natgillin/translations-raw huggingface dataset:
Tidlig erkendelse af atypiske kliniske forekomster af alvorlige infektioner og typiske kliniske forekomster af sjældne og usædvanlige infektioner er afgørende, for at begrænse forsinkelse i diagnosticering og behandling. 
Early recognition of atypical clinical presentations of serious infections and of typical clinical presentation of rare and unusual infections is critical in order to minimise delays in diagnosis and treatment.
Derfor kan kombination af Remicade og anakinra ikke anbefales. 
Therefore, the combination of Remicade and anakinra is not recommended.
Instruktion i anvendelse og håndtering - opbevaring 
Instructions for use and handling - storage conditions
Ved spontan postmarketing rapportering er infektioner den mest almindelige alvorlige bivirkning. 
In post-marketing spontaneous reporting, infections are the most common serious adverse reaction.
Patienter i begge studier havde plaque psoriasis (Body Surface Area [BSA] ≥ 10 % og Psoriasis Area and Severity Index [PASI] score ≥ 12). 
Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥ 10% and Psoriasis Area and Severity Index [PASI] score ≥ 12).
Remicade bruges også til voksne og børn fra 6 år og opefter til behandling af: 
Remicade is also used in adults and children 6 years of age or older for:
Instruktion i anvendelse og håndtering - rekonstitution, fortynding og administration 
Instructions for use and handling - reconstitution, dilution and administration
Den mediane AUCss hos pædiatriske patienter i alderen 2 år til under 6 år var forventet at være ca. 40 % lavere end hos voksne, selvom antallet af patienter, der bekræfter dette estimat, er begrænset. 
The median AUCss in paediatric patients aged 2 years to less than 6 years was predicted to be approximately 40% lower than that in adults, although the number of patients supporting this estimate is limited.
Før initiering af behandling med Remicade skal alle patienter vurderes for både aktiv og inaktiv (“latent”) tuberkulose. 
Before starting treatment with Remicade, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Aktuelle data indikerer ikke, at infliximab-behandling påvirker risikoen for at udvikle dysplasi eller colon cancer. 
Current data do not indicate that infliximab treatment influences the risk for developing dysplasia or colon cancer.
46 % af patienterne fortsatte på stabile doser methotrexat (≤ 25 mg/uge). 
Forty six percent of patients continued on stable doses of methotrexate (≤ 25 mg/week).
Median (Interkvartil interval) Patienter uden forværring/patienter evalueret 
Patients with no deterioration/patients evaluated
• Mangel på interesse eller følelser 
• Lack of interest or emotion
Den nye udløbsdato skal skrives på æsken. 
The new expiry date must be written on the carton.
Andre pædiatriske indikationer 
Other paediatric indications
Alle infusionsreaktioner var lette eller moderate. 
All infusion reactions were mild or moderate in intensity.
Janssen Biotech Inc. 200 Great Valley Parkway Malvern, Pennsylvania 19355-1307, USA 
Janssen Biotech Inc., 200 Great Valley Parkway Malvern, Pennsylvania 19355-1307, United States of America
Det er ukendt, om infliximab udskilles i human mælk eller optages systemisk efter indtagelse. 
It is unknown whether infliximab is excreted in human milk or absorbed systemically after ingestion.
• Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får dette lægemiddel. 
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Effekten af Remicade i uge 54 blev undersøgt i ACT 1 studiet. 
The efficacy of Remicade through week 54 was assessed in the ACT 1 study.
Det beskedne antal prospektivt indsamlede graviditeter eksponeret for infliximab, som resulterede i levendefødsel med kendte resultater, inklusive ca. 1.100 graviditeter, der blev eksponeret under første trimester, indikerer ikke en stigning i hyppigheden af misdannelser hos den nyfødte. 
The moderate number of prospectively collected pregnancies exposed to infliximab resulting in live birth with known outcomes, including approximately 1100 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Yderligere information om særlige populationer Ældre 
Additional information on special populations
Patienter, der ikke havde responderet på infliximab i uge 8 (n = 15) fik ikke yderligere doser og gik tilbage til sikkerhedsopfølgning. 
Patients who did not respond to infliximab at week 8 (n = 15) received no further medicinal product and returned for safety follow-up.
Kasser lægemidlet, hvis det ikke er brugt før den nye udløbsdato eller den dato, der er trykt på æsken, alt efter, hvilken dato der kommer først. 
Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier.
Forsøgspersoner randomiseret Procentvis ACR forbedring Gennemsnit ± SD 
Subjects randomised Percentage ACR improvement Mean ± SD
Efter studiets første år fortsatte 53 patienter i en open-label forlængelse til uge 102. 
After the first year of the study, 53 patients continued into an open-label extension to week 102.
Remicade skal administreres intravenøst over en 2-timers periode. 
Remicade should be administered intravenously over a 2 hour period.
I IMPACT og IMPACT 2 blev klinisk respons observeret så tidligt som uge 2 og blev bibeholdt henholdsvis til og med uge 98 og uge 54. 
In IMPACT and IMPACT 2, clinical responses were observed as early as week 2 and were maintained through week 98 and week 54 respectively.
Advarsler og forsigtighedsregler Kontakt lægen, før eller under behandlingen med Remicade, hvis du har: 
Warnings and precautions Talk to your doctor before or during treatment with Remicade if you have:
Der konstateredes en effekt inden for 2 uger med maksimal effekt efter 4 uger. 
A response was observed within 2 weeks, with a maximum response at 4 weeks.
Der bør udvises forsigtighed, og patienterne skal fortsat monitoreres, ved skift fra et biologisk lægemiddel til et andet, da overlappende biologisk aktivitet kan øge risikoen for bivirkninger yderligere, herunder for infektioner. 
Care should be taken and patients should continue to be monitored when switching from one biologic to another, since overlapping biological activity may further increase the risk for adverse reactions, including infection.
Der er set stigninger i ALAT ≥5 x øvre grænse for normalområdet (ULN) (se tabel 2). 
Elevations of ALT ≥ 5 x Upper Limit of Normal (ULN) have been observed (see Table 2).
Eliminationsvejene for infliximab er ikke karakteriseret. 
The elimination pathways for infliximab have not been characterised.
Data om fistler blev uddraget fra PCDAI-score. 
Data about fistulas were derived from PCDAI scores.
• Brug ikke dette lægemiddel, hvis det er misfarvet, eller hvis det indeholder partikler. 
• Do not use this medicine if it is discoloured or if there are particles present.
Bivirkninger kan også opstå efter ophør af din behandling med Remicade. 
Side effects may also occur after your treatment with Remicade has stopped.
Remicade er ikke undersøgt hos denne patientpopulation. 
Remicade has not been studied in these patient populations.
Median tid til tab af respons frem til uge 54 
Median time to loss of response through week 54
Cirka 3 % af patienterne afbrød behandlingen på grund af infusionsrelaterede reaktioner, og alle patienter kom sig med eller uden behandling. 
Approximately 3% of patients discontinued treatment due to infusion-related reactions and all patients recovered with or without medical therapy.
• Patienter med alvorlig reumatoid arthritis, som har haft sygdommen i lang tid, kan have en større risiko for at udvikle lymfom. 
• Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher risk of developing lymphoma.
17,5 % af de randomiserede patienter i REACH oplevede 1 eller flere infusionsreaktioner. 
In REACH, 17.5% of randomised patients experienced 1 or more infusion reactions.
Forsinket overfølsomhed 
Delayed hypersensitivity
Der var ingen alvorlige infusionsreaktioner, og 2 personer i REACH fik ikke alvorlige anafylaktiske reaktioner. 
There were no serious infusion reactions, and 2 subjects in REACH had non-serious anaphylactic reactions.
Eksisterende resultater tyder på, at det kliniske respons sædvanligvis nås inden for 12 ugers behandling. 
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
AZA blev givet med en dosis på 2,5 mg/kg dagligt. 
AZA was given at a dose of 2.5 mg/kg daily.
Det er vigtigt, at du og din læge noterer produktnavn og lot-nummer på din medicin. 
It is important that you and your doctor record the brand name and batch number of your medicine.
Rapporter om lupus og lupus-lignende syndromer er imidlertid stadig usædvanlige (se pkt. 
Reports of lupus and lupus-like syndromes, however, remain uncommon (see section 4.4).
• Lægen vil bestemme din dosis og hvor ofte, du skal have Remicade. 
• The doctor will decide your dose and how often you will be given Remicade.
En tilsvarende tendens til opnåelse af kortikosteroidfri klinisk remission blev observeret i uge 50. 
Similar trends in the achievement of corticosteroid-free clinical remission were observed at week 50.
Remicade må kun anvendes til børn, hvis de behandles for Crohns sygdom eller colitis ulcerosa. 
Remicade should only be used in children if they are being treated for Crohn's disease or ulcerative colitis.
• voksne patienter med alvorlig, aktiv og progressiv sygdom, der ikke tidligere er behandlet med methotrexat eller andre DMARD. 
• adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
Resultaterne fra uge 54 er vist i tabel 4. 
Results from week 54 are shown in Table 4.
Størstedelen af patienterne (67 %) behøvede ingen dosisjustering. 
The majority (67%) of these patients did not require any dose titration.
Opbevar dette kort på dig i 4 måneder, efter du har fået Remicade, eller i tilfælde af graviditet i mindst 6 måneder, efter du har født. 
Keep this card with you for 4 months after your dose of Remicade, or in case of pregnancy for at least 6 months after the birth of your baby.
Infliximab-behandlede patienter viste signifikant forbedring i fysisk funktionsevne, vurderet ved HAQ. 
Infliximab-treated patients demonstrated significant improvement in physical function as assessed by HAQ.
Undgå at svinge for længe eller for kraftigt. 
Avoid prolonged or vigorous agitation.
Invasive svampeinfektioner kan være disseminerede snarere end lokale sygdomme, og test for tilstedeværelse af antigen og antistof kan være negativ hos nogle patienter med aktiv infektion. 
Invasive fungal infections may present as disseminated rather than localised disease, and antigen and antibody testing may be negative in some patients with active infection.
Patienter, som tager TNF-blokkere, er mere modtagelige for alvorlige infektioner. 
Patients taking TNF-blockers are more susceptible to serious infections.
Behandling med Remicade må ikke fortsættes, hvis en patient udvikler en alvorlig infektion eller sepsis. 
Further treatment with Remicade must not be given if a patient develops a serious infection or sepsis.
Levende vacciner/terapeutiske smitstoffer 
Live vaccines/therapeutic infectious agents
Ikke kendt: Cerebrovaskulære hændelser i tæt tidsmæssig forbindelse med infusionen. 
Not known: Cerebrovascular accidents in close temporal association with infusion.
** PASI 75 respons for IMPACT ikke inkluderet som følge af lav N; p < 0.001 for infliximab vs. placebo i uge 24 for IMPACT 2. 
** PASI 75 response for IMPACT not included due to low N; p < 0.001 for infliximab vs. placebo at week 24 for IMPACT 2.
Remicade bør administreres 
Remicade should be administered
Dette skal der tages hensyn til hos patienter på en kontrolleret natriumdiæt (se pkt. 
This should be taken into consideration for patients on a controlled sodium diet (see section 6.6).
START var et randomiseret, multicenter, dobbelblindt, 3-armet, parallel- gruppe sikkerhedsstudie. 
START was a randomised, multicenter, double-blind, 3-arm, parallel-group safety study.
• Sænke antallet af unormale åbninger (fistler) mellem din tarm og hud, der ikke har kunnet behandles tilfredsstillende med andre lægemidler eller operation. 
• Reduce the number of abnormal openings (fistulae) between your bowel and your skin that have not been controlled by other medicines or surgery.
Der er ingen tegn på, at infliximab forværrer eller forårsager fibrotiske strikturer. 
There is no evidence to suggest that infliximab worsens or causes fibrotic strictures.
Pulveret er en frysetørret hvid pellet. 
The powder is a freeze-dried white pellet.
Efter studiets første år fortsatte 78 patienter i en openlabel forlængelse til uge 98. 
After the first year of the study, 78 patients continued into an open-label extension to week 98.
Derudover gælder, at: 
In addition:
Det bør overvejes at afbryde Remicade-behandlingen, hvis disse forstyrrelser fortsætter. 
Discontinuation of Remicade should be considered if these disorders develop.
Kombinationen af Remicade og abatacept anbefales ikke. 
The combination of Remicade and abatacept is not recommended.
• Fortæl din læge, hvis du har eller nogensinde har haft en lidelse, som påvirker dit nervesystem, før du får Remicade. 
• Tell your doctor if you have or have ever had a problem that affects your nervous system before you are given Remicade.
Der er også set tilfælde af agranulocytose (se pkt. 
Cases of agranulocytosis have also been reported (see section 4.8).
• Ændringer i hvordan din lever fungerer, forhøjede leverenzymer (vist i blodprøver) 
• Changes in how your liver works, increase in liver enzymes (shown in blood tests)
En sammenhæng mellem udvikling af antistoffer over for infliximab og reduceret varighed af respons er også blevet observeret. 
An association between development of antibodies to infliximab and reduced duration of response has also been observed.
Det er vigtigt, at du fortæller dit barns læger og andet sundhedspersonale, at du får Remicade, så de kan finde frem til, hvornår dit barn skal vaccineres; det gælder også levende vacciner som BCG (bruges til at forebygge tuberkulose). 
It is important that you tell your baby's doctors and other healthcare professionals about your Remicade use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis).
Fjern plastiklåget fra hætteglasset og tør toppen med en 70 % alkoholvatpind. 
Remove flip-top from the vial and wipe the top with a 70% alcohol swab.
Alle 3 grupper modtog gentagne infusioner i uge 2 og 6 samt hver 8. uge derefter. 
All 3 groups received repeated infusions at week 2, 6 and every 8 weeks thereafter.
Der var ingen signifikant forskel mellem placebo og infliximab i andelen af patienter med forlænget lukning af alle fistler til og med uge 54, med symptomer som proctalgia, abscesser og urinrørsinfektion eller i antallet af nyudviklede fistler under behandlingen. 
There was no significant difference between placebo and infliximab for the proportion of patients with sustained closure of all fistulas through week 54, for symptoms such as proctalgia, abscesses and urinary tract infection or for number of newly developed fistulas during treatment.
Sjælden: Endoftalmitis. 
Rare: Endophthalmitis.
Klinisk remission 
Clinical Remission
Af de 573 randomiserede patienter, opnåede 335 (58 %) klinisk respons ved uge 2. 
Of the 573 patients randomised, 335 (58%) achieved clinical response by week 2.
Patienter bør informeres efter behov og undgå at blive udsat for potentielle risikofaktorer for infektion. 
Patients should be advised of and avoid exposure to potential risk factors for infection as appropriate.
Patienter, der får seponeret immunsuppressiva før eller under Remicadebehandling, har større risiko for at udvikle disse antistoffer. 
Patients who discontinue immunosuppressants prior to or during Remicade treatment are at greater risk of developing these antibodies.
Hos nøje udvalgte voksne patienter, som har tålt mindst 3 initiale 2-timers infusioner med Remicade (induktionsfase) og får vedligeholdelsesterapi, kan det overvejes at indgive de efterfølgende infusioner over en periode på ikke mindre end 1 time. 
In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of Remicade (induction phase) and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour.
Ved baseline havde 87 % af patienterne perianale fistler, 14 % havde abdominale fistler, 9 % havde rectovaginale fistler. 
At baseline, 87% of the patients had perianal fistulae, 14% had abdominal fistulae, 9% had rectovaginal fistulae.
De primære endepunkter var reduktionen af sygdomstegn og symptomer, i henhold til American College of Rheumatology kriterier (ACR20 for ATTRACT, grænsebestemt ACR-N for ASPIRE), forebyggelsen af strukturel ledskade og forbedringen af fysisk funktionsevne. 
The primary endpoints were the reduction of signs and symptoms as assessed by the American College of Rheumatology criteria (ACR20 for ATTRACT, landmark ACR-N for ASPIRE), the prevention of structural joint damage, and the improvement in physical function.
Hvis der opstår en infusionsreaktion i forbindelse med den forkortede infusionstid, kan en langsommere infusionshastighed overvejes ved fremtidige infusioner, hvis behandlingen skal fortsættes. 
If an infusion reaction occurs in association with a shortened infusion, a slower infusion rate may be considered for future infusions if treatment is to be continued.
Du må ikke få Remicade hvis: 
You should not be given Remicade if:
Samtidig brug af infliximab og disse biologiske lægemidler anbefales ikke på grund af øget risiko for infektioner og andre potentielle farmakologiske interaktioner. 
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.
Fornyet indgift ved Crohns sygdom og reumatoid arthritis Hvis tegn og symptomer på sygdom vender tilbage, kan Remicade indgives på ny inden for 16 uger efter den seneste infusion. 
Re-administration for Crohn's disease and rheumatoid arthritis If the signs and symptoms of disease recur, Remicade can be re-administered within 16 weeks following the last infusion.
Kortet fungerer både som en påmindelse om at registrere datoer for og resultater af specifikke test og gør det lettere for patienten at dele særlige oplysninger med de sundhedspersoner, der behandler patienten, om den igangværende behandling med lægemidlet. 
The card is aimed at both serving as a reminder to record the dates and outcomes of specific tests and to facilitate the patient sharing of special information with healthcare professionals(s) (HCPs) treating the patient about on-going treatment with the product.
Der er ikke iagttaget større aldersrelaterede forskelle i clearance eller fordelingsvolumen i kliniske studier. 
No major age-related differences in clearance or volume of distribution were observed in clinical studies.
Andelen af forsøgspersoner, som fik foretaget kolektomi på et hvilket som helst tidspunkt indenfor 54 uger efter den første infusion af studiemedicin, blev samlet fra ACT 1 og ACT 2 studierne og deres forlængelser. 
The proportion of subjects who underwent colectomy at any time within 54 weeks following the first infusion of study agent were collected and pooled from the ACT 1 and ACT 2 studies and their extensions.
Health Assessment Questionnaire (HAQ; scale 0-3) blev anvendt til at måle patienternes gennemsnitlige ændring i fysisk funktionsevne fra baseline scores over tiden. 
The Health Assessment Questionnaire (HAQ; scale 0-3) was used to measure patients' average change from baseline scores over time, in physical function.
Efter 54 ugers behandling resulterede begge doser af infliximab + methotrexat i statistisk signifikant større forbedring i tegn og symptomer sammenlignet med methotrexat alene, målt ved andelen af patienter, der opnåede ACR20, 50 og 70 respons. 
After 54 weeks of treatment, both doses of infliximab + methotrexate resulted in statistically significantly greater improvement in signs and symptoms compared to methotrexate alone as measured by the proportion of patients achieving ACR20, 50 and 70 responses.
Fordelingsvolumen ved steady state (median Vd på 3,0 til 4,1 liter) var ikke afhængig af den indgivne dosis og indikerede, at infliximab især distribueres i det vaskulære fordelingsrum. 
The volume of distribution at steady state (median Vd of 3.0 to 4.1 litres) was not dependent on the administered dose and indicated that infliximab is predominantly distributed within the vascular compartment.
Patienter skal følges tæt for infektioner, inklusive tuberkulose før, under og efter behandling med Remicade. 
Patients must be monitored closely for infections including tuberculosis before, during and after treatment with Remicade.
• En meddelelse om, at produktnavn og lot-nummer skal registreres. 
• A statement that the brand name and batch number should be recorded
Øvre luftvejsinfektion (7/60 [12 %]) og faryngitis (5/60 [8 %]) var de hyppigst rapporterede luftvejsinfektioner. 
Upper respiratory tract infection (7/60 [12%]) and pharyngitis (5/60 [8%]) were the most frequently reported respiratory system infections.
Hvis patienter genbehandles efter en længere periode, skal de følges nøje vedrørende tegn og symptomer på forsinket overfølsomhed. 
If patients are re-treated after a prolonged period, they must be closely monitored for signs and symptoms of delayed hypersensitivity.
Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer) 
Names and addresses of the manufacturer(s) of the biological active substance(s)
Der bør tages særligt hensyn til risikoen for infektion, når ældre behandles (se pkt. 
Particular attention regarding the risk for infection should be paid when treating the elderly (see section 4.8).
Tabel 7 Effekter på responshastighed, data fra ACCENT II (uge-14 responderende) ACCENT II (uge-14 responderende) Placebo Vedligeholdelse( n = 99) 
Table 7 Effects on response rate, data from ACCENT II (week-14 responders) ACCENT II (week-14 responders) Placebo Maintenance (n = 99)
• Øjenbetændelse, der kan forårsage synsforandringer, inklusive blindhed 
• Inflammation in the eye that may cause changes in the vision, including blindness
ACR-N anvender de samme kriterier som ACR20, beregnet ved at tage den laveste procentvise forbedring i antallet af hævede led, antallet af ømme led og medianen af de sidste 5 komponenter af ACR responset. 
ACR-N uses the same criteria as the ACR20, calculated by taking the lowest percent improvement in swollen joint count, tender joint count, and the median of the remaining 5 components of the ACR response.
Ikke kendt: Gennembrudsinfektion efter vaccination (efter eksponering for infliximab i uterus)* 
Not known: Vaccine breakthrough infection (after in utero exposure to infliximab)*.
I infliximab-gruppen forblev middelændringen i samlet modificeret vdH-S score under 0 i uge 54. 
In the infliximab group, the mean change in total modified vdH-S score remained below 0 at the week 54 timepoint.
Gennemsnitlig NAPSIscore ved baseline var hhv. 4,6 og 4,3 i infliximab- og placebogruppen. 
Mean baseline NAPSI scores were 4.6 and 4.3 in infliximab and placebo group.
Der blev registreret signifikante forbedringer fra baseline i DLQI (p < 0,001) og de fysiske og mentale del-scorer af SF 36 (p < 0,001 for hver enkelt delsammenligning). 
Significant improvements from baseline were demonstrated in DLQI (p < 0.001) and the physical and mental component scores of the SF 36 (p < 0.001 for each component comparison).
Men før du får Remicade, blandes det sammen med en opløsning, som indeholder natrium. 
However, before Remicade is given to you, it is mixed with a solution that contains sodium.