Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ANHYDROUS BECLOMETHASONE DIPROPIONATE
BIOCARE MANUFACTURING SDN. BHD.
ANHYDROUS BECLOMETHASONE DIPROPIONATE
1 Units
BIOCARE MANUFACTURING SDN. BHD.
BIOSONE ® 100 MCG/DOSE HFA INHALATION AEROSOL Beclometasone dipropionate 100 mcg/dose Page 1 of 3 _Consumer Medication Information Leaflet (RiMUP) _ WHAT IS IN THIS LEAFLET 1. What Biosone® 100 mcg/dose HFA Inhalation Aerosol is used for 2. How Biosone®100 mcg/dose HFA Inhalation Aerosol works 3. Before you use Biosone® 100 mcg/dose HFA Inhalation Aerosol 4. How to use Biosone® 100 mcg/dose HFA Inhalation Aerosol 5. While you are using Biosone® 100 mcg/dose HFA Inhalation Aerosol 6. Side effects 7. Storage and disposal of Biosone® 100 mcg/dose HFA Inhalation Aerosol 8. Product description 9. Manufacturer and Product registration holder 10. Date of revision WHAT BIOSONE® 100 MCG/DOSE HFA INHALATION AEROSOL IS USED FOR The active component of Biosone® 100 mcg/dose HFA Inhalation Aerosol is Beclometasone Dipropionate, which is an anti-inflammatory corticosteroid. It helps to prevent asthma in people who need regular treatment. This is why it is sometimes called ‘preventer’. HOW BIOSONE® 100 MCG/DOSE HFA INHALATION AEROSOL WORKS Biosone® 100 mcg/dose HFA Inhalation Aerosol works by reducing swelling and irritation in the lungs. It is a pressurized, metered-dose aerosol intended for oral inhalation only. It is an environment friendly inhaler. BEFORE YOU USE BIOSONE® 100 MCG/DOSE HFA INHALATION AEROSOL Some medicines may increase the effects of Biosone® 100 mcg/dose HFA Inhalation Aerosol and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV such as cobicistat). _ _ _ _ _ _ _ _ _-When you must not use it _ Do not take Biosone® 100 mcg/dose HFA Inhalation Aerosol if you are allergic (hypersensitive) to: _ _ • Beclometasone Dipropionate _ _ • Lactose or milk protein _ _ • Any of the other ingredients of Biosone® 100 mcg/dose HFA Inhalation Aerosol. _ _ • Do not use Biosone® 100 mcg/dose HFA Inhalation Aerosol if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before using Biosone® 100 Baca dokumen lengkap
TM TM TM DESCRIPTION: Biosone HFA is a bulk preparation for inhalation, supplied in a pressurised container. On visual examination, the pressurised container has no sign of physical damage or leakage. The product is a clear solution. INDICATION: Indicated for the prophylactic management of mild, moderate or severe asthma. PHARMACODYNAMICS : The active ingredient of Biosone 100 HFA Inhaler is Beclometasone Dipropionate (BDP) (ATC-Code R03 BA01) a topical corticosteroid endowed with potent anti-inflammatory and anti-allergic activity on the airways mucosa. Beclometasone dipropionate, administered by inhalation and in recommended doses, has a glucocorticoid anti-inflammatory action within the lungs but no systemic effect. PHARMACOKINETICS: Absorption when administered via inhalation by a MDI: Systemic absorption of unchanged beclometasone dipropionate (BDP) occurs through the lungs. There is negligible oral absorption of the swallowed dose of unchanged BD. Prior to absorption there is extensive conversion of BDP to its active metabolite B-17-MP. The systemic absorption of B-17-MP arises from both lung deposition (36%) and oral absorption of the swallowed dose (26%).The absolute bioavailability following inhalation is approximately 2% and 62% of the nominal dose for unchanged BDP and B-17-MP, respectively. BDP is absorbed rapidly with peak plasma concentrations observed (tmax) at 0.3 hour. B-17-MP appears more slowly with a tmax of 1 hour. There is an approximately linear increase in systemic exposure with increasing inhaled dose. When administered orally the bioavailability of BDP is negligible but presystemic conversion to B-17-MP results in 41% of the dose being absorbed as B-17-MP. Distribution: The tissue distribution at steady-state for BDP is moderate (20 L) but more extensive for B-17-MP (424 L). Plasma protein binding is moderately high (87%). Biotransformation: BDP is cleared very rapidly from the systemic circulation, by metabolism mediated via esterase enzymes that are found in most tissues. The main Baca dokumen lengkap