natgillin/translations-raw huggingface dataset:
Andelen af patienter med klinisk respons i uge 8 var 73,3 % (44/60).
The proportion of patients in clinical response at week 8 was 73.3% (44/60).
• Fortæl straks din læge, hvis du har tegn på en infektion.
• Tell your doctor straight away if you have signs of an infection.
Resultater fra uge 54 (ACR20, total van der Heijde-modified Sharp score og HAQ) er vist i tabel 3.
Results from week 54 (ACR20, total van der Heijde-modified Sharp score and HAQ) are shown in Table 3.
Dosis fortsatte for alle patienter til og med uge 46.
Dosing continued for all patients through week 46.
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) ACCENT I (week-2 responders) % of Patients
Den sædvanlige dosis er 5 mg pr. kg kropsvægt.
The usual dose is 5 mg for every kg of body weight.
• Infektion, der skyldes en levende vaccine, som følge af et svækket immunsystem.
• Infection due to a live vaccine because of a weakened immune system.
TNF alfa er involveret i kroppens betændelsesprocesser, så blokering af dette kan mindske betændelsen i din krop.
TNF alpha is involved in inflammatory processes of the body so blocking it can reduce the inflammation in your body.
Eksperimentelle data viser, at TNF er afgørende for at bekæmpe intracellulære infektioner.
Experimental data show that TNF is essential for the clearing of intracellular infections.
I kliniske studier har forsinkede overfølsomhedsreaktioner været rapporteret.
In clinical studies, delayed hypersensitivity reactions have been reported.
Rekonstituer og fortynd før brug.
Reconstitute and dilute before use.
Samlet set var hyppigheden af bivirkninger og infusionsreaktioner den samme i aldersgrupperne 611 år og 12-17 år.
Overall proportions of adverse events and infusion reactions were similar between the 6 to 11 and 12 to 17 year age groups.
Vedvarende remission (i remission både i uge 8 og uge 30)
Sustained remission (in remission at both week 8 and week 30)
Patienter, som udvikler en ny infektion, imens de er under behandling med Remicade, bør monitoreres tæt og gennemgå en komplet diagnostisk evaluering.
Patients who develop a new infection while undergoing treatment with Remicade, should be monitored closely and undergo a complete diagnostic evaluation.
Hvis respons forsvandt under vedligeholdelsesbehandlingen, var cross-over til en højere dosis (10 mg/kg) og/eller kortere doseringsinterval (hver 8. uge) tilladt.
If response was lost during maintenance treatment, crossing over to a higher dose (10 mg/kg) and/or shorter dosing interval (q8 weeks) was allowed.
I P01522 sås forbedring af tegn og symptomer så tidligt som i uge 2.
In P01522, improvement in signs and symptoms was also observed as early as week 2.
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.
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.
Alle patienter havde haft utilstrækkelig effekt af tidligere konventionel behandling.
All patients had experienced an inadequate response to prior conventional therapies.
Selvom sammenlignende resultater mangler, indikerer begrænsede data hos patienter, der initialt responderede på 5 mg/kg, men som mistede respons, at nogle patienter kan genvinde respons med dosisoptrapning (se pkt.
Although comparative data are lacking, limited data in patients who initially responded to 5 mg/kg but who lost response indicate that some patients may regain response with dose escalation (see section 5.1).
Sjælden: Apati
Rare: Apathy.
• Fortæl kirurgen eller tandlægen, at du er i behandling med Remicade ved at vise dem dit patientinformationskort.
• Tell your surgeon or dentist that you are having treatment with Remicade by showing them your patient reminder card.
Der er ikke tilstrækkelige prækliniske data til at drage konklusioner om infliximabs virkning på fertilitet og generel reproduktion (se pkt.
There are insufficient preclinical data to draw conclusions on the effects of infliximab on fertility and general reproductive function (see section 5.3).
Hvis inaktiv (“latent”) tuberkulose diagnosticeres, skal behandling for latent tuberkulose påbegyndes med behandling mod tuberkulose før initiering af Remicadebehandling i henhold til lokale vejledninger.
If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with antituberculosis therapy before the initiation of Remicade, and in accordance with local recommendations.
Denne sjældne type af Tcelle-lymfom har et meget aggressivt sygdomsforløb og er sædvanligvis fatal.
This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
• Blodet tilfører ikke nok ilt til kroppen, kredsløbsproblemer såsom indsnævring af et blodkar
• Your blood not supplying enough oxygen to your body, circulation problems such as narrowing of a blood vessel
Opskumning af koncentratet ved rekonstitution er ikke usædvanligt.
Foaming of the solution on reconstitution is not unusual.
Desuden blev der observeret forbedret livskvalitet ved infliximab-behandling, målt med IBDQ.
Furthermore, improved quality of life as measured by IBDQ was observed with infliximab.
Patientens navn:
Name patient:
Alle patienter, der har fået Remicade, skal observeres i mindst 1-2 timer efter infusionen for akutte infusionsrelaterede reaktioner.
All patients administered Remicade are to be observed for at least 1-2 hours post-infusion for acute infusion-related reactions.
Klinisk remission i uge 8 var 33,3 % (17/51) målt ved pædiatrisk colitis ulcerosa aktivitets-indeks (PUCAI) scoren.
Clinical remission at week 8 was 33.3% (17/51) as measured by the Paediatric Ulcerative Colitis Activity Index (PUCAI) score.
Remicade indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. det er i det væsentlige ”natriumfrit”.
Remicade contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Ingen specifikke øjenundersøgelser er blevet udført hos patienter for at vurdere relevansen af dette fund for mennesker.
No specific ophthalmologic examinations have been performed in patients to investigate the relevance of this finding for humans.
Sjælden: Granulomatøs læsion.
Rare: Granulomatous lesion.
• Din læge skal teste dig for hepatitis B.
• Your doctor should test you for hepatitis B virus.
Patienter med symptomer eller tegn på nedsat leverfunktion bør undersøges for tegn på leverskade.
Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury.
Din læge vil rådgive dig om, hvilke andre lægemidler du skal blive ved med at tage, mens du er i behandling med Remicade.
Your doctor will advise you what other medicines you must keep using while you are having Remicade.
Patienterne fik ingen samtidig immunsuppressiv behandling.
Patients did not receive any concomitant immunosuppressant therapy.
Signifikant forbedring i helbredsrelateret livskvalitet blev også påvist, målt med den fysiske og mentale component summary score af SF-36 i IMPACT 2.
Significant improvements in health-related quality of life were also demonstrated as measured by the physical and mental component summary scores of the SF-36 in IMPACT 2.
Tilfælde af tuberkulose, undertiden dødelige, inklusive miliær tuberkulose og tuberkulose med ekstrapulmonal placering har været rapporteret (se pkt.
Cases of tuberculosis, sometimes fatal, including miliary tuberculosis and tuberculosis with extra-pulmonary location have been reported (see section 4.4).
Eksisterende resultater tyder på, at det kliniske respons sædvanligvis opnås inden for 14 ugers behandling, svarende til tre doser.
Available data suggest that the clinical response is usually achieved within 14 weeks of treatment, i.e. three doses.
Analysen var baseret på patienter med neglepsoriasis ved baseline (81,8 % af patienterne).
Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
Der forekom én alvorlig infusionsrelateret reaktion (< 1 %) hos en patient på infliximab monoterapi.
One serious infusion reaction (< 1%) occurred in a patient on infliximab monotherapy.
Hvis der opstår gulsot og/eller ALAT-forhøjelser ≥ 5 gange øvre grænse af normalområdet, bør Remicade seponeres, og et omhyggelig studie af hændelsen bør foretages.
If jaundice and/or ALT elevations ≥ 5 times the upper limit of normal develop(s), Remicade should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Næsten alle patienterne havde også fået medicin, der indeholder azathioprin eller 6mercaptopurin ud over den TNF-blokerende behandling.
Almost all patients had also received medicines containing azathioprine or 6-mercaptopurine in addition to TNF-blockers.
Vedligeholdelsesbehandling med infliximab hver 8. uge reducerede sygdomsrelateret hospitalisering og kirurgiske indgreb signifikant sammenlignet med placebo.
Maintenance therapy with infliximab every 8 weeks significantly reduced disease-related hospitalisations and surgeries compared with placebo.
Ved enkeltdoser på 3, 5 eller 10 mg/kg var median værdier for Cmax henholdsvis 77, 118 og 277 mikrogram/ml.
At single doses of 3, 5, or 10 mg/kg, the median Cmax values were 77, 118 and 277 micrograms/ml, respectively.
Hos patienter, der har adskillige eller signifikante risikofaktorer for tuberkulose og har en negativ test for latent tuberkulose, bør anti-tuberkulosebehandling overvejes før initieringen af Remicade.
In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, antituberculosis therapy should be considered before the initiation of Remicade.
• Du har hjertesvigt i moderat eller svær grad.
• You have heart failure that is moderate or severe.
I C0168T72 var de almindeligste bivirkninger øvre luftvejsinfektion, faryngitis, abdominalsmerter, feber og hovedpine.
In C0168T72, the most common adverse reactions were upper respiratory tract infection, pharyngitis, abdominal pain, fever, and headache.
Remicade bør anvendes med forsigtighed hos patienter med let hjerteinsufficiens (NYHA funktionsklasse I/II).
Remicade should be used with caution in patients with mild heart failure (NYHA class I/II).
I et klinisk studie hos patienter med reumatiod arthritis (ASPIRE) skulle de 3 første infusioner indgives over 2 timer.
In a clinical study of patients with rheumatoid arthritis (ASPIRE), infusions were to be administered over 2 hours for the first 3 infusions.
Før rekonstitution: 3 år ved 2°C - 8°C.
Before reconstitution: 3 years at 2 °C - 8 °C.
Kortere infusionstid ved doser > 6 mg/kg er ikke blevet undersøgt (se pkt.
Shortened infusions at doses > 6 mg/kg have not been studied (see section 4.8).
For at øge sporbarheden af biologiske lægemidler skal præparatnavnet og lot-nummeret på det administrerede lægemiddel tydeligt noteres.
In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered medicinal product should be clearly recorded.
Hvis en patient får en utilstrækkelig respons eller mangler respons efter denne periode, kan det overvejes at øge dosis trinvis med ca. 1,5 mg/kg op til et maksimum på 7,5 mg/kg hver 8. uge.
If a patient has an inadequate response or loses response after this period, consideration may be given to increase the dose step-wise by approximately 1.5 mg/kg, up to a maximum of 7.5 mg/kg every 8 weeks.
Samtidig brug af stabile doser af konventionel behandling var tilladt, og 83 % af patienterne fortsatte brugen af mindst en af disse behandlinger.
Concurrent use of stable doses of conventional therapies was permitted, and 83% of patients continued to receive at least one of these therapies.
Der er ikke udført specifikke studier af Remicade hos ældre patienter.
Specific studies of Remicade in elderly patients have not been conducted.
I alle tilfælde blev Remicade seponeret og/eller anden behandling igangsat med fuldstændig ophør at tegn og symptomer.
In all cases, Remicade treatment was discontinued and/or other treatment instituted with complete resolution of signs and symptoms.
In vivo danner infliximab hurtigt stabile komplekser med human TNF, en proces der svarer til tabet af TNF bioaktivitet.
In vivo, infliximab rapidly forms stable complexes with human TNF, a process that parallels the loss of TNF bioactivity.
• Fortæl din læge, hvis du har nogen form for hjerteproblemer, såsom let hjertesvigt.
• Tell your doctor if you have any heart problems, such as mild heart failure.
Antal patienter, som er evalueret for ALAT.
Number of patients evaluated for ALT.
Kvinder i den fertile alder skal overveje at anvende sikker antikonception for at undgå graviditet og fortsætte med anvendelsen heraf i mindst 6 måneder efter den sidste behandling med Remicade.
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 Remicade treatment.
På grund af metodologiske begrænsninger udelukkede en negativ undersøgelse ikke forekomsten af antistoffer mod infliximab.
Due to methodological limitations, a negative assay did not exclude the presence of antibodies to infliximab.
178 af de 580 inkluderede patienter (30,7 %) blev defineret som havende svær sygdom (CDAI score > 300 og samtidig kortikoid og/eller immunsupprimerende behandling) svarende til populationen defineret i indikationen (se pkt.
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).
En infusionsrelateret reaktion blev i kliniske studier defineret som enhver bivirkning, der forekom under en infusion eller inden for 1 time efter en infusion.
An infusion-related reaction was defined in clinical studies as any adverse event occurring during an infusion or within 1 hour after an infusion.
Immunogenicitet Antistoffer over for infliximab blev påvist hos 4 (7,7 %) patienter i uge 54.
Immunogenicity Antibodies to infliximab were detected in 4 (7.7%) patients through week 54.
Derefter fortsatte alle patienterne på infliximab hver 6. uge til uge 96.
Thereafter, all subjects continued on infliximab every 6 weeks to week 96.
Hvis disse lægemidler eller behandlinger ikke virker godt nok, vil du få Remicade for at reducere tegn og symptomer på din sygdom.
If these medicines or treatments do not work well enough, you will be given Remicade to reduce the signs and symptoms of your disease.
Patienter, som udviklede antistoffer over for infliximab, havde større sandsynlighed (cirka 2-3 gange) for at udvikle infusionsrelaterede reaktioner.
Patients who developed antibodies to infliximab were more likely (approximately 2-3 fold) to develop infusion-related reactions.
Under kliniske studier med Remicade over alle godkendte indikationer var forekomsten af lymfom hos Remicade-behandlede patienter højere end forventet i den generelle befolkningsgruppe, men forekomsten af lymfom var sjælden.
During clinical studies of Remicade across all approved indications the incidence of lymphoma in Remicade-treated patients was higher than expected in the general population, but the occurrence of lymphoma was rare.
Infliximab + AZA Kombinationsterapi
Infliximab + AZA Combination Therapy
Analyse af lamina propria mononukleære celler udtaget ved biopsi fra den intestinale mucosa viste, at infliximab-behandling forårsagede en reduktion i antallet af celler, som var i stand til at udtrykke TNF og interferon.
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 TNF and interferon.
Farmakokinetikken for infliximab hos ældre patienter er ikke blevet undersøgt.
The pharmacokinetics of infliximab in elderly patients has not been studied.
Remicade virker ved selektivt at binde sig til TNF alfa og blokere dets virkning.
Remicade works by selectively attaching to TNF alpha and blocking its action.
Af de patienter som behøvede dosisjustering opnåede 80 % klinisk respons og størstedelen af disse (64 %) behøvede kun en justering med 1,5 mg/kg.
Of the patients who required a dose titration, 80% achieved clinical response and the majority (64%) of these required only one adjustment of 1.5 mg/kg.
Generelt var patienter, der udviklede ALAT og ASAT stigninger, asymptomatiske, og hændelserne bedredes eller forsvandt med enten fortsættelse eller afbrydelse af Remicade, eller justering af samtidig behandling.
In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of Remicade, or modification of concomitant therapy.
Janssen Biologics B.V., Einsteinweg 101 Leiden 2333 CB, Holland
Janssen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands
Operationer eller tandindgreb
Operations or dental procedures
Antistoffer over for infliximab kan ikke altid påvises i serumprøver.
Antibodies to infliximab cannot always be detected in serum samples.
Anvend kun et infusionssæt med et in-line, sterilt, ikke-pyrogent, minimalt proteinbindende filter (porestørrelse 1,2 mikrometer eller derunder).
Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 1.2 micrometre or less).
Patienter, for hvem doseringsintervallet er afkortet til under 8 uger, kan have større risiko for bivirkninger.
Patients who have had their dose interval shortened to less than 8 weeks may be at greater risk for adverse reactions.
• Hvis du har fået Remicade, mens du var gravid, kan dit barn også have en større risiko for at få en infektion med levende vacciner i op til 6 måneder efter fødslen.
• If you received Remicade while you were pregnant, your baby may also be at higher risk for getting an infection with live vaccines for up to six months after birth.
• Nogle patienter, der får Remicade, har udviklet alvorlige leverproblemer.
• Some patients receiving Remicade have developed serious liver problems.
Tabel 4 Effekter på ACRn, strukturel ledskade og fysisk funktion ved uge 54, ASPIRE Infliximab + MTX Placebo + MTX 3 mg/kg 6 mg/kg Kombineret
Table 4 Effects on ACRn, Structural Joint Damage and Physical Function at week 54, ASPIRE Infliximab + MTX Placebo + MTX 3 mg/kg 6 mg/kg Combined
• En type blodkræft (lymfom)
• A type of blood cancer (lymphoma)
Samtidig brug af stabile doser af konventionel behandling var tilladt, og 92 % af patienterne fortsatte brugen af disse behandlinger.
Concurrent use of stable doses of conventional therapies was permitted, and 92% of patients continued to receive these therapies.
• Disse infektioner kan være alvorlige og indbefatter tuberkulose, infektioner forårsaget af virus, svampe, bakterier eller andre organismer i miljøet samt blodforgiftning, som kan være livstruende.
• These infections may be serious and include tuberculosis, infections caused by viruses, fungi, bacteria, or other organisms in the environment and sepsis that may be life-threatening.
I længerevarende sikkerhedsopfølgninger af kliniske studier med infliximab på op til 5 år, svarende til 6.234 patientår (3.210 patienter), blev der rapporteret 5 tilfælde af lymfom og 38 tilfælde af nonlymfom maligniteter.
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.
Fornyet indgift på tværs af indikationer
Re-administration across indications
• Hvis du fik Remicade under graviditeten, kan dit barn have en øget risiko for at få en infektion.
• If you received Remicade during your pregnancy, your baby may have a higher risk for getting an infection.
Sjælden: Komplementfaktorabnormitet.
Rare: Complement factor abnormal.
Strukturel ledskade (erosioner og forsnævring af ledspalte) i begge hænder og fødder blev målt som ændringen fra baseline i total van der Heijde-modified Sharp score (0-440).
Structural joint damage (erosions and joint space narrowing) in both hands and feet was measured by the change from baseline in the total van der Heijde-modified Sharp score (0-440).
• Børn og voksne i behandling med Remicade kan have en øget risiko for at udvikle lymfom eller anden form for kræft.
• Children and adults taking Remicade may have an increased risk of developing lymphoma or another cancer.
HAQ ændring fra baseline over tiden e (patienter evalueret) Gennemsnit  SD
HAQ change from baseline over time e (patients evaluated) Mean ± SD
Resultaterne ses i tabel 6.
For results see Table 6.
Antal patienter
Indication Number of patients
Histologisk evaluering af biopsier fra colon, som er udtaget før og 4 uger efter indgivelse af infliximab, viste en betydelig reduktion i påviseligt TNF.
Histological evaluation of colonic biopsies, obtained before and 4 weeks after administration of infliximab, revealed a substantial reduction in detectable TNF.
I et fertilitets- og generel reproduktionsfunktionsstudie var antallet af drægtige mus reduceret efter indgift af det samme analoge antistof.
In a fertility and general reproductive function study, the number of pregnant mice was reduced following administration of the same analogous antibody.
Da muligheden for øget risiko for udvikling af cancer hos patienter med nydiagnosticeret dysplasi behandlet med Remicade ikke er vist, bør risiko og gavn af fortsat behandling for de individuelle patienter nøje overvejes af lægen.
Since the possibility of increased risk of cancer development in patients with newly diagnosed dysplasia treated with Remicade is not established, the risk and benefits of continued therapy to the individual patients should be carefully considered by the clinician.
Hvis disse lægemidler ikke virker godt nok, vil du få Remicade, som du skal tage sammen med et andet lægemiddel, der hedder methotrexat, for at:
If these medicines do not work well enough, you will be given Remicade which you will take in combination with another medicine called methotrexate to:
Ved den sidste vurdering var 57 % af infliximab-behandlede patienter fortsat anti-dsDNA positive.
At the last evaluation, 57% of infliximab-treated patients remained anti-dsDNA positive.
Anvendelsen af anti-tuberkulosebehandling bør også overvejes før initieringen af Remicade hos patienter med en tidligere sygdomshistorie med latent eller aktiv tuberkulose, hos hvem et passende behandlingsprogram ikke kan bekræftes.
Use of antituberculosis therapy should also be considered before the initiation of Remicade in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Relevant empirisk antifungal behandling bør overvejes under diagnosticeringen, idet der både tages hensyn til risikoen ved alvorlig svampeinfektion og risikoen ved antifungal behandling.
Appropriate empiric antifungal therapy should be considered while a diagnostic workup is being performed taking into account both the risk for severe fungal infection and the risks of antifungal therapy.
Der var en rapporteret malign sygdom blandt 77 kontrolpatienter (median opfølgningsperiode 0,8 år; incidence 1.3 % [95 % CI 0,03 %-7,0 %]).
There was one reported malignancy amongst 77 control patients (median duration of follow-up 0.8 years; incidence 1.3% [95% CI 0.03%-7.0%]).
Uge 98 data for IMPACT inkluderer kombineret placebo cross-over og infliximab-patienter, der deltog i den åbne undersøgelse.
Week 98 data for IMPACT includes combined placebo crossover and infliximab patients who entered the open-label extension.
• En påmindelse til patienterne om, at de skal vise patientinformationskortet til alle behandlende sundhedspersoner, herunder i nødstilfælde, og en besked til sundhedspersoner om, at patienten anvender Remicade.
• 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 Remicade