SERETIDE DISKUS 250

Country: Ինդոնեզիա

language: ինդոնեզերեն

source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

active_ingredient:

FLUTICASONE PROPIONAT; SALMETEROL XINAFOATE

MAH:

GLAXO WELLCOME INDONESIA - Indonesia

INN:

FLUTICASONE PROPIONAT; SALMETEROL XINAFOATE

dosage:

50/250 MCG

pharmaceutical_form:

SERBUK INHALER

units_in_package:

DUS, STRIP @ 60 BLISTER DOSIS

manufactured_by:

GLAXO SMITHKLINE LLC., ZEBULON - USA

authorization_date:

2017-05-06

SPC

SERETIDE DISKUS
SALMETEROL XINAFOATE
FLUTICASONE PROPIONATE
1. NAME OF THE MEDICINAL PRODUCT
_SERETIDE_ Diskus
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Moulded plastic device containing a foil strip with 60 regularly
placed blisters each containing 50 micrograms
of salmeterol as salmeterol xinafoate and 100 micrograms of
fluticasone propionate.
Moulded plastic device containing a foil strip with 60 regularly
placed blisters each containing 50 micrograms
of salmeterol as salmeterol xinafoate and 250 micrograms of
fluticasone propionate.
Moulded plastic device containing a foil strip with 60 regularly
placed blisters each containing 50 micrograms
of salmeterol as salmeterol xinafoate and 500 micrograms of
fluticasone propionate.
3. PHARMACEUTICAL FORM
Inhalation powder.
4. CLINICAL PARTICULARS
4.1 INDICATIONS
ASTHMA (REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE)
_SERETIDE_ is indicated in the regular treatment of reversible
obstructive airways disease (ROAD), including
asthma in children and adults, where use of a combination
(bronchodilator and inhaled corticosteroid) is
appropriate.
This may include:
Patients on effective maintenance doses of long-acting beta-agonists
and inhaled corticosteroids.
Patients who are symptomatic on current inhaled corticosteroid
therapy.
Patients on regular bronchodilator therapy who require inhaled
corticosteroids.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
_SERETIDE_ is indicated for the regular treatment of chronic
obstructive pulmonary disease (COPD) including
chronic bronchitis and emphysema.
4.2 DOSAGE AND ADMINISTRATION
_SERETIDE_ Diskus is for inhalation only.
Patients should be made aware that _SERETIDE_ Diskus must be used
regularly for optimum benefit, even
when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of _ SERETIDE_ they are receiving
remains optimal and is only changed on medical advice.
ASTHMA (REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE)
The dose should be titrated to the lowest dose at which effective
control of symptoms is mai