Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ZANAMIVIR
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
ZANAMIVIR
5Units Units
GLAXOSMITHKLINE AUSTRALIA PTY LTD
1 RELENZA ROTADISK Zanamivir (5 mg) _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ WHAT IS IN THIS LEAFLET 1. What RELENZA is used for 2. How RELENZA works 3. Before you use RELENZA 4. How to use RELENZA 5. While you are using it 6. Side Effects 7. Storage and Disposal of RELENZA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT RELENZA IS USED FOR Relenza is used to treat flu ( _influenza virus infection_ ). It reduces the symptoms of flu, and helps you recover more quickly. Relenza is also used to help prevent you from getting flu, during a flu outbreak. HOW RELENZA WORKS Relenza contains zanamivir, which belongs to a group of medicines called antivirals. Relenza is not a substitute for flu vaccination. You still need to talk to your doctor about whether you need to be vaccinated against flu. Adults and children aged 5 years or more can be treated with Relenza. BEFORE YOU USE RELENZA - _When you must not use it _ _ _ Do not take Relenza if: • if you are allergic (hypersensitive) to zanamivir or any other ingredients of Relenza If you think this applies to you, don’t use Relenza until you have checked with your doctor. Relenza contains lactose and milk proteins. If you have a severe intolerance to lactose or any other sugars, or to milk protein, check with your doctor that Relenza is suitable for you. - _Before you start to use it _ Your doctor needs to know if you have: • asthma • any other lung disease that causes breathing problems (for example emphysema, COPD or chronic bronchitis). Tell your doctor before you use Relenza, so that he or she can supervise you more closely to check that your condition is being controlled. Using Relenza with inhaled medication for breathing problems • If you use inhaled medication for asthma or any other breathing problem, carry on using your inhaler(s) at the usual times. • If you have been advised to use Relenza at the same time of day as your other inhaled medication, use the other medication a few minutes be Lue koko asiakirja
CONFIDENTIAL _____________________________________________________________________________________ [GSK logo] RELENZA Zanamivir QUALITATIVE AND QUANTITATIVE COMPOSITION Each _RELENZA ROTADISK_ consists of four regularly spaced double foil blisters each containing a white to off-white micronised powder mixture of zanamivir (5 mg) and lactose (20 mg). PHARMACEUTICAL FORM Inhalation powder. CLINICAL PARTICULARS INDICATIONS TREATMENT OF INFLUENZA:_RELENZA_ is indicated for treatment of both influenza A and B in adults and children (5 years and older). PROPHYLAXIS: _RELENZA_ is indicated for prophylaxis of both influenza A and B in adults and children ( 5 years and older). Vaccination remains the primary method of preventing and controlling influenza. _RELENZA_ is indicated for prophylaxis of influenza A and B during community outbreaks only in circumstances where such prophylaxis is justified (such as when vaccine that antigenically matches circulating influenza is not available or there is a pandemic). It is not recommended for routine prophylaxis against influenza infection. DOSAGE AND ADMINISTRATION _RELENZA_ is for administration to the respiratory tract by oral inhalation only, using the _DISKHALER_ device provided. Patients scheduled to take inhaled drugs, e.g. fast acting bronchodilators, at the same time as _RELENZA_ should be advised to administer that drug prior to administration of _RELENZA_. • _Adults _ TREATMENT OF INFLUENZA The recommended dose of _RELENZA_ is two inhalations (2 x 5 mg) twice daily for five days, providing a total daily inhaled dose of 20mg. For maximum benefit, treatment should begin as soon as possible (preferably within two days) after onset of symptoms. PROPHYLAXIS OF INFLUENZA The recommended dose of _RELENZA_ is two inhalations (2 x 5 mg) once daily for 10 days, providing a total daily inhaled dose of 10 mg. This may be increased up to 28 days if the period of exposure risk extends beyond 10 days. The full course of prophylaxis therapy should be completed as prescribed. CONFIDEN Lue koko asiakirja