FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: 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%.
Slovenian: 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 %.
English: Dose proportionality has not been formally evaluated, but there is no apparent saturation of clearance across the dosing range.
Slovenian: Proporcionalnosti v odvisnosti od odmerka niso formalno preverjali, vendar pa v razponu terapevtskih odmerkov ni bilo opaziti nasičenja očistka zdravila.
English: What LIFMIOR is and what it is used for
Slovenian: Kaj je zdravilo LIFMIOR in za kaj ga uporabljamo
English: Select a clean, well-lit, flat working surface.
Slovenian: Izberite čisto, dobro osvetljeno, ravno delovno površino.
English: There have been postmarketing reports of interstitial lung disease (including pneumonitis and pulmonary fibrosis), some of which had fatal outcomes.
Slovenian: V obdobju trženja so poročali o intersticijski bolezni pljuč (vključno s pnevmonitisom in pljučno fibrozo), nekateri od teh primerov so bili tudi smrtni.
English: After preparing the LIFMIOR solution, immediate use is recommended (up to a maximum of 6 hours).
Slovenian: Po pripravi naj se raztopina zdravila LIFMIOR po možnosti uporabi takoj (v največ 6 urah).
English: 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.
Slovenian: 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.
English: Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of LIFMIOR.
Slovenian: Ti simptomi namreč lahko kažejo na pojav življenjsko ogrožajoče bolezni krvi, pri kateri bo zdravljenje z zdravilom LIFMIOR morda treba prekiniti.
English: Healthcare professionals are asked to report any suspected adverse reactions.
Slovenian: Zdravstvene delavce naprošamo, da poročajo o kateremkoli domnevnem neželenem učinku zdravila.
English: Do NOT push down the adaptor at an angle (see Diagram 4).
Slovenian: Adapterja NE POTISKAJTE pod kotom (glejte sliko 4).
English: 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.
Slovenian: Primarno merilo za učinkovitost (ASAS 40) je bilo 40 % izboljšanje vsaj treh od štirih domen ASAS in odsotnost poslabšanja pri četrti domeni.
English: Although not conclusive, data from one of these trials suggest a possible tendency toward worsening CHF in those patients assigned to LIFMIOR treatment.
Slovenian: 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.
English: 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).
Slovenian: Peresnik še naprej čvrsto pritiskajte ob kožo, dokler ne zaslišite drugega klika ali do 10 sekund po prvem kliku
English: LIFMIOR is also prescribed for the treatment of the following diseases in children and adolescents
Slovenian: Zdravilo LIFMIOR se predpisuje tudi za zdravljenje naslednjih bolezni pri otrocih in mladostnikih:
English: Concurrent treatment with abatacept
Slovenian: Sočasno zdravljenje z abataceptom
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Študija 2 je vključevala tudi obdobje odtegnitve zdravila, med katerim so zdravljenje prekinili bolniki, ki so 24. teden dosegli izboljšanje PASI za vsaj 50 %.
English: Responses were similar in patients who were or were not receiving concomitant therapies at baseline.
Slovenian: Odziv je bil podoben tudi pri bolnikih, ki so ali niso prejemali sočasnega zdravljenja na začetku.
English: Inject the solution after it has reached room temperature (15 to 30 minutes after taking the product from the refrigerator).
Slovenian: Raztopino injicirajte, ko se segreje na sobno temperaturo (15 do 30 minut po tem, ko ste zdravilo vzeli iz hladilnika).
English: Do NOT use LIFMIOR if all the powder in the vial is not dissolved within 10 minutes.
Slovenian: NE uporabite zdravila LIFMIOR, če se ves prašek v viali ni raztopil v 10 minutah.
English: The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with LIFMIOR, relative to placebo (p < 0.001).
Slovenian: 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).
English: If someone else is giving you the injection, the outer area of the upper arms may also be used.
Slovenian: Če vam daje injekcijo nekdo drug, lahko uporabi tudi zunanji predel nadlakti.
English: • Alcohol abuse: LIFMIOR should not be used for the treatment of hepatitis related to alcohol abuse.
Slovenian: Zloraba alkohola: Zdravila LIFMIOR ne smete uporabljati za zdravljenje hepatitisa, povezanega z zlorabo alkohola.
English: Hepatitis B reactivation, listeria
Slovenian: reaktivacija hepatitisa B, listerija
English: LIFMIOR has not been studied in children aged less than 2 years.
Slovenian: Zdravila LIFMIOR niso preskušali pri otrocih, mlajših od 2 let.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: When the needle is completely inserted into the skin, release the skin that you are holding.
Slovenian: Ko je igla v celoti v koži, spustite kožo, ki ste jo držali.
English: In lactating rats following subcutaneous administration, etanercept was excreted in the milk and detected in the serum of pups.
Slovenian: Po subkutanem dajanju doječim podganam se je etanercept izločal z mlekom in so ga odkrili v serumu mladičev.
English: Reactions at the injection site (these do not occur as often after the first month of treatment).
Slovenian: Reakcije na mestu injiciranja (njihova pogostnost se po prvem mesecu zdravljenja zmanjša).
English: Do NOT touch this area again before giving the injection.
Slovenian: Nato se tega predela ne dotikajte več, dokler ne daste injekcije.
English: Two juvenile idiopathic arthritis patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae.
Slovenian: Pri dveh bolnikih z juvenilnim idiopatskim artritisom so se razvili okužba z noricami ter znaki in simptomi aseptičnega meningitisa, ki so izzveneli brez posledic.
English: Compared to placebo, treatment with LIFMIOR resulted in statistically significant improvement in the ASAS 40, ASAS 20 and ASAS 5/6.
Slovenian: Zdravljenje z zdravilom LIFMIOR je v primerjavi s placebom povzročilo statistično pomembno izboljšanje ASAS 40, ASAS 20 in ASAS 5/6.
English: Aplastic anaemia*
Slovenian: aplastična anemija*
English: The pen can only be activated when the needle shield is completely pushed inside the pen.
Slovenian: Peresnik lahko aktivirate samo, ko je varnostni ščit v celoti potisnjen v peresnik.
English: LIFMIOR is not recommended for the treatment of Wegener's granulomatosis.
Slovenian: Zdravila LIFMIOR ni priporočljivo uporabljati za zdravljenje Wegenerjeve granulomatoze.
English: • The needle will remain in the long part of the package.
Slovenian: Igla bo ostala v daljšem delu embalaže.
English: Patients receiving DMARDs, NSAIDS, or corticosteroids could continue them on stable doses.
Slovenian: Bolniki, ki so dobivali DMARD, NSAID ali kortikosteroide, so lahko nadaljevali z njihovim jemanjem brez prilagajanja odmerka.
English: There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known pre-existing cardiovascular disease.
Slovenian: Redko (pri manj kot 0,1 % bolnikov) so poročali tudi o nastanku KSP, vključno s KSP pri bolnikih brez predhodne srčno-žilne bolezni.
English: After waiting approximately 15-30 minutes for the solution in the pen to warm to room temperature, wash your hands with soap and water.
Slovenian: Po tem, ko počakate približno 15-30 minut, da se raztopina v peresniku segreje na sobno temperaturo, si umijte roke z milom in vodo.
English: There was some evidence to support a benefit of re-treatment with LIFMIOR in patients initially responding to treatment.
Slovenian: Nekaj podatkov kaže na ugoden odziv na ponovno zdravljenje z zdravilom LIFMIOR pri bolnikih, ki so se prvotno odzvali na zdravljenje.
English: The incidence of non-cutaneous malignancies of various types was significantly higher in patients treated with LIFMIOR than in the control group.
Slovenian: Pojavnost nekožnih malignih obolenj različnih tipov je bila pomembno večja pri bolnikih, zdravljenih z zdravilom LIFMIOR, kot pri tistih v kontrolni skupini.
English: Another study found no increased risk of birth defects when the mother had received LIFMIOR in pregnancy.
Slovenian: V drugi študiji niso ugotovili povečanega tveganja za prirojene napake, kadar je mati med nosečnostjo prejemala zdravilo LIFMIOR.
English: For psoriatic arthritis patients with multiple joint involvement, LIFMIOR can improve your ability to do normal daily activities.
Slovenian: Pri bolnikih s psoriatičnim artritisom in prizadetostjo več sklepov lahko zdravilo LIFMIOR izboljša sposobnost opravljanja običajnih vsakdanjih dejavnosti.
English: 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).
Slovenian: 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.
English: • 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.
Slovenian: 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.
English: PFIZER EΛΛAΣ A.E. (CYPRUS BRANCH) Tηλ: +357 22 817690
Slovenian: PFIZER EΛΛAΣ A.E. (CYPRUS BRANCH) T : +357 22 817690
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Concurrent treatment with anakinra
Slovenian: Sočasno zdravljenje z anakinro
English: The difference between LIFMIOR alone and methotrexate alone was also significant (p<0.05).
Slovenian: Pomembna je bila tudi razlika med monoterapijo z zdravilom LIFMIOR in monoterapijo z metotreksatom (p < 0,05).
English: Inspect the solution in the pen by looking through the clear inspection window.
Slovenian: Preglejte raztopino v peresniku, tako da pogledate skozi prozorno okence za pregledovanje.
English: Serious infections affect fewer than 1 in 100 patients treated with LIFMIOR.
Slovenian: Med zdravljenjem z zdravilom LIFMIOR so se resne okužbe pojavile pri manj kot 1 od 100 bolnikov.
English: Patients who “failed to respond to” in the target population is defined by insufficient response (PASI<50 or PGA less than good), or worsening of the disease while on treatment, and who were adequately dosed for a sufficiently long duration to assess response with at least each of the three major systemic therapies as available.
Slovenian: Bolnike v ciljni populaciji, ki ''se niso odzvali'', opredeljuje nezadosten odziv (PASI  50 ali PGA [PGAPhysician Global Assessment] manj kot dober) ali poslabšanje bolezni med zdravljenjem, ko je bolnik prejemal najmanj vsako od treh glavnih razpoložljivih sistemskih zdravljenj v zadostnem odmerku in dovolj časa, da je bilo mogoče oceniti odziv.
English: In each of the JIA subtypes, the majority of patients met ACR Pedi 30 criteria and demonstrated clinical improvement in secondary endpoints such as number of tender joints and physician global assessment.
Slovenian: Pri vseh podtipih JIA so bili kriteriji ACR Pedi 30 doseženi pri večini bolnikov, prav tako pa so pri večini bolnikov ugotovili tudi klinično izboljšanje pri sekundarnih opazovanih dogodkih, kot sta število občutljivih sklepov in zdravnikova splošna ocena.
English: It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating LIFMIOR therapy (see Vaccinations, above).
Slovenian: Za pediatrične bolnike priporočamo, da pred začetkom zdravljenja z zdravilom LIFMIOR, če je le mogoče, opravijo vsa cepljenja v skladu z veljavnimi smernicami za cepljenje (glejte Cepljenja zgoraj).
English: Serum concentration profiles were similar to those seen in adult rheumatoid arthritis patients.
Slovenian: Profili serumskih koncentracij so bili podobni tistim pri odraslih bolnikih z revmatoidnim artritisom.
English: LIFMIOR is prescribed for the treatment of the following diseases in children and adolescents
Slovenian: Zdravilo LIFMIOR se predpisuje za zdravljenje naslednjih bolezni pri otrocih in mladostnikih:
English: Paediatric plaque psoriasis (age 6 years and above)
Slovenian: Otroška psoriaza v plakih (starost 6 let in več)
English: Do NOT shake the vial.
Slovenian: NE stresajte viale.
English: Use in children and adolescents
Slovenian: Uporaba pri otrocih in mladostnikih
English: Other medicines and LIFMIOR
Slovenian: Druga zdravila in zdravilo LIFMIOR
English: If active tuberculosis is diagnosed, LIFMIOR therapy must not be initiated.
Slovenian: Če je postavljena diagnoza aktivne tuberkuloze, se zdravljenja z zdravilom LIFMIOR ne sme uvesti.
English: During the withdrawal period, symptoms of psoriasis gradually returned, with a median time to disease relapse of 3 months.
Slovenian: Med odtegnitvenim obdobjem so se simptomi psoriaze postopoma znova pojavili; mediani čas do recidiva bolezni je bil 3 mesece.
English: Wegener's granulomatosis
Slovenian: Wegenerjeva granulomatoza
English: No data are available on the secondary transmission of infection by live vaccines in patients receiving LIFMIOR.
Slovenian: Podatkov o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, ki prejemajo zdravilo LIFMIOR, ni na voljo.
English: Your doctor or nurse will tell you how to inject LIFMIOR.
Slovenian: Zdravnik ali medicinska sestra vas bosta natančno poučila, kako si injicirate zdravilo LIFMIOR.
English: In a group of 2,711 plaque psoriasis patients treated with LIFMIOR in double-blind and open-label studies of up to 2.5 years, 30 malignancies and 43 nonmelanoma skin cancers were reported.
Slovenian: V skupini 2.711 bolnikov s psoriazo v plakih, zdravljenih z zdravilom LIFMIOR v dvojno slepih in odprtih študijah, ki so trajale do 2,5 leta, so poročali o 30 malignomih in 43 primerih nemelanomskega kožnega raka.
English: The study evaluated 234 adult patients with active rheumatoid arthritis who had failed therapy with at least one but no more than four disease-modifying antirheumatic drugs (DMARDs).
Slovenian: V študijo je bilo vključenih 234 odraslih bolnikov z aktivnim revmatoidnim artritisom, ki so bili pred tem neuspešno zdravljeni vsaj z enim, a ne več kot 4 imunomodulirajočimi antirevmatičnimi zdravili (DMARD - Disease-Modifying AntiRheumatic Drug).
English: Treatment with LIFMIOR should not be initiated in patients with active infections, including chronic or localised infections.
Slovenian: Zdravljenja z zdravilom LIFMIOR ne smete uvesti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi okužbami.
English: • Instructional materials to share with patients
Slovenian: • gradivo z navodili za bolnike
English: Consequently, LIFMIOR should not be used in patients for the treatment of alcoholic hepatitis.
Slovenian: Zato zdravila LIFMIOR ne smemo uporabljati pri bolnikih za zdravljenje alkoholnega hepatitisa.
English: If LIFMIOR has no effect on the child's condition after 12 weeks, your doctor may tell you to stop using this medicine.
Slovenian: Če zdravilo LIFMIOR po 12 tednih nima nobenega učinka na otrokovo stanje, vam bo zdravnik morda naročil, da prenehajte uporabljati to zdravilo.
English: A different site should be used for each new injection.
Slovenian: Za vsako naslednjo injekcijo morate uporabiti drugo mesto.
English: While neutropenic, one patient developed cellulitis that resolved after hospitalisation (see sections 4.4 and 4.5).
Slovenian: Med nevtropenijo se je pri enem bolniku pojavil celulitis, ki je po hospitalizaciji izzvenel (glejte poglavji 4.4 in 4.5).
English: LIFMIOR (n = 223)
Slovenian: zdravilo LIFMIOR (n = 223)
English: Although no clinical trials have been performed evaluating LIFMIOR therapy in patients with multiple sclerosis, clinical trials of other TNF antagonists in patients with multiple sclerosis have shown increases in disease activity.
Slovenian: Čeprav niso opravili kliničnih preskušanj za ovrednotenje zdravljenja z zdravilom LIFMIOR pri bolnikih z multiplo sklerozo, so klinična preskušanja drugih antagonistov TNF pri teh bolnikih pokazala zvečano aktivnost bolezni.
English: In a pooled data set of clinical trials, the overall incidence of opportunistic infections was 0.09% for the 15,402 subjects who received LIFMIOR.
Slovenian: V združeni zbirki podatkov iz kliničnih preskušanj je bila celokupna pojavnost oportunističnih okužb pri 15.402 bolnikih, ki so prejeli LIFMIOR, 0,09 %.
English: • For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked well enough or is not suitable for them:
Slovenian: • za zdravljenje naslednjih tipov juvenilnega idiopatskega artritisa, če zdravljenje z metotreksatom ni bilo uspešno ali ga bolniki niso prenašali:
English: Clinical improvement, including onset of action within 2 weeks with LIFMIOR 25 mg, was similar to that seen in the previous trials and was maintained for up to 24 months.
Slovenian: Klinično izboljšanje, vključno z nastopom delovanja zdravila v 2 tednih pri 25 mg zdravila LIFMIOR, je bilo podobno tistemu, ki so ga ugotavljali v prejšnjih preskušanjih, in se je ohranjalo do 24 mesecev.
English: Method of administration LIFMIOR is administered by subcutaneous injection (see section 6.6).
Slovenian: Način uporabe Zdravilo LIFMIOR se daje s subkutano injekcijo (glejte poglavje 6.6).
English: Skin cancers
Slovenian: Kožni rak
English: The doctor will provide you with detailed directions for preparing and measuring the appropriate dose.
Slovenian: Otrokov zdravnik vam bo natančno pojasnil, kako pripraviti in odmeriti primeren odmerek.
English: • if you or the child have an infection of any kind.
Slovenian: če imate vi ali otrok kakršnokoli okužbo.
English: You should consult your doctor if you become pregnant, think you may be pregnant, or are planning to have a baby.
Slovenian: Če zanosite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom.
English: If LIFMIOR has no effect on your condition after 12 weeks, your doctor may tell you to stop taking this medicine.
Slovenian: Če zdravilo LIFMIOR po 12 tednih nima nobenega učinka na vašo bolezen, vam zdravnik lahko naroči, da to zdravilo nehate uporabljati.
English: Efficacy Response in Placebo-Controlled nr-AxSpa Study: Percent of Patients Achieving Endpoints
Slovenian: Odziv glede učinkovitosti v s placebom nadzorovani študiji nr-AxSpa: Odstotek bolnikov, ki so dosegli opazovane dogodke
English: If you have questions about how to inject, please ask your doctor or nurse for help.
Slovenian: Če imate vprašanja o tem, kako injicirati, prosite za pomoč zdravnika ali medicinsko sestro.
English: In placebo-controlled trials, no increase in the incidence of serious infections (fatal, life threatening, or requiring hospitalisation or intravenous antibiotics) was observed.
Slovenian: V preskušanjih, nadzorovanih s placebom, niso opazili zvečanja pojavnosti resnih okužb (s smrtnim izidom, življenjsko ogrožajočih okužb ali takih, ki so zahtevale hospitalizacijo ali intravenske antibiotike).
English: In a group of 7,416 patients treated with LIFMIOR in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials, 18 lymphomas were reported.
Slovenian: V skupini 7.416 bolnikov, zdravljenih z zdravilom LIFMIOR v kliničnih preskušanjih revmatoidnega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa in psoriaze, so poročali o 18 limfomih.