FrancophonIA/ELRC3.0 huggingface dataset:
English: In the double-blind periods of controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of adverse events of elevated liver enzymes was 4.18% (frequency common).
Slovenian: V dvojno slepih obdobjih nadzorovanih kliničnih preskušanj, v katerih je bilo dovoljeno sočasno zdravljenje z etanerceptom in metotreksatom, je bila pogostnost (delež pojavnosti) neželenih učinkov zvečanih vrednosti jetrnih encimov 4,18 % (pogostnost: pogosti).
English: The efficacy of LIFMIOR was assessed in a randomised, double-blind, placebo-controlled study.
Slovenian: Učinkovitost zdravila LIFMIOR je bila ugotovljena v randomizirani, dvojno slepi klinični študiji, nadzorovani s placebom.
English: Do NOT rub the injection site.
Slovenian: Mesta injiciranja NE masirajte.
English: Do not rub the injection site.
Slovenian: Mesta injiciranja ne masirajte.
English: For polyarthritis or extended oligoarthritis in patients from the age of 2 years, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12 years, the usual dose is 0.4 mg of LIFMIOR per kg bodyweight (up to a maximum of 25 mg) given twice weekly, or 0.8 mg of LIFMIOR per kg bodyweight (up to a maximum of 50 mg) given once weekly.
Slovenian: Običajni odmerek zdravila LIFMIOR za zdravljenje poliartritisa ali razširjenega oligoartritisa pri bolnikih, starejših od 2 let, in za zdravljenje artritisa, povezanega z entezitisom, ali psoriatičnega artritisa pri bolnikih, starejših od 12 let, je 0,4 mg na kg telesne mase (do največ 25 mg) dvakrat na teden ali 0,8 mg na kg telesne mase (do največ 50 mg) enkrat na teden.
English: Re-introduction of treatment with LIFMIOR after discontinuation of up to 24 months resulted in the same magnitudes of responses as patients who received LIFMIOR without interruption of therapy based on results of open-label studies.
Slovenian: Po podatkih iz odprtih študij so bile velikosti odziva po ponovni uvedbi zdravljenja z zdravilom LIFMIOR po prekinitvah, ki so trajale do 24 mesecev, enake kot pri bolnikih, ki so prejemali zdravilo LIFMIOR brez prekinitve zdravljenja.
English: Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Slovenian: Zdravljenje psoriatičnega artritisa pri mladostnikih, starih 12 let ali več, ki so se nezadostno odzvali na zdravljenje z metotreksatom ali ga niso prenašali.
English: The mean serum steady state trough concentrations ranged from 1.6 to 2.1 mcg/ml at weeks 12, 24, and 48.
Slovenian: Povprečne najnižje serumske koncentracije v stanju dinamičnega ravnovesja so se v 12., 24. in 48. tednu gibale med 1,6 in 2,1 µg/ml.
English: ASAS 50 2 weeks
Slovenian: ASAS 50 2 tedna 3 meseci 6 mesecev a
English: Talk to your doctor before taking LIFMIOR.
Slovenian: Pred začetkom uporabe zdravila LIFMIOR se posvetujte z zdravnikom.
English: There were 4 reports of macrophage activation syndrome in juvenile idiopathic arthritis clinical trials.
Slovenian: V kliničnih preskušanjih pri bolnikih z juvenilnim idiopatskim artritisom so poročali o 4 primerih sindroma aktivacije makrofagov.
English: LIFMIOR 0.8 mg/kg Once Weekly (N = 106)
Slovenian: Rezultati po 12 tednih pri otrocih s psoriazo v plakih LIFMIOR 0,8 mg/kg enkrat na teden (n = 106)
English: The other ingredients in LIFMIOR are: Powder: Mannitol, sucrose and trometamol.
Slovenian: Pomožne snovi v zdravilu LIFMIOR so: prašek: manitol, saharoza in trometamol; vehikel: voda za injekcije.
English: There is insufficient evidence of the efficacy of LIFMIOR in patients with ankylosing spondylitis-like and arthritis mutilans psoriatic arthropathies due to the small number of patients studied.
Slovenian: Zaradi majhnega števila proučevanih bolnikov ni zadostnih dokazov glede učinkovitosti zdravila LIFMIOR pri bolnikih s psoriatičnimi artropatijami, podobnimi ankilozirajočemu spondilitisu, in z artritisom mutilansom.
English: In a population pharmacokinetics analysis in ankylosing spondylitis patients, the etanercept steady state AUCs were 466 μg•hr/ml and 474 μg•hr/ml for 50 mg LIFMIOR once weekly (N= 154) and 25 mg twice weekly (N = 148), respectively.
Slovenian: Pri analizi populacijske farmakokinetike pri bolnikih z ankilozirajočim spondilitisom so vrednosti AUC etanercepta v stanju dinamičnega ravnovesja pri uporabi zdravila LIFMIOR v odmerku 50 mg enkrat na teden (n = 154) znašale 466 μg·h/ml, pri uporabi zdravila LIFMIOR v odmerku 25 mg dvakrat na teden (n = 148) pa 474 μg·h/ml.
English: Allergic reactions associated with LIFMIOR administration have been reported commonly.
Slovenian: V povezavi z uporabo zdravila LIFMIOR so pogosto poročali o alergijskih reakcijah.
English: • Remove the paper backing from the vial adaptor package.
Slovenian: Odstranite papirnato prevleko embalaže, v kateri je adapter za vialo.
English: Diagram 16
Slovenian: Slika 16
English: • if the child has, or is at risk of developing a serious blood infection called sepsis.
Slovenian: če ima otrok resno okužbo krvi (sepso) ali če pri otroku obstaja tveganje za njen pojav.
English: Diagram 12
Slovenian: Slika 12
English: No study has been performed in patients with psoriatic arthritis using the 50 mg once weekly dosing regimen.
Slovenian: Pri bolnikih s psoriatičnim artritisom klinične študije z režimom odmerjanja 50 mg enkrat na teden niso izvedli.
English: The instructions below explain how to use the MYCLIC pen to inject LIFMIOR.
Slovenian: V tem navodilu je opisana uporaba injekcijskega peresnika MYCLIC za injiciranje zdravila LIFMIOR.
English: Antibodies to LIFMIOR
Slovenian: Protitelesa proti zdravilu LIFMIOR
English: Antibodies to etanercept have been detected in the sera of some subjects treated with etanercept.
Slovenian: V serumu nekaterih bolnikov, zdravljenih z etanerceptom, so odkrili protitelesa proti etanerceptu.
English: Interstitial lung disease (including pneumonitis and pulmonary fibrosis)*
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora intersticijska bolezen pljuč (vključno s pnevmonitisom in pljučno fibrozo)*
English: Diagram 11
Slovenian: Slika 11
English: You should allow 15 to 30 minutes for the LIFMIOR solution in the syringe to reach room temperature.
Slovenian: Počakajte 15 do 30 minut, da se raztopina zdravila LIFMIOR v brizgi segreje na sobno temperaturo.
English: If you have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin.
Slovenian: Če imate luskavico, se morate izogibati neposrednemu injiciranju v vsa privzdignjena, zadebeljena, rdeča ali luskava območja kože.
English: This new expiry date should not exceed the expiry date recorded on the outer carton.
Slovenian: Nov datum uporabe zdravila ne sme biti daljši od izteka roka uporabnosti zdravila, navedenega na zunanji ovojnini.
English: The solution is clear, and colourless to pale yellow or pale brown.
Slovenian: Raztopina je bistra in brezbarvna do bledo rumena oziroma bledo rjava.
English: Among patients with psoriatic arthritis who received LIFMIOR, the clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.
Slovenian: Med bolniki s psoriatičnim artritisom, ki so prejemali zdravilo LIFMIOR, so bili klinični odzivi vidni že pri prvem obisku (po 4 tednih) in so se ohranjali vseh 6 mesecev zdravljenja.
English: Thus the combined use of LIFMIOR and anakinra is not recommended (see sections 4.5 and 4.8).
Slovenian: Ta kombinacija ni pokazala povečane klinične koristi, zato uporaba zdravila LIFMIOR skupaj z anakinro ni priporočljiva (glejte poglavji 4.5 in 4.8).
English: After preparing the LIFMIOR solution, immediate use is recommended.
Slovenian: Priporočljivo je, da pripravljeno raztopino zdravila LIFMIOR nemudoma uporabite.
English: • Cancer: Tell your doctor if the child has or has ever had lymphoma (a type of blood cancer) or any other cancer before the child is given LIFMIOR.
Slovenian: Rak: Preden bo vaš otrok prejel zdravilo LIFMIOR, povejte zdravniku, če ima ali je vaš otrok imel limfom (vrsta krvnega raka) ali drugo obliko raka.
English: 4 pre-filled syringes of 1 ml solvent 4 stainless steel injection needles 4 vial adaptors
Slovenian: 4 napolnjene injekcijske brizge z 1 ml vehikla 4 igle iz nerjavečega jekla 4 adapterji za viale
English: Diagram 9
Slovenian: Slika 9
English: Mean serum concentration profiles at steady state in treated RA patients were Cmax of 2.4 mg/l vs. 2.6 mg/l, Cmin of 1.2 mg/l vs. 1.4 mg/l, and partial AUC of 297 mgh/l vs. 316 mgh/l for 50 mg LIFMIOR once weekly (n=21) vs. 25 mg LIFMIOR twice weekly (n=16), respectively.
Slovenian: Pri bolnikih z revmatoidnim artritisom so bile povprečne koncentracije v serumu v stanju dinamičnega ravnovesja naslednje: pri zdravljenju z zdravilom LIFMIOR v odmerku 50 mg enkrat na teden (n = 21) je vrednost Cmax znašala 2,4 mg/l, vrednost Cmin 1,2 mg/l, delna AUC pa 297 mg·h/l, pri zdravljenju z zdravilom LIFMIOR v odmerku 25 mg dvakrat na teden (n = 16) pa je vrednost Cmax znašala 2,6 mg/l, vrednost Cmin 1,4 mg/l, delna AUC pa 316 mg·h/l.
English: • Anti-diabetic medicines: Tell your doctor if you or the child have diabetes or are taking medicines to treat diabetes.
Slovenian: Zdravila za zdravljenje sladkorne bolezni: Povejte zdravniku, če imate vi ali otrok sladkorno bolezen, ali če kateri od vaju jemlje zdravila za zdravljenje sladkorne bolezni.
English: Using the MYCLIC pre-filled pen to inject LIFMIOR (See overleaf)
Slovenian: Uporaba napolnjenega injekcijskega peresnika MYCLIC za injiciranje zdravila LIFMIOR (glejte drugo stran navodila)
English: With experience, you will find the angle that is most comfortable for the child. Be careful not to push the needle into the skin too slowly, or with great force.
Slovenian: Pazite, da igle v kožo ne potisnete prepočasi ali z veliko silo.
English: Diagram 7
Slovenian: Slika 7
English: The needle cap of the pre-filled pen contains latex (dry natural rubber) that may cause hypersensitivity reactions when handled by or when LIFMIOR is administered to persons with known or possible latex sensitivity.
Slovenian: Pokrovček igle napolnjenega injekcijskega peresnika vsebuje lateks (posušen naravni kavčuk), ki lahko povzroči preobčutljivostne reakcije, če z zdravilom LIFMIOR ravna oseba z znano ali možno preobčutljivostjo na lateks ali če ga damo taki osebi.
English: LIFMIOR 10 mg powder and solvent for solution for injection for paediatric use is supplied as a white powder with solvent for solution for injection (powder for injection).
Slovenian: Zdravilo LIFMIOR 10 mg prašek in vehikel za raztopino za injiciranje za uporabo pri otrocih je na voljo v obliki belega praška in vehikla za raztopino za injiciranje (prašek za injekcijo).
English: CARTON TEXT - EU/1/16/1165/002-004
Slovenian: BESEDILO NA NALEPKI VIALE - EU/1/16/1165/002-004
English: Diagram 10
Slovenian: Slika 10
English: For rheumatoid arthritis, LIFMIOR is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is unsuitable for you.
Slovenian: Pri zdravljenju revmatoidnega artritisa se zdravilo LIFMIOR običajno uporablja skupaj z metotreksatom.
English: Diagram 19
Slovenian: Slika 19
English: Disposing of supplies a. Introduction
Slovenian: Odstranjevanje odpadkov a.
English: 50 mg solution for injection in pre-filled syringe EU/1/16/1165/008
Slovenian: 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/16/1165/008
English: Diagram 13
Slovenian: Slika 13
English: 25 mg solution for injection in pre-filled syringe EU/1/16/1165/005
Slovenian: 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/16/1165/005
English: In study 1, the LIFMIOR-treated group had a significantly higher proportion of patients with a PASI 75 response at week 12 (30%) compared to the placebo-treated group (2%) (p<0.0001).
Slovenian: V študiji 1 je bil v 12. tednu delež bolnikov z odzivom PASI 75 pomembno večji v skupini, zdravljeni z zdravilom LIFMIOR (30 %), kot v skupini, ki je dobivala placebo (2 %) (p  0,0001).
English: The usual dose is 25 mg twice a week or 50 mg once a week.
Slovenian: Običajni odmerek je 25 mg dvakrat na teden ali 50 mg enkrat na teden.
English: If you or the child have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches (“psoriasis skin lesions”).
Slovenian: Če imate vi ali otrok luskavico, se morate izogibati neposrednemu injiciranju v vsa privzdignjena, zadebeljena, rdeča ali luskava območja na koži ('psoriatične kožne spremembe').
English: Clinical Efficacy Results at 12 Months: Comparison of LIFMIOR vs Methotrexate vs LIFMIOR in Combination with Methotrexate in Patients with RA of 6 Months To 20 Years Duration
Slovenian: Rezultati klinične učinkovitosti po 12 mesecih: primerjava med zdravilom LIFMIOR, metotreksatom in kombinacijo zdravila LIFMIOR in metotreksata pri bolnikih z RA, ki je trajal 6 mesecev do 20 let
English: If any of the following happen, do not inject more LIFMIOR.
Slovenian: Če se pojavi karkoli od naslednjega, zdravila LIFMIOR ne smete več uporabljati.
English: Responses of Patients with Ankylosing Spondylitis in a Placebo-Controlled Trial Percent of Patients
Slovenian: Odzivi bolnikov z ankilozirajočim spondilitisom v preskušanju, nadzorovanem s placebom Odstotek bolnikov
English: Always leave the pen out of sight and reach of children.
Slovenian: Peresnik naj bo vedno nedosegljiv otrokom!
English: Each pack contains 4, 8 or 24 single dose vials, 4, 8 or 24 pre-filled syringes of water for injections, 4, 8 or 24 needles, 4, 8 or 24 vial adaptors and 8, 16 or 48 alcohol swabs.
Slovenian: Eno pakiranje vsebuje 4, 8 ali 24 enoodmernih vial, 4, 8 ali 24 napolnjenih injekcijskih brizg z vodo za injekcije, 4, 8 ali 24 igel, 4, 8 ali 24 adapterjev za viale in 8, 16 ali 48 alkoholnih blazinic.
English: Remove the needle cover by firmly pulling it straight off the syringe (see Diagram 2).
Slovenian: S potegom naravnost proč od brizge odstranite pokrovček igle z injekcijske brizge (glejte sliko 2).
English: Adults
Slovenian: Starostniki
English: Wipe the site where LIFMIOR is to be injected with the alcohol swab, using a circular motion.
Slovenian: Mesto, kjer nameravate vbrizgati zdravilo LIFMIOR, s krožnim gibom obrišite z alkoholno blazinico.
English: The usual dose is 25 mg given twice a week or 50 mg once a week as an injection under the skin.
Slovenian: Običajni odmerek je 25 mg dvakrat na teden ali 50 mg enkrat na teden v obliki podkožne injekcije.
English: Preparing the LIFMIOR dose for injection d. Adding solvent e.
Slovenian: Priprava odmerka zdravila LIFMIOR za injiciranje d.
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: In study 4, the LIFMIOR-treated group had a higher proportion of patients with PASI 75 at week 12 (38%) compared to the placebo-treated group (2%) (p<0.0001).
Slovenian: V študiji 4 je bil v 12. tednu delež bolnikov z odzivom PASI 75 večji v skupini, zdravljeni z zdravilom LIFMIOR (38 %), kot v skupini, ki je dobivala placebo (2 %) (p < 0,0001).
English: LIFMIOR 25 mg is supplied as a white powder and solvent for solution for injection (powder for injection).
Slovenian: Zdravilo LIFMIOR 25 mg je na voljo v obliki belega praška in vehikla za raztopino za injiciranje (prašek za injekcijo).
English: Paediatric patients with juvenile idiopathic arthritis
Slovenian: Otroci z juvenilnim idiopatskim artritisom
English: 4 MYCLIC pre-filled pens 4 alcohol swabs
Slovenian: 4 napolnjeni injekcijski peresniki MYCLIC 4 alkoholne blazinice
English: CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including GuillainBarré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure
Slovenian: Bolezni živčevja demielinizirajoči pojavi v CŽS, ki kažejo na multiplo sklerozo, ali lokalizirana demielinizirajoča stanja, kot sta optični nevritis in transverzni mielitis (glejte poglavje 4.4), demielinizacija perifernega živčevja, vključno z GuillainBarréjevim sindromom, kronično vnetno demielinizirajočo polinevropatijo, demielinizirajočo polinevropatijo in multifokalno motorično nevropatijo (glejte poglavje 4.4), epileptični napad
English: Cartons contain 4 vials of LIFMIOR, 4 pre-filled syringes of water for injections, 4 needles, 4 vial adaptors and 8 alcohol swabs.
Slovenian: Ena škatla vsebuje 4 viale zdravila LIFMIOR, 4 napolnjene injekcijske brizge z vodo za injekcije, 4 injekcijske igle, 4 adapterje za vialo in 8 alkoholnih blazinic.
English: In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, 43 of 69 (62%) children experienced an infection while receiving LIFMIOR during 3 months of the study (part 1, open-label), and the frequency and severity of infections was similar in 58 patients completing 12 months of open-label extension therapy.
Slovenian: V eni študiji pri otrocih z juvenilnim idiopatskim artritisom, starih od 4 do 17 let, se je pri 43 od 69 otrok (62 %) med trimesečnim zdravljenjem z zdravilom LIFMIOR v času študije (prvi del, odprta) pojavila okužba.
English: Continued durable responses have been seen for up to 10 years in open-label extension treatment trials when patients received LIFMIOR without interruption.
Slovenian: Dolgotrajna odzivnost na neprekinjeno zdravljenje z zdravilom LIFMIOR je bila v odprtih podaljšanih kliničnih preskušanjih potrjena za obdobja do 10 let.
English: • Hepatitis B: Tell your doctor if the child has or has ever had hepatitis B. Your doctor should test for the presence of hepatitis B infection before the child begins treatment with LIFMIOR.
Slovenian: Hepatitis B: Povejte zdravniku, če ima ali je vaš otrok kdaj imel hepatitis B. Preden se bo vaš otrok začel zdraviti z zdravilom LIFMIOR, mora zdravnik opraviti test prisotnosti okužbe s hepatitisom B. Pri bolnikih, ki so kdaj že bili okuženi z virusom hepatitisa B, lahko zdravljenje z zdravilom LIFMIOR povzroči ponoven zagon hepatitisa B. V takem primeru morate zdravilo LIFMIOR prenehati uporabljati.
English: Radiographic Progression: Comparison of LIFMIOR vs Methotrexate vs LIFMIOR in Combination with Methotrexate in Patients with RA of 6 Months To 20 Years Duration (12 Month Results)
Slovenian: Radiografsko napredovanje: primerjava med zdravilom LIFMIOR, metotreksatom in kombinacijo zdravila LIFMIOR in metotreksata pri bolnikih z RA, ki je trajal 6 mesecev do 20 let (rezultati pri 12 mesecih)
English: In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 24 months was higher in the LIFMIOR in combination with methotrexate group compared with the LIFMIOR alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p<0.05).
Slovenian: Odstotek bolnikov brez napredovanja (sprememba TSS ≤ 0,5) je bil po 24 mesecih večji v skupini, ki je dobivala zdravilo LIFMIOR v kombinaciji z metotreksatom, kakor v skupinah, ki sta dobivali zdravilo LIFMIOR ali metotreksat v monoterapiji (62 %, 50 % in 36 %, p < 0,05).
English: In part 2, patients with a clinical response at day 90 were randomised to remain on LIFMIOR or receive placebo for four months and assessed for disease flare.
Slovenian: V drugem delu študije pa so bolnike s kliničnim odzivom na zdravilo LIFMIOR na 90. dan randomizirali v dve podskupini: ena je nadaljevala zdravljenje z zdravilom LIFMIOR, druga pa je nadaljnje štiri mesece prejemala placebo - pri obeh so ocenjevali ponoven izbruh bolezni.
English: Autoimmune hepatitis
Slovenian: Avtoimunski hepatitis
English: A dose response was seen; results with 10 mg were intermediate between placebo and 25 mg. LIFMIOR was significantly better than placebo in all components of the ACR criteria as well as other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness.
Slovenian: Rezultati za zdravilo LIFMIOR so bili statistično pomembno boljši od placeba po vseh kriterijih ACR, prav tako pa tudi po tistih merilih aktivnosti revmatoidnega artritisa, ki v kriterije odziva po ACR niso vključeni, na primer jutranja okorelost.
English: LIFMIOR should be used with caution in patients with a history of hepatitis C.
Slovenian: Pri bolnikih z anamnezo hepatitisa C morate LIFMIOR uporabljati previdno.
English: Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling)*
Slovenian: Splošne težave in spremembe na mestu aplikacije reakcije na mestu injiciranja (vključno s krvavitvijo, podplutbami, eritemom, srbenjem, bolečino in oteklino)*
English: No treatment was given for the majority of injection site reactions in the LIFMIOR treatment groups, and the majority of patients who were given treatment received topical preparations, such as corticosteroids, or oral antihistamines.
Slovenian: Večina bolnikov, pri katerih je zdravljenje le bilo potrebno, pa je prejela lokalna zdravila, npr. kortikosteroide, ali peroralne antihistaminike.
English: 12 MYCLIC pre-filled pens 12 alcohol swabs
Slovenian: 12 napolnjenih injekcijskih peresnikov MYCLIC 12 alkoholnih blazinic
English: Serious allergic reactions (including severe localised swelling of the skin and wheezing); lymphoma (a type of blood cancer); leukaemia (cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); combined low platelet, red, and white blood cell count; nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; new onset congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and tiredness); skin rash, which may lead to severe blistering and peeling of the skin; lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes); inflammation of the liver caused by the body's own immune system (autoimmune hepatitis; in patients also receiving methotrexate treatment, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also receiving methotrexate treatment, the frequency of inflammation or scarring of the lungs is uncommon).
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): resne alergijske reakcije (vključno s hudim lokaliziranim otekanjem kože in piskajočim dihanjem); limfom (vrsta krvnega raka); levkemija (rak, ki prizadene kri in kostni mozeg); melanom (vrsta kožnega raka); kombinacija znižanja števila trombocitov in rdečih ter belih krvnih celic; motnje živčevja (s hudo mišično oslabelostjo ter z znaki in simptomi, podobnimi multipli sklerozi ali vnetje očesnih živcev ali hrbtenjače); tuberkuloza; nastanek kongestivnega srčnega popuščanja; epileptični napadi; lupus ali lupusu podoben sindrom (med simptomi so lahko trdovraten izpuščaj, vročina, bolečine v sklepih in utrujenost); kožni izpuščaj, ki lahko povzroči močno mehurjenje in luščenje kože; lihenoidne reakcije (srbeč rdeče-vijoličast kožni izpuščaj in/ali belo-sive nitaste črte na sluznicah); vnetje jeter, ki je posledica delovanja imunskega sistema proti tkivu lastnega telesa (avtoimunski hepatitis; pri bolnikih, ki sočasno prejemajo metotreksat, je občasen); imunska bolezen, ki lahko prizadene pljuča, kožo in bezgavke (sarkoidoza); vnetje ali brazgotinjenje pljuč (pri bolnikih, ki sočasno prejemajo metotreksat, je vnetje ali brazgotinjenje pljuč občasno).
English: Among patients with ankylosing spondylitis who received LIFMIOR, the clinical responses were apparent at the time of the first visit (2 weeks) and were maintained through 6 months of therapy.
Slovenian: Med bolniki z ankilozirajočim spondilitisom, ki so prejemali zdravilo LIFMIOR, so bili klinični odzivi vidni že pri prvem obisku (po 2 tednih) in so se ohranjali ves čas 6 mesecev zdravljenja.