Țară: Malaezia
Limbă: engleză
Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE
CIPLA MALAYSIA SDN BHD
SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE
60 ACTUATIONS
Cipla Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ SEROFLO CIPHALER SALMETEROL / FLUTICASONE PROPIONATE (50/100, 50/250 MICROGRAMS) ____________________________________________________________________________________ Page | 1 WHAT IS IN THIS LEAFLET 1. What SEROFLO is used for 2. How SEROFLO works 3. Before you use SEROFLO 4. How to use SEROFLO 5. While you are using it 6. Side Effects 7. Storage and Disposal of SEROFLO 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT SEROFLO IS USED FOR The doctor has prescribed this medicine to help with breathing problems in patients who need regular treatment. Asthma is a long-term condition affecting the lungs. Symptoms of asthma include shortness of breath, wheezing, chest tightness and cough. Two main causes of asthma symptoms are bronchoconstriction (tightening of the muscle surrounding the airways) and inflammation (swelling and irritation of the airways). Chronic obstructive pulmonary disease (COPD) is a long-term, progressively worsening condition affecting the lungs, results from chronic bronchitis or emphysema (linings of the air sacs in the lungs damaged beyond repair). HOW SEROFLO WORKS SEROFLO contains two medicines, salmeterol and fluticasone propionate: • Salmeterol is a long-acting bronchodilator. Bronchodilators help the airways in the lungs to stay open. This makes it easier for air to get in and out. The effects last for at least 12 hours • Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs. SEROFLO helps to stop breathlessness and wheeziness coming on. BEFORE YOU USE SEROFLO _ _ _-When you must not use it _ Do not use SEROFLO to relieve a sudden attack of breathlessness or wheezing. If this happens you need to use a fast-acting ‘reliever’ (‘rescue’) inhaler, such as salbutamol. You should always have your fast acting ‘rescue’ inhaler with you. _ _ Do not take SEFOFLO: If you are allergic to salmeterol, fluticasone propionate or to the other ingredient, Citiți documentul complet
_For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only OR for _ _Specialist Use only _ SEROFLO 50 / 100 CIPHALER Salmeterol/Fluticasone Propionate 50 Microgram / 100 Microgram / Dose Inhalation Powder, Pre-Dispensed BP SEROFLO 50 / 250 CIPHALER Salmeterol/Fluticasone Propionate 50 Microgram / 250 Microgram / Dose Inhalation Powder, Pre-Dispensed BP COMPOSITION _ _ SEROFLO 50 / 100 CIPHALER Each single inhalation provides a deliver: Dose (the dose leaving the mouthpiece) of 47 micrograms of salmeterol (as salmeterol Xinafoate BP/Ph. Eur) and 92 micrograms fluticasone propionate BP/Ph. Eur. This corresponds to a pre-dispensed dose of 50 micrograms of salmeterol (as salmeterol Xinafoate BP/Ph. Eur) and 100 micrograms fluticasone propionate BP/Ph. Eur. Also, contains: Lactose Monohydrate. SEROFLO 50 / 250 CIPHALER Each single inhalation provides a deliver: Dose (the dose leaving the mouthpiece) of 47 micrograms of salmeterol (as salmeterol Xinafoate BP/Ph. Eur) and 231 micrograms fluticasone propionate BP/Ph. Eur. This corresponds to a pre-dispensed dose of 50 micrograms of salmeterol (as salmeterol Xinafoate BP/Ph. Eur) and 250 micrograms fluticasone propionate BP/Ph. Eur. Also, contains: Lactose Monohydrate. DOSAGE FORM Pre dispensed inhalation powder PRODUCT DESCRIPTION BULK FINISHED STAGE Salmeterol/Fluticasone Propionate Inhalation powder, pre-dispensed BP, is a white to off white powder filled in a strip of 60 blisters . PACK FINISHED STAGE Device Description Each carton contains a multi-dose device packaged in a moisture protective foil pouch . Multidose device with numeric dose counter displayed on the top of the device containing blister strip inside. PHARMACOLOGY _PHARMACODYNAMICS _ Pharmacotherapeutic Group: Adrenergics in combination with corticosteroids or other drugs, excl. Anticholinergics. ATC Code: R03AK06 Mechanism of action and pharmacodynamic effects: Salmeterol and Fluticasone inhalation powder contains salmeterol and fluticasone propionate which have differing modes Citiți documentul complet