FLIXOTIDE EVOHALER 125 mcg

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

FLUTICASONE PROPIONATE

Disponible desde:

GLAXOSMITHKLINE PTE LTD

Código ATC:

R03BA05

Dosis:

125 mcg

formulario farmacéutico:

AEROSOL, SPRAY

Composición:

FLUTICASONE PROPIONATE 125 mcg

Vía de administración:

RESPIRATORY (INHALATION)

tipo de receta:

Prescription Only

Fabricado por:

GLAXO WELLCOME PRODUCTION

Estado de Autorización:

ACTIVE

Fecha de autorización:

2000-07-12

Información para el usuario

 
1 of 13 
FLIXOTIDE™ EVOHALER™  
FLUTICASONE PROPIONATE 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Fluticasone propionate 50, 125 and 250 micrograms. 
_FLIXOTIDE_ 50 Evohaler, 125 Evohaler and 250
Evohaler are pressurised metered-dose 
inhalers which deliver 50 micrograms, 125 micrograms and
250 micrograms of 
fluticasone propionate per actuation into
the mouthpiece of a specially designed actuator.  
PHARMACEUTICAL FORM 
Pressurised metered-dose aerosol. 
Each canister of _FLIXOTIDE_ 50 Evohaler supplies 120
actuations. 
Each canister of _FLIXOTIDE_ 125 Evohaler and 250
Evohaler supplies 60 or 120 
actuations. 
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 
bronchodilator alone or with other prophylactic therapy. 
Severe asthma requires regular medical assessment as death
may occur.  Patients with 
severe asthma have constant symptoms and frequent exacerbations,
with limited physical 
capacity, and PEF values below 60% predicted at baseline with
greater than 30% 
variability, usually not returning entirely to
normal after a bronchodilator. These patients 
will require high dose inhaled (_see Dosage and
Administration_) or oral corticosteroid 
therapy.  Sudden worsening of symptoms may require increased
corticosteroid dosage 
which should be administered under urgent medical supervision. 
•  ADULTS 
Prophylactic management in: 

2 of 13 
-  Mild asthma (PEF values greater than 80% predicted
at baseline with less than 20% 
variability):
Patients requiring intermittent symptomatic bronchodilator asthma 
medication on more than an occasional basis. 
-  Moderate asthma (PEF values 60-80% predicted
at baseline with 20-30% variability): 
Patients requiring regular asthma medication and patients wi

Ficha técnica

62000000084645
FLIXOTIDE EVOHALER
FLUTICASONE PROPIONATE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluticasone propionate 50, 125 and 250 micrograms.
_FLIXOTIDE_ 50 Evohaler, 125 Evohaler and 250 Evohaler are pressurised
metered-dose inhalers which deliver 50 micrograms,
125 micrograms and 250 micrograms of fluticasone propionate per
actuation into the mouthpiece of a specially designed actuator.
Each canister of _FLIXOTIDE_ 50 Evohaler supplies 120 actuations.
Each canister of _FLIXOTIDE_ 125 Evohaler and 250 Evohaler supplies 60
or 120 actuations.
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 bronchodilator alone or with other prophylactic
therapy.
Severe asthma requires regular medical assessment as death may occur.
Patients with severe asthma have constant symptoms and
frequent exacerbations, with limited physical capacity, and PEF values
below 60% predicted at baseline with greater than 30%
variability, usually not returning entirely to normal after a
bronchodilator. These patients will require high dose inhaled (_see
Dosage _
_and Administration_) or oral corticosteroid therapy. Sudden worsening
of symptoms may require increased corticosteroid dosage which
should be administered under urgent medical supervision.
•
ADULTS
Prophylactic management in:
-
Mild asthma (PEF values greater than 80% predicted at baseline with
less than 20% variability): Patients requiring intermittent
symptomatic bronchodilator asthma medication on more than an
occasional basis.
-
Moderate asthma (PEF values 60-80% predicted at baseline with 20-30%
variability): Patients requiring regular asthma medication
and patients with unstable or worsening asthma on currently available
prophylactic therapy or bronchodilator alone.
-
Severe asthma (PEF values less than 60% predicted at baseline with
greater than 30% variability): Patients with severe chronic
asthma. On introduction of inhaled _FLIXOTIDE,