FrancophonIA/ELRC3.0 huggingface dataset:
English: Serum albumin is considered to be the major binding protein.
Croatian: Serumski albumin smatra se glavnim proteinom vezanja.
English: (see section 4.4)
Croatian: (vidjeti dio 4.4)
English: Safety data for Black and African American patients are limited.
Croatian: Podaci o sigurnosti primjene u bolesnika crne rase i afroameričkih bolesnika su ograničeni.
English: Tell your doctor immediately if you develop fever.
Croatian: Odmah obavijestite svog liječnika ako razvijete vrućicu.
English: Overall survival (OS) was the key secondary endpoint.
Croatian: Ukupno preživljenje (OS; engl. overall survival) bio je ključan sekundarni ishod.
English: Taking the medicine this way ensures that a steady amount of nintedanib is maintained in the body.
Croatian: Uzimanje lijeka na ovaj način osigurava održavanje stalne količine nintedaniba u tijelu.
English: You should not drive or use machines if you feel sick.
Croatian: Ne smijete upravljati vozilima i strojevima ako Vam je mučno.
English: In line with these observations, related trial endpoints such as disease control and change in tumour size showed significant improvements.
Croatian: U skladu s tim opažanjima, povezani ishodi ispitivanja poput kontrole bolesti i promjene u veličini tumora pokazali su značajna poboljšanja.
English: Dose adjustments in 100 mg steps per day (i.e. a 50 mg reduction per dosing) based on individual safety and tolerability are recommended as described in Table 1 and Table 2.
Croatian: Prilagodbe doze u koracima od 100 mg dnevno (tj. smanjenje od 50 mg po dozi), koje se temelje na individualnoj sigurnosti i podnošljivosti, preporučuju se kao što je opisano u tablici 1 i tablici 2.
English: The following side effects were observed under treatment with this medicine:
Croatian: Uočene su sljedeće nuspojave tijekom liječenja ovim lijekom:
English: Studies in paediatric populations have not been performed.
Croatian: Ispitivanja u pedijatrijskim skupinama nisu provedena.
English: The following terms are used to rank the ADRs by frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Upotrijebljeni su sljedeći izrazi za svrstavanje nuspojava na lijek prema učestalosti: vrlo često (≥ 1/10), često (≥ 1/100 i <1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), ili vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The terminal half-life of nintedanib was between 10 and 15 h (gCV % approximately 50 %).
Croatian: Terminalni poluvijek nintedaniba bio je između 10 i 15 sati (gCV % približno 50 %).
English: Start appropriate anti-diarrhoeal treatment, e.g. with loperamide, as soon as possible after having contacted your doctor.
Croatian: Započnite odgovarajuće liječenje protiv proljeva, npr. loperamidom, što je prije moguće nakon što ste se obratili svom liječniku.
English: Do not reduce the dose or stop the treatment yourself without consulting your doctor first.
Croatian: Ne smanjujte dozu i ne prekidajte liječenje sami bez prethodnog savjetovanja sa svojim liječnikom.
English: Other medicines and Vargatef
Croatian: Drugi lijekovi i Vargatef
English: It may harm them,
Croatian: Pomoćne tvari su:
English: Patients with low body weight (< 65 kg), Asian and female patients have a higher risk of elevations in liver enzymes.
Croatian: Bolesnici niske tjelesne težine (< 65 kg), bolesnici azijatskog porijekla i žene imaju viši rizik od povišenja vrijednosti jetrenih enzima.
English: Sepsis and febrile neutropenia have been reported as subsequent complications of neutropenia.
Croatian: Sepsa i febrilna neutropenija prijavljene su kao naknadne komplikacije neutropenije.
English: * CTCAE: Common Terminology Criteria for Adverse Events
Croatian: Common Terminology Criteria for Adverse Events (Zajednički terminološki kriteriji za štetne događaje)
English: There was no evidence of liver enzyme increases in rats, dogs, and Cynomolgus monkeys.
Croatian: Nije bilo dokaza o povećanju vrijednosti jetrenih enzima u štakora, pasa i Cynomolgus majmuna.
English: These changes are known from other VEGFR-2 inhibitors and can be considered class effects.
Croatian: Ove promjene poznate su kod drugih inhibitora receptora VEGFR-2 i mogu se smatrati učincima skupine lijeka.
English: HR: hazard ratio; CI: confidence interval
Croatian: HR: omjer hazarda (HR; engl. hazard ratio); CI: interval pouzdanosti (CI; engl. confidence interval)
English: Vargatef should therefore only be initiated at least 4 weeks after major surgery.
Croatian: Stoga, liječenje Vargatefom se smije započeti najmanje 4 tjedna nakon velike operacije.
English: The majority of fatal bleeding events were tumour-associated.
Croatian: Većina smrtonosnih događaja krvarenja bila je povezana s tumorom.
English: Other efficacy outcomes included objective response, disease control, change in tumour size and health-related quality of life.
Croatian: Drugi ishodi djelotvornosti uključivali su objektivni odgovor, kontrolu bolesti, promjenu u veličini tumora i kvalitetu života vezanu uz zdravlje.
English: You should discuss the most appropriate methods of contraception for you with your doctor.
Croatian: Potrebno je raspraviti s Vašim liječnikom koje su metode kontracepcije za Vas najprikladnije.
English: The majority of these events were reported for patients in the IPF indication.
Croatian: Većina ovih slučajeva bili su prijavljeni u bolesnika s indikacijom IPF-a.
English: Not known (cannot be estimated from the available data) Inflammation of the large bowel
Croatian: Nepoznato (ne može se procijeniti iz dostupnih podataka) - Upala debelog crijeva
English: Fertility The effect of this medicine on human fertility has not been investigated.
Croatian: Plodnost Učinak ovog lijeka na ljudsku plodnost nije istražen.
English: The individual daily doses of nintedanib should not be increased beyond the recommended dose to make up for missed doses.
Croatian: Individualne dnevne doze nintedaniba ne smiju se povećati iznad preporučene doze kako bi se nadoknadile propuštene doze.
English: AST: Aspartate aminotransferase; ALT: Alanine aminotransferase ALKP: Alkaline phosphatase; ULN: Upper limit normal
Croatian: AST: Aspartat aminotransferaza; ALT: Alanin aminotransferaza AP: Alkalna fosfataza; GGN: Gornja granica normale
English: As nintedanib may cause foetal harm also in humans, it should not be used during pregnancy unless the clinical condition requires treatment.
Croatian: Budući da nintedanib može prouzročiti fetalno oštećenje i u ljudi, ne smije se primjenjivati tijekom trudnoće, osim ako kliničko stanje žene ne zahtijeva liječenje.
English: A risk to the breast-fed child cannot be excluded.
Croatian: Rizik za dojenu djecu se ne može isključiti.
English: As a consequence of neutropenia, fever (febrile neutropenia) and blood poisoning (sepsis) may occur.
Croatian: Kao posljedica neutropenije mogu se javiti vrućica (febrilna neutropenija) i trovanje krvi (sepsa).
English: Based on the high inter-individual variability of exposure these effects are not considered clinically relevant.
Croatian: Na temelju visoke interindividualne varijabilnosti u izloženosti, ovi učinci ne smatraju se klinički značajnima.
English: Median OS improved by 3 months (nintedanib: 10.9 months; placebo: 7.9 months).
Croatian: Medijan ukupnog preživljenja se poboljšao za 3 mjeseca (nintedanib: 10,9 mjeseci; placebo: 7,9 mjeseci).
English: In case your doctor has stopped your chemotherapy with docetaxel you should continue to take Vargatef twice daily.
Croatian: U slučaju da Vam je liječnik prekinuo kemoterapiju docetakselom, morate nastaviti uzimati Vargatef dvaput dnevno.
English: Approximately one third of these patients had liver-related adverse reactions of ≥ grade 3 severity.
Croatian: Približno jedna trećina tih bolesnika imala je nuspojave vezane uz jetru težine ≥ stupnja 3.
English: Vargatef capsules must be taken orally, preferably with food, swallowed whole with water, and must not be chewed or crushed.
Croatian: Vargatef kapsule se moraju uzeti peroralno, najbolje s hranom, progutati cijele s vodom i ne smiju se žvakati ili drobiti.
English: Patients with recent pulmonary bleeding (> 2.5 ml of red blood) as well as patients with centrally located tumours with radiographic evidence of local invasion of major blood vessels or radiographic evidence of cavitary or necrotic tumours have been excluded from clinical trials.
Croatian: Bolesnici s nedavnim plućnim krvarenjem (> 2,5 ml crvene krvi) kao i bolesnici sa središnje smještenim tumorima s radiografskim dokazom lokalne invazije u velike krvne žile ili radiografskim dokazom kavitarnih ili nekrotičnih tumora bili su isključeni iz kliničkih ispitivanja.
English: In the event of dehydration, administration of electrolytes and fluids is required.
Croatian: U slučaju dehidracije potrebna je primjena tekućine i elektrolita.
English: You need to pay special attention if you get the following side effects during treatment with Vargatef:
Croatian: Morate obratiti posebnu pažnju ako dobijete sljedeće nuspojave tijekom liječenja Vargatefom:
English: However, close monitoring is recommended in patients with several of these risk factors (see section 4.4).
Croatian: Međutim, preporučuje se povećan nadzor u bolesnika s nekoliko ovih čimbenika rizika (vidjeti dio 4.4).
English: Cases of pulmonary embolism have been reported.
Croatian: Zabilježeni su slučajevi plućne embolije.
English: By blocking the activity of these proteins, nintedanib can help stop the growth and spread of the cancer.
Croatian: Blokiranjem aktivnosti tih proteina, nintedanib može pomoći u zaustavljanju rasta i širenja raka.
English: In preclinical in vivo experiments, BIBF 1202 did not show efficacy despite its activity at target receptors of the substance.
Croatian: U pretkliničkim in vivo pokusima, BIBF 1202 nije pokazao djelotvornost unatoč svojoj aktivnosti na ciljnim receptorima tvari.
English: Absorption and bioavailability are decreased by transporter effects and substantial first-pass metabolism.
Croatian: Apsorpcija i bioraspoloživost smanjuju se sukladno učincima transportera i znatnim metabolizmom prvog prolaza.
English: VEGFR inhibition might be associated with an increased risk of bleeding.
Croatian: Inhibicija VEGFR receptora može biti povezana s povećanim rizikom od krvarenja.
English: Vargatef + Docetaxel Placebo + Docetaxel
Croatian: Vargatef + docetaksel Placebo + docetaksel
English: What Vargatef is and what it is used for
Croatian: Što je Vargatef i za što se koristi
English: The pharmacokinetics of nintedanib can be considered linear with respect to time (i.e. single-dose data can be extrapolated to multiple-dose data).
Croatian: Farmakokinetika nintedaniba može se smatrati linearnom u odnosu na vrijeme (tj. podaci o jednokratnoj dozi mogu se ekstrapolirati na podatke o višekratnima dozama).
English: `Locally recurrent´ was defined as local re-occurrence of the tumour without metastases at trial entry.
Croatian: Lokalno rekurentno je bilo definirano kao lokalno ponovno pojavljivanje tumora bez metastaza pri ulasku u ispitivanje.
English: Other information on drug-drug interactions
Croatian: Ostale informacije o interakcijama s lijekovima
English: Submission of final study report of the single-arm study: Q4 2020
Croatian: Predaja konačnog izvješća iz studije s jednom skupinom: 4. kvartal 2020.
English: Soya lecithin (E322)
Croatian: Soja lecitin (E322)
English: Treatment interruption should be considered in patients who develop signs or symptoms of acute myocardial ischaemia.
Croatian: Privremeni prekid liječenja se mora razmotriti u bolesnika koji razviju znakove ili simptome akutne ishemije miokarda.
English: Data from black individuals was very limited but in the same range as for Caucasians.
Croatian: Podaci o bolesnicima crne rase bili su vrlo ograničeni, ali u istom rasponu kao i podaci o bijelcima.
English: However, the frequency of patients with gastrointestinal perforation was low.
Croatian: Međutim, učestalost bolesnika s gastrointestinalnom perforacijom bila je niska.
English: There is no specific antidote or treatment for nintedanib overdose.
Croatian: Nema specifičnog antidota ili liječenja za predoziranje nintedanibom.
English: Stratified Log-Rank Test p-value*
Croatian: Stratified Log-Rank Test p-vrijednost**
English: The potential for interactions of nintedanib with hormonal contraceptives was not explored.
Croatian: Potencijal interakcija nintedaniba s hormonalnim kontraceptivima nije istražen.
English: A study of male fertility and early embryonic development to implantation in rats did not reveal effects on the male reproductive tract and male fertility.
Croatian: Ispitivanje muške plodnosti i ranog embrionalnog razvoja do implantacije zametka u štakora nije otkrilo učinke na muški reproduktivni sustav i mušku plodnost.
English: Patient characteristics were balanced between treatment arms within the overall population and within subgroups according to histology.
Croatian: Karakteristike bolesnika bile su uravnotežene između liječenih skupina unutar cjelokupne populacije i unutar podskupina prema histološkim nalazima.
English: The frequency of arterial thromboembolic events was comparable between the two treatment arms in the phase 3 trial 1199.13 (LUME-Lung 1).
Croatian: Učestalost arterijskih tromboembolijskih događaja bila je usporediva između dvije liječene skupine u fazi 3 ispitivanja 1199.13 (LUME-Lung 1).
English: No correlation of the DCE-MRI response and subsequent clinically significant reduction in target lesion size was found, but DCE-MRI response was associated with disease stabilization.
Croatian: Nije otkrivena povezanost između odgovora DCE-MRI i naknadnog klinički značajnog smanjenja u ciljnoj veličini lezije, ali odgovor DCE-MRI bio je povezan sa stabilizacijom bolesti.
English: Population pharmocokinetic analysis in special populations The pharmacokinetic properties of nintedanib were similar in healthy volunteers, cancer patients, and patients of the target population.
Croatian: Populacijska farmakokinetička analiza u posebnim skupinama Farmakokinetička svojstva nintedaniba bila su slična u zdravih dobrovoljaca, bolesnika s rakom i bolesnika ciljne populacije.
English: The applicant will implement collection of material for biomarker investigation and analyses of biomarker data into the study protocol of all new oncology studies planned for nintedanib in the future, wherever clinically appropriate.
Croatian: Podnositelj će implementirati prikupljanje materijala za ispitivanje biomarkera i analize podataka o biomarkerima u planu ispitivanju za sve nove onkološke studije planirane ubuduće za nintedanib kad god je to klinički odgovarajuće.
English: Steady state plasma concentrations were achieved within one week of dosing at the latest.
Croatian: Koncentracija u plazmi u stanju dinamičke ravnoteže postigla se najkasnije unutar jednog tjedna doziranja.
English: The in vitro protein binding of nintedanib in human plasma was high, with a bound fraction of 97.8 %.
Croatian: In vitro vezanje nintedaniba za proteine u ljudskoj plazmi bilo je visoko, s udjelom vezanja od 97,8 %.
English: There is no information on the use of Vargatef in pregnant women, but preclinical studies in animals have shown reproductive toxicity of this active substance (see section 5.3).
Croatian: Nema podataka o primjeni Vargatefa u trudnica, ali pretklinička ispitivanja na životinjama pokazala su reproduktivnu toksičnost ove djelatne tvari (vidjeti dio 5.3).
English: After intravenous infusion, a high volume of distribution (Vss: 1050 L, 45.0 % gCV) was observed.
Croatian: Nakon intravenske infuzije opažen je veliki volumen distribucije (Vss: 1050 L, 45,0 % gCV).
English: However, the sample size was small, there was no significant interaction and the CI was wide and included the HR for OS of the overall adenocarcinoma population.
Croatian: Međutim, veličina uzorka je bila mala, nije bilo značajne interakcije, a interval pouzdanosti je bio širok i uključivao je omjer hazarda za ukupno preživljenje za ukupnu populaciju s adenokarcinomom.
English: If you take more Vargatef than you should Contact your doctor or pharmacist immediately.
Croatian: Ako uzmete više Vargatefa nego što ste trebali Odmah se obratite svom liječniku ili ljekarniku.
English: What Vargatef contains
Croatian: Što Vargatef sadrži
English: However, based on the mechanism of action patients treated with Vargatef may have an increased risk of gastrointestinal perforations.
Croatian: Međutim, na temelju mehanizma djelovanja, bolesnici liječeni Vargatefom mogu imati povećani rizik od gastrointestinalne perforacije.
English: In patients with increased liver parameters, the use of the established stepwise dose reduction scheme was the appropriate measure and discontinuation of treatment was only necessary in 2.2 % of patients.
Croatian: U bolesnika s povećanim vrijednostima jetrenih enzima prikladna mjera je bila upotreba utvrđene sheme za postepeno smanjenje doze, a trajni prekid liječenja je bio neophodan samo u 2,2 % bolesnika.
English: Population PK analyses indicated moderate effects on exposure to nintedanib depending on age, body weight, and race (see below).
Croatian: Populacijske PK analize pokazale su umjerene učinke na izloženost nintedanibu, ovisno o dobi, tjelesnoj težini i rasi (vidjeti u nastavku).
English: Dose proportionality was shown by increase of nintedanib exposure (dose range 50 - 450 mg once daily and 150 - 300 mg twice daily).
Croatian: Proporcionalnost doze pokazala se povećanjem izloženosti nintedanibu (raspon doze 50 - 450 mg jedanput dnevno i 150 - 300 mg dvaput dnevno).
English: Efficacy in the pivotal phase 3 trial LUME-Lung 1
Croatian: Djelotvornost u pivotalnom ispitivanju faze 3 LUME-Lung 1
English: Alternative causes of the liver enzyme elevations should be investigated and respective action should be taken as necessary.
Croatian: Potrebno je ispitati postojanje drugih uzroka povišenja jetrenih enzima te se moraju poduzeti odgovarajuće mjere, prema potrebi.
English: In case of further persistence of the adverse reaction(s), i.e. if a patient does not tolerate 100 mg twice daily, treatment with Vargatef should be permanently discontinued.
Croatian: U slučaju daljnje prisutnosti nuspojave(a), tj. ako bolesnik ne podnosi 100 mg dvaput dnevno, liječenje Vargatefom mora se trajno prekinuti.
English: Overall Survival (OS)*** Patients, n
Croatian: Ukupno preživljenje (OS)*** Bolesnici, n
English: It is not known if the medicine passes into breast milk and could cause harm to a breast-fed child.
Croatian: Nije poznato izlučuje li se lijek u majčino mlijeko i može li štetiti dojenoj djeci.
English: Diarrhoea and vomiting accompanied by reduced food consumption and loss of body weight were observed in toxicity studies in non-rodents.
Croatian: Proljev i povraćanje praćeni smanjenim unosom hrane i gubitkom tjelesne težine uočeni su u ispitivanjima toksičnosti u neglodavaca.
English: Patients should be closely monitored for thromboembolic events.
Croatian: Bolesnike se mora pažljivo nadzirati radi tromboembolijskih događaja.
English: Tumour shrinkage [%]° p-value°
Croatian: Smanjenje tumora [%]° p-vrijednost
English: Nintedanib reached maximum plasma concentrations approximately 2 - 4 hours after oral administration as soft gelatin capsule under fed conditions (range 0.5 - 8 hours).
Croatian: Nintedanib je dosegnuo maksimalnu koncentraciju u plazmi približno 2 - 4 sata nakon peroralne primjene u obliku meke želatinske kapsule nakon obroka (raspon 0,5 - 8 sati).
English: Use caution when treating patients with a higher cardiovascular risk including known coronary artery disease.
Croatian: Potreban je oprez u liječenju bolesnika s višim kardiovaskularnim rizikom uključujući koronarnu arterijsku bolest.
English: PK-efficacy analyses were not performed for clinical endpoints.
Croatian: Analize PK-djelotvornosti nisu bile provedene za kliničke mjere ishoda.
English: Since the effect of nintedanib on the metabolism and efficacy of contraceptives has not been investigated, barrier methods should be applied as a second form of contraception, to avoid pregnancy.
Croatian: Budući da učinak nintedaniba na metabolizam i djelotvornost kontraceptiva nije istražen, moraju se primjenjivati metode mehaničke kontracepcije kao drugi oblik kontracepcije kako bi se izbjegla trudnoća.
English: LIST OF EXCIPIENTS Contains soya.
Croatian: POPIS POMOĆNIH TVARI Sadrži soju.
English: Particular caution should be exercised when treating patients with previous abdominal surgery or a recent history of a hollow organ perforation.
Croatian: Osobiti oprez se mora primijeniti pri liječenju bolesnika s prethodnim abdominalnim kirurškim zahvatom ili anamnezom nedavne perforacije šupljeg organa.
English: Co-administration with nintedanib should be carefully considered.
Croatian: Istodobna primjena s nintedanibom mora se pažljivo razmotriti.
English: Treatment with Vargatef should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Croatian: Liječenje Vargatefom mora započeti i nadzirati liječnik s iskustvom u primjeni terapije protiv raka.
English: Patients with active brain metastasis were excluded from clinical trials and are not recommended for treatment with Vargatef.
Croatian: Bolesnici s aktivnim metastazama u mozgu bili su isključeni iz kliničkih ispitivanja te se njima ne preporučuje liječenje Vargatefom.
English: The recommended dose of nintedanib is 200 mg twice daily administered approximately 12 hours apart, on days 2 to 21 of a standard 21 day docetaxel treatment cycle.
Croatian: Preporučena doza nintedaniba je 200 mg primijenjeno dvaput dnevno u razmaku od približno 12 sati, od 2. do 21. dana standardnog 21-dnevnog ciklusa liječenja docetakselom.
English: Patients should be advised to be cautious when driving or using machines during treatment with Vargatef.
Croatian: Potrebno je savjetovati bolesnike da budu oprezni pri upravljanju vozilima ili radu sa strojevima tijekom liječenja Vargatefom.
English: PFS events had been observed based on IRC-assessment in the overall ITT population (332 events in adenocarcinoma patients).
Croatian: PFS događaj na temelju procjene nezavisnog povjerenstva za procjenu u ukupnoj ITT populaciji (332 događaja u bolesnika s adenokarcinomom).
English: Aluminium/aluminium blisters containing 10 capsules each.
Croatian: Aluminij/aluminij blisteri od kojih svaki sadrži 10 kapsula.
English: Vargatef contains soya The capsules contain soya lecithin.
Croatian: Vargatef sadrži soju Kapsule sadrže sojin lecitin.
English: Overall survival analysis in the overall population did not reach statistical significance (HR 0.94; 95 % CI: 0.83 - 1.05).
Croatian: Analiza ukupnog preživljenja u ukupnoj populaciji nije dosegnula statistički značaj (HR 0,94; 95 % CI: 0,83-1,05).
English: Single dose toxicity studies in rats and mice indicated a low acute toxic potential of nintedanib.
Croatian: Ispitivanja toksičnosti jednokratne doze u štakora i miševa ukazale su na nizak akutni toksični potencijal nintedaniba.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 November 2014
Croatian: Datum prvog odobrenja: 21. studenoga 2014.
English: Diarrhoea ≥ grade 2 for more than 7 consecutive days despite anti-diarrhoeal treatment OR
Croatian: Proljev ≥ stupnja 2 u trajanju duljem od 7 uzastopnih dana unatoč liječenju proljeva ILI
English: Before initiating Vargatef, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Croatian: Prije početka primjene lijeka Vargatef potrebno je pažljivo razmotriti ovaj rizik u bolesnika s čimbenicima rizika kao što su hipertenzija ili aneurizma u anamnezi.
English: No adjustment of the starting dose is needed for patients with mild hepatic impairment (Child Pugh A) based on clinical data.
Croatian: Nije potrebna prilagodba početne doze za bolesnike s blagim oštećenjem funkcije jetre (Child Pugh A) na temelju kliničkih podataka.
English: Data on bio-/tumour markers from all clinical studies in the clinical program for nintedanib.
Croatian: 3. Podaci o bio-/tumorskim markerima iz svih kliničkih ispitivanja u kliničkom programu za nintedanib.