natgillin/translations-raw huggingface dataset:
Tabel 4 Virkninger på ACRn, strukturel ledskade og fysisk funktion ved uge 54, ASPIRE
Table 4 Effects on ACRn, Structural Joint Damage and Physical Function at week 54, ASPIRE Infliximab + MTX
≥ 75% forbedring
≥ 75% improvement a
Andelen af patienter med slimhindeheling i uge 26 var signifikant større i grupperne, der fik infliximab plus AZA (43,9%; p < 0,001) eller infliximab-monoterapi (30,1%; p=0,023) sammenlignet med AZA-monoterapigruppen (16,5%).
The proportions of patients with mucosal healing at week 26 were significantly greater in the infliximab plus AZA combination (43.9%, p<0.001) and infliximab monotherapy groups (30.1%, p=0.023) compared to the AZA monotherapy group (16.5%).
≥ 90% forbedring
N ≥ 90% improvement a
Sprøjtekanylen i hætteglasset indsættes i hætteglasset gennem midten af gummiproppen og injektionsvæskestrømmen rettes mod glasvæggen i hætteglasset.
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.
5.1): anæmi (10,7%), blod i afføringen (9,7%), leukopeni (8,7%), rødmen (8,7%), viral infektion (7,8%), neutropeni (6,8%), bakteriel infektion (5,8%) og allergisk reaktion i luftvejene (5,8%).
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%).
• Fornyet administration: Infusion af 5 mg/kg, hvis sygdomstegn og symptomer på sygdommen kommer igen, efterfulgt af infusionsdoser på 5 mg/kg hver 8. uge (se "Fornyet administration"
• Re-administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur followed by infusions of 5 mg/kg every 8 weeks (see ‘Re-administration' below and section 4.4).
Ankyloserende spondylitis Psoriasis arthritis Psoriasis 1 Placebo-patienter fik methotrexat, mens infliximab-patienter fik både infliximab og methotrexat.
1 Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
I uge 4 efter indgivelse af en enkelt dosis opnåede 22/27 (81%) af de infliximab-behandlede patienter, der fik 5 mg/kg dosen en klinisk virkning mod 4/25 (16%) af placebopatienterne (p < 0,001).
At week 4, following administration of a single dose, 22/27 (81%) of infliximab-treated patients receiving a 5 mg/kg dose achieved a clinical response vs. 4/25 (16%) of the placebo-treated patients (p <0.001).
Antallet af hospitalsindlæggelser relateret til colitis ulcerosa var signifikant lavere i 5 og 10 mg/kg infliximab-behandlingsgrupperne end i placebogruppen (gennemsnitligt antal hospitalsindlæggelser per 100 forsøgsperson-år: 21 og 19 versus 40 i placebogruppen; hhv. p=0,019 og p=0,007).
The number of ulcerative colitis-related hospitalisations was significantly lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of hospitalisations per 100 subject-years: 21 and 19 vs. 40 in the placebo group; p=0.019 and p=0.007, respectively).
Den almindeligste bivirkning rapporteret i kliniske studier var øvre luftvejsinfektion, der forekom hos 25,3% af de infliximab-behandlede patienter sammenlignet med hos 16,5% af kontrolpatienterne.
Upper respiratory tract infection was the most common adverse drug reaction (ADR) reported in clinical trials, occurring in 25.3% of infliximab-treated patients compared with 16.5% of control patients.
• Vedligeholdelse: Yderligere infusionsdosis på 5 mg/kg 6 uger efter den første dosis, efterfulgt af infusionsdoser hver 8. uge eller
• Maintenance: Additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or
Hvis infusionsvæsken ikke anvendes straks, er opbevaringstiderne og -betingelserne efter anbrud indtil anvendelse brugerens ansvar, og bør normalt ikke overskride 24 timer ved 2C - 8C med mindre rekonstitution/fortynding har fundet sted under kontrollerede og validerede aseptiske forhold (se pkt.
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions.
Almene symptomer og reaktioner på administrationsstedet Meget almindelig: Almindelig:
General disorders and administration site conditions Very common:
Efter markedsføring er der rapporteret tilfælde af forværret hjerteinsufficiens hos infliximab-patienter, 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.
Studier fra den publicerede litteratur i forskellige indikationer (fx reumatoid arthritis, psoriasis, Crohns sygdom) tyder dog på, at ikke-levende vacciner givet under anti-TNF-behandling,
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.
Antallet af kirurgiske indgreb relateret til colitis ulcerosa var også lavere i 5 og 10 mg/kg infliximab-behandlingsgrupperne end i placebogruppen (gennemsnitligt antal kirurgiske indgreb per 100 forsøgsperson-år: 22 og 19 versus 34; hhv. p=0,145 og p=0,022).
The number of ulcerative colitis-related surgical procedures was also lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of surgical procedures per 100 subject-years: 22 and 19 vs. 34; p=0.145 and p=0.022, respectively).
• Fortæl straks din læge, hvis du får nye eller forværrede tegn på hjertesvigt under behandlingen med Inflectra.
• Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Inflectra.
Andelene af patienter i vedvarende respons og vedvarende remission i uge 54 var større i den kombinerede infliximab-behandlingsgruppe end i placebobehandlingsgruppen (henholdsvis 37,9% mod 14,0%, p < 0,001 og 20,2% mod 6,6%, p < 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<0.001; and 20.2% vs. 6.6%, p<0.001, respectively).
Fortsat behandling bør revurderes nøje hos patienter, som ikke viser tegn på terapeutisk virkning inden for denne periode.
Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.
• Tegn på infektion (inklusive tuberkulose (TB) såsom feber, træthedsfølelse, hoste, som kan være vedvarende, åndenød, influenzalignende symptomer, vægttab, natlig svedtendens, diarré, sår, ansamling af pus i tarmen eller omkring anus (absces), tandproblemer eller brændende følelse, når du lader vandet.
• Signs of infection (including TB) such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection of pus in the gut or around the anus (abscess), dental problems or burning sensation when urinating.
HAQ ændring fra baseline over tiden e (patienter evalueret) Gennemsnit ± SD a Kontrol = Alle patienter havde aktiv RA på trods af behandling med stabile methotrexat doser i 6 måneder før inklusion og skulle fortsætte på stabile doser gennem studiet.
c a control = All patients had active RA despite treatment with stable methotrexate doses for 6 months prior to enrolment and were to remain on stable doses throughout the study.
Lidelse i immunsystemet
Immune system disorder
b CDAI < 150 ved både uge 30 og 54.
b CDAI < 150 at both week 30 and 54 and not receiving corticosteroids in the 3 months prior to week 54
PGA helt væk (0) eller minimale (1)
≥ 50% improvement PGA of cleared (0) or minimal (1)
Infliximab + MTX
Placebo + MTX
Hos patienter, som tog infliximab, er langt størstedelen af tilfældene forekommet hos patienter med Crohns sygdom eller colitis ulcerosa og de fleste blev rapporteret hos unge eller unge voksne mænd.
The vast majority of infliximab cases have occurred in patients with Crohn's disease or ulcerative colitis and most were reported in adolescent or young adult males.
• Tegn på hjerteproblemer såsom ubehag i brystkassen eller brystsmerter, armsmerter, mavesmerter, åndenød, angst, ørhed, svimmelhed, besvimelse, svedtendens, kvalme (utilpashed), opkastning, flakkende hjerte eller trykken i brystet, hurtigt eller langsomt hjerteslag og hævelse af dine fødder.
• Signs of a heart problem such as chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea (feeling sick), vomiting, fluttering or pounding in your chest, a fast or a slow heartbeat, and swelling of your feet.
Klinisk remission og slimhindeheling forekom i en større andel af patienterne i den kombinerede infliximabbehandlingsgruppe sammenlignet med placebobehandlingsgruppen i uge 54 (henholdsvis 34,6% mod 16,5%, p < 0,001 og 46,1% mod 18,2%, p < 0,001).
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<0.001 and 46.1% vs. 18.2%, p<0.001, respectively).
Vertigo, svimmelhed, hypæstesi, paræstesi.
Vertigo, dizziness, hypoaesthesia, paraesthesia.
Brug ikke Inflectra, hvis
You must not be given Inflectra if:
Hos psoriasis patienter behandlet med infliximab som vedligeholdelsesbehandling uden samtidige immunmodulerende midler udviklede 28% antistoffer mod infliximab (se pkt.
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”).
• Tegn på lave blodtal såsom vedvarende feber, blødningstendens eller tendens til lettere at få blå mærker, små røde eller lilla pletter, der skyldes blødning under huden eller bleghed.
• Signs of low blood counts such as persistent fever, bleeding or bruising more easily, small red or purple spots caused by bleeding under the skin, or looking pale.
Reduktionen i hyppigheden af kolektomi blev også undersøgt i et anden randomiseret, dobbelblindet studie (C0168Y06) af hospitaliserede patienter (n=45) med moderat til svær aktiv colitis ulcerosa,
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.
Behold dette kort som reference i 4 måneder efter din sidste Inflectra-dosis, når du starter på et nyt kort.
When starting a new card, please keep this card as a reference for 4 months after your last dose of Inflectra.
Infliximab med eller uden AZA blev vurderet i et randomiseret, dobbeltblindet studie med aktiv komparator (SONIC) hos 508 voksne patienter med moderat til svær Crohns sygdom (CDAI ≥ 220 ≤ 450).
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 ≥ 220 ≤ 450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
• Behold det gamle kort som reference i 4 måneder efter din sidste Inflectra-dosis, når du starter på et nyt kort.
• When starting a new card, keep this card as a reference for 4 months after your last dose of
Tegn inkluderer kortåndethed eller hævede fødder.
Signs include shortness of breath or swelling of your feet.
Efter infliximabbehandling udviste patienter nedsat niveau af serum interleukin 6 (IL-6) og C-reaktivt protein (CRP).
After infliximab treatment, patients exhibited decreased levels of serum interleukin 6 (IL-6) and C-reactive protein (CRP), and increased haemoglobin levels in rheumatoid arthritis patients with reduced haemoglobin levels, compared with baseline.
Inflectra er indiceret til behandling af moderat til svær, aktiv colitis ulcerosa hos voksne patienter, som har haft utilstrækkelig respons af konventionel behandling inklusive kortikosteroider og 6-mercaptopurin (6-MP) eller azathioprin (AZA), eller som er intolerante over for eller har kliniske kontraindikationer for sådanne behandlinger.
Inflectra is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Gennemsnit ± SD a p < 0,001, for hver infliximab-behandlingsgruppe mod kontrol.
Mean ± SDd a p <0.001, for each infliximab treatment group vs control.
Det anbefales, at pædiatriske patienter bliver vaccineret i overensstemmelse med gældende vaccinationsvejledninger, før infliximab-behandling påbegyndes, hvis dette er muligt.
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.
Hos patienter med positiv test for HBV-infektion, anbefales det at rådføre sig med en læge med erfaring i behandling af hepatitis B. Bærere af HBV, hvor behandling med infliximab er nødvendig, skal følges nøje under behandlingen og i adskillige måneder efter afslutning af behandlingen for at registrere tegn og symptomer på aktiv HBV-infektion.
Carriers of HBV who require treatment with infliximab should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Endepunkt blev målt ved ændring fra baseline i samlet modificeret vdH-S score (middel ± SD score var 0,82 ± 2,62 i placebogruppen sammenlignet med -0,70 ± 2,53 i infliximab-gruppen; p < 0,001).
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 ± SD score was 0.82 ± 2.62 in the placebo group compared with -0.70 ± 2.53 in the infliximab group; p<0.001).
Brug af anden medicin sammen med Inflectra
Other medicines and Inflectra
Virkningen af infliximab blev vurderet i to multicenter, randomiserede, dobbeltblindede studier:
The efficacy of infliximab was assessed in two multicentre, randomised, double-blind studies: SPIRIT and EXPRESS.
Inflectra er indiceret til behandling af svær, aktiv Crohns sygdom hos børn og unge mellem 6 og 17 år, som ikke har responderet på konventionel behandling inklusive kortikosteroid, immunmodulator og primær ernæringsbehandling, eller som er intolerante over for eller hvor der er kontraindikationer mod sådanne behandlinger.
Inflectra is indicated for treatment of severe, active Crohn's disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.
• Før du får Inflectra, skal du fortælle det til din læge, hvis du har en infektion, også selvom det er en meget let infektion.
• Tell your doctor before you are given Inflectra if you have an infection, even if it is a very minor one.
Andelen af personer med klinisk respons i uge 10 var 88,4% (99/112), og andelen af personer, som opnåede klinisk remission i uge 10, var 58,9% (66/112).
The proportion of subjects achieving clinical remission at week 10 was 58.9% (66/112).
• Før du får Inflectra, skal du fortælle din læge, hvis du er bærer af, eller nogensinde har haft hepatitis B.
• Tell your doctor before you are given Inflectra if you are a carrier of hepatitis B or have ever had it.
Placebovedligeholdelse (n=110)
Placebo Maintenance (n=99)
• Lægemidlet vil blive givet som en infusion (drop) (i løbet af 2 timer) i en af dine blodårer
• The medicine will be given as an infusion (drip) (over 2 hours) into one of your veins, usually in your arm. After the third treatment, your doctor may decide to give your dose of Inflectra over 1 hour.
Hjælpestoffer: Saccharose, polysorbat 80, natriumdihydrogen-phosphatmonohydrat og dinatriumphosphatdihydrat.
Excipients: sucrose, polysorbate 80, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate
Under den 24 uger dobbeltblindede fase modtog patienterne enten 5 mg/kg infliximab eller placebo i ugerne 0, 2, 6, 14 og 22 (100 patienter i hver gruppe).
During the 24-week double-blind phase, patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6, 14, and 22 (100 patients in each group).
• Svampeinfektioner, såsom gærsvampeinfektion eller svampeinfektion i neglene
• Fungal infections such as yeast infection or fungal infection of the nails
Benigne, maligne og uspecificerede tumorer (inkl.
Neoplasms benign, malignant and unspecified (including cysts and polyps) Rare:
Du må ikke få Inflectra og Kineret samtidig.
Inflectra and Kineret should not be used together.
Under den 16 uger lange dobbeltblindede fase fik patienterne enten 5 mg/kg infliximab eller placebo i uge 0, 2, 6 og 14 (52 patienter i hver gruppe).
During the 16-week double-blind phase, patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6, and 14 (52 patients in each group).
Inflectra er indiceret til behandling af svær, aktiv colitis ulcerosa hos børn og unge i alderen 6 til 17 år, som har responderet utilstrækkeligt på konventionel behandling, inklusive kortikosteroider og 6-MP eller AZA, eller som er intolerante over for eller hvor der er kontraindikationer mod disse behandlinger.
Inflectra is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
I uge 4 opnåede endvidere 13/27 (48%) af infliximab-behandlede patienter en klinisk remission
Also at week 4, 13/27 (48%) of infliximab-treated patients achieved a clinical remission (CDAI < 150) vs. 1/25 (4%) of placebo-treated patients.
• Børn skal have de anbefalede vaccinationer, før behandling med Inflectra påbegyndes.Børn kan få visse vacciner under behandlingen med Inflectra, men må ikke få levende vacciner, mens de får Inflectra.
Children may receive some vaccines during treatment with Inflectra but should not receive live vaccines while using Inflectra.
Inflectra 100 mg pulver til koncentrat til infusionsvæske, opløsning infliximab
Inflectra 100 mg powder for concentrate for solution for infusion infliximab
Inflectra leveres som et hætteglas (glasflaske) indeholdende et pulver til koncentrat til infusionsvæske, opløsning.
What Inflectra looks like and contents of the pack Inflectra is supplied as a glass vial containing a powder for concentrate for solution for infusion.
Før behandlingen med infliximab påbegyndes, skal patienten testes for HBV-infektion.
Patients should be tested for HBV infection before initiating treatment with infliximab.
Tabel 1 Bivirkninger i kliniske studier og efter markedsføring
Table 1 Adverse reactions in clinical studies and from post-marketing experience Infections and infestations Very common:
Der foreligger ingen data om antiviral behandling profylaktisk mod HBV-reaktivering i forbindelse med TNF-antagonist-behandling hos patienter, som er bærere af HBV. Infliximab bør seponeres hos patienter, hvor HBV reaktiveres, og effektiv antiviral behandling med passende understøttende behandling bør igangsættes.
In patients who develop HBV reactivation, infliximab should be stopped and effective antiviral therapy with appropriate supportive treatment should be initiated.
Terapeutiske smitstoffer bør ikke gives samtidig med infliximab (se pkt.
It is recommended that therapeutic infectious agents not be given concurrently with infliximab (see section 4.4).
Uge 30 Klinisk respons
Week 30 Clinical Response a
Procent forsøgspersoner i klinisk remission og vedvarende remission
Percentage of subjects in clinical remission and sustained remission Clinical remission at week 8
Terapeutiske smitstoffer bør ikke gives samtidig med infliximab.
It is recommended that therapeutic infectious agents not be given concurrently with infliximab.
• Kulderystelser, hævelse på grund af ophobning af væske under huden
• Chills, a build-up of fluid under the skin causing swelling
Infliximab (uge 16)
Infliximab (Week 16)
Fornyet administration ved ankyloserende spondylitis Sikkerhed og virkning ved fornyet administration, udover hver 6. til 8. uge, er ikke klarlagt (se pkt.
The safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established (see sections 4.4 and 4.8).
Infliximab (uge 98)
Infliximab (Week 98)
• Alvorlige lidelser i nervesystemet såsom transversel myelitis, multipel sklerose-lignende sygdom, optisk neuritis og Guillain-Barré syndrom
• Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease,
• Fortæl straks din læge, hvis du får tegn på TB under behandlingen med Inflectra.
• Tell your doctor straight away if you get signs of TB during treatment with Inflectra.
Infliximab (uge 54)
Infliximab (Week 54)
(fx BCG vaccine) til spædbørn eksponeret for infliximab i uterus, i mindst 6 måneder efter fødslen (se pkt.
Administration of live vaccines (e.g. BCG vaccine) to infants exposed to infliximab in utero is not recommended for at least 6 months after birth (see sections 4.4 and 4.5).
Infliximab (uge 24)
Infliximab (Week 24)
Forsøgspersoner randomiseret
Subjects randomised
Sådan får du Inflectra
How to store Inflectra
Det drejede sig om 4 ud af 22 (18,2%) i 8-ugers vedligeholdelsesbehandlingsgruppen og 3 ud af 23 (13,0%) i 12-ugers vedligeholdelsesbehandlingsgruppen.
Overall, 8 (13.3%) of 60 treated patients experienced one or more infusion reactions, with 4 of 22 (18.2%) in the q8 week and 3 of 23 (13.0%) in the q12 week treatment maintenance group.
• Fortæl det straks til lægen, hvis du får symptomer på lave blodtal under behandlingen med Inflectra.
• Tell your doctor straight away if you get symptoms of low blood counts during treatment with Inflectra.
Der var designet et klinisk studie med patienter med moderat til svær psoriasis for at undersøge virkning og sikkerhed af langtidsvedligeholdelsesbehandling i forhold til fornyet administration med et induktionsregime med infliximab (højst 4 infusioner efter 0, 2, 6 og 14 uger) efter opblussen af sygdom.
A clinical study in patients with moderate to severe psoriasis was designed to assess the efficacy and safety of long-term maintenance therapy versus re-treatment with an induction regimen of infliximab
De patienter, der fik kortikosteroider ved baseline, fik ikke kortikosteroider i de 3 måneder forud for uge 54.
among patients who were receiving corticosteroids at baseline.
Dette gælder også medicin til behandling af Crohns sygdom, colitis ulcerosa, reumatoid arthritis, ankyloserende spondylitis, psoriasisarthritis eller psoriasis eller medicin, som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler.
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.
Efter rekonstitution indeholder hver ml 10 mg infliximab.
After reconstitution each mL contains 10 mg of infliximab.
• Fortæl straks din læge, hvis du får tegn på infektion under behandling med Inflectra.
• Tell your doctor straight away if you get signs of infection during treatment with Inflectra.