FrancophonIA/ELRC3.0 huggingface dataset:
English: The benefit-risk balance of concomitant treatment with pirfenidone has not been established.
Croatian: Omjer koristi i rizika istodobne primjene s pirfenidonom nije ustanovljen.
English: In the INPULSIS trials no increased risk of venous thromboembolism was observed in nintedanib treated patients.
Croatian: U ispitivanjima INPULSIS nije opažen povećani rizik od venske tromboembolije u bolesnika liječenih nintedanibom.
English: The safety data provided in the following are based on the two Phase III, randomised, double-blind, placebo-controlled studies in 1,061 patients comparing treatment with nintedanib 150 mg twice daily to placebo for 52 weeks (INPULSIS-1 and INPULSIS-2) and based on data observed during the post-marketing period.
Croatian: Podaci o sigurnosti primjene, prikazani u nastavku, temelje se na dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja faze III na 1061 bolesniku tijekom kojih se uspoređivalo liječenje nintedanibom 150 mg dvaput dnevno s placebom u trajanju od 52 tjedna (INPULSIS-1 i INPULSIS-2) i na temelju podataka opaženih tijekom razdoblja nakon stavljanja lijeka u promet.
English: In group 1, the adjusted geometric mean ratios (90% confidence interval (CI)) were 93% (57% - 151%) and 96% (70% - 131%) for Cmax and AUC0-tz of nintedanib, respectively (n=12 for intraindividual comparison).
Croatian: U skupini 1, omjeri prilagođenih geometrijskih srednjih vrijednosti (90%-tni interval pouzdanosti (CI)) iznosili su 93% (57% - 151%) odnosno 96% (70% - 131%) za Cmax i AUC0-tz nintedaniba (n=12 za intraindividualnu usporedbu).
English: This indicates that the risk of having a first acute adjudicated IPF exacerbation was statistically significantly lower in the nintedanib group than in the placebo group at any time point.
Croatian: To pokazuje da je rizik od nastupa prve akutne procijenjene egzacerbacije IPF-a bio statistički značajno niži u skupini liječenoj nintedanibom nego u skupini liječenoj placebom u bilo kojoj vremenskoj točki.
English: Arterial thromboembolic events were infrequently reported: in 0.7% of patients in the placebo and 2.5% in the nintedanib treated group.
Croatian: Arterijski tromboembolijski događaji rijetko su bili prijavljeni: 0,7% bolesnika u skupini liječenoj placebom te 2,5% bolesnika u skupini liječenoj nintedanibom.
English: How to take Ofev
Croatian: Kako uzimati Ofev
English: In a drug-drug interaction study with the potent P-gp inducer rifampicin, exposure to nintedanib decreased to 50.3% based on AUC and to 60.3% based on Cmax upon co-administration with rifampicin compared to administration of nintedanib alone.
Croatian: U ispitivanju interakcija lijekova s potentnim induktorom P-gp-a rifampicinom, izloženost nintedanibu smanjila se na 50,3% na temelju AUC i na 60,3% na temelju Cmax nakon istodobne primjene s rifampicinom u usporedbi s primjenom samo nintedaniba.
English: The potential impact of VEGFR inhibition by nintedanib and the antiangiogenic activity of nintedanib on IPF pathology are currently not fully elucidated.
Croatian: Trenutno nije u potpunosti razjašnjen mogući utjecaj inhibicije receptora VEGFR putem nintedaniba i utjecaj antiangiogene aktivnosti nintedaniba na patologiju IPF-a.
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 8.7-fold 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 4,413,2) odnosno 8,7 puta veća (90% CI 5,7 - 13,1) na temelju AUC u usporedbi sa zdravim dobrovoljcima.
English: Ofev has minor influence on the ability to drive and use machines.
Croatian: Ofev malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The deterioration of HRQoL was smaller in the nintedanib group; the difference between the treatment groups was statistically significant (-2.69; 95% CI: -4.95, -0.43; p=0.0197).
Croatian: Pogoršanje kvalitete života povezane sa zdravljem bilo je manje u skupini liječenoj nintedanibom; razlika između skupina liječenja bila je statistički značajna (-2,69; 95% CI: -4,95, -0,43; p=0,0197).
English: Ofev 100 mg soft capsules EU/1/14/979/001
Croatian: Ofev 100 mg meke kapsule EU/1/14/979/001
English: In a dedicated single dose phase I study 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: Uncommon side effects (may affect up to 1 in 100 people) - Pancreatitis - Inflammation of the large bowel - Serious liver problems - Low platelet count (thrombocytopenia) - High blood pressure (hypertension) - Jaundice, that is a yellow colour to the skin and whites of the eyes due to high levels of bilirubin - Itching - heart attack - Hair loss (alopecia)
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) - upala gušterače - upala debelog crijeva - ozbiljne tegobe s jetrom - nizak broj krvnih pločica (trombocitopenija) - visoki krvni tlak (hipertenzija) - žutica, to jest žuta boja kože i bjeloočnica zbog visokih vrijednosti bilirubina - svrbež - srčani udar - gubitak kose (alopecija)
English: Hepatic function
Croatian: Bubrežna funkcija
English: Each 150 mg soft capsule contains 1.8 mg of soya lecithin.
Croatian: Jedna meka kapsula od 150 mg sadrži 1,8 mg sojinog lecitina.
English: In the INPULSIS-2 trial, the risk of first acute IPF exacerbation over 52 weeks was significantly reduced in patients receiving nintedanib compared to placebo, in the INPULSIS-1 trial there was no difference between the treatment groups.
Croatian: U ispitivanju INPULSIS-2 rizik od prve akutne egzacerbacije IPF-a tijekom 52 tjedna bio je značajno smanjen u bolesnika koji su primali nintedanib u usporedbi sa skupinom koja je primala placebo, u ispitivanju INPULSIS-1 nije bilo razlike između skupina liječenja.
English: The recommended dose is 150 mg nintedanib twice daily administered approximately 12 hours apart.
Croatian: Preporučena doza nintedaniba je 150 mg dvaput dnevno primijenjeno u razmaku od približno 12 sati.
English: The below table provides a summary of the adverse reactions by MedDRA System Organ Class (SOC) and frequency category.
Croatian: Niže navedena tablica daje sažetak nuspojava prema MedDRA klasifikaciji organskih sustava i kategoriji učestalosti.
English: Concomitant treatment with nintedanib and pirfenidone has been investigated in an exploratory openlabel, randomised trial of nintedanib 150 mg twice daily with add-on pirfenidone (titrated to 801 mg three times a day) compared to nintedanib 150 mg twice daily alone in 105 randomised patients for 12 weeks.
Croatian: Istodobno liječenje nintedanibom i pirfenidonom istraženo je u eksplorativnom, otvorenom, randomiziranom ispitivanju nintedaniba 150 mg dvaput dnevno uz dodatak pirfenidona (titriranog na 801 mg triput na dan) u usporedbi sa samim nintedanibom 150 mg dvaput dnevno u 105 randomiziranih bolesnika tijekom 12 tjedana.
English: The safety and efficacy of Ofev has not been studied in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment.
Croatian: Sigurnost i djelotvornost Ofeva nisu ispitane u bolesnika s umjerenim (Child Pugh B) ili teškim (Child Pugh C) oštećenjem funkcije jetre.
English: In rabbits, embryo-foetal lethality and teratogenic effects were observed at an exposure approximately 3 times higher than at the MRHD but equivocal effects on the embryo-foetal development of the axial skeleton and the heart were noted already at an exposure below that at the MRHD of 150 mg twice daily.
Croatian: U kunića su opaženi embriofetalna smrtnost i teratogeni učinci pri izloženosti približno 3 puta višoj od izloženosti pri MRHD, ali primijećeni su upitni učinci na embriofetalni razvoj aksijalnog skeleta i srca već pri izloženosti ispod one pri MRHD od 150 mg dvaput dnevno.
English: The following medicines are examples that may lower the levels of nintedanib in your blood and thus may reduce the effectiveness of Ofev: - an antibiotic used to treat tuberculosis (rifampicin) - medicines to treat seizures (carbamazepine, phenytoin) - a herbal medicine to treat depression (St. John's Wort)
Croatian: Navedeni lijekovi su primjeri lijekova koji mogu sniziti vrijednosti nintedaniba u krvi i stoga mogu dovesti do smanjenja učinkovitosti Ofeva: - antibiotik koji se koristi za liječenje tuberkuloze (rifampicin) - lijekovi za liječenje napadaja (karbamazepin, fenitoin) - biljni lijek za liječenje depresije (gospina trava)
English: Group 1 received a single dose of 150 mg nintedanib before and after uptitration to 801 mg pirfenidone three times a day at steady state (N=20 patients treated).
Croatian: Skupina 1 primila je jednokratnu dozu od 150 mg nintedaniba prije i nakon titracije na 801 mg pirfenidona triput na dan u stanju dinamičke ravnoteže (n=20 liječenih bolesnika).
English: Common side effects (may affect up to 1 in 10 people) - Vomiting - Loss of appetite - Weight loss - Bleeding - Rash - Headache
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba) - povraćanje - gubitak teka - gubitak tjelesne težine - krvarenje - osip - glavobolja
English: The number of patients with acute IPF exacerbations over 52 weeks was lower in the nintedanib group (2.3%, N=86) compared to placebo (13.8%, N=87).
Croatian: Broj bolesnika s akutnim egzacerbacijama IPF-a tijekom 52 tjedna bio je niži za skupinu koja je primala nintedanib (2,3%, N=86) u usporedbi sa skupinom koja je primala placebo (13,8%, N=87).
English: Treating diarrhoea early 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: Rano liječenje proljeva je važno (pogledajte dio 4); - ako povraćate ili osjećate mučninu; - ako imate neobjašnjene simptome poput 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: Based on these results, there is no evidence of a relevant pharmacokinetic drug-drug interaction between nintedanib and pirfenidone when administered in combination (see section 5.2).
Croatian: Na temelju rezultata, nema dokaza da postoje značajne farmakokinetičke interakcije nintedaniba i pirfenidona kada se primjenjuju u kombinaciji (vidjeti dio 5.2).
English: D-55216 Ingelheim am Rhein Germany
Croatian: D-55216 Ingelheim am Rhein Njemačka
English: They should be advised to use adequate contraception during and at least 3 months after the last dose of Ofev.
Croatian: Ženama reproduktivne dobi mora se savjetovati da izbjegavaju trudnoću tijekom liječenja Ofevom, te da tijekom liječenja i najmanje 3 mjeseca nakon posljednje doze Ofeva koriste odgovarajuću kontracepciju.
English: The estimated mean difference for nintedanib compared with placebo was -6.12 (95% CI: -10.57, -1.67; p=0.0071).
Croatian: Procijenjena srednja vrijednost razlike za nintedanib u usporedbi s placebom iznosila je -6,12 (95% CI: -10,57, -1,67; p=0,0071).
English: Diarrhoea was reported in 62.4% of patients treated with nintedanib.
Croatian: Proljev je prijavljen u 62,4% bolesnika liječenih nintedanibom.
English: Very common side effects (may affect more than 1 in 10 people) - Feeling sick (nausea) - Pain in the lower body (abdomen) - Abnormal liver test results.
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) - mučnina - bol u trbuhu - odstupanja u nalazima jetrenih testova.
English: Do not take more than the recommended dose of two Ofev 150 mg capsules per day.
Croatian: Ne uzimajte više od preporučene doze koja iznosi dvije Ofev 150 mg kapsule dnevno.
English: 55216 Ingelheim am Rhein Germany
Croatian: 55216 Ingelheim am Rhein Njemačka
English: In patients with mild hepatic impairment (Child Pugh A), treatment interruption or discontinuation for management of adverse reactions should be considered.
Croatian: U bolesnika s blagim oštećenjem funkcije jetre (Child Pugh A) potrebno je razmotriti privremeni ili trajni prekid liječenja radi zbrinjavanja nuspojava.
English: Patients with FVC baseline < 50% predicted or carbon monoxide diffusing capacity (DLCO, corrected for haemoglobin) < 30% predicted at baseline were excluded from the trials.
Croatian: Forced Vital Capacity, FVC) < 50% predviđene normalne vrijednosti ili početnom vrijednošću difuzijskog kapaciteta ugljičnog monoksida (DLCO, korigiranom za hemoglobin) < 30% predviđene normalne vrijednosti.
English: Do not take Ofev - if you are allergic to nintedanib, peanut or soya, or any of the other ingredients of this medicine
Croatian: Što morate znati prije nego počnete uzimati Ofev Nemojte uzimati Ofev - ako ste alergični na nintedanib, kikiriki ili soju, ili neki drugi sastojak ovog lijeka (naveden u dijelu
English: The recommended dose is one capsule of 150 mg twice daily (a total of 300 mg per day).
Croatian: Preporučena doza je jedna kapsula od 150 mg dvaput dnevno (ukupno 300 mg dnevno).
English: Hepatic enzyme increased
Croatian: Porast vrijednosti jetrenih enzima
English: In the pre-specified pooled analysis of survival data of the INPULSIS trials, overall mortality over 52 weeks was lower in the nintedanib group (5.5%) compared with the placebo group (7.8%).
Croatian: U prethodno specificiranoj združenoj analizi podataka o preživljenju unutar ispitivanja INPULSIS, ukupna smrtnost tijekom 52 tjedna bila je niža u skupini bolesnika liječenih nintedanibom (5,5%) u usporedbi sa skupinom liječenom placebom (7,8%).
English: In the pooled analysis, the HR was 0.60 indicating a 40% reduction in the risk of progression for patients treated with nintedanib compared with placebo.
Croatian: U združenoj analizi, omjer hazarda (engl. hazard ratio, HR) je iznosio 0,60 ukazujući na 40%-tno smanjenje rizika od progresije u bolesnika liječenih nintedanibom u usporedbi s placebom.
English: Nausea led to discontinuation of nintedanib in 2.0% of patients.
Croatian: Mučnina je dovela do prekida liječenja nintedanibom u 2,0% bolesnika.
English: Your doctor may reduce your recommended dose to two times 100 mg per day (a total of 200 mg per day).
Croatian: Liječnik Vam može smanjiti preporučenu dozu na 100 mg dva puta dnevno (ukupno 200 mg dnevno).
English: See leaflet for further information.
Croatian: Za daljnje informacije pogledati uputu o lijeku.
English: Hypertension
Croatian: Hipertenzija
English: Only a minor extent of the biotransformation of nintedanib consisted of CYP pathways.
Croatian: Samo se mali dio biotransformacije nintedaniba odvija putem CYP enzima.
English: INFORMATION IN BRAILLE Ofev 150 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Ofev 150 mg
English: In case of persisting severe diarrhoea despite symptomatic treatment, therapy with Ofev should be discontinued.
Croatian: U slučaju trajnog teškog proljeva unatoč simptomatskom liječenju, liječenje Ofevom mora se prekinuti.
English: Myocardial infarction
Croatian: Srčani poremećaji infarkt miokarda
English: The event was reported to be of severe intensity in 3.3% of nintedanib treated patients.
Croatian: Događaj proljeva teškog intenziteta prijavljen je u 3,3% bolesnika liječenih nintedanibom.
English: INFORMATION IN BRAILLE Ofev 100 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Ofev 100 mg
English: How to store Ofev
Croatian: Kako čuvati Ofev
English: Capsule shell gelatin glycerol (85%) titanium dioxide (E171) iron oxide red (E172) iron oxide yellow (E172)
Croatian: Ovojnica kapsule želatina glicerol (85%) titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, žuti (E172)
English: Women who can become pregnant must use an effective combination of birth control methods, including barrier methods as a second form of contraception, while they are taking Ofev and for at least 3 months after stopping treatment.
Croatian: Žene reproduktivne dobi moraju za vrijeme uzimanja Ofeva i najmanje 3 mjeseca nakon prekida liječenja upotrebljavati učinkovitu kombinaciju kontracepcijskih metoda, uključujući mehaničku metodu kontracepcije kao dodatni oblik kontracepcije.
English: In the INPULSIS trials with Ofev, the frequency of patients who experienced bleeding AEs was slightly higher in the Ofev arm (10.3%) than in the placebo arm (7.8%).
Croatian: U ispitivanjima INPULSIS s lijekom Ofev, učestalost bolesnika s doživljenom nuspojavom krvarenja bila je nešto veća u skupini bolesnika na Ofevu (10,3%) nego u skupini na placebu (7,8%).
English: In rats, embryo-foetal lethality and teratogenic effects were observed at exposure levels below human exposure at the MRHD of 150 mg twice daily.
Croatian: U štakora su opaženi embriofetalna smrtnost i teratogeni učinci pri vrijednostima izloženosti nižim od izloženosti u ljudi pri MRHD od 150 mg dvaput dnevno.
English: The primary endpoint, rate of decline in FVC over 52 weeks was lower in the nintedanib arm (-0.060 L/year, N=84) than the placebo arm (-0.190 L/year, N=83).
Croatian: Primarna mjera ishoda, stopa smanjenja FVC-a tijekom 52 tjedna, bila je niža u skupini na nintedanibu (-0,060 l/godina, N=84) nego u skupini na placebu (-0,190 l/godina, N=83).
English: In INPULSIS-1, the increase from baseline in SGRQ total score at week 52 was comparable between nintedanib and placebo (difference between treatment groups: -0.05; 95% CI: -2.50, 2.40; p=0.9657).
Croatian: U ispitivanju INPULSIS-1 povećanje u odnosu na početne vrijednosti u ukupnom rezultatu upitnika SGRQ nakon tjedna 52 bilo je usporedivo između skupina liječenih nintedanibom i placebom (razlika između skupina liječenja: -0,05; 95% CI: -2,50, 2,40; p=0,9657).
English: The recommended dose is one capsule of 100 mg twice daily (a total of 200 mg per day).
Croatian: Preporučena doza je jedna kapsula od 100 mg dvaput dnevno (ukupno 200 mg dnevno).
English: Do not take more than the recommended dose of two Ofev 100 mg capsules per day.
Croatian: Ne uzimajte više od preporučene doze koja iznosi dvije Ofev 100 mg kapsule dnevno.
English: See Table 2 for individual and pooled study results.
Croatian: Rezultate individualnih i združenih ispitivanja pogledati u tablici 2.
English: FVC responder analysis
Croatian: Analiza osoba s odgovorom u FVC-u
English: In the pooled analysis of the INPULSIS trials, the estimated mean change from baseline to week 52 in SGRQ total score was smaller in the nintedanib group (3.53) than in the placebo group (4.96), with a difference between the treatment groups of -1.43 (95% CI: -3.09, 0.23; p=0.0923).
Croatian: U združenoj analizi ispitivanja INPULSIS procijenjena srednja vrijednost promjene u odnosu na početne vrijednosti do 52. tjedna u ukupnom rezultatu upitnika SGRQ bila je manja u skupini liječenoj nintedanibom (3,53) od one u skupini liječenoj placebom (4,96), uz razliku između skupina liječenja od -1,43 (95% CI: -3,09, 0,23; p=0,0923).
English: Once transaminases have returned to baseline values, treatment with Ofev may be resumed at the full dose (150 mg twice daily) or reintroduced at a reduced dose (100 mg twice daily) which subsequently may be increased to the full dose (see section 4.2).
Croatian: Kada se razine transaminaza vrate na početne vrijednosti, liječenje Ofevom može se nastaviti punom dozom (150 mg dvaput dnevno) ili ponovno započeti smanjenom dozom (100 mg dvaput dnevno), koja se može postupno povećavati do pune doze (vidjeti dio 4.2).
English: Based on the mechanism of action nintedanib may impair wound healing.
Croatian: Na temelju mehanizma djelovanja, nintedanib može usporiti cijeljenje rana.
English: The frequency of patients with at least 1 adjudicated exacerbation occurring within 52 weeks was lower in the nintedanib group (1.9% of patients) than in the placebo group (5.7% of patients).
Croatian: Učestalost bolesnika s najmanje 1 procijenjenom egzacerbacijom koja se pojavila unutar 52 tjedna bila je niža u skupini bolesnika liječenih nintedanibom (1,9% bolesnika) nego u skupini liječenoj placebom (5,7% bolesnika).
English: Diarrhoea, Nausea, Abdominal pain
Croatian: Poremećaji probavnog sustava proljev, mučnina, bol u abdomenu povraćanje pankreatitis kolitis
English: Group 2 received steady state treatment of 801 mg pirfenidone three times a day and had a PK profiling before and after at least 7 days of co-treatment with 150 mg nintedanib twice daily (N=17 patients treated).
Croatian: Skupina 2 liječena je pirfenidonom od 801 mg u stanju dinamičke ravnoteže triput na dan i toj se skupini odredio farmakokinetički profil prije i nakon najmanje 7 dana istodobnog liječenja nintedanibom 150 mg dvaput dnevno (N=17 liječenih bolesnika).
English: Time to event analysis of the adjudicated exacerbation events using pooled data yielded a hazard ratio (HR) of 0.32 (95% CI 0.16, 0.65; p=0.0010).
Croatian: Analiza vremena do događaja procijenjenih kao događaji egzacerbacije korištenjem združenih podataka dale su omjer hazarda (HR) od 0,32 (95% CI 0,16, 0,65; p=0,0010).
English: INPULSIS-1 and INPULSIS-2 Pooled
Croatian: INPULSIS-1 i INPULSIS-2 združeno
English: Shellac glaze, iron oxide black (E172), propylene glycol (E1520)
Croatian: šelak, glazura, crni željezov oksid (E172), propilenglikol (E1520)
English: Number at risk Patients with events, N (%) Comparison vs placebo p-value Hazard ratio 95% CI
Croatian: Broj pod rizikom 204 Bolesnici s događajima, N(%) Usporedba naspram placeba p-vrijednost
English: th percentile) and decreased by 19% for a 100 kg patient th percentile) relative to a patient with the median weight of 71.5 kg.
Croatian: AUCτ,ss se povećao za 25% u bolesnika s 50 kg (5. percentila), a smanjio za 19% u bolesnika sa 100 kg (95. percentila) u odnosu na bolesnika s medijanom težine od 71,5 kg.
English: Serious cases of diarrhoea leading to dehydration and electrolyte disturbances have been reported in the post-marketing.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su ozbiljni slučajevi proljeva koji je doveo do dehidracije i poremećaja elektrolita.
English: The estimated hazard ratio of nintedanib versus placebo was 0.16 (95% CI 0.04, 0.71; p=0.0054).
Croatian: Procijenjeni omjer hazarda za nintedanib naspram placeba iznosio je 0,16 (95% CI 0,04, 0,71; p=0,0054).
English: Frequency of patients with acute IPF exacerbations over 52 weeks and time to first exacerbation analysis based on investigator-reported events in trials INPULSIS-1, INPULSIS-2, and their pooled data - treated set
Croatian: Tablica 5: Učestalost bolesnika s akutnim egzacerbacijama IPF-a tijekom 52 tjedna i analiza vremena do prve egzacerbacije na temelju događaja koje su prijavili ispitivači u ispitivanjima INPULSIS-1, INPULSIS-2 i njihovi združeni podaci - liječena skupina
English: Annual rate of decline in FVC (mL) in trials INPULSIS-1, INPULSIS-2 and their pooled data - treated set
Croatian: Tablica 2: Godišnja stopa smanjenja FVC-a (ml) u ispitivanjima INPULSIS-1, INPULSIS-2 i njihovi združeni podaci - liječena skupina
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava glavobolja
English: Frequency of patients with ≥ 10% absolute decline of FVC % predicted or death over 52 weeks and time to progression in trials INPULSIS-1, INPULSIS-2, and their pooled data - treated set
Croatian: Tablica 4: Učestalost bolesnika s ≥ 10%-tnim apsolutnim smanjenjem FVC-a izraženog kao %-tak previđene normalne vrijednosti ili smrću tijekom 52 tjedna i vrijeme do progresije u ispitivanjima INPULSIS-1, INPULSIS-2 i njihovi združeni podaciliječena skupina
English: Ofev 150 mg soft capsules
Croatian: Ofev 150 mg meke kapsule
English: No dedicated studies investigating the effect of nintedanib on wound healing were performed.
Croatian: Nisu provedena ciljana ispitivanja za istraživanje učinka nintedaniba na cijeljenje rana.