Je was op zoek naar: bikalutamid (Sloveens - Engels)

bikalutamid
bicalutamide

mednarodno nelastniško ime (inn): bikalutamid
international non-proprietary name (inn): bicalutamide

bikalutamid teva 150 mg filmsko obložene tablete
bikalutamid teva 150 mg filmsko oblož ene tablete

kaj je zdravilo bikalutamid in zakaj ga uporabljamo
what bicalutamide is and what it is used for

dogodki (%) pri bolnikih, ki so prejemali bikalutamid
events (%) in bicalutamide patients

dopolnili za zdravila, ki vsebujejo bikalutamid 150 mg.
the committee considered the referral made under article 31 of directive 2001/ 83/ ec, as amended, for medicinal products containing bicalutamide 150 mg.

bikalutamid spada v skupino zdravil, imenovani antiandrogeni.
bicalutamide belongs to the group of anti-androgens.

bikalutamid je nesteroidni antiandrogen brez drugih endokrinih učinkov.
l02bb03 bicalutamide is a non-steroidal anti-androgen without any other endocrine activity.

sploŠni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo bikalutamid 150 mg
overall summary of the scientific evaluation of bicalutamide 150 mg containing medicinal products

bikalutamid je peroralni antiandrogen, ki se uporablja pri zdravljenju raka prostate.
bicalutamide is an oral anti-androgen used in the management of prostate cancer.

- odbor je upošteval, da je bikalutamid 150 mg učinkovit pri zdravljenju lokalno
the committee considered that bicalutamide 150 mg is effective in the treatment of locally advanced prostate cancer; however the chmp considered that the therapeutic indication should be restricted to treatment of patients at high risk of disease progression.

bikalutamid 150 mg se v eu trži na podlagi nacionalnih postopkov in postopka medsebojnega priznavanja.
bicalutamide 150 mg is marketed in the eu following national and mutual recognition application procedures.

o rezultatih mora poročati rms in nacionalnim pristojnim organom, kjer je bikalutamid 150 mg odobren.
the results should be reported to the rms and the ncas where bicalutamide 150 mg is authorised.

razlog za napotitev je bila preverba razmerja med tveganji in koristmi za zdravila, ki vsebujejo bikalutamid 150 mg.
the reasons for referral concerned a review of the benefit/ risk profile of medicinal products containing bicalutamide 150 mg.

pri bolnikih z lokalizirano boleznijo, ki so dobivali samo bikalutamid, ni bilo bistvenih razlik pri preživetju brez napredovanja.
for patients with localised disease, receiving bicalutamide alone, there was no significant difference in progression free survival.

bikalutamid 150 mg se trži v eu po odobritvi vloge za dovoljenje za promet v skladu z nacionalnimi postopki in postopki medsebojnega priznavanja.
bicalutamide 150 mg is marketed in the eu following national and mutual recognition application procedures.

bikalutamid je racemat, katerega antiandrogeno delovanje je skoraj izključno omejeno na (r) - enantiomer.
bicalutamide is a racemate, the (r)-enantiomer of which has most of the anti-androgen activity.

seveda bi bilo treba te rezultate pretehtati ob upoštevanju dobro znanih težav s prenašanjem zdravila casodex (bikalutamid).
these results should of course be balanced against the well-known tolerability issues of casodex (bicalutamide).

chmp je zaključil, da je razmerje med koristmi in tveganji za zdravila, ki vsebujejo bikalutamid 150 mg, pri usklajeni omejeni indikaciji ugodno.
the chmp concluded that the benefit/ risk balance of bicalutamide 150 mg containing medicinal products in the agreed restricted indication is favourable.

bikalutamid je bil uporabljen kot takojšnja hormonska terapija ali kot adjuvantna terapija poleg radikalne prostatektomije ali radioterapije (v prvi vrsti z zunanjim obsevanjem).
bicalutamide 150 mg was studied as a treatment for patients with localized (t1-t2, n0 or nx, m0) or locally advanced (t3-t4, any n, m0; t1-t2, n+, m0) non-metastatic prostate cancer, in a combined analysis of 3 placebo-controlled double-blind studies in 8,113 patients, where the product was given as immediate hormone therapy or as adjuvant to radical prostatectomy or radiotherapy (primarily external beam radiation).