FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptoms included, but were not limited to, dyspnoea, urticaria, facial oedema, and hypotension.
Danish: Symptomerne inkluderede, men var ikke begrænset til dyspnø, urticaria, ødemer i ansigtet og hypotension.
English: Infliximab does not cross react with TNFα from species other than human and chimpanzees.
Danish: Infliximab krydsreagerer ikke med TNFα fra andre arter end mennesker og chimpanser.
English: Discontinuation of Flixabi should be considered if these disorders develop.
Danish: Det bør overvejes at afbryde Flixabibehandlingen, hvis disse forstyrrelser fortsætter.
English: 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).
Danish: 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).
English: • 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.
Danish: • 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.
English: If these medicines or treatments do not work well enough, you will be given Flixabi to reduce the signs and symptoms of your disease.
Danish: Hvis disse lægemidler eller behandlinger ikke virker godt nok, vil du få Flixabi for at reducere tegn og symptomer på din sygdom.
English: 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).
Danish: 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).
English: Slowly add the total volume of reconstituted Flixabi solution to the 250-ml infusion bottle or bag.
Danish: Tilsæt langsomt det samlede volumen af rekonstitueret Flixabi-opløsning til 250 ml infusionsflasken eller -posen.
English: 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:
Danish: 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:
English: 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).
Danish: 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.
English: Patients who have had their dose interval shortened to less than 8 weeks may be at greater risk for adverse reactions.
Danish: for hvem doseringsintervallet er afkortet til under 8 uger, kan have større risiko for bivirkninger.
English: Autoimmune hepatitis, jaundice.
Danish: Autoimmun hepatitis, gulsot.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 1 Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
Danish: 1 Placebo-patienter fik methotrexat, mens infliximab-patienter fik både infliximab og methotrexat.
English: 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.
Danish: 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.
English: This includes multiple sclerosis, Guillain-Barre syndrome, if you have fits or have been diagnosed with ‘optic neuritis'.
Danish: Dette inkluderer dissemineret sklerose, Guillain-Barré syndrom, hvis du har krampeanfald eller har fået stillet diagnosen ”optisk neuritis” (betændelse i synsnerven).
English: • Children and adults taking Flixabi may have an increased risk of developing lymphoma or another cancer.
Danish: • Børn og voksne i behandling med Flixabi kan have en øget risiko for at udvikle lymfom eller anden form for kræft.
English: Flixabi contains the active substance infliximab.
Danish: Flixabi indeholder det aktive stof infliximab.
English: Ask your doctor to record the type and date of last screening(s) for TB below:
Danish: Du skal bede din læge om at notere type og dato for seneste screening(er) for tuberkulose (TB) nedenfor:
English: 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.
Danish: 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.
English: No rebound was observed.
Danish: Der sås intet reboundfænomen.
English: Calculate the total volume of reconstituted Flixabi solution required.
Danish: Beregn det samlede påkrævede volumen rekonstitueret Flixabi-opløsning.
English: 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.
Danish: 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.
English: Lymphoma, non-Hodgkin's lymphoma, Hodgkin's disease, leukaemia, melanoma, cervical cancer.
Danish: Lymfom, non-Hodgkins lymfom, Hodgkins sygdom, leukæmi, melanom, livmoderhalskræft.
English: • Melanoma (a type of skin cancer).
Danish: • Melanom (en type hudkræft)
English: 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).
Danish: 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).
English: 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).
Danish: 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.
English: 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.
Danish: 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.
English: 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%]).
Danish: Der var en rapporteret malign sygdom blandt 77 kontrolpatienter (median opfølgningsperiode 0,8 år; incidens 1,3 % [95 % CI 0,03 %-7,0 %]).
English: 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.
Danish: 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.
English: List of allergies:
Danish: Liste over allergier
English: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease or ulcerative colitis), Merkel cell carcinoma.
Danish: Hepatosplenisk T-celle-lymfom (primært hos unge og unge voksne mænd med Crohns sygdom eller colitis ulcerosa), Merkelcellekarcinom.
English: 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.
Danish: 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.
English: The relative deficiency of TNFα caused by anti-TNF therapy may result in the initiation of an autoimmune process.
Danish: Autoimmune processer Den relative mangel på TNFα som følge af anti-TNF-behandling kan medføre initiering af en autoimmun proces.
English: Change from baseline in total van der Heijde-modified Sharp score b
Danish: Ændring fra baseline i total van der Heijde modificeret Sharp scoreb
English: Flixabi should be administered intravenously over a 2-hour period.
Danish: Flixabi skal administreres intravenøst over en 2-timers periode.
English: 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.
Danish: 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.
English: • If you received Flixabi during your pregnancy, your baby may have a higher risk for getting an infection.
Danish: • Hvis du fik Flixabi under graviditeten, kan dit barn have en øget risiko for at få en infektion.
English: Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB02.
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, tumor nekrose faktor alfa (TNFα)-hæmmere, ATC-kode: L04AB02.
English: • Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Flixabi treatment.
Danish: • Patienter med KOL og patienter, som er storrygere, kan have en øget risiko for at udvikle kræft under behandling med Flixabi.
English: This patient reminder card contains important safety information that you need to be aware of before and during treatment with Flixabi.
Danish: Dette patientinformationskort indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på før og under behandling med Flixabi.
English: 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.
Danish: 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.
English: Cases of TB have been reported in patients treated with Flixabi, even in patients who have already been treated with medicines for TB.
Danish: Tilfælde af TB har været rapporteret hos patienter i behandling med Flixabi, også hos patienter, der allerede har været i behandling med medicin mod
English: Please read the Flixabi ‘Package Leaflet' carefully before you start using this medicine.
Danish: Læs indlægssedlen for Flixabi grundigt, inden du begynder at tage medicinen.
English: At 38 weeks, 9 of 101 patients treated with infliximab (2 at 5 mg/kg and 7 at 10 mg/kg) died compared to one death among the 49 patients on placebo.
Danish: Efter 38 uger var 9 af 101 patienter behandlet med infliximab (2 med 5 mg/kg og 7 med 10 mg/kg) døde sammenlignet med et dødsfald blandt de 49 patienter på placebo.
English: PGA of cleared (0) or minimal (1) PGA of cleared (0), minimal (1), or mild (2) All nails cleared c
Danish: PGA helt væk (0) eller minimale (1) PGA helt væk (0), minimale (1) eller lette (2) Alle negle fri for psoriasis c
English: Because of the nature of the adverse reactions seen with combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNFα-blocking agents.
Danish: Grundet egenskaberne af bivirkningerne set ved kombinationsbehandlingen med etanercept og anakinra, kan lignende toksiciteter muligvis forekomme ved kombination af anakinra med andre TNFα-blokerende midler.
English: In the 3 mg/kg infliximab group, 4 out of 60 patients had a serious infusion reaction and 3 patients reported a possible anaphylactic reaction (2 of which were among the serious infusion reactions).
Danish: I 3 mg/kg infliximabgruppen fik 4 ud af 60 patienter en alvorlig infusionsreaktion, og 3 patienter rapporterede en mulig anafylaktisk reaktion (ud af disse var 2 blandt de alvorlige infusionsreaktioner).
English: Single intravenous infusions of 1, 3, 5, 10 or 20 mg/kg of infliximab yielded dose proportional increases in the maximum serum concentration (Cmax) and area under the concentration-time curve (AUC).
Danish: Enkelte intravenøse infusioner på 1, 3, 5, 10 eller 20 mg/kg infliximab udviste dosis-proportionale stigninger i den maksimale serumkoncentration (Cmax) samt området under koncentrationstidskurven
English: • Tell your doctor before you are given Flixabi if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common.
Danish: • Fortæl din læge, før du får Flixabi, hvis du nogensinde har boet eller rejst i et område, hvor infektioner kaldet histoplasmose, kokcidioidomykose eller blastomykose er almindelige.
English: Bacterial infections (e.g. sepsis, cellulitis, abscess).
Danish: Bakterielle infektioner (fx sepsis, cellulitis, absces).
English: • In case you have received Flixabi while you were pregnant, it is important that you inform your baby's doctor about it before your baby receives any vaccine.
Danish: • Hvis du har fået Flixabi, mens du var gravid, er det vigtigt, at du informerer dit barns læge om det, før dit barn bliver vaccineret.
English: • This medicine can also be stored in the original carton outside of refrigerated storage up to a maximum of 25°C for a single period of up to six months.
Danish: • Dette lægemiddel kan også opbevares i den originale karton uden for køleskab ved maksimalt 25 °C i en enkelt periode på op til seks måneder, men den oprindelige udløbsdato må ikke overskrides.
English: • Talk to your doctor if you have recently received or are scheduled to receive treatment with a therapeutic infectious agent (such as BCG instillation used for the treatment of cancer).
Danish: • Tal med din læge, hvis du for nylig har fået eller det er planlagt, at du skal have behandling med et terapeutisk smitstof (fx instillation af BCG til behandling af kræft).
English: Following administration of 5 mg/kg infliximab every 8 weeks, the predicted median steady-state infliximab exposure (area under concentration-time curve at steady state, AUCss) in paediatric patients aged 6 years to 17 years was approximately 20% lower than the predicted median steadystate drug exposure in adults.
Danish: Efter administration af infliximab 5 mg/kg hver 8. uge var den forventede mediane steady-state infliximab-eksponering (arealet under koncentrations- tids-kurven ved steady-state, AUCss) hos pædiatriske patienter i alderen 6 til 17 år ca. 20 % lavere end den forventede median steady-state lægemiddel-eksponering hos voksne.
English: 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.
Danish: 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, herunder infliximab kan fremkalde et lavere immunrespons end hos patienter, der ikke får anti-TNFbehandling.
English: In the Phase IIIb trial in Crohn's disease, SONIC, placebo patients received AZA 2.5 mg/kg/day as active control in addition to placebo infliximab infusions.
Danish: I fase IIIb-studiet med Crohns sygdom, SONIC, fik placebo-patienterne AZA 2,5 mg/kg/dag som aktiv kontrol i tillæg til placeboinfliximab-infusioner.
English: It is recommended that patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Flixabi therapy.
Danish: Det anbefales, at patienterne, om muligt, bringes up to date med alle vaccinationer i overensstemmelse med gældende vaccinationsvejledninger før initiering af behandling med Flixabi.
English: In a Phase II study aimed at evaluating infliximab in CHF, higher incidence of mortality due to worsening of heart failure were seen in patients treated with infliximab, especially those treated with the higher dose of 10 mg/kg (i.e. twice the maximum approved dose).
Danish: I et fase II studie, der skulle vurdere infliximab ved CHF, sås højere forekomst af dødsfald på grund af forværret hjerteinsufficiens hos patienter behandlet med infliximab, især hos patienter behandlet med den højere dosis på 10 mg/kg (svarende til to gange den maksimale godkendte dosis).
English: Patients should be closely monitored and Flixabi must not be continued in patients who develop new or worsening symptoms of heart failure (see sections 4.3 and 4.8).
Danish: Patienter bør følges nøje, og Flixabi må ikke fortsættes hos patienter, som udvikler nye eller forværrede symptomer på hjerteinsufficiens (se pkt.
English: Almost all patients had received treatment with AZA or 6-MP concomitantly with or immediately prior to a TNF-blocker.
Danish: Næsten alle disse patienter havde fået behandling med AZA eller 6-MP samtidig med eller umiddelbart før TNF- blokerende behandling.
English: If serious reactions occur, symptomatic treatment must be given and further Flixabi infusions must not be administered (see section 4.8).
Danish: Hvis alvorlige reaktioner opstår, skal symptomatisk behandling gives, og der må ikke gives yderligere Flixabi-infusioner (se pkt.
English: Insert the syringe needle into the vial through the centre of the rubber stopper and direct the stream of water for injections to the glass wall of the vial.
Danish: Indsæt sprøjtekanylen i hætteglasset gennem midten af gummiproppen og ret strålen med vand til injektionsvæsker mod glasvæggen i hætteglasset.
English: • Tell your doctor if you have an infection even if it is a very minor one.
Danish: • Fortæl din læge, hvis du har en infektion, også selvom det er en meget let infektion.
English: Since no preservative is present, it is recommended that the administration of the solution for infusion is to be started as soon as possible and within 3 hours of reconstitution and dilution.
Danish: Da der ikke er anvendt konserveringsmiddel, anbefales det, at indgivelsen af infusionsvæsken, opløsningen, påbegyndes så hurtigt som muligt og inden for 3 timer efter rekonstitution og fortynding.
English: • Tell your doctor before you are given Flixabi if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
Danish: • Fortæl din læge, før du får Flixabi, hvis du har eller nogensinde har haft lymfom (en type blodkræft) eller enhver anden form for kræft.
English: Anaphylactic shock, vasculitis, sarcoid-like reaction.
Danish: Anafylaktisk shock, vasculitis, sarkoid-lignende reaktioner.
English: • You may get infections more easily when you are being treated with Flixabi.
Danish: • Du har lettere ved at få infektioner, når du er i behandling med Flixabi.
English: Flixabi is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Danish: Flixabi er indiceret til behandling af aktiv og progressiv psoriasis arthritis hos voksne patienter, hvor respons på tidligere DMARD-behandling har været utilstrækkelig.
English: Flixabi contains sodium
Danish: Flixabi indeholder natrium
English: Table 7 Effects on response rate, data from ACCENT II (week-14 responders)
Danish: Tabel 7 Effekter på responshastighed, data fra ACCENT II (uge-14 responderende) ACCENT II (uge-14 responderende)
English: Elevated concentrations of TNFα have been found in the joints of rheumatoid arthritis patients and correlate with elevated disease activity.
Danish: Forhøjede koncentrationer af TNFα er blevet fundet i leddene hos reumatoid arthritis patienter og korrelerer med øget sygdomsaktivitet.
English: List of other medicines:
Danish: Liste over anden medicin
English: Available data suggest an increased risk for delayed hypersensitivity with increasing infliximab-free interval.
Danish: Eksisterende resultater tyder på en øget risiko for forsinket overfølsomhed ved længerevarende infliximab-fri periode.