FrancophonIA/ELRC3.0 huggingface dataset:
English: TNF alpha is involved in inflammatory processes of the body so blocking it can reduce the inflammation in your body.
Danish: TNF-alfa er involveret i kroppens betændelsesprocesser, og blokering af proteinet kan herved mindske betændelsen i din krop.
English: • In case you have received Inflectra 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 Inflectra, mens du var gravid, er det vigtigt, at du informerer dit barns læge om det, før dit barn bliver vaccineret.
English: Lymphoma, non-Hodgkin's lymphoma, Hodgkin's disease, leukaemia, melanoma, cervical cancer.
Danish: Lymfom, non-Hodgkins lymfom, Hodgkins sygdom, leukæmi, melanom.
English: • It is very important that you tell your doctor if you have ever had TB or if you have been in close contact with someone who has had or has TB.
Danish: • Det er meget vigtigt, at du fortæller du læge, hvis du nogensinde har haft TB, eller hvis du har været i tæt kontakt med en person, som har eller har haft TB.
English: >54 weeks
Danish: > 54 uger
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: Administration of infliximab 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 infliximab 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: Inflectra is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Danish: Inflectra er indiceret til behandling af aktiv og progressiv psoriasis arthritis hos voksne patienter, hvor respons på tidligere DMARD-behandling har været utilstrækkelig.
English: Almost all patients had received treatment with AZA or 6-MP concomitantly with or immediately prior to a TNF-blocker.
Danish: Næsten alle patienterne havde fået behandling med AZA eller 6-MP, samtidig med eller umiddelbart før TNF-blokerende midler.
English: Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g. BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections.
Danish: Anden anvendelse af terapeutiske smitstoffer såsom levende svækkede bakterier (f.eks. instillation af BCG i blæren ved behandling af cancer) kan medføre kliniske infektioner herunder disseminerede infektioner.
English: This patient reminder card contains important safety information that you need to be aware of before and during treatment with Inflectra.
Danish: Dette patientinformationskort indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på før og under behandling med Inflectra.
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 KOL 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: Infections were reported in 31 (51.7%) of 60 treated patients in C0168T72 and 22 (36.7%) required oral or parenteral antimicrobial treatment.
Danish: Der blev rapporteret om infektioner hos 31 (51,7%) af 60 behandlede patienter i C0168T72, og 22 (36,7%) krævede oral eller parenteral antimikrobiel behandling.
English: Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for C-section (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; pværdi) 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: Patients with ACR20 response/Patients evaluated (%) Total score d
Danish: Patienter med ACR20 respons /Patienter evalueret (%)
English: Inflectra may have a minor influence on the ability to drive and use machines.
Danish: Inflectra påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: In patients treated with infliximab, 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 infliximab 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: • Liver problem that causes yellowing of the skin or eyes (jaundice)
Danish: • Leverproblem, der giver gulfarvning af hud eller øjne (gulsot)
English: At week 16, 47 placebo patients with < 10% improvement from baseline in both swollen and tender joint counts were switched to infliximab induction (early escape).
Danish: I uge 16 blev 47 placebopatienter med < 10% forbedring fra udgangspunktet i både hævede og ømme led flyttet til infliximab induktion (tidlig overflytning).
English: • Severe allergic reactions (e.g. anaphylaxis), an immune system disorder called lupus, allergic reactions to foreign proteins
Danish: • Alvorlige allergiske reaktioner (f.eks. anafylaktisk shock), en sygdom i immunsystemet kaldet lupus, allergiske reaktioner over for fremmede proteiner
English: In psoriatic arthritis patients who received 5 mg/kg with and without methotrexate, antibodies occurred overall in 15% of patients (antibodies occurred in 4% of patients receiving methotrexate and in 26% of patients not receiving methotrexate at baseline).
Danish: Hos patienter med psoriasis arthritis, der modtog 5 mg/kg med og uden methotrexat, forekom der i alt antistoffer hos 15% af patienterne (der forekom antistoffer hos 4% af de patienter, der fik methotrexat og hos 26% af de patienter, der ikke fik methotrexat ved baseline).
English: Infliximab + AZA Combination therapy
Danish: Infliximab + AZA Kombinationsterapi
English: THE VIAL MUST NOT BE SHAKEN.
Danish: HÆTTEGLASSET MÅ IKKE RYSTES.
English: Of the infliximab-treated 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: 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 infliximab-gruppen 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: Of these patients, most were teenage boys or young men and most had either Crohn's disease or ulcerative colitis.
Danish: Ud af disse patienter var de fleste teenagedrenge eller unge mænd og de fleste havde enten Crohns sygdom eller colitis ulcerosa.
English: Inflectra should be visually inspected for particulate matter or discolouration prior to administration.
Danish: Inflectra bør undersøges visuelt for partikler eller misfarvning før indgivelsen.
English: 3 Number of patients evaluated for ALT. 4 Median follow-up is based on patients treated.
Danish: 4 Medianopfølgning er baseret på behandlede patienter.
English: • It is recommended that when Inflectra is prepared for infusion, it is used as soon as possible (within 3 hours).
Danish: • Det anbefales, at Inflectra anvendes så hurtigt som muligt (inden for 3 timer), efter den er klargjort til infusion.
English: At baseline 53% of patients were receiving immunomodulator therapy (6-MP, AZA and/or MTX) and 62% of patients were receiving corticosteroids.
Danish: Ved baseline fik 53% af patienterne immunmodulerende behandling (6-MP, AZA og/eller MTX), og 62% af patienterne fik kortikosteroider.
English: • Tell your doctor before you are given Inflectra if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common.
Danish: • Før du får Inflectra, skal du fortælle det til din læge, hvis du nogensinde har levet eller rejst i et område, hvor infektioner kaldet histoplasmose, kokcidioidomykose eller blastomykose er almindelige.
English: • Tell your doctor before you are given Inflectra if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
Danish: • Før du får Inflectra, skal du fortælle det til din læge, hvis du har eller nogensinde har haft lymfom (en type blodkræft) eller enhver anden form for kræft.
English: 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).
Danish: Selvom sammenlignende data 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.
English: In the re-treatment arm, 4% (8/219) of patients experienced a serious infusion reaction versus < 1% (1/222) on maintenance therapy.
Danish: I genbehandlingsarmen fik 4% (8/219) af patienterne en alvorlig infusionsrelateret reaktion sammenlignet med < 1% (1/222) på vedligeholdelsesbehandling.
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 steady-state medicinal product exposure in adults.
Danish: Efter administration af infliximab 5 mg/kg hver 8. uge var den forventede mediane steady-state infliximab-eksponering (arealet under koncentrationstids-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: Hypersensitivity to the active substance, to other murine proteins, or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof over for andre murine proteiner eller over for et eller flere af hjælpestofferne anført i pkt.
English: Placebo (Week 16)
Danish: Placebo (uge 16)
English: EXPRESS evaluated the efficacy of infliximab induction and maintenance therapy in 378 patients with plaque psoriasis.
Danish: EXPRESS vurderede virkningen af infliximab induktions- og vedligeholdelsesbehandling hos 378 patienter med plaque psoriasis.
English: Do not dilute the reconstituted Inflectra solution with any other diluent.
Danish: Fortynd ikke den rekonstituerede Inflectraopløsning med andre infusionsvæsker.
English: By week 26, twenty weeks after the last induction dose, 30% of patients in the 5 mg/kg group and 13.8% of patients in the 3 mg/kg group were PASI 75 responders.
Danish: I uge 26, tyve uger efter den sidste induktionsdosis, var 30% af patienterne i 5 mg/kg gruppen og 13,8% af patienterne i 3 mg/kg gruppen PASI 75 respondere.
English: At 102 weeks there were 80 subjects still on infliximab treatment and among those, 71 (89%) were ASAS 20 responders.
Danish: I 102. uge var 80 patienter stadig på infliximab-behandling og blandt disse var 71 (89%) ASAS 20 respondere.
English: • Melanoma (a type of skin cancer)
Danish: • Melanom (en type hudkræft).
English: Some patients who developed high titres of antibodies to infliximab had evidence of reduced efficacy.
Danish: Nogle patienter, der i høj grad udviklede antistoffer mod infliximab, havde tegn på nedsat virkning.
English: Ask your doctor to record the type and date of last screening(s) for tuberculosis (TB) below: Test
Danish: De skal bede din læge om at notere type og dato for seneste screening(er) for tuberkulose (TB) nedenfor:
English: If you forget or miss an appointment to receive Inflectra, make another appointment as soon as possible.
Danish: Hvis du har glemt eller kommer for sent til din Inflectra-infusion Hvis du glemmer eller kommer for sent til en aftale, hvor Inflectra gives, skal du lave en ny aftale så hurtigt som muligt.
English: Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFα but not to lymphotoxin α (TNFβ).
Danish: Infliximab er et kimærisk humant-murint monoklonalt antistof, der binder sig med høj affinitet til både opløselige og transmembrane former af TNFα, men ikke til lymphotoxin α (TNFß).
English: Corticosteroids do not appear to affect the pharmacokinetics of infliximab to a clinically relevant extent.
Danish: Kortikosteroider har tilsyneladende ingen klinisk relevant virkning på infliximabs farmakokinetik.
English: • Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Inflectra treatment.
Danish: • Patienter med KOL og patienter, som er storrygere, kan have en øget risiko for at udvikle kræft under behandling med Inflectra.
English: Pharmacotherapeutic group: immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB02.
Danish: Farmakoterapeutisk klassifikation: immunosuppressiva, tumornekrosefaktor-alfa (TNFα)-hæmmere, ATC-kode: L04AB02.
English: Infliximab prevented disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNFα and when administered after disease onset, it allowed eroded joints to heal.
Danish: Infliximab forebyggede sygdom hos transgene mus, der udvikler polyarthritis som resultat af konstitutiv ekspression af human TNFα, og fik ved administration efter sygdomsstart eroderede led til at heles.
English: scores were 4.6 and 4.3 in infliximab and placebo group.
Danish: NAPSI-score ved baseline var hhv. 4,6 og 4,3 i infliximab- og placebogruppen.
English: Warnings and precautions Talk to your doctor before or during treatment with Inflectra if you have:
Danish: Kontakt lægen, før eller under behandlingen med Inflectra, hvis du har:
English: The combination of infliximab with other biological therapeutics used to treat the same conditions as infliximab, including anakinra and abatacept, is not recommended (see section 4.4).
Danish: Kombination af infliximabog andre biologiske lægemidler anvendt til behandling af de samme lidelser som infliximab, herunder anakinra og abatacept, kan ikke anbefales (se pkt.
English: Cases of TB have been reported in patients treated with infliximab, even in patients who have already been treated with medicines for TB.
Danish: Tilfælde af TB har været rapporteret hos patienter i behandling med infliximab, og også hos patienter, som allerede har været i behandling med lægemidler for TB.
English: At 54 weeks, 44.9% of patients in the combined infliximab treatment group were in clinical response compared to 19.8% in the placebo treatment group (p<0.001).
Danish: Ved 54 uger var 44,9% af patienterne i den kombinerede infliximab-behandlingsgruppe i klinisk respons sammenlignet med 19,8% i placebobehandlingsgruppen (p < 0,001).
English: A total of 573 patients with moderately to severely active Crohn's disease (CDAI ≥ 220 ≤ 400) received a single infusion of 5 mg/kg at week 0.
Danish: I alt 573 patienter med moderat til svært aktiv Crohns sygdom (CDAI ≥ 220 ≤ 400) fik en enkelt infusionsdosis på 5 mg/kg ved uge 0.
English: However, if the solution is prepared in germ-free conditions, it can be stored in a refrigerator at 2 °C - 8 °C up to 28 days and for an additional 24 hours at 25 °C after removal from the refrigerator.
Danish: Hvis opløsningen er klargjort under aseptiske betingelser, kan den dog opbevares i køleskab ved 2°C - 8°C i op til 28 dage og i yderligere 24 timer ved 25°C efter udtagning fra køleskab.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with infliximab and is positive for antibodies against double-stranded DNA, further treatment with infliximab must not be given (see section 4.8).
Danish: Hvis en patient udvikler symptomer, der viser tegn på et lupus-lignende syndrom efter behandling med infliximab og er positiv over for antistoffer mod dobbeltstrenget DNA, må behandling med infliximab ikke fortsættes (se pkt.
English: • Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome and acute generalised exanthematous pustulosis
Danish: • Alvorlige hudproblemer såsom toksisk epidermal nekrolyse, Stevens-Johnsons syndrom og akut generaliseret eksantematøs pustulose
English: In this study 150 patients with NYHA Class III-IV CHF (left ventricular ejection fraction ≤ 35%) were treated with 3 infusions of infliximab 5 mg/kg, 10 mg/kg, or placebo over 6 weeks.
Danish: I dette studie blev 150 patienter med NYHA funktionsklasse III-IV CHF (venstre ventrikels uddrivningsfraktion ≤ 35%) behandlet med 3 infusioner infliximab 5 mg/kg, 10 mg/kg eller placebo i løbet af 6 uger.
English: Concurrent administration of TNF-alpha inhibitor and anakinra
Danish: Samtidig administration af TNF-alfahæmmer og anakinra
English: In a clinical study of patients with Crohn's disease (SONIC), infusion-related reactions occurred in 16.6% (27/163) of patients receiving infliximab monotherapy, 5% (9/179) of patients receiving infliximab in combination with AZA, and 5.6% (9/161) of patients receiving AZA monotherapy.
Danish: I et klinisk studie med patienter med Crohns sygdom (SONIC) forekom infusionsrelaterede reaktioner hos 16,6% (27/163) af de patienter, som fik infliximab monoterapi, hos 5% (9/179) af de patienter, som fik infliximab kombineret med AZA, og hos 5,6% (9/161) af de patienter, som fik AZA monoterapi.
English: Placebo (Week 24)
Danish: Placebo (uge 24)
English: Total peripheral white blood cell counts were minimally affected in infliximab-treated patients, although changes in lymphocytes, monocytes and neutrophils reflected shifts towards normal ranges.
Danish: Det totale perifere antal hvide blodlegemer blev kun påvirket i ubetydeligt omfang hos patienter behandlet med infliximab, omend ændringer i lymfocytter, monocytter og neutrofiler viste skift inden for normalområderne.
English: Patients with no deterioration/patients evaluated (%)
Danish: Median (Interkvartilt interval) Patienter uden forværring/patienter evalueret
English: Patients may be pre-treated with e.g. an antihistamine, hydrocortisone and/or paracetamol and infusion rate may be slowed in order to decrease the risk of infusion-related reactions especially if infusion-related reactions have occurred previously (see section 4.4).
Danish: Patienter kan præmedicineres med fx et antihistamin, hydrocortison og/eller paracetamol og infusionshastigheden reduceres for at nedsætte risikoen for infusionsrelaterede reaktioner, især hvis infusionsrelaterede reaktioner er set tidligere (se pkt.
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 placebopatienterne AZA 2,5 mg/kg/dag som aktiv kontrol i tillæg til placebo-infliximab-infusioner.
English: • You may get infections more easily when you are being treated with Inflectra.
Danish: • Du har lettere ved at få infektioner, når du er i behandling med Inflectra.
English: Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of > 5% include pneumocystosis, candidiasis, listeriosis and aspergillosis.
Danish: Nogle af disse infektioner har været letale; de opportunistiske infektioner, der oftest er set med en mortalitetsrate > 5%, indbefatter pneumocystose, candidiasis, listeriose og aspergillose.
English: Available data suggest an increased risk for delayed hypersensitivity with increasing infliximab-free interval.
Danish: Foreliggende data tyder på en øget risiko for forsinket overfølsomhed ved længerevarende infliximab-fri periode.
English: In rheumatoid arthritis patients who received the recommended repeated treatment dose regimens with methotrexate, 8% of patients developed antibodies to infliximab.
Danish: Hos patienter med reumatoid arthritis, der fik det anbefalede regimen med gentagne behandlingsdoser med methotrexat, udviklede 8% af patienterne antistoffer mod infliximab.
English: Patients should be closely monitored and infliximab 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 infliximab må ikke fortsættes hos patienter, som udvikler nye eller forværrede symptomer på hjerteinsufficiens (se pkt.
English: Please read the Inflectra ‘Package Leaflet' carefully before you start using this medicine.
Danish: Læs indlægssedlen for Inflectra grundigt, inden du begynder at tage medicinen.
English: Infections occurred in 68% (41/60) of children receiving 3 mg/kg over 52 weeks, 65% (37/57) of children receiving infliximab 6 mg/kg over 38 weeks and 47% (28/60) of children receiving placebo over 14 weeks (see section 4.4).
Danish: Der opstod infektioner hos 68% (41/60) af de børn, som fik 3 mg/kg over 52 uger, 65% (37/57) af de børn, som fik infliximab 6 mg/kg over 38 uger og 47% (28/60) af de børn, som fik placebo over 14 uger (se pkt.
English: Type 1 glass vial with a (butyl) rubber stopper and an aluminium seal with a flip-off button.
Danish: Hætteglas (type 1 glas) med en (butyl) gummiprop og en aluminiumsforsegling med en flip-off-knap.
English: At the last observation at 12 weeks, 13/27 (48%) of infliximab-treated patients were still responding.
Danish: Ved den sidste observation efter 12 uger sås stadig virkning hos 13/27 (48%) af patienterne behandlet med infliximab.
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Inflectra.
Danish: Hvis du er i tvivl, om noget af ovenstående gælder for dig, skal du kontakte lægen eller apotekspersonalet, før du bruger Inflectra.
English: Additionally, closure of all fistulae was achieved in 55% of infliximab-treated patients compared with 13% of placebo-treated patients (p=0.001).
Danish: Det lykkedes desuden at lukke alle fistler hos 55% af infliximabbehandlede patientersammenlignet med 13% af patienter behandlet med placebo (p = 0,001).