natgillin/translations-raw huggingface dataset:
• Det er meget vigtigt, at du fortæller din læge, hvis du nogensinde har haft tuberkulose (TB), eller hvis du har været i tæt kontakt med en person, som har haft TB. 
• It is very important that you tell your doctor if you have ever had tuberculosis (TB), or if you have been in close contact with someone who has had TB.
Du skal bede din læge om at notere type og dato for din(e) seneste screening(er) for TB på kortet. 
Ask your doctor to record the type and date of your last screening(s) for TB on the card.
• Forsinke skaden i dit led 
• Slow down the damage in your joints,
Under Flixabi-behandling bør anden samtidig behandling såsom kortikosteroider og immunsuppressiva optimeres. 
During Flixabi treatment, other concomitant therapies, e.g. corticosteroids and immunosuppressants should be optimised.
Overfølsomhed over for det aktive stof, over for andre murine proteiner eller over for et eller flere af hjælpestofferne anført i pkt. 
Hypersensitivity to the active substance, to other murine proteins, or to any of the excipients listed in section
Hvis der opstår gulsot og/eller ALAT- forhøjelser ≥ 5 gange øvre grænse af normalområdet, bør Flixabi seponeres, og et omhyggelig studie af hændelsen bør foretages. 
If jaundice and/or ALT elevations ≥ 5 times the upper limit of normal develop(s), Flixabi should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Patienter, som udvikler en ny infektion, imens de er under behandling med Flixabi, bør monitoreres tæt og gennemgå en komplet diagnostisk evaluering. 
Patients who develop a new infection while undergoing treatment with Flixabi, should be monitored closely and undergo a complete diagnostic evaluation.
Flixabi kan evt. i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner. 
Flixabi may have a minor influence on the ability to drive and use machines.
Kontroller at opløsningen er farveløs til lysegul og opaliserende. 
Check that the solution is colourless to light yellow and opalescent.
• Fortæl kirurgen eller tandlægen, at du er i behandling med Flixabi ved at vise dem dit patientinformationskort. 
• Tell your surgeon or dentist that you are having treatment with Flixabi by showing them your patient reminder card.
På grund af hæmningen af TNFα kan infliximab indgivet under graviditet påvirke det normale immunrespons hos den nyfødte. 
Due to its inhibition of TNFα, infliximab administered during pregnancy could affect normal immune responses in the newborn.
I de fleste patienter med fistulerende Crohns sygdom blev infliximab påvist i serum i 12 uger (interval 4- 28 uger) efter indgift af regimen. 
In most fistulising Crohn's disease patients, infliximab was detected in serum for 12 weeks (range 4-28 weeks) after administration of the regimen.
Placebo Vedligeholdelse (n = 99) 
Placebo Maintenance (n=99)
N ≥ 90 % forbedring 
N ≥ 90% improvement
Median opfølgningsperioden var 0,8 år (incidens 5,7 % [95 % CI 2,65 %-10,6 %]. 
The median duration of follow-up was 0.8 years (incidence 5.7% [95% CI 2.65%-10.6%].
Flixabi påvirker sandsynligvis ikke din evne til at føre motorkøretøj eller betjene værktøj eller maskiner. 
Flixabi is not likely to affect your ability to drive or use tools or machines.
In vivo danner infliximab hurtigt stabile komplekser med human TNFα, en proces der svarer til tabet af TNFα bioaktivitet. 
In vivo, infliximab rapidly forms stable complexes with human TNFα, a process that parallels the loss of TNFα bioactivity.
Der kendes ikke til nogen bivirkninger efter at have fået for meget Flixabi. 
There are no known side effects of having too much of Flixabi.
Under kliniske studier med infliximab over alle godkendte indikationer var forekomsten af lymfom hos infliximab-behandlede patienter højere end forventet i den generelle befolkningsgruppe, men forekomsten af lymfom var sjælden. 
During clinical studies of infliximab across all approved indications the incidence of lymphoma in infliximab-treated patients was higher than expected in the general population, but the occurrence of lymphoma was rare.
Hvis inaktiv (“latent”) tuberkulose diagnosticeres, skal behandling for latent tuberkulose påbegyndes med behandling mod tuberkulose før initiering af Flixabibehandling 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 Flixabi, and in accordance with local recommendations.
Det er vigtigt, at du fortæller dit barns læger og andet sundhedspersonale, at du får Flixabi, 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 health care professionals about your Flixabi use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis).
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 patientsyears (3,210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma malignancies were reported.
Flixabi indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. det er i det væsentlige ”natriumfrit”. 
Flixabi contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Vedblivende steroidfri remissionb a Reduktion i CDAI ≥ 25 % og ≥ 70 point. 
a Reduction in CDAI ≥ 25% and ≥ 70 points.
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 TNFα og interferon-γ. 
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 TNFα and interferon γ.
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 Flixabi. 
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 Flixabi.
Infliximab er ikke undersøgt hos denne patientpopulation. 
Infliximab has not been studied in these patient populations.
≥ 50 % forbedring PGA helt væk (0) eller minimale (1) 
≥ 50% improvement PGA of cleared (0) or minimal (1)
Der er ikke udført specifikke studier af infliximab hos ældre patienter. 
Specific studies of infliximab in elderly patients have not been conducted.
Den almindeligste utilsigtede hændelse var forværring af colitis ulcerosa, hvor hyppigheden var større hos patienter i 12-ugers behandlingsregimen vs. 8-ugers behandlingsregimen. 
The most common adverse event was worsening of ulcerative colitis, the incidence of which was higher in patients on the q12 week vs. the q8 week dosing regimen.
d p = 0,030 og < 0,001 for henholdsvis 3 mg/kg og 6 mg/kg behandlingsgruppen mod placebo + MTX. 
d p = 0.030 and < 0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs. placebo + MTX.
Histologisk evaluering af biopsier fra colon, som er udtaget før og 4 uger efter indgivelse af infliximab, viste en betydelig reduktion i påviseligt TNFα. 
Histological evaluation of colonic biopsies, obtained before and 4 weeks after administration of infliximab, revealed a substantial reduction in detectable TNFα.
Flixabi bør anvendes med forsigtighed hos patienter med let hjerteinsufficiens (NYHA funktionsklasse I/II). 
Flixabi should be used with caution in patients with mild heart failure (NYHA class I/II).
Alle patienterne skulle være på en stabil dosis af 6- MP, AZA eller MTX (35 % fik også kortiokosteroid ved baseline). 
All patients were required to be on a stable dose of 6-MP, AZA or MTX (35% were also receiving corticosteroids at baseline).
* Infliximab er et kimerisk monoklonalt human-murin IgG1-antistof fremstillet i celler fra kinesiske hamsterovarier (CHO) ved rekombinant DNA-teknologi. 
* Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
• Det anbefales, at Flixabi anvendes så hurtigt som muligt (inden for 3 timer), efter det er klargjort til infusion. 
• It is recommended that when Flixabi is prepared for infusion, it is used as soon as possible (within 3 hours).
ATTRACT studiet evaluerede responset ved ugerne 30, 54 og 102 i en placebokontrolleret studie hos 428 patienter med aktiv reumatoid arthritis på trods af behandling med methotrexat. 
The ATTRACT study evaluated responses at 30, 54 and 102 weeks in a placebo-controlled study of 428 patients with active rheumatoid arthritis despite treatment with methotrexate.
For instruktioner om tilberedning og administration, se pkt. 
For preparation and administration instructions, see section 6.6.
Generelt var patienter, der udviklede ALAT og ASAT stigninger, asymptomatiske, og hændelserne bedredes eller forsvandt med enten fortsættelse eller afbrydelse af infliximab, 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 infliximab, or modification of concomitant therapy.
Været i behandling med lægemidler indeholdende infliximab tidligere 
Had treatment with any medicine containing infliximab before
Passende screeningundersøgelser (fx tuberkulintest, røntgen af thorax og/eller Interferon Gamma Relase Assay) bør udføres hos alle patienter (lokale vejledninger kan være gældende). 
Appropriate screening tests, e.g. tuberculin skin test, chest X-ray, and/or Interferon Gamma Release Assay), should be performed in all patients (local recommendations may apply).
• Lave blodtal, herunder svært nedsat antal hvide blodlegemer. 
• Low blood counts, including a severely decreased number of white blood cells.
Symptomerne inkluderede, men var ikke begrænset til dyspnø, urticaria, ødemer i ansigtet og hypotension. 
Symptoms included, but were not limited to, dyspnoea, urticaria, facial oedema, and hypotension.
Infliximab krydsreagerer ikke med TNFα fra andre arter end mennesker og chimpanser. 
Infliximab does not cross react with TNFα from species other than human and chimpanzees.
Det bør overvejes at afbryde Flixabibehandlingen, hvis disse forstyrrelser fortsætter. 
Discontinuation of Flixabi should be considered if these disorders develop.
Strukturel ledskade (erosioner og forsnævring af ledspalte) i begge hænder og fødder blev målt som ændringen fra baseline i total van der Heijdemodified 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).
• Hvis du har fået Flixabi, 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 Flixabi 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.
Hvis disse lægemidler eller behandlinger ikke virker godt nok, vil du få Flixabi for at reducere tegn og symptomer på din sygdom. 
If these medicines or treatments do not work well enough, you will be given Flixabi to reduce the signs and symptoms of your disease.
1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
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 < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Tilsæt langsomt det samlede volumen af rekonstitueret Flixabi-opløsning til 250 ml infusionsflasken eller -posen. 
Slowly add the total volume of reconstituted Flixabi solution to the 250-ml infusion bottle or bag.
Hvis disse lægemidler ikke virker godt nok, vil du få Flixabi, 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 Flixabi which you will take in combination with another medicine called methotrexate to:
Patienter med fistulerende Crohns sygdom med akut pusdannende fistler må ikke påbegynde Flixabibehandling, før en kilde til mulig infektion, specielt abscesser, er blevet udelukket (se pkt. 
Patients with fistulising Crohn's disease with acute suppurative fistulas must not initiate Flixabi therapy until a source for possible infection, specifically abscess, has been excluded (see section 4.3).
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.
Autoimmun hepatitis, gulsot. 
Autoimmune hepatitis, jaundice.
Behandling med Flixabi bør seponeres, hvis en patient udvikler en ny alvorlig infektion eller sepsis, og passende antimikrobiel eller antimykotisk behandling bør initieres, indtil infektionen er under kontrol. 
Administration of Flixabi should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Anvendelsen af anti-tuberkulosebehandling bør også overvejes før initieringen af Flixabi hos patienter med en tidligere sygdomshistorie med latent eller aktiv tuberkulose, hos hvem et passende behandlingsprogram ikke kan bekræftes. 
Use of anti-tuberculosis therapy should also be considered before the initiation of Flixabi in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Den samlede data analyse for ACT 1- og ACT 2-studierne og deres forlængelser, som blev analyseret fra baseline til uge 54, viste en reduktion af colitis ulcerosa-relaterede hospitalsindlæggelser og kirurgiske indgreb med infliximab-behandling. 
The pooled data analysis from the ACT 1 and ACT 2 studies and their extensions, analysed from baseline through 54 weeks, demonstrated a reduction of ulcerative colitis-related hospitalisations and surgical procedures with infliximab treatment.
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.
2 Placebo-patienter i de 2 fase III-studier med Crohns sygdom, ACCENT I og ACCENT II, fik som startdosis 5 mg/kg infliximab ved studiets begyndelse og var på placebo i vedligeholdelsesfasen. 
2 Placebo patients in the 2 Phase III studies in Crohn's disease, ACCENT I and ACCENT II, received an initial dose of 5 mg/kg infliximab at study start and were on placebo in the maintenance phase.
Dette inkluderer dissemineret sklerose, Guillain-Barré syndrom, hvis du har krampeanfald eller har fået stillet diagnosen ”optisk neuritis” (betændelse i synsnerven). 
This includes multiple sclerosis, Guillain-Barre syndrome, if you have fits or have been diagnosed with ‘optic neuritis'.
• Børn og voksne i behandling med Flixabi kan have en øget risiko for at udvikle lymfom eller anden form for kræft. 
• Children and adults taking Flixabi may have an increased risk of developing lymphoma or another cancer.
Flixabi indeholder det aktive stof infliximab. 
Flixabi contains the active substance infliximab.
Du skal bede din læge om at notere type og dato for seneste screening(er) for tuberkulose (TB) nedenfor: 
Ask your doctor to record the type and date of last screening(s) for TB below:
I en af armene (gruppe 2, n = 329) blev patienter med utilstrækkeligt respons tilladt dosisjustering med 1,5 mg/kg intervaller fra 3 op til 9 mg/kg. 
In one of the study arms (group 2, n=329), patients with an inadequate response were allowed to dose titrate with 1.5 mg/kg increments from 3 up to 9 mg/kg.
Der sås intet reboundfænomen. 
No rebound was observed.
Beregn det samlede påkrævede volumen rekonstitueret Flixabi-opløsning. 
Calculate the total volume of reconstituted Flixabi solution required.
Hos patienter behandlet med Flixabi bør en invasiv svampeinfektion såsom aspergillose, candidiasis, pneumocystose, histoplasmose, kokcidioidomykose eller blastomykose mistænkes, hvis en alvorlig systemisk sygdom udvikles, og en læge med ekspertise i diagnosticering og behandling af invasive svampeinfektioner bør konsulteres på et tidligt stadie, når disse patienter undersøges. 
In patients treated with Flixabi, an invasive fungal infection such as aspergillosis, candidiasis, pneumocystosis, histoplasmosis, coccidioidomycosis or blastomycosis should be suspected if they develop a serious systemic illness, and a physician with expertise in the diagnosis and treatment of invasive fungal infections should be consulted at an early stage when investigating these patients.
Lymfom, non-Hodgkins lymfom, Hodgkins sygdom, leukæmi, melanom, livmoderhalskræft. 
Lymphoma, non-Hodgkin's lymphoma, Hodgkin's disease, leukaemia, melanoma, cervical cancer.
• Melanom (en type hudkræft) 
• Melanoma (a type of skin cancer).
På basis af et observationsstudie fra Nordeuropa blev der observeret øget risiko (OR, 95 % CI; p-værdi) for kejsersnit (1,50; 1,14-1,96; p = 0,0032), for tidligt fødte børn (1,48; 1,05-2,09; p = 0,024), børn født små i forhold til gestationsalder (2,79; 1,54-5,04; p = 0,0007) og lav fødselsvægt (2,03; 1,41-2,94; p = 0,0002) hos kvinder, som blev eksponeret for infliximab under graviditeten (med eller uden immunmodulatorer/kortikosteroider, 270 graviditeter) sammenlignet med kvinder, som udelukkende blev eksponeret for immunmodulatorer/kortikosteroider (6.460 graviditeter). 
Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for Csection (1.50, 1.14-1.96; p=0.0032), preterm birth (1.48, 1.05-2.09; p=0.024), small for gestational age (2.79, 1.54-5.04; p=0.0007), and low birth weight (2.03, 1.41-2.94; p=0.0002) was observed in women exposed during pregnancy to infliximab (with or without immunomodulators/corticosteroids, 270 pregnancies) as compared to women exposed to immunomodulators and/or corticosteroids only (6,460 pregnancies).
Kombination af Flixabi og andre biologiske lægemidler anvendt til behandling af de samme lidelser som Flixabi, herunder anakinra og abatacept, kan ikke anbefales (se pkt. 
The combination of Flixabi with other biological therapeutics used to treat the same conditions as Flixabi, including anakinra and abatacept, is not recommended (see section 4.4).
Hvis du har fået Flixabi under graviditeten, kan vaccination af dit barn med BCG-vaccine (bruges til at forebygge tuberkulose) inden for 6 måneder efter fødslen medføre infektion med alvorlige komplikationer herunder død. 
If you received Flixabi while pregnant, giving BCG vaccine (used to prevent tuberculosis) to your baby within 6 months after birth may result in infection with serious complications, including death.
Der var en rapporteret malign sygdom blandt 77 kontrolpatienter (median opfølgningsperiode 0,8 år; incidens 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%]).
I et uddybende klinisk studie omfattende patienter, som havde moderat til svær COPD og var enten nuværende eller tidligere rygere, var 157 voksne patienter behandlet med infliximab i doser svarende til dem, der anvendes ved reumatoid arthritis og Crohns sygdom. 
In an exploratory clinical study involving patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 adult patients were treated with infliximab at doses similar to those used in rheumatoid arthritis and Crohn's disease.
Liste over allergier 
List of allergies:
Hepatosplenisk T-celle-lymfom (primært hos unge og unge voksne mænd med Crohns sygdom eller colitis ulcerosa), Merkelcellekarcinom. 
Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease or ulcerative colitis), Merkel cell carcinoma.
Alle patienter med colitis ulcerosa, som har forhøjet risiko for dysplasi eller colon cancer (for eksempel patienter med langvarig colitis ulcerosa eller primær sklerotisk cholangitis), eller som tidligere har haft dysplasi eller colon cancer, bør screenes for dysplasi med regelmæssige intervaller før behandling og under deres sygdomsforløb. 
All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course.
Autoimmune processer Den relative mangel på TNFα som følge af anti-TNF-behandling kan medføre initiering af en autoimmun proces. 
The relative deficiency of TNFα caused by anti-TNF therapy may result in the initiation of an autoimmune process.
Ændring fra baseline i total van der Heijde modificeret Sharp scoreb 
Change from baseline in total van der Heijde-modified Sharp score b
Flixabi skal administreres intravenøst over en 2-timers periode. 
Flixabi should be administered intravenously over a 2-hour period.
Der er visse vaccinationer, du kan få, mens du er i behandling med Flixabi, men du må ikke få levende vacciner (vacciner der indeholder et levende men svækket smitstof), da de kan give infektioner. 
You may receive some vaccines during treatment with Flixabi but you should not receive live vaccines (vaccines that contain a living but weakened infectious agent) while using Flixabi because they may cause infections.
• Hvis du fik Flixabi under graviditeten, kan dit barn have en øget risiko for at få en infektion. 
• If you received Flixabi during your pregnancy, your baby may have a higher risk for getting an infection.
Farmakoterapeutisk klassifikation: Immunsuppressiva, tumor nekrose faktor alfa (TNFα)-hæmmere, ATC-kode: L04AB02. 
Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB02.
• Patienter med KOL og patienter, som er storrygere, kan have en øget risiko for at udvikle kræft under behandling med Flixabi. 
• Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Flixabi treatment.
Dette patientinformationskort indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på før og under behandling med Flixabi. 
This patient reminder card contains important safety information that you need to be aware of before and during treatment with Flixabi.
Hos de patienter, der blev behandlet med infliximab, og som fik mindst en kort infusion, opstod infusionsrelaterede reaktioner hos 15 % af patienterne, og alvorlige infusionsreaktioner opstod hos 0,4 % af patienterne. 
Of the infliximabtreated 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.
Tilfælde af TB har været rapporteret hos patienter i behandling med Flixabi, også hos patienter, der allerede har været i behandling med medicin mod 
Cases of TB have been reported in patients treated with Flixabi, even in patients who have already been treated with medicines for TB.
Læs indlægssedlen for Flixabi grundigt, inden du begynder at tage medicinen. 
Please read the Flixabi ‘Package Leaflet' carefully before you start using this medicine.