Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
oseltamivir
Actavis Group PTC ehf
J05AH02
oseltamivir
Antivirals for systemic use, Neuraminidase inhibitors
Influenza, Human
Treatment of influenzaIn patients one year of age and older who present with symptoms typical of influenza, when influenza virus is circulating in the community.Ebilfumin is indicated for the treatment of infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2 of the SmPC). The treating physician should take into account the pathogenicity of the circulating strain and the underlying condition of the patient to ensure there is a potential benefit to the child.Prevention of influenzaPost-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 Ebilfumin 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.Ebilfumin is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2 of the SmPC).Ebilfumin is not a substitute for influenza vaccination.
Revision: 15
Authorised
2014-05-22
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE USER EBILFUMIN 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 any 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 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 Ebilfumin is and what it is used for 2. What you need to know before you take Ebilfumin 3. How to take Ebilfumin 4. Possible side effects 5. How to store Ebilfumin 6. Contents of the pack and other information 1. WHAT EBILFUMIN IS AND WHAT IT IS USED FOR • Ebilfumin 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. • Ebilfumin 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. • Ebilfumin may be prescribed for adults, adolescents, children and infants (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. Ebilfumin 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 Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ebilfumin 30 mg hard capsules Ebilfumin 45 mg hard capsules Ebilfumin 75 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ebilfumin 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. Ebilfumin 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. Ebilfumin 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 Ebilfumin 30 mg hard capsules The hard capsule consists of a rich yellow body and cap bearing the black imprint “OS 30”. Capsule size: 4 The capsule contains a white granulated powder. Ebilfumin 45 mg hard capsules The hard capsule consists of a white opaque body and cap bearing the black imprint “OS 45”. Capsule size: 4 The capsule contains a white granulated powder. Ebilfumin 75 mg hard capsules The hard capsule consists of a white opaque body and a rich yellow cap bearing the black imprint “OS 75”. Capsule size: 2 The capsule contains a white granulated powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Treatment of influenza _ Ebilfumin 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_ 3 - 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 Ebilfumin for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protectio Aqra d-dokument sħiħ