유럽 연합 - 슬로베니아어 - EMA (European Medicines Agency)

bayer ag  - vardenafil - erektilna disfunkcija - urološki - zdravljenje erektilne disfunkcije pri odraslih moških. erektilna disfunkcija je nezmožnost za doseganje ali vzdrževanje erekcije penisa, ki zadošča za zadovoljivo spolno delovanje. da bi levitra, da bo učinkovito, spolne stimulacije je potrebno. levitra ni označeno za uporabo žensk.

유럽 연합 - 슬로베니아어 - EMA (European Medicines Agency)

ucb pharma s.a. - rotigotin - restless legs syndrome; parkinson disease - anti-parkinsonska zdravila - parkinsonova bolezen: zdravilo neupro je indicirano za zdravljenje znakov in simptomov zgodnje stopnje idiopatske parkinsonove bolezni kot monoterapije (i. brez levodope) ali v kombinaciji z levodopo, i. v času bolezni, do poznih stopenj, ko se učinek levodope izčrpa ali postane neskladen, pojavijo pa se tudi nihanja terapevtskega učinka (konec odmerka ali nihanja). nemirna-noge sindrom: neupro je primerna za simptomatsko zdravljenje zmerne do hude idiopatsko nemirna-noge sindrom pri odraslih.

유럽 연합 - 슬로베니아어 - 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.

유럽 연합 - 슬로베니아어 - EMA (European Medicines Agency)

sanofi winthrop industrie - alirocumab - dislipidemije - sredstva za spreminjanje lipidov - primarni hypercholesterolaemia in mešani dyslipidaemiapraluent je indicirana pri odraslih z osnovnošolsko hypercholesterolaemia (heterozygous družinsko in ne-družinsko) ali mešana dyslipidaemia, kot dodatek k prehrani:v kombinaciji z statin ali statin z drugimi zniževanje lipidov terapije pri bolnikih, ki ne more doseči ldl-c ciljev z največjo prenaša odmerek statin ali samostojno ali v kombinaciji z drugimi lipidov-znižanje terapije pri bolnikih, ki so statin-nestrpen ali, za katero statin je kontraindiciran. sedež atherosclerotic bolezni srca in ožilja praluent je navedeno v odrasli s sedežem atherosclerotic bolezni srca in ožilja za zmanjšanje kardiovaskularno tveganje za zniževanje ldl-c ravni, kot dodatek za popravo drugih dejavnikov tveganja:v kombinaciji z največjo prenaša odmerek statin z ali brez drugih lipidov-znižanje terapije ali samostojno ali v kombinaciji z drugimi lipidov-znižanje terapije pri bolnikih, ki so statin-nestrpen ali, za katero statin je kontraindiciran. za študijski rezultati v zvezi z učinki na ldl-c, srčno-žilne dogodke in populacije študiral glej oddelek 5.

유럽 연합 - 슬로베니아어 - EMA (European Medicines Agency)

zentiva k.s. - riluzola - amiotrofična lateralna skleroza - druga zdravila na živčnem sistemu - zdravilo riluzole zentiva je indicirano, da podaljša življenjsko dobo ali čas do mehanskega prezračevanja pri bolnikih z amiotrofično lateralno sklerozo (als). clinical trials have demonstrated that riluzole zentiva extends survival for patients with als. preživetje je bil opredeljen kot bolniki, ki so bili živi, ne intubated za mehansko prezračevanje in tracheotomy-brezplačno. ni dokazov, da riluzola zentiva privlačnost terapevtski učinek na motor funkcija, delovanje pljuč, fascikulacijama, mišične moči in motorične simptome. riluzola zentiva ne bi bilo dokazano, da so učinkovite v poznih fazah als. varnost in učinkovitost riluzola zentiva je samo študiral v als. zato, riluzola zentiva ne sme uporabljati pri bolnikih s katero koli drugo obliko motornih-neurone bolezni.

유럽 연합 - 슬로베니아어 - EMA (European Medicines Agency)

amgen europe b.v. - evolocumab - dyslipidemias; hypercholesterolemia - sredstva za spreminjanje lipidov - hypercholesterolaemia in mešani dyslipidaemiarepatha je indicirana pri odraslih z osnovnošolsko hypercholesterolaemia (heterozygous družinsko in ne-družinsko) ali mešana dyslipidaemia, kot dodatek k prehrani:v kombinaciji z statin ali statin z drugimi zniževanje lipidov terapije pri bolnikih, ki ne more doseči ldl-c ciljev z največjo prenaša odmerek statin ali samostojno ali v kombinaciji z drugimi lipidov-znižanje terapije pri bolnikih, ki so statin-nestrpen ali, za katero statin je kontraindiciran. homozygous družinsko hypercholesterolaemiarepatha je navedeno v odrasli in mladostniki, stari 12 let in več, z homozygous družinsko hypercholesterolaemia v kombinaciji z drugimi lipidov-znižanje terapije. sedež atherosclerotic srca in ožilja diseaserepatha je navedeno v odrasli s sedežem atherosclerotic bolezni srca in ožilja (miokardni infarkt, kap ali periferne arterijske bolezni) za zmanjšanje kardiovaskularno tveganje za zniževanje ldl-c ravni, kot dodatek za popravo drugih dejavnikov tveganja:v kombinaciji z največjo prenaša odmerek statin z ali brez drugih lipidov-znižanje terapije ali samostojno ali v kombinaciji z drugimi lipidov-znižanje terapije pri bolnikih, ki so statin-nestrpen ali, za katero statin je kontraindiciran. za študijski rezultati v zvezi z učinki na ldl-c, srčno-žilne dogodke in populacije študiral glej oddelek 5.

유럽 연합 - 슬로베니아어 - EMA (European Medicines Agency)

sanofi winthrop industrie - riluzola - amiotrofična lateralna skleroza - druga zdravila na živčnem sistemu - rilutek je indiciran, da podaljša življenjsko dobo ali čas do mehanskega prezračevanja pri bolnikih z amiotrofično lateralno sklerozo (als). klinična preskušanja so pokazala, da rilutek podaljša preživetje bolnikov z als. preživetje je bil opredeljen kot bolniki, ki so bili živi, ne intubated za mehansko prezračevanje in tracheotomy-brezplačno. ni dokazov, da rilutek privlačnost terapevtski učinek na motor funkcija, delovanje pljuč, fascikulacijama, mišične moči in motorične simptome. rilutek ne bi bilo dokazano, da so učinkovite v poznih fazah als. varnost in učinkovitost rilutek je samo študiral v als. zato, rilutek ne sme uporabljati pri bolnikih s katero koli drugo obliko motornih-neurone bolezni.

유럽 연합 - 슬로베니아어 - EMA (European Medicines Agency)

merck sharp & dohme b.v. - efavirenz - okužbe z virusom hiv - antivirusi za sistemsko uporabo - stocrin navedeno kombinacijo protivirusno zdravljenje človekove-imunske pomanjkljivosti-virus-1 (hiv-1)-okuženih odraslih, mladostnikih in otrocih treh let in starejši. stocrin ni bilo ustrezno preučevali pri bolnikih z napredovalim hiv bolezni, in sicer pri bolnikih s cd4 šteje < 50 celic/mm3, ali okvari protease-serotonina (pi), ki vsebujejo regimens. Čeprav navzkrižno odpornost efavirenz s pis ni bil dokumentiran, je zdaj na voljo dovolj podatkov o učinkovitosti poznejšo uporabo pi-temelji kombinacija terapije po okvari regimens, ki vsebujejo stocrin.

유럽 연합 - 슬로베니아어 - EMA (European Medicines Agency)

merck sharp dohme ltd. - laropiprant, nicotinic kisline - dislipidemije - sredstva za spreminjanje lipidov - tredaptive je indiciran za zdravljenje dyslipidaemia, zlasti pri bolnikih s kombinirano mešani dyslipidaemia (značilno povišane ravni nizko-gostoto-nizke gostote (ldl) holesterola in trigliceridov in nizko visoko-gostoto-lipoprotein (hdl ) holesterol) in pri bolnikih s primarno hiperholesterolemijo (heterozigotno družinsko in družinsko). tredaptive je treba uporabljati pri bolnikih, ki v kombinaciji z 3-hidroksi-3-metil-glutaryl-co-encim-a (hmg-coa)-reductase inhibitorji (statins), ko je raven holesterola,-znižuje učinek hmg-coa-reductase zaviralec monotherapy je neustrezna. lahko se uporablja kot monotherapy le pri bolnikih, pri katerih hmg-coa-reductase inhibitorji so se štejejo za neprimerne ali ne prenaša. prehrana in druge ne-farmakološko zdravljenje (e. vadba, zmanjšanje telesne mase), bi bilo treba še naprej med terapijo z tredaptive.

유럽 연합 - 슬로베니아어 - EMA (European Medicines Agency)

merck sharp dohme ltd - laropiprant, nicotinic kisline - dislipidemije - sredstva za spreminjanje lipidov - trevaclyn je indicirano za zdravljenje dyslipidaemia, zlasti pri bolnikih s kombinirano mešani dyslipidaemia (značilno povišane ravni nizko-gostoto-nizke gostote (ldl) holesterola in trigliceridov in nizko visoko-gostoto-lipoprotein (hdl) holesterol) in pri bolnikih s primarno hiperholesterolemijo (heterozigotno družinsko in družinsko). trevaclyn je treba uporabljati pri bolnikih, ki v kombinaciji z 3-hidroksi-3-metil-glutaryl-co-encim-a (hmg-coa)-reductase inhibitorji (statins), ko je raven holesterola,-znižuje učinek hmg-coa-reductase-inhibitor monotherapy je neustrezna. lahko se uporablja kot monotherapy le pri bolnikih, pri katerih hmg-coa-reductase inhibitorji so se štejejo za neprimerne ali ne prenaša. prehrana in druge ne-farmakološko zdravljenje (e. vadba, zmanjšanje telesne mase), bi bilo treba še naprej med terapijo z trevaclyn.