FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with a recent history of myocardial infarction or stroke were excluded from this trial.
Croatian: Bolesnici s anamnezom nedavnog infarkta miokarda ili moždanog udara bili su isključeni iz ovog ispitivanja.
English: Treatment with Vargatef may lead to a higher risk of bleeding - if you have recently had a surgery or plan to have a surgery.
Croatian: Liječenje Vargatefom može povećati rizik od krvarenja - ako ste nedavno imali kirurški zahvat ili planirate imate kirurški zahvat.
English: In trial 1199.13 (LUME-Lung 1), there was a higher frequency of SAEs in patients treated with nintedanib plus docetaxel with a body weight of less than 50 kg compared to patients with a weight ≥ 50 kg; however the number of patients with a body weight of less than 50 kg was small.
Croatian: U ispitivanju 1199.13 (LUME-Lung 1) učestalost ozbiljnih štetnih događaja je bila veća u bolesnika liječenih nintedanibom uz docetaksel koji su imali tjelesnu težinu manju od 50 kg u usporedbi s bolesnicima s težinom ≥ 50 kg; međutim broj bolesnika s tjelesnom težinom manjom od 50 kg bio je mali.
English: It is for adult patients whose NSCLC is of a certain type (“adenocarcinoma”) and who had already received one treatment with another medicine to treat this cancer but whose tumour started to grow again.
Croatian: To je lijek za odrasle bolesnike s određenim tipom raka pluća nemalih stanica („adenokarcinomom“) i u kojih je već ranije provedeno liječenje drugim lijekom protiv tog raka, ali čiji tumor je ponovno počeo rasti.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Vargatef in all subsets of the paediatric population in non-small cell lung cancer (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Vargatef u svim podskupinama pedijatrijske populacije s rakom pluća nemalih stanica (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Therapeutic anticoagulation
Croatian: Terapija antikoagulansima
English: Nintedanib treatment may be resumed at a reduced dose.
Croatian: Liječenje nintedanibom može se nastaviti u smanjenoj dozi.
English: If the patient becomes pregnant while receiving Vargatef, she should be apprised of the potential hazard to the foetus.
Croatian: Ako bolesnica zatrudni tijekom primanja Vargatefa, mora ju se obavijestiti o potencijalnoj opasnosti za fetus.
English: Based on the high inter-individual variability of exposure observed in the clinical LUME-Lung-1 trial these effects are not considered clinically relevant.
Croatian: Na temelju visoke interindividualne varijabilnosti u izloženosti, koja je opažena u kliničkom ispitivanju LUME-Lung-1, ovi učinci se ne smatraju klinički značajnima.
English: Therefore treatment with Vargatef will usually be interrupted if you are having surgery.
Croatian: Stoga će se liječenje Vargatefom u pravilu privremeno prekinuti ako idete na operaciju.
English: Mild liver enzyme increases, which were not due to serious adverse effects such as diarrhoea, were only observed in Rhesus monkeys.
Croatian: Blaga povećanja vrijednosti jetrenih enzima, koja nisu bila povezana s ozbiljnim štetnim učincima poput proljeva, opažena su samo u Rhesus majmuna.
English: Treatment with nintedanib did not significantly change the time to deterioration of the pre-specified symptoms cough, dyspnoea and pain, but resulted in a significant deterioration in the diarrhoea symptom scale.
Croatian: Liječenje nintedanibom nije značajno promijenilo vrijeme do pogoršavanja prethodno specificiranih simptoma kašlja, dispneje i boli, ali je rezultiralo značajnim pogoršanjem u skali simptoma proljeva.
English: Patients with known allergy to peanut protein carry an enhanced risk for severe reactions to soya preparations.
Croatian: Bolesnici s poznatom preosjetljivošću na protein kikirikija imaju povećani rizik od teških reakcija na sojine preparate.
English: No QT prolongation was observed for nintedanib in the clinical trial program (see section 5.1).
Croatian: Nije opaženo produljenje QT intervala za nintedanib u programu kliničkih ispitivanja (vidjeti dio 5.1).
English: The highest single dose of nintedanib administered in phase I studies was 450 mg once daily.
Croatian: Najveća jednokratna doza nintedaniba primijenjena u ispitivanjima faze I bila je 450 mg jedanput dnevno.
English: The population mean exposure to nintedanib was 33 - 50 % higher in Chinese, Taiwanese, and Indian patients and 16 % higher in Japanese patients while it was 16 - 22 % lower in Koreans compared to Caucasians (body weight corrected).
Croatian: Populacijska srednja vrijednost izloženosti nintedanibu bila je 33 - 50 % veća u kineskih, tajvanskih i indijskih bolesnika i 16 % viša u japanskih bolesnika, dok je 16 - 22 % niža bila u korejskih u usporedbi s bolesnicima bijele rase (korigirano prema tjelesnoj težini).
English: Do not stop taking Vargatef without consulting your doctor first.
Croatian: Nemojte prestati uzimati Vargatef bez prethodne konzultacije sa svojim liječnikom.
English: No adjustment of the initial dosing is required on the basis of a patient's age (see section 5.2).
Croatian: Nije potrebno prilagoditi početnu dozu na temelju dobi bolesnika (vidjeti dio 5.2).
English: Women of childbearing potential being treated with Vargatef should be advised to avoid becoming pregnant while receiving this treatment and to use adequate contraception during and at least 3 months after the last dose of Vargatef.
Croatian: Ženama reproduktivne dobi koje se liječe Vargatefom mora se savjetovati da izbjegavaju trudnoću tijekom ovog liječenja te da koriste odgovarajuću kontracepciju tijekom i najmanje 3 mjeseca nakon posljednje doze Vargatefa.
English: Dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) measurements showed an anti-angiogenic effect of nintedanib in humans.
Croatian: Dinamička mjerenja kontrastom pojačanom magnetskom rezonancijom (DCE-MRI) pokazala su antiangiogeni učinak nintedaniba u ljudi.
English: Within each frequency grouping adverse reactions are presented in order of decreased seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane prema redoslijedu smanjenja ozbiljnosti.
English: Therefore close monitoring is recommended in patients weighing < 50 kg.
Croatian: Preporučuje se pažljivo nadzirati bolesnike koji teže manje od 50 kg.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE31
Croatian: Farmakoterapijska skupina: Antineoplastici, inhibitori protein-kinaze, ATK oznaka: L01XE31.
English: If a dose of nintedanib is missed, administration should resume at the next scheduled time at the recommended dose.
Croatian: Ako se propusti doza nintedaniba, primjenu treba nastaviti u sljedeće predviđeno vrijeme u preporučenoj dozi.
English: Patients were randomized (1:1) to receive nintedanib 200 mg orally twice daily in combination with 75 mg/m of intravenous docetaxel every 21 days (n = 655) or placebo orally twice daily in combination with 75 mg/m2 of docetaxel every 21 days (n = 659).
Croatian: Bolesnici su bili randomizirani (1:1) kako bi primili nintedanib 200 mg peroralno dvaput dnevno u kombinaciji s 75 mg/m intravenskog docetaksela svakih 21 dan (n = 655) ili placebo peroralno dvaput dnevno u kombinaciji s 75 mg/m2 docetaksela svakih 21 dan (n = 659).
English: Elevation of liver enzymes (ALT, AST, ALKP, gammaglutamyltransferase (GGT)) and bilirubin were reversible upon dose reduction or interruption in the majority of cases.
Croatian: Povišenja vrijednosti jetrenih enzima (ALT, AST, AP, gama-glutamiltransferaze (GGT)) i bilirubina su u većini slučajeva nakon sniženja doze ili prekida primjene bila reverzibilna.
English: In patients on chronic low dose therapy with low molecular weight heparins or acetylsalicylic acid, no increased frequency of bleeding was observed.
Croatian: U bolesnika na kroničnoj niskodoznoj terapiji heparinima male molekulske mase ili acetilsalicilatnom kiselinom, nije opažena povećana učestalost krvarenja.
English: The trial included 658 patients (50.1 %) with adenocarcinoma, 555 patients (42.2 %) with squamous cell carcinoma, and 101 patients (7.7 %) with other tumour histologies.
Croatian: Ispitivanje je uključivalo 658 bolesnika (50,1 %) s adenokarcinomom, 555 bolesnika (42,2 %) s karcinomom skvamoznih stanica i 101 bolesnika (7,7 %) s tumorom drugog histološkog nalaza.
English: Based on population pharmacokinetic (PK) analyses, no a priori dose adjustments of Vargatef are necessary (see section 5.2).
Croatian: Na temelju populacijskih farmakokinetičkih analiza, a priori nisu potrebne prilagodbe doze Vargatefa (vidjeti dio 5.2).
English: Patients who developed thromboembolic events during treatment and who required anticoagulant treatment were allowed to continue Vargatef and did not show an increased frequency of bleeding events.
Croatian: Bolesnicima koji su razvili tromboembolijske događaje tijekom liječenja i koji su trebali antikoagulacijsko liječenje, bilo je dozvoljeno nastaviti primjenu Vargatefa, i oni nisu pokazali veću učestalost događaja krvarenja.
English: Neutropenia and sepsis
Croatian: Neutropenija i sepsa
English: It is important that the patient's blood counts are monitored during therapy, in particular during the combination treatment with docetaxel (see section 4.4).
Croatian: Važno je kontrolirati krvnu sliku bolesnika tijekom terapije, a naročito tijekom kombiniranog liječenja s docetakselom (vidjeti dio 4.4).
English: Progression free survival (PFS)* - primary analysis Patients, n
Croatian: Preživljenje bez progresije (PFS)* - primarna analiza Bolesnici, n
English: Tell your doctor or pharmacist immediately if you become pregnant during treatment with Vargatef.
Croatian: Odmah obavijestite svog liječnika ili ljekarnika ako zatrudnite tijekom liječenja Vargatefom.
English: A pre-specified evaluation was performed in the population of adenocarcinoma patients considered to have entered the trial with a particularly poor treatment prognosis, namely, patients who progressed during or shortly after first-line therapy prior to trial entry.
Croatian: Prethodno specificirana procjena izvedena je u populaciji bolesnika s adenokarcinomom za koje se smatralo da su u ispitivanje ušli s posebno lošom prognozom liječenja, odnosno, bolesnici čija je bolest napredovala tijekom ili neposredno nakon prve linije liječenja prije ulaska u ispitivanje.
English: BIBF 1202 is subsequently glucuronidated by UGT enzymes, namely UGT 1A1, UGT 1A7, UGT 1A8, and UGT 1A10 to BIBF 1202 glucuronide.
Croatian: BIBF 1202 se potom glukuronizira enzimima UGT, i to UGT 1A1, UGT 1A7, UGT 1A8 i UGT 1A10, u BIBF 1202 glukuronid.
English: In rats, small amounts of radiolabelled nintedanib and/or its metabolites were excreted into the milk (≤ 0.5 % of the administered dose).
Croatian: U štakora, male količine radiooznačenog nintedaniba i/ili njegovih metabolita izlučile su se u mlijeko (≤ 0,5% primijenjene doze).
English: Total plasma clearance after intravenous infusion was high (CL: 1390 mL/min, 28.8 % gCV).
Croatian: Ukupni plazmatski klirens nakon intravenske infuzije bio je visok (CL: 1390 ml/min., 28,8 % gCV).
English: Only a minor extent of the biotransformation of nintedanib consisted of CYP pathways with CYP 3A4 being the predominant enzyme involved.
Croatian: Samo je mali dio biotransformacije nintedaniba uključivao CYP puteve s CYP 3A4 kao glavnim uključenim enzimom.
English: The proportion of adenocarcinoma patients with stage < IIIB/IV at diagnosis was small and balanced across treatment arms (placebo: 54 patients (16.1 %); nintedanib: 50 patients, (15.5 %)).
Croatian: Udio bolesnika s adenokarcinomom sa stadijem bolesti < IIIB/IV prilikom dijagnoze bio je malen i uravnotežen kroz liječene skupine (placebo: 54 bolesnika (16,1 %); nintedanib: 50 bolesnika (15,5 %)).
English: If you cannot tolerate the recommended dose of 400 mg per day because of side effects (see section 4), your doctor may reduce the daily dose of Vargatef.
Croatian: Ako ne podnosite preporučenu dozu od 400 mg dnevno zbog nuspojava (vidjeti dio 4), Vaš liječnik može smanjiti dnevnu dozu Vargatefa.
English: During treatment with Vargatef your doctor will regularly monitor your blood cells and examine you for signs of infection, such as inflammation, fever or tiredness.
Croatian: Tijekom liječenja Vargatefom Vaš liječnik će redovito provjeravati Vašu kompletnu krvnu sliku i pregledavati Vas radi znakova infekcije, poput upale, vrućice ili umora.
English: Do not take Vargatef on the same day as your chemotherapy treatment with docetaxel.
Croatian: Ne uzimajte Vargatef istog dana kada primate kemoterapijsko liječenje docetakselom.
English: Limited safety data available from 9 patients with moderate hepatic impairment (Child Pugh B) are insufficient to characterize this population.
Croatian: Ograničeni podaci o sigurnosti primjene lijeka dobiveni od 9 bolesnika s umjerenim oštećenjem funkcije jetre (Child Pugh B) nisu dovoljni za karakterizaciju ove populacije.
English: There are no data available from clinical trials for patients with inherited predisposition to bleeding or for patients receiving a full dose of anticoagulative treatment prior to start of treatment with Vargatef (for post-marketing experience, see ‘Haemorrhage' above).
Croatian: Nema dostupnih podataka iz kliničkih ispitivanja za bolesnike s nasljeđenom predispozicijom za krvarenje ili bolesnike koji primaju punu dozu antikoagulacijskog liječenja prije počinjanja liječenja Vargatefom (za iskustvo nakon stavljanja lijeka u promet, vidjeti „Krvarenje“ gore).
English: Nintedanib may cause foetal harm in humans (see section 5.3).
Croatian: Nintedanib može prouzročiti fetalno oštećenje u ljudi (vidjeti dio 5.3).
English: This result was confirmed in the follow-up PFS analysis (HR 0.85, 95 % CI: 0.75 - 0.96; p = 0.0070) which included all events collected at the time of the final OS analysis.
Croatian: Ovaj je rezultat potvrđen u analizi praćenja preživljenja bez napredovanja bolesti (HR 0,85 %, 95 % CI: 0,75-0,96; p = 0,0070), koja je uključivala sve događaje prikupljene u vrijeme zaključne analize ukupnog preživljenja.
English: Co-administration of nintedanib with docetaxel (75 mg/m²) did not alter the pharmacokinetics of either medicinal product to a relevant extent.
Croatian: Istodobna primjena nintedaniba s docetakselom (75 mg/m²) nije značajno promijenila farmakokinetiku niti jednog od lijekova.
English: Mild to moderate epistaxis represented the most frequent bleeding event.
Croatian: Blaga do umjerena epistaksa je predstavljala najčešći oblik krvarenja.
English: As several other tyrosine kinase inhibitors are known to exert an effect on QT, caution should be exercised when administering nintedanib in patients who may develop QTc prolongation.
Croatian: Budući da je za nekoliko drugih inhibitora tirozin kinaza poznato da utječu na QT interval, nintedanib se mora primjenjivati s oprezom u bolesnika koji mogu razviti produljenje QTc intervala.
English: In the clinical trial LUME-Lung 1 (see section 5.1), the majority of patients had mild to moderate diarrhoea.
Croatian: U kliničkom ispitivanju LUME-Lung 1 (vidjeti dio 5.1), većina bolesnika je imala blagi do umjereni proljev.
English: Patients treated with Vargatef have an increased risk of venous thromboembolism including pulmonary embolism and deep vein thrombosis.
Croatian: Bolesnici liječeni Vargatefom imaju povećani rizik od venske tromboembolije uključujući plućnu emboliju i duboku vensku trombozu.
English: Based on preclinical investigations there is no evidence for impairment of male fertility (see section 5.3).
Croatian: Na temelju pretkliničkih istraživanja, ne postoje dokazi o smanjenju muške plodnosti (vidjeti dio 5.3).
English: Logistic regression revealed a statistically significant association between nintedanib exposure and DCE-MRI response.
Croatian: Logistička regresija utvrdila je statistički značajnu povezanost između izloženosti nintedanibu i odgovora DCE-MRI.
English: Patients may continue therapy with nintedanib after discontinuation of docetaxel for as long as clinical benefit is observed or until unacceptable toxicity occurs.
Croatian: Bolesnici mogu nastaviti liječenje nintedanibom nakon prekida terapije docetakselom sve dok je vidljiva klinička dobrobit ili do pojave neprihvatljive toksičnosti.
English: The frequency of gastrointestinal perforation was comparable between the treatment arms in the clinical trial.
Croatian: Učestalost gastrointestinalne perforacije je bila usporediva između liječenih skupina u kliničkom ispitivanju.
English: Transaminase, ALKP and bilirubin levels should be investigated before initiation of the combination treatment with Vargatef plus docetaxel.
Croatian: Vrijednosti transaminaza, AP i bilirubina treba ispitati prije početka kombiniranog liječenja Vargatefom i docetakselom.
English: Nevertheless, the overall treatment benefit of nintedanib was observed without adversely affecting self-reported quality of life.
Croatian: Unatoč tome, cjelokupna korist liječenja nintedanibom uočena je bez štetnog djelovanja na kvalitetu života koju je bolesnik sam prijavio.
English: Therefore, it is not recommended to treat these patients with Vargatef.
Croatian: Stoga se ne preporučuje liječiti ove skupine bolesnika Vargatefom.
English: Of note, pre-planned analyses according to histology showed statistically significant difference in OS between treatment arms in the adenocarcinoma population only (Table 4).
Croatian: Potrebno je napomenuti da su prethodno planirane analize u skladu s histološkim nalazima pokazale značajnu razliku u ukupnom preživljavanju između liječenih skupina samo u populaciji adenokarcinoma (tablica 4).
English: Nintedanib blocks the activity of a group of proteins which are involved in the development of new blood vessels that cancer cells need to supply them with food and oxygen.
Croatian: Nintedanib blokira aktivnost skupine proteina koji su uključeni u razvoj novih krvnih žila koje su potrebne stanicama raka kako bi ih opskrbljivale hranom i kisikom.
English: What you need to know before you take Vargatef
Croatian: Što morate znati prije nego počnete uzimati Vargatef
English: The contribution of renal excretion to the total clearance was low (0.649 % of dose, 26.3 % gCV).
Croatian: Doprinos bubrežnog izlučivanja ukupnom klirensu bio je nizak (0,649 % doze, 26,3 % gCV).
English: No increased frequency of cerebral bleeding in patients with adequately pre-treated brain metastases which were stable for ≥ 4 weeks before start of treatment with Vargatef was observed.
Croatian: Nije opažena povećana učestalost cerebralnog krvarenja u bolesnika s prethodno odgovarajuće liječenim metastazama u mozgu koje su bile stabilne ≥ 4 tjedana prije početka liječenja Vargatefom.
English: Less than 1 % of a single dose of nintedanib is excreted via the kidney (see section 5.2).
Croatian: Manje od 1 % jednokratne doze nintedaniba se izlučuje putem bubrega (vidjeti dio 5.2).
English: For information about special populations, recommended measures and dosing adjustments in case of liver enzyme and bilirubin elevations, see sections 4.4 and 4.2, respectively.
Croatian: Za informacije o posebnim skupinama, preporučenim mjerama i prilagodbama doziranja u slučaju porasta vrijednosti jetrenih enzima i bilirubina vidjeti dio 4.4 odnosno 4.2.
English: Myocardial infarction (see section 4.4)
Croatian: Srčani poremećaji infarkt miokarda (vidjeti dio 4.4)
English: The primary endpoint was progression-free survival (PFS) as assessed by an independent review committee (IRC) based on the intent-to-treat (ITT) population and tested by histology.
Croatian: Primarni ishod bio je preživljenje bez progresije bolesti (PFS; engl. progression-free survival) prema procjeni neovisnog povjerenstva za procjenu (IRC; engl. independent review committee) na temelju skupine planirane za liječenje (ITT; engl. intent-to-treat) i histološkog ispitivanja.
English: Supportive care for nausea and vomiting may include medicinal products with anti-emetic properties, e.g. glucocorticoids, anti-histamines or 5-HT3 receptor antagonists and adequate hydration.
Croatian: Potporno liječenje mučnine i povraćanja može uključivati lijekove s antiemetičkim djelovanjem, npr. glukokortikoide, antihistaminike ili antagoniste 5-HT3 receptora te odgovarajući nadomjestak tekućine.
English: In addition Fms-like tyrosine-protein kinase (Flt)-3, lymphocyte-specific tyrosine-protein kinase (Lck) and proto-oncogene tyrosine-protein kinase Src (Src) are inhibited.
Croatian: Nadalje, inhibirane su Fms-slična protein-tirozin-kinaza (Flt)-3, limfocit-specifična protein-tirozin-kinaza (Lck) i proto-onkogen protein-tirozin-kinaza Src (Src).
English: Therapy with Vargatef should be permanently discontinued in patients who develop gastrointestinal perforation.
Croatian: Liječenje Vargatefom se mora trajno prekinuti u bolesnika koji razviju gastrointestinalnu perforaciju.
English: Nausea and vomiting, mostly of mild to moderate severity, were frequently reported gastrointestinal adverse reactions (see section 4.8).
Croatian: Mučnina i povraćanje, najčešće blage do umjerene težine, bile su često prijavljene gastrointestinalne nuspojave (vidjeti dio 4.8).
English: Nintedanib is predominantly eliminated via biliary/faecal excretion (> 90 %).
Croatian: Nintedanib se pretežno izlučuje putem žuči/stolice (> 90%).
English: The rates of sepsis (1.3 %) and febrile neutropenia (7.5 %) were increased under treatment with nintedanib as compared to the placebo arm.
Croatian: Učestalost sepse (1,3 %) i febrilne neutropenije (7,5 %) bila je povećana pri liječenju nintedanibom u usporedbi sa skupinom koja je primala placebo.
English: If necessary, your doctor may further reduce your daily dose to 200 mg per day (two capsules of 100 mg).
Croatian: Ako je potrebno, liječnik može dodatno smanjiti Vašu dnevnu dozu na 200 mg dnevno (dvije kapsule od 100 mg).
English: In vitro, CYP-dependent metabolism accounted for about 5 % compared to about 25 % ester cleavage.
Croatian: O CYP-u ovisan metabolizam u in vitro uvjetima bio je odgovoran za približno 5 % cijepanja u usporedbi s 25 % cijepanja estera.
English: Subsequent complications such as sepsis or febrile neutropenia have been observed.
Croatian: Opažene su naknadne komplikacije poput sepse ili febrilne neutropenije.
English: Observed adverse events were consistent with the known safety profile of nintedanib, i.e. increased liver enzymes and gastrointestinal symptoms.
Croatian: Uočeni štetni događaji odgovarali su poznatom profilu sigurnosti nintedaniba, tj. povećanim vrijednostima jetrenih enzima i gastrointestinalnim simptomima.
English: Patients taking concomitant anticoagulation, such as warfarin or phenprocoumon should be monitored regularly for changes in prothrombin time, international normalised ratio (INR), and clinical bleeding episodes.
Croatian: Bolesnike, koji su istodobno na antikoagulacijskoj terapiji, poput varfarina ili fenprokumona, mora se redovito nadzirati u smislu promjene protrombinskog vremena, internacionalnog normaliziranog omjera (INR) i kliničkih epizoda krvarenja.
English: Treatment with Vargatef should therefore only be initiated or - in case of perioperative interruption - resumed based on clinical judgement of adequate wound healing.
Croatian: Liječenje Vargatefom stoga se smije započeti ili, u slučaju perioperativnog prekida, nastaviti na temelju kliničke procjene odgovarajućeg cijeljenja rane.
English: Five point eight percent (5.8 %) of the patients had stable brain metastasis at trial entry and 3.8 % had prior bevacizumab treatment.
Croatian: Pri ulasku u ispitivanje, 5,8 % bolesnika imalo je stabilne metastaze u mozgu, a 3,8 % ih je prethodno bilo liječeno bevacizumabom.
English: Diarrhoea occurred in 43.4 % (≥ grade 3: 6.3 %) of adenocarcinoma patients in the nintedanib arm.
Croatian: Proljev se javio u 43,4 % (≥ stupanj 3: 6,3 %) bolesnika s adenokarcinomom u skupini liječenoj nintedanibom.
English: Common side effects(may affect up to 1 in10 people) Blood poisoning (sepsis) -please see above
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba) - Trovanje krvi (sepsa) - molimo pogledati tekst gore