FrancophonIA/ELRC3.0 huggingface dataset:
English: A greater proportion of patients in the combined infliximab treatment group were able to discontinue corticosteroids while remaining in clinical remission compared to the placebo treatment group at both week 30 (22.3% vs. 7.2%, p < 0.001, pooled study 6 & study 7 data) and week 54 (21.0% vs. 8.9%, p = 0.022, study 6 data).
Slovenian: V (združeni) skupini, ki se je zdravila z infliksimabom, so pri večjem odstotku bolnikov lahko ukinili kortikosteroide ob ohranjeni klinični remisiji kot pri skupini, ki je prejemala placebo, kar velja tako za 30. teden (22,3 % v primerjavi s 7,2 %, p < 0,001, združeni podatki iz študije 6 in študije 7) kot za 54. teden (21,0 % v primerjavi z 8,9 %, p = 0,022, podatki iz študije 6).
English: • Psoriasis.
Slovenian: • Psoriaza
English: Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia.
Slovenian: srčno popuščanje (novo nastalo ali poslabšanje), aritmija, sinkopa,
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu .
English: Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections.
Slovenian: Uporaba povzročiteljev okužb, kot so žive oslabljene bakterije (npr. instilacija BCG v sečni mehur za zdravljenje raka), v druge terapevtske namene lahko povzroči klinične okužbe, vključno z razsejanimi okužbami, zato priporočamo, da jih ne dajete sočasno z zdravilom Zessly.
English: • If your doctor feels that you are at risk for TB, you may be treated with medicines for TB
Slovenian: • Če zdravnik sumi, da je možno, da imate tuberkulozo, vas bo lahko zdravil z zdravili za tuberkulozo, preden boste začeli zdravljenje z zdravilom Zessly.
English: What Zessly looks like and contents of the pack
Slovenian: Izgled zdravila Zessly in vsebina pakiranja
English: Patients who were randomised to the placebo maintenance group and then later crossed over to infliximab are included in the infliximab group in the ALT analysis.
Slovenian: Bolniki, ki so jih naključno razporedili v skupino za vzdrževalno zdravljenje s placebom in so potem prešli v skupino za zdravljenje z infliksimabom, so bili pri analizi ALT
English: In clinical studies delayed hypersensitivity reactions have been uncommon and have occurred after infliximab-free intervals of less than 1 year.
Slovenian: Pozna preobčutljivost V kliničnih študijah so bile pozne preobčutljivostne reakcije občasne in so se pojavile po premoru brez prejemanja infliksimaba, krajšem od enega leta.
English: In Phase III clinical studies, 18% of infliximabtreated patients compared with 5% of placebo-treated patients experienced an infusion-related reaction.
Slovenian: V kliničnih študijah faze III se je pri 18 % bolnikov zdravljenih z infliksimabom med infundiranjem pojavila z infuzijo povezana reakcija, v primerjavi s 5 % bolnikov, ki so prejemali placebo.
English: In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.
Slovenian: opravljena na miših z uporabo analognega protitelesa, ki selektivno zavira delovanje mišjega TNFα, ni pokazala znakov toksičnosti za mater, embriotoksičnosti ali teratogenosti.
English: • Possible signs of cancer including but not limited to swelling of lymph nodes, weight loss, fever, unusual skin nodules, changes in moles or skin colouring, or unusual vaginal bleeding.
Slovenian: • možni znaki raka, ki med drugim vključujejo otekanje bezgavk, izgubo telesne mase, zvišano telesno temperaturo, nenavadne kožne vozliče, spremembe znamenj ali barve kože ali nenavadne krvavitve iz nožnice.
English: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease and ulcerative colitis), Merkel cell carcinoma.
Slovenian: melanom, rak materničnega vratu neznana pogostnost: hepatosplenični limfom celic T (primarno pri mladostnikih in mlajših odraslih moških s Crohnovo boleznijo in ulceroznim kolitisom), karcinom Merklovih celic
English: Zessly is supplied as a glass vial containing a powder for concentrate for solution for infusion (powder for concentrate).
Slovenian: Zdravilo Zessly je na voljo v steklenih vialah s praškom za koncentrat za raztopino za infundiranje (prašek za koncentrat).
English: Table 7 Effects on response rate in patients with fistulising Crohn's disease, data from study 5 (week14 responders)
Slovenian: Učinki na stopnjo odziva; podatki pri bolnikih s Crohnovo boleznijo s fistulami iz študije 5 (bolniki z odzivom v 14. tednu) Študija 5 (bolniki z odzivom v 14. tednu)
English: In clinical studies, mild or moderate elevations of ALT and AST have been observed in patients receiving infliximab without progression to severe hepatic injury.
Slovenian: Pojavi na jetrih, žolčniku in žolčevodih V kliničnih preskušanjih so opažali blago ali zmerno zvišanje vrednosti ALT in AST pri bolnikih, ki so prejemali infliksimab, brez napredovanja motnje do hude jetrne poškodbe.
English: Among patients classified as non-responders at week 2, 32% (26/81) in the placebo maintenance group and 42% (68/163) in the infliximab group achieved clinical response by week 6.
Slovenian: (26/81) iz skupine za vzdrževalno zdravljenje s placebom in 42 % (68/163) iz skupine za prejemanje infliksimaba doseglo klinični odziv v 6. tednu.
English: Dilute the total volume of the reconstituted Zessly solution dose to 250 ml with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Slovenian: Celoten volumen (odmerek) rekonstituirane raztopine zdravila Zessly razredčite do 250 ml z 9 mg/ml (0,9 %) raztopino natrijevega klorida za infundiranje.
English: Date:
Slovenian: Datum
English: infliximab Maintenance 10 mg/kg (n = 112) (p value)
Slovenian: Vzdrževalno zdravljenje z infliksimabom 10 mg/kg (n = 112) (p vrednost)
English: Some cases of active tuberculosis have been reported in patients treated with infliximab during and after treatment for latent tuberculosis.
Slovenian: Pri bolnikih, zdravljenih z infliksimabom, so med in po zdravljenju latentne tuberkuloze poročali o nekaj primerih pojava aktivne tuberkuloze.
English: In the first study, (study 8), which had a 3 month double-blind phase, 70 patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6 (35 patients in each group).
Slovenian: V prvi študiji (študija 8), ki je vsebovala tudi 3-mesečno dvojno slepo fazo, je 70 bolnikov prejemalo bodisi infliksimab v odmerku 5 mg/kg bodisi placebo v 0., 2. in 6. tednu (po 35 bolnikov v vsaki skupini).
English: Zessly may be stored at temperatures up to a maximum of 30°C for a single period of up to 6 months, but not exceeding the original expiry date.
Slovenian: Zdravilo Zessly se lahko shranjuje pri temperaturah do največ 30 °C za enkratno obdobje do 6 mesecev, vendar ne dlje od originalnega datuma izteka roka uporabnosti.
English: • Signs of infection (including TB) such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection of pus in the gut or around the anus (abscess), dental problems or burning sensation when urinating.
Slovenian: • znaki okužbe (vključno s TBC), na primer zvišana telesna temperatura, občutek utrujenosti, kašelj, ki je lahko dolgotrajen, kratka sapa, gripi podobni simptomi, hujšanje, nočno potenje, driska, rane, nabiranje ognojkov v črevesju ali okoli anusa (absces), težave z zobmi ali pekoč občutek med uriniranjem;
English: Week 10 Week 24
Slovenian: 10. teden 24. teden
English: Patients with ACR20 response/
Slovenian: ACR 20* Odziv
English: The safety and efficacy of infliximab have not been studied in children with ulcerative colitis below the age of 6 years.
Slovenian: Varnost in učinkovitost infliksimaba pri otrocih z ulceroznim kolitisom, mlajših od 6 let, niso preučevali.
English: Zessly is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA (see section 5.1).
Slovenian: Zdravilo Zessly je indicirano za zdravljenje zmerne do hude psoriaze s plaki pri odraslih bolnikih, ki se niso odzvali na druge sistemske terapije, na primer ciklosporine, metotreksat ali PUVA (glejte poglavje 5.1), ali pa imajo kontraindikacijo zanje ali jih ne prenašajo.
English: Table 2 Proportion of patients with increased ALT activity in clinical studies
Slovenian: Delež bolnikov s povišano vrednostjo ALT v kliničnih preskušanjih
English: Therefore, the combination of Zessly and anakinra is not recommended.
Slovenian: Kombiniranje zdravila Zessly in anakinre torej ni priporočljivo.
English: Clinical remission at week 8a Clinical remission at week 30a Sustained remission (in remission at both week 8 and week 30)a
Slovenian: Trajnejša remisija (remisija tako v 8. tednu kot v 30. tednu)a
English: Caution should be exercised when considering the use of Zessly in patients with chronic infection or a history of recurrent infections, including concomitant immunosuppressive therapy.
Slovenian: Pri odločanju o uporabi zdravila Zessly pri bolnikih s kroničnimi okužbami ali ponavljajočimi se okužbami v pretekli anamnezi, pa tudi pri tistih, s sočasno imunosupresivno terapijo, je potrebna previdnost.
English: Placebo + MTX 3 mg/kg
Slovenian: infliksimab + MTX 3 mg/kg 6 mg/kg kombinirano
English: The concurrent administration of live vaccines with Zessly is not recommended.
Slovenian: Sočasna uporaba živih cepiv in zdravila Zessly ni priporočljiva.
English: • Signs of an immune system disorder such as joint pain or a rash on cheeks or arms that is sensitive to the sun (lupus) or cough, shortness of breath, fever or skin rash (sarcoidosis)..
Slovenian: • znaki motnje v delovanju imunskega sistema, na primer bolečine v sklepih ali izpuščaj na licih ali rokah, ki je občutljiv na sončno svetlobo (lupus), ali kašelj, kratka sapa, zvišana telesna temperatura ali kožni izpuščaj (sarkoidoza);
English: Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNFα-blocking agent, etanercept, with no added clinical benefit compared to etanercept alone.
Slovenian: V kliničnih študijah, v katerih so sočasno uporabljali anakinro in drug zaviralec TNFα - etanercept, so opažali resne okužbe in nevtropenijo, ni pa bilo nikakršnih dodatnih koristnih kliničnih učinkov v primerjavi z uporabo samega etanercepta.
English: Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation.
Slovenian: [pnevmocistoza, histoplazmoza, aspergiloza, kokcidioidomikoza, kriptokokoza, blastomikoza], bakterijske okužbe [okužbe z atipičnimi mikobakterijami, listerioza, salmoneloza] in virusne okužbe [s citomegalovirusom]), okužbe s paraziti, reaktivacija hepatitisa B neznana pogostnost: okužba po cepljenju (po in utero izpostavitvi infliksimabu)*
English: Do not use if opaque particles, discolouration, or other foreign particles are present.
Slovenian: Če pa so prisotni neprosojni delci, obarvanje ali drugi tuji delci,
English: The vast majority of infliximab cases have occurred in patients with Crohn's disease or ulcerative colitis and most were reported in adolescent or young adult males.
Slovenian: Velika večina teh primerov se je pojavila pri bolnikih s Crohnovo boleznijo in ulceroznim kolitisom, večina od teh pri mladostnikih ali mlajših odraslih moških
English: When reconstitution and dilution are performed under aseptic conditions, Zessly infusion solution can be used within 24 hours if stored at 2°C - 8°C.
Slovenian: Če sta rekonstitucija in razredčenje opravljena v aseptičnih pogojih, smete infuzijsko raztopino zdravila Zessly uporabiti v roku 24 ur, če je shranjena pri temperaturi od 2 °C-8 °C.
English: It is recommended that live vaccines not be given concurrently with Zessly.
Slovenian: Priporočamo, da živih cepiv ne dajete sočasno z zdravilom Zessly.
English: In both studies, patients were randomised to receive either placebo, 5 mg/kg infliximab, or 10 mg/kg infliximab at weeks 0, 2, 6, 14, and 22, and in study 6 at weeks 30, 38, and 46.
Slovenian: V obeh študijah so bili bolniki randomizirani bodisi v skupino za placebo, skupino, ki je prejemala 5 mg/kg infliksimaba, ali pa v skupino, ki je prejemala 10 mg/kg infliksimaba v 0., 2., 6., 14. in 22. tednu in v študiji 6 v 30., 38. in 46. tednu.
English: A risk for the development for hepatosplenic T-cell lymphoma in patients treated with infliximab cannot be excluded (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z infliksimabom, ne moremo izključiti tveganja za pojav hepatospleničnega limfoma celic T (glejte poglavje 4.8).
English: Do not dilute the reconstituted Zessly solution with any other diluent.
Slovenian: Rekonstituirane raztopine zdravila Zessly ne redčite z nobeno drugo tekočino.
English: Psoriatic arthritis, ankylosing spondylitis (Bechterew's disease), psoriasis, ulcerative colitis and Crohn's disease
Slovenian: Psoriatični artritis, ankilozirajoči spondilitis (Bechterew sindrom), psoriaza, ulcerozni kolitis in
English: infliximab (week 54)
Slovenian: Infliksimab (54. teden)
English: Change from baseline in total van der Heijde-modified Sharp scoreb Mean ± SDa
Slovenian: Sprememba z začetne vrednosti za skupni rezultat po metodi van der Heijde, modificirani po Sharpub Srednja vrednost ± SDa
English: Zessly should be administered intravenously.
Slovenian: Zdravilo Zessly je treba dajati intravensko.
English: • treat active Crohn's disease
Slovenian: • zdravljenje aktivne Crohnove bolezni,
English: Tell your doctor if you are using or have recently used any other medicines, including any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis or medicines obtained without a prescription, such as vitamins and herbal medicines.
Slovenian: Obvestite zdravnika, če jemljete ali ste pred kratkim jemali katero koli zdravilo, vključno s katerimi koli drugimi zdravili za zdravljenje Crohnove bolezni, ulceroznega kolitisa, revmatoidnega artritisa,
English: Patients received 3 or 6 mg/kg infliximab as a 3dose induction regimen (weeks 0, 2, 6 or weeks 14, 16, 20 respectively) followed by maintenance therapy every 8 weeks, in combination with methotrexate.
Slovenian: Ti bolniki so prejemali uvodno shemo iz treh odmerkov infliksimaba 3 mg/kg oziroma 6 mg/kg (v tednih 0, 2 in 6 oziroma v tednih 14, 16 in 20), potem pa je sledilo vzdrževalno zdravljenje na vsakih 8 tednov, v kombinaciji z metotreksatom.
English: Placebo → infliximab 5 mg/kg (at week 24)
Slovenian: infliksimab 5 mg/kg (24. teden)
English: Efficacy was similar in the subgroup of patients that were exposed to previous systemic therapies compared to the overall study population.
Slovenian: V celotni populaciji, vključeni v študijo, je bila učinkovitost primerljiva s skupino bolnikov, ki so predhodno že bili sistemsko zdravljeni.
English: The safety and efficacy of infliximab were assessed in a multicenter, randomised, open-label, parallel-group clinical study 15 in 60 paediatric patients aged 6 through 17 years (median age 14.5 years) with moderately to severely active ulcerative colitis (Mayo score of 6 to 12; endoscopic subscore ≥ 2) with an inadequate response to conventional therapies.
Slovenian: Ulcerozni kolitis pri pediatričnih bolnikih (od 6 do 17 let) Varnost in učinkovitost infliksimaba so ocenili v multicentrični, randomizirani, odprti klinični študiji vzporednih skupin (študija 15) pri 60 pediatričnih bolnikih, starih od 6 do 17 let (mediana starost 14,5 let) z zmerno do močno aktivnim ulceroznim kolitisom (ocena Mayo od 6 do 12; delna endoskopska ocena ≥ 2), ki so se nezadostno odzvali na običajno zdravljenje.
English: Re-administration for ankylosing spondylitis
Slovenian: Ponovna uporaba zdravila pri ankilozirajočem spondilitisu
English: Clinical response at week 8a Clinical response at week 30a Sustained response (clinical response at both week 8 and week 30)a
Slovenian: (klinični odziv tako v 8. tednu kot v 30. tednu)a
English: Zessly is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Slovenian: Zdravilo Zessly je indicirano za zdravljenje zmerno do močno aktivnega ulceroznega kolitisa pri odraslih bolnikih, ki so se nezadostno odzvali na običajno zdravljenje, na primer na kortikosteroide in 6-merkaptopurin (6-MP) ali azatioprin (AZA), ter pri tistih, ki ne prenašajo takšnega zdravljenja ali imajo medicinske kontraindikacije zanj.
English: At week 14, 282 patients were assessed for clinical response and randomised to receive either placebo or 5 mg/kg infliximab every 8 weeks through week 46.
Slovenian: V štirinajstem tednu zdravljenja so pri 282 bolnikih ocenili klinični odziv in jih naključno razvrstili v skupino, zdravljeno s placebom ali skupino, ki je prejemala infliksimab 5 mg/kg vsakih 8 tednov skupaj 46 tednov.
English: The most common adverse event was worsening of ulcerative colitis, the incidence of which was higher in patients on the q12 week vs. the q8 week dosing regimen.
Slovenian: Najpogostejši neželeni učinek je bil poslabšanje ulceroznega kolitisa, pogostnost katerega je bila večja pri bolnikih, ki so zdravilo prejemali na 12 tednov, kot pri bolnikih,
English: Improvement from baseline in HAQ averaged over time from week 30 to week 54c
Slovenian: Izboljšanje z začetne vrednosti za HAQ -časovno povprečje od 30.
English: A population-based retrospective cohort study found an increased incidence of cervical cancer in women with rheumatoid arthritis treated with infliximab compared to biologics-naïve patients or the general population, including those over 60 years of age (see section 4.4).
Slovenian: V populacijski retrospektivni kohortni študiji so ugotovili povečano pojavnost raka materničnega vratu pri ženskah z revmatoidnim artritisom in zdravljenih z infliksimabom, v primerjavi z bolnicami, ki še niso prejemale bioloških zdravil, ali s splošno populacijo, vključno s starejšimi od 60 let
English: The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indications of juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.
Slovenian: Juvenilni idiopatski artritis, psoriatični artritis in ankilozirajoči spondilitis Varnost in učinkovitost infliksimaba pri otrocih in mladostnikih, mlajših od 18 let, za indikacije juvenilni idiopatski artritis, psoriatični artritis in ankilozirajoči spondilitis nista bili dokazani.
English: Week 50
Slovenian: 50. teden
English: Study 2 evaluated responses at 54 weeks in 1,004 methotrexate naive patients with early (≤ 3 years disease duration, median 0.6 years) active rheumatoid arthritis (median swollen and tender joint count of 19 and 31, respectively).
Slovenian: V študiji 2 so ovrednotili odzive v 54. tednu pri 1004 bolnikih z zgodnjim (trajanje bolezni ≤ 3 let, mediana vrednost 0,6 let) aktivnim revmatoidnim artritisom (mediana števila oteklih sklepov je bila 19 in mediana števila bolečih sklepov 31), ki še niso prejemali metotreksata.
English: Of the 22 subjects that had fistulas at baseline, 63.6% (14/22), 59.1% (13/22) and 68.2% (15/22) were in complete fistula response at week 10, 30, and 54, respectively, in the combined q8 weeks and q12 weeks maintenance groups.
Slovenian: Od 22 preiskovancev, ki so imeli fistule na začetku preskušanja, so pri 63,6 % (14/22) ugotovili popoln odziv fistule na zdravljenje v 10. tednu, pri 59,1 % (13/22) v 30. tednu in pri 68,2 % (15/22) v 54. tednu, kar velja za združeni skupini za vzdrževalno zdravljenje z infuzijami na vsakih 8 in 12 tednov.
English: • adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate.
Slovenian: (DMARD - disease modifying antirheumatic drugs), ki vplivajo na imunsko odzivnost, vključno z metotreksatom, ni zadosten.
English: Zessly is indicated for treatment of severely active ulcerative colitis, in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Slovenian: Zdravilo Zessly je indicirano za zdravljenje močno aktivnega ulceroznega kolitisa pri otrocih in mladostnikih, starih od 6 do 17 let, ki so se nezadostno odzvali na običajno zdravljenje, na primer na kortikosteroide in 6-MP ali AZA, ter pri tistih, ki ne prenašajo takšnega zdravljenja ali imajo medicinske kontraindikacije zanj.
English: Table 1 lists ADRs based on experience from clinical studies as well as adverse reactions, some with fatal outcome, reported from post-marketing experience.
Slovenian: Tabelarični pregled neželenih učinkov V Preglednici 1 so podani neželeni učinki, ki so bili zbrani v kliničnih študijah, in tisti, ki so jih prijavljali v okviru izkušenj v obdobju trženja, od tega jih je bilo nekaj s smrtnim izidom.
English: • Some patients receiving treatment with medicines containing infliximab have developed serious liver problems.
Slovenian: Težave z jetri • Pri nekaterih bolnikih, ki prejemajo infliksimab, so se pojavile resne težave z jetri.
English: A total of 306 patients received 3 doses of infliximab 5 mg/kg at week 0, 2, and 6.
Slovenian: Skupaj 306 bolnikov je prejelo 3 odmerke infliksimaba v odmerku 5 mg/kg na začetku, po 2 tednih in po 6 tednih.
English: ≥ 5 x ULN placebo infliximab placebo infliximab placebo infliximab placebo infliximab
Slovenian: placeb o infliksima b placeb o infliksima b placeb o infliksima b placeb o infliksima b
English: Maintenance (n = 99)
Slovenian: Vzdrževalno zdravljenje s placebom (n = 99)
English: Median follow-up (wks)4
Slovenian: Mediana dolžina spremljanja bolnikov (tedni)4
English: Dizziness may occur following administration of infliximab (see section 4.8).
Slovenian: Pri uporabi infliksimaba se lahko pojavi omotica (glejte poglavje 4.8).
English: Talk to your doctor if you are on a low salt diet.
Slovenian: Obvestite zdravnika, če ste na dieti z nadzorovanim vnosom natrija.
English: Bullous eruption, seborrhoea, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation.
Slovenian: bulozni izpuščaj, seboreja, rozacea, kožni papilom, hiperkeratoza,
English: d p = 0.030 and < 0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs. placebo + MTX.
Slovenian: HAQ = vprašalnik za oceno zdravstvenega stanja; večje vrednosti pomenijo manjšo okvaro sklepov d p = 0,030 in < 0,001 za terapevtski skupini, ki sta prejemali 3 mg/kg in 6 mg/kg v primerjavi s placebom + MTX
English: Re-administration for ulcerative colitis
Slovenian: Ponovna uporaba zdravila pri ulceroznem kolitisu
English: Tuberculosis, fungal infections (e.g. candidiasis, onychomycosis ).
Slovenian: tuberkuloza, glivične okužbe (npr. kandidiaza, onihomikoza)
English: Excipients: Disodium succinate hexahydrate, succinic acid, sucrose, polysorbate 80.
Slovenian: Pomožne snovi: dinatrijev sukcinat heksahidrat, jantarna kislina, saharoza, polisorbat 80.
English: • These infections may be serious and include tuberculosis, infections caused by viruses, fungi, bacteria or other organisms in the environment and sepsis that may be life-threatening.
Slovenian: • Te okužbe so lahko resne in vključujejo tuberkulozo, okužbe, ki jih povzročajo virusi, glive,