Pays: Pays-Bas
Langue: néerlandais
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
OSELTAMIVIRFOSFAAT 39,4 mg/stuk SAMENSTELLING overeenkomend met ; OSELTAMIVIR 30 mg/stuk
Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)
OSELTAMIVIRFOSFAAT 39,4 mg/stuk SAMENSTELLING overeenkomend met ; OSELTAMIVIR 30 mg/stuk
Capsule, hard
AMMONIA (E 527) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT, AMMONIA (E 527) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT
Oraal gebruik
2020-04-22
Oseltamivir hard capsules NL_en_NL-H-4651_del BRS Wessling 202312 PACKAGE LEAFLET: INFORMATION FOR THE USER SEGOSANA 30 MG HARDE 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. Whatis and what it is used for 2. What you need to know before you take Lire le document complet3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR • 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. • 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. • 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. 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 i
Oseltamivir hard capsules NL_en_NL-H-4651_EPAR_2020_09 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Segosana 30 mg harde capsules Segosana 45 mg harde capsules Segosana 75 mg harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION30 mg hard capsules Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir. Lire le document complet45 mg hard capsules Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir. 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 30 mg hard capsules Size “4” hard gelatin capsules with light yellow opaque colour body with black colour band, imprinted with “M” and light yellow opaque colour cap imprinted with “30 mg”. The size is approximately 14.37 mm. 45 mg hard capsules Size “4” hard gelatin capsules with grey opaque colour body with black colour band, imprinted with “M” and grey opaque colour cap imprinted with “45 mg”. The size is approximately 14.37 mm. 75 mg hard capsules Size “2” hard gelatin capsules with grey opaque colour body with black colour band, imprinted with “M” and light yellow opaque colour cap imprinted with “75 mg”. The size is approximately 17.66 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Treatment of influenza _ Oseltamivir 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 oseltamivir for prevention of i