Evropska unija - slovenščina - 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

les laboratoires servier - trifluridine, tipiracil hidroklorid - kolorektalne neoplazme - antineoplastična sredstva - colorectal cancerlonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (crc) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and/or anti-egfr agents. lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and anti egfr agentsgastric cancerlonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - lopinavir, ritonavir - okužbe z virusom hiv - antivirusi za sistemsko uporabo - lopinavir/ritonavir, ki je naveden v kombinaciji s drugih protiretrovirusna zdravila za zdravljenje virusom človeške imunske pomanjkljivosti (hiv-1) okuženih odrasli, mladostniki in otroci v starosti nad 2 leti. izbira lopinavir/ritonavir za zdravljenje protease inhibitor izkušeni hiv-1 okuženih bolnikov, ki mora temeljiti na posameznih virusnih odpornost testiranje in zdravljenje zgodovina bolnikov.

Evropska unija - slovenščina - EMA (European Medicines Agency)

teva b.v.  - nevirapin - okužbe z virusom hiv - antivirusi za sistemsko uporabo - zdravilo nevirapin teva je indicirano v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje odraslih, mladostnikov in otrok vseh okuženih s hiv 1. največ izkušenj z nevirapine je v kombinaciji z nucleoside reverse transcriptase inhibitorji (nrtis). izbira naknadno terapije po nevirapine mora temeljiti na klinične izkušnje in odpornost testiranje.

Evropska unija - slovenščina - EMA (European Medicines Agency)

viiv healthcare bv - dolutegravir - okužbe z virusom hiv - antivirusi za sistemsko uporabo - tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg. tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.

Evropska unija - slovenščina - 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.

Evropska unija - slovenščina - 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - efavirenz - okužbe z virusom hiv - antivirusi za sistemsko uporabo - zdravilo sustiva je indicirano za protivirusno kombinirano zdravljenje odraslih, mladostnikov in otrok, starih tri ali več let, z virusom hiv-1 (virus hiv-1). sustiva 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 sustiva.

Evropska unija - slovenščina - EMA (European Medicines Agency)

gilead sciences ireland uc - cobicistat - okužbe z virusom hiv - antivirusi za sistemsko uporabo - tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (hiv-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.

Evropska unija - slovenščina - EMA (European Medicines Agency)

janssen-cilag international nv - simeprevir - hepatitis c, kronični - antivirusi za sistemsko uporabo - zdravilo olysio je indicirano v kombinaciji z drugimi zdravili za zdravljenje kroničnega hepatitisa c (chc) pri odraslih bolnikih. za virus hepatitisa c (hcv) genotip določene dejavnosti,.