FrancophonIA/ELRC3.0 huggingface dataset:
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 etanercept in combination with methotrexate group compared with the etanercept 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 etanercept v kombinaciji z metotreksatom, kakor v skupinah, ki sta dobivali etanercept ali metotreksat v monoterapiji (62 %, 50 % in 36 %, p < 0,05).
English: Among patients with ankylosing spondylitis who received etanercept, 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 etanercept, so bili klinični odzivi vidni že pri prvem obisku (po 2 tednih) in so se ohranjali vseh 6 mesecev zdravljenja.
English: Some vaccines, such as oral polio vaccine, should not be given while using Benepali.
Slovenian: Med zdravljenjem z zdravilom Benepali nekaterih cepiv, npr. peroralnega cepiva proti otroški paralizi, ni dovoljeno uporabljati.
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: • Do not use heat sources, such as a microwave or hot water, to warm Benepali.
Slovenian: • Za ogrevanje zdravila Benepali ne uporabljajte virov toplote.
English: Among patients with plaque psoriasis who received etanercept, significant responses relative to placebo were apparent at the time of the first visit (2 weeks) and were maintained through 24 weeks of therapy.
Slovenian: Med bolniki s psoriazo v plakih, ki so dobivali etanercept, je bil pomemben odziv v primerjavi s placebom opazen na prvem pregledu (po 2 tednih) in se je ohranil skozi 24 tednov zdravljenja.
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
Slovenian: Opravljena je bila analiza, v kateri so vse bolnike, ki so iz kakršnega koli razloga izpadli iz študije, obravnavali, kot da jim je bolezen napredovala.
English: 2 to 18 years with juvenile idiopathic arthritis, 39 of whom were 2 to 3 years of age.
Slovenian: 39 otrok je bilo starih od 2 do 3 leta.
English: A.
Slovenian: Ab,
English: Renal and hepatic impairment No dose adjustment is required.
Slovenian: Pri bolnikih z okvaro jeter odmerka ni treba prilagajati.
English: distal interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis like ankylosis.
Slovenian: Starost bolnikov je bila od 18 do 70 let in vsi so imeli aktivni psoriatični artritis (≥ 3 otekli sklepi in ≥ 3 občutljivi sklepi) v najmanj eni od naslednjih oblik: (1) distalna interfalangealna prizadetost (DIP); (2) poliartikularni artritis (odsotnost revmatoidnih nodulov in prisotnost psoriaze); (3) artritis mutilans; (4) asimetrični psoriatični artritis ali (5) spondilitisu podobna ankiloza.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (25 mg PRE-FILLED SYRINGE)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (25 mg NAPOLNJENA INJEKCIJSKA BRIZGA)
English: After taking a syringe from the refrigerator, wait approximately 30 minutes to allow the Benepali solution in the syringe to reach room temperature.
Slovenian: Ko napolnjeno injekcijsko brizgo vzamete iz hladilnika, počakajte približno 30 minut, da se raztopina zdravila Benepali v brizgi segreje na sobno temperaturo.
English: The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of etanercept in adult patients with rheumatoid arthritis, and the majority were mild.
Slovenian: Neželeni učinki pri bolnikih z juvenilnim idiopatskim artritisom so bili po vrstah in deležih podobni tistim, opisanim v preskušanjih enteracepta pri odraslih bolnikih z revmatoidnim artritisom.
English: Etanercept 0.8 mg/kg Once Weekly (N = 106)
Slovenian: 0,8 mg/kg enkrat na teden
English: Τηλ: + 357 22 00 04 93
Slovenian: Genesis Pharma S.A. Τηλ: + 357 22 00 04 93
English: Elevated liver enzymes*
Slovenian: žolčnika in žolčevodov zvišane vrednosti jetrnih encimov*
English: The recommended dose of etanercept is 50 mg administered once weekly.
Slovenian: Priporočeni odmerek je 50 mg etanercepta enkrat na teden.
English: Cases of active tuberculosis, including miliary tuberculosis and tuberculosis with extra-pulmonary location, have been reported in patients treated with etanercept.
Slovenian: Pri bolnikih, zdravljenih z etanerceptom, so poročali o primerih aktivne tuberkuloze, vključno z miliarno tuberkulozo in ekstrapulmonarno tuberkulozo.
English: Firmly press the pre-filled pen down into the site to start the injection.
Slovenian: Za začetek injiciranja čvrsto pritisnite napolnjen injekcijski peresnik na mesto injiciranja.
English: Women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during Benepali therapy and for three weeks after discontinuation of therapy.
Slovenian: Nosečnost in dojenje Ženskam v rodni dobi je treba svetovati, naj uporabljajo ustrezno kontracepcijo, da med zdravljenjem z zdravilom Benepali in še tri tedne po njem ne zanosijo.
English: Rotate the site for each injection.
Slovenian: Za vsako injiciranje izberite drugo mesto.
English: Serious and fatal infections have been reported during use of etanercept; reported pathogens include bacteria, mycobacteria (including tuberculosis), viruses and fungi.
Slovenian: Med povzročitelji, o katerih so poročali, so bile bakterije, mikobakterije (vključno s tuberkulozo), virusi in glivice.
English: Women using Benepali should not breast-feed, since Benepali passes into human breast milk.
Slovenian: Zdravilo Benepali prehaja v materino mleko, zato bolnice med zdravljenjem z zdravilom Benepali ne smejo dojiti.
English: Pancytopenia* Aplastic anaemia*
Slovenian: aplastična anemija*
English: Keep the pre-filled syringes or pens in the outer carton in order to protect from light.
Slovenian: Shranjujte v napolnjeni injekcijski brizgi ali peresniku v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Benepali is available in packs containing 4 pre-filled syringes, multipacks comprising 2 cartons, each containing 4 pre-filled syringes and multipacks comprising 6 cartons, each containing 4 pre-filled syringes.
Slovenian: Zdravilo Benepali je na voljo v pakiranjih, ki vsebujejo 4 napolnjene injekcijske brizge, večodmernih pakiranjih, ki vsebujejo 2 škatli, od katerih vsaka vsebuje 4 napolnjene injekcijske brizge in večodmernih pakiranjih, ki vsebujejo 6 škatel, od katerih vsaka vsebuje 4 napolnjene injekcijske brizge.
English: A 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg.
Slovenian: Pri otrocih z juvenilnim idiopatskim artritisom, ki imajo telesno maso manjšo od 25 kg, bo morda primernejša uporaba 10 mg viale.
English: Serious infections (including pneumonia, cellulitis, arthritis bacterial, sepsis and parasitic infection)*
Slovenian: bakterijskim artritisom, sepso in parazitsko okužbo)*
English: Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; low blood platelet count; skin cancer (excluding melanoma); localised swelling of the skin (angioedema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); inflammation of the blood vessels affecting multiple organs; elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common); Abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems.
Slovenian: Resne okužbe (vključno s pljučnico, globokimi okužbami kože, okužbami sklepov, okužbo krvi in okužbami na različnih mestih); poslabšanje kongestivnega srčnega popuščanja; nizko število rdečih krvnih celic, nizko število belih krvnih celic, nizko število nevtrofilcev (vrste belih krvnih celic); nizko število krvnih ploščic; kožni rak (razen melanoma); lokalizirano otekanje kože (angioedem); koprivnica (rdeče ali blede kožne spremembe nad ravnijo kože, ki pogosto srbijo); očesno vnetje; luskavica (na novo nastala ali poslabšanje obstoječe); vnetje krvnih žil, ki negativno vpliva na več organov; zvečane vrednosti jetrnih encimov pri krvnih preiskavah (pri bolnikih, ki sočasno prejemajo metotreksat, so zvečane vrednosti jetrnih encimov pri krvnih preiskavah pogoste); krči in bolečina v trebuhu, driska, izguba telesne mase ali kri v blatu (znaki težav s črevesjem).
English: Congestive heart failure (Cardiac failure congestive) Physicians should use caution when using Benepali in patients who have congestive heart failure (CHF).
Slovenian: Zdravniki morajo biti previdni, kadar predpišejo zdravilo Benepali bolnikom s kongestivnim srčnim popuščanjem (KSP).
English: Benepali 50 mg injection etanercept
Slovenian: Benepali 50 mg injekcija etanercept s.c.
English: Please ask your doctor if you have any questions about this.
Slovenian: Če imate v tej zvezi kakršna koli vprašanja, se posvetujte z zdravnikom.
English: • Blood disorders: Seek medical advice immediately if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness.
Slovenian: • Bolezni krvi: Če se pri vas ali otroku pojavi kateri koli od znakov ali simptomov, kot so trdovratna vročina, vnetje žrela, podplutbe na koži, krvavitve ali bledica, se nemudoma posvetujte s svojim zdravnikom.
English: Patients aged 4 to 17 years with moderately to severely active polyarticular-course juvenile idiopathic arthritis refractory to, or intolerant of, methotrexate were enrolled; patients remained on a stable dose of a single nonsteroidal antiinflammatory drug and/or prednisone (< 0.2 mg/kg/day or 10 mg maximum).
Slovenian: Bolniki so nadaljevali zdravljenje s stalnim odmerkom enega nesteroidnega protivnetnega zdravila in/ali prednizona (< 0,2 mg/kg/dan ali največ 10 mg).
English: There is generally no applicable use of etanercept in children aged below 2 years in the indication juvenile idiopathic arthritis.
Slovenian: Etanercepta se običajno ne uporablja za zdravljenje juvenilnega idiopatskega artritisa pri otrocih,
English: Tell your doctor if you or the child develop any change in the appearance of the skin or growths on the skin.
Slovenian: Pri nekaterih bolnikih, ki so prejemali zdravilo Benepali, se je pojavil kožni rak. Povejte zdravniku, če se pri vas ali otroku razvije kakšna sprememba videza kože ali rašče na koži.
English: Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNFantagonists, including etanercept.
Slovenian: Pri bolnikih, zdravljenih z antagonisti TNF, vključno z etanerceptom, so poročali o melanomu in nemelanomskem kožnem raku (NMSC- Non-Melanoma Skin Cancer).
English: Antibodies to etanercept
Slovenian: Protitelesa proti etanerceptu
English: Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or a dose of 50 mg once weekly.
Slovenian: Alternativno je zdravilo mogoče uporabljati tudi v odmerku 50 mg dvakrat na teden do 12 tednov, čemur po potrebi sledi odmerek 25 mg dvakrat na teden ali odmerek 50 mg enkrat na teden.
English: In a fourth study, the safety and efficacy of 50 mg etanercept (two 25 mg SC injections) administered once weekly vs. 25 mg etanercept administered twice weekly were evaluated in a double-blind, placebo-controlled study of 356 patients with active ankylosing spondylitis.
Slovenian: V četrti, dvojno slepi in s placebom nadzorovani študiji so pri 356 bolnikih z aktivnim ankilozirajočim spondilitisom vrednotili varnost in učinkovitost dajanja etanercepta v odmerku 50 mg enkrat na teden (dve 25 mg subkutani injekciji) v primerjavi z dajanjem etanercepta v odmerku 25 mg dvakrat na teden.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON (50 mg 2 PRE-FILLED SYRINGES) WITHOUT BLUE BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI NOTRANJA ŠKATLA (50 mg 2 NAPOLNJENI INJEKCIJSKI BRIZGI) BREZ BLUE BOX
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 etanercept.
Slovenian: 15.402 bolnikih, ki so prejeli etanercept, 0,09 %.
English: Paediatric Plaque Psoriasis Outcomes at 12 Weeks
Slovenian: Rezultati po 12 tednih pri pediatričnih bolnikih s psoriazo v plakih
English: Paediatric plaque psoriasis
Slovenian: Pediatrična psoriaza v plakih
English: Name and address of the manufacturer of the biological active substance Biogen (Denmark) Manufacturing ApS Biogen Allé 1
Slovenian: Biogen (Denmark) Manufacturing ApS Biogen Allé 1
English: Keep the pre-filled syringes in the outer carton in order to protect from light.
Slovenian: Napolnjene injekcijske brizge shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 50 mg once weekly.
Slovenian: Alternativno je zdravilo mogoče uporabljati tudi v odmerku 50 mg dvakrat na teden do 12 tednov, čemur po potrebi sledi odmerek 50 mg enkrat na teden.
English: Treatment with Benepali may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus.
Slovenian: B, lahko zdravljenje z zdravilom Benepali povzroči ponoven zagon hepatitisa B. V takšnem primeru morate zdravilo Benepali prenehati uporabljati.
English: Benepali 25 mg injection etanercept
Slovenian: Benepali 25 mg injekcija etanercept s.c.
English: Biogen Hungary Kft. Tel.: + 36 (0)6 1 848 04 64
Slovenian: Tel.: + 36 (0)6 1 848 04 64
English: Patient Alert Card Benepali Etanercept
Slovenian: Benepali etanercept
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Slovenian: HBV, je priporočljivo posvetovanje z zdravnikom specialistom za zdravljenje hepatitisa B. Pri dajanju zdravila Benepali bolnikom, ki so že bili okuženi s HBV, je potrebna previdnost.
English: Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate heptahydrate Water for injections
Slovenian: 6.1 Seznam pomožnih snovi saharoza natrijev klorid natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat heptahidrat voda za injekcije
English: A single-use pre-filled syringe contains one 25 mg dose of Benepali.
Slovenian: Napolnjena injekcijska brizga za enkratno uporabo vsebuje en 25-mg odmerek zdravila Benepali.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 12 (3 PACKS OF 4 PRE-FILLED SYRINGES) (WITH BLUE BOX)
Slovenian: VEČODMERNO PAKIRANJE Z 12 (3 PAKIRANJA S PO 4 NAPOLNJENIMI INJEKCIJSKIMI PERESNIKI) (Z BLUE BOX)
English: Solution for injection 4 pre-filled pens
Slovenian: raztopina za injiciranje 4 napolnjeni injekcijski peresniki
English: For psoriasis in patients from the age of 6 years and weighing 62.5 kg or more, the usual dose is 50 mg and should be given once weekly.
Slovenian: Za psoriazo pri bolnikih od 6. leta starosti naprej in s telesno maso 62,5 kg ali več je običajni odmerek
English: C. Injection site care
Slovenian: C. Nega mesta injiciranja
English: Neoplasms benign, malignant and
Slovenian: demielinizirajočo polinevropatijo in multifokalno
English: In this study, most psoriatic arthritis patients receiving etanercept were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine, but titres in aggregate were moderately lower, and few patients had two-fold rises in titres compared to patients not receiving etanercept.
Slovenian: Večina bolnikov s psoriatičnim artritisom, ki so dobivali etanercept, je v tej študiji zmogla učinkovit imunski odziv celic B na polisaharidno cepivo proti pnevmokokom.
English: Immune system disorders
Slovenian: Bolezni imunskega sistema alergijske reakcije
English: The side effects and their frequencies seen in children and adolescents are similar to those described above.
Slovenian: Neželeni učinki pri otrocih in mladostnikih Neželeni učinki pri otrocih in mladostnikih so bili po vrsti in pogostnosti podobni neželenim učinkom,
English: Benepali 25 mg solution for injection in pre-filled syringe.
Slovenian: Benepali 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Each pre-filled syringe contains 25 mg of etanercept.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 25 mg etanercepta.
English: Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with etanercept use.
Slovenian: Pri uporabi etanercepta so poročali o redkih primerih demielinizacije centralnega in zelo redkih primerih demielinizacije perifernega živčevja.
English: Package leaflet: Information for the user Benepali 25 mg solution for injection in pre-filled syringe etanercept This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Benepali 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi etanercept Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Benepali is available in packs containing 4 pre-filled syringes and multipacks containing 12 (3 packs of 4) pre-filled syringes.
Slovenian: Zdravilo Benepali je na voljo v pakiranjih, ki vsebujejo 4 napolnjene injekcijske brizge, in v večodmernih pakiranjih, ki vsebujejo 12 (3 pakiranja s po 4) napolnjenimi injekcijskimi brizgami.
English: Package leaflet: Information for the user Benepali 50 mg solution for injection in pre-filled syringe etanercept This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Benepali 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi etanercept Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: For patients who received 50 mg once weekly throughout the study, the efficacy responses continued to improve with 71% achieving PASI 75 at week 24.
Slovenian: Pri bolnikih, ki so dobivali 50 mg enkrat na teden ves čas študije, so se odzivi glede učinkovitosti še naprej izboljševali,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON (25 mg 2 PRE-FILLED SYRINGES) WITHOUT BLUE BOX
Slovenian: NOTRANJA ŠKATLA (25 mg 2 NAPOLNJENI INJEKCIJSKI BRIZGI) BREZ BLUE BOX
English: • Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because Benepali needs to be used with caution under these circumstances.
Slovenian: • Kongestivno srčno popuščanje: Povejte zdravniku, če se je pri vas ali otroku kdaj pojavilo kongestivno srčno popuščanje.
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; 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); opportunistic infections (infections that occur because of a weakened immune system); lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes).
Slovenian: 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 s 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; 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); oportunistične okužbe (okužbe, ki se lahko pojavijo zaradi oslabljenega imunskega sistema); Lihenoidne reakcije (srbeč rdeče-vijoličast kožni izpuščaj in/ali belo-sive nitaste črte na sluznicah).
English: By looking though the inspection window, the solution should be clear to slightly opalescent, colourless or pale yellow and may contain small translucent or white particles of protein.
Slovenian: Skozi okence za pregledovanje mora biti raztopina bistra do rahlo opalescentna, brezbarvna ali bledorumena ter lahko vsebuje majhne prosojne ali bele delce beljakovine.
English: The medicine should be clear to slightly opalescent, colourless or pale yellow, and may contain small white or almost transparent particles of protein.
Slovenian: Zdravilo mora biti bistro do rahlo opalescentno, brezbarvno ali bledorumeno ter lahko vsebuje majhne bele ali skoraj prosojne delce beljakovine.
English: Continue to hold the pre-filled pen firmly pressed into the site.
Slovenian: Napolnjen injekcijski peresnik še naprej čvrsto pritiskajte na mesto injiciranja.
English: 50 mg solution for injection in pre-filled syringe
Slovenian: 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Serious adverse reactions have also been reported for etanercept.
Slovenian: Pri uporabi etanercepta so poročali tudi o pojavu resnih neželenih učinkov.
English: A single-use pre-filled syringe contains one 50 mg dose of Benepali.
Slovenian: Napolnjena injekcijska brizga za enkratno uporabo vsebuje en 50-mg odmerek zdravila Benepali.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON WITHIN MULTIPACK (4 PRE-FILLED SYRINGES) (WITHOUT BLUE BOX)
Slovenian: VMESNA ŠKATLA V VEČODMERNEM PAKIRANJU (4 NAPOLNJENI INJEKCIJSKI PERESNIKI) (BREZ BLUE BOX)
English: distal interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitislike ankylosis.
Slovenian: Starost bolnikov je bila od 18 do 70 let in vsi so imeli aktivni psoriatični artritis (≥ 3 otekli sklepi in ≥ 3 občutljivi sklepi) v najmanj eni od naslednjih oblik: (1) distalna interfalangealna prizadetost (DIP); (2) poliartikularni artritis (odsotnost revmatoidnih nodulov in prisotnost psoriaze); (3) artritis mutilans; (4) asimetrični psoriatični artritis ali
English: Placebo n = 106 to 109*
Slovenian: Dvojno slepi klinični odzivi po 12 tednih Placebo n = 106 do 109*
English: Benepali should be used with caution in patients with a history of hepatitis C.
Slovenian: Pri bolnikih z anamnezo hepatitisa C morate zdravilo Benepali uporabljati previdno.