Ypozane Европска Унија - Словеначки - EMA (European Medicines Agency)

ypozane

virbac s.a. - osateron acetat - urološki - psi - zdravljenje benigne hipertrofije prostate (bph) pri moških pseh.

Prezista Европска Унија - Словеначки - EMA (European Medicines Agency)

prezista

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.

Rezolsta Европска Унија - Словеначки - EMA (European Medicines Agency)

rezolsta

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.

Onsenal Европска Унија - Словеначки - EMA (European Medicines Agency)

onsenal

pfizer limited - celecoxib - adenomatozna polipoza coli - antineoplastična sredstva - onsenal je indiciran za zmanjšanje števila adenomatoznih črevesnih polipov v družinski adenomatozni polipoziji (fap), kot dopolnilo kirurgiji in nadaljnjemu endoskopskemu nadzoru (glejte poglavje 4. učinek onsenal povzroča zmanjšanje polyp breme tveganja črevesni rak še ni bila dokazana (glej točki 4. 4 in 5.

Emtricitabine/Tenofovir disoproxil Krka d.d. Европска Унија - Словеначки - EMA (European Medicines Agency)

emtricitabine/tenofovir disoproxil krka d.d.

krka, d.d., novo mesto - emtricitabine, tenofovir disoproxil succinate - okužbe z virusom hiv - antivirusi za sistemsko uporabo - emtricitabin / tenofovirdizoproksil krka d. je indiciran pri protiretrovirusnem kombiniranem zdravljenju za zdravljenje odraslih, okuženih s hiv-1. emtricitabin / tenofovirdizoproksil krka d. je tudi navedeno, za zdravljenje okužbe z virusom hiv-1 okuženih mladostniki, z nrti odpornost ali toxicities nasprotuje uporabi prvo vrstico agenti, starih od 12 < 18 let.

Darunavir Krka d.d. Европска Унија - Словеначки - EMA (European Medicines Agency)

darunavir krka d.d.

krka, d.d., novo mesto - darunavir - okužbe z virusom hiv - antivirusi za sistemsko uporabo - 400 mg in 800 mg film-coated tabletsdarunavir krka d. co-daje z nizkim odmerkom ritonavir je navedeno v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje bolnikov z virusom humane imunske pomanjkljivosti (hiv-1) okužbe. darunavir krka d. co-daje z cobicistat je navedeno v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje bolnikov z virusom humane imunske pomanjkljivosti (hiv-1) okužbe pri odraslih bolnikih (glejte poglavje 4. darunavir krka d. 400 mg in 800 mg tablete se lahko uporabljajo za zagotavljanje primeren odmerek regimens za zdravljenje okužbe z virusom hiv-1 okužbe pri odraslih in pediatričnih bolnikih od starosti 3 let in z vsaj 40 kg telesne teže, ki so:antiretrovirusne terapije (art)-naivna (glej poglavje 4. art-izkušeni brez darunavir odpornost, povezanih mutacije (drv-ram) in ki so plazemske hiv-1 rna < kot 100.000 kopij/ml in cd4 število celic ≥ 100 x 106 celic/l. pri odločanju za uvedbo zdravljenja z darunavir v takih art-izkušeni bolniki, genotipa testiranje mora vodnik za uporabo darunavir (glej točki 4. 2, 4. 3, 4. 4 in 5. 600 mg film-coated tabletsdarunavir krka d. co-daje z nizkim odmerkom ritonavir je navedeno v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje bolnikov z virusom humane imunske pomanjkljivosti (hiv-1) okužbe. darunavir krka d. 600 mg tablete se lahko uporabljajo za zagotavljanje primeren odmerek regimens (glej poglavje 4. 2):za zdravljenje okužbe z virusom hiv-1 okužba v protiretrovirusno zdravljenje (art)-izkušeni odraslih bolnikih, vključno s tistimi, ki so bili zelo pre-obravnava. za zdravljenje okužbe z virusom hiv-1 okužba pri pediatričnih bolnikih od starosti 3 let in najmanj 15 kg telesne teže. pri odločanju za uvedbo zdravljenja z darunavir co-daje z nizkim odmerkom ritonavir, previdni, upoštevati je treba zdravljenje zgodovino posameznih bolnikov in vzorcev mutacije, povezane z različnimi agenti. genotipa ali phenotypic preskušanju (če je na voljo) in zdravljenje je treba zgodovino vodnik za uporabo darunavir.

Symtuza Европска Унија - Словеначки - EMA (European Medicines Agency)

symtuza

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.

Abiraterone Accord Европска Унија - Словеначки - EMA (European Medicines Agency)

abiraterone accord

accord healthcare s.l.u. - abirateron acetat - prostatične neoplazme - endokrini terapija - abiraterone accord is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedthe treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.