FrancophonIA/ELRC3.0 huggingface dataset:
English: As shown in Table 4, the addition of nintedanib to docetaxel led to a statistically significant reduction in the risk of progression or death by 23 % for the adenocarcinoma population (HR 0.77; 95 % CI: 0.62 - 0.96).
Slovenian: Kot prikazuje preglednica 4, je dodajanje nintedaniba k docetakselu povzročilo statistično značilno zmanjšanje tveganja za napredovanje bolezni ali smrt za 23 % za populacijo z adenokarcinomom (RO 0,77; 95-odstotni IZ: 0,62-0,96).
English: Peripheral neuropathy was reported in 16.5 % of patients in the placebo arm and in 19.1 % of patients in the nintedanib arm.
Slovenian: O njej so poročali pri 16,5 % bolnikov v skupini s placebom in pri 19,1 % bolnikov v skupini z nintedanibom.
English: Do not use this medicine after the expiry date which is stated on the carton and blisters.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnih omotih.
English: Co-administration with the potent P-gp inhibitor ketoconazole increased exposure to nintedanib 1.61-fold based on AUC and 1.83-fold based on Cmax in a dedicated drug-drug interaction study.
Slovenian: Sočasno dajanje z močnim zaviralcem P-gp, ketokonazolom, je povečalo izpostavljenost nintedanibu za 1,61-krat na podlagi AUC in za 1,83-krat na podlagi Cmax v namenskih študijah o medsebojnem delovanju med zdravili.
English: Dietary soya-products are known to cause allergic reactions including severe anaphylaxis in persons with soya allergy.
Slovenian: Znano je, da sojini prehranski izdelki pri osebah z alergijo na sojo povzročajo alergijske reakcije, vključno z resno anafilaksijo.
English: The recommended dose is two capsules per day (this is a total of 300 mg nintedanib per day).
Slovenian: Priporočeni odmerek sta dve kapsuli na dan (skupaj 300 mg nintedaniba na dan).
English: PK-efficacy analyses were not performed for clinical endpoints.
Slovenian: Farmakokinetičnih analiz učinkovitosti za klinične opazovane dogodke niso opravili.
English: If you cannot tolerate the recommended dose of 300 mg per day because of side effects (see section 4), your doctor may reduce your recommended daily dose of Vargatef to 200 mg per day (two capsules of 100 mg).
Slovenian: Če zaradi neželenih učinkov ne prenašate priporočenega odmerka 300 mg zdravila Vargatef na dan (glejte 4. poglavje), lahko zdravnik zmanjša vaš dnevni odmerek na 200 mg na dan (dve kapsuli po 100 mg).
English: Therefore, women should not breast-feed during treatment with Vargatef.
Slovenian: Zato ženske med zdravljenjem z zdravilom Vargatef ne bi smele dojiti.
English: In case of specific elevations of aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) values to > 3 x upper limit normal (ULN) in conjunction with an increase of total bilirubin to ≥ 2 x ULN and alkaline phosphatase (ALKP) < 2 x ULN (see Table 2) treatment with Vargatef should be interrupted.
Slovenian: V primeru specifičnih povišanih vrednosti aspartat-aminotransferaze (AST) / alanin-aminotransferaze (ALT) na > 3 x zgornjo mejo normalnih vrednosti (ULN) v povezavi s povečanjem celokupnega bilirubina na ≥ 2 x ULN in alkalne fosfataze (ALKP) < 2 x ULN (glejte Preglednico 2) je treba zdravljenje z zdravilom Vargatef prekiniti.
English: Vargatef 150 mg soft capsules Pack-size: 60 capsules.
Slovenian: Vargatef 150 mg mehke kapsule Velikost pakiranja: 60 kapsul.
English: If you stop taking Vargatef
Slovenian: Če ste prenehali jemati zdravilo Vargatef
English: Randomization was stratified according to Eastern Cooperative Oncology Group (ECOG) status (0 versus 1), bevacizumab pretreatment (yes versus no), brain metastasis (yes versus no) and tumour histology (squamous versus non-squamous tumour histology).
Slovenian: Randomizacija je bila stratificirana glede na stanje zmogljivosti po lestvici Eastern Cooperative Oncology Group (ECOG) (0 ali 1), predhodno zdravljenje z bevacizumabom (da ali ne), metastaze v možganih (da ali ne) in histologijo tumorja (ploščatocelična ali neploščatocelična histologija tumorja).
English: For patients with tumour of adenocarcinoma histology, 15.8 % had disease stage < IIIB/IV, 15.2 %, had disease stage IIIB and 69.0 % had disease stage IV. 5.8 % of the adenocarcinoma patients entered the trial with locally recurrent disease stage as had been evaluated at baseline.
Slovenian: Pri bolnikih s tumorjem s histologijo adenokarcinoma je 15,8 % bolnikov imelo bolezen stopnje < IIIB/IV, 15,2 % bolezen stopnje IIIB in 69,0 % jih je imelo bolezen stopnje IV. 5,8 % bolnikov z adenokarcinomom je vstopilo v preskušanje z lokalno ponovljeno boleznijo na stopnji izhodiščne ocene.
English: In volunteers with moderate hepatic impairment (Child Pugh B), exposure was 7.6-fold higher based on Cmax (90 % CI 4.4 - 13.2) and 8.7fold higher (90 % CI 5.7 - 13.1) based on AUC, respectively, compared to healthy volunteers.
Slovenian: Pri prostovoljcih z zmerno jetrno okvaro (Child Pugh B) je bila izpostavljenost v primerjavi z zdravimi osebami 7,6-krat večja na podlagi Cmax (90-% IZ 4,4 - 13,2) oz. 8,7-krat večja (90-% IZ 5,7 - 13,1) na podlagi AUC.
English: Figure 1: Kaplan-Meier curve for overall survival for patients with adenocarcinoma tumour histology by treatment group in trial LUME-Lung 1
Slovenian: Kaplan-Meierjeva krivulja celokupnega preživetja za bolnike s tumorjem z adenokarcinomsko histologijo po skupinah v preskušanju LUME-Lung 1
English: Women who can become pregnant must use an effective combination of birth control methods, including barrier methods as a second form of contraception, while they are taking Vargatef and for at least 3 months after stopping treatment.
Slovenian: Ženske, ki lahko zanosijo, morajo med jemanjem zdravila Vargatef in še vsaj 3 mesece po koncu zdravljenja, uporabljati zanesljivo kombinacijo kontracepcije, vključno s pregradnimi metodami kot drugo obliko kontracepcije.
English: You will be prescribed the appropriate capsule strength by your doctor if this happens.
Slovenian: Če se to zgodi, vam bo zdravnik predpisal kapsule ustrezne jakosti.
English: Do not use this medicine after the expiry date which is stated on the carton, wrapper and blisters.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, ovojnini ali pretisnih omotih.
English: If a dose of nintedanib is missed, administration should resume at the next scheduled time at the recommended dose.
Slovenian: Če bolnik pozabi vzeti priporočeni odmerek nintedaniba, naj ga začne ponovno jemati ob naslednjem načrtovanem času.
English: For recommended measures and dosing adjustments in case of diarrhoea, see sections 4.4 and 4.2, respectively.
Slovenian: Za priporočene ukrepe in prilagajanje odmerjanja pri driski glejte poglavji 4.4 in 4.2.
English: After treatment interruption and recovery of transaminase-values to ≤ 2.5 x ULN in conjunction with bilirubin to normal, dose reduction from 200 mg twice daily to 150 mg twice daily and - if a 2
Slovenian: Po prekinitvi zdravljenja in vrnitvi vrednosti transaminaze na ≤ 2,5 x ULN in bilirubina na normalno vrednost je treba odmerek zmanjšati z 200 mg dvakrat na dan na 150 mg dvakrat na dan.
English: In preclinical disease models nintedanib, as single agent, effectively interfered with the formation and maintenance of the tumour vascular system resulting in tumour growth inhibition and tumour stasis.
Slovenian: V predkliničnih modelih te bolezni je nintedanib kot samostojna učinkovina uspešno oviral nastajanje in ohranjanje tumorskega žilnega sistema, kar je zavrlo rast tumorja in povzročilo njegov zastoj.
English: The frequency of gastrointestinal perforation was comparable between the treatment arms in the clinical trial.
Slovenian: Pogostnost predrtja prebavil je bila v kliničnem preskušanju med dvema skupinama primerljiva.
English: Vargatef capsules contain the active substance nintedanib.
Slovenian: Kapsule Vargatef vsebujejo zdravilno učinkovino nintedanib.
English: For the management of selected adverse reactions, see section 4.4.
Slovenian: Za obravnavo izbranih neželenih učinkov glejte poglavje 4.4.
English: This could be symptoms of serious liver problems - if you develop fever as this could be a symptom of febrile neutropenia or sepsis (see section 4) - if you experience severe pain in your stomach area, fever, chills, sickness, vomiting, or abdominal rigidity or bloating, as these could be symptoms of a hole in the wall of your gut (‘gastrointestinal perforation') - if you experience pain, swelling, reddening, warmth of a limb or if you experience chest pain and difficulty to breathe as these could be symptoms of a blood clot in one of your veins - if you have any major bleeding - if you experience chest pressure or pain, typically on the left side of the body, pain in the neck, jaw, shoulder or arm, a fast heartbeat, shortness of breath, nausea, vomiting, as this could be symptoms of a heart attack - if any side effect(s) you may get (see section 4) becomes serious
Slovenian: To so lahko simptomi resnih težav z jetri; - če se pojavi zvišana telesna temperatura, saj je lahko to simptom febrilne nevtropenije ali sepse (glejte poglavje 4); - če se pojavijo: huda bolečina v predelu trebuha, zvišana telesna temperatura, mrzlica, siljenje na bruhanje, bruhanje, otrdelost ali napihnjenost trebuha, ker so to lahko simptomi luknje v črevesni steni (predrtja prebavil); - če se pojavijo bolečina, oteklina, rdečina, toplota okončine ali bolečina v prsnem košu in oteženo dihanje, saj so to lahko simptomi krvnega strdka v kateri od ven; - če imate kakršnokoli večjo krvavitev, - če vas tišči ali boli v prsih, običajno na levi strani telesa, imate bolečine v vratu, čeljusti, rami ali roki, vam srce hitreje bije, imate kratko sapo, vam je slabo, bruhate, saj so to lahko simptomi srčnega infarkta; - če katerikoli neželeni učinek/učinki (glejte poglavje 4) postanejo resni.
English: Elevation of AST and/or ALT values to > 2.5 x ULN in conjunction with total bilirubin elevation to ≥ 1.5 x ULN
Slovenian: Povečane vrednosti AST in/ali ALT na > 2,5 x ULN, v povezavi s povečanimi celokupnimi vrednostmi bilirubina ≥1,5 x ULN ALI
English: The following medicines may increase the blood levels of nintedanib, the active substance of Vargatef, and hence may increase the risk for side effects (see section 4): - Ketoconazole (used to treat fungal infections) - Erythromycin (used to treat bacterial infections) The following medicines may decrease the blood levels of nintedanib and thus may lead to reduction of the effectiveness of Vargatef: - Rifampicin (an antibiotic used to treat tuberculosis) - Carbamazepine, phenytoin (used to treat seizures) - St. John's Wort (a herbal medicine to treat depression)
Slovenian: Zdravili, ki lahko povečata raven nintedaniba (zdravilne učinkovine v zdravilu Vargatef) v krvi, in s tem tveganje za neželene učinke (glejte poglavje 4): - ketokonazol (za zdravljenje glivičnih okužb), - eritromicin (uporablja se za zdravljenje bakterijskih okužb), Zdravila, ki lahko zmanjšajo raven nintedaniba v krvi in s tem učinkovitost zdravila Vargatef, pa so: - rifampicin (antibiotik za zdravljenje tuberkuloze), - karbamazepin in fenitoin (za zdravljenje epileptičnih napadov), - šentjanževka (zdravilo rastlinskega izvora za zdravljenje depresije).
English: BIBF 1202 is subsequently glucuronidated by UGT enzymes, namely UGT 1A1, UGT 1A7, UGT 1A8, and UGT 1A10 to BIBF 1202 glucuronide.
Slovenian: Prevladujoča presnovna reakcija nintedaniba je hidrolizna cepitev s pomočjo esteraz, pri kateri nastane prosta kislina BIBF 1202, ki jo nato glukuronizirajo encimi UGT, in sicer UGT 1A1, UGT 1A7, UGT 1A8, in UGT 1A10 v glukuronid BIBF 1202.
English: Post-marketing bleeding events include but are not limited to gastrointestinal, respiratory and central nervous system organs, with the most frequent being respiratory.
Slovenian: Krvavitve v obdobju trženja zdravila vključujejo prebavila, dihala in organe osrednjega živčnega sistema, vendar na njih niso omejene, najbolj pogoste pa so krvavitve v dihalih.
English: Capsule content:Triglyceridesmedium-chain, hard fat, soya lecithin(E322)
Slovenian: Vsebina kapsule trigliceridi, srednjeverižni trda maščoba sojin lecitin (E322)
English: Unless there is an alternative cause established, Vargatef should be permanently discontinued
Slovenian: Če ni ugotovljen drug vzrok, je treba zdravljenje z zdravilom Vargatef trajno prenehati.
English: In a drug-drug interaction study with the potent P-gp inducer rifampicin, exposure to nintedanib decreased to 50.3 % based on AUC and to 60.3 % based on Cmax upon co-administration with rifampicin compared to administration of nintedanib alone.
Slovenian: V njih se je ob sočasnem dajanju močnega induktorja P-gp rifampicina izpostavljenost nintedanibu zmanjšala za 50,3 % na podlagi AUC in za 60,3 % na podlagi Cmax v primerjavi z dajanjem samega nintedaniba.
English: Treatment of diarrhoea at the first signs is important (see section 4) - if you vomit or feel sick (nausea) - if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea coloured) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, or feeling tired.
Slovenian: Pomembno je, da jo zdravite takoj po prvih znakih (glejte poglavje 4); - če bruhate ali vam je slabo (navzea); - če imate nepojasnjene simptome, kot je porumenelost kože ali beločnic (zlatenica), urin temne ali rjave barve (barve čaja), bolečina v zgornjem desnem predelu trebuha (abdomna), hitrejša krvavitev ali nastajanje podplutb kot običajno ali občutek utrujenosti.
English: How to take Vargatef
Slovenian: Kako jemati zdravilo Vargatef
English: Treatment of these patients with nintedanib in combination with docetaxel reduced the risk of death by 25 %, compared with placebo plus docetaxel (HR 0.75; 95 % CI: 0.60 - 0.92; p = 0.0073).
Slovenian: Zdravljenje teh bolnikov z nintedanibom v kombinaciji z docetakselom je zmanjšalo tveganje smrti za 25 % v primerjavi s placebom in docetakselom (RO 0,75; 95-odstotni IZ: 0,60 do 0,92; p = 0,0073).
English: Pack-sizes: 60 or 120 capsules, or multipack of 120 (2 x 60) capsules (2 cartons of 60 capsules each,
Slovenian: Velikosti pakiranja: 60 ali 120 kapsul ali večkratno pakiranje po 120 (2 x 60) kapsul (2 škatli po 60
English: INFORMATION IN BRAILLE Vargatef 150 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Vargatef 150 mg
English: Objective response [%] Odds ratio (95 % CI) p-value+
Slovenian: Razmerje obetov (95-odstotni IZ) vrednost p+
English: The safety, efficacy, and pharmacokinetics of nintedanib have not been studied in patients with severe renal impairment (< 30 ml/min creatinine clearance).
Slovenian: Varnosti, učinkovitosti in farmakokinetike nintedaniba pri bolnikih s hudo ledvično okvaro (očistek kreatinina < 30 ml/min) niso proučevali.