natgillin/translations-raw huggingface dataset:
Within the organ system classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). 
Znotraj organskih sistemov so neželeni učinki navedeni po pogostnosti (število bolnikov, pri katerih se pričakuje pojav učinka), z uporabo naslednjih kategorij: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Serious infections occurred in 6.3% of rheumatoid arthritis patients treated with LIFMIOR for up to 48 months. 
Resne okužbe so se pojavile pri 6,3 % bolnikov z revmatoidnim artritisom, ki so prejemali zdravilo LIFMIOR do 48 mesecev.
This section is divided into the following subsections: 
To poglavje je razdeljeno na naslednja podpoglavja:
The safety and efficacy profiles of the two LIFMIOR treatment regimens were comparable at week 8 in their effect on signs and symptoms of RA; data at week 16 did not show comparability (non-inferiority) between the two regimens. 
Profil varnosti in učinkovitosti obeh shem zdravljenja z zdravilom LIFMIOR je bil po 8 tednih primerljiv glede učinka na znake in simptome revmatoidnega artritisa; podatki po 16 tednih niso pokazali primerljivosti (neinferiornosti) med obema shemama.
The conduct of these tests should be recorded on the Patient Alert Card. 
Rezultati teh testov morajo biti vpisani na opozorilni kartici za bolnika.
In this situation, the benefit/risk balance of LIFMIOR therapy should be very carefully considered. 
V takem primeru je treba zelo skrbno pretehtati razmerje med koristmi in tveganji zdravljenja z zdravilom LIFMIOR.
If you notice any of the following, you or the child may need urgent medical attention. 
Če opazite karkoli od naslednjega, boste vi ali vaš otrok morda potrebovali nujno zdravniško pomoč:
Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State comprising of information provided to all healthcare professionals expected to prescribe the product on the correct and safe use of the pre-filled pen and a Patient Alert Card which is to be given to patients using LIFMIOR. 
Imetnik dovoljenja za promet z zdravilom se mora pred pričetkom trženja napolnjenega peresnika v vsaki državi članici s pristojnim organom v tej državi dogovoriti glede končnega izobraževalnega gradiva, sestavljenega iz informacij za predpisovalce glede pravilne in varne uporabe napolnjenega peresnika, ter opozorilne kartice za bolnika, ki jo morajo izročiti bolnikom, ki se zdravijo z zdravilom LIFMIOR.
Children and adults taking LIFMIOR may have an increased risk of developing lymphoma or another cancer. 
Pri otrocih in odraslih, ki prejemajo zdravilo LIFMIOR, je morda tveganje za nastanek limfoma ali druge oblike raka večje.
Hold the pen at a right angle (90º) to the injection site. 
Peresnik držite pod pravim kotom (90°) na mesto injiciranja.
The recommended injection site is the middle of the front of the thighs. 
Priporočeno mesto injiciranja je sredina sprednjega dela stegen.
They should not be used after the month and year shown. 
Po preteku označenega meseca in leta ju ne smete uporabiti.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
The specific activity of etanercept is 1.7 x 106 units/mg. 
Specifična aktivnost etanercepta je 1,7 x 10
Neoplasms benign, malignant and unspecified (including cysts and polyps) 
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
If you feel that the effect of LIFMIOR is too strong or too weak, talk to your doctor or pharmacist. 
Če menite, da je učinek zdravila LIFMIOR premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher than average risk of developing lymphoma. 
Pri bolnikih s hudim revmatoidnim artritisom, ki že dlje časa trpijo za to boleznijo, je lahko tveganje za nastanek limfoma večje od povprečnega.
If you use more LIFMIOR than you should 
Če ste uporabili večji odmerek zdravila LIFMIOR, kot bi smeli
It is recommended that you record the date that LIFMIOR is removed from the refrigerator and the date after which LIFMIOR should be discarded (no more than 4 weeks following the removal from the refrigerator). 
Priporočljivo si je zabeležiti datum odvzema zdravila LIFMIOR iz hladilnika in datum, po katerem je treba zdravilo LIFMIOR zavreči (do 4 tedne po odvzemu iz hladilnika).
LIFMIOR did not induce lethality or notable signs of toxicity in mice or rats following a single subcutaneous dose of 2000 mg/kg or a single intravenous dose of 1000 mg/kg. 
Zdravilo LIFMIOR ni povzročilo smrtnosti ali pomembne toksičnosti pri miših ali podganah po enkratnem subkutanem odmerku 2.000 mg/kg ali enkratnem intravenskem odmerku 1.000 mg/kg.
The other cases represented a variety of different malignancies and included rare malignancies typically associated with immunosuppression. 
Med drugimi primeri so bile raznolike vrste malignosti, ki so vključevale redke vrste malignosti, običajno povezane z imunosupresijo.
Radiographic changes were assessed in the psoriatic arthritis study. 
V študiji psoriatičnega artritisa so ocenjevali radiografske spremembe.
Patients who develop a new infection while undergoing treatment with LIFMIOR should be monitored closely. 
Bolnike, pri katerih se med zdravljenjem z zdravilom LIFMIOR pojavi nova okužba, je treba skrbno spremljati.
There is no known antidote to LIFMIOR. 
Znanega antidota za zdravilo LIFMIOR ni.
When you remove the needle cover, there may be a drop of liquid at the end of the needle; this is normal. 
Ko odstranite pokrovček igle, lahko na konici igle opazite kapljico tekočine, kar je normalno.
Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors, ATC code: L04AB01 
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, Antagonisti tumorje nekrotizirajočega faktorja alfa (TNF-α), oznaka ATC: L04AB01
Waiting until the solution reaches room temperature may make the injection more comfortable for you. 
Če počakate, da bo raztopina dosegla sobno temperaturo, bo injekcija za vas manj neprijetna.
LIFMIOR works by reducing the inflammation associated with certain diseases. 
Deluje tako, da zmanjšuje vnetje, ki spremlja določene bolezni.
Sepsis or risk of sepsis. 
Sepsa ali tveganje za nastanek sepse.
The impact of long-term treatment with LIFMIOR on the development of autoimmune diseases is unknown. 
Vpliv dolgotrajnega zdravljenja z zdravilom LIFMIOR na razvoj avtoimunskih bolezni ni znan.
If you notice any of the following, the child may need urgent medical attention. 
Če opazite karkoli od naslednjega, bo otrok morda potreboval nujno zdravniško pomoč:
Each injection should be given at least 3 cm from where you last injected. 
Vsako naslednjo injekcijo morate dati vsaj 3 cm stran od mesta prejšnje injekcije.
The needle cover contains dry natural rubber (latex) (see section 4.4). 
Pokrovček igle vsebuje posušen naravni kavčuk (lateks) (glejte poglavje 4.4).
After you have withdrawn the LIFMIOR from the vial, you may have some air in the syringe. 
Po tem, ko ste potegnili zdravilo LIFMIOR iz viale, je možno, da je v brizgo prišlo tudi nekaj zraka.
Patients should be evaluated for infections before, during, and after treatment with LIFMIOR, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours). 
Pred zdravljenjem z zdravilom LIFMIOR, med njim in po njem je treba bolnike pregledati glede okužb in pri tem upoštevati, da je povprečni razpolovni čas izločanja etanercepta iz telesa približno 70 ur (razpon 7 do 300 ur).
What you need to know before you use LIFMIOR 
Kaj morate vedeti, preden boste uporabili zdravilo LIFMIOR
A slight depression in the skin will be seen (see Diagram 4). 
Vidna bo rahla vdrtina v koži (glejte sliko 4).
Tell the doctor or pharmacist if you or the child are taking, have recently taken or might take any other medicines (including anakinra, abatacept or sulfasalazine), even those not prescribed by the doctor. 
Obvestite zdravnika ali farmacevta, če vi ali otrok jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo (vključno z anakinro, abataceptom ali sulfasalazinom), tudi če ste ga dobili brez recepta.
Use only the items listed. 
Vedno uporabljajte le naštete pripomočke.
It is very important that you tell your doctor if you or the child have ever had tuberculosis, or have been in close contact with someone who has had tuberculosis. 
Zelo pomembno je, da poveste zdravniku, če ste vi ali vaš otrok kdaj imeli tuberkulozo ali bili v tesnem stiku s kom, ki je imel tuberkulozo.
In patients who develop HBV infection, LIFMIOR should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated. 
Pri bolnikih, pri katerih se razvije okužba s HBV, je treba zdravljenje z zdravilom LIFMIOR prekiniti in uvesti učinkovito protivirusno ter ustrezno podporno zdravljenje.
This may include a thorough medical history, a chest X-ray and a tuberculin test. 
To bo storil s temeljito medicinsko anamnezo, rentgenskim slikanjem prsnega koša in tuberkulinskim testom.
The 10 mg LIFMIOR dose had consistently less effect on structural damage than the 25 mg dose. 
10 mg odmerek zdravila LIFMIOR je imel ves čas manjši učinek na strukturno poškodbo sklepov kot 25 mg odmerek.
You may now lift the pen from your skin (see Diagram 7). 
Sedaj lahko peresnik umaknete s kože (glejte sliko 7).
Whilst pushing the pen firmly against the skin to ensure that the needle safety shield is fully depressed inside the pen, press the centre of the green button on top of the pen with your thumb to start the injection (see Diagram 5). 
Medtem ko peresnik čvrsto pritiskate ob kožo in s tem zagotovite, da je varnostni ščit v celoti skrit v peresniku, s palcem pritisnite sredino zelenega gumba na vrhu peresnika, da se prične injiciranje (glejte sliko 5).
During the first 12 weeks of the double-blind treatment period, patients received placebo or one of the above three LIFMIOR doses. 
V prvih 12 tednih dvojno slepega obdobja zdravljenja so bolniki dobivali placebo ali enega od navedenih odmerkov zdravila LIFMIOR.
There have been rare reports of lupus, lupus-related conditions, and vasculitis. 
Poročali so tudi o redkih primerih lupusa, lupusu podobnih stanj in vaskulitisa.
The exposure-adjusted rate was 0.06 events per 100 patient-years. 
Za stopnjo izpostavljenosti popravljena pogostnost je bila 0,06 dogodka na 100 bolnikov-let.
Etanercept may also modulate biologic responses controlled by additional downstream molecules (e.g., cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF. 
Etanercept morda tudi uravnava biološke odzive, ki jih nadzirajo druge molekule nižje v kaskadi (kot so citokini, adhezijske molekule ali proteinaze), ki jih prav tako inducira ali regulira TNF.
In a long-term psoriasis study in which patients received 50 mg twice weekly for 96 weeks, the incidence of antibodies observed at each assessment point was up to approximately 9%. 
V dolgoročni študiji psoriaze, v kateri so bolniki dobivali po 50 mg etanercepta dvakrat na teden 96 tednov, je bila pojavnost protiteles, ki so jih našli pri posameznem periodičnem določanju, do približno 9 %.
Dose proportionality has not been formally evaluated, but there is no apparent saturation of clearance across the dosing range. 
Proporcionalnosti v odvisnosti od odmerka niso formalno preverjali, vendar pa v razponu terapevtskih odmerkov ni bilo opaziti nasičenja očistka zdravila.
What LIFMIOR is and what it is used for 
Kaj je zdravilo LIFMIOR in za kaj ga uporabljamo
Select a clean, well-lit, flat working surface. 
Izberite čisto, dobro osvetljeno, ravno delovno površino.
There have been postmarketing reports of interstitial lung disease (including pneumonitis and pulmonary fibrosis), some of which had fatal outcomes. 
V obdobju trženja so poročali o intersticijski bolezni pljuč (vključno s pnevmonitisom in pljučno fibrozo), nekateri od teh primerov so bili tudi smrtni.
After preparing the LIFMIOR solution, immediate use is recommended (up to a maximum of 6 hours). 
Po pripravi naj se raztopina zdravila LIFMIOR po možnosti uporabi takoj (v največ 6 urah).
LIFMIOR was significantly better than placebo in all measures of disease activity (p < 0.001), and responses were similar with and without concomitant methotrexate therapy. 
Zdravilo LIFMIOR je bilo pomembno boljše kot placebo po vseh kriterijih aktivnosti bolezni (p < 0,001) in odzivi so bili podobni, ne glede na sočasno zdravljenje z metotreksatom.
Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of LIFMIOR. 
Ti simptomi namreč lahko kažejo na pojav življenjsko ogrožajoče bolezni krvi, pri kateri bo zdravljenje z zdravilom LIFMIOR morda treba prekiniti.
Healthcare professionals are asked to report any suspected adverse reactions. 
Zdravstvene delavce naprošamo, da poročajo o kateremkoli domnevnem neželenem učinku zdravila.
Do NOT push down the adaptor at an angle (see Diagram 4). 
Adapterja NE POTISKAJTE pod kotom (glejte sliko 4).
The primary measure of efficacy (ASAS 40) was a 40% improvement in at least three of the four ASAS domains and absence of deterioration in the remaining domain. 
Primarno merilo za učinkovitost (ASAS 40) je bilo 40 % izboljšanje vsaj treh od štirih domen ASAS in odsotnost poslabšanja pri četrti domeni.
Although not conclusive, data from one of these trials suggest a possible tendency toward worsening CHF in those patients assigned to LIFMIOR treatment. 
Izsledki sicer še niso dokončni, vendar podatki iz enega od teh preskušanj kažejo na morebitno tendenco k poslabšanju KSP pri bolnikih, zdravljenih s tem zdravilom.
Continue to hold the pen firmly against your skin until you hear a second click, or until 10 seconds after the first click (whichever happens first). 
Peresnik še naprej čvrsto pritiskajte ob kožo, dokler ne zaslišite drugega klika ali do 10 sekund po prvem kliku
LIFMIOR is also prescribed for the treatment of the following diseases in children and adolescents 
Zdravilo LIFMIOR se predpisuje tudi za zdravljenje naslednjih bolezni pri otrocih in mladostnikih:
Concurrent treatment with abatacept 
Sočasno zdravljenje z abataceptom
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. 
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). 
Zdravljenje odraslih s hudim radiografsko nezaznavnim aksialnim spondilartritisom in objektivnimi znaki vnetja (na katerega kažejo povišana vrednost C-reaktivnega proteina (CRP) in/ali dokazi magnetnoresonančnega slikanja (MRI)), ki imajo nezadostni odziv na nesteroidna protivnetna zdravila (NSAID).
Study 2 also had a drug withdrawal period during which patients who achieved a PASI improvement of at least 50% at week 24 had treatment stopped. 
Študija 2 je vključevala tudi obdobje odtegnitve zdravila, med katerim so zdravljenje prekinili bolniki, ki so 24. teden dosegli izboljšanje PASI za vsaj 50 %.
Responses were similar in patients who were or were not receiving concomitant therapies at baseline. 
Odziv je bil podoben tudi pri bolnikih, ki so ali niso prejemali sočasnega zdravljenja na začetku.
Inject the solution after it has reached room temperature (15 to 30 minutes after taking the product from the refrigerator). 
Raztopino injicirajte, ko se segreje na sobno temperaturo (15 do 30 minut po tem, ko ste zdravilo vzeli iz hladilnika).
Do NOT use LIFMIOR if all the powder in the vial is not dissolved within 10 minutes. 
NE uporabite zdravila LIFMIOR, če se ves prašek v viali ni raztopil v 10 minutah.
The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with LIFMIOR, relative to placebo (p < 0.001). 
Rezultat indeksa invalidnosti je bil bistveno boljši v vseh časovnih točkah pri bolnikih s psoriatičnim artritisom, zdravljenih z zdravilom LIFMIOR, v primerjavi s placebom (p < 0,001).
If someone else is giving you the injection, the outer area of the upper arms may also be used. 
Če vam daje injekcijo nekdo drug, lahko uporabi tudi zunanji predel nadlakti.
• Alcohol abuse: LIFMIOR should not be used for the treatment of hepatitis related to alcohol abuse. 
Zloraba alkohola: Zdravila LIFMIOR ne smete uporabljati za zdravljenje hepatitisa, povezanega z zlorabo alkohola.
Hepatitis B reactivation, listeria 
reaktivacija hepatitisa B, listerija
LIFMIOR has not been studied in children aged less than 2 years. 
Zdravila LIFMIOR niso preskušali pri otrocih, mlajših od 2 let.
The efficacy of LIFMIOR versus other systemic therapies in patients with moderate to severe psoriasis (responsive to other systemic therapies) has not been evaluated in studies directly comparing LIFMIOR with other systemic therapies. 
Učinkovitosti zdravila LIFMIOR v primerjavi z drugimi sistemskimi zdravljenji pri bolnikih z zmerno do hudo psoriazo (ki se odziva na druga sistemska zdravljenja) niso ovrednotili s študijami, v katerih bi neposredno primerjali zdravilo LIFMIOR z drugimi sistemskimi terapijami.
A placebo-controlled trial, in which 89 adult patients were treated with LIFMIOR in addition to standard therapy (including cyclophosphamide or methotrexate, and glucocorticoids) for a median duration of 25 months, has not shown LIFMIOR to be an effective treatment for Wegener's granulomatosis. 
S placebom nadzorovano preskušanje, v katerem je 89 odraslih bolnikov poleg standardnega zdravljenja (vključno s ciklofosfamidom ali metotreksatom in glukokortikoidi) jemalo zdravilo LIFMIOR z medianim časom zdravljenja 25 mesecev, ni pokazalo učinkovitosti zdravila LIFMIOR za zdravljenje Wegenerjeve granulomatoze.
When the needle is completely inserted into the skin, release the skin that you are holding. 
Ko je igla v celoti v koži, spustite kožo, ki ste jo držali.
In lactating rats following subcutaneous administration, etanercept was excreted in the milk and detected in the serum of pups. 
Po subkutanem dajanju doječim podganam se je etanercept izločal z mlekom in so ga odkrili v serumu mladičev.
Reactions at the injection site (these do not occur as often after the first month of treatment). 
Reakcije na mestu injiciranja (njihova pogostnost se po prvem mesecu zdravljenja zmanjša).
Do NOT touch this area again before giving the injection. 
Nato se tega predela ne dotikajte več, dokler ne daste injekcije.
Two juvenile idiopathic arthritis patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae. 
Pri dveh bolnikih z juvenilnim idiopatskim artritisom so se razvili okužba z noricami ter znaki in simptomi aseptičnega meningitisa, ki so izzveneli brez posledic.
Compared to placebo, treatment with LIFMIOR resulted in statistically significant improvement in the ASAS 40, ASAS 20 and ASAS 5/6. 
Zdravljenje z zdravilom LIFMIOR je v primerjavi s placebom povzročilo statistično pomembno izboljšanje ASAS 40, ASAS 20 in ASAS 5/6.
The pen can only be activated when the needle shield is completely pushed inside the pen. 
Peresnik lahko aktivirate samo, ko je varnostni ščit v celoti potisnjen v peresnik.
LIFMIOR is not recommended for the treatment of Wegener's granulomatosis. 
Zdravila LIFMIOR ni priporočljivo uporabljati za zdravljenje Wegenerjeve granulomatoze.
• The needle will remain in the long part of the package. 
Igla bo ostala v daljšem delu embalaže.
Patients receiving DMARDs, NSAIDS, or corticosteroids could continue them on stable doses. 
Bolniki, ki so dobivali DMARD, NSAID ali kortikosteroide, so lahko nadaljevali z njihovim jemanjem brez prilagajanja odmerka.
There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known pre-existing cardiovascular disease. 
Redko (pri manj kot 0,1 % bolnikov) so poročali tudi o nastanku KSP, vključno s KSP pri bolnikih brez predhodne srčno-žilne bolezni.
After waiting approximately 15-30 minutes for the solution in the pen to warm to room temperature, wash your hands with soap and water. 
Po tem, ko počakate približno 15-30 minut, da se raztopina v peresniku segreje na sobno temperaturo, si umijte roke z milom in vodo.
There was some evidence to support a benefit of re-treatment with LIFMIOR in patients initially responding to treatment. 
Nekaj podatkov kaže na ugoden odziv na ponovno zdravljenje z zdravilom LIFMIOR pri bolnikih, ki so se prvotno odzvali na zdravljenje.
The incidence of non-cutaneous malignancies of various types was significantly higher in patients treated with LIFMIOR than in the control group. 
Pojavnost nekožnih malignih obolenj različnih tipov je bila pomembno večja pri bolnikih, zdravljenih z zdravilom LIFMIOR, kot pri tistih v kontrolni skupini.
Another study found no increased risk of birth defects when the mother had received LIFMIOR in pregnancy. 
V drugi študiji niso ugotovili povečanega tveganja za prirojene napake, kadar je mati med nosečnostjo prejemala zdravilo LIFMIOR.
For psoriatic arthritis patients with multiple joint involvement, LIFMIOR can improve your ability to do normal daily activities. 
Pri bolnikih s psoriatičnim artritisom in prizadetostjo več sklepov lahko zdravilo LIFMIOR izboljša sposobnost opravljanja običajnih vsakdanjih dejavnosti.
Clinical responses were expressed as percentages of patients achieving the ACR 20, 50, and 70 response and percentages with improvement in Psoriatic Arthritis Response Criteria (PsARC). 
Klinični odzivi so bili izraženi v odstotkih bolnikov, ki so dosegli odziv ACR 20, 50 in 70 in v odstotkih bolnikov z izboljšanjem ocene po kriterijih PsARC - Psoriatic Arthritis Response Criteria.
• Tuberculosis: As cases of tuberculosis have been reported in patients treated with LIFMIOR, your doctor will check for signs and symptoms of tuberculosis before starting LIFMIOR. 
Tuberkuloza: Ker so pri bolnikih, ki so se zdravili z zdravilom LIFMIOR, poročali o primerih tuberkuloze, se bo vaš zdravnik prepričal, da nimate znakov ali simptomov tuberkuloze, preden se boste začeli zdraviti z zdravilom LIFMIOR.
These included headache (19% of patients, 1.7 events per patient year), nausea (9%, 1.0 event per patient year), abdominal pain (19%, 0.74 events per patient year), and vomiting (13%, 0.74 events per patient year). 
Pojavljali so se glavoboli (19 %, 1,7 dogodka na bolnik-leto), navzea (9 %, 1,0 dogodek na bolnikleto), bolečine v trebuhu (19 %, 0,74 dogodka na bolnik-leto) in bruhanje (13 %, 0,74 dogodka na bolnik-leto).
The majority of the reports with a fatal outcome were in patients with Pneumocystis pneumonia, unspecified systemic fungal infections, and aspergillosis (see section 4.4). 
Večina poročil o smrtnih izidih je opisovala bolnike s pljučnico, ki jo je povzročila glivica Pneumocystis, z nedoločenimi sistemskimi glivičnimi okužbami in aspergilozo (glejte poglavje 4.4).
Methotrexate doses were escalated from 7.5 mg/week to a maximum of 20 mg/week over the first 8 weeks of the trial and continued for up to 24 months. 
Odmerke metotreksata so stopnjevali od 7,5 mg/teden do največ 20 mg/teden v prvih 8 tednih preskušanja in z njimi nadaljevali do 24 mesecev.
Concurrent treatment with anakinra 
Sočasno zdravljenje z anakinro