Den europeiske union - engelsk - EMA (European Medicines Agency)

schering-plough europe - interferon alfa-2b - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - chronic hepatitis b: treatment of adult patients with chronic hepatitis b associated with evidence of hepatitis b viral replication (presence of hbv-dna and hbeag), elevated alanine aminotransferase (alt) and histologically proven active liver inflammation and/or fibrosis.chronic hepatitis c:adult patients:introna is indicated for the treatment of adult patients with chronic hepatitis c who have elevated transaminases without liver decompensation and who are positive for serum hcv-rna or anti-hcv (see section 4.4).the best way to use introna in this indication is in combination with ribavirin.chidren and adolescents:introna is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis c, not previously treated, without liver decompensation, and who are positive for serum hcv-rna. the decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, hcv genotype and viral load. the expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).

Den europeiske union - fransk - EMA (European Medicines Agency)

schering-plough europe - interféron alfa-2b - hepatitis c, chronic; hepatitis b, chronic - les immunostimulants, - hépatite b chronique: le traitement de patients adultes atteints d'hépatite b chronique associée à des éléments de preuve de l'hépatite b de la réplication virale (présence de l'adn du vhb et de l'aghbe), élévation de l'alanine aminotransférase (alt) et histologiquement prouvé, une inflammation hépatique active et/ou une fibrose. la chronique de l'hépatite c:les patients adultes:introna est indiqué pour le traitement des patients adultes atteints d'hépatite c chronique, qui ont des taux élevés de transaminases sans décompensation hépatique et qui sont positifs pour sérique d'arn du vhc ou anti-vhc (voir la section 4. la meilleure façon d'utiliser introna dans cette indication est en association avec la ribavirine. enfants et adolescents:introna est prévu pour une utilisation dans un traitement combinaison avec la ribavirine, pour le traitement des enfants et des adolescents de 3 ans et plus, qui ont une hépatite c chronique, non préalablement traités, sans décompensation hépatique, et qui sont positifs pour sérique d'arn du vhc. la décision de traiter doit être faite au cas par cas, en tenant compte de toute la preuve de la progression de la maladie tels que l'inflammation et la fibrose hépatique, ainsi que les facteurs pronostiques de réponse, le vhc de génotype et de la charge virale. le bénéfice attendu du traitement doit être pesé à l'encontre de la sécurité des résultats observés pour les sujets pédiatriques dans les essais cliniques (voir les sections 4. 4, 4. 8 et 5.

Den europeiske union - tysk - EMA (European Medicines Agency)

schering-plough europe - interferon alfa-2b - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - chronische hepatitis b: behandlung von erwachsenen patienten mit chronischer hepatitis b assoziiert mit dem nachweis des hepatitis-b virale replikation (vorhandensein von hbv-dna und hbeag), erhöhte alanin-aminotransferase (alt) und histologisch nachgewiesene aktive leberentzündung und/oder fibrose. chronische hepatitis c:bei erwachsenen patienten:introna ist indiziert für die behandlung von erwachsenen patienten mit chronischer hepatitis c, die erhöhte transaminasen ohne leber-dekompensation und, wer positiv für die serum-hcv-rna oder anti-hcv (siehe abschnitt 4. der beste weg, um zu verwenden, introna bei dieser indikation in kombination mit ribavirin. kinder und jugendliche:introna ist vorgesehen für die verwendung in einer kombination therapie mit ribavirin für die behandlung von kindern und jugendlichen alter von 3 jahren und älter, bei denen eine chronische hepatitis c, die zuvor nicht behandelt wurden, ohne leber-dekompensation, und die sind positiv für die serum-hcv-rna. die entscheidung zur behandlung sollte auf einer von fall zu fall, unter berücksichtigung aller beweise des fortschreitens der krankheit, wie hepatische entzündung und fibrose, sowie prognostische faktoren für response, hcv-genotyp und viruslast. der erwartete nutzen der behandlung abgewogen werden sollten gegen die sicherheit der ergebnisse beobachtet bei pädiatrischen probanden in den klinischen studien (siehe abschnitt 4. 4, 4. 8 und 5.

Den europeiske union - gresk - EMA (European Medicines Agency)

schering-plough europe - ιντερφερόνη άλφα-2b - hepatitis c, chronic; hepatitis b, chronic - Ανοσοδιεγερτικά, - Χρόνια Ηπατίτιδα Β: Θεραπεία ενήλικων ασθενών με χρόνια ηπατίτιδα Β συνδεόμενη με απόδειξη αναδίπλωσης του ιού της ηπατίτιδας Β ιικό πολλαπλασιασμό (παρουσία hbv-dna και hbeag), αυξημένη αλανινική αμινοτρανσφεράση (alt) και ιστολογικά αποδεδειγμένη ενεργό ηπατική φλεγμονή και/ή ίνωση. Χρόνια Ηπατίτιδα c:Ενήλικες ασθενείς:το introna ενδείκνυται για τη θεραπεία ενήλικων ασθενών με χρόνια ηπατίτιδα c, που έχουν αυξημένες τρανσαμινάσες χωρίς άρση της ηπατικής αντιρρόπησης και που είναι θετικοί για hcv-rna ορού ή αντι-hcv (βλ. παράγραφο 4. Ο καλύτερος τρόπος για να χρησιμοποιήσετε το introna σε αυτή την ένδειξη είναι σε συνδυασμό με ριμπαβιρίνη. Παιδιά και έφηβοι:το introna προορίζεται για χρήση, για θεραπευτική αγωγή σε συνδυασμό με ριμπαβιρίνη, για τη θεραπεία παιδιών και εφήβων ηλικίας 3 ετών και άνω που έχουν χρόνια ηπατίτιδα c, χωρίς προηγούμενη θεραπευτική αντιμετώπιση, χωρίς ηπατική ανεπάρκεια, και που είναι θετικοί για hcv-rna. Η απόφαση για θεραπεία θα πρέπει να γίνεται σε κατά περίπτωση βάση, λαμβάνοντας υπόψη στοιχεία της εξέλιξης της νόσου όπως ηπατική φλεγμονή και ίνωση, καθώς και προγνωστικοί παράγοντες ανταπόκρισης, γονότυπο και ιικό φορτίο. Το αναμενόμενο όφελος της θεραπείας θα πρέπει να σταθμίζεται με τα ευρήματα ασφαλείας σε παιδιατρικούς ασθενείς σε κλινικές δοκιμές (βλέπε παραγράφους 4. 4, 4. 8 και 5.

Den europeiske union - islandsk - EMA (European Medicines Agency)

merck sharp dohme ltd  - sýnt alfa-2b - lifrarbólga c, langvinn - Ónæmisörvandi, - adults (tritherapy)viraferonpeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. vinsamlegast vísa til sögu og boceprevir samantekt af einkenni vara (smpcs) þegar mikilvægt er að nota í ásamt þessi lyf. adults (bitherapy and monotherapy)viraferonpeg is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv. ef meðferð í bland með sögu (bitherapy) er ætlað fyrir meðferð chc sýkingu í fullorðinn sjúklingum sem eru áður ómeðhöndlað þar á meðal sjúklinga með vísindalega stöðugt hiv co-sýkingu og hjá fullorðnum sjúklingum sem hafa mistekist fyrri meðferð með sjúklinga alfa (mjög eða ekki mjög) og sögu samsetning meðferð eða fylgjast alfa sér. sjúklinga sér, þar á meðal mikilvægt, er ætlað aðallega ef óþol eða frábending sýni. vinsamlegast vísa til sögu um smpc þegar mikilvægt er að vera notuð í bland með sögu. paediatric population (bitherapy)viraferonpeg is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents, who have chronic hepatitis c, previously untreated, without liver decompensation, and who are positive for hcv-rna. Þegar ákveðið að fresta meðferð fyrr en fullorðinsár, það er mikilvægt að íhuga að samsetning meðferð völdum vöxt hindrunar sem kann að vera óafturkræft í sumir sjúklinga. sú ákvörðun að meðhöndla ætti að vera á tilfelli grundvöllur. vinsamlegast vísa til sögu um smpc fyrir hylki eða mixtúru þegar mikilvægt er að vera notuð í bland með sögu.

Den europeiske union - norsk - EMA (European Medicines Agency)

merck sharp dohme ltd  - peginterferon alfa-2b - hepatitt c, kronisk - immunostimulants, - adults (tritherapy)viraferonpeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. vennligst henvis til ribavirin og boceprevir sammendrag av produktegenskaper (smpcs) når viraferonpeg er å bli brukt i kombinasjon med disse legemidlene. adults (bitherapy and monotherapy)viraferonpeg is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv. viraferonpeg i kombinasjon med ribavirin (bitherapy) er indisert for behandling av chc-infeksjon hos voksne pasienter som er tidligere ubehandlet inkludert pasienter med klinisk stabil hiv-co-infeksjon og hos voksne pasienter som har mislyktes med tidligere behandling med interferon alfa (pegylated eller ikke-pegylated) og ribavirin kombinasjon terapi eller interferon alfa monoterapi. interferon monoterapi, inkludert viraferonpeg, er angitt i hovedsak i tilfelle av intoleranse eller kontraindikasjon mot ribavirin. vennligst henvis til ribavirin smpc når viraferonpeg er å brukes i kombinasjon med ribavirin. paediatric population (bitherapy)viraferonpeg is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents, who have chronic hepatitis c, previously untreated, without liver decompensation, and who are positive for hcv-rna. når du bestemmer deg for ikke å utsette behandling til voksen alder, er det viktig å vurdere at kombinasjonsbehandling indusert en vekst hemming, som kan være irreversible hos noen pasienter. beslutningen om å behandle bør gjøres på en sak-til-sak grunnlag. vennligst henvis til ribavirin smpc for kapsler eller mikstur når viraferonpeg er å brukes i kombinasjon med ribavirin.

Den europeiske union - kroatisk - EMA (European Medicines Agency)

merck sharp dohme ltd  - пэгинтерферон alfa-2b - hepatitis c, kronični - Иммуностимуляторы, - adults (tritherapy)viraferonpeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. molimo vas, obratite se ribavirin i боцепревир kratke specifikacije robe (smpcs), kada viraferonpeg se koristi u kombinaciji s ovi lijekovi. adults (bitherapy and monotherapy)viraferonpeg is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv. viraferonpeg u kombinaciji s ribavirinom (bitherapy) indiciran za liječenje ХГС-infekcije kod odraslih pacijenata koji nisu prethodno tretirani tretman, uključujući i bolesnike s klinički stabilan hiv-infekcije i kod odraslih pacijenata koji nisu prethodno liječenje interferonom alfa (пегилированным ili пегилированным) i ribavirinom kombinirana terapija ili монотерапия interferonom alfa. Монотерапия interferonom, uključujući viraferonpeg, navedeno je u slučaju netolerancije ili kontraindikacija za рибавирину. molimo vas, obratite se Смпц ribavirinom, kada viraferonpeg se koristi u kombinaciji s ribavirinom. paediatric population (bitherapy)viraferonpeg is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents, who have chronic hepatitis c, previously untreated, without liver decompensation, and who are positive for hcv-rna. donošenju odluke da se neće odgoditi liječenje do odrasle dobi, važno je uzeti u obzir da je kombinirana terapija uzrokuje zadržavanje rasta, koji može biti nepovratan u nekih bolesnika. odluka mora biti donesena na individualnoj osnovi. molimo vas, obratite se Смпц ribavirin kapsule ili usmeno rješenje, kada viraferonpeg se koristi u kombinaciji s ribavirinom.

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - peginterferon alfa-2b - powder and solvent for solution for injection - 50microgram

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - peginterferon alfa-2b - powder and solvent for solution for injection - 80microgram

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - peginterferon alfa-2b - powder and solvent for solution for injection - 120microgram