Capecitabine SUN Evropska unija - slovenščina - EMA (European Medicines Agency)

capecitabine sun

sun pharmaceutical industries europe b.v. - kapecitabin - stomach neoplasms; breast neoplasms; colonic neoplasms; colorectal neoplasms - kapecitabin - kapecitabin je indiciran za adjuvantno zdravljenje bolnikov po operaciji stopnje iii (dukes 'stadij c) raka debelega črevesa. capecitabine je primerna za zdravljenje metastatskega raka debelega črevesa in danke. capecitabine je določen za prvo linijo zdravljenja naprednih raka želodca v kombinaciji z platinum, ki temelji režim. capecitabine v kombinaciji z docetaxel je indiciran za zdravljenje bolnikov z lokalno napredno ali metastatskega raka dojke po okvari citotoksična kemoterapija. predhodno zdravljenje bi moralo vključiti antraciklin. capecitabine je prikazano tudi kot monotherapy za zdravljenje bolnikov z lokalno napredno ali metastatskega raka dojke po okvari taxanes in anthracycline-ki vsebujejo kemoterapijo režim ali za koga še anthracycline zdravljenje ni navedeno.

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

mepsevii

ultragenyx germany gmbh - vestronidase alfa - mucopolysaccharidosis vii - encimi - mepsevii je primerna za zdravljenje ne-nevrološke manifestacije mucopolysaccharidosis vii (mps vii; sly sindrom).

Sugammadex Amomed Evropska unija - slovenščina - EMA (European Medicines Agency)

sugammadex amomed

aop orphan pharmaceuticals gmbh - sugammadex sodium - neuromuskularna blokada - vsi drugi terapevtski izdelki - zavrnitev nevromuskularne blokade, ki jo inducira rocuronium ali vecuronium. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

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

cuprymina

a.c.o.m. - advanced center oncology - baker (64cu) klorid - radionuklidno slikanje - various diagnostic radiopharmaceuticals - cuprymina je predhodnik radiofarmaka. niso namenjeni za neposredno uporabo pri bolnikih. to zdravilo je uporabiti le za radioaktivno označevanje prevoznika molekul, ki so bili posebej razviti in dovoljenje za radioaktivno označevanje s tem radionuklida.

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

myalepta

amryt pharmaceuticals dac - metreleptin - lipodystrophy, družinsko delno - drugi zdravljene bolezni prebavil in presnove izdelki, - myalepta je indicirano kot dodatek k dieti kot nadomestno zdravljenje za zdravljenje zapletov leptin pomanjkljivost v lipodystrophy (ld) bolnikov:s potrjeno prirojene splošnih ld (berardinelli-seip sindrom) ali pridobljenih splošnih ld (lawrence sindrom) pri odraslih in otrok do 2 let starosti in abovewith potrdili družinsko delno ld ali pridobljeno delno ld (barraquer-simons sindrom), pri odraslih in otrok 12 let in zgoraj za katere standardno zdravljenje ni uspelo doseči ustrezno presnovno nadzor.

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

kalydeco

vertex pharmaceuticals (ireland) limited - ivacaftor - cistična fibroza - drugi proizvodi dihal - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 in 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 in 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.