Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - monohidrat zoledronske kisline - hypercalcemia; fractures, bone; cancer - bisfosfonati - preprečevanje skeletnih povezane dogodke (patološki zlomi, hrbtenice stiskanje, sevanja ali operacijo kosti ali tumor povzroča hypercalcaemia) pri odraslih bolnikih z napredno malignih bolezni, ki vključujejo kosti. zdravljenje odraslih bolnikov z tumor povzroča hypercalcaemia (tih).

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - arzenov trioksid - levkemija, promyelocytic, akutna - antineoplastična sredstva - arzenov trioksid, ki je primerna za indukcijo remisije, in konsolidacije pri odraslih bolnikih z:novo diagnosticiranih nizko-za-srednje tveganje akutna promyelocytic levkemijo (apl) (belih krvnih telesc, ≤ 10 x 103/µl) v kombinaciji z all-trans-retinojske kisline (atra)relapsed/ognjevzdržni akutna promyelocytic levkemijo (apl)(prejšnje zdravljenje mora imeti vključen retinoid in kemoterapijo) značilna prisotnost t(15;17) translokacija in/ali prisotnosti promyelocytic levkemijo/retinojske kisline-receptor-alfa (pml/rar-alfa) gena. odgovor stopnja drugih akutnih myelogenous levkemijo podtipov, da arzenov trioksid, ki še niso bili pregledani.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - kapecitabin - colonic neoplasms; breast neoplasms; colorectal neoplasms; stomach neoplasms - antineoplastična sredstva - capecitabine accord je indiciran za adjuvantno zdravljenje bolnikov po operaciji stopnje iii (dukes 'stadij c) raka debelega črevesa. capecitabine soglasju je primerna za zdravljenje metastatskega raka debelega črevesa in danke. capecitabine soglasju je določen za prvo linijo zdravljenja naprednih raka želodca v kombinaciji z platinum, ki temelji režim. capecitabine sebe v kombinaciji z docetaxel je indiciran za zdravljenje bolnikov z lokalno napredno ali metastatskega raka dojke po okvari citotoksična kemoterapija. predhodno zdravljenje bi moralo vključiti antraciklin. capecitabine soglasju navede tudi kot monotherapy za zdravljenje bolnikov z lokalno napredno ali metastatskega raka dojke po okvari taxanes in anthracycline, ki vsebujejo kemoterapijo režim ali za koga še anthracycline zdravljenje ni navedeno.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - dexmedetomidine - premedication - psiholeptiki - za sedacijo odraslih icu (enoti za intenzivno nego) bolnikov, ki potrebujejo sedacijo ravni ne globlje, kot je vzburjenje v odgovor na verbalne dražljaje (ustrezno richmond vznemirjenost-sedacija lestvici (rass) 0 -3). za sedacijo non-intubated odraslih bolnikov pred in/ali v diagnostične ali kirurški postopki, ki zahtevajo sedacijo, i. postopkovna/buden sedacijo.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimikotiki za sistemsko uporabo - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 in 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 in 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 in 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 in 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 in 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 in 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 in 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):- invazivne aspergillosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b ali itraconazole ali pri bolnikih, ki ne prenašajo teh zdravil;- fusariosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b ali pri bolnikih, ki so nestrpne amphotericin b;- chromoblastomycosis in mycetoma pri bolnikih z boleznijo, ki je neodzivna, da itraconazole ali pri bolnikih, ki so nestrpne itraconazole;- coccidioidomycosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b, itraconazole ali fluconazole ali pri bolnikih, ki ne prenašajo teh zdravil;- Žrela kandidoza: kot prvo linijo zdravljenja pri bolnikih, ki imajo hude bolezni ali so immunocompromised, v kateri je odziv na aktualne terapija je pričakovati, da bo slaba. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Evropska unija - slovenščina - EMA (European Medicines Agency)

teva b.v. - zoledronska kislina - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - zdravila za zdravljenje bolezni kosti - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture including those with a recent low-trauma hip fracture. treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: , in post-menopausal women;, in men; , at increased risk of fracture. zdravljenje paget je bolezen kosti v odrasli.

Evropska unija - slovenščina - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - docetaksel - stomach neoplasms; adenoma; breast neoplasms; carcinoma, non-small-cell lung; prostatic neoplasms - antineoplastična sredstva - prsi cancerdocetaxel v kombinaciji z doxorubicin in ciklofosfamid je primerna za adjuvant zdravljenje bolnikov z upravljajo node-pozitivnega raka dojk. docetaxel v kombinaciji z doxorubicin je indiciran za zdravljenje bolnikov z lokalno napredno ali metastatskega raka dojke, ki pred tem še niso prejele citotoksična terapija za to stanje. docetaxel monotherapy je indiciran za zdravljenje bolnikov z lokalno napredno ali metastatskega raka dojke po okvari citotoksična terapija. predhodna kemoterapija je morala vključevati antraciklin ali sredstvo za alkiliranje. docetaxel v kombinaciji z trastuzumab je indiciran za zdravljenje bolnikov z metastatskim rakom dojke, katerih tumorji, nad express her2 in ki predhodno še niso prejeli kemoterapijo za metastatskim bolezni. docetaxel v kombinaciji z capecitabine je indiciran za zdravljenje bolnikov z lokalno napredno ali metastatskega raka dojke po okvari citotoksična kemoterapija. predhodno zdravljenje bi moralo vključiti antraciklin. non-small cell lung cancerdocetaxel je indiciran za zdravljenje bolnikov z lokalno napredno ali metastatskim non-small cell lung cancer po izpadu pred kemoterapijo. docetaxel v kombinaciji z cisplatin je indiciran za zdravljenje bolnikov z unresectable, lokalno napredno ali metastatskim non-small cell lung cancer, pri bolnikih, ki pred tem še niso prejele kemoterapijo za to stanje. prostate cancerdocetaxel v kombinaciji z prednizon ali prednizolon je indiciran za zdravljenje bolnikov z hormon ognjevzdržni metastatskega raka prostate. Želodčni adenocarcinomadocetaxel v kombinaciji z cisplatin in 5-fluorouracil je indiciran za zdravljenje bolnikov z metastatskim želodca, adenokarcinom, vključno z adenokarcinom v gastroezofagealna križišču, ki ga še niso prejeli pred kemoterapijo za metastatskim bolezni. glave in vratu cancerdocetaxel v kombinaciji z cisplatin in 5-fluorouracil je primerna za indukcijsko zdravljenje bolnikov z lokalno napredno skvamoznih celic karcinom glave in vratu,.

Evropska unija - slovenščina - EMA (European Medicines Agency)

teva pharma b.v. - docetaksel - carcinoma, non-small-cell lung; breast neoplasms; prostatic neoplasms - antineoplastična sredstva - prsi cancerdocetaxel teva pharma monotherapy je indiciran za zdravljenje bolnikov z lokalno napredno ali metastatskega raka dojke po okvari citotoksična terapija. predhodna kemoterapija je morala vključevati antraciklin ali sredstvo za alkiliranje. non-small-cell lung cancerdocetaxel teva pharma je indiciran za zdravljenje bolnikov z lokalno napredno ali metastatskim non-small-cell lung cancer po izpadu pred kemoterapijo. docetaxel teva pharma v kombinaciji z cisplatin je indiciran za zdravljenje bolnikov z unresectable, lokalno napredno ali metastatskim non-small-celice pljučnega raka, pri bolnikih, ki pred tem še niso prejele kemoterapijo za to stanje. prostate cancerdocetaxel teva pharma v kombinaciji z prednizon ali prednizolon je indiciran za zdravljenje bolnikov z hormon ognjevzdržni metastatskega raka prostate.

Evropska unija - slovenščina - EMA (European Medicines Agency)

teva b.v. - imatinib mesilate - dermatofibrosarcoma; gastrointestinal stromal tumors; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastična sredstva - imatinib teva b. is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. , pediatričnih bolnikih s ph+ cml v kronični fazi po izpadu interferon-alfa terapije, ali v pospešeni fazi ali pišu krize. odrasli bolniki s ph+ cml v blastni krizi. , odraslih in pediatričnih bolnikih, ki so na novo zboleli za philadelphia kromosom pozitivno acute lymphoblastic levkemijo (ph+ all), ki je integriran z kemoterapijo. odrasli bolniki z relapsed ali ognjevzdržni ph+ all, kot monotherapy. odrasli bolniki z myelodysplastic/myeloproliferative bolezni (mds/mpd), ki je povezana z trombocitov, pridobljenih iz rastni dejavnik receptorjev (pdgfr) gena ponovno ureditev. odrasli bolniki z napredno hypereosinophilic sindromom (hes) in/ali kronično eozinofilno levkemijo (cel) z fip1l1-pdgfra preureditev. učinek imatinib na izid presaditev kostnega mozga, ni bilo določeno. imatinib teva b. is indicated for: , the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). , adjuvant zdravljenje odraslih bolnikov, ki so na veliko nevarnost ponovitve naslednje resekcija kit (cd117)-pozitivno bistvo. bolniki, ki imajo nizko ali zelo nizko tveganje za ponovitev, ne bi smel imeti adjuvant treatment. , zdravljenje odraslih bolnikov z unresectable dermatofibrosarcoma protuberans (dfsp) in odraslih bolnikih s ponavljajočimi in/ali metastatskim dfsp, ki niso primerni za operacijo. v izobraževanju odraslih in pediatričnih bolnikov, učinkovitost imatinib temelji na splošno hematoloških in postopek citogenetske stopnjo odziva in napredovanje-free survival v cml, na hematoloških in postopek citogenetske stopnjo odziva, v ph+ all, mds/mpd, na hematoloških stopnjo odziva, v hes/cel in na cilj stopnjo odziva pri odraslih bolnikih z unresectable in/ali metastatskim bistvo in dfsp in na ponovitev-free survival v adjuvant bistvo. izkušnje z imatinib pri bolnikih z mds/mpd, povezanih z pdgfr gena ponovno ureditev je zelo omejena. ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.

Evropska unija - slovenščina - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - eprinomectin, esafoxolaner, praziquantel - eprinomectin, combinations, , avermectins, antiparasitic products, insecticides and repellents - mačke - for cats with, or at risk from mixed infections by cestodes, nematodes and ectoparasites. zdravilo je izključno navedeno ko so vse tri skupine, ki so usmerjeni na istem času.