Liên Minh Châu Âu - Tiếng Slovenia - EMA (European Medicines Agency)

astrazeneca ab - olaparib - ovarijske neoplazme - antineoplastična sredstva - ciste na cancerlynparza je označen kot monotherapy za:vzdrževanje zdravljenje odraslih bolnikov z napredovalim (figo fazah iii in iv) brca1/2-mutiral (germline in/ali somatski) high-grade epitelnih jajčnikov, fallopian tube ali primarni trebušno raka, ki so v odziv (popolna ali delna) po koncu prve vrstice platinum, ki temelji kemoterapijo. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 in 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. bolniki morajo imeti predhodno že bili zdravljeni z anthracycline in taxane v (neo)adjuvant ali metastatskim nastavitev, če bolniki niso bili primerni za temi postopki (glej točko 5. bolniki z hormon receptorjev (hr)-pozitivnega raka dojk, je treba tudi napredovala na ali po predhodnem endokrine terapije, ali neprimerna za endokrine terapija. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Liên Minh Châu Âu - Tiếng Slovenia - EMA (European Medicines Agency)

astrazeneca ab - osimertinib mesilate - karcinom, pljučni pljuč - druga zdravila z delovanjem na novotvorbe agenti, protein kinaza inhibitorji - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations. - the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

Liên Minh Châu Âu - Tiếng Slovenia - EMA (European Medicines Agency)

astrazeneca ab - metformin hidroklorid, dapagliflozin propanediol monohidrat - diabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - xigduo je navedeno pri odraslih za zdravljenje diabetesa tipa 2 bolezni, kot dodatek k prehrani in izvajanje:• pri bolnikih, premalo nadzorovana na njihovo maksimalno dopustne odmerek metforminom sam • v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni pri bolnikih zadostno nadzorovana z metforminom in teh zdravil• pri bolnikih, ki se že zdravijo z kombinacijo dapagliflozin in metforminom kot ločene tablete. za študijski rezultati glede kombinacija terapij, vplivi na glycaemic nadzor in srčno-žilne dogodke, in populacije, ki je študiral glej poglavji 4. 4, 4. 5 in 5.

Liên Minh Châu Âu - Tiếng Slovenia - EMA (European Medicines Agency)

astrazeneca ab - saxagliptin - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - add-on combination therapyonglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy:in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate;in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate;as triple oral therapy:in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control;as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Liên Minh Châu Âu - Tiếng Slovenia - EMA (European Medicines Agency)

astrazeneca ab - benralizumab - astma - zdravila za obstruktivne pljučne bolezni, - fasenra je indicirano kot dodatek na vzdrževanje zdravljenje pri odraslih bolnikih s hudo eozinofilno astmo neustrezno nadzorovano kljub visoki odmerki vdihavajo kortikosteroide plus dolgo delujoči beta agonistov.

Liên Minh Châu Âu - Tiếng Slovenia - EMA (European Medicines Agency)

astrazeneca ab - natrijev cirkonij cyclosilicate - hiperkalemija - vsi drugi terapevtski izdelki - lokelma je primerna za zdravljenje hyperkalaemia pri odraslih bolnikih,.

Liên Minh Châu Âu - Tiếng Slovenia - EMA (European Medicines Agency)

astrazeneca ab - durvalumab - karcinom, pljučni pljuč - antineoplastična sredstva - non-small cell lung cancer (nsclc)imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (nsclc) in adults whose tumours express pd-l1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5. imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations. small cell lung cancer (sclc)imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (es-sclc). biliary tract cancer (btc)imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (btc). hepatocellular carcinoma (hcc)imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

Liên Minh Châu Âu - Tiếng Slovenia - EMA (European Medicines Agency)

astrazeneca ab - glycopyrronium, formoterol fumarate dihydrate - pljučna bolezen, kronična obstruktivna bolezen - formoterol in glycopyrronium bromid - bevespi aerosphere je označen kot vzdrževanje bronchodilator zdravljenje za lajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno bolezen (kopb).

Liên Minh Châu Âu - Tiếng Slovenia - EMA (European Medicines Agency)

astrazeneca ab - metformin hidroklorid, saxagliptin, dapagliflozin - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - qtrilmet je navedeno pri odraslih, starih 18 let in več, z vrsto 2 sladkorna bolezen:za izboljšanje glycaemic nadzora, ko je z metforminom ali brez sulfonil sečnine (su) in bodisi saxagliptin ali dapagliflozin ne zagotavlja primerne glycaemic nadzor. ko se že zdravijo z metforminom in saxagliptin in dapagliflozin.

Liên Minh Châu Âu - Tiếng Slovenia - EMA (European Medicines Agency)

astrazeneca ab - formoterol fumarate dihydrate, glycopyrronium bromide, budesonide - pljučna bolezen, kronična obstruktivna bolezen - zdravila za obstruktivne pljučne bolezni, - trixeo aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.