FrancophonIA/ELRC3.0 huggingface dataset:
English: It is important that you tell your baby's doctors and other healthcare professionals about your Zessly use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis).
Croatian: Zessly, tako da mogu odlučiti kada Vaše dijete treba primiti bilo koje cjepivo, uključujući živa cjepiva kao što je BCG (primjenjuje se za sprječavanje tuberkuloze).
English: • Signs of a liver problem (including hepatitis B infection when you have had hepatitis B in the past) such as yellowing of the skin or eyes, dark-brown coloured urine pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever.
Croatian: • Znakove problema s jetrom (uključujući infekciju hepatitisom B ako ste u prošlosti već imali hepatitis B) kao što su žutilo kože ili bjeloočnica, tamnosmeđa boja mokraće, bol ili oticanje u gornjem desnom dijelu trbuha, bol u zglobovima, kožni osipi ili vrućica.
English: Patients treated with infliximab should be given the patient reminder card.
Croatian: Bolesnici koji se liječe infliksimabom moraju dobiti karticu s podsjetnikom za bolesnika.
English: The side effects that happened more in children were: low red blood cells (anaemia), blood in stool, low overall levels of white blood cells (leukopenia), redness or blushing (flushing), viral infections, low levels of white blood cells that fight infection (neutropenia), bone fracture, bacterial infection and allergic reactions of the breathing tract.
Croatian: U djece su se više javljale sljedeće nuspojave: smanjen broj crvenih krvnih stanica (anemija), krv u stolici, smanjen ukupan broj bijelih krvnih stanica (leukopenija), crvenilo ili crvenjenje (navale crvenila), virusne infekcije, smanjen broj bijelih krvnih stanica koje se bore protiv infekcije (neutropenija), lom kostiju, bakterijske infekcije te alergijske reakcije dišnog sustava.
English: Analysis of lamina propria mononuclear cells obtained by biopsy of the intestinal mucosa showed that infliximab treatment caused a reduction in the number of cells capable of expressing TNFα and interferonγ.
Croatian: Analiza mononuklearnih stanica u lamini propriji, dobivenih biopsijom sluznice crijeva, pokazala je da je liječenje infliksimabom dovelo do smanjenja broja stanica koje mogu izraziti
English: There are insufficient data on the incidence of delayed hypersensitivity reactions after infliximabfree intervals of more than 1 year but limited data from clinical studies suggest an increased risk for delayed hypersensitivity with increasing infliximab-free interval (see section 4.4).
Croatian: Nema dovoljno podataka o incidenciji reakcija kasne preosjetljivosti nakon prekida davanja infliksimaba u trajanju duljem od jedne godine, ali ograničeni podaci iz kliničkih ispitivanja ukazuju na povećanje rizika od kasne preosjetljivosti što je dulje razdoblje u kojemu se lijek ne primjenjuje
English: Repeated administration of infliximab (5 mg/kg at 0, 2, and 6 weeks in fistulising Crohn´'s disease, 3 or 10 mg/kg every 4 or 8 weeks in rheumatoid arthritis) resulted in a slight accumulation of infliximab in serum after the second dose.
Croatian: Ponovna primjena infliksimaba (5 mg/kg u 0., 2. i 6. tjednu u fistulirajućem obliku Crohnove bolesti, 3 ili 10 mg/kg svakih 4 ili 8 tjedana u bolesnika s reumatoidnim artritisom) dovela je do blage akumulacije infliksimaba u serumu nakon druge doze.
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including infliximab, who are chronic carriers of this virus.
Croatian: Reaktivacija hepatitisa B (HBV) Reaktivacija hepatitisa B dogodila se u bolesnika koji su primali antagonist TNF-a uključujući infliksimab, a kronični su nositelji tog virusa.
English: Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Croatian: Infliksimab je kimerično humano-mišje monoklonsko protutijelo IgG1 proizvedeno na stanicama jajnika kineskog hrčka (engl.
English: a control = All patients had active RA despite treatment with stable methotrexate doses for 6 months prior to enrolment and were to remain on stable doses throughout the study.
Croatian: Prosječna vrijednost ± SDc a kontrolna skupina = svi su bolesnici imali aktivni reumatoidni artritis usprkos liječenju ustaljenim dozama metotreksata tijekom 6 mjeseci prije uključenja u ispitivanje i trebali su nastaviti s uzimanjem istih doza tijekom čitavog ispitivanja.
English: • Merkel cell carcinoma (a type of skin cancer)
Croatian: • zatajenje jetre • karcinom Merkelovih stanica (vrsta raka kože)
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 Zessly therapy.
Croatian: U bolesnika s već postojećim ili novonastalim demijelinizacijskim bolestima treba pažljivo procijeniti rizike i koristi anti-TNF terapije prije početka liječenja lijekom Zessly.
English: This will depend on your disease, weight and how well you respond to Zessly.
Croatian: Vašoj bolesti, tjelesnoj težini i odgovoru na liječenje.
English: In the paediatric Crohn's disease study 14, 112 patients (6 to 17 years, median age 13.0 years) with moderate to severe, active Crohn's disease (median paediatric CDAI of 40) and an inadequate response to conventional therapies were to receive 5 mg/kg infliximab at weeks 0, 2, and 6.
Croatian: U kliničkom ispitivanju Crohnove bolesti u pedijatrijskih bolesnika, 112 bolesnika (raspon dobi: 6-17 godina, medijan 13 godina) s umjerenom do teškom, aktivnom Crohnovom bolešću (srednji pedijatrijski CDAI bio je 40) i neodgovarajućim odgovorom na konvencionalnu terapiju primilo je infliksimab u dozi od 5 mg/kg u 0., 2. i 6. tjednu.
English: Placebo patients in the two Phase III studies in Crohn's disease, received an initial dose of 5 mg/kg infliximab at study start and were on placebo in the maintenance phase.
Croatian: 2 Bolesnici u placebo skupini u dva klinička ispitivanja faze III u Crohnovoj bolesti, primili su inicijalnu dozu infliksimaba od 5 mg/kg na početku ispitivanja, dok su u fazi održavanja primali placebo.
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.
Croatian: Potreban je oprez kad se razmatra mogućnost primjene lijeka Zessly u bolesnika s kroničnim ili rekurirajućim infekcijama, uključujući one koji istodobno primaju imunosupresive.
English: How Zessly is given
Croatian: Kako se primjenjuje Zessly
English: a Week 98 data for study 10 includes combined placebo crossover and infliximab patients who entered the open-label extension.
Croatian: a Podaci za 98. tjedan ispitivanja 10 uključuju i bolesnike koji su prebačeni sa liječenja placebom i one koji su primali infliksimab i ušli u fazu otvorenog ispitivanja.
English: In the Phase IIIb trial in Crohn's disease, placebo patients received AZA 2.5 mg/kg/day as active control in addition to placebo infliximab infusions.
Croatian: Crohnovoj bolesti, bolesnici u placebo skupini primali su AZA u dozi od 2,5 mg/kg/dan kao aktivnu kontrolu uz placebo infuzije infliksimaba.
English: Placebo (week 16)
Croatian: Placebo (16. tjeda n)
English: There is insufficient information regarding the concomitant use of infliximab with other biological therapeutics used to treat the same conditions as infliximab.
Croatian: Istodobna primjena s drugim biološkim lijekovima Nema dovoljno podataka o istodobnoj primjeni infliksimaba s drugim biološkim lijekovima koji se primjenjuju za liječenje istih stanja kao i infliksimab.
English: The combination of Zessly with other biological therapeutics used to treat the same conditions as Zessly, including anakinra and abatacept, is not recommended (see section 4.4).
Croatian: Ne preporučuje se primjena lijeka Zessly u kombinaciji s drugim biološkim lijekovima koji se primjenjuju za liječenje istih stanja kao i Zessly, uključujući anakinru i abatacept (vidjeti dio 4.4)
English: • It is important that you tell your baby's doctors and other health care professionals about your Zessly use before your baby is given any vaccine.
Croatian: • Važno je obavijestiti pedijatra Vašeg djeteta i druge zdravstvene radnike o Vašem primanju lijeka Zessly prije nego što Vaše dijete primi bilo koje cjepivo.
English: Zessly treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis.
Croatian: Liječenje lijekom Zessly uvodi se i provodi pod nadzorom liječnika specijaliste s iskustvom u dijagnosticiranju i liječenju reumatoidnog artritisa, upalnih bolesti crijeva, ankilozantnog spondilitisa, psorijatičnog artritisa ili psorijaze.
English: Bacterial infections (e.g. sepsis, cellulitis, abscess).
Croatian: Često: bakterijske infekcije (npr. sepsa, celulitis, apsces)
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).
Croatian: Rijetko: transverzalni mijelitis, demijelinizacijski poremećaji središnjeg živčanog sustava (bolest nalik multiploj sklerozi i optički neuritis), demijelinizacijski poremećaji perifernog živčanog sustava (kao što su Guillain-Barréov sindrom, kronična upalna demijelinizacijska polineuropatija i multifokalna motorička neuropatija)
English: In an exploratory clinical study evaluating the use of infliximab in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies were reported in infliximabtreated patients compared with control patients.
Croatian: U eksplorativnom kliničkom ispitivanju u kojem se ocjenjivala primjena infliksimaba u bolesnika s srednje teškom do teškom kroničnom opstruktivnom plućnom bolešću (KOPB), prijavljeno je više slučajeva zloćudnih bolesti u bolesnika liječenih infliksimabom nego u bolesnika u kontrolnoj skupini.
English: Study 10
Croatian: Ispitivanje 10
English: Under aseptic conditions, reconstitute each Zessly vial with 10 ml of water for injections, using a syringe equipped with a 21-gauge (0.8 mm) or smaller needle.
Croatian: U aseptičkim uvjetima, rekonstituirajte otopinu u svakoj bočici lijeka Zessly s 10 ml vode za injekcije, koristeći štrcaljku s iglom promjera 21 G (0,8 mm) ili užom.
English: A risk for the development for hepatosplenic T-cell lymphoma in patients treated with infliximab cannot be excluded (see section 4.8).
Croatian: Ne može se isključiti rizik od razvoja hepatospleničkog limfoma T-stanica u bolesnika koji se liječe infliksimabom (vidjeti dio 4.8).
English: 2nd dose
Croatian: 2. doza
English: Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFα but not to lymphotoxin α (TNFß).
Croatian: Infliksimab je kimerično ljudsko-mišje monoklonsko protutijelo koje se vezuje s velikim afinitetom za topive i transmembranske oblike faktora nekroze tumora alfa (TNFα), ali ne i za limfotoksin alfa (TNFβ).
English: Significant improvements in health-related quality of life were also demonstrated as measured by the physical and mental component summary scores of the SF-36 in study 11.
Croatian: Dokazano je i značajno poboljšanje kvalitete života povezane sa zdravljem, mjereno ukupnim zbrojem rezultata fizičkih i mentalnih parametara u upitniku SF-36 u ispitivanju 11. Psorijaza u odraslih bolesnika
English: • That treatment with Zessly may increase the risks of serious infections/sepsis, opportunistic infections, tuberculosis, hepatitis B reactivation, and BCG breakthrough in infants with in utero exposure to infliximab, and when to seek attention from a HCP
Croatian: • napomenu da liječenje lijekom Zessly može povećati rizik od ozbiljnih infekcija/sepse, oportunističkih infekcija, tuberkuloze, reaktivacije hepatitisa B i probojne infekcije BCG-om u dojenčadi koja je bila izložena infliksimabu in utero, te kada je potrebno zatražiti medicinsku pomoć od zdravstvenog radnika • kontakt podatke liječnika koji je propisao lijek
English: In the paediatric ulcerative colitis trial, the most common adverse reactions were upper respiratory tract infection, pharyngitis, abdominal pain, fever, and headache.
Croatian: U ispitivanju ulceroznog kolitisa u pedijatrijskih bolesnika najčešće nuspojave bile su infekcije gornjih dišnih puteva, faringitis, bol u abdomenu, vrućica i glavobolja.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing infliximab in all subsets of the paediatric population in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis and Crohn's disease (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja referentnog lijeka koji sadrži infliksimab u svim podskupinama pedijatrijske populacije u reumatoidnom artritisu, juvenilnom idiopatskom artritisu, psorijatičnom artritisu, ankilozantnom spondilitisu, psorijazi i Crohnovoj bolesti
English: The overall incidence of infections in the paediatric ulcerative colitis trial was 13/22 (59%) in the every 8 week maintenance treatment group and 14/23 (60.9%) in the every 12 week maintenance treatment group.
Croatian: Ukupna incidencija infekcija u ispitivanju ulceroznog kolitisa u pedijatrijskih bolesnika bila je 13/22 (59%) u skupini koja je primala terapiju održavanja svakih 8 tjedana, a 14/23 (60,9%) u skupini koja je tu terapiju primala svakih 12 tjedana.
English: Vaccine breakthrough infection (after in utero exposure to infliximab)*.
Croatian: Nepoznato: probojna infekcija uzrokovana cjepivom (nakon izlaganja infliksimabu in utero)*
English: Agranulocytosis (including infants exposed in utero to infliximab), thrombotic thrombocytopenic purpura, pancytopenia, haemolytic anaemia, idiopathic thrombocytopenic purpura.
Croatian: Rijetko: agranulocitoza (uključujući dojenčad izloženu infliksimabu in utero), trombotička trombocitopenična purpura, pancitopenija, hemolitička anemija, idiopatska trombocitopenična purpura
English: The proportion of patients with infections in the paediatric ulcerative colitis trial was similar to that in the paediatric Crohn's disease study but higher than the proportion in the adults' ulcerative colitis studies.
Croatian: Udio bolesnika s infekcijama u ispitivanju ulceroznog kolitisa u pedijatrijskih bolesnika bio je sličan kao u ispitivanju Crohnove bolesti u pedijatrijskih bolesnika, ali veći nego udio u ispitivanjima ulceroznog kolitisa u odraslih.
English: Date:
Croatian: Datum
English: In the second clinical study, (study 9), 279 patients were randomised to receive either placebo (Group 1, n = 78) or 5 mg/kg infliximab (Group 2, n = 201) at 0, 2, and 6 weeks and every 6 weeks to week 24.
Croatian: U drugom kliničkom ispitivanju (ispitivanje 9), 279 bolesnika randomizirano je u skupinu koja je primala placebo (skupina 1, n = 78) ili u skupinu koja je primala infliksimab u dozi od 5 mg/kg (skupina 2, n = 201) u 0., 2. i 6. tjednu, a zatim svakih 6 tjedana do ukupno 24 tjedna.
English: Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥ 10% and
Croatian: U oba su ispitivanja bolesnici imali plak psorijazu (zahvaćenost površine tijela,
English: Hepatitis, hepatocellular damage, cholecystitis.
Croatian: Manje često: hepatitis, hepatocelularna oštećenja, kolecistitis
English: infliximab Maintenance (5 mg/kg) (n = 96)
Croatian: Terapija održavanja infliksimabom (5 mg/kg) (n = 96)
English: Store at 2°C - 8°C.
Croatian: Čuvati na temperaturi od 2°C-8°C.
English: TB.
Croatian: tuberkulozu.
English: The safety and efficacy of infliximab were assessed in two (studies 6 and 7) randomised, doubleblind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6-MP, AZA)].
Croatian: Sigurnost i djelotvornost infliksimaba ispitivane su u dva randomizirana, dvostruko slijepa, placebom kontrolirana klinička ispitivanja (ispitivanja 6 i 7) u odraslih bolesnika s umjerenim do teškim, aktivnim ulceroznim kolitisom (Mayo bodovi 6 do 12; endoskopski ≥ 2), koji nisu odgovorili na konvencionalno liječenje na odgovarajući način [peroralne kortikosteroide, aminosalicilate i/ili imunomodulatore (6-MP, AZA)].
English: Cases of TB have been reported in patients treated with infliximab, even in patients who have already been treated with medicines for
Croatian: U bolesnika liječenih infliksimabom prijavljeni su slučajevi tuberkuloze, čak i u bolesnika koji su već bili liječeni lijekovima protiv TBC-a.
English: • Inflamed lining of the lung, causing sharp chest pains that feel worse with breathing
Croatian: • upala plućne ovojnice, koja uzrokuje oštru bol u prsnom košu koja se pogoršava disanjem
English: In vivo, infliximab rapidly forms stable complexes with human TNFα, a process that parallels the loss of TNFα bioactivity.
Croatian: In vivo, infliksimab brzo stvara stabilne komplekse s humanim TNFα,
English: Infliximab was studied in a clinical study in 120 patients (age range: 4-17 years old) with active juvenile rheumatoid arthritis despite methotrexate.
Croatian: Bolesnici s juvenilnim reumatoidnim artritisom Kliničko ispitivanje infliksimaba provedeno je u 120 bolesnika (dobni raspon: 4-17 godina) s aktivnim juvenilnim reumatoidnim artritisom usprkos liječenju metotreksatom.
English: Week 30
Croatian: 30. tjedan
English: Zessly contains the active substance infliximab.
Croatian: Zessly sadrži djelatnu tvar infliksimab.
English: Therefore, the combination of Zessly and anakinra is not recommended.
Croatian: Stoga se ne preporučuje kombinirana primjena lijeka Zessly i anakinre.
English: • Tell your doctor if you have any heart problems, such as mild heart failure.
Croatian: Problemi sa srcem • Obavijestite svog liječnika ako imate nekih problema sa srcem, npr. blagi stupanj zatajenja srca.
English: infliximabb
Croatian: Infliksimab
English: Patients received three doses of either placebo or infliximab at weeks 0, 2, and 6.
Croatian: Bolesnici su primili tri doze placeba ili infliksimaba u 0., 2. i 6. tjednu.
English: What you need to know before you use Zessly You should not be given Zessly if:
Croatian: Što morate znati prije nego počnete primati Zessly
English: Zessly is a biosimilar medicinal product.
Croatian: Zessly je biosličan lijek.
English: No physical biochemical compatibility studies have been conducted to evaluate the coadministration of Zessly with other agents.
Croatian: Nisu provedena ispitivanja fizikalno-biokemijske kompatibilnosti istodobne primjene lijeka Zessly s drugim lijekovima.
English: Viral infection (e.g. influenza, herpes virus infection).
Croatian: Vrlo često: virusne infekcije (npr. gripa, infekcija virusom herpesa)
English: Hepatic function abnormal, transaminases increased.
Croatian: Često: poremećaj funkcije jetre, povišene transaminaze
English: Carriers of HBV who require treatment with Zessly should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Croatian: Nositelje virusa hepatitisa B koji se moraju liječiti lijekom Zessly treba pažljivo nadzirati za vrijeme i nekoliko mjeseci nakon završetka liječenja kako bi se uočili mogući znakovi i simptomi aktivne HBV infekcije.
English: • treat active Crohn's disease
Croatian: • liječila aktivna Crohnova bolest
English: Re-administration for Crohn's disease and rheumatoid arthritis If the signs and symptoms of disease recur, Zessly can be re-administered within 16 weeks following the last infusion.
Croatian: Ako se ponovno pojave znakovi i simptomi bolesti, Zessly se može ponovno primijeniti u roku od 16 tjedana od zadnje infuzije.
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.
Croatian: Zessly se može čuvati na temperaturi do najviše 30°C neprekinuto tijekom razdoblja od najviše 6 mjeseci, ali ne izvan originalnog roka valjanosti.
English: Psoriatic arthritis, ankylosing spondylitis (Bechterew's disease), psoriasis, ulcerative colitis and Crohn's disease
Croatian: Psorijatični artritis, ankilozantni spondilitis (Bechterewljeva bolest), psorijaza, ulcerozni kolitis i
English: In study 12 in patients with plaque psoriasis, the proportion of patients achieving PASI 75 at week 10 was 71.7% in the 3 mg/kg infliximab group, 87.9% in the 5 mg/kg infliximab group, and 5.9% in the placebo group (p < 0.001).
Croatian: U ispitivanju 12 u bolesnika s plak psorijazom, udio bolesnika koji su postigli PASI 75 u 10. tjednu bio je 71,7% u skupini koja je primala infliksimab u dozi od 3 mg/kg, 87,9% u skupini koja je primala infliksimab u dozi od 5 mg/kg te 5,9% u skupini koja je primala placebo (p < 0,001).
English: A total of 306 patients received 3 doses of infliximab 5 mg/kg at week 0, 2, and 6.
Croatian: Ukupno je 306 bolesnika primilo 3 doze infliksimaba u dozi od 5 mg/kg u 0., 2. i 6. tjednu.
English: Table 4 Effects on ACRn, Structural Joint Damage and Physical Function at week 54, study 2
Croatian: Učinci na ACRn, strukturna oštećenja zglobova i funkcionalnu sposobnost u 54. tjednu,
English: • Tell your doctor before you are given Zessly if you have an infection, even if it is a very minor one.
Croatian: • Prije nego primite Zessly, obavijestite svog liječnika ako imate neku infekciju, čak i ako je vrlo blaga.
English: Approximately half of infliximab-treated patients in clinical studies who were ANA negative at baseline developed a positive ANA during the study compared with approximately one fifth of placebo-treated patients.
Croatian: Antinuklearna protutijela (ANA)/protutijela na dvolančanu DNK (dsDNK) Otprilike polovica bolesnika liječenih infliksimabom u kliničkim ispitivanjima koji su na početku ispitivanja bili negativni na ANA postali su pozitivni na ANA tijekom ispitivanja, u odnosu na približno jednu petinu bolesnika koji su primali placebo.
English: Change from baseline (Mean ± SDc) Median (Interquartile range)
Croatian: Promjena od početne vrijednosti (srednja vrijednost ± SDc)
English: If these medicines do not work well enough, you will be given Zessly to:
Croatian: Ako ti lijekovi ne djeluju dovoljno dobro, dobit ćete Zessly kako bi se:
English: In psoriatic arthritis, short-term treatment with infliximab reduced the number of T-cells and blood vessels in the synovium and psoriatic skin.
Croatian: U bolesnika s psorijatičnim artritisom kratkotrajno liječenje infliksimabom smanjilo je broj T-stanica i krvnih žila u sinovijalnoj membrani i koži zahvaćenoj psorijazom.
English: This applies to both Crohn's disease patients and rheumatoid arthritis patients.
Croatian: Crohnovom bolešću i na bolesnike s reumatoidnim artritisom.
English: > 40 weeks
Croatian: > 54 tjedna
English: infliximab Maintenance 5 mg/kg (n = 113) (p value)
Croatian: Terapija održavanja infliksimabom 5 mg/kg (n = 113) (p-vrijednost)
English: Nail psoriasis was assessed using the Nail Psoriasis Severity Index (NAPSI).
Croatian: Psorijaza noktiju procijenjena je pomoću indeksa težine psorijaze noktiju (engl.
English: Limit of Normal (ULN) have been observed (see Table 2).
Croatian: ALT ≥ 5 puta iznad gornje granice normale (GGN) (vidjeti Tablicu 2).
English: Table 7 Effects on response rate in patients with fistulising Crohn's disease, data from study 5 (week14 responders)
Croatian: Učinci na stopu odgovora u bolesnika s fistulirajućim oblikom Crohnove bolesti, podaci iz ispitivanja 5 (bolesnici s odgovorom u 14. tjednu)