natgillin/translations-raw huggingface dataset:
I SPIRIT var andelen af patienter, der opnåede PASI 75 i uge 10 71,7 % i 3 mg/kg infliximab- gruppen, 87,9 % i 5 mg/kg infliximab-gruppen og 5,9 % i placebogruppen (p < 0,001).
In SPIRIT, the proportion of patients achieving PASI 75 at week 10 was 71.7% in the 3 mg/kg infliximab group, 87.9% in the 5 mg/kg infliximab group, and 5.9% in the placebo group (p < 0.001).
Flixabi kan opbevares ved temperaturer på maksimalt 25 °C i en enkelt periode på op til 6 måneder, som ikke overskrider den oprindelige udløbsdato.
Flixabi may be stored at temperatures up to a maximum of 25°C for a single period of up to 6 months, but not exceeding the original expiry date.
• hvis du er allergisk over for infliximab (det aktive indholdsstof i Flixabi) eller et af de øvrige indholdsstoffer i Flixabi (angivet i punkt 6),
• You are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6).
Antallet af patienter i hver undergruppe er for lille til at drage definitive konklusioner om alderens indflydelse på bivirkninger, men der var en større andel af patienter med alvorlige bivirkninger og patienter, som stoppede behandlingen på grund af bivirkninger, i den yngre aldersgruppe end i den ældre aldersgruppe.
While the numbers of patients in each subgroup are too small to make any definitive conclusions about the effect of age on safety events, there were higher proportions of patients with serious adverse events and discontinuation due to adverse events in the younger age group than in the older age group.
Sikkerhed og effekt ved infliximab blev vurderet i to (ACT 1 og ACT 2) randomiserede, dobbeltblinde, placebokontrollerede kliniske studier hos voksne patienter med moderat til svær, aktiv colitis ulcerosa (Mayo-score 6 til 12; Endoskopi subscore ≥ 2) med et utilstrækkeligt respons på konventionel behandling [orale kortikosteroider, aminosalicylater og/eller immunmodulatorer (6-MP, AZA)].
The safety and efficacy of infliximab were assessed in two (ACT 1 and ACT 2) randomised, double-blind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6-MP, AZA)].
Flixabi er indiceret til behandling af svær, aktiv ankyloserende spondylitis hos voksne patienter, som har responderet utilstrækkeligt på konventionel behandling.
Flixabi is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
• behandling af fistulerende, aktiv Crohns sygdom hos voksne patienter, som ikke har responderet på trods af en fuldstændig og adækvat behandlingsperiode med konventionel behandling (inklusive antibiotika, drænage og immunsuppressiv behandling).
 treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
Tabel 3 Virkninger på ACR20, strukturel ledskade og fysisk funktionsevne ved uge 54, ATTRACT infliximab b
Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, ATTRACT
I et 6-måneders flerdosis toksicitetsstudie hos mus, ved brug af det samme analoge antistof mod muse TNFα, sås krystalaflejringer på linsekapslerne hos nogle af de behandlede hanmus.
In a 6-month repeated dose toxicity study in mice, using the same analogous antibody against mouse TNFα, crystalline deposits were observed on the lens capsule of some of the treated male mice.
Det skal du vide, før du begynder at bruge Flixabi
What you need to know before you use Flixabi
• hvis du er allergisk over for proteiner, som stammer fra mus,
• You are allergic (hypersensitive) to proteins that come from mice.
Transversel myelitis, demyeliniseringsforstyrrelser i centralnervesystemet (dissemineret sklerose-lignende sygdom og optisk neuritis), perifere demyeliniseringsforstyrrelser (såsom Guillain-Barré syndrom, kronisk inflammatorisk demyeliniserende polyneuropati og multifokal motorisk neuropati).
Transverse myelitis, central nervous system demyelinating disorders (multiple sclerosis-like disease and optic neuritis), peripheral demyelinating disorders (such as Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy).
Lægen kan tilråde, at kvinder, der får infliximab, herunder kvinder over 60 år, bliver regelmæssigt screenet for livmoderhalskræft.
For women taking infliximab including those over 60 years of age, your doctor may recommend regular screening for cervical cancer.
Patienterne fik 3 eller 6 mg/kg infliximab som et induktionsregimen med 3 doser (hhv. uge 0, 2, 6 eller uge 14, 16, 20) fulgt af vedligeholdelsesbehandling hver 8. uge i kombination med methotrexat.
Patients received 3 or 6 mg/kg infliximab as a 3-dose induction regimen (weeks 0, 2, 6 or weeks 14, 16, 20, respectively) followed by maintenance therapy every 8 weeks, in combination with methotrexate.
Alle patienter skal informeres om at søge læge, hvis sygdomstegn/symptomer, der tyder på tuberkulose (fx vedvarende hoste, skranten/vægttab, let feber), forekommer under eller efter Flixabibehandling.
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 Flixabi treatment.
I begge studier var samtidig brug af konstante doser af folinsyre, orale kortikosteroider (≤ 10 mg/dag) og/eller nonsteroide anti-inflammatoriske stoffer (NSAIDs) tilladt.
In both studies concurrent use of stable doses of folic acid, oral corticosteroids (≤ 10 mg/day) and/or non-steroidal anti-inflammatory drugs (NSAIDs) was permitted.
Der er ikke gennemført biokemiske forligelighedsstudier for at vurdere samtidig indgivelse af Flixabi med andre midler.
No physical biochemical compatibility studies have been conducted to evaluate the co-administration of Flixabi with other agents.
I kliniske studier af reumatoid arthritis var hyppigheden af alvorlige infektioner højere hos infliximabplus methotrexatbehandlede patienter på 65 år og derover (11,3 %) sammenlignet med patienter under 65 år (4,6 %).
In rheumatoid arthritis clinical studies, the incidence of serious infections was greater in infliximab plus methotrexate-treated patients 65 years and older (11.3%) than in those under 65 years of age (4.6%).
Hvis disse lægemidler ikke virker godt nok, vil du få Flixabi for at:
If these medicines do not work well enough, you will be given Flixabi to:
Trombocytopeni, lymfopeni, lymfocytose.
Thrombocytopenia, lymphopenia, lymphocytosis.
Dato for start af Flixabi-behandling:
Date of Flixabi therapy initiation:
Efter markedsføring er der rapporteret maligniteter, hvoraf nogle har været letale, hos børn, unge og unge voksne (op til 22 år), som er behandlet med TNF-blokkere inklusive infliximab (behandlingsstart før 18-års alderen).
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.
Tumor nekrose faktor alfa (TNFα) frembringer betændelse og modulerer cellulært immunrespons.
Tumour necrosis factor alpha (TNFα) mediates inflammation and modulates cellular immune responses.
Der er begrænset erfaring med sikkerheden af infliximab-behandling hos patienter, som har gennemgået kirurgiske indgreb inklusive atroplastik.
There is limited safety experience of infliximab treatment in patients who have undergone surgical procedures, including arthroplasty.
Uge 50
Week 50
Hos patienter med allerede eksisterende eller nyligt opståede demyeliniseringssygdomme skal vurdering af forventet gavn og risiko ved anti-TNF-behandlingen overvejes omhyggeligt før initiering af behandling med Flixabi.
In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of anti-TNF treatment should be carefully considered before initiation of Flixabi therapy.
Ved aktiv tuberkulose, må Flixabibehandling ikke påbegyndes (se pkt.
If active tuberculosis is diagnosed, Flixabi therapy must not be initiated (see section 4.3).
Effekt og sikkerhed blev vurderet i to dobbeltblinde, placebokontrollerede multicenterstudier hos patienter med aktiv psoriasis arthritis.
Efficacy and safety were assessed in two multicentre, double-blind, placebo-controlled studies in patients with active psoriatic arthritis.
I et toksicitetsstudie vedrørende udvikling udført på mus ved brug af et analogt antistof, der selektivt hæmmer den funktionelle aktivitet af muse TNFα, var der ingen tegn på maternal toksicitet, embryotoksicitet eller teratogenicitet.
In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.
De alvorligste bivirkninger forbundet med brugen af TNF-blokkere, som er blevet rapporteret for infliximab, inkluderer HBV-reaktivering, CHF (kongestivt hjertesvigt), alvorlige infektioner (inklusive sepsis, opportunistiske infektioner og TB), serumsygdom (forsinkede overfølsomhedsreaktioner), hæmatologiske reaktioner, systemisk lupus erythematosus/lupus-lignende syndrom, demyeliniserende sygdomme, hepatobiliære bivirkninger, lymfomer, HSTCL, leukæmi, Merkelcellekarcinom, melanom, pædiatrisk malignitet, sarkoidose/sarkoid-lignende reaktion, byld i tarmen eller ved endetarmen (ved Crohns sygdom) og alvorlige infusionsreaktioner (se pkt.
The most serious ADRs associated with the use of TNF blockers that have been reported for infliximab include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, paediatric malignancy, sarcoidosis/sarcoid-like reaction, intestinal or perianal abscess (in Crohn's disease), and serious infusion reactions (see section 4.4).
Samtidig administration af levende vacciner og Flixabi frarådes.
The concurrent administration of live vaccines with Flixabi is not recommended.
• Fortæl din læge, før du får Flixabi, hvis du har en lungesygdom kaldet kronisk obstruktiv lungesygdom (KOL, rygerlunger), eller hvis du er storryger.
• Tell your doctor before you are given Flixabi if you have a lung disease called Chronic Obstructive Pulmonary Disease (COPD) or if you are a heavy smoker.
Gastrointestinal blødning, diarré, dyspepsi, gastroøsofageal refluks, forstoppelse.
Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation.
• Hvis din læge tror, at du har risiko for at få TB, kan du blive behandlet med lægemidler mod TB,
• If your doctor feels that you are at risk for TB, you may be treated with medicines for TB before you are given Flixabi.
Flixabi fortyndes dog med natriumchlorid 9 mg/ml (0,9%) infusionsvæske, opløsning.
Flixabi is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
I uge 30 var andelen af personer med klinisk remission højere i 8-ugers gruppen (59,6 %; 31/52) end i 12-ugers gruppen (35,3 %, 18/51; p = 0,013).
At week 30, the proportion of subjects in clinical remission was higher in the q8 week (59.6%, 31/52) than the q12 week maintenance treatment group (35.3%, 18/51; p=0.013).
5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering hos børn under 6 år.
Currently available pharmacokinetic data are described in section 5.2 but no recommendation on a posology can be made in children younger than 6 years.
Infunder ikke Flixabi i den samme intravenøse slange med andre midler.
Do not infuse Flixabi concomitantly in the same intravenous line with other agents.
Komplet fistula respons (%)b a A ≥ 50 % reduktion fra baseline i antallet af drænede fistulaer over en periode på ≥ 4 uger.
b a A ≥ 50% reduction from baseline in the number of draining fistulas over a period of ≥ 4 weeks b Absence of any draining fistulas
Rekonstituer under aseptiske forhold hvert Flixabi-hætteglas med 10 ml vand til injektionvæsker ved hjælp af en sprøjte med en gauge 21 (0,8 mm) kanyle eller en mindre kanyle.
Under aseptic conditions, reconstitute each Flixabi vial with 10 ml of water for injections, using a syringe equipped with a 21-gauge (0.8 mm) or smaller needle.
Hvis disse lægemidler ikke virker godt nok, vil du få Flixabi til behandling af din sygdom.
If these medicines do not work well enough, you will be given Flixabi to treat your disease.
Under behandling med Flixabi
During treatment with Flixabi
Procent forsøgspersoner i klinisk respons og i vedvarende klinisk respons Klinisk respons i uge 8a
Percentage of subjects in clinical response and in sustained clinical response Clinical response at week 8
Ikke almindelig: Kramper, neuropati.
Seizure, neuropathy.
Gennembrudsinfektion efter vaccination (efter eksponering for infliximab i uterus)* Benigne, maligne og uspecificerede tumorer (inkl.
Vaccine breakthrough infection (after in utero exposure to infliximab) Neoplasms benign, malignant and unspecified (including cysts and polyps) Rare:
Procent forsøgspersoner i klinisk remission og vedvarende remission Klinisk remission i uge 8a
Percentage of subjects in clinical remission and sustained remission Clinical remission at week 8
Infliximab Vedligeholdelse (5 mg/kg) (n = 96)
Infliximab Maintenance (5 mg/kg) (n=96)
• Infektioner, som skyldes et nedsat immunforsvar
• Infections due to a weakened immune system
Infliximab + AZA Kombinationsterap i
Infliximab + AZA Combination therapy
Tabel 5 Effekter på respons og remissionshastighed, data fra ACCENT I (uge-2 responderende) ACCENT I (uge-2 responderende) % patienter
Table 5 Effects on response and remission rate, data from ACCENT I (week-2 responders)
• Behandle aktiv Crohns sygdom
• Treat active Crohn's disease,
Placebovedligeholdelse (n = 110)
Placebo Maintenance (n=110)
• Du må kun få Flixabi under graviditeten, hvis lægen finder det nødvendigt.
Flixabi should only be used during pregnancy if your doctor feels it is necessary for you.
Du har en højere risiko, hvis du er 65 år eller derover.
If you are 65 or older,
Tegn på lungeproblemer såsom hoste, åndedrætsbesvær eller trykken for brystet Tegn på et problem i nervesystemet (inklusive øjenproblemer) såsom tegn på slagtilfælde (pludselig følelsesløshed eller svaghed i ansigt, arme eller ben, særligt i den ene side af kroppen; pludselig forvirring, besvær med at tale eller forstå; besvær med at se med det ene eller begge øjne, gangbesvær, svimmelhed, tab af balance- eller koordinationsevne eller svær hovedpine), krampeanfald, prikken/følelsesløshed et sted i kroppen, eller svaghed i arme eller ben, ændringer i synet såsom dobbeltsyn eller andre øjenproblemer.
• Signs of a nervous system problem (including eye problems) such as signs of a stroke (sudden numbness or weakness of your face, arm or leg, especially on one side of your body; sudden confusion, trouble speaking or understanding; trouble seeing in one or both eyes, trouble walking, dizziness, loss of balance or coordination or a severe headache), fits, tingling/numbness in any part of your body, or weakness in arms or legs, changes in eyesight such as double vision or other eye problems
I det andet kliniske studie (ASSERT) blev 279 patienter randomiseret til behandling med enten placebo (gruppe 1, n = 78) eller 5 mg/kg infliximab (gruppe 2, n = 201) i uge 0, 2 og 6 og derefter hver 6. uge indtil uge 24.
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.
Bulløst udslæt, seborre, rosacea, hudpapilom, hyperkeratose, unormal hudpigmentering.
Bullous eruption, seborrhoea, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation.
Fortynd det samlede volumen af den rekonstituerede dosis Flixabi-opløsning til 250 ml med natriumchlorid 9 mg/ml (0,9 %) infusionsvæske, opløsning.
Dilute the total volume of the reconstituted Flixabi solution dose to 250 ml with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Dit barn bør ikke få levende vacciner som BCG indenfor 6 måneder efter fødslen.
Live vaccines such as BCG should not be given to your baby within 6 months after birth.
Induktionsbehandling af moderat til svært aktiv Crohns sygdom Effekten af en enkeltdosisbehandling med infliximab blev vurderet hos 108 patienter med aktiv Crohns sygdom (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) i et randomiseret, dobbeltblind,
Induction treatment in moderately to severely active Crohn's disease The efficacy of a single dose treatment with infliximab was assessed in 108 patients with active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) in a randomised, double-blinded, placebocontrolled, dose-response study.
Meget almindelig: Abdominalsmerter, kvalme.
Abdominal pain, nausea.
Klinisk respons i uge 30a
Clinical response at week 30
En større andel patienter i den kombinerede infliximab-behandlingsgruppe var i stand til at afbryde kortikosteroider og stadig blive i klinisk remission sammenlignet med placebobehandlingsgruppen i både uge 30 (22,3 % mod 7,2 %, p < 0,001, samlede ACT 1- & ACT 2-data) og uge 54 (21,0 % mod 8,9 %, p = 0,022, ACT 1-data).
A greater proportion of patients in the combined infliximab treatment group were able to discontinue corticosteroids while remaining in clinical remission compared to the placebo treatment group at both week 30 (22.3% vs. 7.2%, p < 0.001, pooled ACT 1 & ACT 2 data) and week 54 (21.0% vs. 8.9%, p=0.022, ACT 1 data).
Før behandling med Flixabi
Before treatment with Flixabi
Hypotension, hypertension, ekkymose, hedeture, blussen.
Hypotension, hypertension, ecchymosis, hot flush, flushing.
• Øvrige indholdsstoffer: saccharose, polysorbat 80, monobasisk natriumphosphatmonohydrat og dibasisk natriumphosphatheptahydrat.
• The other ingredients are sucrose, polysorbate 80, monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate.
Uge 30
Week 30
Infliximabs sikkerhed og virkning hos børn under 6 år med Crohns sygdom er ikke undersøgt.
The safety and efficacy of infliximab have not been studied in children with Crohn's disease below the age of 6 years.
• Flere børn end voksne, der får Flixabi, fik infektioner.
• More children taking Flixabi developed infections as compared to adults.
I begge studier var patienterne randomiseret til at få enten placebo, 5 mg/kg infliximab eller 10 mg/kg infliximab i uge 0, 2, 6, 14 og 22, og i ACT 1 i uge 30, 38 og 46.
In both studies, patients were randomised to receive either placebo, 5 mg/kg infliximab, or 10 mg/kg infliximab at weeks 0, 2, 6, 14 and 22, and in ACT 1 at weeks 30, 38 and 46.
Tegn på leverproblemer (inklusive hepatitis B-infektion, hvis du tidligere har haft hepatitis B) såsom gulfarvning af hud eller øjne, mørkebrun urin, smerter eller hævelser i øvre højre side af maven, ledsmerter, hududslæt eller feber
• Signs of a liver problem (including hepatitis B infection when you have had hepatitis B in the past) such as yellowing of the skin or eyes, dark-brown coloured urine, pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever
Otteogtres procent (21/31) af patienter behandlet med infliximab, der fik et 5 mg/kg doseringsregimen, opnåede en klinisk effekt mod 26 % (8/31) af placebobehandlede patienter (p = 0,002).
Sixty eight percent (21/31) of infliximab-treated patients receiving a 5 mg/kg dose regimen achieved a clinical response vs. 26% (8/31) placebo-treated patients (p=0.002).
Seponering af Flixabi-behandling bør overvejes hos patienter, hvor signifikante blodanormaliteter er bekræftet.
Discontinuation of Flixabi therapy should be considered in patients with confirmed significant haematologic abnormalities.
Crohns sygdom er en betændelsessygdom i tarmen.
Crohn's disease Crohn's disease is an inflammatory disease of the bowel.
• Andre hudproblemer såsom erythema multiforme, lichenoide reaktioner (kløende, rødligt-lilla hududslæt og/eller trådlignende gråhvide linjer på slimhinderne), blærer og afskalning af huden eller bylder (furunkulose)
• 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
Efter markedsføring er der rapporteret tilfælde af forværret hjerteinsufficiens hos infliximabpatienter, med eller uden identificerbare prædisponerende faktorer.
There have been post-marketing reports of worsening heart failure, with and without identifiable precipitating factors, in patients taking infliximab.
Flixabi er indiceret til behandling af moderat til svær plaque psoriasis hos voksne patienter, som ikke responderede på, eller som har en kontraindikation for eller som ikke tåler anden systemisk behandling inklusive ciclosporin, methotrexat eller psoralen ultraviolet A (PUVA) (se pkt.
Flixabi 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 ciclosporin, methotrexate or psoralen ultra-violet A (PUVA) (see section 5.1).
Hjerteinsufficiens (debuterende eller forværret), arytmi, besvimelse, bradykardi.
Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia.
• En sjælden blodkræft, som hovedsageligt rammer teenagedrenge eller unge mænd
• A rare blood cancer affecting mostly teenage boys or young men (hepatosplenic T-cell lymphoma)
• Du skal have de anbefalede vaccinationer, før du starter behandling med Flixabi.
• You should receive recommended vaccinations before starting Flixabi treatment.
En risiko for udvikling af hepatosplenisk T-celle-lymfom hos patienter, der bliver behandlet med Flixabi, kan ikke udelukkes (se pkt.
A risk for the development for hepatosplenic T-cell lymphoma in patients treated with Flixabi cannot be excluded (see section 4.8).
Hvis du er i tvivl, så kontakt lægen, før du får Flixabi.
If you are not sure, talk to your doctor before you are given Flixabi.
• Hævelse af lever (hepatitis) eller galdeblæren, leverskade
• Swelling of the liver (hepatitis) or gall bladder, liver damage
I det første studie (P01522), som havde en dobbeltblind fase på 3 måneder, modtog 70 patienter enten 5 mg/kg infliximab eller placebo i uge 0, 2, 6 (35 patienter i hver gruppe).
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).
• Små røde eller lilla pletter, der skyldes blødning under huden • Unormale værdier for et protein i blodet kaldet ‘komplementfaktor', som er en del af immunsystemet.
• Abnormal values of a blood protein called ‘complement factor' which is part of the immune system.
Flixabi administreres intravenøst.
Flixabi should be administered intravenously.
Efter markedsføring er hændelser af anafylaktisk lignende reaktioner, inklusive strube/spiserørs ødemer og alvorlige bronkospasmer, og kramper blevet forbundet med administrering af infliximab (se pkt.
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).
Tuberkulose, bakterieinfektioner, inklusive sepsis og pneumoni, invasive svampeinfektioner, virale infektioner og andre opportunistiske infektioner har været observeret hos patienter, der fik infliximab.
Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients receiving infliximab.