natgillin/translations-raw huggingface dataset:
If you do not tolerate the recommended dose of two Ofev 100 mg capsules per day (see possible side effects in section 4) your doctor may advise you to stop taking this medicine.
Ako ne podnosite preporučenu dozu od dvije Ofev 100 mg kapsule dnevno (pogledajte moguće nuspojave u dijelu 4), liječnik Vam može savjetovati prekid primjene ovog lijeka.
The 100 mg twice daily dose is only recommended to be used in patients who do not tolerate the 150 mg twice daily dose.
Primjena doze od 100 mg dvaput dnevno preporučuje se samo u bolesnika koji ne podnose dozu od 150 mg dvaput dnevno.
If coadministered with Ofev, potent P-gp inhibitors (e.g. ketoconazole, erythromycin or cyclosporine) may increase exposure to nintedanib.
Ako su primijenjeni istodobno s Ofevom, potentni inhibitori P-gp-a (npr. ketokonazol, eritromicin ili ciklosporin) mogu povećati izloženost nintedanibu.
Very common
Vrlo često
Liver enzyme elevations (see section 4.4) were reported in 13.6% of nintedanib treated patients.
Povišene vrijednosti jetrenih enzima (vidjeti dio 4.4) prijavljene su u 13,6% bolesnika liječenih nintedanibom.
In preclinical disease models of lung fibrosis nintedanib exerts potent anti-fibrotic and anti-inflammatory activity.
U pretkliničkim modelima plućne fibroze nintedanib ispoljava potentnu protufibroznu i protuupalnu aktivnost.
In a dedicated study in renal cell cancer patients, QT/QTc measurements were recorded and showed that a single oral dose of 200 mg nintedanib as well as multiple oral doses of 200 mg nintedanib administered twice daily for 15 days did not prolong the QTcF interval.
U ciljanom ispitivanju bolesnika s karcinomom bubrežnih stanica, zabilježena su mjerenja QT/QTc koja su pokazala da jednokratna peroralna doza od 200 mg nintedaniba kao i višekratne peroralne doze od 200 mg nintedaniba primjenjivane dvaput dnevno tijekom 15 dana nisu uzrokovale produljenje korigiranog QT-intervala (QTcF).
The following medicines are examples that may increase the levels of nintedanib in your blood, and hence may increase the risk for side effects (see section 4): - a medicine used to treat fungal infections (ketoconazole) - a medicine used to treat bacterial infections (erythromycin) - a medicine that affects your immune system (cyclosporine)
Navedeni lijekovi su primjeri lijekova koji mogu povećati razine nintedaniba u krvi te stoga mogu povećati rizik od nuspojava (pogledajte dio 4): - lijek koji se koristi za liječenje gljivičnih infekcija (ketokonazol) - lijek koji se koristi za liječenje bakterijskih infekcija (eritromicin) - lijek koji djeluje na Vaš imunološki sustav (ciklosporin)
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 h; fed: 3.98 h).
Nakon unosa hrane izloženost nintedanibu se povećala za približno 20% u usporedbi s primjenom natašte (CI: 95,3 - 152,5%), a apsorpcija je bila odgođena (medijan tmax natašte: 2,00 h; nakon obroka: 3,98 h).
This could be symptoms of serious liver problems; - if you have severe pain in your stomach, 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').
To mogu biti simptomi ozbiljnih problema s jetrom; - ako imate jaku bol u trbuhu, vrućicu, zimicu, mučninu, povraćanje, tvrdi ili naduti trbuh, jer bi to mogli biti simptomi pucanja stijenke crijeva („gastrointestinalna perforacija“).
Due to the mechanism of action of nintedanib patients might have an increased risk of thromboembolic events.
Zbog mehanizma djelovanja nintedaniba, bolesnici mogu imati povećani rizik tromboembolijskih događaja.
Patients should be treated at first signs with adequate hydration and anti-diarrhoeal medicinal products, e.g. loperamide, and may require treatment interruption.
Bolesnike se mora liječiti pri pojavi prvih znakova odgovarajućim nadomještanjem tekućine i lijekovima protiv proljeva, npr. loperamidom, a može biti potreban i privremeni prekid terapije.
In vitro, CYP-dependent metabolism accounted for about 5% compared to about 25% ester cleavage.
O CYP-u ovisan metabolizam u in vitro uvjetima bio je odgovoran za približno 5% cijepanja u usporedbi s 25% cijepanja estera.
Patients should be monitored during nintedanib therapy, with particular attention to those patients exhibiting risk factors for renal impairment/failure.
Bolesnike je potrebno nadzirati tijekom terapije nintedanibom, s time da osobitu pozornost treba posvetiti bolesnicima koji imaju čimbenike rizika za oštećenje/zatajenje bubrega.
Based on increased exposure, the risk for adverse reactions may be increased in patients with mild hepatic impairment (Child Pugh A).
Na temelju povećane izloženosti može postojati povećan rizik od nuspojava u bolesnika s blagim oštećenjem funkcije jetre (Child Pugh A).
Adjustment of the starting dose in patients with mild to moderate renal impairment is not required.
Prilagodba početne doze u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega nije potrebna.
10% threshold Number (%) of FVC responders
10%-tni prag Broj (%) osoba s odgovorom u
Do not use this medicine after the expiry date which is stated on the carton and the blister.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „EXP“.
If transaminase (AST or ALT) elevations > 3x ULN are measured, dose reduction or interruption of the therapy with Ofev is recommended and the patient should be monitored closely.
Ako su izmjerena povišenja transaminaza (AST ili ALT) ˃ 3x od GGN, preporučuje se smanjiti dozu ili privremeno prekinuti terapiju Ofevom, a bolesnika se mora pomno nadzirati.
Pre-clinical studies showed that small amounts of nintedanib and its metabolites (≤ 0.5% of the administered dose) were secreted into milk of lactating rats.
Pretklinička ispitivanja pokazala su da su se male količine nintedaniba i njegovih metabolita (≤ 0,5% primijenjene doze) izlučile u mlijeko štakorica u laktaciji.
Diarrhoea led to dose reduction in 10.7% of the patients and to discontinuation of nintedanib in 4.4% of the patients in clinical trials.
Proljev je bio razlog smanjenja doze u 10,7% bolesnika i prekida liječenja nintedanibom u 4,4% bolesnika u kliničkim ispitivanjima.
Due to the mechanism of action of nintedanib patients might have an increased risk of gastrointestinal perforation.
Zbog mehanizma djelovanja nintedaniba, bolesnici mogu imati povećani rizik gastrointestinalne perforacije.
Female patients should be advised to notify their doctor or pharmacist if they become pregnant during therapy with Ofev.
Bolesnice se mora uputiti da obavijeste svog liječnika ili ljekarnika ako zatrudne tijekom terapije Ofevom.
Diarrhoea, nausea and vomiting were the most frequent adverse events reported in 20 (37.7%) versus 16 (31.4%), in 22 (41.5%) versus 6 (11.8%) and in 15 (28.3%) versus 6 (11.8%) patients, treated with pirfenidone added to nintedanib versus nintedanib alone, respectively.
Proljev, mučnina i povraćanje bili su najčešći štetni događaji prijavljeni u 20 (37,7%) naspram 16 (31,4%), u 22 (41,5%) naspram 6 (11,8%) te u 15 (28,3%) naspram 6 (11,8%) bolesnika, liječenih pirfenidonom kao dodatkom nintedanibu naspram samog nintedaniba.
Aneurysms and artery dissections
Aneurizme i disekcije arterije
The absolute bioavailability of a 100 mg dose was 4.69% (90% CI: 3.615 - 6.078) in healthy volunteers.
Apsolutna bioraspoloživost doze od 100 mg u zdravih dobrovoljaca iznosila je 4,69% (90% CI: 3,615 - 6,078).
Blood and lymphatic system disorders
Poremećaji krvi i limfnog sustava trombocitopenija
Termination of the treatment with Ofev should be considered.
Mora se razmotriti prestanak liječenja Ofevom.
Additional data from the phase IV INJOURNEY trial with Ofev 150 mg twice daily and add-on pirfenidone:
Dodatni podaci ispitivanja IV. faze INJOURNEY s Ofevom 150 mg dvaput dnevno i dodatkom pirfenidona:
The annual rate of decline of FVC (in mL) was significantly reduced in patients receiving nintedanib compared to patients receiving placebo.
Godišnja stopa smanjenja FVC-a (u ml) bila je značajno smanjena u bolesnika koji su primali nintedanib u usporedbi s bolesnicima koji su primali placebo.
While adverse events reflecting ischaemic heart disease were balanced between the nintedanib and placebo groups, a higher percentage of patients experienced myocardial infarctions in the nintedanib group (1.6%) compared to the placebo group (0.5%).
Dok su štetni događaji, koji odražavaju ishemijsku bolest srca, bili uravnoteženi između skupina liječenih nintedanibom i placebom, veći postotak bolesnika doživio je infarkt miokarda u skupini liječenoj nintedanibom (1,6%) u usporedbi sa skupinom liječenom placebom (0,5%).
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 the dose (24.2% gCV) after intravenous administration; the renal clearance was 20 mL/min (32.6% gCV).
Izlučivanje nepromijenjene djelatne tvari urinom 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).
Patients were randomized in a 3:2 ratio to treatment with Ofev 150 mg or placebo twice daily for 52 weeks.
Bolesnici su bili randomizirani u omjeru 3:2 za liječenje Ofevom 150 mg ili placebom dvaput dnevno u trajanju od 52 tjedna.
Capsule content triglycerides, medium-chain hard fat lecithin (soya) (E322)
Sadržaj kapsule trigliceridi srednje duljine lanca tvrda mast lecitin (soja) (E322)
Ofev contains the active substance nintedanib and it is used for the treatment of idiopathic pulmonary fibrosis (IPF) in adults.
Ofev sadrži djelatnu tvar nintedanib i koristi se za liječenje idiopatske plućne fibroze (IPF) u odraslih.
In both INPULSIS trials, the proportion of FVC responders, defined as patients with an absolute decline in FVC % predicted no greater than 5% (a threshold indicative of the increasing risk of mortality in IPF), was significantly higher in the nintedanib group as compared to placebo.
U oba ispitivanja INPULSIS, udio osoba s odgovorom u FVC-u, definiranih kao bolesnici s apsolutnim smanjenjem FVC-a izraženog kao %-tak previđene normalne vrijednosti, koje ne prelazi 5% (prag koji ukazuje na povećani rizik od smrtnosti u IPF-u), bio je značajno viši u skupini koja je primala nintedanib u usporedbi s placebom.
- If you have any further questions, ask your doctor or pharmacist.
- Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
Dose adjustments
Prilagodbe doze
Based on a PopPK model, an increase in nintedanib exposure of approximately 20 - 25% was observed in patients ≥ 75 years compared with patients under 65 years.
Na temelju modela PopPK, povećanje izloženosti nintedanibu od približno 20-25% opaženo je u bolesnika u dobi
If you do not tolerate the recommended dose of two Ofev 150 mg capsules per day (see possible side effects in section 4) your doctor may reduce the daily dose of Ofev.
Ako ne podnosite preporučenu dozu od dvije Ofev 150 mg kapsule dnevno (pogledajte moguće nuspojave u dijelu 4), liječnik Vam može smanjiti dnevnu dozu Ofeva.
Selection of an alternate concomitant medicinal product with no or minimal Pgp induction potential should be considered.
Mora se razmotriti odabir drugog istodobnog lijeka, koji nema, ili ima minimalan potencijal indukcije P-gp-a.
Nintedanib, BIBF 1202, and BIBF 1202 glucuronide did not inhibit or induce CYP enzymes in preclinical studies, either.
Nintedanib, BIBF 1202 i BIBF 1202 glukuronid nisu niti inhibirali niti inducirali CYP enzime u pretkliničkim ispitivanjima.
In repeat dose toxicology studies in rats, adverse effects (e.g. thickening of epiphyseal plates, lesions of the incisors) were mostly related to the mechanism of action (i.e. VEGFR-2 inhibition) of nintedanib.
Štetni učinci (npr. zadebljanje epifiznih ploča, lezije sjekutića) u ispitivanjima toksičnosti ponovljenih doza u štakora većinom su bili povezani s mehanizmom djelovanja nintedaniba (tj. inhibicijom VEGFR-2).
In case of interruptions due to aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations > 3x upper limit of normal (ULN), once transaminases have returned to baseline values, treatment with Ofev may be reintroduced at a reduced dose (100 mg twice daily) which subsequently may be increased to the full dose (150 mg twice daily) (see sections 4.4 and 4.8).
U slučaju privremenog prekida liječenja zbog povišenih vrijednosti aspartat aminotransferaze (AST) ili alanin aminotransferaze (ALT) ˃ 3x od gornje granice normale (GGN), nakon što se vrijednosti transaminaza vrate na početne vrijednosti, liječenje Ofevom može se ponovno započeti u smanjenoj dozi (100 mg dvaput dnevno), koja se postupno može povećavati do pune doze (150 mg dvaput dnevno) (vidjeti dijelove 4.4 i 4.8).
The primary endpoint was the percentage of patients with gastrointestinal adverse events from baseline to week 12.
Primarna mjera ishoda bila je postotak bolesnika s gastrointestinalnim štetnim događajima u odnosu na početnu vrijednost do 12. tjedna.
Nintedanib is a substrate of P-gp.
Nintedanib je supstrat za P-gp.
Responder patients are those with no absolute decline greater than 5% or greater than 10% in FVC % predicted, depending on the threshold and with an FVC evaluation at 52 weeks.
Bolesnici s odgovorom su oni čije apsolutno smanjenje FVC-a izraženog kao %-tak predviđene normalne vrijednosti nije veće od 5% ili 10%, ovisno o pragu i uz procjenu FVC-a nakon 52 tjedna.
In group 2, the adjusted geometric mean ratios (90% CI)) were 97% (86% - 110%) and 95% (86% - 106%) for Cmax,ss and AUCτ,ss of pirfenidone, respectively (n=12 for intraindividual comparison).
U skupini 2, omjeri prilagođenih geometrijskih srednjih vrijedosti (90% CI) bili su 97% (86% - 110%) odnosno 95% (86% - 106%) za Cmax,ss i AUCτ,ss pirfenidona (n=12 za intraindividualnu usporedbu).
Co-administration with other medicinal products The potential for interactions of nintedanib with hormonal contraceptives was not explored.
Istodobna primjena s drugim lijekovima Potencijal interakcija nintedaniba s hormonskim kontraceptivima nije istražen.
Ofev helps to reduce scarring and stiffening of the lungs.
Ofev pomaže smanjiti nastanak ožiljaka i pojavu krutosti pluća.
Talk to your doctor or pharmacist before taking Ofev, - if you have or ever had liver problems, - if you have or ever had problems with your kidney, - if you have or ever had bleeding problems, - if you take blood-thinning medicines (such as warfarin, phenprocoumon or heparin) to prevent blood clotting, - if you take pirfenidone as this may increase the risk of having diarrhoea, nausea, vomiting and liver problems, - if you have or ever had problems with your heart (for example a heart attack), - if you have recently had surgery.
Obratite se svom liječniku ili ljekarniku prije nego uzmete Ofev: - ako imate ili ste ikada imali probleme s jetrom; - ako imate ili ste ikada imali probleme s bubrezima; - ako imate ili ste ikada imali probleme s krvarenjem; - ako uzimate lijekove za razrjeđivanje krvi (poput varfarina, fenprokumona ili heparina) radi sprječavanja zgrušavanja krvi; - ako uzimate pirfenidon, jer to može povećati rizik za dobivanje proljeva, mučnine, povraćanja ili problema s jetrom; - ako imate ili ste ikada imali probleme sa srcem (na primjer srčani udar); - ako ste nedavno imali kirurški zahvat.
Patients ≥75 years may be more likely to require dose reduction to manage adverse effects (see section 5.2).
Veća je vjerojatnost da će u bolesnika ≥ 75 godina biti potrebno smanjenje doze radi zbrinjavanja nuspojava (vidjeti dio 5.2).
In a dedicated pharmacokinetic study, concomitant treatment of nintedanib with pirfenidone was investigated in patients with IPF.
U ciljanom farmakokinetičkom ispitivanju istraženo je istodobno liječenje nintedanibom s pirfenidonom u bolesnika s IPF-om.
Subjects with severe hepatic impairment (Child Pugh C) have not been studied.
Izloženost u osoba s teškim oštećenjem jetre (Child Pugh C) nije ispitana.
Breast-feeding should be discontinued during treatment with Ofev.
Dojenje se mora prekinuti za vrijeme liječenja Ofevom.
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).
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).
Potent P-gp inducers (e.g. rifampicin, carbamazepine, phenytoin, and St. John's Wort) may decrease exposure to nintedanib.
Potentni induktori P-gp-a (npr. rifampicin, karbamazepin, fenitoin i gospina trava) mogu smanjiti izloženost nintedanibu.
The analysis of time to death resulted in a HR of 0.70 (95% CI 0.43, 1.12; p=0.1399).
Analiza vremena do smrti rezultirala je omjerom hazarda od 0,70 (95% CI 0,43, 1,12; p=0,1399).
Nintedanib trough concentrations remained stable for more than one year.
Najniže koncentracije nintedaniba ostale su stabilne više od jedne godine.
Also, tell your doctor if you had peptic ulcers or diverticular disease in the past, or are concomitantly treated with anti-inflammatory drugs (NSAIDs) (used to treat pain relief and swelling) or steroids (used for inflammation and allergies), as this may increase this risk; - if you have pain, swelling, reddening, warmth of a limb as this could be symptoms of a blood clot in one of your veins (a type of blood vessel); - if you have 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 you have any major bleeding.
Također obavijestite svog liječnika ako ste u prošlosti imali peptički ulkus ili divertikularnu bolest, ili ako se istodobno liječite protuupalnim lijekovima (NSAIL-ovima) (primjenjuju se za ublažavanje boli i oticanja) ili steroidima (primjenjuju se kod upale i alergija), jer to može povećati ovaj rizik; - ako primijetite bol, oticanje, crvenilo i toplinu udova, jer bi to mogli biti simptomi nastanka krvnog ugruška u nekoj od vena (vrsta krvnih žila); - ako imate pritisak ili bol u prsnom košu, tipično na lijevoj strani tijela, bol u vratu, čeljusti, ramenu ili ruci, ubrzane otkucaje srca, nedostatak zraka, mučninu i povraćanje, jer to mogu biti simptomi srčanog udara; - ako imate bilo kakvo veće krvarenje.
In case of persisting severe symptoms therapy with Ofev should be discontinued.
U slučaju trajnih teških simptoma, terapija Ofevom mora se prekinuti.
Each 100 mg soft capsule contains 1.2 mg of soya lecithin.
Jedna meka kapsula od 100 mg sadrži 1,2 mg sojinog lecitina.
In the INPULSIS trials (see section 5.1), diarrhoea was the most frequent gastro-intestinal adverse reaction reported in 62.4% versus 18.4% of patients treated with Ofev and placebo, respectively (see section 4.8).
U ispitivanjima INPULSIS (vidjeti dio 5.1), proljev je bio najčešća nuspojava probavnog sustava prijavljena u 62,4% bolesnika liječenih Ofevom naspram 18,4% bolesnika liječenih placebom (vidjeti dio 4.8).
See Figure 1 for the evolution of change from baseline over time in both treatment groups, based on the pooled analysis of studies INPULSIS-1 and INPULSIS-2.
Na slici 1 može se vidjeti razvoj promjene od početne vrijednosti tijekom vremena za obje skupine liječenja, na temelju združene analize ispitivanja INPULSIS-1 i INPULSIS-2.
Ofev is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF).
Ofev je indiciran za liječenje idiopatske plućne fibroze (IPF) u odraslih osoba.
In a sensitivity analysis which assumed that in patients with missing data at week 52 the FVC decline after the last observed value would be the same as in all placebo patients, the adjusted difference in the annual rate of decline between nintedanib and placebo was 113.9 mL/year (95% CI 69.2, 158.5) in INPULSIS-1 and 83.3 mL/year (95% CI 37.6, 129.0) in INPULSIS-2.
U analizi osjetljivosti koja je pretpostavila da će u bolesnika za koje nedostaju podaci u 52. tjednu, smanjenje FVC-a nakon posljednje opažene vrijednosti biti isto kao u svih bolesnika liječenih placebom, prilagođena razlika u godišnjoj stopi smanjenja između nintedaniba i placeba iznosila je 113,9 ml/godina (95% CI 69,2, 158,5) u ispitivanju INPULSIS-1, te 83,3 ml/godina (95% CI 37,6, 129,0) u ispitivanju INPULSIS-2.
In INPULSIS-2, patients receiving placebo had a larger increase from baseline SGRQ total score as compared to patients receiving nintedanib 150 mg twice daily.
U ispitivanju INPULSIS-2, bolesnici koji su primali placebo imali su veće povećanje u odnosu na početne vrijednosti ukupnog rezultata upitnika SGRQ, u usporedbi s bolesnicima koji su primali nintedanib 150 mg dvaput dnevno.
Ofev 150 mg soft capsules EU/1/14/979/003
Ofev 150 mg meke kapsule EU/1/14/979/003
Ofev may have minor influence on your ability to drive and use machines.
Ofev može u manjoj mjeri utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
Management of side effects may require interruption, dose reduction, or discontinuation of therapy with Ofev (see section 4.2).
Zbrinjavanje nuspojava može zahtijevati privremeni prekid, smanjenje doze ili trajni prekid terapije Ofevom (vidjeti dio 4.2).
Table 1 summarizes the frequencies of adverse drug reactions (ADRs) that were reported in the nintedanib group (638 patients) pooled from the two placebo-controlled Phase III clinical trials of 52 weeks duration or from the post-marketing period.
Tablica 1 sažima učestalosti nuspojava na lijek koje su bile prijavljene u skupini na nintedanibu (638 bolesnika) združenih iz dvaju placebom kontroliranih kliničkih ispitivanja faze III u trajanju od 52 tjedna ili tijekom razdoblja nakon stavljanja lijeka u promet.
Cases of drug-induced liver injury have been observed with nintedanib treatment, including severe liver injury with fatal outcome.
Tijekom liječenja nintedanibom opaženi su slučajevi oštećenja jetre uzrokovanog lijekovima, uključujući teško oštećenje jetre sa smrtnim ishodom.
Race
Rasa
No evidence of QT prolongation was observed for nintedanib in the clinical trial programme (Section 5.1).
U programu kliničkog ispitivanja nije opažen dokaz produljenja QT-intervala za nintedanib (dio 5.1).
Co-administration with pirfenidone
Istodobna primjena s pirfenidonom
In the INPULSIS trials, the frequency of patients with perforation was very low in both treatment groups: 0% placebo, 0.3% Ofev (involving two patients).
U ispitivanjima INPULSIS, učestalost bolesnika s perforacijom bila je vrlo niska u obje liječene skupine: 0% u skupini koja je primala placebo i 0,3% u skupini koja je primala Ofev (u dva bolesnika).
From subchronic and chronic toxicity studies, there is no evidence that female fertility in rats is impaired at a systemic exposure level comparable with that at the maximum recommended human dose (MRHD) of 150 mg twice daily (see section 5.3).
Ispitivanja supkronične i kronične toksičnosti nisu pružila dokaze o smanjenju plodnosti ženki štakora pri razini sistemske izloženosti usporedivoj s maksimalnom preporučenom dozom za ljude (engl. maximum recommended human dose, MRHD) od 150 mg dvaput dnevno (vidjeti dio 5.3).
Ofev contains soya lecithin If you are allergic to soya or peanut, do not take this medicine (see section 2).
Ako ste alergični na soju ili kikiriki, nemojte uzimati ovaj lijek (pogledajte dio 2).
Supportive evidence from the phase II trial (1199.30) Ofev 150 mg twice daily results Additional evidence of efficacy is provided by the randomised, double-blind, placebo-controlled, dose finding phase II trial including a nintedanib 150 mg twice daily dose group.
Podupirući dokaz iz rezultata ispitivanja faze II (1199.30) s Ofevom 150 mg dvaput dnevno Dodatni dokaz djelotvornosti pruža randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje faze II s ciljem utvrđivanja doze, koje je uključivalo skupinu s dozom nintedaniba od 150 mg dvaput dnevno.