Evropska unija - slovenščina - EMA (European Medicines Agency)

roche registration gmbh - rituksimab - lymphoma, non-hodgkin; arthritis, rheumatoid; leukemia, lymphocytic, chronic, b-cell - antineoplastična sredstva - mabthera je navedeno v odraslih za naslednje indikacije:ne‑hodgkinova limfomi (nhl)mabthera je primerna za zdravljenje predhodno nezdravljenih odraslih bolnikov z faza iii‑iv folikularni limfom v kombinaciji s kemoterapijo. mabthera vzdrževanje terapija je primerna za zdravljenje odraslih, folikularni limfom bolniki odzivajo na indukcijsko zdravljenje. mabthera monotherapy je indiciran za zdravljenje odraslih bolnikov z faza iii‑iv folikularni limfom, ki so chemoresistant ali so v drugi ali poznejši ponovitve po kemoterapijo. mabthera je indiciran za zdravljenje odraslih bolnikov s cd20 pozitivni razpršenih velika b celic non‑hodgkinova limfom v kombinaciji z chop (ciklofosfamid, doxorubicin, vincristine, prednizolon) kemoterapijo. mabthera v kombinaciji s kemoterapijo je primerna za zdravljenje pediatričnih bolnikih (starih ≥ 6 mesecev do < 18 let) s predhodno nezdravljenih napredni fazi cd20 pozitivni razpršenih veliko b-celični limfom (dlbcl), burkitt limfom (bl)/burkitt levkemijo (mature b-celic akutno levkemijo) (bal) ali burkitt-kot so limfom (bll). kronično limfocitno levkemijo (cll)mabthera v kombinaciji s kemoterapijo je indiciran za zdravljenje bolnikov z predhodno nezdravljenih in relapsed/ognjevzdržni cll. samo omejeni so na voljo podatki o učinkovitosti in varnosti za bolnike predhodno zdravljenih z monoklonalna protitelesa, vključno z mabthera ali bolniki, ognjevzdržni, da prejšnji mabthera plus kemoterapijo. revmatoidni arthritismabthera v kombinaciji z metotreksatom je indiciran za zdravljenje odraslih bolnikov s hudo aktivnega revmatoidnega artritisa, ki so imeli z neustreznim odzivom ali nestrpnosti do drugih bolezni spreminjajo anti‑revmatičnih zdravila (dmard) vključno z enim ali več tumor nekroze faktor (tnf) inhibitor terapije. mabthera je dokazano, da zmanjša stopnjo napredovanja skupno škodo, merjeno z x‑ray in izboljšati telesno funkcijo, če bi imeli v kombinaciji z metotreksatom. granulomatosis z polyangiitis in mikroskopsko polyangiitismabthera, v kombinaciji z glucocorticoids, je indicirano za zdravljenje odraslih bolnikov s hudo, aktivno granulomatosis z polyangiitis (wegener je) (gpa) in mikroskopsko polyangiitis (mpa). mabthera v kombinaciji z glucocorticoids, je primerna za indukcijo remisije pri pediatričnih bolnikih (starih ≥ 2 < 18 let) s hudo, aktivno gpa (wegener je) in mpa. pemphigus vulgarismabthera je indiciran za zdravljenje bolnikov z zmerno do hudo pemphigus vulgaris (pv).

Evropska unija - slovenščina - EMA (European Medicines Agency)

roche registration gmbh - metoksi polietilen glikol-epoetin beta - anemia; kidney failure, chronic - antianemični preparati - treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adult patients (see section 5. treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (esa) after their haemoglobin level was stabilised with the previous esa (see section 5.

Evropska unija - slovenščina - EMA (European Medicines Agency)

roche registration gmbh - epoetin beta - kidney failure, chronic; anemia; cancer; blood transfusion, autologous - antianemični preparati - zdravljenje simptomatsko anemija, povezanih s kronično odpovedjo ledvic (crf) pri odraslih in pediatričnih bolnikih;zdravljenje simptomatsko anemija pri odraslih bolnikih z ne-mieloično malignancies, ki prejemajo kemoterapijo, povečuje donos autologous blood od bolnikov v pre-donacija program. njegova uporaba v ta prikaz mora biti uravnotežena glede na sporočene povečano tveganje thromboembolic dogodkov. zdravljenje je treba dajati bolnikom z zmerno anemija (hb 10 - 13 g/dl [6. 21 - 8. 07 mmol/l], ni pomanjkanja železa) če krvi ohranjanje postopki, ki niso na voljo ali nezadostno ko načrtovanih večjih izbirni operacijo je potrebna velika količina krvi (4 ali več enot krvi za samice, ali 5 ali več enot za moške).

Evropska unija - slovenščina - EMA (European Medicines Agency)

roche registration gmbh - vemurafenib - melanoma - antineoplastična sredstva - zdravilo vemurafenib je indicirano v monoterapiji za zdravljenje odraslih bolnikov z braf-v600-mutacijskim pozitivnim neresektabilnim ali metastatskim melanomom.

Evropska unija - slovenščina - EMA (European Medicines Agency)

roche registration gmbh  - pertuzumab - neoplazme dojke - antineoplastic agents, monoclonal antibodies - metastatski rak dojk:perjeta je primerna za uporabo v kombinaciji z trastuzumab in docetaxel pri odraslih bolnikih s her2 pozitiven metastatskega ali lokalno periodično unresectable raka dojk, ki ga še niso prejeli prejšnji anti-her2 terapijo ali kemoterapijo za njihovo metastatskim bolezni. neoadjuvant zdravljenje raka dojk:perjeta je primerna za uporabo v kombinaciji z trastuzumab in kemoterapijo za neoadjuvant zdravljenje odraslih bolnikov s her2 pozitiven, lokalno napredovalo, protivnetno, ali zgodnji fazi raka dojke na visoko tveganje za ponovitev.

Evropska unija - slovenščina - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - antineoplastična sredstva - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq kot monotherapy je indiciran za zdravljenje odraslih bolnikov z lokalno napredno ali metastatskim nsclc po predhodno kemoterapijo. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq kot monotherapy je indiciran za zdravljenje odraslih bolnikov z lokalno napredno ali metastatskim nsclc po predhodno kemoterapijo. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

Evropska unija - slovenščina - EMA (European Medicines Agency)

roche registration limited - emicizumab - hemofilija a - antihemoragije - hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia a (congenital factor viii deficiency):with factor viii inhibitorswithout factor viii inhibitors who have:severe disease (fviii < 1%)moderate disease (fviii ≥ 1% and ≤ 5%) with severe bleeding phenotype. hemlibra se lahko uporablja v vseh starostnih skupinah.

Evropska unija - slovenščina - EMA (European Medicines Agency)

roche registration gmbh - polatuzumab vedotin - limfom, b-celice - antineoplastična sredstva - polivy v kombinaciji z bendamustine in rituksimabom je indiciran za zdravljenje odraslih bolnikov z relapsed/ognjevzdržni razpršenih veliko b-celični limfom (dlbcl), ki niso kandidati za haematopoietic matičnih celic za presajanje. polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma (dlbcl).

Evropska unija - slovenščina - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - antineoplastična sredstva - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Evropska unija - slovenščina - EMA (European Medicines Agency)

roche registration gmbh - pertuzumab, trastuzumab - neoplazme dojke - antineoplastična sredstva - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.