natgillin/translations-raw huggingface dataset:
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. 
Pri otrocih so se pogosteje pojavili naslednji neželeni učinki: nizko število rdečih krvnih celic (anemija), kri v blatu, nizko celokupno število belih krvnih celic (levkopenija), rdečica ali zardevanje, virusne okužbe, nizko število belih krvnih celic, ki se borijo proti okužbi
Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for C-section (1.50, 1.14-1.96; p = 0.0032), preterm birth (1.48, 1.05-2.09; p = 0.024), small for gestational age (2.79, 1.54-5.04; p = 0.0007), and low birth weight (2.03, 1.41-2.94; p = 0.0002) was observed in women exposed during pregnancy to infliximab (with or without immunomodulators/corticosteroids, 270 pregnancies) as compared to women exposed to immunomodulators and/or corticosteroids only (6,460 pregnancies). 
Na podlagi severnoevropske opazovalne študije so pri ženskah, ki so bile v nosečnosti izpostavljene infliksimabu (z ali brez imunomodulatorjev/kortikosteroidov, 270 nosečnosti), v primerjavi z ženskami, ki so bile izpostavljene samo imunomodulatorjem in/ali kortikosteroidom (6.460 nosečnosti), opazili zvečano tveganje (OR; 95 % IZ; vrednost p) za carski rez (1,50; 1,14 - 1,96; p = 0,0032), prezgodnji porod (1,48; 1,05 - 2,09; p = 0,024), majhnost glede na gestacijsko starost (2,79; 1,54 - 5,04; p = 0,0007) in nizko porodno težo (2,03; 1,41 - 2,94; p = 0,0002).
a. Hold the syringe by its body in one hand between your thumb and index finger. 
a. Injekcijsko brizgo primite za ohišje s palcem in kazalcem.
• The other ingredients are acetic acid, sodium acetate trihydrate, sorbitol, polysorbate 80 and water for injections. 
• Pomožne snovi so ocetna kislina, natrijev acetat trihidrat, sorbitol, polisorbat 80 in voda za injekcije.
In the second clinical study (ASSERT), 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. 
V drugem preskušanju (ASSERT) so 279 bolnikov naključno razporedili bodisi v skupino, ki bo prejemala placebo (1. skupina, n = 78), ali pa v skupino, ki bo prejemala infliksimab v odmerku 5 mg/kg (2. skupina, n=201) v 0., 2. in 6. tednu in kasneje na vsakih 6 tednov, do 24. tedna.
In clinical studies with infliximab in which 5,780 patients were treated, representing 5,494 patient years, 5 cases of lymphomas and 26 non-lymphoma malignancies were detected as compared with no lymphomas and 1 non-lymphoma malignancy in 1,600 placebo-treated patients representing 941 patient years. 
V kliničnih študijah z infliksimabom, v katerih je bilo zdravljenih 5.780 bolnikov, to pomeni skupaj 5.494 bolnikov let, so odkrili 5 primerov limfoma in 26 nelimfomskih rakavih bolezni, pri 1.600 s placebom zdravljenih bolnikih, to pomeni skupaj 941 bolnikovih-let, pa nič limfomov in 1 nelimfomsko rakavo bolezen.
Infliximab Maintenance (5 mg/kg) (n=96) 
Vzdrževalno zdravljenje z infliksimabom (5 mg/kg) (n=96)
Induction treatment in fistulising active Crohn's disease The efficacy was assessed in a randomised, double-blinded, placebo-controlled study in 94 patients with fistulising Crohn's disease who had fistulae that were of at least 3 months' duration. 
Učinkovitost zdravila so ocenjevali tudi v randomizirani, dvojno slepi, s placebom kontrolirani študiji pri 94 bolnikih s Crohnovo boleznijo s fistulami, ki so trajale najmanj 3 mesece.
• The outer area of the upper arms (caregiver ONLY). 
• Zunanji del nadlahti (to smejo izvajati SAMO negovalci).
A population-based retrospective cohort study using data from Swedish national health registries 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. 
V populacijski retrospektivni kohortni študiji, v kateri so uporabili podatke iz švedskih nacionalnih zdravstvenih registrov, so ugotovili povečano pojavnost raka materničnega vratu pri ženskah z revmatoidnim artritisom zdravljenih z infliksimabom, v primerjavi z bolnicami, ki še niso prejemale bioloških zdravil, ali s splošno populacijo, vključno s starejšimi od 60 let.
• If you received Remsima while you were pregnant, your baby may also be at higher risk for getting an infection with live vaccines for up to six months after birth. 
• Če ste zdravilo Remsima prejemali v času nosečnosti, lahko tudi pri vašem dojenčku še šest mesecev po rojstvu obstaja večje tveganje, za okužbo z živimi cepivi.
In a subset of 90 adult patients with rheumatoid arthritis from the ASPIRE study a similar proportion of patients in each treatment group (methotrexate plus: placebo [n = 17], 3 mg/kg [n = 27] or 6 mg/kg infliximab [n = 46]) mounted an effective two-fold increase in titers to a polyvalent pneumococcal vaccine, indicating that infliximab did not interfere with T-cell independent humoral immune responses. 
V podskupini 90 odraslih bolnikov z revmatoidnim artritisom iz študije ASPIRE se je učinkovito dvakratno zvišanje titrov protiteles pri polivalentnem pnevmokoknem cepivu pokazalo pri podobnem deležu bolnikov iz vsake zdravljene skupine (metotreksat in: placebo [n = 17], infliksimab 3 mg/kg [n = 27] ali 6 mg/kg [n = 46]), kar kaže, da infliksimab ni motil od celic T neodvisne humoralne imunske odgovore.
Pharmacotherapeutic group: immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB02 
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci tumorje nekrotizirajočega faktorja alfa (TNFα), oznaka ATC: L04AB02.
b n = 292. c Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects). 
c Analiza se nanaša na preiskovance, ki so imeli psoriazo nohtov na začetku študije (81,8 % preiskovancev).
Remsima contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'. 
Zdravilo Remsima vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni "brez natrija".
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 and psoriasis (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje infliksimab, za vse podskupine pediatrične populacije z revmatoidnim artritisom, juvenilnim idiopatskim artritisom, psoriatičnim artritisom, ankilozirajočim spondilitisom in psoriazo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Indication Number of patients3 Median follow-up (wks)4 
Mediana dolžina spremljanja bolnikov (tedni)4
The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2 weeks regardless of weight. 
Običajni priporočeni odmerek zdravila Remsima za subkutano injiciranje je 120 mg enkrat na dva tedna ne glede na telesno maso.
b. Gently press a cotton ball or gauze over the injection site and hold for 10 seconds. 
b. Kosem vate ali gazo nežno pritisnite na mesto injiciranja in ga pridržite za 10 sekund.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA
• Tell your doctor before you are given Remsima if you have an infection even if it is a very minor one. 
• Preden prejmete zdravilo Remsima, povejte zdravniku, če imate okužbo, tudi če je zelo blaga.
If you were using Remsima during pregnancy, tell your baby's doctor and other health care professionals caring for your baby about your Remsima use before the baby receives any vaccines. 
Če ste prejemali zdravilo Remsima med nosečnostjo, je pomembno, da o tem obvestite otrokovega zdravnika in druge zdravstvene delavce, ki skrbijo za vašega dojenčka, preden vaš dojenček prejme katerokoli cepivo.
Do not dilute the reconstituted Remsima solution with any other diluent. 
Rekonstituirane raztopine zdravila Remsima ne redčite z nobeno drugo tekočino.
Contents of the pack and other information 
Shranjevanje zdravila Remsima Vsebina pakiranja in dodatne informacije
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. 
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 infliksimabom.
Infliximab Maintenance 5 mg/kg (n=113) (p value) 
Vzdrževalno zdravljenje z infliksimabom 5 mg/kg (n=113) (p vrednost)
Table 1 Adverse reactions in clinical studies and from post-marketing experience 
Neželeni učinki v kliničnih študijah in iz obdobja trženja zdravila
Single subcutaneous injections of 120, 180 and 240 mg of infliximab yielded approximately dose proportional increases in the maximum serum concentration (Cmax) and area under the concentrationtime curve (AUC). 
Približno sorazmerno s povečanjem enkratnega odmerka infliksimaba 120, 180 in 240 mg v subkutanih injekcijah sta se povečali tudi največja koncentracija tega zdravila v serumu (Cmaks) in površina pod krivuljo koncentracije po času (AUC).
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions. 
Če je ne uporabite takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik in navadno to ne bi smelo presegati 24 ur pri temperaturi 2°C - 8°C, razen če je rekonstitucija/redčenje potekala(o) v nadzorovanih in validiranih aseptičnih pogojih.
The apparent volume of distribution during the terminal phase (mean of 7.3 to 8.8 litres) was not dependent on the administered dose. 
(povprečje od 7,3 do 8,8 litra) ni bil odvisen od danega odmerka
The medicinal product must be discarded if not used within the 14-day period. 
Če zdravila ne uporabite v 14 dneh,
However, before Remsima is given to you, it is mixed with a solution that contains sodium. 
Zdravilo Remsima je pred uporabo zmešano z raztopino, ki vsebuje natrij.
In the first study (P01522), 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). 
V prvi študiji (P01522), 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).
All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g. persistent cough, wasting/weight loss, low-grade fever) appear during or after infliximab treatment. 
Bolniki morajo biti obveščeni, naj pridejo k zdravniku, če se v času zdravljenja z infliksimabom ali po njem pojavijo znaki ali simptomi, ki kažejo na tuberkulozo (npr. trdovraten kašelj, hujšanje ali nekoliko zvišana telesna temperatura).
In rheumatoid arthritis clinical studies, the incidence of serious infections including pneumonia was higher in infliximab plus methotrexate-treated patients compared with methotrexate alone especially at doses of 6 mg/kg or greater (see section 4.4). 
V študijah revmatoidnega artritisa so se resne okužbe vključno s pljučnico pojavile pogosteje pri bolnikih zdravljenih z infliksimabom skupaj z metotreksatom, če jih primerjamo s tistimi, zdravljenimi samo z metotreksatom posebno pri odmerkih 6 mg/kg ali višjih (glejte poglavje 4.4).
How much Remsima is given 
Koliko zdravila Remsima uporabiti
If serious reactions occur, symptomatic treatment must be given and further infliximab must not be administered (see section 4.8). 
Če se pojavijo resne reakcije, morate uvesti simptomatično zdravljenje in bolniku ne smete več dajati infliksimaba (glejte poglavje 4.8).
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. 
meningitis, oportunistične okužbe (npr. invazivne glivične okužbe [pnevmocistoza, histoplazmoza, aspergiloza, kokcidioidomikoza, kriptokokoza, blastomikoza], bakterijske okužbe [okužbe z atipičnimi mikobakterijami, listerioza,
Reports of lupus and lupus-like syndromes, however, remain uncommon (see section 4.4). 
Občasno poročajo o pojavu lupusa in lupusu podobnih sindromov (glejte poglavje 4.4).
In Group 2, starting with the week 36 infusion, patients who had a BASDAI ≥3 at 2 consecutive visits, received 7.5 mg/kg infliximab every 6 weeks thereafter through week 96. 
1. skupina je prejemala 5 mg/kg infliksimaba, v 2. skupini pa so od infuzije v 36. tednu vsi bolniki, ki so imeli BASDAI ≥ 3 pri 2 zaporednih obiskih, prejemali po 7,5 mg/kg infliksimaba na vsakih 6. tednov, do 96. tedna.
• 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. 
• 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, nabiranje ognojkov v črevesju ali okoli anusa (absces), težave z zobmi ali pekoč občutek med uriniranjem.
In clinical studies, mild or moderate elevations of ALT and AST have been observed in patients receiving infliximab without progression to severe hepatic injury. 
V kliničnih preskušanjih so opazili blago do zmerno zvišanje vrednosti ALT in AST pri bolnikih, ki so prejemali infliksimab, brez napredovanja motnje do hude jetrne poškodbe.
Intravenous formulation 
intravenska uporaba
Infliximab Maintenance 10 mg/kg (n=112) (p value) 
Vzdrževalno zdravljenje z infliksimabom 10 mg/kg (n=112) (p vrednost)
Re-administration for Crohn's disease and rheumatoid arthritis If the signs and symptoms of disease recur, infliximab can be re-administered within 16 weeks following the last infusion. 
Če se znaki in simptomi bolezni ponovijo, lahko infliksimab ponovno uporabite v roku 16 tednov po zadnji infuziji.
The ASPIRE study 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). 
V študiji ASPIRE so ovrednotili odzive v 54. tednu pri 1.004 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.
Prepare for the injection 1. 
Pripravite pripomočke za injiciranje.
Patients may be pre-treated with e.g., an antihistamine, hydrocortisone and/or paracetamol and infusion rate may be slowed in order to decrease the risk of infusion-related reactions especially if infusion-related reactions have occurred previously (see section 4.4). 
Za zmanjšanje tveganja za pojav z infuzijo povezanih reakcij lahko bolnikom že prej date npr. antihistaminik, hidrokortizon in/ali paracetamol in upočasnite hitrost infundiranja, še posebej, če so se z infuzijo povezane reakcije pojavile že kdaj prej (glejte poglavje 4.4).
b. Push the plunger down slowly and as far as it will go until the syringe is empty. 
b. Bat počasi potisnite do konca, dokler ni injekcijska brizga prazna.
* p-values represent each infliximab treatment group vs. AZA monotherapy. 
(p = 0,001)* * P vrednosti predstavljajo vsako skupino, zdravljeno z infliksimabom, v primerjavi z monoterapijo z AZA.
The pharmacokinetics of infliximab injected via subcutaneous route in elderly patients has not been studied. 
Farmakokinetike infliksimaba, injiciranega subkutano pri starejših bolnikih, niso raziskovali.
vomiting, fluttering or pounding in your chest, a fast or a slow heartbeat, and swelling of your feet. 
(občutek slabosti), bruhanje, drhtenje ali razbijanje v prsnem košu, hitro ali počasno bitje srca in otekanje stopal.
How to use Remsima 
Kako uporabljati zdravilo Remsima
Do not touch the needle. 
Ne prijemajte igle.
In clinical studies with intravenous infliximab, delayed hypersensitivity reactions have been uncommon and have occurred after infliximab-free intervals of less than 1 year (see sections 4.4 and 4.8). 
V kliničnih študijah z intravenskim infliksimabom so bile pozne preobčutljivostne reakcije občasne in so se pojavile po premoru brez prejemanja infliksimaba manj kot 1 leto (glejte poglavji 4.4 in 4.8).
Overall, 8 (13.3%) of 60 treated patients experienced one or more infusion reactions, with 4 of 22 (18.2%) in the q8 week and 3 of 23 (13.0%) in the q12 week treatment maintenance group. 
Skupaj se je ena ali več infuzijskih reakcij pojavilo pri 8 (13,3 %) od 60 zdravljenih bolnikov in sicer pri 4 od 22 (18,2 %) v skupini, ki je dobivala vzdrževalno zdravljenje na 8 tednov, in pri 3 od 23 (13,0 %) v skupini, ki je dobivala vzdrževalno zdravljenje na 12 tednov.
Complete fistula response (%)b a A ≥50% reduction from baseline in the number of draining fistulas over a period of ≥4 weeks. 
Odziv fistule (%) a Popoln odziv fistule (%) b a Zmanjšanje števila fistul z izcedkom za ≥ 50 % glede na stanje na začetku študije v obdobju
Remsima 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. 
Zdravilo Remsima 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.
• Do not reuse the syringe. 
• Injekcijske brizge ne smete ponovno uporabiti.
(≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to 
V okviru razvrstitve po organskih sistemih so neželeni učinki razvrščeni po naslednjih kategorijah pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki
Remsima 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 psoralen ultra-violet A (PUVA) (see section 5.1). 
Zdravilo Remsima je indicirano za zdravljenje zmerne do hude psoriaze s plaki pri odraslih bolnikih, ki se niso odzvali na druge sistemske terapije, na primer ciklosporin, metotreksat ali psoralen in obsevanje z ultravijolično svetlobo A (PUVA) (glejte poglavje 5.1), ali pa imajo kontraindikacijo zanje ali jih ne prenašajo.
• Do not breast-feed when you are being treated with Remsima or for 6 months after your last treatment with Remsima. 
• Med zdravljenjem z zdravilom Remsima in še 6 mesecev po zadnjem zdravljenju ne smete dojiti.
Since no preservative is present, it is recommended that the administration of the solution for infusion is to be started as soon as possible and within 3 hours of reconstitution and dilution. 
priporočamo, da z dajanjem infuzije začnete čim prej, v roku 3 ur po rekonstituciji in redčenju.
• Do not use the syringe if it has been dropped or is visibly damaged. 
• Injekcijske brizge ne smete uporabiti, če je padla na tla ali če ima vidne znake poškodb.
At week 12, the number of BASDAI 50 responders were 3/35 (9%) in the placebo group, and 20/35 (57%) in the 5 mg/kg group (p<0.01). 
V 12. tednu je bilo število bolnikov z odzivom BASDAI 50 v skupini za placebo 3 od 35 (9 %), v skupini, ki je prejemala odmerek 5 mg/kg pa 20 od 35 (57 %) (p< 0,01).
Pack sizes of 1, 2, 3, 4, 5 vials. 
Zdravilo Remsima je pakirano po 1, 2, 3, 4 ali 5 vial.
The dilution can be accomplished by withdrawing a volume of the sodium chloride 9 mg/mL (0.9%) solution for infusion from the 250-mL glass bottle or infusion bag equal to the volume of reconstituted Remsima. 
To naredite tako, da iz 250 ml steklenice ali infuzijske vrečke odvzamete tisti volumen 9 mg/ml (0,9 %) raztopine natrijevega klorida za infundiranje, ki ustreza volumnu rekonstituiranega zdravila Remsima.
• Signs of a lung problem such as coughing, breathing difficulties or tightness in the chest. 
• znaki težav s pljuči, na primer kašelj, težave z dihanjem ali stiskanje v prsih.
Change from baseline in total van der Heijde-modified Sharp scoreb Mean ± SDa 
Sprememba z začetne vrednosti za skupni rezultat po metodi van der Heijde, modificirani po Sharpub Srednja vrednost ± SDa Mediana
• Tell your doctor before you are given Remsima if you are a carrier of hepatitis B or have ever had it. 
• Preden prejmete zdravilo Remsima, povejte zdravniku, če ste prenašalec hepatitisa B ali če ste ga imeli kdaj v preteklosti.
In the post-marketing setting, cases of leukaemia have been reported in patients treated with a TNF-antagonist. 
Pri spremljanju zdravila v obdobju trženja so poročali o primerih levkemije pri bolnikih zdravljenih z zaviralec TNF.
Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤18 years of age), including infliximab in the post-marketing setting. 
Maligne in limfoproliferativne bolezni Pri otrocih, mladostnikih in mlajših odraslih (do 22 let starosti), ki so se zdravili z zaviralci TNF (z začetkom zdravljenja pri starosti ≤ 18 let), vključno z infliksimabom v obdobju trženja zdravila, so poročali o pojavu malignomov, od katerih so bili nekateri smrtni.
The safety and efficacy of Remsima subcutaneous therapy in children aged below 18 years of age have not yet been established. 
Varnost in učinkovitost terapije z zdravilom Remsima v subkutani obliki pri otrocih, mlajših od 18 let,
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%). 
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 %).
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. 
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.