FrancophonIA/ELRC3.0 huggingface dataset:
English: Liver enzyme elevations and hyperbilirubinaemia
Croatian: Porast vrijednosti jetrenih enzima i hiperbilirubinemija
English: In rabbits, embryofoetal lethality was observed at an exposure approximately 8 times higher than at the MRHD.
Croatian: U kunića je zamijećena embriofetalna smrtnost pri izloženosti približno 8 puta većoj od izloženosti pri MRHD-u.
English: Nintedanib is a triple angiokinase inhibitor blocking vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR α and ß) and fibroblast growth factor receptors (FGFR 1-3) kinase activity.
Croatian: Nintedanib je trostruki angiokinazni inhibitor koji blokira kinaznu aktivnost receptora za vaskularni endotelni faktor rasta (VEGFR 1-3; engl. vascular endothelial growth factor receptors), receptora za trombocitni faktor rasta (PDGFR α i ß; engl. platelet-derived growth factor receptors) i receptora za fibroblastni faktor rasta (FGFR 1-3; engl. fibroblast growth factor receptors).
English: Events of pancreatitis have been reported in patients taking nintedanib for the treatment of IPF and NSCLC.
Croatian: Slučajevi pankreatitisa zabilježeni su u bolesnika koji su uzimali nintedanib za liječenje IPF-a i NSCLC-a.
English: Single arm study to examine whether genetic/genomic markers (alone or combined with clinical covariates) could be used to predict overall survival (OS) in NSCLC patients eligible for treatment with nintedanib.
Croatian: 2. Provesti studiju s jednom skupinom kako bi se ispitalo mogu li se genetički/genomski markeri (sami ili u kombinaciji s kliničkim kovarijatama) koristiti za predviđanje ukupnog preživljenja (OS) bolesnika s NSCLC-om koji su podobni za liječenje nintedanibom.
English: Urinary excretion of the unchanged active substance within 48 h was about 0.05 % of the dose (31.5 % gCV) after oral and about 1.4 % of dose (24.2 % gCV) after intravenous administration; the renal clearance was 20 mL/min (32.6 % gCV).
Croatian: Urinarno izlučivanje nepromijenjene djelatne tvari unutar 48 h iznosilo je približno 0,05 % doze (31,5 % gCV) nakon peroralne i približno 1,4 % doze (24,2 % gCV) nakon intravenske primjene; bubrežni klirens je iznosio 20 ml/min. (32,6 % gCV).
English: Your doctor may reduce your recommended dose to 300 mg per day (two capsules of 150 mg).
Croatian: Liječnik Vam može smanjiti preporučenu dozu na 300 mg dnevno (dvije kapsule od 150 mg).
English: In the majority of patients, elevations of liver parameters were reversible.
Croatian: U većine bolesnika porast vrijednosti jetrenih enzima je bio reverzibilan.
English: In the clinical trial (LUME-Lung 1; see section 5.1) with Vargatef, the frequency of bleeding in both treatment arms was comparable (see section 4.8).
Croatian: U kliničkom ispitivanju Vargatefa (LUME-Lung 1; vidjeti dio 5.1), učestalost krvarenja u obje liječene skupine bila je usporediva (vidjeti dio 4.8).
English: The values should be monitored as clinically indicated or periodically during treatment, i.e. in the combination phase with docetaxel at the beginning of each treatment cycle and monthly in case Vargatef is continued as monotherapy after discontinuation of docetaxel.
Croatian: Vrijednosti treba nadzirati prema kliničkoj indikaciji ili povremeno tijekom liječenja, tj. u fazi kombinacije s docetakselom na početku svakog ciklusa liječenja i jednom mjesečno u slučaju kada se Vargatef primjenjuje kao monoterapija nakon prekida liječenja docetakselom.
English: The prevalent metabolic reaction for nintedanib is hydrolytic cleavage by esterases resulting in the free acid moiety BIBF 1202.
Croatian: Dominanta metabolička reakcija za nintedanib je hidrolitičko cijepanje esterazama koje rezultira nastankom BIBF 1202 sa slobodnom kiselinskom skupinom.
English: Diarrhoea (very common, may affect more than 1 in 10 people) Diarrhoea may lead to a loss of fluid and important salts (electrolytes, such as sodium or potassium) in your body.
Croatian: - Proljev (vrlo često, može se javiti u više od 1 na 10 osoba) Proljev može dovesti do gubitka tekućine i važnih soli (elektrolita, poput natrija ili kalija) u Vašem tijelu.
English: Peripheral neuropathy is also known to occur with docetaxel treatment.
Croatian: Poznato je da se periferna neuropatija javlja i pri liječenju docetakselom.
English: The absolute bioavailability of a 100 mg dose was 4.69 % (90 % CI: 3.615 - 6.078) in healthy volunteers.
Croatian: Apsolutna bioraspoloživost doze od 100 mg u zdravih dobrovoljaca iznosila je 4,69 % (90 % CI: 3,615 - 6,078).
English: After food intake, nintedanib exposure increased by approximately 20 % compared to administration under fasted conditions (CI: 95.3 - 152.5 %) and absorption was delayed (median tmax fasted: 2.00 hours; fed: 3.98 h).
Croatian: Nakon unosa hrane izloženost nintedanibu se povećala za približno 20 % u usporedbi s primjenom pod natašte (CI: 95,3 - 152,5 %), a apsorpcija je bila odgođena (medijan tmax natašte: 2,00 sata; uz hranu: 3,98 sati).
English: wrapped in plastic foil).
Croatian: omotanih zajedno s folijom).
English: Neutropenia, febrile neutropenia and sepsis
Croatian: Neutropenija, febrilna neutropenija i sepsa
English: For the management of selected adverse reactions, see section 4.4.
Croatian: Za zbrinjavanje odabranih nuspojava vidjeti dio 4.4.
English: Dietary soya-products are known to cause allergic reactions including severe anaphylaxis in persons with soya allergy.
Croatian: Poznato je da prehrambeni proizvodi soje uzrokuju alergijske reakcije uključujući tešku anafilaksu u osoba preosjetljivih na soju.
English: QT/QTc measurements were recorded and analysed from a dedicated trial comparing nintedanib monotherapy against sunitinib monotherapy in patients with renal cell carcinoma.
Croatian: Mjerenja QT/QTc su zabilježena i analizirana u ispitivanju koje je uspoređivalo nintedanib u monoterapiji nasuprot sunitinibu u monoterapiji u bolesnika s karcinomom bubrežnih stanica.
English: Diarrhoea was the most frequently reported gastro-intestinal adverse reaction and appeared in close temporal relationship with the administration of docetaxel (see section 4.8).
Croatian: Proljev je bio najčešće prijavljena gastrointestinalna nuspojava i pojavio se s uskom vremenskom povezanošću u odnosu na primjenu docetaksela (vidjeti dio 4.8).
English: Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these receptors and blocks the intracellular signalling which is crucial for the proliferation and survival of endothelial as well as perivascular cells (pericytes and vascular smooth muscle cells).
Croatian: Nintedanib se kompetitivno veže na vezno mjesto za adenozin-trifosfat (ATP) ovih receptora i blokira unutarstanični prijenos signala, koji je ključan za proliferaciju i preživljenje kako endotelnih tako i perivaskularnih stanica (pericita i vaskularnih glatkomišićnih stanica).
English: Hypersensitivity to nintedanib, to peanut or soya, or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na nintedanib, na kikiriki ili soju, ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: In rats, embryofoetal lethality and teratogenic effects were observed at exposure levels below human exposure, at the maximum recommended human dose (MRHD) of 200 mg b.i.d.
Croatian: U štakora su zamijećena embriofetalna smrtnost i teratogeni učinci pri izloženosti nižoj od izloženosti u ljudi, pri maksimalnoj preporučenoj ljudskoj dozi (MRHD; engl. maximum recommended human dose) od 200 mg dvaput dnevno.
English: Teratogenic effects on the aortic arches in combination with the heart and the urogenital system were noted at an exposure 4 times higher than at the MRHD and on the embryofoetal development of the axial skeleton at an exposure 3 times higher than at the MRHD.
Croatian: Teratogeni učinci na aortne lukove, srce i urogenitalni sustav primijećeni su pri izloženosti 4 puta većoj od izloženosti pri MRHD-u te na embriofetalni razvoj aksijalnog skeleta pri izloženosti 3 puta većoj od one pri MRHD-u.
English: Vargatef has minor influence on the ability to drive and use machines.
Croatian: Vargatef malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Preclinical studies showed that small amounts of nintedanib and its metabolites (≤ 0.5 % of the administered dose) were secreted into milk of lactating rats.
Croatian: Pretklinička ispitivanja pokazala su da su se male količine nintedaniba i njegovih metabolita (≤ 0,5 % primijenjene doze) izlučile u mlijeko štakora u laktaciji.
English: Adjustment of the starting dose in patients with mild to moderate renal impairment is not required.
Croatian: Prilagodba početne doze u bolesnika s blagim do umjerenim oštećenjem bubrega nije potrebna.
English: Nintedanib and its metabolites, the free acid moiety BIBF 1202 and its glucuronide BIBF 1202 glucuronide, did not inhibit or induce CYP enzymes in preclinical studies(see section 5.2).
Croatian: Nintedanib i njegovi metaboliti, BIBF 1202 sa slobodnom kiselinskom skupinom i njegov glukuronid, BIBF 1202 glukuronid, nisu inhibirali ili inducirali CYP enzime u pretkliničkim ispitivanjima (vidjeti dio 5.2).
English: Tumour angiogenesis is an essential feature contributing to tumour growth, progression and metastasis formation and is predominantly triggered by the release of pro-angiogenic factors secreted by the tumour cell (i.e. VEGF and bFGF) to attract host endothelial as well as perivascular cells to facilitate oxygen and nutrient supply through the host vascular system.
Croatian: Tumorska angiogeneza je esencijalno obilježje koje doprinosi tumorskom rastu, progresiji i nastanku metastaza, te je prvenstveno pokrenuta oslobađanjem proangiogenih faktora koje luče tumorske stanice (tj. VEGF i bFGF) kako bi se privukle endotelne i perivaskularne stanice domaćina u svrhu olakšanja opskrbe kisikom i hranjivim tvarima kroz krvožilni sustav domaćina.
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
Croatian: - ako razvijete vrućicu, jer bi to mogao biti simptom febrilne neutropenije ili sepse (vidjeti dio 4) - ako osjetite jaku bol u području trbuha, dobijete vrućicu, zimicu, mučninu, povraćanje, krutost ili nadutost trbuha, jer bi to mogli biti simptomi pucanja stijenke crijeva (‘gastrointestinalna perforacija‘) - ako osjetite bol u udovima ili razvijete oticanje, crvenilo i toplinu udova ili ako osjetite bol u prsnom košu i otežano dišete, jer bi to mogli biti simptomi nastanka krvnog ugruška u Vašim venama - ako imate veliko krvarenje bilo koje vrste - ako osjetite pritisak ili bol u prsima, tipično na lijevoj strani tijela, bol u vratu, čeljusti, ramenu ili ruci, brze otkucaje srca, nedostatak zraka, mučninu i povraćanje, jer bi to mogli biti simptomi srčanog udara - ako bilo koja od nuspojava koju možete dobiti (vidjeti dio 4) postane ozbiljna
English: Nintedanib is a substrate of P-gp (see section 5.2).
Croatian: Nintedanib je supstrat P-gp-a (vidjeti dio 5.2).
English: As initial measure for the management of adverse reactions (see Tables 1 and 2) treatment with nintedanib should be temporarily interrupted until the specific adverse reaction has resolved to levels that allow continuation of therapy (to grade 1 or baseline).
Croatian: Kao početnu mjeru za zbrinjavanje nuspojava (vidjeti tablice 1 i 2) liječenje nintedanibom treba privremeno prekinuti sve dok se specifična nuspojava ne smanji do razine koja dozvoljava nastavak terapije (do stupnja 1 ili početne vrijednosti).
English: Nintedanib was shown to be not a substrate or inhibitor of OATP-1B1, OATP-1B3, OATP-2B1, OCT-2, or MRP-2 in vitro.
Croatian: In vitro je pokazano da nintedanib nije supstrat niti inhibitor proteina OATP-1B1, OATP-1B3, OATP-2B1, OCT-2 ili MRP-2.
English: Drug-drug interactions between nintedanib and CYP substrates, CYP inhibitors, or CYP inducers are not expected, since nintedanib, BIBF 1202, and BIBF 1202 glucuronide did not inhibit or induce CYP enzymes in preclinical studies nor was nintedanib metabolized by CYP enzymes to a relevant extent.
Croatian: Ne očekuju se interakcije između nintedaniba i CYP supstrata, CYP inhibitora ili CYP induktora, budući da nintedanib, BIBF 1202 i BIBF 1202 glukuronid nisu inhibirali niti inducirali CYP enzime u pretkliničkim ispitivanjima niti su CYP enzimi metabolizirali nintedanib u značajnoj mjeri.
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.
Croatian: U dobrovoljaca s umjerenim oštećenjem funkcije jetre (Child Pugh B), izloženost je bila 7,6 puta veća na temelju Cmax (90% CI 4,4 - 13,2) odnosno 8,7 puta veća (90% CI 5,7 - 13,1) na temelju AUC u usporedbi sa zdravim dobrovoljcima.
English: Post-marketing bleeding events include but are not limited to gastrointestinal, respiratory and central nervous system organs, with the most frequent being respiratory (see also section 4.4).
Croatian: Slučajevi krvarenja nakon stavljanja lijeka u promet uključuju, ali nisu ograničeni na organe probavnog, dišnog i središnjeg živčanog sustava, s time da su najučestaliji bili slučajevi dišnog krvarenja (vidjeti također dio 4.4).
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).
Croatian: Ako ne podnosite preporučenu dozu od 300 mg dnevno zbog nuspojava (vidjeti dio 4), Vaš liječnik može smanjiti Vašu preporučenu dnevnu dozu Vargatefa na 200 mg dnevno (dvije kapsule od 100 mg).
English: In a post-hoc analysis in adenocarcinoma patients having progressed and entered the trial ≥ 9 months since start of their first-line therapy the difference did not reach statistical significance (HR for OS: 0.89, 95 % CI 0.66 - 1.19).
Croatian: U post-hoc analizama bolesnika s adenokarcinomom s uznapredovalom bolešću koji su ušli u ispitivanje nakon 9 ili više mjeseci od početka prve linije liječenja razlika nije dosegla statistički značaj (HR za OS: 0,89, 95 % CI 0,66 - 1,19).
English: However, no thorough QT-trial of nintedanib administered in combination with docetaxel was conducted.
Croatian: Međutim, nije se provelo temeljito QT ispitivanje nintedaniba primijenjenog u kombinaciji s docetakselom.
English: Efficacy results for trial LUME-Lung 1 for patients with adenocarcinoma tumour histology
Croatian: Rezultati djelotvornosti za ispitivanje LUME-Lung 1 za bolesnike s histološkim nalazom adenokarcinoma
English: - if you have high blood pressure - if you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall
Croatian: - ako imate visok krvni tlak - ako imate ili ste imali aneurizmu (proširenje i slabljenje stijenke krvne žile) ili rascjep stijenke krvne žile
English: In case of renal impairment/failure, therapy adjustment should be considered (see section 4.2 Dose adjustments).
Croatian: U slučaju oštećenja/zatajenja bubrega, potrebno je razmotriti prilagodbu terapije (vidjeti dio 4.2 Prilagodba doze).
English: However, an increased frequency of arterial thromboembolic events was observed in patients with idiopathic pulmonary fibrosis (IPF) when treated with nintedanib monotherapy.
Croatian: Međutim, opažena je povećana učestalost arterijskih tromboembolijskih događaja u bolesnika s idiopatskom plućnom fibrozom (IPF) liječenih nintedanibom u monoterapiji.
English: The efficacy and safety of Vargatef was investigated in 1314 adult patients with locally advanced, metastatic or recurrent NSCLC after one prior line of chemotherapy.
Croatian: Djelotvornost i sigurnost Vargatefa bila je istražena u 1314 odraslih bolesnika s lokalno uznapredovalim, metastatskim ili rekurentnim NSCLC-om nakon primjene kemoterapije kao prve linije liječenja.
English: Increased liver enzyme values (gamma-glutamyltransferase) in the blood as seen from blood tests
Croatian: - Porast vrijednosti jetrenih enzima (gama-glutamiltransferaze) u krvi kao što se vidi iz krvnih pretraga
English: In both cases, you should take one capsule of the appropriate strength twice daily approximately 12 hours apart with food (for example in the morning and in the evening) at about the same time of the day.
Croatian: U oba slučaja, morate uzeti po jednu kapsulu odgovarajuće jačine dvaput dnevno u razmaku od približno 12 sati s hranom u otprilike isto vrijeme u danu, (primjerice ujutro i navečer).
English: Caution should be used especially in patients with additional risk factors for thromboembolic events.
Croatian: S oprezom treba pristupati osobito bolesnicima s dodatnim čimbenicima rizika za razvoj tromboembolijskih događaja.
English: Blood counts should be monitored during therapy, in particular during the combination treatment with docetaxel.
Croatian: Tijekom liječenja potrebno je nadzirati krvnu sliku, osobito tijekom kombiniranog liječenja s docetakselom.
English: AST / ALT and bilirubin elevations
Croatian: Povišenje AST-a / ALT-a i bilirubina
English: This population included those adenocarcinoma patients identified at baseline as having progressed and entered the trial less than 9 months since start of their first-line therapy.
Croatian: Ova populacija je uključivala bolesnike s adenokarcinomom koji su na početku ispitivanja identificirani kao bolesnici s uznapredovalom bolešću i ušli su u ispitivanje manje od 9 mjeseci od početka prve linije liječenja.
English: Unless there is an alternative cause established, Vargatef should be permanently discontinued
Croatian: Ukoliko nije utvrđen drugi uzrok, primjena Vargatefa se mora trajno prekinuti.
English: The recommended dose is four capsules per day (this is a total of 400 mg nintedanib per day).
Croatian: Preporučena doza su četiri kapsule na dan (to čini ukupno 400 mg nintedaniba dnevno).
English: 120 x 1 soft capsule
Croatian: 120 x 1 meka kapsula
English: Three pack-sizes of Vargatef 100 mg soft capsules are available: One box containing 60 capsules (6 aluminium blisters of 10 capsules each).
Croatian: Dostupne su tri veličine pakiranja Vargatef 100 mg mekih kapsula: - Jedna kutija koja sadrži 60 kapsula (6 aluminijskih blistera od kojih svaki sadrži 10 kapsula).
English: Liver-related adverse reactions occurred in 42.8 % of nintedanib-treated patients.
Croatian: Nuspojave vezane uz jetru pojavile su se u 42,8 % bolesnika liječenih nintedanibom.
English: In particular, treatment of tumour xenografts with nintedanib led to a rapid reduction in tumour micro vessel density, pericytes vessel coverage and tumour perfusion.
Croatian: Posebice je liječenje tumorskih ksenografta nintedanibom dovelo do brzog smanjenja gustoće mikrovaskularija u tumoru, pokrivenosti žila pericitima i tumorske perfuzije.
English: Female patients should be advised to notify their doctor or pharmacist if they become pregnant during therapy with Vargatef.
Croatian: Bolesnice se mora uputiti da obavijeste svog liječnika ili ljekarnika ako zatrudne tijekom terapije Vargatefom.
English: If you forget to take Vargatef
Croatian: Ako ste zaboravili uzeti Vargatef
English: If you stop taking Vargatef
Croatian: Ako prestanete uzimati Vargatef
English: Exposure to nintedanib was not influenced by gender (body weight corrected), mild and moderate renal impairment (estimated by creatinine clearance), liver metastases, ECOG performance score, alcohol consumption, and P-gp genotype.
Croatian: Na izloženost nintedanibu nije utjecao spol (korigiran na tjelesnu težinu), blago i umjereno oštećenje bubrega (procijenjeno prema klirensu kreatinina), metastaze u jetri, opće stanje bolesnika bodovano prema ECOG-u, konzumacija alkohola i genotip P-gp-a.
English: Vargatef must not be taken on the same day of docetaxel chemotherapy administration (= day 1).
Croatian: Vargatef se ne smije uzeti na dan primjene kemoterapije docetakselom (= 1. dan).
English: Nintedanib is a substrate of P-gp.
Croatian: Nintedanib je supstrat P-gp-a.
English: For posology, methods of administration, and dose modifications of docetaxel, please refer to the corresponding product information for docetaxel.
Croatian: Za doziranje nintedaniba, način primjene i prilagodbu doze docetaksela, molimo pogledati odgovarajuće informacije o lijeku za docetaksel.
English: Potent P-gp inducers (e.g. rifampicin, carbamazepine, phenytoin, and St. John's Wort) may decrease exposure to nintedanib.
Croatian: Potentni induktori P-gp-a (npr. rifampicin, karbamazepin, fenitoin, i gospina trava) mogu smanjiti izloženost nintedanibu.
English: Stable brain metastasis
Croatian: Stabilne metastaze u mozgu
English: In a dedicated single dose phase I trial and compared to healthy subjects, exposure to nintedanib based on Cmax and AUC was 2.2-fold higher in volunteers with mild hepatic impairment (Child Pugh A; 90 % CI 1.3 - 3.7 for Cmax and 1.2 - 3.8 for AUC, respectively).
Croatian: U ciljanom ispitivanju faze I jednokratne doze te u usporedbi sa zdravim osobama, izloženost nintedanibu na temelju Cmax i AUC bila je 2,2 puta veća u dobrovoljaca s blagim oštećenjem funkcije jetre (Child Pugh A; 90% CI 1,3 - 3,7 za Cmax odnosno 1,2 - 3,8 za AUC).
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.
Croatian: Liječenje proljeva pri pojavi prvih znakova je važno (vidjeti dio 4) - ako povraćate ili osjećate mučninu - ako imate neobjašnjene simptome poput poprimanja žute boje kože ili bjeloočnica (žutica), tamne ili smeđe (boje čaja) mokraće, boli na gornjoj desnoj strani u području trbuha (abdomena), lakše krvarenje ili stvaranje modrica od uobičajenog ili se osjećate umorno.
English: Inform your doctor immediately while taking this medicine - if you get diarrhoea.
Croatian: Tijekom uzimanja ovog lijeka odmah obavijestite svog liječnika - ako dobite proljev.
English: Diarrhoea ≥ grade 3 despite anti-diarrhoeal treatment
Croatian: Mučnina ≥ stupnja 3 unatoč antiemetičkom liječenju
English: The active substance is nintedanib.
Croatian: Djelatna tvar je nintedanib.
English: Peripheral neuropathy was reported in 16.5 % of patients in the placebo arm and in 19.1 % of patients in the nintedanib arm.
Croatian: Periferna neuropatija je bila prijavljena u 16,5 % bolesnika u skupini koja je primala placebo te u 19,1 % bolesnika u skupini liječenoj nintedanibom.
English: twice daily for 15 days did not prolong the QTcF interval.
Croatian: 200 mg nintedaniba primijenjene dvaput dnevno tijekom 15 dana nisu produljile interval QTcF.
English: Vargatef capsules contain the active substance nintedanib.
Croatian: Vargatef kapsule sadrže djelatnu tvar nintedanib.
English: Termination of the treatment with Vargatef should be considered.
Croatian: Potrebno je razmotriti prestanak liječenja Vargatefom.
English: An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections)
Croatian: - Proširenje i slabljenje stijenke krvne žile ili rascjep stijenke krvne žile (aneurizme i disekcije arterije)