Страна: Сингапур
Язык: английский
Источник: HSA (Health Sciences Authority)
BUDESONIDE
ORION PHARMA (SG) PTE. LTD.
R03BA02
200 mcg/dose
POWDER, METERED
BUDESONIDE 200 mcg/dose
RESPIRATORY (INHALATION)
Prescription Only
ORION CORPORATION
ACTIVE
2004-12-06
1. NAME OF THE MEDICINAL PRODUCT Giona Easyhaler 100 micrograms/dose inhalation powder. Giona Easyhaler 200 micrograms/dose inhalation powder. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Giona Easyhaler 100 micrograms/dose inhalation powder : One metered dose contains 100 micrograms of budesonide. Giona Easyhaler 200 micrograms/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 Bronchial asthma requiring maintenance treatment with glucocorticoids for control of underlying airway inflammation. (Note: Giona Easyhaler is not suitable for the treatment of acute asthma attacks.) 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 with mild asthma (Step 2) 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 and the dose for periods of severe asiluua can be up to 1600 micrograms/day. For children _5 _ —7 years old, the starting dose and the dose for periods of severe asthma is 200 — 400 mcg daily. For Прочитать полный документ
REVISED PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT Giona Easyhaler™ 100 micrograms/dose inhalation powder. Giona Easyhaler™ 200 micrograms/dose inhalation powder. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Giona Easyhaler™ 100 micrograms/dose inhalation powder : One metered dose contains 100 micrograms of budesonide. Giona Easyhaler™ 200 micrograms/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 Bronchial asthma requiring maintenance treatment with glucocorticoids for control of underlying airway inflammation. (Note: Giona Easyhaler is not suitable for the treatment of acute asthma attacks.) 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 with mild asthma (Step 2) 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 and the dose for periods of severe asiluua can be up to 1600 micrograms/day. For children _5 _ —7 years old, the starting dose and the dose for periods of sev Прочитать полный документ