
Fertility, pregnancy and lactation
Fertility There are no data on human fertility. Animal studies indicate no effects of fluticasone propionate on male or female fertility. Pregnancy There are limited data in pregnant women. Administration ...
Effects on ability to drive and use machines
Fluticasone propionate is unlikely to produce an effect.
Undesirable effects
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), ...
Overdose
Acute Inhalation of the drug in doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not necessitate emergency action being taken. In these patients treatment ...
Pharmacodynamic properties
Fluticasone propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in a reduction of both symptoms and exacerbations of asthma, ...
Pharmacokinetic properties
In healthy subjects the mean systemic bioavailability of Flixotide Evohaler is 28.6%. In patients with asthma (FEV<sub>1</sub> <75% predicted) the mean systemic absolute bioavailability was reduced by ...
Preclinical safety data
Toxicology has shown only those class effects typical of potent corticosteroids, and these only at doses greatly in excess of that proposed for therapeutic use. No novel effects were identified in repeat ...
List of excipients
HFA 134a
Incompatibilities
None reported.
Shelf life
24 months.
Special precautions for storage
Do not store above 30°C (86°F). Do not refrigerate or freeze. Protect from frost and direct sunlight. As with most medicines in pressurised canisters, the therapeutic effect of this medication may decrease ...
Nature and contents of container
An inhaler comprising an aluminium alloy can sealed with a metering valve, actuator and dust cap. Each canister contains 120 metered actuations of either 50, 125 or 250 micrograms of fluticasone propionate. ...
Special precautions for disposal and other handling
The aerosol spray is inhaled through the mouth into the lungs. After shaking the inhaler the patient should exhale, the mouthpiece should be placed in the mouth and the lips closed around it. The actuator ...
Marketing authorization holder
Glaxo Wellcome UK Ltd, trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Marketing authorization number(s)
Flixotide 50 micrograms Evohaler: PL 10949/0324 Flixotide 125 micrograms Evohaler: PL 10949/0265 Flixotide 250 micrograms Evohaler: PL 10949/0266
Date of first authorization / renewal of the authorization
Flixotide Evohaler 50 micrograms: 27 June 2000 Flixotide Evohaler 125/250 micrograms: 14 March 2000
Date of revision of the text
12 December 2018
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