Mircera Evropska unija - slovenščina - EMA (European Medicines Agency)

mircera

roche registration gmbh - metoksi polietilen glikol-epoetin beta - anemia; kidney failure, chronic - antianemični preparati - treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adult patients (see section 5. treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (esa) after their haemoglobin level was stabilised with the previous esa (see section 5.

Darunavir Mylan Evropska unija - slovenščina - EMA (European Medicines Agency)

darunavir mylan

mylan pharmaceuticals limited - darunavir - okužbe z virusom hiv - antivirusi za sistemsko uporabo - darunavir, 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 (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 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. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 in 5. darunavir 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 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) (see section 4.  darunavir mylan 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 (see section 4.  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. 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.