natgillin/translations-raw huggingface dataset:
In most patients the adverse reaction was of mild to moderate intensity and occurred within the first 3 months of treatment.
Pri večini bolnikov je bil neželeni učinek blag do zmeren in se je pojavil v prvih 3 mesecih zdravljenja.
Not all pack-sizes may be marketed.
Na trgu morda ni vseh navedenih pakiranj.
In most patients with nausea and vomiting, the event was of mild to moderate intensity.
Pri večini bolnikov z navzeo in bruhanjem je bil dogodek blag do zmeren.
Serious bleeding events occurred with low and similar frequencies in the 2 treatment groups (placebo: 1.4%; Ofev: 1.3%).
Resne krvavitve so se pojavile z nizko pogostnostjo in podobno pogosto v obeh zdravljenih skupinah (placebo: 1,4 %; zdravilo Ofev: 1,3 %).
For the interaction potential of nintedanib with this transporter, see section 4.5.
Za možne interakcije nintedaniba s tem prenašalcem glejte poglavje 4.5.
Elevations of liver enzymes (ALT, AST, blood alkaline phosphatase (ALKP), gamma-glutamyltransferase (GGT)) and bilirubin were reversible upon dose reduction or interruption in the majority of cases.
Povečanja jetrnih encimov (ALT, AST, alkalne-fosfataze v krvi (ALKP) in gama-glutamiltransferaze (GGT)) in bilirubina so bila v večini primerov reverzibilna po zmanjšanju odmerka ali prekinitvi uporabe.
The 100 mg twice daily dose is only recommended to be used in patients who do not tolerate the 150 mg twice daily dose.
Odmerek po 100 mg dvakrat na dan se priporoča samo za uporabo pri bolnikih, ki ne prenašajo odmerka po 150 mg dvakrat na dan.
BATCH NUMBER Lot
ŠTEVILKA SERIJE Lot
Treatment with Ofev should be initiated by physicians experienced in the diagnosis and treatment of IPF.
Zdravljenje z zdravilom Ofev mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem IPF.
In preclinical disease models of lung fibrosis nintedanib exerts potent anti-fibrotic and anti-inflammatory activity.
V predkliničnih modelih bolezni pljučne fibroze kaže nintedanib močno protifibrotsko in protivnetnoaktivnost.
1 (SE) of decline over 52 weeks Comparison vs placebo Difference 95% CI
1 (SE) upada v 52 tednih Primerjava s placebom Razlika 95 % IZ
If any liver test elevations are associated with clinical signs or symptoms of liver injury, e.g. jaundice, treatment with Ofev should be permanently discontinued.
Če so zvišane vrednosti jetrnih testov povezane s kliničnimi znaki ali simptomi poškodbe jeter, npr. z zlatenico, je treba zdravljenje z zdravilom Ofev trajno ukiniti.
From the 2-year carcinogenicity studies in mice and rats, there was no evidence for a carcinogenic potential of nintedanib.
Iz 2-letnih študij kancerogenosti pri miših in podganah ni dokazov o kancerogenem potencialu nintedaniba.
Only a minor extent of the biotransformation of nintedanib consisted of CYP pathways, with CYP 3A4 being the predominant enzyme involved.
Le manjši del biotransformacije nintedaniba je potekal po poteh CYP, pri čemer je prevladujoči vpleteni encim CYP 3A4.
After intravenous infusion, a high volume of distribution (Vss: 1,050 L, 45.0% gCV) was observed.
Po intravenskem infundiranju so opazili velik porazdelitveni volumen (Vss: 1.050 l; 45,0 % gCV).
In rats, small amounts of radiolabelled nintedanib and/or its metabolites were excreted into the milk (≤ 0.5% of the administered dose).
Pri podganah so se majhne količine radioaktivno označenega nintedaniba in/ali njegovih presnovkov izločale v mleko (≤ 0,5 % uporabljenega odmerka).
In addition nintedanib inhibits Flt-3 (Fms-like tyrosine-protein kinase), Lck (lymphocyte-specific tyrosine-protein kinase), Lyn (tyrosine-protein kinase lyn) and Src (proto-oncogene tyrosine-protein kinase src) kinases.
Poleg tega nintedanib zavira kinazo flt-3 (fms-podobno tirozin-protein kinazo), kinazo lck (za limfocite specifično tirozin-protein kinazo), kinazo lin (tirozin-protein kinazo lin) in kinazo src (proto-onkogeno tirozin-protein kinazo src).
Nintedanib is a small molecule tyrosine kinase inhibitor including the receptors platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, and VEGFR 1-3.
Nintedanib je zaviralec tirozin-kinaze v obliki majhne molekule, vključno z receptorji rastnega faktorja iz trombocitov (PDGFR-platelet derived growth factor receptors) α in β, receptorjev rastnega faktorja fibroblastov (FGFR-fibroblast growth factor receptors) 1-3 in receptorjev žilnega endotelijskega rastnega faktorja (VEGFR-vascular endothelial growth factor receptors) 1-3.
Non-serious and serious bleeding events, some of which were fatal, have been reported in the postmarketing period (including patients with or without anticoagulant therapy or other medicinal products that could cause bleeding).
V obdobju trženja zdravila so poročali o neresnih in resnih krvavitvah, od katerih je bilo nekaj s smrtnim izidom (vključno pri bolnikih, ki niso zdravljeni z antikoagulanti, in tistih, ki so zdravljeni z antikoagulanti ali drugimi zdravili, ki bi lahko povzročili krvavitve).
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 podlagi modela PopPK so pri bolnikih, starih 75 let ali več, opazili povečano izpostavljenost nintedanibu za približno 20-25 % v primerjavi z bolniki, mlajšimi od 65 let.
Nintedanib is a substrate of P-gp (see section 5.2).
Nintedanib je substrat P-gp (glejte poglavje 5.2).
The clinical efficacy of nintedanib has been studied in patients with IPF in two phase III, randomised, double-blind, placebo-controlled studies with identical design (INPULSIS-1 (1199.32) and INPULSIS-2 (1199.34)).
Klinično učinkovitost nintedaniba so preučili pri bolnikih z IPF v dveh randomiziranih, dvojno slepih, s placebom nadzorovanih študija faze III z identično zasnovo (INPULSIS-1 (1199.32) in INPULSIS-2 (1199.34)).
Nintedanib inhibits the activation of FGFR and PDGFR signalling cascades which are critically involved in proliferation, migration and differentiation of lung fibroblasts/myofibroblasts, the hallmark cells in the pathology of IPF.
Nintedanib zavira aktivacijo signalnih kaskad za FGFR in PDGFR, ki so bistvene za proliferacijo, migracijo in diferenciacijo pljučnih fibroblastov/miofibroblastov, celic, ki so odločilnega pomena v patologiji IPF.
Tell your doctor or pharmacist immediately if you become pregnant during treatment with Ofev.
Takoj povejte zdravniku ali farmacevtu, če boste med zdravljenjem z zdravilom Ofev zanosili.
In such cases, patients should be monitored closely for tolerability of nintedanib.
V teh primerih je treba pri bolnikih skrbno spremljati prenašanje nintedaniba.
Less than 1% of a single dose of nintedanib is excreted via the kidney (see section 5.2).
Manj kot 1 % enkratnega odmerka nintedaniba se izloči skozi ledvice (glejte poglavje 5.2).
Subjects with severe hepatic impairment (Child Pugh C) have not been studied.
Oseb s hudo jetrno okvaro (Child Pugh C) niso preučevali.
Gastrointestinal adverse events were frequent and in line with the established safety profile of each component.
Neželeni učinki prebavil so bili pogosti in v skladu z uveljavljenim varnostnim profilom vsake učinkovine.
Capsule content triglycerides, medium-chain hard fat lecithin (soya) (E322)
Vsebina kapsule trigliceridi, srednjeverižni trda maščoba lecitin (sojin) (E322)
If symptoms persist despite appropriate supportive care (including anti-emetic therapy), dose reduction or treatment interruption may be required.
Pri trdovratnih simptomih, ki kljub podporni oskrbi ne izginejo (vključno z zdravljenjem z antiemetiki), je morda treba odmerek zmanjšati ali zdravljenje prekiniti.
C] nintedanib was via faecal/biliary excretion (93.4% of dose, 2.61% gCV).
C] nintedaniba je bila izločanje z blatom/žolčem (93,4 % odmerka, 2,61 % gCV).
In case of renal impairment/failure, therapy adjustment should be considered (see section 4.2 Dose adjustments).
V primeru ledvične okvare/odpovedi je treba razmisliti o prilagoditvi odmerka (glejte poglavje 4.2, Prilagajanje odmerka).
If you forget to take Ofev
Če ste pozabili vzeti zdravilo Ofev
An inverse correlation between body weight and exposure to nintedanib was observed.
Opazili so inverzno korelacijo med telesno maso in izpostavljenostjo nintedanibu.
Based on preclinical investigations there is no evidence for impairment of male fertility (see section 5.3).
Na podlagi predkliničnih preiskav ni znakov vpliva na plodnost pri moških (glejte poglavje 5.3).
60 x 1 soft capsules
60 x 1 mehka kapsula
Vomiting led to discontinuation in 0.8% of the patients.
Zaradi bruhanja so zdravljenje prekinili pri 0,8 % bolnikov.
Do not take Ofev - if you are allergic to nintedanib, peanut or soya, or any of the other ingredients of this medicine
Ne jemljite zdravila Ofev - če ste alergični na nintedanib, arašide ali sojo ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
There is no information on the use of Ofev in pregnant women, but pre-clinical studies in animals have shown reproductive toxicity of this active substance (see section 5.3).
Ni podatkov o uporabi zdravila Ofev pri nosečnicah, vendar predklinične študije pri živalih kažejo, da ima lahko zdravilna učinkovina vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
Observed adverse reactions were consistent with the known safety profile of nintedanib, i.e. increased liver enzymes and gastrointestinal symptoms.
Neželeni učinki, ki so jih opazili, so bili skladni z znanim varnostnim profilom nintedaniba, tj. zvečanje vrednosti jetrnih encimov in prebavni simptomi.
Elevations of liver enzymes were reversible and not associated with clinically manifest liver disease.
Zvečanja vrednosti jetrnih encimov so bila reverzibilna in niso povzročila klinično zaznavnega obolenja jeter.
The most frequently reported adverse reactions associated with the use of nintedanib included diarrhoea, nausea and vomiting, abdominal pain, decreased appetite, weight decreased and hepatic enzyme increased.
Najpogostejši neželeni učinki, povezani z uporabo nintedaniba, vključujejo drisko, navzeo in bruhanje, bolečine v trebuhu, zmanjšan apetit, zmanjšanje telesne mase in zvečanje jetrnih encimov.
Diarrhoea led to permanent treatment discontinuation in 4.4% of patients; otherwise the events were managed by antidiarrhoeal therapy, dose reduction or treatment interruption (see section 4.4).
Zaradi driska so ukinili zdravljenje 4,4 % bolnikov; sicer so dogodke obravnavali z zdravili proti driski, zmanjšanjem odmerka in prekinitvijo zdravljenja (glejte poglavje 4.4).
The major CYP-dependent metabolite could not be detected in plasma in the human ADME study.
Glavnega od CYP odvisnega presnovka v študiji ADME pri ljudeh ni bilo mogoče zaznati v njihovi plazmi.
Nintedanib may affect the way your wounds heal.
Nintedanib lahko vpliva na celjenje ran.
Patients with mild hepatic impairment (Child Pugh A) should be treated with a reduced dose of Ofev (see sections 4.2 and 5.2).
Bolnike z blago jetrno okvaro (Child Pugh A) je treba zdraviti z nižjim odmerkom zdravila Ofev (glejte poglavji 4.2 in 5.2).
D-55216 Ingelheim am Rhein Germany
D-55216 Ingelheim am Rhein Nemčija
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.
Če ne prenašate priporočenega odmerka dveh kapsul po 100 mg zdravila Ofev na dan (glejte možne neželene učinke v poglavju 4), vam lahko zdravnik svetuje, da prenehate jemati to zdravilo.
Based on results of a Population PK (PopPK) analysis in patients with IPF and non small cell lung cancer (NSCLC) (N=1,191) and descriptive investigations, exposure to nintedanib was not influenced by sex (body weight corrected), mild and moderate renal impairment (estimated by creatinine clearance), alcohol consumption, or P-gp genotype.
Na podlagi analize populacijske farmakokinetike pri bolnikih z IPF in nedrobnoceličnim pljučnim rakom (N=1.191), ter opisnimi raziskavami na izpostavljenost nintedanibu niso vplivali spol (prilagojen za telesno maso), blaga ali zmerna ledvična okvara (ocenjeno z očistkom kreatinina), pitje alkohola in genotip P-gp.
In addition, similar effects were observed on other lung function endpoints e.g. change from baseline in FVC at week 52 and FVC responder analyses providing further substantiation of the effects of nintedanib on slowing disease progression.
Poleg tega so podobne učinke opazili pri drugih opazovanih dogodkih delovanja pljuč, npr. v spremembi FVC od izhodišča v 52. tednu in v analizah odzivnih FVC, ki so dodatno utemeljile učinke nintedaniba na upočasnitev napredovanja bolezni.
Only a minor extent of the biotransformation of nintedanib consisted of CYP pathways.
Le manjši obseg biotransformacije nintedaniba poteka po poteh CYP.
Patients should be monitored during nintedanib therapy, with particular attention to those patients exhibiting risk factors for renal impairment/failure.
Med zdravljenjem z nintedanibom je treba bolnike spremljati, posebna pozornost pa je potrebna pri tistih bolnikih, ki imajo dejavnike tveganja za ledvično okvaro/odpoved.
Inform your doctor immediately while taking this medicine, - if you get diarrhoea.
Zdravnika takoj obvestite, če boste med jemanjem tega zdravila: - dobili drisko.
A study of male fertility and early embryonic development up to implantation in rats did not reveal effects on the male reproductive tract and male fertility.
Študija vpliva na sposobnost razmnoževanja pri samcih in zgodnjega razvoja zarodka do implantacije pri podganah ni razkrila učinkov na reproduktivni sistem niti na sposobnost razmnoževanja pri samcih.
Do not breast-feed during the treatment with Ofev since there may be a risk for harm to the breastfeeding child.
Med zdravljenjem z zdravilom Ofev ne smete dojiti, ker obstaja tveganje, da bi zdravilo škodilo dojenemu otroku.
Not known (cannot be estimated from the available data) - Renal failure - An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections)
Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov) - ledvična odpoved - razširitev in oslabitev stene krvne žile ali raztrganina v steni krvne žile (anevrizme in disekcije arterij)
Patients with a recent history of myocardial infarction or stroke were excluded from the INPULSIS trials.
Bolniki z miokardnim infarktom ali možgansko kapjo v nedavni anamnezi so bili iz preskušanj INPULSIS izključeni.
Single dose toxicity studies in rats and mice indicated a low acute toxic potential of nintedanib.
Študije toksičnosti po enkratnem odmerku pri podganah in miših kažejo na majhen akutni toksični potencial nintedaniba.
Arterial thromboembolic events
Arterijski trombembolični dogodki
The below table provides a summary of the adverse reactions by MedDRA System Organ Class (SOC) and frequency category.
Spodnja preglednica prikazuje povzetek neželenih učinkov po organskih sistemih MedDRA in kategorijah pogostnosti.
The population mean exposure to nintedanib was 33 - 50% higher in Chinese, Taiwanese, and Indian patients and 16% higher in Japanese patients while it was 16 - 22% lower in Koreans compared to Caucasians (body weight corrected).
Populacijska srednja izpostavljenost nintedanibu je bila 33-50 % večja pri Kitajcih, Tajvancih in Indijcih ter 16 % večja pri Japoncih, pri Korejcih pa 16-22 % manjša v primerjavi z belci (popravljena glede na telesno maso).
PopPK analyses indicated moderate effects on exposure to nintedanib depending on age, body weight, and race (see below).
Populacijske farmakokinetične analize nakazujejo zmerne učinke na izpostavljenost nintedanibu, ki so odvisni od starosti, telesne mase in rase (glejte spodaj).
Patients should be treated at first signs with adequate hydration and anti-diarrhoeal medicinal products, e.g. loperamide, and may require treatment interruption.
Bolnike je treba zdraviti takoj, ko se pojavijo prvi znaki, in sicer z ustrezno hidracijo in zdravili proti driski, npr. loperamidom, včasih je treba zdravljenje prekiniti.
Based on increased exposure, the risk for adverse reactions may be increased in patients with mild hepatic impairment (Child Pugh A).
Na podlagi večje izpostavljenosti se lahko poveča tudi tveganje za neželene učinke pri bolnikih z blago jetrno okvaro (Child Pugh A).
Arterial thromboembolic events were infrequently reported: in 0.7% of patients in the placebo and 2.5% in the nintedanib treated group.
O arterijskih trombemboličnih dogodkih so poročali redko: pri 0,7 % bolnikov v skupini s placebom in pri 2,5 % bolnikov v skupini z nintedanibom.
What Ofev looks like and contents of the pack
Izgled zdravila Ofev in vsebina pakiranja
Dose proportionality was shown by increase of nintedanib exposure (dose range 50 - 450 mg once daily and 150 - 300 mg twice daily).
Na sorazmernost z odmerkom je pokazalo povečanje izpostavljenosti nintedanibu (razpon odmerka 50 do 450 mg enkrat na dan in 150 do 300 mg dvakrat na dan).
- if you have high blood pressure - if you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall
- če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
Steady state plasma concentrations were achieved within one week of dosing at the latest.
Koncentracije v stanju dinamičnega ravnovesja so bile dosežene po največ enem tednu odmerjanja.
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.
Ženske, ki bi lahko zanosile, morajo v obdobju jemanja zdravila Ofev in še vsaj 3 mesece po koncu zdravljenja uporabljati učinkovito kombinacijo kontracepcijskih metod, vključno s pregradnimi metodami kot drugo obliko kontracepcije.
The annual rate of decline of FVC (in mL) was significantly reduced in patients receiving nintedanib compared to patients receiving placebo.
Letna stopnja upada FVC (v ml) se je značilno zmanjšala pri bolnikih, ki so prejemali nintedanib, v primerjavi z bolniki, ki so prejemali placebo.
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.