Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
BUDESONIDE
ASTRAZENECA INDONESIA - Indonesia
BUDESONIDE
0.5 Mg
CAIRAN INHALASI
DUS, 4 PAK @ 5 RESPULES @ 2 ML
ASTRAZENECA AB - Sweden
2021-01-27
Pulmicort Product Information (budesonide for inhalation), sterile 1 (15) PULMICORT (budesonide for oral inhalation) Sterile PRODUCT INFORMATION QUALITATIVE & QUANTITATIVE COMPOSITION One single dose unit contains 0.5 mg or 1.0 mg budesonide per 2 mL. For excipients, see section LIST OF EXCIPIENTS. PHARMACEUTICAL FORM Sterile nebuliser suspension. White to off-white suspension in plastic single dose units. NAME OF THE DRUG The active ingredient, budesonide, is a non-halogenated glucocorticoid structurally related to 16α hydroxyprednisolone. The chemical name is 16α, 17α - 22R, S-propylmethylenedioxy-pregna-1, 4-diene-11β, 21-diol-3, 20-dione; MW 430.5. CAS Number: 51333-22-3 DESCRIPTION Budesonide is a white to off-white powder, freely soluble in chloroform, sparingly soluble in ethanol and practically insoluble in water and heptane. Budesonide melts with decomposition between 224°C and 231.5°C. PULMICORT RESPULES nebulising suspension for inhalation is a white to off-white suspension in plastic single dose units. PULMICORT RESPULES contain budesonide 0.5 mg/2 mL or 1.0 mg/2 mL as the active ingredient plus, disodium edetate, sodium chloride, polysorbate 80 (E433) citric acid – anhydrous (E330), sodium citrate (E331) and water for injections. PHARMACOLOGY Pharmacotherapeutic group: Inhalation drugs for obstructive airway diseases. ATC-code R03B A02 PULMICORT is a corticosteroid for inhalation use in the treatment and prophylaxis of asthma. Studies in animals and humans have shown an advantageous ratio between topical anti-inflammatory activity and systemic glucocorticoid effect over a wide dose range. This is explained by the extensive first pass hepatic degradation of budesonide after systemic DISETUJUI OLEH BPOM: 21/11/2022 ID: EREG10042212000107 EREG10042212000108 Pulmicort Product Information (budesonide for inhalation), sterile 2 (15) absorption, approximately 85 – 90%, in combination with the low potency of formed metabolites. Budesonide is approximately twice as potent as beclomet Baca dokumen lengkapnya