Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BUDESONIDE
AVERROES PHARMACEUTICALS SDN. BHD.
BUDESONIDE
20 x 2 mL
Genetic S.p.A.
TALGAN NEBULIZER SUSPENSION Budesonide (0.25 mg/ml, 0.5 mg/ml) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Talgan is used for 2. How Talgan _ _ works 3. Before you use Talgan 4. How to use Talgan 5. While you are using it 6. Side effects 7. Storage and Disposal of Talgan 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT TALGAN_ _IS USED FOR Talgan is used for the treatment of asthma. HOW TALGAN WORKS Talgan contains a medicine called budesonide. This belongs to a group of medicines called corticosteroids. It works by reducing and preventing swelling and inflammation in the airways caused by asthma. BEFORE YOU USE TALGAN _When you must not use it _ _ _ In case of allergy or hypersensitivity to the Budesonide or to any of the other ingredients of Talgan. _Pregnancy and lactation _ Do not take Talgan if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take Talgan if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. _ _ _ _ - _Before you start use it _ _ _ Tell your doctor or pharmacist if: • You have a lung infection. • You have a cold or chest infection. • You have liver problems. - _Taking other medicines _ _ _ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. This is because Talgan can affect the way some medicines work and some medicines can have an effect on Talgan. In particular, tell your doctor or pharmacist if you are taking any of the following medicines: • Steroid medicines. • Medicines to treat fungal infections (such as itraconazole and ketoconazole). HOW TO USE TALGAN • Always use Talgan exactly as your doctor, nurse or pharmacist has told you. Ask one of them for advice if you are not sure. • The solution in a single dose unit must be put into a nebuliser and made into a fine mist before it can be breathed in. It is then inhal Baca dokumen lengkap
TALGAN NEBULIZER SUSPENSION 0.5 MG/2ML TALGAN NEBULIZER SUSPENSION 1 MG/2ML Budesonide DESCRIPTION _Talgan Nebulizer suspension 0.5 mg/2ml _ Preparation for inhalation in form of inhalation solution. Sterile nebuliser suspension. White to off- white suspension in plastic single dose units. _Talgan Nebulizer suspension 1 mg/2ml _ Preparation for inhalation in form of inhalation solution. Sterile nebuliser suspension. White to off- white suspension in plastic single dose units. COMPOSITION _Talgan Nebulizer suspension 0.5 mg/2ml _ Each ml nebuliser suspension contains 0.25mg of Budesonide. _Talgan Nebulizer suspension 1 mg/2ml _ Each ml nebuliser suspension contains 0.50mg of Budesonide. PHARMACODYNAMICS Budesonide is a glucocorticosteroid which possesses a high local anti-inflammatory action, with a lower incidence and severity of adverse effects than those seen with oral corticosteroids. The precise mechanism of action of glucocorticosteroids in the treatment of asthma is not fully understood. Anti-inflammatory effects (including T-cells, eosinophilic cells and mast cells) such as inhibition of the release of inflammatory mediators and inhibition of cytokine-mediated immune response, are probably important. The strength of budesonide, measured as affinity for glucocorticoid receptors, is approximately 15 times stronger than that of prednisolone. Glucocorticoids reduce airway inflammation and thus reduce airway hyper-responsiveness to a variety of stimuli, as well as to effectively prevent exercise-induced asthma. Regular treatment with glucocorticoids improves lung function, reduces the number of acute exacerbations and reduces surrogate markers of airway inflammation including decreased eosinophils in sputum and decreased exhaled NO. The most important aspect of inhaled glucocorticoids is that they exert their effects locally and have much reduced systemic exposure thus reducing side effects substantially. Following inhalation the proportion of drug absorbed and which together with the swallowed fraction could r Baca dokumen lengkap