Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BECLOMETHASONE DIPROPIONATE
Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.
BECLOMETHASONE DIPROPIONATE
1units Units
Glenmark Pharmaceuticals Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 IBICAR 100 _®_ _ _ BECLOMETASONE PRESSURISED INHALATION BP 100 MCG/ACTUATION WHAT IS IN THIS LEAFLET 1. What Ibicar 100 is used for 2. How Ibicar 100 works 3. Before you use Ibicar 100 4. How to use Ibicar 100 5. While you are using it 6. Side Effects 7. Storage and Disposal of Ibicar 100 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT IBICAR 100 IS USED FOR Ibicar 100 contains beclometasone dipropionate, which is one of a group of medicines known as glucocorticoid. Beclometasone Inhaler is used in the prophylactic management of asthma. HOW IBICAR 100 WORKS The anti-inflammatory effect of Beclometasone dipropionate plays an important role in the efficacy of Beclometasone dipropionate in controlling symptoms and improving lung function in asthma. It is a pressurized, metered-dose spray is for oral inhalation use only. Beclometasone inhaler is not indicated for the immediate relief of asthma attacks. BEFORE YOU USE IBICAR 100 _- When you must not use it _ Do not use Ibicar 100 if you are allergic (hypersensitive) to: Beclometasone Dipropionate any of the other ingredients of Do not use Ibicar 100 if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before using Ibicar 100. _- Before you start to use it _ Check with your doctor, nurse or pharmacist before taking your medicine if: you are suffering from active or latent pulmonary tuberculosis. your asthma seems to be getting worse. Perhaps you are more wheezy and short of breath than usual, your ‘reliever’ inhaler seems to be less effective, you require more puffs from your ‘reliever’ inhaler than usual, or you do not seem to be getting better. Your doctor may need to increase the dose of your steroid inhaler or give you a course of steroid tablets, or change your treatment altogether. If you have had an infection in your chest your doctor may prescribe a course of antibiotics. when transferring Prečítajte si celý dokument
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory Beclometasone Pressurised Inhalation BP 100 mcg/actuation 100 SAME SIZE ARTWORK LEAFLET: 225 mm x 270 mm FOLDING SIZE: 38 mm x 135 mm 135 mm 38 mm 25 mm PE00000 MY PANTONE BLACK PROCESS C SUPERSEDES ARTWORK CODE: PANTONE SHADE ICONGRAPHICS CODE: PHARMACODE: GRAIN DIRECTION SPACE FOR PHARMACODE SPACE FOR PHARMACODE SPACE FOR PHARMACODE SPACE FOR PHARMACODE SPACE FOR PHARMACODE SPACE FOR PHARMACODE COMPOSITION BECLOMETASONE PRESURRISED INHALATION BP 100 MCG Each actuation delivers : Beclometasone Dipropionate Anhydrous Ph. Eur 100 µg Ethanol BP 14.0%w/w (20%v/v) DESCRIPTION Clear Solution filled in aluminium aerosol can with silver ferrule valve provided with actuator suitable for oral inhalation, when actuated a metered spray is produced. DOSAGE FORM Inhalation Aerosol PHARMACOLOGY PHARMACODYNAMICS Beclometasone dipropionate is a synthetic glucocorticoid. Glucocorticoids have multiple anti-inflammatory effects inhibiting both inflammatory cells and release of inflammatory mediators. It is presumed that these anti-inflammatory actions play an important role in the efficacy of Beclometasone dipropionate in controlling symptoms and improving lung function in asthma, although the exact mechanism of action of Beclometasone in the lungs is unknown. It is hydrolysed via esterase enzymes to the active metabolite, Beclometasone-17-monopropionate (B-17-MP) which probably acts topically at the site of deposition in the bronchial tree after inhalation. Inhaled Beclometasone at recommended doses reduces systemic exposure compared to oral administration thereby minimizing systemic side effects, including pituitary adrenal suppression. PHARMACOKINETICS When administered via inhalation, Beclometasone dipropionate is hydrolysed in the lungs to the active metabolite, B-17-MP prior to systemic circulation and is further metabolized during its passage through the liver. When administered orally in healthy male volunteers, the bioavailability of Beclo Prečítajte si celý dokument