natgillin/translations-raw huggingface dataset:
The safety, efficacy, and pharmacokinetics of nintedanib have not been studied in patients with severe renal impairment (<30 ml/min creatinine clearance). 
Varnosti, učinkovitosti in farmakokinetike nintedaniba pri bolnikih s hudo ledvično okvaro (očistek kreatinina < 30 ml/min) niso proučevali.
Nintedanib may cause foetal harm in humans (see section 5.3). 
Nintedanib lahko povzroči poškodbe ploda pri ljudeh (glejte poglavje 5.3).
The estimated difference between the treatment groups was 0.131 L/year (95% CI 0.027, 0.235). 
Ocenjena razlika med skupinama zdravljenja je bila 0,131 l/leto (95 % IZ 0,027; 0,235).
Drug-drug interactions between nintedanib and CYP substrates, CYP inhibitors, or CYP inducers are therefore not expected. 
Medsebojno delovanje med nintedanibom in substrati CYP, zaviralci CYP ali induktorji CYP zato ni pričakovano.
Start appropriate anti-diarrhoeal treatment, e.g. with loperamide, as soon as possible. 
Takoj, ko je mogoče, začnite jemati ustrezno zdravilo proti driski, npr. loperamid.
If you take more Ofev than you should Contact your doctor or pharmacist immediately. 
Če ste vzeli večji odmerek zdravila Ofev, kot bi smeli Takoj se posvetujte z zdravnikom ali farmacevtom.
Given the similarity in safety profiles for both medicinal products, additive adverse events, including gastrointestinal and hepatic adverse events, may be expected. 
Zaradi podobnosti varnostnega profila obeh zdravil lahko pričakujemo kombinirane neželene učinke, vključno z neželenimi učinki prebavil in jetrnimi neželenimi učinki.
There is no information on the excretion of nintedanib and its metabolites in human milk. 
Ni podatkov o izločanju nintedaniba in njegovih presnovkov v materino mleko.
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. 
V študiji, namenjeni bolnikom z rakom ledvičnih celic, so zabeležene izmerjene vrednosti QT/QTc pokazale, da enkratni peroralni odmerek nintedaniba po 200 mg in večkratni peroralni odmerki nintedaniba po 200 mg, ki so jih dajali 15 dni dvakrat na dan, ne podaljšajo intervala QTcF.
No evidence of QT prolongation was observed for nintedanib in the clinical trial programme (Section 5.1). 
V programu kliničnega preskušanja z nintedanibom niso opazili podaljšanja intervala QT (poglavje 5.1).
Liver enzyme elevations (see section 4.4) were reported in 13.6% of nintedanib treated patients. 
O zvečanju vrednosti jetrnih encimov (glejte poglavje 4.4) so poročali pri 13,6 % bolnikov, zdravljenih z nintedanibom.
General toxicology 
Splošna toksikologija
If you stop taking Ofev 
Če ste prenehali jemati zdravilo Ofev
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. 
V preglednici 1 so povzete pogostnosti neželenih učinkov zdravila (NUZ), o katerih so poročali v skupini z nintedanibom (638 bolnikov), združenih iz dveh s placebom nadzorovanih kliničnih preskušanj faze III, ki sta trajali 52 tednov ali iz obdobja trženja zdravila.
Time to progression (≥ 10% absolute decline of FVC % predicted or death) In both INPULSIS trials, the risk of progression was statistically significantly reduced for patients treated with nintedanib compared with placebo. 
Čas do napredovanja bolezni (≥ 10-odstotni absolutni upad napovedanega % FVC ali smrt) V obeh preskušanjih INPULSIS se je tveganje za napredovanje bolezni statistično pomembno zmanjšalo pri bolnikih, zdravljenih z nintedanibom, v primerjavi s placebom.
The key secondary endpoints were change from baseline in Saint George's Respiratory Questionnaire (SGRQ) total score at 52 weeks and time to first acute IPF exacerbation. 
Ključni sekundarni opazovani dogodki so bili sprememba skupnega seštevka od izhodišča po vprašalniku o dihanju bolnišnice St. Georg (SGRQ-Saint George's Respiratory Questionnaire) v 52. tednu in čas do prvega akutnega poslabšanja IPF.
This ensures that a steady amount of nintedanib is maintained in your blood stream. 
Tako boste zagotovili enakomerno količino nintedaniba v krvnem obtoku.
SPECIAL STORAGE CONDITIONS Do not store above 25°C. 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25 °C.
Patients were randomized in a 3:2 ratio to treatment with Ofev 150 mg or placebo twice daily for 52 weeks. 
Bolnike so v razmerju 3:2 randomizirali za 52-tedensko zdravljenje z zdravilom Ofev 150 mg ali placebom dvakrat na dan.
Swallow the whole capsules with water and do not chew or crush the capsules. 
Kapsule pogoltnite cele z vodo in jih ne žvečite niti drobite.
The following other side effects were observed during treatment with this medicine. 
Med zdravljenjem s tem zdravilom so opazili naslednje druge neželene učinke.
Cytochrome (CYP)-enzymes 
Encimi citokroma (CYP)
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). 
V primeru prekinitev zaradi zvišanja vrednosti aspartat-aminotransferaze (AST) ali alanin aminotransferaze (ALT) na > 3x zgornjo mejo normalnih vrednosti (ULN-upper limit of normal), se lahko zdravljenje z zdravilom Ofev po vrnitvi vrednosti aminotransferazna izhodiščno raven nadaljuje z zmanjšanim odmerkom (100 mg dvakrat na dan), nato pa se lahko poveča na polni odmerek (150 mg dvakrat na dan) (glejte poglavji 4.4 in 4.8).
Patients with FVC baseline < 50% predicted or carbon monoxide diffusing capacity (DLCO, corrected for haemoglobin) < 30% predicted at baseline were excluded from the trials. 
Bolniki s predvideno izhodiščno vrednostjo FVC < 50 % ali predvideno izhodiščno vrednostjo difuzijske zmogljivosti za ogljikov monoksid (DLCO korigirano z vrednostjo hemoglobina ) < 30 %, so bili izključeni iz kliničnih preskušanj.
In vitro, CYP-dependent metabolism accounted for about 5% compared to about 25% ester cleavage. 
Delež od CYP odvisne presnove in vitro je približno 5 % v primerjavi s približno 25 % cepitve estra.
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. 
V obeh preskušanjih INPULSIS je bil delež odzivnih FVC, opredeljen kot bolniki z absolutnim upadom napovedanega % FVC do 5 % (meja, ki nakazuje na večje tveganje za smrtnost pri IPF), značilno višji v skupini z nintedanibom v primerjavi s placebom.
In patients with mild hepatic impairment (Child Pugh A), treatment interruption or discontinuation for management of adverse reactions should be considered. 
Pri bolnikih z blago jetrno okvaro (Child Pugh A) je treba razmisliti o možnosti začasne ali dokončne prekinitve zdravljenja zaradi obvladovanja neželenih učinkov.
Potent P-gp inducers (e.g. rifampicin, carbamazepine, phenytoin, and St. John's Wort) may decrease exposure to nintedanib. 
Močni induktorji P-gp (npr. rifampicin, karbamazepin, fenitoin in šentjanževka) lahko zmanjšajo izpostavljenost nintedanibu.
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. 
V preskušanju INPULSIS-2 je bilo tveganje za prvo akutno poslabšanje IPF v 52 tednih značilno manjše pri bolnikih, ki so prejemali nintedanib v primerjavi s placebom, v preskušanju INPULSIS-1 ni bilo razlike med skupinami zdravljenja.
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. 
To kaže, da je bilo tveganje za prvo ocenjeno akutno poslabšanje IPF v vsaki časovni točki statistično značilno manjše v skupini z nintedanibom, kot v skupini s placebom.
Cases of drug-induced liver injury have been observed with nintedanib treatment, including severe liver injury with fatal outcome. 
Pri zdravljenju z nintedanibom so opazili poškodbe jeter, povzročene z zdravilom, vključno s hudo poškodbo jeter s smrtnim izidom.
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). 
V preskušanjih INPULSIS je bila pogostnost bolnikov s predrtjem zelo nizka, tako v preizkusni kot tudi v kontrolni skupini: 0 % placebo, 0,3 % zdravilo Ofev (prizadeta dva bolnika).
Ofev is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). 
Zdravilo Ofev je indicirano za zdravljenje odraslih bolnikov z idiopatsko pljučno fibrozo (IPF).
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). 
Poslabšanje HRQoL je bilo manjše v skupini z nintedanibom; razlika med skupinama zdravljenja je bila statistično značilna (-2,69; 95 % IZ: -4,95; -0,43; p=0,0197).
Ofev 150 mg soft capsules EU/1/14/979/003 
Ofev 150 mg mehke kapsule EU/1/14/979/003
The analysis of time to death resulted in a HR of 0.70 (95% CI 0.43, 1.12; p=0.1399). 
Analiza časa do smrti je pokazala, da je HR 0,70 (95 % IZ 0,43; 1,12; p=0,1399).
The recommended dose is 150 mg nintedanib twice daily administered approximately 12 hours apart. 
Priporočeni odmerek je 150 mg nintedaniba dvakrat na dan, ki ga je treba jemati v približno 12-urnem razmiku.
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE31 
Farmakoterapevtska skupina: zdravila z delovanjam na novotvorbe (citostatiki), zaviralci proteinskih kinaz, oznaka ATC: L01XE31.
You need to pay special attention if you get the following side effects during treatment with Ofev: 
Bodite posebno pozorni na pojav naslednjih neželenih učinkov med zdravljenjem z zdravilom Ofev:
LIST OF EXCIPIENTS Contains soya lecithin. 
SEZNAM POMOŽNIH SNOVI Vsebuje sojin lecitin.
Nintedanib inhibits proliferation, migration and fibroblast to myofibroblast transformation of human lung fibroblasts from patients with IPF. 
Nintedanib zavira proliferacijo, migracijo in transformacijo humanih pljučnih fibroblastov v miofibroblaste v pljučih bolnikov z IPF.
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. 
V študiji INPULSIS-2 so imeli bolniki, ki so dobivali placebo, večje povečanje skupnega seštevka SGRQ od izhodišča v primerjavi z bolniki, ki so prejemali nintedanib 150 mg dvakrat na dan.
Female patients should be advised to notify their doctor or pharmacist if they become pregnant during therapy with Ofev. 
Ženskam je treba svetovati, naj obvestijo zdravnika ali farmacevta, če med zdravljenjem z zdravilom Ofev zanosijo.
If coadministered with Ofev, potent P-gp inhibitors (e.g. ketoconazole, erythromycin or cyclosporine) may increase exposure to nintedanib. 
Pri sočasnem dajanju z zdravilom Ofev lahko močni zaviralci P-gp (npr. ketokonazol, eritromicin ali ciklosporin) povečajo izpostavljenost nintedanibu.
Mean (SE) absolute changes from baseline in FVC at week 12 were −13.3 (17.4) mL in patients treated with nintedanib with add-on pirfenidone (n=48) compared to −40.9 (31.4) mL in patients treated with nintedanib alone (n=44). 
Povprečne (SE) absolutne spremembe FVC od izhodišča so bile v 12. tednu -13,3 (17,4) ml pri bolnikih, ki so jemali nintedanib in pirfenidon (n = 48), v primerjavi z -40,9 (31,4) ml pri bolnikih, ki so jemali samo nintedanib (n = 44).
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. 
Zgodnje zdravljenje driske je pomembno (glejte poglavje 4); - če bruhate ali vas sili na bruhanje (navzea); - če imate nepojasnjene simptome, kot je porumenelost kože ali beločnic (zlatenica), urin temne ali rjave barve (barve čaja), bolečina v zgornjem desnem predelu trebuha (abdomna), hitrejša krvavitev ali nastajanje podplutb kot običajno ali občutek utrujenosti.
Selection of an alternate concomitant medicinal product with no or minimal Pgp induction potential should be considered. 
Razmisliti je treba o alternativnem sočasnem zdravilu, ki P-gp inducira le malo ali pa sploh ne.
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). 
V 48 urah se je s sečem izločilo približno 0,05 % odmerka nespremenjene zdravilne učinkovine (31,5 % gCV) po peroralnem zaužitju in približno 1,4 % odmerka (24,2 % gCV) po intravenskem vnosu; ledvični očistek je bil 20 ml/min (32,6 % gCV).
SGRQ total score measuring health related quality of life (HRQoL) was analysed at 52 weeks. 
Sprememba od izhodišča v skupnem seštevku SGRQ v 52. tednu Skupni seštevek SGRQ merjenja z zdravjem povezane kakovosti življenja (HRQoL-health related quality of life), je bil analiziran v 52. tednu.
Capsule shell gelatin glycerol (85%) titanium dioxide (E171) iron oxide red (E172) iron oxide yellow (E172) 
Ovojnica kapsule želatina glicerol (85 %) titanov dioksid (E171) rdeči železov oksid (E172) rumeni železov oksid (E172)
In a dedicated pharmacokinetic study, concomitant treatment of nintedanib with pirfenidone was investigated in patients with IPF. 
V namenski farmakokinetični študiji so sočasno dajanje nintedaniba in pirfenidona preučevali pri bolnikih z IPF.
Total plasma clearance after intravenous infusion was high (CL: 1,390 mL/min, 28.8% gCV). 
Skupni plazemski očistek po intravenskem infundiranju je bil velik (očistek: 1.390 ml/min; 28,8 % gCV).
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. 
Če ne prenašate priporočenega odmerka dveh kapsul po 150 mg zdravila Ofev na dan (glejte možne neželene učinke v poglavju 4), lahko zdravnik zmanjša vaš dnevni odmerek zdravila Ofev.
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). 
Po vnosu hrane se je izpostavljenost nintedanibu povečala za približno 20 % v primerjavi z uporabo na tešče (IZ: 95,3 do 152,5 %), absorpcija pa je bila upočasnjena (mediana tmax na tešče: 2,00 uri; s hrano: 3,98 ure).
BIBF 1202 is subsequently glucuronidated by uridine 5'-diphosphoglucuronosyltransferase enzymes (UGT) enzymes, namely UGT 1A1, UGT 1A7, UGT 1A8, and UGT 1A10 to BIBF 1202 glucuronide. 
Prevladujoča presnovna reakcija nintedaniba je hidrolizna cepitev s pomočjo esteraz, pri kateri nastane prosta kislina BIBF 1202, ki jo nato glukuronizirajo encimi uridin 5'-difosfo-glukuronoziltransferaze (UGT), in sicer UGT 1A1, UGT 1A7, UGT 1A8, in UGT 1A10 v glukuronid BIBF 1202.
Particular caution should be exercised when treating patients with previous abdominal surgery, previous history of peptic ulceration, diverticular disease or receiving concomitant corticosteroids or NSAIDs. 
Posebno pozornost je treba nameniti zdravljenju bolnikov s predhodno abdominalno operacijo, peptično razjedo, divertikularno boleznijo v anamnezi ali bolnikom, ki sočasno jemljejo kortikosteroide ali nesteroidna protivnetna zdravila (NSAID - non-steroidal anti-inflammatory drugs).
Post-marketing bleeding events include but are not limited to gastrointestinal, respiratory and central nervous organ systems, with the most frequent being gastrointestinal. 
Krvavitve v obdobju trženja zdravila vključujejo prebavila, dihala in osrednji živčni sistem, vendar na njih niso omejene, najbolj pogoste pa so krvavitve v prebavilih.
Adjustment of the starting dose in patients with mild to moderate renal impairment is not required. 
Bolnikom z blago do zmerno ledvično okvaro začetnega odmerka ni treba prilagajati.
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). 
Število bolnikov z akutnim poslabšanjem IPF v obdobju 52 tednov je bilo manjše v skupini z nintedanibom (2,3 %, N=86) v primerjavi s placebom (13,8 %, N=87).
Ofev 100 mg soft capsules EU/1/14/979/001 
Ofev 100 mg mehke kapsule EU/1/14/979/001
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%). 
Čeprav so bili neželeni učinki, ki kažejo na ishemično bolezen srca, enakomerno razporejeni med skupino z nintedanibom in skupino s placebom, je doživel miokardni infarkt večji odstotek bolnikov v skupini z nintedanibom (1,6 %) v primerjavi s skupino s placebom (0,5 %).
Ofev contains soya lecithin If you are allergic to soya or peanut, do not take this medicine (see section 2). 
Če ste alergični na sojo ali arašide, ne jemljite tega zdravila (glejte poglavje 2).
If a dose is missed, administration should resume at the next scheduled time at the recommended dose. 
Če bolnik pozabi vzeti priporočeni odmerek, naj ga ponovno vzame ob naslednjem načrtovanem času.
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) 
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) - vnetje trebušne slinavke - vnetje debelega črevesa - resne težave z jetri - nizko število trombocitov (trombocitopenija) - visok krvni tlak (hipertenzija) - zlatenica, ki je rumeno obarvanje kože in očesnih beločnic zaradi visokih ravni bilirubina - srbenje - miokardni infarkt - izpadanje las (alopecija)
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). 
Pogostnost bolnikov z vsaj 1 ovrednotenim poslabšanjem, ki se je pojavilo v 52 tednih, je bila manjša v skupini z nintedanibom (1,9 % bolnikov) kot v skupini s placebom (5,7 % bolnikov).
Therefore, hepatic transaminase and bilirubin levels should be investigated before treatment initiation and during the first month of treatment with Ofev. 
Zato je treba pred uvedbo zdravljenja z zdravilom Ofev in v prvem mesecu zdravljenja določiti raven jetrnih aminotransferaz in bilirubina.
If a dose is missed the patient should not take an additional dose. 
Bolnik ne sme vzeti dodatnega odmerka, če odmerek izpusti.
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. 
Zaradi driske so v kliničnih preskušanjih zmanjšali odmerek pri 10,7 % bolnikov in ukinili zdravljenje z nintedanibom pri 4,4 % bolnikov.
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). 
V namenski študiji z enojnim odmerkom faze I in v primerjavi z zdravimi osebami je bila izpostavljenost nintedanibu na podlagi Cmax in AUC 2,2-krat večja pri prostovoljcih z blago jetrno okvaro (Child Pugh A; 90 % IZ 1,3 - 3,7 za Cmax oz. 1,2 - 3,8 za AUC).
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. 
Podatki o varnosti v nadaljevanju temeljijo na dveh randomiziranih, dvojno slepih, s placebom nadzorovanih študijah faze III, s 1.061 bolniki, v katerih so primerjali 52-tedensko zdravljenje z nintedanibom 150 mg dvakrat na dan s placebom (INPULSIS-1 in INPULSIS-2) in na podlagi podatkov, opaženih v obdobju trženja.
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. 
V analizi občutljivosti, kjer so domnevali, da bo upad FVC po zadnji opaženi vrednosti pri bolnikih z manjkajočimi podatki v 52. tednu enak kot pri vseh bolnikih, ki so prejemali placebo, je bila prilagojena razlika v letni stopnji upada med nintedanibom in placebom 113,9 ml/leto (95 % IZ 69,2; 158,5) v študiji INPULSIS-1 in 83,3 ml/leto (95 % IZ 37,6; 129,0) v študiji INPULSIS-2.
Additional data from the phase IV INJOURNEY trial with Ofev 150 mg twice daily and add-on pirfenidone for 12 weeks are described in section 5.1. 
Dodatni podatki iz preskušanja INJOURNEY faze IV z zdravilom Ofev 150 mg dvakrat na dan in dodajanjem pirfenidona 12 tednov so opisani v poglavju 5.1.
Dietary soya products are known to cause allergic reactions including severe anaphylaxis in persons with soya allergy. 
Znano je, da izdelki s sojo pri osebah z alergijo na sojo povzročajo alergijske reakcije, vključno z resno anafilaksijo.
Blood and lymphatic system disorders 
Bolezni krvi in limfatičnega sistema trombocitopenija
In the INPULSIS trials no increased risk of venous thromboembolism was observed in nintedanib treated patients. 
V preskušanjih INPULSIS niso opazili povečanega tveganja za vensko trombembolijo pri bolnikih, zdravljenih z nintedanibom.
Diarrhoea was reported in 62.4% of patients treated with nintedanib. 
O driski so poročali pri 62,4 % bolnikov, zdravljenih z nintedanibom.
Placebo Ofev 150 mg twice daily 
Placebo Zdravilo Ofev 150 mg dvakrat na dan
Do not take more than the recommended dose of two Ofev 100 mg capsules per day if your daily dose was reduced to 200 mg per day. 
Ne vzemite večjega odmerka od priporočenega, to je dveh 100 mg kapsul zdravila Ofev na dan, če je bil vaš dnevni odmerek zmanjšan na 200 mg na dan.