Riik: Iisrael
keel: inglise
Allikas: Ministry of Health
ZANAMIVIR MICRONIZED
GLAXO SMITH KLINE (ISRAEL) LTD
J05AH01
POWDER FOR INHALATION
ZANAMIVIR MICRONIZED 5 MG
INHALATION
Required
GLAXO SMITHKLINE TRADING SERVICES LIMITED, IRELAND
ZANAMIVIR
ZANAMIVIR
Zanamivir is indicated for the treatment of both uncomplicated acute illness due to influenza A and B virus in adults and adolescents (> or = 12 years) who have been symptomatic for no more than 48 hours and pediatric patients 7 years and older who have been symptomatic for no more than 36 hours.
2022-02-28
_Page 1 of 14 _ _ _ _The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in March _ _2017_ _ _ RELENZA TM QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-dispensed quantity of inhalation powder (one blister) contains 5 mg zanamivir. Each delivered inhalation (the amount that leaves the mouthpiece of the Diskhaler) contains 4.0 mg zanamivir. Excipients with known effect: Lactose monohydrate (approximately 20 mg which contains milk protein). For the full list of excipients, see section 11. 1 INDICATIONS AND USAGE 1.1 TREATMENT OF INFLUENZA RELENZA is indicated for treatment of both uncomplicated acute illness due to influenza A and B virus in adults and adolescents (> or = 12 years) who have been symptomatic for no more than 48 hours and pediatric patients 7 years and older who have been symptomatic for no more than 36 hours. 1.2 IMPORTANT LIMITATIONS ON USE OF RELENZA RELENZA is not recommended for treatment of influenza in individuals with underlying airways disease (such as asthma or chronic obstructive pulmonary disease) due to risk of serious bronchospasm _[see Warnings and Precautions (5.1)]_ . RELENZA has not been proven effective for treatment of influenza in individuals with underlying airways disease. Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RELENZA. There is no evidence for efficacy of zanamivir in any illness caused by agents other than influenza virus A and B. Patients should be advised that the use of RELENZA for treatment of influenza has not been shown to reduce the risk of transmission of influenza to others. 2 DOSAGE AND ADMINISTRATION 2.1 DOSING CONSIDERATIONS _Page 3 of 14 _ _ _ RELENZA is for admini Lugege kogu dokumenti