Land: Singapore
Sprog: engelsk
Kilde: HSA (Health Sciences Authority)
FLUTICASONE PROPIONATE (micronised)
GLAXOSMITHKLINE PTE LTD
R03BA05
0.5 mg/2 ml
SOLUTION
FLUTICASONE PROPIONATE (micronised) 0.5 mg/2 ml
RESPIRATORY (INHALATION)
Prescription Only
GLAXOSMITHKLINE AUSTRALIA PTY LTD
ACTIVE
1999-09-14
1 of 10 FLIXOTIDE™ NEBULES™ FLUTICASONE PROPIONATE QUALITATIVE AND QUANTITATIVE COMPOSITION Fluticasone propionate 0.5 mg in 2 ml._ _ _FLIXOTIDE_ _NEBULES_ (plastic ampoules) are intended for nebulisation and contain 0.5 mg of fluticasone propionate (micronised) as a 2 ml buffered isotonic saline suspension. PHARMACEUTICAL FORM Suspension for inhalation by nebulisation. CLINICAL PARTICULARS INDICATIONS ASTHMA _FLIXOTIDE_ has a marked anti-inflammatory effect in the lungs. It reduces symptoms and exacerbations of asthma in patients previously treated with bronchodilators alone or with other prophylactic therapy. Relatively brief symptomatic episodes can generally be relieved by the use of fast-acting bronchodilators, but longer lasting exacerbations require, in addition, the use of corticosteroid therapy as soon as possible, to control the inflammation. • ADULTS AND ADOLESCENTS OVER 16 YEARS OF AGE Prophylactic management in severe asthma (Patients requiring high dose inhaled or oral corticosteroid therapy): On introduction of inhaled _FLIXOTIDE _many patients who are dependent on systemic corticosteroids for adequate control of symptoms may be able to reduce significantly or to eliminate their requirement for oral corticosteroids. • CHILDREN AND ADOLESCENTS FROM 4 TO 16 YEARS OF AGE Treatment of acute exacerbations of asthma: 2 of 10 Subsequent maintenance dosing may be more conveniently accomplished using a pressurised metered-dose inhaler or powder formulation. DOSAGE AND ADMINISTRATION Patients should be made aware of the prophylactic nature of therapy with inhaled _FLIXOTIDE_ and that it should be taken regularly even when they are asymptomatic._ _ _FLIXOTIDE _Nebules should be administered as an aerosol produced by a jet nebuliser, as directed by a physician. As drug Læs hele dokumentet
1 of 11 FLIXOTIDE NEBULES FLUTICASONE PROPIONATE QUALITATIVE AND QUANTITATIVE COMPOSITION Fluticasone propionate 0.5 mg in 2 ml. _ _ _FLIXOTIDE_ _NEBULES_ (plastic ampoules) are intended for nebulisation and contain 0.5 mg of fluticasone propionate (micronised) as a 2 ml buffered isotonic saline suspension. CLINICAL INFORMATION INDICATIONS ASTHMA _FLIXOTIDE_ has a marked anti-inflammatory effect in the lungs. It reduces symptoms and exacerbations of asthma in patients previously treated with bronchodilators alone or with other prophylactic therapy. Relatively brief symptomatic episodes can generally be relieved by the use of fast-acting bronchodilators, but longer lasting exacerbations require, in addition, the use of corticosteroid therapy as soon as possible, to control the inflammation. • ADULTS AND ADOLESCENTS OVER 16 YEARS OF AGE Prophylactic management in severe asthma (Patients requiring high dose inhaled or oral corticosteroid therapy): On introduction of inhaled _FLIXOTIDE _ many patients who are dependent on systemic corticosteroids for adequate control of symptoms may be able to reduce significantly or to eliminate their requirement for oral corticosteroids. • CHILDREN AND ADOLESCENTS FROM 4 TO 16 YEARS OF AGE Treatment of acute exacerbations of asthma: Subsequent maintenance dosing may be more conveniently accomplished using a pressurised metered-dose inhaler or powder formulation. DOSAGE AND ADMINISTRATION Pharmaceutical form: Suspension for inhalation by nebulisation. Patients should be made aware of the prophylactic nature of therapy with inhaled _FLIXOTIDE_ and that it should be taken regularly even when they are asymptomatic. _ _ 2 of 11 _FLIXOTIDE _ Nebules should be administered as an aerosol produced by a jet nebuliser, as directed by a physician. As drug delivery can be affected by a wide range of criteria, please refer to the directions recommended by the manufacturer of the nebuliser equipment. Use of _FLIXOTIDE _ Nebules with ultrasonic nebulisers is not generally recommended. _FLIXOTI Læs hele dokumentet