natgillin/translations-raw huggingface dataset:
Differences in efficacy between the 4 mg and the 2 mg doses were most notable in the bDMARD-IR population (RA-BEACON), in which statistically significant improvements in the ACR components of swollen joint count, tender joint count and ESR were shown for Olumiant 4 mg compared to placebo at Week 24 but not for Olumiant 2 mg compared to placebo. 
Razlike v učinkovitosti med odmerkoma 4 mg in 2 mg so bile najbolj očitne v populaciji bDMARD-IR (študija RA-BEACON), v kateri so opazili statistično značilna izboljšanja komponent
Treatment should not be initiated, or should be temporarily interrupted, in patients with an ANC < 1 x 109 cells/L, ALC < 0.5 x 109 cells/L or haemoglobin < 8 g/dL observed during routine patient management (see section 4.2). 
Pri bolnikih, pri katerih med redno obravnavo bolnika opazimo vrednosti ANC < 1 x 109 celic/l, ALC < 0,5 x 109 celic/l ali hemoglobin < 8 g/dl, zdravljenja ne smemo uvesti oziroma ga moramo začasno prekiniti.
It belongs to a group of medicines called Janus kinase inhibitors, which help to reduce inflammation. 
Janus kinaze, ki pomagajo zmanjšati vnetje.
Week 12 6 % 14 %* 20 %*** 2 % 8 %*** 7 %*** 1 % 9 %*** 9 %*** 2 % 2 % 5 % Week 24 10 % 22 %** 23 %*** 3 % 16 %*** 14 %*** 4 % 17 %*** 15 %*** 2 % 5 % 9 %** Week 52 13 % 25 %** 30 %*** 
12. teden 6 % 14 %* 20 %*** 2 % 8 %*** 7 %*** 1 % 9 %*** 9 %*** 2 % 2 % 5 % 24. teden 10 % 22 %** 23 %*** 3 % 16 %*** 14 %*** 4 % 17 %*** 15 %*** 2 % 5 % 9 %** 52. teden 13 % 25 %** 30 %***
A dose relationship was observed with CPK elevations ≥ 5 x ULN of normal reported in 1.5 %, 0.8 % and 0.6 % of patients at 16 weeks in the 4 mg, 2 mg and placebo groups, respectively. 
od običajnih so v obdobju do 16 tednov poročali pri 1,5 % bolnikov v skupini s 4 mg, 0,8 % bolnikov v skupini z 2 mg in pri 0,6 % bolnikov v skupini s placebom.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster, herpes simplex), were reported in clinical studies (see section 4.8). 
(npr. herpes zoster, herpes simpleks) (glejte poglavje 4.8).
The pattern and incidence of increases in platelet counts remained stable at a higher value than baseline over time including in the long term extension study. 
Vzorec in incidenca zvišanja števila krvnih ploščic sta ostala v nadaljevanju stabilna, z višjo vrednostjo od izhodiščne, vključno z dolgoročno podaljšano študijo.
Week 12 59 % 79 %*** 77 %*** 40 % 70 %***† 61 %*** 39 % 66 %*** 62 %*** 27 % 49 %*** 55 %*** Week 24 62 % 77 %** 78 %*** 37 % 74 %***† 66 %*** 42 % 61 %*** 65 %*** 27 % 45 %*** 46 %*** Week 52 56 % 73 %*** 73 %*** 
12. teden 59 % 79 %*** 77 %*** 40 % 70 %***† 61 %*** 39 % 66 %*** 62 %*** 27 % 49 %*** 55 %*** 24. teden 62 % 77 %** 78 %*** 37 % 74 %***† 66 %*** 42 % 61 %*** 65 %*** 27 % 45 %*** 46 %*** 52. teden 56 % 73 %*** 73 %***
What Olumiant contains - The active substance is baricitinib. 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Olumiant - Učinkovina je baricitinib.
In controlled studies, for up to 16 weeks, increases in platelet counts above 600 x 109 cells/L occurred in 2.0 % of patients treated with Olumiant 4 mg and 1.1 % of patients treated with placebo. 
600 x 109 celic/l prišlo pri 2,0 % bolnikov, zdravljenih z zdravilom Olumiant 4 mg, in pri 1,1 %
Inhibition of IL-6 induced STAT3 phosphorylation 
Bolniki, ki so prejemali konvencionalna imunomodulirajoča protirevmatična zdravila5
Olumiant 4 mg film-coated tablets 
Olumiant 4 mg filmsko obložene tablete
Swelling of the face, Urticaria 
- akne - pridobivanje telesne mase - otekanje obraza, - urtikarija,
Week 12 30 % 47 %*** 56 %*** 14 % 44 %***†† 35 %*** 17 % 36 %*** 39 %*** 9 % 24 %*** 32 %*** Week 24 38 % 57 %*** 60 %*** 19 % 52 %*** 48 %*** 24 % 46 %*** 52 %*** 11 % 20 %* 33 %*** Week 52 38 % 57 %*** 63 %*** 
12. teden 30 % 47 %*** 56 %*** 14 % 44 %***†† 35 %*** 17 % 36 %*** 39 %*** 9 % 24 %*** 32 %*** 24. teden 38 % 57 %*** 60 %*** 19 % 52 %*** 48 %*** 24 % 46 %*** 52 %*** 11 % 20 %* 33 %*** 52. teden 38 % 57 %*** 63 %***
Week 24 68 % 76 % 81 %** 70 % 81 %*** 83 %*** 74 % 72 % 80 % Week 52 66 % 69 % 80 %** 70 % 79 %** 81 %** 
24. teden 68 % 76 % 81 %** 70 % 81 %*** 83 %*** 74 % 72 % 80 % 52. teden 66 % 69 % 80 %** 70 % 79 %** 81 %** Razlaga kratic: ADA = adalimumab; MTX = metotreksat; OLU = Olumiant; PBO = placebo a Podatki za placebo so bili v 52. tednu izpeljani s pomočjo linearne ekstrapolacije.
• talc 
• smukec
What Olumiant looks like and contents of the pack Olumiant 2 mg film-coated tablets are light pink, oblong tablets, with “Lilly” on one side and “2” on the other. 
Olumiant 2 mg filmsko obložene tablete so svetlo rožnate, podolgovate tablete, z vtisnjenim napisom »Lilly« na eni strani in »2« na drugi strani.
Haematological abnormalities 
Hematološke anomalije
Olumiant 2 mg film-coated tablets 
Olumiant 2 mg filmsko obložene tablete
Week 12 15 % 21 % 34 %*** 7 % 24 %*** 21 %*** 7 % 21 %*** 22 %*** 4 % 13 %** 12 %** Week 24 23 % 36 %** 39 %*** 10 % 32 %*** 34 %*** 10 % 29 %*** 32 %*** 7 % 11 % 17 %** Week 52 27 % 36 % 45 %*** 
12. teden 15 % 21 % 34 %*** 7 % 24 %*** 21 %*** 7 % 21 %*** 22 %*** 4 % 13 %** 12 %** 24. teden 23 % 36 %** 39 %*** 10 % 32 %*** 34 %*** 10 % 29 %*** 32 %*** 7 % 11 % 17 %** 52. teden 27 % 36 % 45 %***
Week 12 33 % 55 %*** 60 %*** 17 % 45 %***†† 35 %*** 13 % 33 %*** 34 %*** 8 % 20 %** 28 %*** Week 24 43 % 60 %** 63 %*** 19 % 51 %*** 45 %*** 21 % 41 %*** 44 %*** 13 % 23 %* 29 %*** Week 52 38 % 57 %*** 62 %*** 
12. teden 33 % 55 %*** 60 %*** 17 % 45 %***†† 35 %*** 13 % 33 %*** 34 %*** 8 % 20 %** 28 %*** 24. teden 43 % 60 %** 63 %*** 19 % 51 %*** 45 %*** 21 % 41 %*** 44 %*** 13 % 23 %* 29 %*** 52. teden 38 % 57 %*** 62 %***
Week 12 16 % 31 %*** 34 %*** 5 % 19 %***† 13 %*** 3 % 18 %*** 18 %*** 2 % 13 %*** 11 %** Week 24 21 % 42 %*** 40 %*** 8 % 30 %***† 22 %*** 8 % 25 %*** 24 %*** 3 % 13 %*** 17 %*** Week 52 25 % 42 %*** 46 %*** 
12. teden 16 % 31 %*** 34 %*** 5 % 19 %***† 13 %*** 3 % 18 %*** 18 %*** 2 % 13 %*** 11 %** 24. teden 21 % 42 %*** 40 %*** 8 % 30 %***† 22 %*** 8 % 25 %*** 24 %*** 3 % 13 %*** 17 %*** 52. teden 25 % 42 %*** 46 %***
HAQ-DI Minimum Clinically Important Difference (decrease in HAQ-DI score of ≥ 0.30): Week 12 60 % 81 %*** 77 %*** 46 % 68 %*** 64 %*** 44 % 60 %*** 56 %** 35 % 48 %* 54 %*** Week 24 66 % 77 %* 74 % 37 % 67 %***† 60 %*** 37 % 58 %*** 55 %*** 24 % 41 %*** 44 %*** Week 52 53 % 65 %* 67 %** 
12. teden 60 % 81 %*** 77 %*** 46 % 68 %*** 64 %*** 44 % 60 %*** 56 %** 35 % 48 %* 54 %*** 24. teden 66 % 77 %* 74 % 37 % 67 %***† 60 %*** 37 % 58 %*** 55 %*** 24 % 41 %*** 44 %*** 52. teden 53 % 65 %* 67 %**
No adverse foetal effects were observed at exposures 2 times the human exposure based on AUC. 
ustrezajo 2-kratni izpostavljenosti pri človeku, niso opazili neželenih učinkov na zarodek.
RA-BEGIN MTX-naïve patients 
RA-BEGIN Bolniki, ki še niso bili zdravljeni z MTX
Taking into account the PRAC Assessment Report on the PSUR(s) for baricitinib, the scientific conclusions of CHMP are as follows: 
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni redno posodobljenih poročil o varnosti zdravila (PSUR) za baricitinib je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke: V s placebom nadzorovanih preskušanjih so opazili neravnovesje v številu poročil o VTE, in sicer 0 %
Joint Space Narrowing Score, mean change from baseline: 
Ocena zožitve sklepne špranje, povprečna sprememba od izhodišča:
Week 12 7 % 14 %* 19 %*** 2 % 8 %*** 7 %** 2 % 10 %*** 9 %*** 2 % 3 % 6 % Week 24 11 % 21 %** 22 %** 4 % 16 %*** 12 %*** 4 % 15 %*** 15 %*** 3 % 5 % 9 %* Week 52 16 % 25 %* 28 %** 
12. teden 7 % 14 %* 19 %*** 2 % 8 %*** 7 %** 2 % 10 %*** 9 %*** 2 % 3 % 6 % 24. teden 11 % 21 %** 22 %** 4 % 16 %*** 12 %*** 4 % 15 %*** 15 %*** 3 % 5 % 9 %* 52. teden 16 % 25 %* 28 %**
There was no clinically relevant effect on the PK of baricitinib in patients with mild or moderate hepatic impairment. 
Pri bolnikih z blago ali zmerno okvaro jeter niso opazili klinično pomembnega učinka na farmakokinetiko baricitiniba.
Olumiant contains the active substance baricitinib. 
Zdravilo Olumiant vsebuje učinkovino baricitinib.
Hepatic Impairment 
Maligne bolezni
Physical function response and health-related outcomes Treatment with Olumiant 4 mg, alone or in combination with cDMARDs, resulted in a significant improvement in physical function compared to all comparators (placebo, MTX, adalimumab), as measured by HAQ-DI, at 12, 24 and 52 weeks. 
* p ≤ 0,05; ** p ≤ 0,01; *** p ≤ 0,001 v primerjavi s placebom (v primerjavi z MTX za študijo RA-BEGIN) Odzivi, povezani s telesno zmogljivostjo in izidi, povezani z zdravjem Zdravljenje z zdravilom Olumiant 4 mg samim ali v kombinaciji s konvencionalnimi imunomodulirajočimi protirevmatičnimi zdravili je povzročilo bistveno izboljšanje telesne zmogljivosti v primerjavi z vsemi primerjalnimi zdravili (placebo, MTX, adalimumab), kot so ocenili s pomočjo vprašalnika HAQ-DI, v 12., 24. in 52. tednu.
Tell your doctor if you get persistent cough, fever, night sweats and weight loss during Olumiant treatment as these can be signs of tuberculosis - have had a herpes infection (shingles), because Olumiant may allow it to come back. 
Obvestite svojega zdravnika, če se med zdravljenjem z zdravilom Olumiant pri vas pojavi boleč kožni izpuščaj z mehurji, saj so to lahko znaki pasavca.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 4 MG FILM-COATED TABLETS 
PODATKI NA ZUNANJI OVOJNINI ŠKATLE ZA 4 MG FILMSKO OBLOŽENE TABLETE
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 2 MG FILM-COATED TABLETS 
PODATKI NA ZUNANJI OVOJNINI ŠKATLE ZA 2 MG FILMSKO OBLOŽENE TABLETE
Very common side effects (may affect more than 1 in 10 people): - throat and nose infections - high levels of blood fat (cholesterol) shown by blood test 
- visoke ravni krvnih maščob (holesterola), ki jih pokaže krvna preiskava Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
How to take Olumiant 
Če ste prenehali jemati zdravilo Olumiant
Acne 
Navzea
• Use effective contraception while taking Olumiant (and for 1 week after, if you stop treatment). 
• Med jemanjem zdravila Olumiant uporabljajte učinkovito kontracepcijo
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTERS NON-PERFORATED FOR 4 MG FILM-COATED TABLETS 
NEPERFORIRANI KOLEDARSKI PRETISNI OMOTI ZA 4 MG FILMSKO OBLOŽENE TABLETE
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS PERFORATED UNIT DOSE FOR 2 MG FILM-COATED TABLETS 
PERFORIRANI ENOODMERNI PRETISNI OMOTI ZA 2 MG FILMSKO OBLOŽENE TABLETE
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS PERFORATED UNIT DOSE FOR 4 MG FILM-COATED TABLETS 
PERFORIRANI ENOODMERNI PRETISNI OMOTI ZA 4 MG FILMSKO OBLOŽENE TABLETE
Uncommon side effects (may affect up to 1 in 100 people): - low number of white bloods cells (neutrophils), shown by blood test - increase in an enzyme called creatine kinase, shown by blood test - high levels of blood fat (triglycerides), shown by blood test - acne - weight gain - swelling of the face - urticaria - blood clots in the blood vessels of the lungs - blood clot in the veins of the legs or pelvis, called a deep vein thrombosis (DVT) 
- povečanje ravni encima, imenovanega kreatin-kinaza, ki ga pokaže krvna preiskava - visoke ravni krvnih maščob (trigliceridov), ki jih pokaže krvna preiskava
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTERS NON-PERFORATED FOR 2 MG FILM-COATED TABLETS 
NEPERFORIRANI KOLEDARSKI PRETISNI OMOTI ZA 2 MG FILMSKO OBLOŽENE TABLETE
‘Idiopathic' means that the cause of the disease is unknown. 
„Idiopatska“ pomeni, da vzrok bolezni ni znan.
The European Commission granted a marketing authorisation valid throughout the European Union for Ofev on 15 January 2015. 
Evropska komisija je dovoljenje za promet z zdravilom Ofev, veljavno po vsej Evropski uniji, izdala 15. januarja 2015.
What measures are being taken to ensure the safe and effective use of Ofev? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ofev?
Ofev is available as capsules (100 and 150 mg). 
Zdravilo Ofev je na voljo v obliki kapsul (100 in 150 mg).
Other information about Ofev 
Druge informacije o zdravilu Ofev
The average FVC of patients before treatment was between 2600 and 2700 millilitre (ml). 
Povprečna FVC bolnikov pred zdravljenjem je znašala od 2600 do 2700 mililitrov (ml).
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ofev's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Ofev večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
A risk management plan has been developed to ensure that Ofev is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Ofev je bil pripravljen načrt obvladovanja tveganj.
In patients who do not tolerate this dose, the dose should be reduced to 100 mg twice a day or treatment should be interrupted. 
Pri bolnikih, ki tega odmerka ne prenašajo, je treba odmerek zmanjšati na 100 mg dvakrat dnevno ali pa prekiniti z zdravljenjem.
What benefits of Ofev have been shown in studies? 
Kakšne koristi je zdravilo Ofev izkazalo v študijah?
This is a summary of the European public assessment report (EPAR) for Ofev. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ofev.
The summary of the opinion of the Committee for Orphan Medicinal Products for Ofev can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Ofev je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
What is Ofev and what is it used for? 
Kaj je zdravilo Ofev in za kaj se uporablja?
The recommended dose is 150 mg taken twice a day with food, approximately 12 hours apart. 
Priporočeni odmerek je 150 mg dvakrat dnevno s hrano, med odmerkoma pa mora biti približno 12-urni presledek.
It is not intended to provide practical advice on how to use Ofev. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Regarding safety, the side effects associated with Ofev were considered manageable with dose interruptions or reductions. 
Kar zadeva varnost, so bili neželeni učinki zdravila Ofev ocenjeni kot obvladljivi s prekinitvijo ali zmanjšanjem odmerkov.
These enzymes are present in certain receptors (such as VEGF, FGF and PDGF receptors) in cells in the lungs, where they activate several processes involved in the generation of fibrous tissue seen in IPF. 
Ti encimi so prisotni v določenih receptorjih (kot so receptorji VEGF, FGF in PDGF) v celicah v pljučih, kjer aktivirajo več procesov, ki sodelujejo pri tvorbi fibroznega tkiva, kot ga opazimo pri idiopatski pljučni fibrozi.
Ofev must not be used in patients who are hypersensitive (allergic) to nintedanib, peanut or soya, or any of the other ingredients. 
Zdravilo Ofev se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) nintedanib, arašide ali sojo ali katero koli drugo sestavino zdravila.
The most common side effects with Ofev (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), abdominal pain (stomach ache) and raised levels of liver enzymes in the blood (a sign of liver problems); vomiting, decreased appetite and weight loss are also common. 
Najpogostejši neželeni učinki zdravila Ofev (ki lahko prizadenejo več kot 1 osebo od 10) so driska, navzeja (slabost), abdominalne bolečine (bolečine v predelu trebuha) in povišane ravni jetrnih encimov v krvi (znak težav z jetri).
Because the number of patients with IPF is low, the disease is considered ‘rare', and Ofev was designated an ‘orphan medicine' (a medicine used in rare diseases) on 26 April 2013. 
Ker je bolnikov z idiopatsko pljučno fibrozo malo, velja ta bolezen za redko, zato je bilo zdravilo Ofev 26. aprila 2013 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
What are the risks associated with Ofev? 
Kakšna tveganja so povezana z zdravilom Ofev?
Why is Ofev approved? 
Zakaj je bilo zdravilo Ofev odobreno?
A further analysis of the results of the 2 main studies, which took into account that some patients stopped treatment, confirmed the benefits of Ofev over placebo, although the difference in FVC between the two was less pronounced. 
Nadaljnja analiza rezultatov dveh glavnih študij, pri kateri so upoštevali dejstvo, da so nekateri bolniki prenehali z zdravljenjem, je potrdila koristi zdravila Ofev v primerjavi s placebom, čeprav je bila razlika v FVC med njima manj izrazita.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ofev, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Ofev in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
In both studies, the main measure of effectiveness was the decline in the functioning of the patients' lungs over the course of 1 year of treatment, measured by their forced vital capacity (FVC). 
Glavno merilo učinkovitosti v obeh študijah je bilo poslabšanje delovanja pljuč pri bolnikih v enem letu zdravljenja, kar so merili z njihovo forsirano vitalno kapaciteto (FVC).
By blocking these enzymes, nintedanib helps to reduce the formation of fibrous tissue in the lungs, thereby helping to prevent the symptoms of IPF from getting worse. 
Z zaviranjem teh encimov nintedanib pomaga zmanjšati tvorbo fibroznega tkiva v pljučih in tako pomaga preprečiti slabšanje simptomov idiopatske pljučne fibroze.
The full EPAR and risk management plan summary for Ofev can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Ofev sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Ofev is a medicine used to treat adults with idiopathic pulmonary fibrosis (IPF). 
Zdravilo Ofev se uporablja za zdravljenje odraslih z idiopatsko pljučno fibrozo (IPF).
Ofev has been compared with placebo (a dummy treatment) in two main studies involving a total of 1,066 patients with IPF. 
Zdravilo Ofev so primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh glavnih študijah, v katerih je sodelovalo skupno 1 066 bolnikov z idiopatsko pljučno fibrozo.
For more information about treatment with Ofev, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Ofev preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The active substance in Ofev, nintedanib, blocks the activity of some enzymes known as tyrosine kinases. 
Zdravilna učinkovina zdravila Ofev, nintedanib, zavira delovanje določenih encimov, imenovanih tirozin kinaze.
In the second study, the average decrease was 114 ml for Ofev compared with 207 ml for placebo. 
V drugi študiji je povprečno zmanjšanje pri zdravilu Ofev znašalo 114 ml, pri placebu pa 207 ml.
IPF is a long-term disease in which hard fibrous tissue continuously forms in the lungs, causing persistent cough and severe shortness of breath. 
Idiopatska pljučna fibroza je dolgotrajna bolezen, pri kateri se v pljučih neprestano tvori trdo fibrozno tkivo, ki povzroča stalen kašelj in hudo zasoplost.
For practical information about using Ofev, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Ofev naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The CHMP considered that Ofev has been shown to be effective at slowing down the worsening of lung function in patients with IPF. 
CHMP je menil, da je bilo dokazano, da je zdravilo Ofev učinkovito pri upočasnjevanju slabšanja delovanja pljuč pri bolnikih z idiopatsko pljučno fibrozo.
In both studies, patients taking Ofev had a smaller decline in FVC than patients taking placebo, meaning that Ofev slowed down the worsening of the condition. 
V obeh študijah se je pri bolnikih, ki so prejemali zdravilo Ofev, FVC zmanjšala manj kot pri bolnikih, ki so prejemali placebo, kar pomeni, da je zdravilo Ofev upočasnilo slabšanje bolezni.
In the first study, the average decrease in FVC over 1 year was 115 ml in patients taking Ofev compared with a decrease of 240 ml in patients taking placebo. 
V prvi študiji se je FVC pri bolnikih, ki so jemali zdravilo Ofev, v enem letu zmanjšala za povprečno 115 ml v primerjavi z 240 ml pri bolnikih, ki so jemali placebo.
Ofev can only be obtained with a prescription, and treatment should be started by a doctor experienced in the diagnosis and treatment of IPF. 
Izdaja zdravila Ofev je le na recept, zdravljenje pa mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem idiopatske pljučne fibroze.
FVC is the maximum amount of air the patient can breathe out forcefully after taking in a deep breath and this decreases as the condition gets worse. 
FVC je maksimalna količina zraka, ki jo bolnik lahko na silo izdihne po globokem vdihu.
How does Ofev work? 
Kako zdravilo Ofev deluje?
For the full list of all side effects reported with Ofev, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ofev, glejte navodilo za uporabo.
Ofev contains the active substance nintedanib. 
Zdravilo Ofev vsebuje zdravilno učinkovino nintedanib.
How is Ofev used? 
Kako se zdravilo Ofev uporablja?
Very rare, not known 
Zelo redki, neznana
You should take your medicine at the same time each day. 
Zdravilo morate jemati vsak dan ob istem času.
• low blood sugar 
• nizek krvni sladkor,
The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. 
Absolutno tveganje za kardiovaskularne malformacije se je povečalo z manj kot 1 % na približno 1,5 %.
• worsening of food allergies. 
• poslabšanje alergij na hrano.
Pliva Croatia Ltd Prilaz baruna Filipovica 25 10 000 Zagreb Croatia 
Pliva Croatia Ltd Prilaz baruna Filipovica 25 10 000 Zagreb Hrvaška
• Third trimester of pregnancy (see section 4.6). 
• tretje tromesečje nosečnosti (glejte poglavje 4.6).
The tablets have a length of 14.0 mm and a width of 6.8 mm. 
Tablete so dolge 14,0 mm in široke 6,8 mm.
• If you are in your last trimester of pregnancy 
• če ste v zadnjem tromesečju nosečnosti.
• In children under 18 years of age, there is a possible association between ASA and Reye's syndrome. 
• Pri otrocih, mlajših od 18 let, je možna povezava med ASA in Reyevim sindromom.
Do not use this medicine if you notice any visible signs of deterioration 
Ne uporabljajte tega zdravila, če opazite vidne znake kvarjenja.
• Adults and elderly population 
• Odrasli in starejši
• breathing difficulties sometimes associated with cough 
• težave pri dihanju, ki so včasih povezane s kašljem,
• the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which may occur even 
• mater in novorojenčka ob koncu nosečnosti: - možnemu podaljšanju časa krvavitve, antiagregacijskemu učinku, ki se lahko pojavi celo
From the beginning of the sixth month of pregnancy, all prostaglandin synthesis inhibitors may expose: 
Od začetka šestega meseca nosečnosti lahko vsi zaviralci sinteze prostaglandinov izpostavijo:
The patient population included 19.7% women and 29.2% patients ≥65 years. 
Populacijo bolnikov je sestavljalo 19,7 % žensk in 29,2 % bolnikov starosti ≥ 65 let.
At low concentrations (<100 micrograms/ml), approximately 90% of salicylic acid is bound to albumin. 
Pri nizkih koncentracijah (< 100 mikrogramov/ml) je približno 90 % salicilne kisline vezane na albumin.
Following toxic doses (10-20 g), the plasma half-life may be increased to over 20 hours. 
Po toksičnih odmerkih (10 do 20 g) se lahko razpolovni čas v plazmi podaljša na več kot 20 ur.