国家: 印度尼西亚
语言: 印度尼西亚文
来源: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
FLUTICASONE PROPIONAT; SALMETEROL XINAFOATE
GLAXO WELLCOME INDONESIA - Indonesia
FLUTICASONE PROPIONAT; SALMETEROL XINAFOATE
25/125 MCG
CAIRAN INHALASI
DUS, CANISTER @ 120 DOSIS DENGAN DOSE COUNTER
GLAXO WELLCOME SA - Spain
2017-01-31
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 阅读完整的文件