natgillin/translations-raw huggingface dataset:
Between weeks 6 and 26, symptoms of psoriasis gradually returned with a median time to disease relapse of &gt; 20 weeks.
6. ja 26. nädala vahelisel perioodil psoriaasi sümptomid järkjärgult taastusid ning keskmine haiguse taastekke aeg oli &gt; 20 nädalat.
Shortened infusions at doses &gt; 6 mg/kg have not been studied (see section 4.8).
Lühendatud infusioonide kasutamist annuste &gt; 6 mg/kg puhul ei ole uuritud (vt lõik 4.8).
p = 0.030 and &lt; 0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs. placebo + MTX.
p = 0,030 ja &lt; 0,001 vastavalt 3 mg/kg ja 6 mg/kg ravirühmades vs. platseebo + MTX.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10); uncommon (≥ 1/1,000 to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
Kõrvaltoimed on loetletud vastavalt organsüsteemi klassidele ja esinemissagedusele järgmiste kategooriate alusel: väga sage (≥ 1/10); sage (≥ 1/100 kuni &lt; 1/10); aeg-ajalt (≥ 1/1000 kuni &lt; 1/100); harv (≥ 1/10 000 kuni &lt; 1/1000); väga harv ( &lt; 1/10 000), teadmata (ei saa hinnata olemasolevate andmete alusel).
Infliximab crosses the placenta and has been detected in the serum of infants up to 6 months following birth.
Infliksimab lÃ¤bib platsenta ja on olnud tuvastatav imikute vereseerumis kuni 6 kuu jooksul pÃ¤rast sÃ¼ndi.
The concomitant use of infliximab with these biologics is not recommended because of the possibility of an increased risk of infection, and other potential pharmacological interactions.
Infliksimabi samaaegset kasutamist koos nende bioloogiliste preparaatidega ei soovitata vÃµimaliku infektsiooni suurenenud tekkeriski ja teiste vÃµimalike farmakoloogiliste koostoimete tÃµttu.
CDAI &lt; 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.
CDAI &lt; 150 nii nädalaks 30 kui ka 54 ning kortikosteroidide mittemanustamine 3 kuud enne nädalat 54 patsientidel, kes said algselt kortikosteroide.
Of the infliximab-treated 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.
Infliksimab-ravi saanud patsientidel, kes said vÃ¤hemalt Ã¼he lÃ¼hendatud infusiooni, ilmnes infusiooniga seotud reaktsioone 15%-l patsientidest ning tÃµsiseid infusioonireaktsioone esines 0,4%-l patsientidest.
** PASI 75 response for IMPACT not included due to low N; p &lt; 0.001 for infliximab vs. placebo at week 24 for IMPACT 2.
** PASI 75 ravivastus uuringus IMPACT, mitte arvestatud madala N väärtuse tõttu; p &lt; 0,001 infliksimab vs platseebo nädalal 24 uuringus IMPACT 2.
One serious infusion reaction ( &lt; 1%) occurred in a patient on infliximab monotherapy.
Üks raske infusioonireaktsioon ( &lt; 1%) esines infliksimabi monoteraapiana saanud patsiendil.
&gt; 40 weeks
&gt; 40 nädalat
all infliximab doses given in combination with methotrexate and folate with some on corticosteroids and/or NSAIDs p &lt; 0.001, for each infliximab treatment group vs. control greater values indicate more joint damage.
kõik infliksimabi annused anti kombinatsioonis metotreksaadiga ja folaadiga ning mõne kortikosteroidi ja/või MSPVA-ga p &lt; 0,001, iga infliksimabi grupi puhul vs. kontroll suuremad väärtused näitavad rohkem liigeskahjustusi.
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.
Infliksimabi kliiniliste uuringute jÃ¤rgselt lÃ¤biviidud pika-ajalise kuni 5 aastat kestnud ohutusalase jÃ¤lgimisperioodi jooksul, mis hÃµlmas 6234 patsiendiaastat (3210 patsienti), on teatatud 5 lÃ¼mfoomi juhust ning 38 mitte-lÃ¼mfoomse pahaloomulise kasvaja esinemisest.
&gt; 54 weeks
&gt; 54 nädalat
The primary endpoint of the study was corticosteroid-free clinical remission at week 26, defined as patients in clinical remission (CDAI of &lt; 150) who, for at least 3 weeks, had not taken oral systemic corticosteroids (prednisone or equivalent) or budesonide at a dose &gt; 6 mg/day.
Uuringu esmane tulemusnäitaja oli kortikosteroidivaba kliiniline remissioon 26. nädalal, mida määratleti kui kliinilises remissioonis patsiendid (CDAI &lt; 150), kes polnud vähemalt 3 nädalat võtnud suukaudseid süsteemseid kortikosteroide (prednisoon või samaväärse toimega) või budesoniidi &gt; 6 mg/ööpäev annusena.
Administer the infusion solution over a period of not less than the infusion time recommended (see section 4.2).
Infundeerige lahus perioodi jooksul, mis ei oleks lÃ¼hem soovituslikust infusiooniajast (vt lÃµik 4.2).
Tell your doctor straight away if you notice any of the following:
Informeerige oma arsti koheselt kui te mÃ¤rkate midagi jÃ¤rgnevast:
Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology.
Infliksimab on kimeerne inimese-hiire IgG1 monoklonaalne antikeha, mida toodetakse hiire hÃ¼bridoomi rakkudes rekombinantse DNA tehnoloogia abil.
Infections occurred in 68% (41/60) of children receiving 3 mg/kg over 52 weeks, 65% (37/57) of children receiving infliximab 6 mg/kg over 38 weeks and 47% (28/60) of children receiving placebo over 14 weeks (see section 4.4).
Infektsioonid tekkisid 68%-l (41/60) lastest, kes said ravimit 3 mg/kg kohta 52 nÃ¤dala jooksul, 65%-l (37/57) lastest, kes said infliksimabi 6 mg/kg kohta 38 nÃ¤dala jooksul ja 47%-l (28/60) lastest, kes said platseebot 14 nÃ¤dala jooksul (vt lÃµik 4.4).
Infliximab-treated patients demonstrated significant improvement in physical function as assessed by HAQ.
Infliksimabiga ravitud patsientidel oli jÃ¤lgitav mÃ¤rkimisvÃ¤Ã¤rne fÃ¼Ã¼silise funktsiooni paranemine HAQ-skoori jÃ¤rgi.
Infliximab inhibits the functional activity of TNFï¡ in a wide variety of in vitro bioassays.
Infliksimab pÃ¤rsib TNFÎ± funktsionaalset aktiivsust mitmetes in vitro katsetes.
Infliximab is a monoclonal antibody - a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha.
Infliksimab on monoklonaalne antikeha - teatud tÃ¼Ã¼pi valk, mis organismis kinnitub teatud sihtmÃ¤rkide (nimetatakse TNF (tuumorinekroosifaktor) alfa) kÃ¼lge.
Significant improvements from baseline were demonstrated in DLQI (p &lt; 0.001) and the physical and mental component scores of the SF 36 (p &lt; 0.001 for each component comparison).
Võrreldes algväärtusega täheldati märkimisväärset paranemist DLQI (Dermatology Life Quality Index) (p &lt; 0,001) osas ning SF 36 füüsilise ja vaimse komponendi skoorides (p &lt; 0,001 iga komponendi võrdluses).
Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of &gt; 5% include pneumocystosis, candidiasis, listeriosis and aspergillosis.
Mõned nendest infektsioonidest on lõppenud surmaga; kõige sagedamini teatatud oportunistlike infektsioonide hulka suremusmääraga &gt; 5% kuuluvad pneumotsüstoos, kandidiaas, listerioos ja aspergilloos.
Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of &gt; 5% include pneumocystosis, candidiasis, listeriosis and aspergillosis (see section 4.4).
Mõned nendest infektsioonidest on lõppenud surmaga; kõige sagedamini teatatud oportunistlike infektsioonide hulka suremusmääraga &gt; 5% kuuluvad pneumotsüstoos, kandidiaas, listerioos ja aspergilloos (vt lõik 4.4).
Approximately 3% of patients discontinued treatment due to infusion-related reactions and all patients recovered with or without medical therapy.
Infusioonireaktsioonide tÃµttu katkestas ravi umbes 3% patsiente ja kÃµik patsiendid paranesid kas raviga vÃµi ilma.
Of infliximab-treated patients who had an infusion reaction during the induction period, through week 6, 27% experienced an infusion reaction during the maintenance period, week 7 through week 54.
Infliksimabi saanud patsientidest, kellel tekkis induktsiooniperioodil (kuni 6. nÃ¤dalani) infusioonireaktsioon, esines 27%-l infusioonireaktsioon sÃ¤ilitusravi ajal (7. kuni 54. nÃ¤dalal).
Antibodies to infliximab developed in 38% of patients receiving 3 mg/kg compared with 12% of patients receiving 6 mg/kg.
Infliksimabi vastased antikehad tekkisid 38%-l patsientidest, kes said ravimit 3 mg/kg kohta vÃµrreldes 12%-ga patsientidest, kes said 6 mg/kg kohta.
Infliximab Maintenance 5 mg/kg (n = 113) (p value)
Infliksimab sÃ¤ilitusravi 5 mg/kg (n = 113) (p-vÃ¤Ã¤rtus)
Infliximab Maintenance (5 mg/kg) (n = 96)
Infliksimab sÃ¤ilitusravi (5 mg/kg) (n = 96)
In infliximab treated subjects, significant PASI 50 responses were apparent at the first visit (week 2) and PASI 75 responses by the second visit (week 6).
Infliksimabiga ravitud patsientide grupis esines ilmne PASI 50 saavutanute osakaal esimesel visiidil (2. nÃ¤dal) ja PASI 75 saavutanute osakaal teisel visiidil (6.nÃ¤dal).
Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFï¡ but not to lymphotoxin ï¡ (TNFÃ).
Infliksimab on kimeerne inimese-hiire monoklonaalne antikeha, mis on kÃµrge afiinsusega nii lahustuvate kui transmembraansete TNFÎ± vormide suhtes, kuid mitte lÃ¼mfotoksiin-Î± (TNFÃ) suhtes.
Efficacy and safety of infliximab were assessed in two multicenter, double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score ≥ 4 and spinal pain ≥ 4 on a scale of 1-10).
Infliksimabi efektiivsust ja ohutust hinnati kahes mitmekeskuselises, topeltpimedas, platseebokontrolliga uuringus, mis viidi lÃ¤bi aktiivse ankÃ¼loseeriva spondÃ¼liidiga patsientidel (haiguse aktiivsuse skoor BASDAI [Bath Ankylosing Spondylitis Disease Activity Index] â¥ 4 ja spinaalse valu skoor â¥ 4 1 skaalal 1â¦10).
The efficacy of infliximab was assessed in two multicentre, randomised, double-blind, pivotal clinical studies: ATTRACT and ASPIRE.
Infliksimabi efektiivsust on hinnatud kahes mitmekeskuselises, randomiseeritud, topeltpimedas pÃ¶Ã¶rdelises kliinilises uuringus: ATTRACT ja ASPIRE.
In the re-treatment arm, 4% (8/219) of patients experienced a serious infusion reaction versus &lt; 1% (1/222) on maintenance therapy.
Kordusravi rühmas esines 4%-l (8/219) patsientidest tõsine infusioonireaktsioon võrreldes &lt; 1%-ga (1/222) säilitusravi rühmas.
The overall incidence of infections in C0168T72 was 13/22 (59%) in the every 8 week maintenance treatment group and 14/23 (60.9%) in the every 12 week maintenance treatment group.
Infektsioonide Ã¼ldine esinemissagedus uuringus C0168T72 oli sÃ¤ilitusravi grupis 13/22 (59%), kes said ravi iga 8 nÃ¤dala jÃ¤rel ja 14/23 (60,9%), kes said ravi iga 12 nÃ¤dala jÃ¤rel.
Infliximab Maintenance 10 mg/kg (n = 112) (p value)
Infliksimab sÃ¤ilitusravi 10 mg/kg (n = 112) (p-vÃ¤Ã¤rtus)
The efficacy of infliximab was assessed in two multicenter, randomised, double-blind studies: SPIRIT and EXPRESS.
Infliksimabi tÃµhusust hinnati kahes mitmekeskuselises randomiseeritud topeltpimedas uuringus: SPIRIT ja EXPRESS.
Infusion reactions occurred in 35% of patients with juvenile rheumatoid arthritis receiving 3 mg/kg compared with 17.5% of patients receiving 6 mg/kg.
Infusioonireaktsioonid ilmnesid 35%-l juveniilse reumatoidartriidiga patsientidest, kellele manustati ravimit 3 mg/kg kohta vÃµrreldes 17,5%-ga patsientidest, kellele manustati 6 mg/kg kohta.
At week 16, 47 placebo patients with &lt; 10% improvement from baseline in both swollen and tender joint counts were switched to infliximab induction (early escape).
16. nädalal lülitati 47 platseebo patsienti, kellel täheldati &lt; 10% paranemist nii turses kui valulike liigeste algtasemest, infliksimabi induktsioonravile (varane muutmine).
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 &lt; 0.001).
54. nädalaks esines kliiniline ravivastus 44,9%-l patsientidest kombineeritud infliksimabi ravirühmas võrreldes 19,8%-ga platseebo ravirühmas (p &lt; 0,001).
The co-primary endpoints were the proportion of patients in clinical remission (CDAI &lt; 150) at week 30 and time to loss of response through week 54.
Esmaseks tulemusnäitajaks oli ka kindlaks teha kliinilises remissioonis patsientide hulk (CDAI &lt; 150) nädalaks 30 ning aeg ravivastuse kadumiseni nädalaks 54.
p &lt; 0.001, for each infliximab treatment group vs. control.
p &lt; 0,001, iga infliksimabi grupi puhul vs. kontroll.
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).
Infliksimabi Ã¼hekordse intravenoosse annuse 1, 3, 5, 10 vÃµi 20 mg/kg manustamisel suurenesid proportsionaalselt maksimaalne plasmakontsentratsioon (Cmax) ja AUC.
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 &lt; 0.001).
SPIRIT uuringus oli kümnendaks nädalaks PASI 75 saavutanud patsientide osakaal 3 mg/kg infliksimabigrupis 71,7%, 5 mg/kg infliksimabigrupis 87,9% ja platseebogrupis 5,9% (p &lt; 0,001).
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 &lt; 0.001, pooled ACT 1 &amp; ACT 2 data) and week 54 (21.0% vs. 8.9%, p = 0.022, ACT1 data).
Suurem hulk patsiente kombineeritud infliksimabi ravirühmast võrreldes platseebo ravirühmaga olid võimelised katkestama kortikosteroidravi säilitades endiselt kliinilise remissiooni nii 30. nädalal (22,3% vs 7,2%, p &lt; 0,001, ACT 1 &amp; ACT 2 ühendatud andmed) kui ka 54. nädalal (21,0% vs 8,9%, p = 0,022, ACT 1 andmed).
Administer the infusion solution over a period of not less than the infusion time recommended.
Infundeerige lahus perioodi jooksul, mis ei oleks lÃ¼hem soovituslikust infusiooniajast.
Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study (SONIC) of 508 adult patients with moderate to severe Crohn's disease (CDAI â¥ 220 â¤ 450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Infliksimabi koos vÃµi ilma AZA-ta hinnati randomiseeritud, topeltpimedas, aktiivses vÃµrdlevas uuringus (SONIC) 508 Crohni tÃµve mÃµÃµdukalt kuni Ã¤gedalt aktiivse vormiga tÃ¤iskasvanul (CDAI â¥ 220 â¤ 450), kes olid varasemalt bioloogiliste ravimite vÃµi immunosupressantidega ravimata ja keskmise haiguse kestvusega 2,3 aastat.
The safety and efficacy of infliximab were assessed in a multicenter, randomised, open-label, parallel-group clinical study (C0168T72) in 60 paediatric patients aged 6 through 17 years (median age 14.5 years) with moderately to severely active ulcerative colitis (Mayo score of 6 to 12; endoscopic subscore ≥ 2) with an inadequate response to conventional therapies.
Infliksimabi efektiivsust ja ohutust hinnati multitsentrilises, randomiseeritud, avatud, paralleel-grupiga kliinilises uuringus (C0168T72) 60 lapsel vanuses 6 kuni 17 eluaastat (mediaanvanus 14,5 aastat), kellel oli mÃµÃµdukas kuni raske aktiivne haavandiline koliit (Mayo skoor 6 kuni 12; endoskoopia alamskoor â¥ 2) ja kes ei olnud adekvaatselt allunud konventsionaalsele ravile.
Patients on infliximab may receive concurrent vaccinations, except for live vaccines (see sections 4.5 and 4.6).
Infliksimabiga ravi saavatele patsientidele vÃµib vaktsiine manustada, vÃ¤lja arvatud elusvaktsiine (vt lÃµigud 4.5 ja 4.6).
Repeated administration of infliximab (5 mg/kg at 0, 2 and 6 weeks in fistulising Crohn's disease, 3 or 10 mg/kg every 4 or 8 weeks in rheumatoid arthritis) resulted in a slight accumulation of infliximab in serum after the second dose.
Infliksimabi korduv manustamine (5 mg/kg nÃ¤dalatel 0, 2 ja 6 Crohni tÃµve fistulitega vormi raviks; 3 vÃµi 10 mg/kg iga 4 vÃµi 8 nÃ¤dala jÃ¤rel reumatoidartriidi korral) viis infliksimabi vÃ¤hese kogunemiseni seerumis pÃ¤rast teist annust.
Post-marketing spontaneous serious adverse reactions with infliximab in the paediatric population have included malignancies including hepatosplenic T-cell lymphomas, transient hepatic enzyme abnormalities, lupus-like syndromes, and positive auto-antibodies (see sections 4.4 and 4.8).
Infliksimabi turuletulekujÃ¤rgsete kogemuste pÃµhjal hÃµlmasid spontaansed tÃµsised kÃµrvaltoimed lastel pahaloomulisi kasvajaid, sealhulgas hepatospleenilist T-rakulist lÃ¼mfoomi, mÃ¶Ã¶duvaid kÃµrvalekaldeid maksaensÃ¼Ã¼mide aktiivsuses, luupusesarnaseid sÃ¼ndroome ja positiivseid autoantikehasid (vt lÃµigud 4.4 ja 4.8).
Secondary endpoints included the proportion of patients in clinical remission at week 4 (CDAI &lt; 150) and clinical response over time.
Teise väljundina määrati patsientide hulk, kes olid neljandal nädalal kliinilises remissioonis (CDAI &lt; 150) ja kliinilise vastuse püsimine.
Infusion reactions and hypersensitivity
Infusioonireaktsioonid ja Ã¼litundlikkus
Infliximab does not cross react with TNFï¡ from species other than human and chimpanzees.
Infliksimab reageerib ainult inimese ja Å¡impansi, mitte teiste liikide TNFÎ±-ga.
At week 24, the number of ASAS 20 responders was 15/78 (19%) in the placebo group, and 123/201 (61%) in the 5 mg/kg infliximab group (p &lt; 0.001).
24. nädalaks oli ASAS 20 (ASsessment in Ankylosing Spondylitis) saavutanuid platseebogrupis 15/78 (19%) ja 123/201 (61%) infliksimabi annuses 5 mg/kg saanute grupis (p &lt; 0,001).
Also at week 4, 13/27 (48%) of infliximab-treated patients achieved a clinical remission (CDAI &lt; 150) vs. 1/25 (4%) of placebo-treated patients.
Neljandal nädalal saavutas kliinilise remissiooni (CDAI &lt; 150) 48% (13/27) infliksimabi saanud patsientidest, võrreldes 4% (1/25) platseebot saanud patsientidega.
Infections were reported more frequently for subjects who received q8 week as opposed to q12 week infusions (73.6% and 38.0%, respectively), while serious infections were reported for 3 subjects in the q8 week and 4 subjects in the q12 week maintenance treatment group.
Infektsioone esines sagedamini isikutel, kes said infusioonravi iga 8 nÃ¤dala jÃ¤rel vÃµrreldes nendega, kes said seda iga 12 nÃ¤dala jÃ¤rel (vastavalt 73,6% ja 38,0%), sÃ¤ilitusravi grupis esines tÃµsiseid infektsioone iga 8 nÃ¤dala jÃ¤rel infusioonravi saanud isikutest kolmel ja iga 12 nÃ¤dala jÃ¤rel infusioonravi saanutest neljal isikul.
At week 54, the figures were 55.8% (29/52) and 23.5% (12/51) in the q8 weeks and q12 weeks maintenance groups, respectively (p &lt; 0.001).
54. nädalal olid need näitajad vastavalt 8- ja 12-nädalase annustamisintervalliga säilitusravi gruppides 55,8% (29/52) ja 23,5% (12/51) (p &lt; 0,001).
Tell your doctor straight away if you notice any of the above.
Informeerige oma arsti kohe, kui te mÃ¤rkate midagi Ã¼laltoodust.
At week 12, the number of BASDAI 50 responders were 3/35 (9%) in the placebo group, and 20/35 (57%) in the 5 mg/kg group (p &lt; 0.01).
12. nädalaks oli BASDAI 50 saavutanuid platseebogrupis 3/35 (9%) ja 20/35 (57%) infliksimabi annuses 5 mg/kg saanute grupis (p &lt; 0,01).
Infliximab prevented disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNFï¡ and when administered after disease onset, it allowed eroded joints to heal.
Infliksimab vÃµimaldab transgeensel hiirel inimese TNFÎ± pideva ekspressiooni tulemusena tekitatud polÃ¼artriidi korral erosiivsete liigeste paranemist, kui manustada ravimit kohe pÃ¤rast haiguse vallandumist.
Clinical remission and mucosal healing occurred in a greater proportion of patients in the combined infliximab treatment group compared to the placebo treatment group at week 54 (34.6% vs. 16.5%, p &lt; 0.001 and 46.1% vs. 18.2%, p &lt; 0.001, respectively).
Kliiniline remissioon ja limaskesta paranemine ilmnes 54. nädalaks suuremal hulgal patsientidest kombineeritud infliksimabi ravirühmas võrreldes platseebo ravirühmaga (vastavalt 34,6% vs 16,5%, p &lt; 0,001 ja 46,1% vs 18,2%, p &lt; 0,001).
The proportions of patients in sustained response and sustained remission at week 54 were greater in the combined infliximab treatment group than in the placebo treatment group (37.9% vs. 14.0%, p &lt; 0.001; and 20.2% vs. 6.6%, p &lt; 0.001, respectively).
Püsiva ravivastusega ning püsiva remissiooniga patsientide hulk 54. nädalaks oli suurem kombineeritud infliksimabi ravirühmas kui platseebo ravirühmas (vastavalt 37,9% vs 14,0% p &lt; 0,001; ja 20,2% vs 6,6%, p &lt; 0,001).
The proportions of patients with mucosal healing at week 26 were significantly greater in the infliximab plus AZA combination (43.9%, p &lt; 0.001) and infliximab monotherapy groups (30.1%, p = 0.023) compared to the AZA monotherapy group (16.5%).
26. nädalal oli paranenud limaskestaga patsientide osakaal märgatavalt suurem rühmas, kus saadi infliksimabi ja AZA-t kombineeritud teraapiana (43,9%, p &lt; 0,001) ja rühmas, kus saadi infliksimabi monoteraapiana (30,1%, p = 0,023), võrreldes rühmaga, kus saadi AZA-t monoteraapiana (16,5%).
178 of the 580 enrolled patients (30.7%) were defined as having severe disease (CDAI score &gt; 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Vastavalt näidustuses määratletud populatsioonile (vt lõik 4.1), defineeriti uuringusse kaasatud 580-st patsiendist 178 (30,7%) kui raske haigusega patsiendid (CDAI skoor &gt; 300 ning kaasuvad kortikosteroidid ja/või immunosupressandid).
Infliximab (week 98)
Infliksimab (nÃ¤dal 98)
Infliximab (week 24)
Infliksimab (nÃ¤dal 24)
Infliximab (week 54)
Infliksimab (nÃ¤dal 54)
Patients who developed antibodies to infliximab were more likely (approximately 2-3 fold) to develop infusion-related reactions.
Infliksimabivastaste antikehadega patsientidel oli infusioonireaktsioonide teke umbes 2...3 korda tÃµenÃ¤olisem.
Infliximab (week 16)
Infliksimab (nÃ¤dal 16)
Maintenance treatment in fistulising active Crohn's disease The efficacy of repeated infusions with infliximab in patients with fistulising Crohn's disease was studied in a 1-year clinical study (ACCENT II).
Infliksimabi kordusinfusioonide efektiivsust Crohni tÃµve fistulitega vormi pÃµdevatel patsientidel uuriti 1-aastases kliinilises uuringus (ACCENT II).
Infliximab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment at the week 24 primary endpoint as measured by change from baseline in total modified vdH-S score (mean Â± SD score was 0.82 Â± 2.62 in the placebo group compared with -0.70 Â± 2.53 in the infliximab group; p &lt; 0.001).
Nädalaks 24 saavutatud tulemusnäitaja alusel, mida mõõdeti kui kogu modifitseeritud vdH-S skoori muutust võrreldes algväärtusega (keskmine ± SD skoor oli 0,82 ± 2,62 platseebogrupis võrreldes -0,70 ± 2,53 infliksimabi grupis; p &lt; 0,001), vähendas infliksimab ravi võrreldes platseeboga perifeerse liigeskahjustuse progresseerumise määra.
Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients receiving Remicade.
Infliksimabiga ravitud patsientidel on tÃ¤heldatud tuberkuloosi, bakteriaalseid infektsioone, sh sepsist ning pneumooniat, invasiivseid seen-, viirus- ning teisi oportunistlikke infektsioone.
Infliximab was administered at a dose of 5 mg/kg at weeks 0, 2, 6, and then every 8 weeks.
Infliksimabi manustati 5 mg/kg annusena 0., 2., 6. nÃ¤dalal ja seejÃ¤rel iga 8 nÃ¤dala tagant.
Infliximab has been associated with acute infusion-related reactions, including anaphylactic shock, and delayed hypersensitivity reactions (see section 4.8).
Infliksimabi kasutamisel vÃµib tekkida nii Ã¤ge infusioonireaktsioon, kaasa arvatud anafÃ¼laktiline Å¡okk, kui ka hilist tÃ¼Ã¼pi Ã¼litundlikkusreaktsioon (vt lÃµik 4.8).
p &lt; 0.001, for each infliximab treatment group vs. placebo.
p &lt; 0,001, igas infliksimabi ravirühmas vs platseebo.