Evropska unija - slovenščina - EMA (European Medicines Agency)

schering-plough europe - interferon alfa-2b - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - kronični hepatitis b: zdravljenje odraslih bolnikov s kroničnim hepatitisom b, povezanih z dokazi, hepatitis b virusno replikacijo (prisotnost hbv-dna in hbeag), povišana alanin aminotransferase (alt) in histologically dokazano aktivno vnetje jeter in/ali fibroza. kronični hepatitis c:odrasli bolniki:introna je indiciran za zdravljenje odraslih bolnikov s kroničnim hepatitisom c, ki so povišani transaminases brez jeter decompensation in ki so pozitivne za serum hcv-rna ali anti-hcv (glej poglavje 4. najboljši način za uporabo introna v ta navedba je v kombinaciji z ribavirin. chidren in mladostniki:introna je namenjen za uporabo v kombinaciji režim z ribavirin, za zdravljenje otrok in mladostnikov 3 let starosti in starejših, ki imajo kronični hepatitis c, ki še niso bila obdelana, brez jeter decompensation, in ki so pozitivne za serum hcv-rna. odločitev za zdravljenje mora biti vložena na podlagi primera, ob upoštevanju kakršne koli dokaze o napredovanja bolezni, kot so vnetje jeter in fibroza, kot tudi prognostic dejavnikov za odgovor, hcv genotip in virusno obremenitev. pričakovano korist zdravljenja je treba pretehtati varnost ugotovitve opaženi pri pediatričnih bolnikov v kliničnih preskušanjih (glej točki 4. 4, 4. 8 in 5.

Evropska unija - slovenščina - EMA (European Medicines Agency)

gilead sciences ireland uc - emtricitabin - okužbe z virusom hiv - antivirusi za sistemsko uporabo - emtriva je indicirana za zdravljenje odraslih in otrok, okuženih s hiv-1 v kombinaciji z drugimi protiretrovirusnimi zdravili. ta navedba temelji na študijah, v zdravljenje-naivnih bolnikov in zdravljenje-izkušeni bolniki s stabilno virological nadzor. ni izkušenj z uporabo emtriva pri bolnikih, ki ne morejo sedanji režim ali ki je ni več regimens. pri odločanju o novi režim za bolnike, ki so neuspešne protiretrovirusnimi režim, paziti je treba upoštevati vzorce mutacije, povezane z različnimi zdravili in obravnavanje zgodovine posameznih bolnikov. Če so na voljo, odpornost testiranja je lahko primerno.

Evropska unija - slovenščina - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - adalimumab - spondylitis, ankylosing; arthritis, juvenile rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; arthritis, rheumatoid - imunosupresivi - prosimo, glejte dokument o izdelku.

Evropska unija - slovenščina - EMA (European Medicines Agency)

biontech manufacturing gmbh - single-stranded, 5’-capped messenger rna produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - cepiva - comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty original/omicron ba. 1 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against covid-19. comirnaty original/omicron ba. 4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty original/omicron ba. 4-5 (1. 5/1. 5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty omicron xbb. 5 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty omicron xbb. 5 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 10 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years. uporaba tega cepiva mora biti v skladu z uradnimi priporočili.

Evropska unija - slovenščina - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - deucravacitinib - psoriaza - imunosupresivi - treatment of moderate-to-severe plaque psoriasis in adults.

Evropska unija - slovenščina - EMA (European Medicines Agency)

pfizer europe ma eeig - topotekan - uterine cervical neoplasms; small cell lung carcinoma - drugi antineoplastiki - monoterapija s topotekanom je indicirana za zdravljenje bolnikov z relapsom drobnoceličnega pljučnega raka (sclc), pri katerih se ponovno zdravljenje z režimom prve linije ne šteje za primerno. topotecan v kombinaciji z cisplatin je indicirano za bolnike z karcinom materničnega vratu periodično po radioterapija in za bolnike z stadiju ivb bolezni. bolniki s predhodno izpostavljenosti cisplatin zahtevajo trajno zdravljenje-prosti interval, da se upraviči zdravljenje s kombinacijo.

Evropska unija - slovenščina - EMA (European Medicines Agency)

pfizer europe ma eeig - anidulafungin - kandidoza - antimikotiki za sistemsko uporabo - zdravljenje invazivne kandidoze pri odraslih in pediatričnih bolnikih, starih od 1 meseca do < 18 let.

Evropska unija - slovenščina - EMA (European Medicines Agency)

astrazeneca ab - olaparib - ovarijske neoplazme - antineoplastična sredstva - ciste na cancerlynparza je označen kot monotherapy za:vzdrževanje zdravljenje odraslih bolnikov z napredovalim (figo fazah iii in iv) brca1/2-mutiral (germline in/ali somatski) high-grade epitelnih jajčnikov, fallopian tube ali primarni trebušno raka, ki so v odziv (popolna ali delna) po koncu prve vrstice platinum, ki temelji kemoterapijo. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 in 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. bolniki morajo imeti predhodno že bili zdravljeni z anthracycline in taxane v (neo)adjuvant ali metastatskim nastavitev, če bolniki niso bili primerni za temi postopki (glej točko 5. bolniki z hormon receptorjev (hr)-pozitivnega raka dojk, je treba tudi napredovala na ali po predhodnem endokrine terapije, ali neprimerna za endokrine terapija. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Evropska unija - slovenščina - EMA (European Medicines Agency)

ab science s.a. - masitinib mesilate - antineoplastična sredstva - psi - zdravljenje neresetabilnih tumorjev mastocitov (razred 2 ali 3) s potrjenim mutiranim c-kit tirozin-kinaznim receptorjem.

Evropska unija - slovenščina - EMA (European Medicines Agency)

pfizer europe ma eeig - levetiracetam - epilepsija - antiepileptics, - levetiracetam hospira je označen kot monoterapije pri zdravljenju zasegov delno nastopa z ali brez sekundarnega posplošitev v odrasli in mladostniki, od 16 let z novo diagnosticirano epilepsijo. levetiracetam hospira je označen kot adjunctive therapyin zdravljenje delno nastop napadi z ali brez sekundarne posplošitev pri odraslih, mladostnikih in otrocih od 4 let z epilepsijo. pri zdravljenju myoclonic zasegov v odrasle in mladostnike od 12. leta starosti z mladoletnimi myoclonic epilepsijo. v zdravljenju primarne splošni tonik-clonic zasegov v odrasle in mladostnike od 12. leta starosti z idiopatsko splošnih epilepsijo. levetiracetam hospira koncentrat je alternativa za bolnike, ko ustni uprava je začasno ni izvedljivo,.