Composition
One dose contains:
- fluticasone propionate - 50 μg, or 125 μg, or 250 μg;
- excipients: 1,1,1,2-tetrafluoroethane (does not contain freon).
The detailed information on the ingredients is stated on the package
Packaging
60 or 120 doses in an aluminium can equipped with a plastic dispenser with a protective cap. Each aluminium can equipped with a plastic dispenser with a protective cap, together with the package leaflet is placed in the secondary packing (boxboard package).
Storage conditions
Store in a place protected from light, at the temperature no more than 25 ºС.
Do not freeze.Do not freeze. Keep out of reach of children.
The following is not permitted: to expose the can to direct sunlight; to pinch the can; do not disassemble the can or throw it in fire, even the can is empty.
Indications for use
Prophylactic treatment for bronchial asthma
Adults
Mild asthma: the patients who need in the regular symptomatic treatment with bronchodilators every day.
Moderate asthma: patients with instable asthma or with worsened condition with the existing prophylactic treatment or therapy with bronchodilators only.
Severe asthma: patients with severe chronic asthma and patients dependent on systemic corticosteroids for symptom control. Starting to use the fluticasone propionate inhalations, many such patients will be able to reduce significantly or abandon completely oral corticosteroids.
Children
Because of absence of experience in use of SELEFLU E in pediatric patients, this drug should not be used in the children younger than 16 years.
Pharmacotherapeutic group: glucocorticosteroid for inhalations.
The drug is intended for the inhalation application through mouth only. The patients for whom it is difficult to synchronize breathing with valve actuation, are recommended to use the spacer (the device to facilitate the introduction of inhalation drugs). Patients should be informed that SELEFLU E inhaler should be used for prophylaxis of the disease regularly, even in the period when asthma attacks are absent. The beginning of the therapeutic action is observed in 4-7 days.
The physician should be informed that fluticasone propionate is effective in the dose equal to a half of dose of other inhalation corticosteroids. For example, 100 μg of fluticasone propionate is near equivalent to 200 μg of the dose of beclometasone dipropionate (freon-containing) or budesonide.
The starting dose should correspond to severity of the disease. The dosage should be lowered to the minimum effective dose enabling the effective control over the disease.
Adults and children over 16 years: 125-1000 μg twice a day, usually 2 inhalations 2 times a day.
Because of the risk of appearance of systemic effects, doses over 500 μg daily may be prescribed only to adult patients with severe asthma, when improvement of of lung functions and/or control of symptoms or reduction of use of oral corticosteroids are expected.
Typical starting dose
For the patients with mild persistent asthma, the typical starting dose is 125 μg twice a day. For moderate or severe persistent asthma, the starting dose may be 250 to 500 μg twice a day. If necessary, the doses of 1000 μg twice a day may be prescribed. Such doses may be prescribed only by the medical professional for asthmatic patients.
Children younger than 16 years: Because of absence of clinical trials with such category of patients, do not use SELEFLU E in children younger than 16 years.
Special patient populations
The dose adjustment is not required for elderly patients or patients with renal or hepatic failure.
