natgillin/translations-raw huggingface dataset:
• severe infection in the blood (sepsis) 
• hudo okužbo krvi (sepso)
Some side effects observed with Humira may not have symptoms and may only be discovered through blood tests. 
Nekateri neželeni učinki, ki so bili opaženi pri zdravilu Humira, nimajo simptomov in se jih lahko odkrije le pri krvnih testih.
Treatment with Humira can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents. 
Zdravljenje z zdravilom Humira se lahko začne v kombinaciji s kortikosteroidi in/ali z drugimi nebiološkimi imunomodulatorji.
Do not use the product after the month and year shown. 
Zdravila ne uporabljajte po preteku navedenega meseca in leta.
Corticosteroid taper was permitted after Week 8. 
Postopno zmanjšanje odmerka kortikosteroidov je bilo dovoljeno po 8. tednu.
Leave Humira at room temperature for 15 to 30 minutes before injecting. 
Zdravilo Humira pred injiciranjem pustite na sobni temperaturi 15 do 30 minut.
Other medicines and Humira 
Druga zdravila in zdravilo Humira
The Patient Reminder Cards (adult and paediatric) contain the following key elements 
Opozorilna kartica za bolnika (za odrasle in otroke) vsebuje naslednje ključne podatke:
Humira can also be given alone. 
Zdravilo Humira se lahko daje tudi samo.
• Release the skin with the first hand 
• Spustite kožo s prvo roko.
Clinical remission results remained relatively constant irrespective of previous TNF-antagonist exposure. 
Rezultati klinične remisije so ostali relativno konstantni ne glede na prejšnjo izpostavljenost TNF
A large number (approximately 2100) of prospectively collected pregnancies exposed to adalimumab resulting in live birth with known outcomes, including more than 1500 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn. 
Veliko število (približno 2100) v naprej izbranih nosečnosti, med katerimi so bile matere izpostavljene adalimumabu in jim je sledilo rojstvo živorojenih otrok z znanim izidom, vključno s 1500 izpostavljenimi v prvem trimesečju, ne nakazuje povečanja razmerja malformacij pri novorojenčkih.
BCVA was either improved or maintained (< 5 letters deterioration) in 88.6% of the eyes at week 78. 
Najboljša korigirana ostrina vida se je ali izboljšala ali pa ohranila (poslabšanje ostrine vida < 5 črk) pri 88,6 % očeh v 78. tednu.
• If you have moderate or severe heart failure. 
• če imate zmerno ali hudo srčno popuščanje.
N Failure N (%) 
N Neuspeh N (%)
Pull the plum safety cap (labelled ‘2') straight off to expose the plum coloured activation button. 
Snemite škrlatni varnostni pokrovček (označen z '2') naravnost dol, da se bo pokazal škrlatni sprožilni gumb.
Germany and 
Nemčija in
• On the front of your child's thighs or 
• na sprednji strani stegen vašega otroka ali
• liquid has been frozen or left in direct sunlight 
• je bila tekočina zamrznjena ali izpostavljena neposredni sončni svetlobi
In all situations described below, the benefit/risk balance of therapy should be very carefully considered. 
V vseh spodaj opisanih okoliščinah je treba korist in tveganje zdravljenja z zdravilom Humira zelo natančno pretehtati.
Treatment with Humira 40 mg every week significantly reduced the risk of worsening of abscesses and draining fistulas. 
Zdravljenje z zdravilom Humira 40 mg vsak teden signifikantno zmanjša tveganje za poslabšanje abscesov in fistul z izcedkom.
If retreatment with Humira is indicated, the above guidance on dose and treatment duration should be followed. 
Če je indicirano vnovično zdravljenje z zdravilom Humira, je treba upoštevati zgoraj navedena navodila za odmerjanje in trajanje zdravljena.
Choose a site on the top of your thigh or stomach (except the area around the navel). 
Izberite mesto na zgornjem delu stegna ali trebuha (ne v okolici popka).
• The Humira syringe should NEVER be reused. 
• Brizge z zdravilom Humira NIKDAR ne smete ponovno uporabiti.
• According to a pregnancy study, there was no higher risk of birth defects when the mother had received Humira during pregnancy compared with mothers with the same disease who did not receive Humira. 
• Glede na študije v nosečnosti ni bilo večjega tveganja za defekte ob rojstvu, če je mati jemala zdravilo Humira med nosečnostjo, v primerjavi z materami z enako boleznijo, ki zdravila Humira niso jemale.
TNF-antagonists, such as Humira affect the immune system and their use may affect the body's defence against infection and cancer. 
Humira, prizadenejo imunski sistem in njihova uporaba lahko vpliva na obrambo telesa proti okužbi in raku.
Side effects may occur at least up to 4 months after the last Humira injection. 
Neželeni učinki se lahko pojavijo vsaj še 4 mesece po zadnji injekciji zdravila Humira.
NA NA 24.0% 58.9% 
NP 24,0 % 58,9 %
Of the 364 remaining patients, 269 evaluable patients (74%) reached 78 weeks of open-label adalimumab treatment. 
Od preostalih 364 bolnikov je 269 ovrednotenih bolnikov (74 %) zaključilo 78. tedensko odprto zdravljenje z adalimumabom.
• Choose a site on your thigh or stomach. 
• Izberite mesto na stegnu ali trebuhu.
Yellow Indicator Visible 
Rumeni kazalnik viden
General handling: DO NOT dispose of any waste items until after the injection is completed. 
Splošno ravnanje: NE ZAVRZITE nobenega uporabljenega dela, dokler ne dokončate injiciranja.
Rhabdomyolysis, systemic lupus erythematosus 
občasni rabdomioliza, sistemski eritematozni lupus
Patients in clinical response (decrease in CDAI ≥ 70) at Week 4 were stratified and analysed separately from those not in clinical response at Week 4. 
Bolnike s kliničnim odzivom (zmanjšanje CDAI ≥ 70) v 4. tednu so preučili in analizirali ločeno od tistih brez kliničnega odziva v 4. tednu.
• anakinra 
• anakinro
Radiographic response 
Radiografski odziv
Patients who completed Studies UV I and UV II were eligible to enroll in an uncontrolled long-term extension study with an originally planned duration of 78 weeks. 
Bolniki, ki so zaključili študiji UV I in UV II, so bili primerni za vključitev v nenadzorovano, dolgoročno, podaljšano študijo, s prvotno načrtovanim trajanjem 78 tednov.
Before initiation of therapy with Humira, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection. 
Pred začetkom zdravljenja z zdravilom Humira je vse bolnike treba pregledati glede aktivne ali neaktivne (latentne) tuberkulozne okužbe.
Wash your hands thoroughly. 
Dobro si umijte roke.
Detailed instructions on how to inject Humira are provided in section 7 ‘Injecting Humira'. 
Podrobna navodila o tem, kako injicirati zdravilo Humira, so navedena v poglavju 7 ‘Injiciranje zdravila Humira'.
Thus additional caution should be exercised in considering Humira treatment of these patients (see section 4.8). 
Torej je potrebna dodatna previdnost, kadar razmišljamo o zdravljenju z zdravilom Humira pri teh bolnikih (glejte poglavje 4.8).
Treatment with Humira should not be initiated in patients with active infections including chronic or localised infections until infections are controlled. 
Zdravljenja z zdravilom Humira se ne sme začeti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi, dokler te niso obvladane.
Name and address of the manufacturers of the biological active substance 
Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine
• It is normal to see 1 or more bubbles in the window 
• Normalno je, če skozi okence vidite enega ali več mehurčkov.
Tell your doctor immediately if you notice any of the following • severe rash, hives or other signs of allergic reaction; 
Svojemu zdravniku takoj povejte, če opazite kaj od naslednjega: • hud izpuščaj, koprivnico ali druge znake alergijske reakcije;
Longer term treatment with Humira 40 mg weekly for 96 weeks identified no new safety findings. 
Dolgotrajno zdravljenje z zdravilom Humira 40 mg na teden, ki je trajalo 96 tednov, ni dalo nobenih novih ugotovitev o varnosti.
Population pharmacokinetic analyses with data from over 1,300 RA patients revealed a trend toward higher apparent clearance of adalimumab with increasing body weight. 
Analize populacijske farmakokinetike s podatki za več kot 1300 bolnikov z revmatoidnim artritisom so pokazale trend k večjemu navideznemu očistku adalimumaba z večanjem telesne teže.
By attaching to TNFα, Humira decreases the process of inflammation in these diseases. 
Z vezavo na TNF zdravilo Humira zmanjša vnetni proces pri teh boleznih.
Humira in combination with methotrexate, is indicated for: 
Zdravilo Humira je v kombinaciji z metotreksatom indicirano za:
• If you are over 65 years you may be more susceptible to infections while taking Humira. 
• Če ste starejši od 65 let, ste morda dovzetnejši za okužbe, če jemljete zdravilo Humira.
Surgery or dental procedure 
Kirurški ali dentalni poseg
For paediatric use 
za pediatrično uporabo
Hold the body of the pre-filled syringe in one hand between the thumb and index fingers, like you would a pencil. 
Telo napolnjene injekcijske brizge držite v eni roki, med palcem in kazalcem, kot bi držali svinčnik.
15 Seconds 
15 sekund
Due to its inhibition of TNF, adalimumab administered during pregnancy could affect normal immune responses in the newborn. 
Ker adalimumab zavira TNFα, bi njegova uporaba med nosečnostjo lahko okrnila normalne imunske odzive novorojenčka.
• Do not warm Humira in any other way. 
• Zdravila Humira ne smete segrevati na kateri koli drug način.
In patients with Crohn's disease, a reduction of the number of cells expressing inflammatory markers in the colon including a significant reduction of expression of TNFα was seen. 
Pri bolnikih s Crohnovo boleznijo so opazili zmanjšanje števila celic, ki izražajo vnetne označevalce v kolonu, vključno z bistvenim zmanjšanjem ekspresije TNFα.
Because immunogenicity analyses are product-specific, comparison of antibody rates with those from other products is not appropriate. 
Ker so analize imunogenosti specifične za posamezno zdravilo, primerjava z deleži protiteles pri drugih zdravilih ne pride v poštev.
Improvement in health-related quality of life and physical function was maintained during the open-label extension through Week 156. 
Izboljšanje z zdravjem povezane kakovosti življenja in telesne funkcije se je pri podaljšanih odprtih študijah ohranjalo do 156. tedna.
If a few small drops of liquid come out of the needle, that is okay. 
Če iz brizge pride nekaj majhnih kapljic tekočine, je to normalno.
Patients on Humira may receive concurrent vaccinations, except for live vaccines. 
Bolniki, ki prejemajo zdravilo Humira, lahko sočasno dobijo cepiva, razen živih cepiv.
With your other hand, pull the grey cap (1) straight off, check that the small black needle cover of the syringe has been removed with the cap, then discard cap. 
Z drugo roko snemite sivi pokrovček (1), preverite, da ste s pokrovčkom vred odstranili tudi malo črno pokrivalo igle na brizgi in ga nato zavrzite.
117/276 patients from CD study I and 272/777 patients from CD studies II and III were followed through at least 3 years of open-label adalimumab therapy. 
117/276 bolnikov iz študije Crohnove bolezni I in 272/777 bolnikov iz študij Crohnove bolezni II in III so spremljali vsaj 3 leta odprtega zdravljenja z adalimumabom.
• autoantibodies present in the blood 
• avtoprotitelesa prisotna v krvi
At Week 12 and Week 24, PedACR30 response was 93.5% and 90.0%, respectively, using the observed data approach. 
12. teden je bil odziv PedACR30 93,5 % in 24. teden 90,0 % (z uporabo pristopa z opaženimi podatki).
The proportions of subjects with PedACR50/70/90 at Week 12 and Week 24 were 90.3%/61.3%/38.7% and 83.3%/73.3%/36.7%, respectively. 
Deleži preiskovancev s PedACR50/70/90 so bili 12. teden 90,3 %/61,3 %/38,7 % in 24. teden 83,3 %/73,3 %/36,7 %.
• It is normal to see a drop of liquid at the end of the needle 
• Normalno je, da na koncu igle vidite kapljico tekočine.
Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Humira, who are chronic carriers of this virus (i.e. surface antigen positive). 
Reaktivacijo hepatitisa B so opažali pri bolnikih, ki so dobivali antagonist TNF (vključno z zdravilom Humira) in ki so bili kronični nosilci virusa (tj. pozitivni na površinski antigen).
This may mean there is an infection. 
Te spremembe lahko pomenijo okužbo.
Clinical remission Clinical response (CR-100) 
Klinični odziv (CR-100)
• If your child has moderate or severe heart failure. 
• če ima vaš otrok zmerno ali hudo srčno popuščanje.
If your doctor determines that methotrexate is inappropriate, Humira can be given alone. 
Če vaš zdravnik ugotovi, da metotreksat ni primeren, lahko zdravilo Humira dobivate samo.
• Your doctor should test you for HBV. 
• Zdravnik vas mora testirati na HBV.
Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposureresponse relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels. 
Učinkovitost adalimumaba za zdravljenje mladostnikov s HS je napovedana na podlagi dokazane učinkovitosti in razmerja med izpostavljenostjo in odzivom pri odraslih bolnikih s HS ter verjetnosti, da so potek bolezni, patofiziologija in učinek zdravila bistveno podobni kot pri odraslih bolnikih, pri enaki ravni izpostavljenosti.
Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Humira (see section 4.4). 
Oftalmologom se svetuje, da se pred začetkom zdravljenja z zdravilom Humira posvetujejo z ustreznim specialistom (glejte poglavje 4.4).
Patients subsequently underwent a mandatory taper schedule, with complete corticosteroid discontinuation by Week 19. 
Bolniki so bili kasneje deležni obveznega programa postopnega zmanjševanja, s popolno ukinitvijo kortikosteroidov do 19. tedna.
Phase OL-LI 16 weeks Ped ACR 30 response (n/N) 
Faza Odprta uvajalna faza 16 tednov Odziv »Ped ACR« 30 (n/N)
In rare cases, these infections can be life-threatening. 
V redkih primerih so lahko te okužbe smrtno nevarne.
In CD Study III, at Week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis. 
V študiji Crohnove bolezni III je bilo v 4. tednu 58 % (499/854) bolnikov klinično odzivnih in so bili ocenjeni v primarni analizi.
The injection is complete when the yellow indicator has stopped moving. 
Injiciranje je končano, ko se rumeni kazalnik neha premikati.
Should treatment be interrupted, Humira may be re-introduced as appropriate. 
Če je treba zdravljenje prekiniti, je možno zdravljenje z zdravilom Humira znova uvesti, kakor je primerno.
The primary endpoint in RA studies VI and VII was injection site pain immediately after injection as measured by a 0-10 cm VAS. 
Primarna končna točka študij revmatoidnega artritisa VI in VII je bila bolečina na mestu injiciranja takoj po injiciranju, merjena z vizualno analogno lestvico od 0 do 10 cm.
One hundred patients (n=100) from the Paediatric CD Study continued in an open-label long-term extension study. 
Sto bolnikov (n = 100) iz študije Crohnove bolezni pri pediatričnih bolnikih je nadaljevalo v odprti dolgoročni podaljšani študiji.
Insert the needle all the way into the skin at about a 45degree angle with one quick, short motion. 
Iglo v celoti zabodite v kožo pod kotom 45 stopinj s hitrim, kratkim gibom.
Results from the overall UC-II study population are shown in Table 18. 
Rezultate celotne populacije v študiji UC-II prikazuje preglednica 18.
• high blood sugar 
• visok krvni sladkor
• To reduce the chance of infection, wipe the injection site with the other alcohol pad. 
• Za zmanjšanje možnosti okužbe obrišite injekcijsko mesto s priloženim alkoholnim zložencem.
Clinical remission (defined as Mayo score ≤ 2 with no subscore > 1) was assessed at Week 8. 
Klinično remisijo (opredeljeno kot ocena Mayo ≤ 2 in nobena podocena > 1) so ocenili 8. teden.
Improvement in quality of life was measured up to Week 156 (36 months) and improvement was maintained through that time. 
Do 156. tedna (36. meseca) se je ocenjevalo izboljšanje kvalitete življenja, ki se je v tem času tudi ohranilo.
If active tuberculosis is diagnosed, Humira therapy must not be initiated (see section 4.3). 
Če se odkrije aktivna tuberkuloza, se zdravljenja z zdravilom Humira ne sme začeti (glejte poglavje 4.3).
Of those in clinical response at Week 4, 48% had been previously exposed to other TNFantagonists. 
Od teh s kliničnim odzivom v 4. tednu jih je bilo 48 % prej izpostavljenih drugim TNF antagonistom.
Check the liquid in the pre-filled syringe. 
Preverite tekočino v napolnjeni injekcijski brizgi.
The white needle sleeve is there to protect you from touching the needle. 
Beli tulec je nameščen zato, da prepreči dotikanje igle.
Administration of Humira without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1). 
Humira brez metotreksata je zvečala nastajanje protiteles, zvečala očistek in zmanjšala učinkovitost adalimumaba (glejte poglavje 5.1).
The frequency of serious infections among Humira treated subjects over 65 years of age (3.7%) was higher than for those under 65 years of age (1.5%). 
Pri bolnikih nad 65 let, ki so prejemali zdravilo Humira, je bila pogostost resnih okužb večja (3,7 %) kot pri tistih pod 65 let starosti (1,5 %).
An embryo-foetal developmental toxicity/perinatal developmental study has been performed in cynomologous monkeys at 0, 30 and 100 mg/kg (9-17 monkeys/group) and has revealed no evidence of harm to the foetuses due to adalimumab. 
Raziskava embrio-fetalne razvojne toksičnosti/perinatalnega razvoja je bila narejena pri opicah Cynomologous z odmerki 0,30 in 100 mg/kg (od 9 do 17 opic na skupino) in ni pokazala znakov okvare plodov zaradi adalimumaba.
The injection is complete when the yellow indicator stops moving. 
Injiciranje je zaključeno, ko se rumeni indikator neha premikati.
Humira works by reducing this inflammation. 
Humira deluje tako, da zmanjša tako vnetje.
Change the place that you inject each time so that you do not become sore in one area. 
Mesto injiciranja vsakokrat zamenjajte, tako da se en predel ne bo razbolel.
Maintenance of clinical remission was evaluated in CD study III (CHARM). 
Vzdrževanje klinične remisije so ovrednotili v študiji Crohnove bolezni III (CHARM).
Your symptoms may return if you stop using Humira. 
Vaši simptomi se lahko povrnejo, če prenehate jemati zdravilo Humira.
Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful. 
Psoriaza v plakih lahko vpliva tudi na nohte, zaradi česar le-ti razpadejo, postanejo debelejši in se dvignejo od svojega ležišča, kar je lahko boleče.
Table 13 Efficacy Responses in Placebo-Controlled AS Study - Study I Reduction of Signs and Symptoms 
Preglednica 13 - Odzivi učinkovitosti v študiji pri ankilozirajočem spondilitisu, kontrolirani s placebom - študija I Zmanjšanje znakov in simptomov
• steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs). 
• steroidi in zdravili proti bolečinam, vključno z nesteroidnimi protivnetnimi zdravili.
The impact of long-term treatment with Humira on the development of autoimmune diseases is unknown. 
Vpliv dolgoročnega zdravljenja z zdravilom Humira na nastanek avtoimunskih bolezni ni znan.
This risk may increase if you have problems with your lungs. 
Tveganje je lahko večje, če imate težave s pljuči.
Your doctor may decide to stop treatment. 
Vaš zdravnik se bo morda odločil, da vaše zdravljenje prekine.
Humira treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Humira is indicated. 
Zdravljenje z zdravilom Humira mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju bolezni, za katere je zdravilo Humira indicirano.
The presence of one or more bubbles in the window is normal. 
Normalno je, če v okencu opazite enega ali več mehurčkov.
A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Humira cannot be excluded (see section 4.8). 
Tveganja za razvoj hepatospleničnega limfoma celic T pri bolnikih, ki dobivajo zdravilo Humira, ni mogoče izključiti (glejte poglavje 4.8).
• tuberculosis 
• tuberkulozo
The Humira pre-filled pen is available in packs containing: 
Napolnjeni injekcijski peresnik zdravila Humira je na voljo v pakiranjih, ki vsebujejo:
1 sterile injection syringe 1 sterile needle 
1 sterilna injekcijska brizga 1 sterilna igla
In patients who develop HBV reactivation, Humira should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated. 
Pri bolnikih, ki se jim pojavi reaktivacija HBV, je treba uporabo zdravila Humira prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim zdravljenjem.
Results from the Short Form Health Survey (SF 36) for all doses/schedules of Humira in all four studies support these findings, with statistically significant physical component summary (PCS) scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose. 
Te izsledke podpirajo rezultati SF 36 (Short Form Health Survey) za vse odmerke/sheme zdravila Humira v vseh štirih študijah, s statistično značilnim seštevkom PCS (Physical Component Summary) in statistično značilnima seštevkoma za področje bolečin in vitalnosti za odmerek 40 mg vsak drugi teden.
Among patients who had failed prior anti-TNF treatment, Week 52 remission was achieved by 3% on placebo and 10% on adalimumab. 
Med bolniki, pri katerih predhodno anti-TNF zdravljenje ni bilo uspešno, jih je 52. teden doseglo remisijo 3 % na placebu in 10 % na adalimumabu.
A modified Total Sharp Score (mTSS), which included distal interphalangeal joints (i.e. not identical to the TSS used for rheumatoid arthritis), was used. 
mTSS), ki je vključil distalne interfalangealne sklepe (tj. ni bil enak TSS, ki se uporablja za revmatoidni artritis).
2) Choosing and preparing an injection site 
2) Izbira in priprava injekcijskega mesta
Keep pressing and continue to hold the pre-filled pen with steady pressure in place for about 10 seconds to ensure a complete injection. 
Napolnjeni injekcijski peresnik še naprej pritiskajte in držite s stalnim pritiskom na mestu približno 10 sekund, da bo injiciranje popolno.
10 Seconds 
10 sekund
Turn the pre-filled pen so that the white arrow points toward the injection site. 
Napolnjen injekcijski peresnik obrnite tako, da bela puščica kaže proti mestu injiciranja.
Patients treated with Humira had significantly reduced risk of disease flare during the initial 12 weeks of treatment. 
Bolniki, zdravljeni z zdravilom Humira, so imeli signifikantno zmanjšanje tveganja novega izbruha bolezni v začetnih 12 tednih zdravljenja.
If your child has active tuberculosis, do not use Humira. 
Če ima vaš otrok aktivno tuberkulozo, zdravila Humira ne smete uporabiti.
The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percent of patients who achieved an ACR 20 response at Week 24 or 26. 
Primarna končna točka v študijah revmatoidnega artritisa I, II in III ter sekundarna končna točka v študiji revmatoidnega artritisa IV je bil odstotek bolnikov, ki so po 24 oz. 26 tednih dosegli odziv 20 po ACR.
Patients who develop a new infection while undergoing treatment with Humira should be monitored closely and undergo a complete diagnostic evaluation. 
Bolnike, pri katerih se med zdravljenjem z zdravilom Humira pojavi nova okužba, je treba natančno nadzirati in opraviti morajo popolno diagnostično obravnavo.
Consequently, Humira can be used during breastfeeding. 
Posledično se zdravilo Humira lahko uporablja med dojenjem.