Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BUDESONIDE
ORION PHARMA (MY) SDN. BHD.
BUDESONIDE
1Units Units; 1Units Units
ORION CORP
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159914-1 1. NAME OF THE MEDICINAL PRODUCT GIONA EASYHALER 100 MCG / DOSE INHALATION POWDER. GIONA EASYHALER 200 MCG / DOSE INHALATION POWDER. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION GIONA EASYHALER 100 microg/dose inhalation powder : One metered dose contains 100 micrograms of budesonide. GIONA EASYHALER 200 microg/dose inhalation powder : One metered dose contains 200 micrograms of budesonide. With the EASYHALER device the delivered dose (ex-actuator) contains the same quantity of active substance as the metered dose (ex-reservoir). Excipient with known effect: Lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder. White or almost white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of mild, moderate and severe asthma. 4.2 DOSAGE AND METHOD OF ADMINISTRATION Method of administration: For inhalation use. For optimum response, GIONA EASYHALER inhalation powder should be used regularly. The therapeutic effect begins after a few days’ treatment and reaches its maximum after some weeks of treatment. When transferring a patient to GIONA EASYHALER from other inhalation devices, the treatment should be individualised. The previous active substance, dose regimen, and method of delivery should be considered. The patients should be prescribed a starting dose of inhaled budesonide which is appropriate for the severity or level of control of their disease. THE STARTING DOSE for adults (including the elderly and children/ adolescents over 12 years of age) with mild asthma (Step 2) and for children 6 to 12 years of age is 200-400 micrograms/day. If needed, the dose can be increased up to 800 micrograms/day. For adult patients with moderate (Step 3) and severe (Step 4) asthma the starting dose can be up to 1600 micrograms/day. The maintenance dose should be adjusted to meet the requirements of an individual patient, taking into account the severity of the disease and the clinical response of the patient. The dose should be adjusted until contro Прочитать полный документ