Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
oseltamivir
Roche Registration GmbH
J05AH02
oseltamivir
Antivirals for systemic use
Influenza, Human
Treatment of influenzaTamiflu is indicated in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.Prevention of influenzaPost-exposure prevention in individuals one year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community.The appropriate use of Tamiflu for prevention of influenza should be determined on a case-by-case basis by the circumstances and the population requiring protection. In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older.Tamiflu is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic-influenza outbreak.Tamiflu is not a substitute for influenza vaccination.The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations. Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations.
Revision: 42
Authorised
2002-06-20
65 B. PACKAGE LEAFLET 66 PACKAGE LEAFLET: INFORMATION FOR THE USER TAMIFLU 30 MG HARD CAPSULES oseltamivir READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT TAMIFLU IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMIFLU 3. HOW TO TAKE TAMIFLU 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TAMIFLU 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT TAMIFLU IS AND WHAT IT IS USED FOR • Tamiflu is used for adults, adolescents, children and infants (including full-term newborn babies) for TREATING FLU ( _influenza_ ). It can be used when you have flu symptoms, and the flu virus is known to be going round in your community. • Tamiflu can also be prescribed for adults, adolescents, children and infants above 1 year of age for PREVENTING FLU, on a case-by-case basis – for instance, if you have been in contact with someone who has flu. • Tamiflu may be prescribed for adults, adolescents, children and infant (including full-term newborn babies) as PREVENTIVE TREATMENT in exceptional circumstances – for example, if there is a global epidemic of flu (a flu _pandemic_ ) and the seasonal flu vaccine may not provide sufficient protection. Tamiflu contains _oseltamivir_ , which belongs to a group of medicines named _neuraminidase inhibitors_ . These medicines prevent the flu virus from spreading inside the body. They help to ease or prevent the symptoms of the flu virus infection. Influenza, usually called flu, is an infection caused by a virus. The signs of flu often includ Lesen Sie das vollständige Dokument
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tamiflu 30 mg hard capsules Tamiflu 45 mg hard capsules Tamiflu 75 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Tamiflu 30 mg hard capsules Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir. For the full list of excipients, see section 6.1. Tamiflu 45 mg hard capsules Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir. For the full list of excipients, see section 6.1. Tamiflu 75 mg hard capsules Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tamiflu 30 mg hard capsules The hard capsule consists of a light yellow opaque body bearing the imprint “ROCHE” and a light yellow opaque cap bearing the imprint “30 mg”. Imprints are blue. Tamiflu 45 mg hard capsules The hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a grey opaque cap bearing the imprint “45 mg”. Imprints are blue. Tamiflu 75 mg hard capsules The hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a light yellow opaque cap bearing the imprint “75 mg”. Imprints are blue. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Treatment of influenza_ Tamiflu is indicated in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms. _Prevention of influenza _ - Post-exposure prevention in individuals 1 year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community. - The appropriate use of Tamiflu for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection. In exceptional situa Lesen Sie das vollständige Dokument