FrancophonIA/ELRC3.0 huggingface dataset:
English: The solution must not be used if opaque particles, discolouration, or other foreign particles are present.
Slovenian: Raztopine ne smete uporabiti, če so prisotni neprosojni delci, obarvanje ali drugi tuji delci.
English: b CDAI < 150 at both week 30 and 54 and not receiving corticosteroids in the 3 months prior to week 54
Slovenian: b CDAI< 150 tako v 30. tednu kot v 54. tednu, brez prejemanja kortikosteroidov v 3 mesecih pred 54. tednom pri bolnikih, ki so prejemali kortikosteroide na začetku študije
English: Inflectra is produced in packs of 1, 2, 3, 4, or 5 vials.
Slovenian: Zdravilo Inflectra je pakirano po 1, 2, 3, 4 ali 5 vial.
English: TNF alpha is involved in inflammatory processes of the body so blocking it can reduce the inflammation in your body.
Slovenian: TNF alfa sodeluje v procesu vnetja, zato se z zaviranjem tega faktorja lahko zmanjša vnetje v vašem telesu.
English: In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6,234 patients-years (3,210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma malignancies were reported.
Slovenian: Pri spremljanju dolgoročne varnosti infliksimaba do 5 let po kliničnih študijah, to pomeni pri skupaj 6.234 bolnikiov-let (3.210 bolnikov), pa so poročali o 5 primerih limfoma in 38 primerih nelimfomskih rakavih bolezni.
English: If patients are re-treated after a prolonged period, they must be closely monitored for signs and symptoms of delayed hypersensitivity.
Slovenian: Če bolnik po daljšem obdobju ponovno prejme infliksimab, ga morate skrbno spremljati zaradi morebitnega pojava znakov in simptomov pozne preobčutljivosti.
English: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last infliximab treatment.
Slovenian: Ženske v rodni dobi morajo za preprečevanje nosečnosti razmisliti o uporabi ustrezne kontracepcije in z njo nadaljevati še najmanj 6 mesecev po zaključku zdravljenja z infliksimabom.
English: • Tell your doctor straight away if you have signs of an infection.
Slovenian: • Zdravniku nemudoma povejte, če imate znake okužbe.
English: The flip-top from the vial has to be removed and the top has to be wiped with a 70% alcohol swab.
Slovenian: »Flip-off« sistem na zaporki viale odstranite in njen vrh obrišite z zložencem, prepojenim s 70 % alkoholom.
English: The dose and the number of Inflectra vials have to be calculated.
Slovenian: Odmerek in število potrebnih vial zdravila Inflectra morate izračunati.
English: • Treatment with TNF blockers such as Inflectra may result in reactivation of hepatitis B virus in patients who carry this virus, which can be life-threatening in some cases.
Slovenian: • Zdravljenje z zaviralci TNF, kot je zdravilo Inflectra, lahko vodi do reaktivacije virusa hepatitisa B pri bolnikih, ki prenašajo ta virus, kar je lahko v nekaterih primerih smrtno nevarno.
English: Myocardial ischaemia/myocardial infarction.
Slovenian: ishemija miokarda ali miokardni infarkt
English: Side effects may occur a long time after your last dose.
Slovenian: Neželeni učinki zdravila se lahko pojavijo tudi dlje časa po zadnjem odmerku zdravila.
English: Tell your doctor if you are using, have recently used or might use any other medicines, including any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis or medicines obtained without a prescription, such as vitamins and herbal medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo, vključno s katerimikoli drugimi zdravili za zdravljenje Crohnove bolezni, ulceroznega kolitisa, revmatoidnega artritisa, ankilozirajočega spondilitisa, psoriatičnega artritisa ali psoriaze in z zdravili, ki se jih dobi brez recepta, kot so vitamini in rastlinski pripravki.
English: • or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.
Slovenian: • ali samostojno pri bolnikih, ki ne prenašajo metotreksata ali pri katerih je metotreksat kontraindiciran.
English: Placebo (Week 16)
Slovenian: Placebo (16. teden)
English: 102 weeks there were 49 subjects still on infliximab treatment and among those, 30 (61%) were BASDAI 50 responders.
Slovenian: Čez 102 tedna se je 49 preiskovancev še vedno zdravilo z infliksimabom in od tega jih je imelo 30 (61 %) odziv BASDAI 50.
English: • Tell your doctor if you have had treatment with medicines containing infliximab in the past and are now starting Inflectra treatment again.
Slovenian: • Povejte zdravniku, če ste se v preteklosti že zdravili z zdravili, ki vsebujejo infliksimab in sedaj ponovno začenjate zdravljenje z zdravilom Inflectra.
English: If you received Inflectra while pregnant, giving BCG vaccine (used to prevent tuberculosis) to your baby within 6 months after birth may result in infection with serious complications, including death.
Slovenian: Če ste v času nosečnosti prejeli zdravilo Inflectra, lahko cepljenje dojenčka s cepivom BCG (uporablja se za preprečevanje tuberkuloze) v obdobju 6 mesecev po rojstvu povzroči okužbo z resnimi zapleti, vključno s smrtjo.
English: • Talk to your doctor if you have recently received or are scheduled to receive treatment with a therapeutic infectious agent (such as BCG instillation used for the treatment of cancer).
Slovenian: • Obvestite svojega zdravnika, če ste pred kratkim prejeli ali boste prejeli povzročitelje okužb v terapevtske namene (kot je uporaba BCG za zdravljenje raka).
English: The following adverse reactions were reported more commonly in paediatric Crohn's disease patients in the REACH study (see section 5.1) than in adult Crohn's disease patients: anaemia (10.7%), blood in stool (9.7%), leukopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%).
Slovenian: O naslednjih neželenih učinkih so poročali pogosteje pri pediatričnih bolnikih s Crohnovo boleznijo v študiji REACH (glejte poglavje 5.1) kot pri odraslih bolnikih s Crohnovo boleznijo: anemija (10,7 %), kri v blatu (9,7 %), levkopenija (8,7 %), pordelost (8,7 %), virusna okužba (7,8 %), nevtropenija (6,8 %), bakterijska okužba (5,8 %), alergijska reakcija dihal (5,8 %).
English: Signs include changes in your vision, weakness in your arms or legs, numbness or tingling in any part of your body.
Slovenian: Znaki vključujejo spremembe vida, šibkost v rokah in nogah, odrevenelost ali mravljinčenje v kateremkoli delu telesa.
English: The combination of infliximab with other biological therapeutics used to treat the same conditions as infliximab, including anakinra and abatacept, is not recommended (see section 4.4).
Slovenian: Kombiniranje infliksimaba z drugimi biološkimi zdravili za zdravljenje enakih bolezni kot z infliksimabom, vključno z anakinro in abataceptom, ni priporočljivo (glejte poglavje 4.4).
English: You may receive some vaccines during treatment with Inflectra but you should not receive live vaccines (vaccines that contain a living but weakened infectious agent) while using Inflectra because they may cause infections.
Slovenian: Med zdravljenjem z zdravilom Inflectra lahko prejmete nekatera cepiva, vendar med uporabo zdravila Inflectra ne smete prejeti živih cepiv (cepiva, ki vsebujejo žive, vendar oslabljene povzročitelje okužb), saj lahko povzročijo okužbe.
English: • Children and adults taking Inflectra may have an increased risk of developing lymphoma or another cancer.
Slovenian: • Otroci in odrasli, ki prejemajo zdravilo Inflectra, imajo lahko povečano tveganje za pojav limfoma ali katere druge vrste raka.
English: If these medicines or treatments do not work well enough, you will be given Inflectra to reduce the signs and symptoms of your disease.
Slovenian: Če ta zdravila ali terapije ne bodo dovolj dobro delovale, boste prejeli zdravilo Inflectra za zmanjševanje znakov in simptomov bolezni.
English: Any unused portion of the infusion solution should not be stored for reuse.
Slovenian: Neporabljenih ostankov raztopine za infundiranje ne smete shraniti za poznejšo uporabo.
English: Administration of infliximab should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Slovenian: Uporabo infliksimaba prekinite, če se pri bolniku pojavi nova resna okužba ali sepsa, in mu uvedite ustrezno protimikrobno ali protiglivično terapijo, dokler ne bo okužba obvladana.
English: NSAIDs.
Slovenian: NSAID.
English: * Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology.
Slovenian: * Infliksimab je himerno človeško-glodalsko monoklonsko protitelo IG1, pridobljeno iz celic glodalskega hibridoma s tehnologijo rekombinantne DNK.
English: If jaundice and/or ALT elevations ≥ 5 times the upper limit of normal develop(s), infliximab should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Slovenian: Če se pojavi zlatenica in/ali zvišanje vrednosti ALT ≥ 5-kratno zgornjo mejo normale, prenehajte z uporabo infliksimaba in temeljito raziščite vzroke za nenormalne izvide.
English: • Store in a refrigerator (2 °C - 8 °C).
Slovenian: • Shranjujte v hladilniku (2 C - 8 C).
English: Inflectra may have a minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Inflectra ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
English: • Some children and teenage patients who have received TNF-blockers such as infliximab have developed cancers, including unusual types, which sometimes resulted in death.
Slovenian: • Pri nekaterih otrocih in najstnikih, ki so prejemali zaviralce TNF, kot je infliksimab, se je razvil rak, vključno z zelo neobičajnimi oblikami, ki se včasih končajo s smrtnim izidom.
English: Events (some fatal) of myocardial ischaemia/infarction and arrhythmia have been reported, some in close temporal association with infusion of infliximab, cerebrovascular accidents have also been reported in close temporal association with infusion of infliximab.
Slovenian: Poročali so o dogodkih (nekaterih s smrtnim izidom) ishemije miokarda/miokardnega infarkta in aritmije, nekaterih v tesni časovni povezanosti z infundiranjem infliksimaba, prav tako so v tesni časovni povezanosti z infundiranjem infliksimaba poročali o cerebrovaskularnih insultih.
English: Your doctor will record these tests on your patient reminder card.
Slovenian: Zdravnik bo vpisal te preiskave na vašo opozorilno kartico.
English: Other medicines and Inflectra
Slovenian: Druga zdravila in zdravilo Inflectra
English: • When starting a new card, keep this card as a reference for 4 months after your last dose of
Slovenian: • Ko prejmete novo kartico, imejte to kartico pri sebi še 4 mesece po zadnjem odmerku zdravila
English: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease and ulcerative colitis), Merkel cell carcinoma.
Slovenian: hepatosplenični limfom celic T (primarno pri mladostnikih in mlajših odraslih moških s Crohnovo boleznijo in ulceroznim kolitisom), karcinom Merklovih celic
English: • Your doctor will also give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Inflectra.
Slovenian: • Zdravnik vam bo dal tudi opozorilno kartico za bolnika, na kateri so navedeni pomembnejši varnostni podatki, ki jih morate poznati, preden prejmete zdravilo Inflectra in tudi med zdravljenjem z njim.
English: In infants exposed in utero to infliximab, fatal outcome due to disseminated Bacillus Calmette-Guérin (BCG) infection has been reported following administration of BCG vaccine after birth.
Slovenian: Pri dojenčkih, ki so bili in utero izpostavljeni infliksimabu, so poročali o smrtnem izidu zaradi razsejane okužbe z bacilom Calmette-Guerin (BCG) po cepljenju s cepivom BCG po rojstvu.
English: Elevations of ALT ≥5 x Upper 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: Placebo (Week 24)
Slovenian: Placebo (24. teden)
English: • Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome and acute generalised exanthematous pustulosis
Slovenian: • resne težave s kožo, na primer toksična epidermalna nekroliza, Stevens-Johnsonov sindrom in akutna generalizirana eksantematozna pustuloza,
English: • Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes)
Slovenian: • lihenoidne reakcije (srbeč rdeče-vijoličast kožni izpuščaj in/ali belo-sive nitaste črte na sluznicah)
English: • A statement that the brand name and batch number should be recorded
Slovenian: • navedbo, da je treba zabeležiti ime in številko serije zdravila;
English: >54 weeks
Slovenian: > 54 tednov
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 interferon .
Slovenian: Analiza mononuklearnih celic iz lamine proprie, dobljenih z biopsijo črevesne sluznice, je pokazala, da zdravljenje z infliksimabom povzroči zmanjšanje števila celic, ki lahko tvorijo TNFα in interferon γ.
English: Infliximab should be used with caution in patients with mild heart failure (NYHA class I/II).
Slovenian: Infliksimab morate uporabljati previdno pri bolnikih z blagim srčnim popuščanjem (razred I/II po NYHA).
English: • Inflectra will be given to you by your doctor or nurse, in a hospital or clinic.
Slovenian: • Zdravilo Inflectra vam bo dal zdravnik ali medicinska sestra v bolnišnici ali na kliniki.
English: In one of the study arms (group 2, n=329), patients with an inadequate response were allowed to dose titrate with 1.5 mg/kg increments from 3 up to 9 mg/kg.
Slovenian: V enem kraku študije (skupina 2, n = 329) so bolnikom z nezadostnim odzivom na zdravilo omogočili titracijo tj. povečevanje odmerka v korakih po 1,5 mg/kg, od 3 do največ 9 mg/kg.
English: It is recommended that paediatric patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating infliximab therapy.
Slovenian: Priporočamo, da pri pediatričnih bolnikih, če je le mogoče, opravite vsa cepljenja v skladu s trenutno veljavnimi smernicami za cepljenje otrok, preden pri njih uvedete zdravljenje z infliksimabom.
English: Your doctor may recommend temporarily stopping Inflectra.
Slovenian: Vaš zdravnik vam bo mogoče začasno prekinil zdravljenje z zdravilom Inflectra.
English: (DMARDs), including methotrexate, has been inadequate.
Slovenian: (DMARD-disease modifying antirheumatic drugs), ki vplivajo na imunsko odzivnost, vključno z metotreksatom, ni zadosten.
English: In an exploratory clinical study involving patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 adult patients were treated with infliximab at doses similar to those used in rheumatoid arthritis and Crohn's disease.
Slovenian: V poskusnem kliničnem preskušanju pri bolnikih z zmerno do hudo KOPB, ki so bili bodisi aktivni kadilci ali bivši kadilci, je bilo 157 odraslih bolnikov zdravljenih z zdravilom infliksimab v odmerkih, podobnih tistim, ki se uporabljajo pri revmatoidnem artritisu in pri Crohnovi bolezni.
English: >40 weeks
Slovenian: > 40 tednov
English: • Tell your doctor before you are given Inflectra if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common.
Slovenian: • Preden prejmete zdravilo Inflectra, povejte zdravniku, če ste kadarkoli živeli v ali potovali po krajih, kjer so pogoste okužbe, imenovane histoplasmoza, kokcidioidomikoza ali blastomikoza.
English: Chemical and physical in use stability of the diluted solution has been demonstrated for up to 28 days at 2 °C - 8 °C and for an additional 24 hours at 25 C after removal from refrigeration.
Slovenian: Pokazali so, da je razredčena raztopina kemično in fizikalno stabilna do 28 dni pri temperaturi 2 °C8 °C ter dodatnih 24 ur pri 25 C, po tem ko se vzame iz hladilnika.
English: Inflectra should only be used in children if they are being treated for Crohn's disease or ulcerative colitis.
Slovenian: Zdravilo Inflectra se sme pri otrocih uporabljati samo za zdravljenje Chronove bolezni ali ulceroznega kolitisa.
English: The syringe needle should be inserted into the vial through the centre of the rubber stopper and the stream of water for injections directed to the glass wall of the vial.
Slovenian: Iglo je treba zabosti skozi osrednji del gumijastega zamaška viale in usmeriti curek vode za injekcije proti stekleni steni viale.
English: Pharmacotherapeutic group: immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB02.
Slovenian: Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, zaviralci tumorjenekrotizirajočega faktor alfa (TNFα), oznaka ATC: L04AB02
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).
Slovenian: 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, psoriazo in Crohnovo boleznijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: 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).
Slovenian: 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).
English: Use of anti-tuberculosis therapy should also be considered before the initiation of infliximab in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Slovenian: O potrebi po predhodnem zdravljenju tuberkuloze premislite tudi, preden boste uvedli infliksimab pri bolniku, ki ima latentno ali aktivno tuberkulozo v pretekli anamnezi in pri katerem ni mogoče zagotovo potrditi, da je prejel zadostno zdravljenje.
English: Please make sure you also have a list of all other medicines that you are using with you at any visit to a healthcare professional.
Slovenian: Pri vsakem obisku kateregakoli zdravstvenega delavca imejte pri sebi tudi seznam vseh drugih zdravil, ki jih jemljete.
English: The combination of infliximab and abatacept is not recommended.
Slovenian: Kombiniranje infliksimaba in abatacepta torej ni priporočljivo.
English: Every 6 to 8 weeks depending on your disease
Slovenian: 6 tednov po prejetju prvega odmerka nadaljni odmerki vsakih 6 do 8 tednov, odvisno od vaše bolezni
English: In C0168T72, the most common adverse reactions were upper respiratory tract infection, pharyngitis, abdominal pain, fever,
Slovenian: V preskušanju C0168T72 so bili najpogostejši neželeni učinki okužba zgornjih dihal, faringitis, bolečine v trebuhu, zvišana telesna temperatura in glavobol.
English: Inflectra and Orencia should not be used together.
Slovenian: Zdravili Inflectra in Orencia se ne smeta uporabljati skupaj.
English: However, if the solution is prepared in germ-free conditions, it can be stored in a refrigerator at 2 °C - 8 °C up to 28 days and for an additional 24 hours at 25 °C after removal from the refrigerator.
Slovenian: Vendar, če je bila raztopina pripravljena v aseptičnih pogojih, jo lahko do 28 dni shranjujete v hladilniku pri temperaturi 2 C - 8 C ter dodatnih 24 ur pri temperaturi 25 °C, po tem ko jo vzamete iz hladilnika.
English: • Immune disorders that could affect the lungs, skin and lymph nodes (such as sarcoidosis)
Slovenian: • imunske bolezni, ki lahko prizadenejo pljuča, kožo in bezgavke (na primer sarkoidoza)
English: ACR response (% of patients) N
Slovenian: Odziv ACR (% bolnikov)
English: Table 1 Adverse reactions in clinical studies and from post-marketing experience Infections and infestations Very common:
Slovenian: Preglednica 1 Neželeni učinki v kliničnih študijah in v obdobju trženja zdravila Infekcijske in parazitske bolezni zelo pogosti:
English: • Tell your doctor if you have hepatitis B or if you know or suspect you are a carrier of the hepatitis B virus.
Slovenian: • Zdravniku povejte, če imate hepatitis B ali sumite, da ste prenašalec virusa hepatitis B.
English: Infliximab is a monoclonal antibody - a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha.
Slovenian: Infliksimab je monoklonsko protitelo, tj. vrsta beljakovine, ki se veže na točno določeno tarčno mesto v telesu, imenovano TNF (tumorje nekrotizirajoči faktor) alfa.
English: The reduction in incidence of colectomy was also examined in another randomised, double-blind study (C0168Y06) in hospitalised patients (n=45) with moderately to severely active ulcerative colitis who failed to respond to intravenous corticosteroids and who were therefore at higher risk for colectomy.
Slovenian: Zmanjšanje incidence kolektomij so proučevali še v eni randomizirani, dvojno slepi študiji (C0168Y06) pri hospitaliziranih bolnikih (n = 45) z zmerno do močno aktivnim ulceroznim kolitisom, ki se niso odzvali na zdravljenje z intravenskimi kortikosteroidi in so imeli zato večje tveganje, da bo pri njih potrebna kolektomija.
English: • Low blood counts, including a severely decreased number of white blood cells
Slovenian: • nizko število krvnih celic, vključno z močnim znižanjem števila belih krvnih celic
English: While using Inflectra you should not receive live vaccines.
Slovenian: Med uporabo zdravila Inflectra ne smete prejeti živih cepiv.
English: What Inflectra is and what it is used for What you need to know before you use Inflectra How Inflectra will be given Possible side effects
Slovenian: Kaj je zdravilo Inflectra in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Inflectra Kako boste dobivali zdravilo Inflectra Možni neželeni učinki
English: Population pharmacokinetic analysis based on data obtained from patients with ulcerative colitis (N=60), Crohn's disease (N=112), juvenile rheumatoid arthritis (N=117) and Kawasaki disease (N=16) with an overall age range from 2 months to 17 years indicated that exposure to infliximab was dependent on body weight in a non-linear way.
Slovenian: Analiza populacijske farmakokinetike na podlagi podatkov, pridobljenih pri bolnikih z ulceroznim kolitisom (n = 60), Crohnovo boleznijo (n = 112), juvenilnim revmatoidnim artritisom (n = 117) in boleznijo Kawasaki (n = 16) v starostni skupini od 2 mesecev do 17 let, je pokazala, da je izpostavljenost infliksimabu nelinearno odvisna od telesne mase.
English: In psoriasis patients treated with infliximab as a maintenance regimen in the absence of concomitant immunomodulators, approximately 28% developed antibodies to infliximab (see section 4.4: “Infusion reactions and hypersensitivity”).
Slovenian: Pri bolnikih, ki so jim psoriazo vzdrževalno zdravili z infliksimabom brez spremljajočega imunomodulatorja, so se pri približno 28 % razvila protitelesa proti infliksimabu (glejte poglavje 4.4: "Z infuzijo povezane reakcije in preobčutljivost'').
English: N/A 139 N/A 53.0 N/A 4.4% N/A 1.5%
Slovenian: N/A 4,4 % N/A 1,5 %