यूरोपीय संघ - स्लोवेनियाई - EMA (European Medicines Agency)

janssen-cilag international nv - etravirine - okužbe z virusom hiv - non-nucleoside reverse transcriptase inhibitors, antivirals for systemic use - intelence, v kombinaciji z inhibitor proteaz povečala in drugih protiretrovirusna zdravila, je indicirano za zdravljenje okužbe ljudi-imunske pomanjkljivosti-virus-tipa 1 (hiv-1) v doživeli protiretrovirusno zdravljenje odraslih bolnikov in v protiretrovirusno zdravljenje, izkušeni pediatrični bolniki iz šestih let. ta navedba temelji na teden-48 analize iz dveh faza-iii preskušanj v zelo pretreated bolnikih, kjer intelence je v preiskavi v kombinaciji z optimalnim ozadju režim (obr), ki je vključevala darunavir/ritonavir. navedba v pediatričnih bolnikih, ki temelji na 48-tedensko analiz eno roko, faza ii sojenja v protiretrovirusno zdravljenje z izkušenimi pediatričnih bolnikih.

यूरोपीय संघ - स्लोवेनियाई - EMA (European Medicines Agency)

janssen-cilag international nv - paliperidon - schizophrenia; psychotic disorders - psiholeptiki - zdravilo invega je indicirano za zdravljenje shizofrenije pri odraslih in pri mladostnikih, starih 15 let ali več. invega je primerna za zdravljenje schizoaffective motnje pri odraslih.

यूरोपीय संघ - स्लोवेनियाई - EMA (European Medicines Agency)

janssen-cilag international nv - kanaglifozin - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 in 5.

यूरोपीय संघ - स्लोवेनियाई - EMA (European Medicines Agency)

janssen-cilag international n.v. - paliperidon palmitat - shizofrenija - psiholeptiki - zdravilo xeplion je indicirano za vzdrževalno zdravljenje shizofrenije pri odraslih bolnikih, stabiliziranih z paliperidonom ali risperidonom. in selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

यूरोपीय संघ - स्लोवेनियाई - EMA (European Medicines Agency)

janssen-cilag international n.v. - abirateron acetat - prostatične neoplazme - endokrini terapija - zytiga je označena z prednizon ali prednizolon za:zdravljenje metastatskega kastracije odporne raka na prostati pri odraslih moških, ki so asimptomatsko ali lahko simptomatsko po okvari androgen odvzem terapije, pri katerih kemoterapijo še ni klinično indicatedthe zdravljenje metastatskega kastracije odporne raka na prostati pri moških odraslih, katerih bolezen je napredovala na ali po docetaxel temelji kemoterapijo režim.

यूरोपीय संघ - स्लोवेनियाई - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - okužbe z virusom hiv - antivirusi za sistemsko uporabo - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

यूरोपीय संघ - स्लोवेनियाई - EMA (European Medicines Agency)

janssen-cilag international n.v. - darunavir, cobicistat - okužbe z virusom hiv - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - zdravilo rezolsta je indicirano v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje okužbe z virusom humane imunske pomanjkljivosti 1 (hiv 1) pri odraslih, starih 18 let ali več. genotipa testiranje mora vodnik za uporabo rezolsta.

यूरोपीय संघ - स्लोवेनियाई - EMA (European Medicines Agency)

janssen-cilag international nv - bedakvilin fumarat - tuberkuloza, odporna proti multidrugom - antimikobakterij - sirturo je primerna za uporabo kot del ustrezno kombinacijo režim za pljučne multidrug odporne tuberkuloze (mdr-tb) pri odraslih in mladostnikov bolnikov (12 let na manj kot 18 let starosti, ki tehta vsaj 30 kg), ko je za učinkovito zdravljenje režim ne more drugače biti sestavljen zaradi odpornosti ali prenašanje. upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

यूरोपीय संघ - स्लोवेनियाई - EMA (European Medicines Agency)

janssen-cilag international nv - bosentan (as monohydrate) - hypertension, pulmonary; scleroderma, systemic - drugi antihipertenzivi - zdravljenje pljučne arterijske hipertenzije (pah) za izboljšanje telesne zmogljivosti in simptomov pri bolnikih s funkcionalnim razredu iii. svetovne zdravstvene organizacije (who). učinkovitosti je bilo prikazano v:primarne (idiopatsko in družinsko) pah;pah sekundarne za sklerodermijo brez večjih intersticijski pljučni bolezni;pah, povezane s prirojeno sistemsko-za-pljučna uporabo in eisenmenger je fiziologija. nekatere izboljšave so tudi pokazale, pri bolnikih s pah, ki funkcijski razred ii. stayveer je tudi navedeno, da se zmanjša število novih digitalnih razjede pri bolnikih s sistemsko sklerozo in tekoče digital-razjede bolezni.

यूरोपीय संघ - स्लोवेनियाई - EMA (European Medicines Agency)

janssen-cilag international n.v.   - bosentan (as monohydrate) - scleroderma, systemic; hypertension, pulmonary - antihipertenzivi, - zdravljenje pljučne arterijske hipertenzije (pah) za izboljšanje telesne zmogljivosti in simptomov pri bolnikih s funkcionalnim razredom iii szo. efficacy has been shown in: , primary (idiopathic and familial) pah;, pah secondary to scleroderma without significant interstitial pulmonary disease;, pah associated with congenital systemic-to-pulmonary shunts and eisenmenger's physiology. nekatere izboljšave so tudi pokazale, pri bolnikih s pah, ki funkcijski razred ii. tracleer je bilo tudi navedeno, da se zmanjša število novih digitalnih razjede pri bolnikih s sistemsko sklerozo in tekoče digitalni razjede bolezni.