natgillin/translations-raw huggingface dataset:
b CDAI < 150 at both week 30 and 54 and not receiving corticosteroids in the 3 months prior to week 54 among patients who were receiving corticosteroids at baseline. 
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.
3 Number of patients evaluated for ALT. 
3 Število bolnikov, pri katerih so ovrednotili vrednost ALT.
Before reconstitution 4 years at 2°C - 8°C. 
Pred rekonstitucijo: 4 leta pri temperaturi 2 °C-8 °C.
• Infections due to a weakened immune system 
• okužbe zaradi oslabljenega imunskega sistema,
≥ 50% improvement PGA of cleared (0) or minimal (1) 
≥ 50 % izboljšanje PGA brez plakov (0) ali minimalni (1)
What Flixabi is and what it is used for 
Kaj je zdravilo Flixabi in za kaj ga uporabljamo
Subjects randomised Percentage ACR improvement Mean ± SD 
Randomizirani preiskovanci Odstotek izboljšanja ACR Srednja vrednost ± SD
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C. 
Če raztopina ni uporabljena takoj, je za pogoje in čas shranjevanja pred uporabo odgovoren uporabnik, in le-to ne sme trajati dlje kot 24 ur pri temperaturi med 2 °C in 8 °C.
4 Median follow-up is based on patients treated. 
4 Mediana dolžine spremljanja bolnikov je bila določena samo z upoštevanjem zdravljenih bolnikov.
178 of the 580 enrolled patients (30.7%) were defined as having severe disease (CDAI score > 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1). 
Pri 178 od 580 v študijo vključenih bolnikov (30,7 %) so ugotovili hudo obliko bolezni (ocena CDAI > 300 in sočasna uporaba kortikosteroidov in/ali imunosupresivov), kar ustreza populaciji, opredeljeni v indikacijah (glejte poglavje 4.1).
Infliximab + MTX 
infliksimab + MTX
It is important that you tell your baby's doctors and other health care professionals about your Flixabi use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis). 
Pomembno je, da zdravnike svojega otroka in druge zdravstvene delavce obvestite, da ste prejemali zdravilo Flixabi, da bodo lahko presodili, kdaj sme vaš dojenček prejeti katero koli cepivo, vključno z živimi cepivi, kot je cepivo BCG (uporablja se za preprečevanje tuberkuloze).
(anaphylactic shock) 
(anafilaktični šok),
• Melanoma (a type of skin cancer). 
• melanom (vrsta kožnega raka),
Flixabi should only be used in children and adolescents if they are being treated for Crohn`s disease or ulcerative colitis. 
Zdravilo Flixabi se sme pri otrocih in mladostnikih uporabljati samo za zdravljenje Crohnove bolezni ali ulceroznega kolitisa.
ACR 20 response* ACR 50 response* ACR 70 response* PASI response (% of patients)b 
Odziv ACR (% bolnikov) N odziv ACR 20* odziv ACR 50* odziv ACR 70* Odziv PASI (% bolnikov)b
Acute infusion reactions including anaphylactic reactions may develop during (within seconds) or within a few hours following infusion. 
Akutna z infuzijo povezana reakcija, vključno z anafilaktično reakcijo, lahko nastopi med infuzijo (t. j. v nekaj sekundah) ali v roku nekaj ur po infuziji.
• Low blood counts, including a severely decreased number of white blood cells. 
• nizko število krvnih celic, vključno z močnim znižanjem števila belih krvnih celic.
If you feel tired, dizzy, or unwell after having Flixabi, do not drive or use any tools or machines. 
Če se po prejemu zdravila Flixabi počutite utrujeni ali se ne počutite dobro, ne smete voziti ali upravljati kakršnih koli orodij ali strojev.
c HAQ = Health Assessment Questionnaire; greater values indicate less disability. 
c HAQ = vprašalnik za oceno zdravstvenega stanja; večje vrednosti pomenijo manjšo okvaro funkcije.
What Flixabi is and what it is used for What you need to know before you use Flixabi How Flixabi will be given Possible side effects 
Kaj je zdravilo Flixabi in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Flixabi Kako uporabljati zdravilo Flixabi Možni neželeni učinki
• Treatment with TNF blockers such as Flixabi may result in reactivation of hepatitis B virus in patients who carry this virus, which can be life-threatening in some cases. 
• Zdravljenje z zaviralci TNF, kot je zdravilo Flixabi, lahko vodi do reaktivacije virusa hepatitisa B pri bolnikih, ki prenašajo ta virus, kar je lahko v nekaterih primerih življenjsko nevarno.
N ≥ 90% improvement ≥ 75% improvement ≥ 50% improvement 
50. teden n ≥ 90 % izboljšanje ≥ 75 % izboljšanje ≥ 50 % izboljšanje
Flixabi may have a minor influence on the ability to drive and use machines. 
Zdravilo Flixabi ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with antituberculosis therapy before the initiation of Flixabi, and in accordance with local recommendations. 
V primeru diagnoze neaktivne (latentne) tuberkuloze morate uvesti zdravljenje za latentno tuberkulozo z antituberkulozno terapijo še pred uvedbo zdravila Flixabi, v skladu z lokalnimi priporočili.
Table 1 Undesirable effects in clinical studies and from post-marketing experience Infections and infestations Very Common: 
Preglednica 1 Neželeni učinki v kliničnih študijah in v obdobju trženja zdravila Infekcijske in parazitske bolezni zelo pogosti:
However, studies from the published literature in various indications (e.g. rheumatoid arthritis, psoriasis, Crohn's disease) suggest that non-live vaccinations received during treatment with anti-TNF therapies, including infliximab, may elicit a lower immune response than in patients not receiving anti-TNF therapy. 
Vseeno pa študije iz objavljene literature za različne indikacije (npr. revmatoidni artritis, psoriaza, Crohnova bolezen) nakazujejo, da cepljenja z neživimi cepivi med prejemanjem anti-TNF terapije, vključno z infliksimabom, lahko izzovejo manjši imunski odgovor kot pri bolnikih, ki ne prejemajo anti-TNF terapije.
• Hepatitis B infection when you have had hepatitis B in the past 
• okužba s hepatitisom B, če ste ga že preboleli v preteklosti,
• 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). 
• Obvestite zdravnika, če ste pred kratkim prejeli ali boste prejeli povzročitelje okužb v terapevtske namene (kot je uporaba BCG za zdravljenje raka).
Telephone number doctor: 
Telefon zdravnika:
Calculate the dose and the number of Flixabi vials needed. 
Izračunajte odmerek in število potrebnih vial zdravila Flixabi.
• Psoriasis. 
• psoriaza.
• Pain in the joints, muscles or back 
• bolečine v sklepih, mišicah ali hrbtu,
• It is very important that you tell your doctor if you have ever had tuberculosis (TB), or if you have been in close contact with someone who has had TB. 
• Zelo pomembno je, da zdravniku poveste, če ste kdaj imeli tuberkulozo (TBC) ali če ste bili v tesnem stiku s tuberkuloznim bolnikom.
The relative deficiency of TNFα caused by anti-TNF therapy may result in the initiation of an autoimmune process. 
Relativno pomanjkanje TNFα kot posledica anti-TNF terapije lahko sproži avtoimunski proces.
Store in a refrigerator Can be stored at room temperature (up to 25°C) for a single period up to 6 months. 
Lahko shranjujete pri sobni temperaturi (do 25 °C) za eno obdobje do 6 mesecev.
There are no known side effects of having too much of Flixabi. 
Ni poznanih neželenih učinkov zaradi prejetja prevelikega odmerka zdravila Flixabi.
If you received Flixabi 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. 
Če ste v času nosečnosti prejeli zdravilo Flixabi, 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.
The potential risk with the combination of AZA or 6-MP and Flixabi should be carefully considered. 
Natančno je treba pretehtati potencialno tveganje pri sočasnem dajanju AZA ali 6-MP z zdravilom Flixabi.
Studies in mice deficient in TNFα demonstrated no increase in tumours when challenged with known tumour initiators and/or promoters. 
Študije pri miših s pomanjkanjem TNFα niso pokazale povečanja pogostnosti tumorjev po provokaciji z znanimi sprožilci novih tumorjev in/ali spodbujevalci.
• Worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness) 
• poslabšanje dermatomiozitisa (ki se kaže kot kožni izpuščaj, ki spremlja šibkost mišic),
Specific studies of infliximab in elderly patients have not been conducted. 
Specifične študije infliksimaba pri starejših bolnikih niso bile izvedene.
Since the possibility of increased risk of cancer development in patients with newly diagnosed dysplasia treated with infliximab is not established, the risk and benefits of continued therapy to the individual patients should be carefully considered by the clinician. 
Ker verjetnost povečanega tveganja za nastanek karcinoma pri bolnikih z novo diagnosticirano displazijo, ki se zdravijo z infliksimabom, ni ugotovljena, mora zdravnik skrbno pretehtati tveganje in koristi nadaljevanja zdravljenja za posameznega bolnika.
Placebo (week 16) 
placebo (16. teden)
≥ 5 x ULN placebo infliximab placebo infliximab placebo infliximab placebo infliximab 
placebo infliksima b placebo infliksimab placebo infliksimab placebo infliksimab
Table 4 Effects on ACRn, Structural Joint Damage and Physical Function at week 54, ASPIRE 
Preglednica 4 Učinki na ACRn, strukturno poškodbo sklepov in funkcijo sklepov v 54. tednu, ASPIRE
Invasive fungal infections may present as disseminated rather than localised disease, and antigen and antibody testing may be negative in some patients with active infection. 
Invazivne glivične okužbe lahko namesto v obliki lokalizirane nastopajo v obliki razsejane bolezni, poleg tega pa sta lahko pri nekaterih bolnikih z aktivno okužbo testa na antigen in protitelesa negativna.
Flixabi must be given concomitantly with methotrexate. 
Zdravilo Flixabi morate uporabljati sočasno z metotreksatom.
• Collections of immune cells resulting from an inflammatory response (granulomatous lesions) 
• kopičenje imunskih celic zaradi vnetnega odziva (granulomatozne lezije),
• A reminder to patients to show the patient reminder card to all treating HCPs, including in conditions of emergency, and a message for HCPs that the patient is using Flixabi 
• Opomnik za bolnike, da morajo pokazati opozorilno kartico za bolnika vsem zdravstvenim delavcem, ki sodelujejo pri zdravljenju (tudi v nujnih stanjih) ter sporočilo za zdravstvene delavce, da bolnik uporablja zdravilo Flixabi.
In all situations described below, the benefit/risk balance of Flixabi therapy should be very carefully considered. 
V vseh spodaj opisanih okoliščinah je treba zelo skrbno pretehtati razmerje med koristmi in tveganji zdravljenja z zdravilom Flixabi.
Available data suggest an increased risk for delayed hypersensitivity with increasing infliximab-free interval. 
Podatki, ki so na voljo, kažejo povečano tveganje za pozno preobčutljivost pri povečevanju premora brez prejemanja infliksimaba.
• Tell your doctor if you have had treatment with medicines containing infliximab in the past and are now starting Flixabi treatment again. 
• Povejte zdravniku, če ste se v preteklosti že zdravili z zdravili, ki vsebujejo infliksimab, in sedaj ponovno začenjate zdravljenje z zdravilom Flixabi.
Marketing Authorisation Holder Samsung Bioepis NL B.V. 
Imetnik dovoljenja za promet z zdravilom Samsung Bioepis NL B.V.
• Feeling forgetful, irritable, confused, nervous 
• občutek pozabljivosti, razdražljivosti, zmedenosti, živčnosti,
Tell your doctor if you are using or have recently used 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. 
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno s katerimi koli 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.
For more information about the safety of infliximab in elderly patients (see sections 4.4 and 4.8). 
Za več informacij o varnosti infliksimaba pri starejših glejte poglavji 4.4 in 4.8.
What you need to know before you use Flixabi 
Kaj morate vedeti, preden boste uporabili zdravilo Flixabi
Infliximab has been studied only in combination with conventional immunosuppressive therapy. 
Infliksimab so preučevali le v kombinaciji z običajno imunosupresivno terapijo.
It should be noted that suppression of TNFα may mask symptoms of infection such as fever. 
Treba je tudi poudariti, da lahko zaviranje TNFα prikrije simptome okužbe, npr. zvišano telesno temperaturo.
• Some children and teenage patients who have received TNF-blockers such as Flixabi have developed cancers, including unusual types, which sometimes resulted in death. 
• Pri nekaterih otrocih in najstnikih, ki so prejemali zaviralce TNF, kot je zdravilo Flixabi, se je razvil rak, vključno z neobičajnimi oblikami, ki se je včasih končal s smrtnim izidom.
• Serious lung problems (such as interstitial lung disease) 
• resne težave s pljuči (na primer intersticijska pljučna bolezen),
d p = 0.030 and < 0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs. placebo + MTX. 
d p = 0,030 in < 0,001 za terapevtski skupini, ki sta prejemali 3 mg/kg in 6 mg/kg v primerjavi s placebom + MTX
• Tell your surgeon or dentist that you are having treatment with Flixabi by showing them your patient reminder card. 
• Obvestite kirurga ali zobozdravnika, da prejemate zdravilo Flixabi, in mu pokažite svojo opozorilno kartico za bolnika.
• Children and adults taking Flixabi may have an increased risk of developing lymphoma or another cancer. 
• Otroci in odrasli, ki prejemajo zdravilo Flixabi, imajo lahko povečano tveganje za pojav limfoma ali katere druge vrste raka.
In all cases, infliximab treatment was discontinued and/or other treatment instituted with complete resolution of signs and symptoms. 
V vseh primerih je bilo zdravljenje z infliksimabom ukinjeno in/ali so bolniku uvedli drugo zdravljenje, znaki in simptomi bolezni pa so izginili.
The median duration of follow-up was 0.8 years (incidence 5.7% [95% CI 2.65%-10.6%]. 
Mediana dolžine spremljanja bolnikov je bila 0,8 let (incidenca 5,7 % [95 % IZ 2,65 %-10,6 %].
Of the infliximabtreated patients who received at least one shortened infusion, infusion-related reactions occurred in 15% of patients and serious infusion reactions occurred in 0.4% of patients. 
Pri bolnikih, zdravljenih z infliksimabom, ki so prejeli najmanj eno skrajšano infuzijo, so se z infuzijo povezane reakcije pojavljale pri 15 % bolnikov, resne z infuzijo povezane reakcije pa pri 0,4 % bolnikov.
Administration of Flixabi 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. 
Uporabo zdravila Flixabi prekinite, če se pri bolniku pojavi nova resna okužba ali sepsa, in mu uvedite ustrezno protimikrobno ali protiglivično terapijo, dokler ne bo okužba obvladana.
Psoriatic arthritis Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. 
Psoriatični artritis je vnetna bolezen sklepov, ki jo običajno spremlja psoriaza.
Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier. 
Zavrzite to zdravilo, če ga ne uporabite do zgodnejšega od obeh datumov, novega datuma izteka roka uporabnosti ali datuma izteka roka uporabnosti, natisnjenega na škatli.
Single intravenous infusions of 1, 3, 5, 10 or 20 mg/kg of infliximab yielded dose proportional increases in the maximum serum concentration (Cmax) and area under the concentration-time curve (AUC). 
Sorazmerno s povečanjem enkratnega odmerka infliksimaba 1, 3, 5, 10 ali 20 mg/kg v intravenski infuziji sta se povečali tudi največja koncentracija tega zdravila v serumu (Cmax) in površina pod krivuljo koncentracije po času (AUC).
In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of infliximab, or modification of concomitant therapy. 
Na splošno bolniki, pri katerih se je pojavilo zvišanje ALT in AST, niso imeli simptomov in nenormalni izvidi so se zmanjšali ali normalizirali bodisi z nadaljevanjem ali z ukinitvijo zdravljenja z infliksimabom ali pa ob prilagoditvi drugih sočasnih terapij.
In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6,234 patientsyears (3,210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma malignancies were reported. 
Pri spremljanju dolgoročne varnosti infliksimaba do 5 let po kliničnih študijah, to pomeni pri skupaj 6.234 bolnikih x letih (3.210 bolnikov), pa so poročali o 5 primerih limfoma in 38 primerih nelimfomskih rakavih bolezni.
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 Flixabi treatment. 
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 zdravilom Flixabi.
Patients with moderate or severe heart failure (NYHA class III/IV) (see sections 4.4 and 4.8). 
Bolniki z zmernim do hudim srčnim popuščanjem (razred III/IV po NYHA) (glejte poglavji 4.4 in 4.8).
• Some patients receiving infliximab have developed symptoms of an immune system disorder called lupus. 
• Pri nekaterih bolnikih, ki prejemajo infliksimab, so se pojavili simptomi bolezni imunskega sistema, imenovane lupus.
* Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. 
* Infliksimab je himerno človeško-glodavsko monoklonsko protitelo IgG1, pridobljeno iz celic jajčnika kitajskega hrčka s tehnologijo rekombinantne DNA.
• Tell your doctor before you are given Flixabi if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common. 
• Preden prejmete zdravilo Flixabi, povejte zdravniku, če ste kdaj živeli v ali potovali po krajih, kjer so pogoste okužbe, imenovane histoplazmoza, kokcidioidomikoza ali blastomikoza.
• Narrowed airway in the lungs, causing difficulty breathing 
• zoženje dihalnih poti v pljučih, ki povzroča težave z dihanjem,
 adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. 
• pri odraslih bolnikih s hudo, aktivno in progresivno boleznijo, ki še niso bili zdravljeni z metotreksatom ali drugimi protirevmatičnimi zdravili DMARD.
The volume of distribution at steady state (median Vd of 3.0 to 4.1 litres) was not dependent on the administered dose and indicated that infliximab is predominantly distributed within the vascular compartment. 
Porazdelitveni volumen v stanju dinamičnega ravnovesja (mediana Vd od 3,0 do 4,1 litra) ni bil odvisen od danega odmerka, kar pomeni, da se infliksimab razporedi pretežno po žilnem razdelku.
• New or worsening heart failure, slow heart rate 
• novo nastalo srčno popuščanje ali poslabšanje srčnega popuščanja, počasen srčni utrip,
Flixabi is available in packs containing 1, 2, 3, 4, and 5 vial(s). 
Zdravilo Flixabi je na voljo v pakiranjih, ki vsebujejo po 1, 2, 3, 4 ali 5 vial.
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.
Flixabi should be used with caution in patients with mild heart failure (NYHA class I/II). 
Zdravilo Flixabi morate uporabljati previdno pri bolnikih z blagim srčnim popuščanjem (razred I/II po NYHA).
• Treat active Crohn's disease, 
• zdravljenje aktivne Crohnove bolezni,
If these medicines or treatments do not work well enough, you will be given Flixabi to reduce the signs and symptoms of your disease. 
Če ta zdravila ali terapije ne delujejo dovolj dobro, boste prejeli zdravilo Flixabi za zmanjševanje znakov in simptomov bolezni.
Viral infection (e.g. influenza, herpes virus infection). 
virusna okužba (npr. gripa, okužba z virusom herpesa)
• Liver problem that causes yellowing of the skin or eyes (jaundice) 
• težave z jetri, ki povzročajo porumenelost kože ali oči (zlatenica),
Placebo (week 24) 
placebo (24. teden)
Flixabi works by selectively attaching to TNF alpha and blocking its action. 
Zdravilo Flixabi deluje tako, da se selektivno veže na TNF-alfa in zavira njegovo delovanje.
• Talk to your doctor if you recently have had or are due to have a vaccine. 
• Posvetujte se z zdravnikom, če ste bili pred kratkim cepljeni ali boste cepljeni.
• Stomach pain, feeling sick 
• želodčne bolečine, občutek slabosti,
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. 
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 infliksimabom v odmerkih, podobnih tistim, ki se uporabljajo pri revmatoidnem artritisu in pri Crohnovi bolezni.
• That treatment with Flixabi 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 
• Da lahko zdravljenje z zdravilom Flixabi zveča tveganje za resne okužbe/sepso, oportunistične okužbe, tuberkulozo, reaktivacijo hepatitisa B in okužbo z BCG pri dojenčkih, ki so bili in utero izpostavljeni infliksimabu, in kdaj poiskati zdravniško pomoč.
During Flixabi treatment, other concomitant therapies, e.g. corticosteroids and immunosuppressants should be optimised. 
Med zdravljenjem z zdravilom Flixabi je treba optimizirati druge sočasne terapije, npr. s kortikosteroidi in zdravili za zaviranje imunske odzivnosti.
• Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson Syndrome and acute generalised exanthematous pustulosis 
• resne težave s kožo, na primer toksična epidermalna nekroliza, Stevens-Johnsonov sindrom in akutna generalizirana eksantematozna pustuloza,
Bacterial infections (e.g. sepsis, cellulitis, abscess). 
bakterijske okužbe (npr. sepsa, celulitis, absces)
There are insufficient data on the incidence of delayed hypersensitivity reactions after infliximab-free 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). 
Podatki o incidenci poznih preobčutljivostnih reakcij po premoru brez infliksimaba, daljšem od enega leta, so nezadostni, vendar omejeni podatki iz kliničnih preskušanj kažejo povečano tveganje za pozno preobčutljivost pri povečevanju premora brez infliksimaba (glejte poglavje 4.4).
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 γ. 
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.