FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: so bolniki iz placebo skupine, poleg placebo infuzij infliksimaba, prejemali kot kontrolno učinkovino AZA v odmerku 2,5 mg/kg na dan.
English: infliximabb
Slovenian: Zessly infliksimab
English: • Pain in the joints, muscles or back
Slovenian: • bolečine v sklepih, mišicah ali hrbtu • okužbe sečil
English: • You should avoid getting pregnant when you are being treated with Zessly and for 6 months after you stop being treated with it.
Slovenian: • Če prejemate zdravilo Zessly, je treba preprečiti nosečnost med zdravljenjem in še vsaj 6 mesecev po prenehanju zdravljenja.
English: Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) in a randomised, double blinded, placebo-controlled, dose-response study.
Slovenian: Začetno zdravljenje pri zmerno do močno aktivni Crohnovi bolezni Učinkovitost infliksimaba v enkratnem odmerku so ocenjevali pri 108 bolnikih z aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 ≤ 400) v randomizirani, dvojno slepi s placebom kontrolirani študiji odziva na različne odmerke zdravila.
English: At single doses of 3, 5, or 10 mg/kg, the median Cmax values were 77, 118, and 277 micrograms/ml, respectively.
Slovenian: Cmaks 77, 118 in 277 mikrogramov/ml.
English: infliximab (week 98)
Slovenian: Infliksimab (98. teden)
English: infliximab (week 24)
Slovenian: Infliksimab (24. teden)
English: Immune system disorders Common:
Slovenian: Bolezni imunskega sistema pogosti:
English: Signs include persistent fever, bleeding or bruising more easily, small red or purple spots caused by bleeding under the skin, or looking pale.
Slovenian: Znaki vključujejo dolgotrajno zvišano telesno temperaturo, večjo nagnjenost h krvavitvam ali nastanku podplutb, majhne rdeče ali vijoličaste pike, ki jih povzroči podkožna krvavitev, ali bledico.
English: * P-values represent each infliximab treatment group vs. AZA monotherapy.
Slovenian: (p < 0,001)* * P vrednosti predstavljajo vsako skupino, zdravljeno z infliksimabom, v primerjavi z monoterapijo z AZA.
English: At 54 weeks, 44.9% of patients in the combined infliximab treatment group were in clinical response compared to 19.8% in the placebo treatment group (p < 0.001).
Slovenian: (združeni) skupini, ki se je zdravila z infliksimabom, kazalo klinični odziv, v primerjavi z 19,8 % v skupini, ki je prejemala placebo (p < 0,001).
English: Efficacy and safety of infliximab were assessed in two multicenter, double-blind, placebocontrolled studies 8 and 9 in patients with active ankylosing spondylitis (Bath Ankylosing
Slovenian: Učinkovitost in varnost infliksimaba so ocenjevali v dveh multicentričnih, dvojno slepih, s placebom nadzorovanih študijah 8 in 9 pri bolnikih z aktivnim ankilozirajočim spondilitisom (Bathov indeks aktivnosti ankilozirajočega spondilitisa [BASDAI] ≥ 4 in indeks jakosti bolečin v hrbtenici ≥ 4 na lestvici od 1 do 10).
English: Patients treated with Zessly should be given the package leaflet and the patient reminder card.
Slovenian: Bolniki, zdravljeni z zdravilom Zessly, morajo prejeti navodilo za uporabo in opozorilno kartico za bolnika.
English: Tell your doctor straight away if you get signs of infection during treatment with Zessly.
Slovenian: Zdravniku takoj povejte, če ste dobili simptome okužbe med zdravljenjem z zdravilom Zessly.
English: • The other ingredients are disodium succinate hexahydrate, succinic acid, sucrose, polysorbate 80.
Slovenian: • Pomožne snovi so dinatrijev sukcinat heksahidrat, jantarna kislina, saharoza, polisorbat 80.
English: Infections were reported in 31 (51.7%) of 60 treated patients in the paediatric ulcerative colitis trial and 22 (36.7%) required oral or parenteral antimicrobial treatment.
Slovenian: od 60 zdravljenih bolnikov in 22 (36,7 %) jih je potrebovalo peroralno ali parenteralno protimikrobno zdravljenje.
English: Limit of Normal (ULN) have been observed (see Table 2).
Slovenian: Opazili so zvišanje vrednosti ALT na ≥ 5-kratnik zgornje meje normalnih vrednosti (glejte preglednico 2).
English: Paediatric ulcerative colitis
Slovenian: Pediatrični ulcerozni kolitis
English: • Swelling of the liver (hepatitis) or gall bladder, liver damage
Slovenian: • počasnejše celjenje ran • otekanje jeter (hepatitis) ali žolčnika, okvara jeter
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 hudega bronhospazma, ter epileptičnimi napadi (glejte poglavje 4.4).
English: Zessly 100 mg powder for concentrate for solution for infusion infliximab
Slovenian: Zessly 100 mg prašek za koncentrat za raztopino za infundiranje infliksimab
English: Elevations of ALT ≥ 5 x Upper
Slovenian: ≥ 3-kratnik ZMN ≥ 5-kratnik ZMN
English: • Periodic safety update reports (PSUR)
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU
English: • Side effect due to an infusion
Slovenian: • neželeni učinek zaradi infuzije • bolečine
English: Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Zessly.
Slovenian: Zdravniku povejte takoj, če se pojavijo simptomi nevrološke bolezni med zdravljenjem z zdravilom Zessly.
English: b n = 292. c Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
Slovenian: Analiza se nanaša na preiskovance, ki so imeli psoriazo nohtov na začetku študije (81,8 % preiskovancev).
English: Zessly 100 mg powder for concentrate for solution for infusion.
Slovenian: Zessly 100 mg prašek za koncentrat za raztopino za infundiranje
English: Patients received three doses of either placebo or infliximab at weeks 0, 2, and 6.
Slovenian: Bolniki so prejeli tri odmerke bodisi placeba ali infliksimaba na začetku, po 2 tednih in po 6 tednih.
English: Signs include a fever, feeling tired, (persistent) cough, shortness of breath, weight loss, night sweats, diarrhoea, wounds, dental problems, burning when urinating or ‘flu-like' signs.
Slovenian: Ti znaki so zvišana telesna temperatura, utrujenost, (trdovraten) kašelj, kratka sapa, izguba telesne mase, nočno potenje, driska, rane, težave z zobmi, pekoče uriniranje ali gripi podobni znaki.
English: Discontinuation of Zessly therapy should be considered in patients with confirmed significant haematologic abnormalities.
Slovenian: Pri bolnikih s potrjenimi bistvenimi hematološkimi anomalijami lahko tudi ukinete zdravljenje z zdravilom Zessly.
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 vijoličaste pike zaradi podkožne krvavitve ali bledica;
English: Ulcerative colitis
Slovenian: • Ulcerozni kolitis
English: • Severely decreased numbers of white blood cells have been reported in infants born to women treated with infliximab during pregnancy.
Slovenian: • Pri dojenčkih, rojenih materam, ki so bile med nosečnostjo zdravljenje z infliksimabom, so poročali o močnem znižanju števila belih krvnih celic.
English: Maintenance treatment in fistulising active Crohn's disease
Slovenian: Vzdrževalno zdravljenje pri aktivni Crohnovi bolezni s fistulami
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: Varnosti in učinkovitosti ponovne uporabe zdravila, razen na vsakih 6 do 8 tednov, še niso ugotovili
English: Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Zessly.
Slovenian: Zdravniku povejte takoj, če se med zdravljenjem z zdravilom Zessly pojavijo novi znaki srčnega popuščanja ali se obstoječi znaki poslabšajo.
English: Patients with moderate or severe heart failure (NYHA class III/IV) (see sections 4.4 and 4.8).
Slovenian: Bolniki z zmernim do hudim srčnim popuščanjem (razred III/IV po NYHA)
English: How to store Zessly
Slovenian: Kako uporabljati zdravilo Zessly
English: infliximab (week 16)
Slovenian: Infliksimab (16. teden)
English: Each Zessly vial contains 100 mg infliximab.
Slovenian: Ena viala vsebuje 100 mg infliksimaba.
English: After preparation each ml contains 10 mg of infliximab.
Slovenian: Po pripravi en ml vsebuje 10 mg infliksimaba.
English: The primary endpoint of the study was corticosteroid-free clinical remission at week 26, defined as patients in clinical remission (CDAI of < 150) who, for at least 3 weeks, had not taken oral systemic corticosteroids (prednisone or equivalent) or budesonide at a dose > 6 mg/day.
Slovenian: CDAI < 150), ki najmanj 3 tedne niso jemali peroralnih sistemskih kortikosteroidov (prednizona oziroma njemu enakovrednih kortikosteroidov) ali budezonida v odmerku > 6 mg/dan.
English: Ankylosing spondylitis Psoriatic arthritis Plaque psoriasis
Slovenian: Ankilozirajo či spondilitis 76 Psoriatični artritis
English: • Ankylosing spondylitis (Bechterew's disease)
Slovenian: • Psoriatični artritis • Ankilozirajoči spondilitis (Bechterew sindrom)
English: • Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson Syndrome and acute generalised exanthematous pustulosis
Slovenian: toksična epidermalna nekroliza, Stevens-Johnsonov sindrom,
English: • 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
English: No physical biochemical compatibility studies have been conducted to evaluate the coadministration of Zessly with other agents.
Slovenian: Študije za ovrednotenje fizikalno biokemične združljivosti zdravila Zessly z drugimi zdravili niso bile izvedene, zato ga ne smete dati sočasno v isti intravenski liniji z drugimi zdravili.
English: Discontinuation of Zessly should be considered if these disorders develop.
Slovenian: Če se pojavijo te motnje, je potrebno razmisliti o ukinitvi zdravila Zessly.
English: Neutropenia, leukopenia, anaemia, lymphadenopathy.
Slovenian: nevtropenija, levkopenija, anemija, limfadenopatija občasni:
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: Varnosti in učinkovitosti ponovne uporabe, razen na vsakih 8 tednov, še niso ugotovili
English: In the controlled portions of clinical studies of TNF-blocking agents, more cases of malignancies including lymphoma have been observed among patients receiving a TNF blocker compared with control patients.
Slovenian: V kontroliranih delih kliničnih študij zaviralcev TNF so opažali več primerov rakavih bolezni,
English: 10 mg/kg Combined
Slovenian: 10 mg/kg
English: Tell your doctor straight away if you get symptoms of low blood counts during treatment with Zessly.
Slovenian: Takoj obvestite zdravnika, če se med zdravljenjem z zdravilom Zessly pojavijo simptomi nizkega števila krvnih celic.
English: Vertigo, dizziness, hypoesthesia, paraesthesia.
Slovenian: vrtoglavica, omotica, hipestezija, parestezije občasni:
English: • Other skin problems such as erythema multiforme, lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes), blisters and peeling skin, or boils (furunculosis)
Slovenian: • resne težave s kožo, na primer toksična epidermalna nekroliza, Stevens-Johnsonov sindrom in akutna generalizirana eksantematozna pustuloza • ostale težave s kožo, kot so multiformni eritem, lihenoidne reakcije (srbeč rdeče-vijoličast kožni izpuščaj in/ali belo-sive nitaste črte na sluznicah), mehurji na koži in luščenje kože, ali turi
English: 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 Zessly.
Slovenian: Razredčite 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, nato pa vanjo počasi dodajte celoten volumen rekonstituirane raztopine zdravila Zessly in rahlo premešajte.
English: Zessly contains Sodium
Slovenian: Zdravilo Zessly vsebuje natrij
English: 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age),
Slovenian: Pri otrocih, mladostnikih in mlajših odraslih (do 22 let starosti), ki so se zdravili z zaviralci TNF
English: If active tuberculosis is diagnosed, Zessly therapy must not be initiated (see section 4.3).
Slovenian: Če postavite diagnozo aktivne tuberkuloze, ne smete uvesti zdravljenja z zdravilom Zessly
English: Post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with TNF-blocking agents including infliximab.
Slovenian: Dodatno so v obdobju trženja poročali o primerih hepatospleničnega limfoma celic T pri bolnikih, ki so se zdravili z infliksimabom.
English: • Rheumatoid arthritis
Slovenian: • Revmatoidni artritis
English: Zessly.
Slovenian: pielonefritis
English: During the 24-week double blind phase, patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6, 14, and 22
Slovenian: V 24-tedenski dvojno slepi fazi študije so bolniki prejemali bodisi 5 mg/kg infliksimaba ali pa placebo v 0., 2., 6., 14. in 22. tednu (100 bolnikov v vsaki skupini).
English: Patients should be tested for HBV infection before initiating treatment with Zessly.
Slovenian: Pred začetkom zdravljenja z zdravilom Zessly, morate bolnike testirati na okužbo z virusom hepatitisa B (HBV).
English: Toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, furunculosis, linear IgA bullous dermatosis (LABD), acute generalised exanthematous pustulosis (AGEP), lichenoid reactions.
Slovenian: multiformni eritem, furunkuloza, linearna IgA bulozna dermatoza (LABD), akutna generalizirana eksantematozna pustuloza (AGEPacute generalised exanthematous pustulosis), lihenoidne reakcije neznana pogostnost: poslabšanje simptomov dermatomiozitisa
English: Tell your doctor straight away if you develop symptoms of lupus during treatment with Zessly.
Slovenian: Takoj obvestite zdravnika, če se med zdravljenjem z zdravilom Zessly pojavijo simptomi lupusa.
English: Table 8 Effects on clinical response in adult patients with moderately to severely active ulcerative colitis, clinical remission and mucosal healing at weeks 8 and 30.
Slovenian: Učinki na klinični odziv pri bolnikih z zmerno do močno aktivnim ulceroznim kolitisom,
English: Zessly is a biosimilar medicinal product.
Slovenian: Zdravilo Zessly je podobno biološko zdravilo.
English: * ITT-analysis where subjects with missing data were included as non-responders.
Slovenian: N Odziv PASI 75** * Analiza namere zdravljenja (ITT), v kateri so preiskovance brez nekaterih podatkov šteli med neodzivne bolnike a
English: Type 1 glass vial with rubber stopper and aluminium crimp protected by a plastic cap. Zessly is available in packs containing 1, 2, 3, 4 or 5 vials.
Slovenian: Viala (steklo tipa 1) z gumijastim zamaškom in aluminijasto zaporko, zaščiteno s plastično ploščico.
English: All patients were required to be on a stable dose of 6-MP, AZA or MTX (35% were also receiving corticosteroids at baseline).
Slovenian: Vsi bolniki so morali prejemati stalen odmerek 6-MP, AZA ali MTX
English: After reconstitution each ml contains 10 mg of infliximab.
Slovenian: Po rekonstituciji vsebuje en ml 10 mg infliksimaba.
English: • Skin problems such as blistering, warts, abnormal skin colouration or pigmentation, or swollen lips, or thickening of the skin, or red, scaly, and flaky skin
Slovenian: otekle ustnice, ali zadebelitev kože ali rdeča, krastasta in luskasta koža
English: 10 mg/kg q 8 wks
Slovenian: 10 mg/kg na 8 tedno v
English: The powder is a freeze-dried white pellet.
Slovenian: prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat) Prašek vsebuje liofilizirane bele pelete.
English: • Bruising, hot flush or nosebleed, warm, red skin (flushing)
Slovenian: • podplutbe, vročinski oblivi ali krvavitev iz nosu, topla in pordela koža (zardevanje) • občutek utrujenosti ali šibkosti
English: 3 mg/kg q 8 wks
Slovenian: 3 mg/kg na 8 tedno v
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
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: • Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease,
Slovenian: • multiformni eritem, mehurji na koži in luščenje kože, ali turi (furunkuloza) • resne težave z živčevjem, na primer transverzni mielitis, multipli sklerozi podobna bolezen,
English: Mean ± SDc b all infliximab doses given in combination with methotrexate and folate with some on corticosteroids and/or NSAIDs c p < 0.001, for each infliximab treatment group vs. control d greater values indicate more joint damage.
Slovenian: do 54. tednac Srednja vrednost ± SDd a p < 0,001 za vsako terapevtsko skupino, ki je prejemala infliksimab, v primerjavi s kontrolno skupino b večje vrednosti pomenijo večjo okvaro sklepov c
English: In psoriatic arthritis, short-term treatment with infliximab reduced the number of T-cells and blood vessels in the synovium and psoriatic skin.
Slovenian: Pri psoriatičnem artritisu je kratkotrajno zdravljenje z infliksimabom zmanjšalo število celic
English: Children who took infliximab for Crohn's disease showed some differences in side effects compared with adults who took infliximab for Crohn's disease.
Slovenian: Neželeni učinki pri otrocih in odraslih, ki so prejemali infliksimab za zdravljenje Crohnove bolezni, so se nekoliko razlikovali.
English: If these medicines do not work well enough, you will be given Zessly which you will take in combinationwith another medicine called methotrexate to:
Slovenian: Če ta zdravila ne delujejo dovolj dobro, boste prejeli zdravilo Zessly skupaj z zdravilom metotreksat za: • zmanjšanje znakov in simptomov te bolezni,
English: Fertility
Slovenian: heilitis
English: In a clinical study of patients with rheumatoid arthritis, infusions were to be administered over 2 hours for the first 3 infusions.
Slovenian: V klinični študiji pri bolnikih z revmatoidnim artritisom so pri prvih 3 infuzijah zdravilo infundirali v času 2 ur, pozneje pa so pri tistih bolnikih, ki niso imeli resne z infuzijo povezane reakcije, trajanje infuzij skrajšali na 40 minut, vendar ne manj.
English: Percentage of subjects in clinical response and in sustained clinical response
Slovenian: Odstotek preiskovancev s kliničnim odzivom in trajnejšim kliničnim odzivom Klinični odziv v 8. tednua
English: Although comparative data are lacking, limited data in patients who initially responded to 5 mg/kg but who lost response indicate that some patients may regain response with dose escalation (see section 5.1).
Slovenian: Čeprav so omejeni razpoložljivi podatki o bolnikih, ki so se najprej odzvali na odmerek 5 mg/kg,
English: More signs of allergic side effects that may happen up to 12 days after your injection include pain in the muscles, fever, joint or jaw pain, sore throat or headache.
Slovenian: Drugi znaki z alergijo povezanih neželenih učinkov, ki se lahko pojavijo do 12 dni po prejemu injekcije, so bolečina v mišicah, zvišana telesna temperatura, bolečine v sklepih ali v čeljusti, vnetje žrela ali glavobol; • znaki težav s srcem, na primer nelagodje ali bolečina v prsnem košu, bolečina v roki, bolečina v trebuhu, kratka sapa, tesnoba, vrtoglavica, omotica, omedlevica, potenje, siljenje na bruhanje
English: In clinical studies, infections have been reported in a higher proportion of paediatric patients compared to adult patients (see section 4.8).
Slovenian: V kliničnih študijah so o okužbah poročali pogosteje pri pediatričnih bolnikih kot pri odraslih bolnikih
English: Concurrent use of stable doses of oral corticosteroids (≤ 10 mg/day) and/or NSAIDs was permitted, and folate supplementation was given.
Slovenian: (≤ 10 mg/dan) in/ali NSAID je bila dovoljena, bolniki pa so prejemali tudi dodatke folata.
English: Tell your doctor straight away if you get symptoms of liver problems during treatment with Zessly.
Slovenian: Takoj obvestite zdravnika, če se med zdravljenjem z zdravilom Zessly pojavijo simptomi težav z jetri.
English: Infliximab does not cross react with TNFα from species other than human and chimpanzee.
Slovenian: Infliksimab ne reagira navzkrižno s TNFα drugih vrst, le s človeškim in šimpanzovim, zato je malo konvencionalnih predkliničnih podatkov o varnosti infliksimaba.
English: • It is very important that you tell your doctor if you have ever had TB, or if you have been in close contact with someone who has had TB.
Slovenian: če ste kdaj imeli tuberkulozo ali če ste bili v tesnem stiku s tuberkuloznim bolnikom.
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.
Slovenian: Uporabite brizgo z iglo premera 0,8 mm (21 G) ali tanjšo.
English: • A hole in the bowel or blockage of the intestine, stomach pain or cramps
Slovenian: • epileptični krči, težave z živčevjem • odprtina v debelem črevesju ali zamašitev tankega črevesja, želodčne bolečine ali krči
English: Controla
Slovenian: uporabo
English: PASI 75 response**
Slovenian: ACR 70*
English: Adult ankylosing spondylitis
Slovenian: Ankilozirajoči spondilitis pri odraslih bolnikih
English: Induction treatment in fistulising active Crohn's disease
Slovenian: Začetno zdravljenje pri aktivni Crohnovi bolezni s fistulami
English: Headache.
Slovenian: bolnikov.
English: The primary endpoint was the proportion of patients who experienced a clinical response, defined as a decrease in CDAI by ≥ 70 points from baseline at the 4-week evaluation and without an increase in the use of medicinal products or surgery for Crohn's disease.
Slovenian: za ≥ 70 točk od izhodiščne vrednosti ob pregledu v 4. tednu zdravljenja, z nespremenjeno potrebo po zdravilih ali operativnih posegih za zdravljenje Crohnove bolezni.
English: Overall, the adverse reactions reported in the paediatric ulcerative colitis trial and adult ulcerative colitis studies were generally consistent.
Slovenian: Neželeni učinki, o katerih so poročali v preskušanju pri pediatričnih bolnikih z ulceroznim kolitisom, so bili večinoma v skladu z neželenimi učinki, o katerih so poročali v študijah pri odraslih bolnikih z ulceroznim kolitisom.
English: mg/kg infliximab or placebo infusions at weeks 0, 2 and 6.
Slovenian: Bolniki so prejeli bodisi 3 ali 5 mg/kg infliksimaba ali placeba v infuziji v tednih 0, 2 in 6.
English: • You may get infections more easily when you are being treated with Zessly.
Slovenian: • Med zdravljenjem z zdravilom Zessly se lahko poveča dovzetnost za okužbe.
English: There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates risk estimation.
Slovenian: Pri bolnikih z revmatoidnim artritisom, ki imajo dolgotrajno, močno aktivno vnetno bolezen, je osnovno tveganje za limfom in levkemijo povečano,
English: Percentage of subjects in clinical remission and sustained remission
Slovenian: Odstotek preiskovancev v klinični remisiji in trajnejši remisiji Klinična remisija v 8. tednua