FrancophonIA/ELRC3.0 huggingface dataset:
English: The proportions of patients with mucosal healing at week 26 were significantly greater in the infliximab plus AZA combination (43.9%, p < 0.001) and infliximab monotherapy groups (30.1%, p=0.023) compared to the AZA monotherapy group (16.5%).
Slovenian: Odstotki bolnikov z zacelitvijo sluznice v 26. tednu so bili statistično značilno večji v skupini, ki je prejemala kombinacijo infliksimaba in AZA (43,9 %, p < 0,001), in v skupini, ki je prejemala infliksimab v monoterapiji (30,1 %, p = 0,023), kot pa v skupini, ki je prejemala AZA v monoterapiji (16,5 %).
English: The concurrent administration of live vaccines with Flixabi is not recommended.
Slovenian: Sočasna uporaba živih cepiv in zdravila Flixabi 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 bolečina 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: ≥ 75% improvement a
Slovenian: ≥ 75 % izboljšanje a
English: The safety and efficacy of infliximab were assessed in a multicentre, randomised, open-label, parallel-group clinical study (C0168T72) 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 (C0168T72) 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: Infections • Tell your doctor before you are given Flixabi if you have an infection even if it is a very minor one.
Slovenian: • Preden prejmete zdravilo Flixabi, povejte zdravniku, če imate okužbo, tudi če je zelo blaga.
English: It is recommended that live vaccines not be given concurrently with Flixabi.
Slovenian: Priporočamo, da živih cepiv ne dajete sočasno z zdravilom Flixabi.
English: Infliximab (week 54)
Slovenian: infliksimab (54. teden)
English: Allergic respiratory symptom.
Slovenian: alergijski simptomi v dihalih občasni:
English: Caution should be exercised in considering treatment of patients with increased risk for malignancy due to heavy smoking.
Slovenian: Pri odločanju o uvedbi zdravljenja pri bolnikih, ki veliko kadijo in imajo zato povečano tveganje za nastanek rakave bolezni, je potrebna previdnost.
English: Transverse myelitis, central nervous system demyelinating disorders (multiple sclerosis-like disease and optic neuritis), peripheral demyelinating disorders (such as Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy).
Slovenian: transverzni mielitis, demielinizirajoče bolezni osrednjega živčevja (bolezen, podobna multipli sklerozi, in optični nevritis), periferne demielinizirajoče bolezni (na primer Guillain-Barréjev sindrom, kronična vnetna demielinizirajoča polinevropatija in multifokalna motorična nevropatija) neznana pogostnost: cerebrovaskularni insulti v tesni časovni povezanosti z infuzijo
English: If you are not sure, talk to your doctor before you are given Flixabi.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom, preden začnete prejemati zdravilo Flixabi.
English: • A hole in the bowel or blockage of the intestine, stomach pain or cramps
Slovenian: • odprtina v debelem črevesju ali zamašitev tankega črevesja, želodčne bolečine ali krči,
English: Patients may be pre-treated with e.g., an antihistamine, hydrocortisone and/or paracetamol to prevent mild and transient effects.
Slovenian: Za preprečevanje blagih in prehodnih učinkov lahko bolnikom pred zdravljenjem daste premedikacijo, npr. antihistaminik, hidrokortizon in/ali paracetamol.
English: START was a randomised, multicentre, double-blind, 3-arm, parallel-group safety study.
Slovenian: Študija START je bila randomizirana, multicentrična, dvojno slepa študija varnosti zdravila pri vzporednih skupinah in je imela tri krake.
English: Flixabi 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 ciclosporin, methotrexate or psoralen ultra-violet A (PUVA) (see section 5.1).
Slovenian: Zdravilo Flixabi 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 psoralen in obsevanje z ultravijoličnimi žarki A (PUVA) (glejte poglavje 5.1), ali pa imajo kontraindikacijo zanje ali jih ne prenašajo.
English: It is recommended that therapeutic infectious agents not be given concurrently with Flixabi (see section 4.4).
Slovenian: Priporočamo, da povzročiteljev okužb v terapevtske namene ne dajete sočasno z zdravilom Flixabi (glejte poglavje 4.4).
English: • Signs of a lung problem such as coughing, breathing difficulties or tightness in the chest
Slovenian: • znaki težav s pljuči, na primer kašelj, težave z dihanjem ali stiskanje v prsih;
English: • Severely decreased numbers of white blood cells have been reported in infants born to women treated with Flixabi during pregnancy.
Slovenian: • Pri dojenčkih, rojenih materam, ki so bile med nosečnostjo zdravljenje z zdravilom Flixabi, so poročali o močnem znižanju števila belih krvnih celic.
English: Flixabi is indicated for treatment of severe, active Crohn's disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.
Slovenian: Zdravilo Flixabi je indicirano za zdravljenje hude, aktivne Crohnove bolezni pri otrocih in mladostnikih, starih od 6 do 17 let, ki se niso odzvali na običajno terapijo, vključno s kortikosteroidi, imunomodulatorji in primarno prehransko terapijo, ter pri tistih, ki ne prenašajo teh običajnih načinov zdravljenja oziroma imajo kontraindikacije zanje.
English: • Bruising, hot flush or nosebleed, warm, red skin (flushing)
Slovenian: • podplutbe, vročinski oblivi ali krvavitev iz nosu, topla in pordela koža (zardevanje),
English: a p < 0.001, for each infliximab treatment group vs. control b n = 292 c Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
Slovenian: b n = 292 c Analiza se nanaša na preiskovance, ki so imeli psoriazo nohtov na začetku študije (81,8 % preiskovancev).
English: Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili z zaviralci TNF, vključno z infliksimabom, so poročali o melanomu in karcinomu Merklovih celic (glejte poglavje 4.8).
English: In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of anti-TNF treatment should be carefully considered before initiation of Flixabi therapy.
Slovenian: Pri bolnikih z obstoječo ali nedavno nastalo demielinizirajočo boleznijo morate pred uvedbo terapije z zdravilom Flixabi skrbno pretehtati razmerje med tveganji in koristmi anti-TNF zdravljenja za bolnika.
English: Flixabi 100 mg
Slovenian: Flixabi 100 mg infliksimab
English: In responding patients, the alternative strategies for continued treatment are:  Maintenance: Additional infusions of 5 mg/kg every 8 weeks or  Re-administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur followed by infusions of 5 mg/kg every 8 weeks (see ‘Re-administration' below and section 4.4).
Slovenian: • Ponovna uporaba zdravila: Infuzija v odmerku 5 mg/kg, če se ponovijo znaki in simptomi bolezni, čemur naj sledijo infuzije v odmerku 5 mg/kg na vsakih 8 tednov (glejte poglavje “Ponovna uporaba zdravila” spodaj in poglavje 4.4).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.However, before Flixabi is given to you, it is mixed with a solution that contains sodium.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: Some cases of active tuberculosis have been reported in patients treated with Flixabi during and after treatment for latent tuberculosis.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Flixabi, so med zdravljenjem latentne tuberkuloze in po njem poročali o nekaj primerih pojava aktivne tuberkuloze.
English: (DMARDs), including methotrexate, has been inadequate.
Slovenian: disease modifying antirheumatic drugs), ki vplivajo na imunsko odzivnost, vključno z metotreksatom, ni zadosten.
English: • More children taking Flixabi developed infections as compared to adults.
Slovenian: • V primerjavi z odraslimi so se pri otrocih, ki so uporabljali zdravilo Flixabi, pogosteje pojavile okužbe.
English: Tuberculosis, fungal infections (e.g. candidiasis, onychomycosis).
Slovenian: tuberkuloza, glivične okužbe (npr. kandidiaza, onihomikoza)
English: Pulmonary oedema, bronchospasm, pleurisy, pleural effusion.
Slovenian: pljučni edem, bronhospazem, plevritis, plevralni izliv redki:
English: Arthralgia, myalgia, back pain.
Slovenian: artralgija, mialgija, bolečine v hrbtu
English: • The other ingredients are sucrose, polysorbate 80, monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate.
Slovenian: • Pomožne snovi so saharoza, polisorbat 80, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat heptahidrat.
English: During treatment with Flixabi
Slovenian: Med zdravljenjem z zdravilom Flixabi
English: Excipients: sucrose, polysorbate 80, monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate.
Slovenian: Pomožne snovi: saharoza, polisorbat 80, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat heptahidrat.
English: Infliximab has been associated with acute infusion-related reactions, including anaphylactic shock, and delayed hypersensitivity reactions (see section 4.8).
Slovenian: Z infuzijo povezane reakcije in preobčutljivost Zdravljenje z infliksimabom je bilo povezano z akutnimi infuzijskimi reakcijami, vključno z anafilaktičnim šokom in poznimi preobčutljivostnimi reakcijami (glejte poglavje 4.8).
English: The number of ulcerative colitis-related surgical procedures was also lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of surgical procedures per 100 subject-years: 22 and 19 vs. 34; p=0.145 and p=0.022, respectively).
Slovenian: Tudi število kirurških posegov zaradi ulceroznega kolitisa je bilo manjše v obeh terapevtskih skupinah, ki sta prejemali po 5 mg/kg oziroma 10 mg/kg infliksimaba, kot pa v skupini, ki je prejemala placebo (srednje število kirurških posegov na 100 preiskovancev x let je bilo 22 za 5 mg/kg infliksimaba in 19 za 10 mg/kg infliksimaba, v primerjavi s 34 za placebo; p = 0,145 in p = 0,022).
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, nista bili dokazani.
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 trdovraten, kratka sapa, gripi podobni simptomi, hujšanje, nočno potenje, driska, rane, težave z zobmi ali pekoč občutek med uriniranjem;
English: At week 8, 45 patients were randomised and received 5 mg/kg infliximab at either q8 weeks or q12 weeks as a maintenance treatment regimen.
Slovenian: Po 8 tednih so 45 bolnikov randomizirali in so za vzdrževalno zdravljenje prejemali 5 mg/kg infliksimaba bodisi na 8, bodisi na 12 tednov.
English: • These infections may be serious and include tuberculosis, infections caused by viruses, fungi,
Slovenian: • Te okužbe so lahko resne in vključujejo tuberkulozo, okužbe, ki jih povzročajo virusi, glive, bakterije ali drugi organizmi iz okolja, ter sepso, kar je lahko življenjsko nevarno.
English: Flixabi contains the active substance infliximab.
Slovenian: Zdravilo Flixabi vsebuje učinkovino infliksimab.
English: If you are not sure if any of the above applies to you, talk to your doctor before you are given Flixabi.
Slovenian: Če niste prepričani, ali kaj od naštetega velja za vas, se posvetujte z zdravnikom, preden boste prejeli zdravilo Flixabi.
English: In post-marketing surveillance, cases of jaundice and hepatitis, some with features of autoimmune hepatitis, have been reported in patients receiving infliximab (see section 4.4).
Slovenian: V okviru izkušenj v obdobju trženja so pri bolnikih, ki so prejemali infliksimab, poročali o primerih zlatenice in hepatitisa, pri nekaterih tudi z znaki avtoimunskega hepatitisa (glejte poglavje 4.4).
English: The safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8).
Slovenian: Ponovna uporaba zdravila pri ulceroznem kolitisu Varnost in učinkovitost ponovne uporabe zdravila, razen na vsakih 8 tednov, še nista bili dokazani (glejte poglavji 4.4 in 4.8).
English: Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation.
Slovenian: krvavitev iz prebavil, driska, dispepsija, gastroezofagealni refluks, zaprtje občasni:
English: A risk for the development for hepatosplenic T-cell lymphoma in patients treated with Flixabi cannot be excluded (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z zdravilom Flixabi, ne moremo izključiti tveganja za pojav hepatospleničnega limfoma celic T (glejte poglavje 4.8).
English: N ≥ 90% improvement a
Slovenian: 10. teden n ≥ 90 % izboljšanje a
English: • Bleeding in the stomach or intestines, diarrhoea, indigestion, heartburn, constipation
Slovenian: • krvavitev v želodcu ali črevesju, driska, prebavne motnje, zgaga, zaprtje,
English: • Fungal infections such as yeast infection or fungal infection of the nails
Slovenian: • glivične okužbe, na primer okužba s kvasovkami ali glivična okužba nohtov,
English: Infliximab (week 98)
Slovenian: infliksimab (98. teden)
English: Flixabi 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 6-mercaptopurine (6MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Slovenian: Zdravilo Flixabi 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: Infliximab (week 24)
Slovenian: infliksimab (24. teden)
English: New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis,
Slovenian: novo nastala in poslabšana psoriaza, vključno s pustulozno psoriazo (predvsem na dlaneh in podplatih), urtikarija, izpuščaj, pruritus, hiperhidroza, suha koža, glivični dermatitis, ekcem, alopecija občasni:
English: Paediatric Crohn's disease
Slovenian: Pediatrična Crohnova bolezen
English: Tachycardia, palpitation.
Slovenian: tahikardija, palpitacije občasni:
English: After reconstitution one mL contains 10 mg infliximab.
Slovenian: Po rekonstituciji en ml vsebuje 10 mg infliksimaba.
English: Flixabi 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 Flixabi 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: Dizziness may occur following administration of Flixabi (see section 4.8).
Slovenian: Pri uporabi zdravila Flixabi se lahko pojavi omotica (glejte poglavje 4.8).
English: What Flixabi contains
Slovenian: Kaj vsebuje zdravilo Flixabi
English: • Signs of low blood counts such as persistent fever, bleeding or bruising more easily, small red or purple spots caused by bleeding under the skin, or looking pale.
Slovenian: • znaki znižanega števila krvnih celic, na primer dolgotrajno zvišana telesna temperatura, večja nagnjenost h krvavitvam ali k nastanku podplutb, majhne rdeče ali vijolične pike zaradi podkožne krvavitve ali bledica.
English: • Ankylosing spondylitis (Bechterew's disease)
Slovenian: • ankilozirajoči spondilitis (Bechterew sindrom),
English: Tell your doctor straight away if you notice any of the following:
Slovenian: Če opazite katerega od naslednjih učinkov, takoj obvestite zdravnika:
English: In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/pharyngeal oedema and severe bronchospasm, and seizure have been associated with infliximab administration (see section 4.4).
Slovenian: V okviru izkušenj v obdobju trženja je bila uporaba infliksimaba povezana s primeri anafilaktoidnih reakcij, vključno z edemom grla ali žrela in hudim bronhospazmom, ter epileptičnimi napadi (glejte poglavje 4.4).
English: • Slow down the damage in your joints,
Slovenian: • upočasnitev napredovanja okvare sklepov,
English: Each Flixabi vial contains 100 mg infliximab.
Slovenian: Ena viala zdravila Flixabi vsebuje 100 mg infliksimaba.
English: Patients treated with Flixabi should be given the package leaflet and the patient reminder card.
Slovenian: Bolniki, zdravljeni z zdravilom Flixabi, morajo prejeti navodilo za uporabo in opozorilno kartico za bolnika.
English: Signs include a fever, feeling tired, (persistent) cough, shortness of breath, weight loss, night sweats, diarrhea, wounds, dental problems, burning when urinating or ‘flulike' signs.
Slovenian: Ti znaki vključujejo zvišano telesno temperaturo, utrujenost, (trdovraten) kašelj, kratko sapo, izgubo telesne mase, nočno potenje, drisko, rane, težave z zobmi, pekoče uriniranje ali gripi podobne znake.
English: • Psoriatic arthritis
Slovenian: • psoriatični artritis,
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 ACT 1 at weeks 30, 38 and 46.
Slovenian: 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 ACT 1 v 30., 38. in 46. tednu.
English: Week 10 Week 24
Slovenian: 10. teden 24. teden a
English: The safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established (see sections 4.4 and 4.8).
Slovenian: Ponovna uporaba zdravila pri ankilozirajočem spondilitisu Varnost in učinkovitost ponovne uporabe zdravila, razen na vsakih 6 do 8 tednov, še nista bili dokazani (glejte poglavji 4.4 in 4.8).
English: Flixabi 100 mg powder for concentrate for solution for infusion.
Slovenian: Flixabi 100 mg prašek za koncentrat za raztopino za infundiranje
English: • You should avoid getting pregnant when you are being treated with Flixabi and for 6 months after you stop being treated with it.
Slovenian: • Če prejemate zdravilo Flixabi, je treba preprečiti nosečnost med zdravljenjem in še vsaj 6 mesecev po prenehanju zdravljenja.
English: How Flixabi is given
Slovenian: Kako se daje zdravilo Flixabi
English: Infliximab
Slovenian: placebo infliksimab
English: The number of ulcerative colitis-related hospitalisations was significantly lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of hospitalisations per 100 subject-years: 21 and 19 vs. 40 in the placebo group; p=0.019 and p=0.007, respectively).
Slovenian: V obeh terapevtskih skupinah, ki sta prejemali 5 mg/kg oziroma 10 mg/kg infliksimaba, je bilo število hospitalizacij zaradi ulceroznega kolitisa bistveno manjše kot pa v skupini, ki je prejemala placebo (srednje število hospitalizacij na 100 preiskovancev x let je znašalo 21 v skupini, ki je prejemala 5 mg/kg infliksimaba in 19 v skupini, ki je prejemala 10 mg/kg infliksimaba, medtem ko je v skupini za placebo znašalo kar 40; p = 0,019 in p = 0,007).
English: Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients receiving infliximab.
Slovenian: Pri bolnikih, ki so prejemali infliksimab, so opažali tuberkulozo, bakterijske okužbe vključno s sepso in pljučnico, invazivne glivične, virusne in druge oportunistične okužbe.
English: ≥ 3 x ULN
Slovenian: ≥ 3-kratnik ZMN ≥ 5-kratnik ZMN
English: Tell your doctor straight away if you notice any of the above.
Slovenian: Če opazite katerega od zgornjih znakov, morate takoj obvestiti zdravnika.
English: Depression, insomnia.
Slovenian: depresija, nespečnost občasni:
English: Infliximab (week 16)
Slovenian: infliksimab (16. teden)
English: Cases of jaundice and non-infectious hepatitis, some with features of autoimmune hepatitis, have been observed in the post-marketing experience of infliximab.
Slovenian: Med izkušnjami z infliksimabom v obdobju trženja so opažali primere zlatenice in neinfekcijskega hepatitisa in nekateri od njih so imeli značilnosti avtoimunskega hepatitisa.
English: • Fluid in the lining of the heart (pericardial effusion)
Slovenian: • tekočina v srčni ovojnici (perikardni izliv),
English: Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis.
Slovenian: perforacija črevesja, stenoza črevesja, divertikulitis, pankreatitis, heilitis Bolezni jeter, žolčnika in žolčevodov pogosti:
English: Monobasic sodium phosphate monohydrate Dibasic sodium phosphate heptahydrate
Slovenian: 6.1 Seznam pomožnih snovi saharoza polisorbat 80 natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat heptahidrat
English: • Infections of the vagina.
Slovenian: • okužbe nožnice.
English: Percentage of subjects in clinical response and in sustained clinical response Clinical response at week 8
Slovenian: Odstotek preiskovancev s kliničnim odzivom in trajnejšim kliničnim odzivom klinični odziv v 8. tednua klinični odziv v 30. tednua trajnejši odziv (klinični odziv tako v 8. tednu kot v 30. tednu)a
English: If a patient does not respond by 6 weeks (i.e. after 2 doses), no additional treatment with Flixabi should be given.
Slovenian: Če se bolnik ne odzove na zdravilo do 6. tedna (t. j. po 2 odmerkih), ga ne smete več zdraviti zdravilom Flixabi.
English: Flixabi 100 mg powder for concentrate for solution for infusion infliximab
Slovenian: Flixabi 100 mg prašek za koncentrat za raztopino za infundiranje infliksimab
English: Infliximab + AZA Combination therapy
Slovenian: AZA v monoterapiji infliksimab v monoterapiji infliksimab + AZA v kombinirani terapiji