SERETIDE 125

Land: Indonesia

Språk: indonesisk

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

Aktiv ingrediens:

SALMETEROL XINAFOATE, FLUTICASONE PROPIONAT

Tilgjengelig fra:

GLAXO WELLCOME INDONESIA - Indonesia

INN (International Name):

SALMETEROL XINAFOATE, FLUTICASONE PROPIONAT

Dosering :

25 MCG /125 MCG

Legemiddelform:

CAIRAN INHALASI

Enheter i pakken:

DUS, 1 CANISTER @ 120 DOSIS DENGAN DOSE COUNTER

Autorisasjon dato:

2021-09-21

Preparatomtale

BF_leSERInh_GDS35IPI19_circ1_18Feb19
ERS_leSERInh_GDS35IPI19_circ2_2Jul2018
Page 1 of 11
SERETIDE INHALER
Salmeterol xinafoate
Fluticasone propionate
1. NAME OF THE MEDICINAL PRODUCT
_SERETIDE_ Inhaler
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single actuation of _SERETIDE_ provides:
Salmeterol xinafoate equivalent to 25 micrograms of salmeterol and 50
or 125 micrograms of
fluticasone propionate.
3.
PHARMACEUTICAL FORM
Inhalation aerosol.
4.
CLINICAL PARTICULARS
4.1 INDICATIONS
ASTHMA (REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE)
_SERETIDE_ is indicated in the regular treatment of asthma (Reversible
Obstructive Airways
Disease).
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_ Inhaler is for inhalation only.
Patients should be made aware that _SERETIDE_ Inhaler 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 maintained.
Where the control of symptoms is maintained with twice daily
_SERETIDE_, titration to the lowest
effective dose could include _SERETIDE_ given once daily.
Patients should be given the strength of _ SERETIDE_ containing the
appropriate fluticasone
propionate dosage for the severity of their disease.
If a patient is inadequately controlled on inhaled corticosteroid
therapy alone, substitution with
_SERETIDE_ at a therapeutically equivalent cortic