البلد: أندونيسيا
اللغة: الإندونيسية
المصدر: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE
GLAXO WELLCOME INDONESIA - Indonesia
FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE
500 MCG /72.5 Mcg
SERBUK INHALER
DUS, 1 DISKUS @ 60 DOSIS
Glaxo Wellcome Production - Evreux - France
2021-04-22
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 اقرأ الوثيقة كاملة