FrancophonIA/ELRC3.0 huggingface dataset:
English: Both colestyramine and activated powdered charcoal may influence the absorption of oestrogens and progestogens such that reliable contraception with oral contraceptives may not be guaranteed during the washout procedure with colestyramine or activated powdered charcoal.
Croatian: Stoga se kontracepcija oralnim kontraceptivima ne može smatrati pouzdanom tijekom postupka ispiranja u kojem se primjenjuje kolestiramin ili aktivni ugljen u prahu.
English: A randomised study assessed the clinical efficacy response rate in DMARD-naïve patients (n=121) with early RA, who received either 20 mg or 100 mg of leflunomide in two parallel groups during the initial three day double blind period.
Croatian: Bolesnici su podijeljeni u dvije paralelne skupine i dobivali su ili 20 mg ili 100 mg leflunomida tijekom prva tri dana dvostruko slijepog ispitivanja.
English: Talc (E553b) Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000
Croatian: Ovojnica tablete: talk (E553b) hipromeloza (E464) titanijev dioksid (E171) makrogol 8000
English: Human pharmacology
Croatian: Farmakologija u ljudi
English: Hepatic impairment
Croatian: zatajenje bubrega
English: Vaccination with live attenuated vaccines is, however, not recommended.
Croatian: Ne preporučuje se, međutim, cijepljenje živim atenuiranim cjepivima.
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit/risk aspects.
Croatian: Nedavno ili istodobno liječenje hepatotoksičnim ili hematotoksičnim DMARD-ima (npr. metotreksatom) može povećati rizik od ozbiljnih nuspojava.
English: (pancytopenia), - severe increase in blood pressure, - inflammation of the lung (interstitial lung disease), - an increase in some liver results which may develop into serious conditions such as hepatitis and jaundice, - severe infections called sepsis which may be fatal, - an increase of certain enzymes in the blood (lactate dehydrogenase).
Croatian: Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba): - porast broja krvnih stanica zvanih eozinofili (eozinofilija), blago smanjenje broja bijelih krvnih stanica (leukopenija), smanjenje broja svih krvnih stanica (pancitopenija), - značajan porast krvnog tlaka, - upala pluća (intersticijska plućna bolest), - porast vrijednosti određenih jetrenih enzima koji može dovesti do ozbiljnih stanja poput hepatitisa i žutice, - teške infekcije koje se nazivaju sepsa, a mogu dovesti do smrtnog ishoda, - porast vrijednosti određenih enzima u krvi (laktat dehidrogenaze).
English: Povidone (E1201) Crospovidone (E1202) Silica colloidal anhydrous Magnesium stearate (E470b) Lactose monohydrate
Croatian: kukuruzni škrob povidon (E1201) krospovidon (E1202) silicijev dioksid, koloidni, bezvodni magnezijev stearat (E470b) laktoza hidrat
English: Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000
Croatian: hipromeloza (E464), titanijev dioksid (E171) i makrogol 8000 u film ovojnici.
English: 3 film-coated tablets
Croatian: 50 filmom obloženih tableta
English: Silica colloidal anhydrous Magnesium stearate (E470b) Lactose monohydrate
Croatian: bezvodni koloidni silicijev dioksid, magnezijev stearat (E470b) i laktoza hidrat u jezgri tablete,
English: In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6% versus 28.6% (study MN301), and 49.4% versus 26.3% (study US301).After 12 months with active treatment, the ACR response rates in leflunomide patients were 52.3% (studies MN301/303), 50.5% (study MN302) and 49.4% (study US301), compared to 53.8% (studies
Croatian: U ispitivanjima faze III terapijske stope prema ACR-u bile su 54,6% za leflunomid 20 mg/dan naspram 28,6% za placebo (ispitivanje MN301), odnosno 49,4% naspram 26,3% (ispitivanje US301).
English: - colitis, - diarrhoea, - nausea, vomiting, - inflammation of the mouth or mouth ulcers, - abdominal pain, - an increase in some liver test results, - increased hair loss, - eczema, dry skin, rash, itching, - tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the feet or hands), - an increase of certain enzymes in the blood (creatine phosphokinase), - problems in the nerves of the arms or legs (peripheral neuropathy).
Croatian: - gubitak teka, gubitak težine (obično beznačajan), - umor (astenija), - glavobolja, omaglica, - neuobičajeni osjeti na koži, poput trnaca (parestezije), - blaži porast krvnog tlaka, - kolitis, - proljev, - mučnina, povraćanje, - upala ili čirevi u ustima, - bol u trbuhu, - porast vrijednosti određenih jetrenih enzima, - pojačan gubitak kose, - ekcem, suha koža, osip, svrbež, - tendinitis (bol izazvana upalom membrane koja okružuje tetive, obično na stopalima ili šakama), - porast koncentracije određenih enzima u krvi (kreatin fosfokinaze), - problemi sa živcima u rukama ili nogama (periferna neuropatija).
English: Leflunomide Zentiva 20 mg film-coated tablets are yellowish to ochre and triangular.
Croatian: Kako Leflunomide Zentiva izgleda i sadržaj pakiranja Leflunomide Zentiva 20 mg filmom obložene tablete su žućkaste do oker boje i trokutastog oblika.
English: Leflunomide Zentiva 20 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Leflunomide Zentiva 20 mg
English: 30 film-coated tablets 100 film-coated tablets
Croatian: OBLIK I SADRŽAJ 30 filmom obloženih tableta 100 filmom obloženih tableta
English: In this trial, the loading dose and maintenance dose of leflunomide was based on three weight categories: <20 kg, 20-40 kg, and >40 kg. After 16 weeks treatment, the difference in response rates was statistically significant in favour of methotrexate for the JRA Definition of Improvement (DOI) ≥30% (p=0.02).
Croatian: U ovom su se ispitivanju udarna doza i doza održavanja leflunomida zasnivale na 3 kategorije tjelesne težine: < 20 kg, 20-40 kg i > 40 kg.
English: Liver reactions
Croatian: Jetrene reakcije
English: Leflunomide Zentiva 20 mg film-coated tablets leflunomide
Croatian: Leflunomide Zentiva 20 mg filmom obložene tablete leflunomid
English: Each film-coated tablet contains 20 mg leflunomide.
Croatian: Jedna filmom obložena tableta sadrži 20 mg leflunomida.
English: Leflunomide Zentiva 100 mg film-coated tablets leflunomide
Croatian: Leflunomide Zentiva 100 mg filmom obložene tablete leflunomid
English: - if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction,
Croatian: Nemojte uzimati lijek Leflunomide Zentiva - ako ste ikada imali alergijsku reakciju na leflunomid (pogotovo tešku kožnu reakciju, često udruženu s vrućicom, bolovima u zglobovima, crvenim kožnim mrljama ili mjehurićima, npr.
English: Leflunomide Zentiva 10 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Leflunomide Zentiva 10 mg
English: Also contains lactose.
Croatian: POPIS POMOĆNIH TVARI Također sadrži laktozu.
English: General disorders and administration site conditions Common:
Croatian: Opći poremećaji i reakcije na mjestu primjene Često:
English: cysts and polyps) The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some immunosuppressive agents.
Croatian: Neki od imunosupresivnih lijekova mogu povećati rizik od pojave tumora, osobito limfoproliferativnih poremećaja.
English: INSTRUCTIONS ON USE 16.
Croatian: 15. UPUTE ZA UPORABU
English: Luxembourg/Luxemburg
Croatian: Luxembourg/Luxemburg Zentiva, k.s.
English: One film-coated tablet contains 100 mg of leflunomide.
Croatian: Jedna filmom obložena tableta sadrži 100 mg leflunomida.
English: Leflunomide Zentiva 100 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Leflunomide Zentiva 100 mg
English: Each tablet contains 20 mg leflunomide.
Croatian: TVARI Jedna tableta sadrži 20 mg leflunomida
English: • The Summary of Product Characteristics
Croatian: • Sažetak opisa svojstava lijeka
English: Leflunomide Zentiva 10 mg film-coated tablets leflunomide
Croatian: Leflunomide Zentiva 10 mg filmom obložene tablete leflunomid
English: - if you are male and wish to father a child. As it can not be excluded that Leflunomide Zentiva passes into semen, reliable contraception should be used during treatment with Leflunomide Zentiva.
Croatian: Budući da se ne može isključiti izlučivanje lijeka Leflunomide Zentiva u spermu, tijekom terapije lijekom Leflunomide Zentiva treba primjenjivati učinkovitu kontracepciju.
English: One film-coated tablet contains 10 mg of leflunomide.
Croatian: Jedna filmom obložena tableta sadrži 10 mg leflunomida.
English: Postmarketing studies
Croatian: Ispitivanja nakon stavljanja lijeka u promet
English: Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: Talc (E553b) Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000.
Croatian: te talk (E553b), hipromeloza (E464), titanijev dioksid (E171) i makrogol 8000 u film ovojnici.
English: The time to peak plasma concentrations of A771726 is very variable; peak plasma levels can occur between 1 hour and 24 hours after single administration.
Croatian: Vrijeme do postizanja vršne koncentracije A771726 u plazmi jako varira.
English: Each tablet contains 10 mg leflunomide.
Croatian: TVARI Jedna tableta sadrži 10 mg leflunomida
English: Leflunomide Zentiva 20 mg film-coated tablets
Croatian: NAZIV LIJEKA Leflunomide Zentiva 20 mg filmom obložene tablete
English: In either case it should be confirmed by a blood test that Leflunomide Zentiva has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant.
Croatian: U oba slučaja krvnim pretragama treba potvrditi da je Leflunomide Zentiva u dovoljnoj mjeri uklonjen iz Vašega organizma.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Croatian: Ispiranje („washout“ postupak)
English: Crospovidone (E1202) Talc (E553b)
Croatian: - Drugi sastojci su: kukuruzni škrob, povidon (E1201), krospovidon (E1202), talk (E553b),
English: EU/1/09/604/010 3 tablets
Croatian: EU/1/09/604/002 100 tableta
English: Leflunomide Zentiva 100 mg film-coated tablets
Croatian: NAZIV LIJEKA Leflunomide Zentiva 100 mg filmom obložene tablete
English: Very rare:
Croatian: Vrlo rijetko: pankreatitis
English: EU/1/09/604/008 30 tablets EU/1/09/604/009 100 tablets
Croatian: EU/1/09/604/009 100 tableta
English: The extent of leflunomide absorption is not affected if it is taken with food.
Croatian: Istodobno uzimanje s hranom ne ometa apsorpciju leflunomida.
English: Reliable contraception during treatment with leflunomide should also be guaranteed.
Croatian: Tijekom liječenja leflunomidom potrebno je koristiti učinkovitu kontracepciju.
English: - an increase in the numbers of blood cells called eosinophiles (eosinophilia); mild decrease in the number of white blood cells (leucopenia); decrease in the number of all blood cells
Croatian: Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba): - blago smanjen broj bijelih krvnih stanica (leukopenija), - blage alergijske reakcije,
English: Zentiva, a.s.
Croatian: Slovenská republika Zentiva, a.s.
English: Leflunomide Zentiva 10 mg film-coated tablets
Croatian: NAZIV LIJEKA Leflunomide Zentiva 10 mg filmom obložene tablete
English: Similarly, recent treatment with hepatotoxic or haematotoxic medicinal products (e.g. methotrexate) may result in increased side effects; therefore, the initiation of leflunomide treatment has to carefully be considered regarding these benefit/risk aspects and closer monitoring is recommended in the initial phase after switching.
Croatian: Isto tako, nedavno provedeno liječenje hepatotoksičnim ili hematotoksičnim lijekovima (npr. metotreksatom) može dovesti do pojave većeg broja nuspojava.
English: EU/1/09/604/003 30 tablets EU/1/09/604/004 100 tablets
Croatian: EU/1/09/604/004 100 tableta
English: PV-Estonia@zentiva.com
Croatian: PV-Hungary@zentiva.com
English: Oral use.
Croatian: Primjena kroz usta.
English: Elderly patients (≥ 65 years)
Croatian: Stariji bolesnici (≥ 65 godina)
English: This leaflet was last revised in
Croatian: Ova uputa je zadnji puta revidirana u
English: 3 years
Croatian: 3 godine.
English: - The other ingredients are:
Croatian: - Drugi sastojci su:
English: OTHER Do not open before use.
Croatian: Ne otvarati prije uporabe.
English: Date of latest renewal: 23 September 2019
Croatian: Datum posljednje obnove odobrenja: 23. rujna 2019
English: Similar results were observed in analyses using a conservative threshold of 10%.
Croatian: Slični rezultati opaženi su u analizama u kojima je primijenjen konzervativni prag od 10%.
English: The treatment effect was consistent in both trials.
Croatian: Učinak liječenja bio je konzistentan u oba ispitivanja.
English: It is recommended that you take the capsules with food, i.e. during or immediately before or after a meal.
Croatian: Preporučeno je kapsule uzeti s hranom, tj. tijekom ili neposredno prije ili nakon obroka.
English: Based on a Log-rank test.
Croatian: Temeljeno na log-rang testu.
English: Other medicines and Ofev
Croatian: Drugi lijekovi i Ofev
English: Your doctor will discuss the results of these tests with you and decide whether you may receive Ofev.
Croatian: Vaš liječnik će s Vama raspraviti rezultate ovih pretraga i odlučiti možete li primati Ofev.
English: Based on this information your doctor may do some blood tests, for example to check your liver function.
Croatian: Na temelju ovih informacija Vaš liječnik može odlučiti napraviti krvne pretrage, primjerice da provjeri funkciju Vaše jetre.
English: No overall differences in safety and efficacy were observed for elderly patients.
Croatian: Nisu primijećene ukupne razlike u sigurnosti i djelotvornosti u starijih bolesnika.
English: Studies in paediatric populations have not been performed.
Croatian: Ispitivanja u pedijatrijskim populacijama nisu provedena.
English: It is important to take this medicine every day, as long as your doctor prescribes it for you.
Croatian: Važno je da uzimate ovaj lijek svakog dana sve dok Vam ga Vaš liječnik propisuje.
English: Ofev can interact with certain other medicines.
Croatian: Ofev može imati interakcije s nekim drugim lijekovima.
English: Allergic reaction
Croatian: Alergijska reakcija
English: A risk to the newborns/infants cannot be excluded.
Croatian: Rizik za novorođenče/dojenče se ne može isključiti.
English: Do not take two capsules together if you have forgotten to take your earlier dose.
Croatian: Nemojte uzimati dvije kapsule odjednom, ako ste zaboravili uzeti prethodnu dozu.
English: Based on a logistic regression.
Croatian: Temeljeno na logističkoj regresiji.
English: The overall recovery was considered complete (above 90%) within 4 days after dosing.
Croatian: Cjelokupno izlučivanje smatralo se potpunim (iznad 90%) unutar 4 dana nakon doziranja.
English: Both patients recovered from these adverse reactions.
Croatian: Oba bolesnika oporavila su se od tih nuspojava.
English: You should not drive or use machines if you feel sick.
Croatian: Ne smijete upravljati vozilima i strojevima ako osjećate mučninu.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik ili ljekarnik.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
English: Survival analysis
Croatian: Analiza preživljenja
English: What Ofev looks like and contents of the pack
Croatian: Kako Ofev izgleda i sadržaj pakiranja
English: The age range covered by the analysis was 29 to 85 years; approximately 5% of the population were older than 75 years.
Croatian: Raspon dobi pokriven ovom analizom iznosio je 29 do 85 godina; približno 5% populacije bilo je starije od 75 godina.
English: You should discuss the most appropriate methods of contraception for you with your doctor.
Croatian: Sa svojim liječnikom morate raspraviti o najprikladnijim metodama kontracepcije za Vas.
English: The safety and efficacy of Ofev in children aged 0-18 years have not been established.
Croatian: Sigurnost i djelotvornost Ofeva u djece u dobi od 0 - 18 godina nisu još ustanovljene.
English: The major route of elimination of drug related radioactivity after oral administration of [
Croatian: Glavni put eliminacije radioaktivnosti vezane uz lijek nakon peroralne primjene [
English: Serum albumin is considered to be the major binding protein.
Croatian: Serumski albumin se smatra glavnim proteinom vezanja.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC
English: The recommended maximum daily dose of 300 mg should not be exceeded.
Croatian: Preporučena maksimalna dnevna doza od 300 mg ne smije se prekoračiti.
English: What Ofev is and what it is used for
Croatian: Što je Ofev i za što se koristi
English: Package leaflet: Information for the patient
Croatian: Uputa o lijeku: Informacije za bolesnika
English: Gastrointestinal adverse events were frequent and in line with the established safety profile of each component.
Croatian: Gastrointestinalni štetni događaji bili su česti i u skladu s ustanovljenim sigurnosnim profilom za svaku od komponenata.
English: Based on a Cox's regression model.
Croatian: Temeljeno na Coxovom regresijskom modelu.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: Administration of Ofev may increase blood pressure.
Croatian: Primjena Ofeva može povisiti krvni tlak.
English: Systemic blood pressure should be measured periodically and as clinically indicated.
Croatian: Sistemski krvni tlak se mora mjeriti periodički i prema kliničkoj indikaciji.
English: At the first signs of diarrhoea drink plenty of fluids and contact your doctor immediately.
Croatian: Pri prvim znakovima proljeva, pijte puno tekućine i odmah se obratite svom liječniku.
English: Children and adolescents Ofev should not be taken by children and adolescents under 18 years of age.
Croatian: Djeca i adolescenti Djeca i adolescenti mlađi od 18 godina ne smiju uzimati Ofev.
English: Time to first acute IPF exacerbation
Croatian: Vrijeme do prve akutne egzacerbacije IPF-a
English: Do not use this medicine if you notice that the blister containing the capsules is opened or a capsule is broken.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je blister, koji sadrži kapsule, otvoren ili je kapsula slomljena.
English: If a dose is missed the patient should not take an additional dose.
Croatian: U slučaju propuštene doze, bolesnik ne smije uzeti dodatnu dozu.
English: Ofev should only be initiated at least 4 weeks after abdominal surgery.
Croatian: Liječenje Ofevom se smije započeti najmanje 4 tjedna nakon abdominalnog kirurškog zahvata.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines and medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući biljne lijekove i lijekove dobivene bez recepta.
English: Do not take this medicine during pregnancy, as it can harm your unborn baby and cause birth defects.
Croatian: Ne uzimajte ovaj lijek tijekom trudnoće, jer može naškoditi nerođenom djetetu i uzrokovati urođene mane.
English: P-glycoprotein (P-gp)
Croatian: P-glikoprotein (P-gp)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer box
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjska kutija
English: Patients should then be monitored at regular intervals during the subsequent two months of treatment and periodically thereafter, e.g. at each patient visit or as clinically indicated.
Croatian: Bolesnike je zatim potrebno nadzirati u redovitim intervalima tijekom naredna dva mjeseca liječenja te potom periodično, npr. pri svakom dolasku bolesnika na pregled ili prema kliničkoj indikaciji.
English: Patients with low body weight (< 65 kg), Asian and female patients have a higher risk of elevations of liver enzymes.
Croatian: Bolesnici niske tjelesne težine (< 65 kg), bolesnici azijatskog porijekla i žene imaju viši rizik od povišenja vrijednosti jetrenih enzima.
English: Diarrhoea (very common, may affect more than 1 in 10 people):
Croatian: Proljev (vrlo često, može se javiti u više od 1 na 10 osoba):
English: Frequency categories are defined using the following convention: 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: Kategorije učestalosti definirane su primjenom sljedeće konvencije: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: There is no specific antidote or treatment for Ofev overdose.
Croatian: Nema specifičnog antidota ili liječenja za predoziranje Ofevom.
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.
English: Nintedanib may affect the way your wounds heal.
Croatian: Nintedanib može utjecati na način cijeljenja Vaših rana.
English: The following other side effects were observed during treatment with this medicine.
Croatian: Opažene su sljedeće druge nuspojave tijekom liječenja ovim lijekom.
English: Effect on QT interval
Croatian: Učinak na QT-interval
English: Do not reduce the dose or stop the treatment by yourself without consulting your doctor first.
Croatian: Ne smanjujte dozu i ne prekidajte liječenje sami bez prethodnog savjetovanja sa svojim liječnikom.
English: There was no evidence of liver enzyme increases in rats, dogs, and Cynomolgus monkeys.
Croatian: Nije bilo dokaza o povećanju jetrenih enzima u štakora, pasa i Cynomolgus majmuna.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2015
Croatian: Datum prvog odobrenja: 15. siječnja 2015.
English: Start appropriate anti-diarrhoeal treatment, e.g. with loperamide, as soon as possible.
Croatian: Započnite odgovarajuće liječenje protiv proljeva, npr. loperamidom, što je prije moguće.
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: Do not stop taking Ofev without consulting your doctor first.
Croatian: Nemojte prestati uzimati Ofev bez prethodnog savjetovanja sa svojim liječnikom.
English: As nintedanib may cause foetal harm also in humans, it must not be used during pregnancy.
Croatian: Budući da nintedanib može uzrokovati fetalno oštećenje i u ljudi, ne smije se primjenjivati tijekom trudnoće.
English: The primary endpoint was the annual rate of decline in Forced Vital Capacity (FVC).
Croatian: Primarna mjera ishoda bila je godišnja stopa smanjenja forsiranog vitalnog kapaciteta (FVC).
English: Linearity/non-linearity
Croatian: Linearnost/nelinearnost