Unió Europea - eslovè - EMA (European Medicines Agency)

janssen-cilag international nv - apalutamide - prostatične neoplazme - endokrini terapija - erleada je navedeno:pri odraslih moških za zdravljenje brez metastatskim kastracije odporne raka prostate (nmcrpc), ki so na visoko tveganje za razvoj bolezni metastatskim. pri odraslih moških za zdravljenje metastatskega hormonsko občutljivih raka prostate (mhspc) v kombinaciji z androgen odvzem terapija (adt).

Unió Europea - eslovè - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir, cobicistat, emtricitabine, tenofovir alafenamide - okužbe z virusom hiv - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - zdravilo symtuza je indicirano za zdravljenje okužbe z virusom humane imunske pomanjkljivosti tipa 1 (hiv-1) pri odraslih in mladostnikih (starih 12 let in več, z telesno maso najmanj 40 kg). genotypic testing should guide the use of symtuza.

Unió Europea - eslovè - EMA (European Medicines Agency)

janssen cilag international nv - miglustat - gaucher disease; niemann-pick diseases - drugi zdravljene bolezni prebavil in presnove izdelki, - zdravilo zavesca je indicirano za oralno zdravljenje odraslih bolnikov z blago do zmerno gaucherjevo boleznijo tipa 1. zdravilo zavesca se lahko uporablja le pri zdravljenju bolnikov, pri katerih je nadomestno zdravljenje z encimi nezadostno. zavesca je primerna za zdravljenje progresivne nevrološke manifestacije pri odraslih bolnikih in pediatričnih bolnikih z niemann-pick tip-c bolezen.

Unió Europea - eslovè - 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.

Unió Europea - eslovè - 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.

Unió Europea - eslovè - 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.

Unió Europea - eslovè - EMA (European Medicines Agency)

janssen-cilag international nv - canagliflozin, metformin hidroklorid - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - vokanamet je navedeno pri odraslih, starih 18 let in več, z vrsto 2 sladkorna bolezen kot dodatek k prehrani in vadbi za izboljšanje glycaemic nadzor:pri bolnikih, ki ni ustrezno nadzorovana na njihovo maksimalno dopustne koncentracije metforminom alonein bolnikov na njihovo maksimalno dopustne koncentracije metforminom skupaj z drugimi glukoze znižanje medicini, vključno z insulina, ko te ne zagotavljajo ustrezne glycaemic nadzor. pri bolnikih, ki se že zdravijo z kombinacijo canagliflozin in metforminom kot ločene tabletsfor študijski rezultati glede kombinacija terapij, vplivi na glycaemic nadzor in srčno-žilne dogodke, in populacije, ki je študiral glej poglavji 4. 4, 4. 5 in 5.

Unió Europea - eslovè - EMA (European Medicines Agency)

janssen-cilag international nv - guselkumab - psoriaza - imunosupresivi - plaque psoriasis tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. psoriatic arthritis tremfya, alone or in combination with methotrexate (mtx), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (dmard) therapy (see section 5.

Unió Europea - eslovè - EMA (European Medicines Agency)

janssen-cilag international nv - esketamine hidroklorid - depresivno motnjo - drugi antidepresivi - spravato, v kombinaciji s ssri ali snri, je indiciran za zdravljenje odraslih z odporno huda depresivna motnja, ki se niso odzvali na vsaj dveh različnih načinov zdravljenja z antidepresivi v tekočem zmerna do huda depresivna epizoda.

Unió Europea - eslovè - 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.