FrancophonIA/ELRC3.0 huggingface dataset:
English: • Signs of infection (including TB) such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection of pus in the gut or around the anus (abscess), dental problems or burning sensation when urinating.
Danish: • Tegn på infektion (inklusive tuberkulose (TB)) såsom feber, træthedsfølelse, hoste, der kan være vedvarende, åndenød, influenzalignende symptomer, vægttab, natlig svedtendens, diarré, sår, ansamling af pus i tarmen eller omkring anus (absces), tandproblemer eller brændende smerte, når du lader vandet.
English: Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF-blocking agents including infliximab.
Danish: Efter markedsføring har tilfælde af hepatosplenisk T-celle-lymfom (HSTCL) været rapporteret hos patienter behandlet med TNF-blokkere inklusive infliximab.
English: There have been reports of active tuberculosis in patients receiving Remicade.
Danish: Der er set tilfælde af aktiv tuberkulose hos patienter behandlet med Remicade.
English: Monobasic sodium phosphate Dibasic sodium phosphate
Danish: Natriumdihydrogenphosphat Dinatriumphosphatdihydrat
English: Immune system disorders Common: Allergic respiratory symptom.
Danish: Almindelig: Allergiske luftvejssymptomer.
English: Patients received placebo, 3 mg/kg or 10 mg/kg infliximab at weeks 0, 2 and 6, and then every 4 or 8 weeks thereafter.
Danish: Patienterne fik placebo, 3 mg/kg eller 10 mg/kg infliximab i ugerne 0, 2 og 6, samt hver 4. eller 8. uge herefter.
English: It is also recommended that live vaccines not be given to infants after in utero exposure to infliximab for at least 6 months following birth (see section 4.4).
Danish: Det frarådes også at give levende vacciner til spædbørn, der har været eksponeret for infliximab i uterus, i mindst 6 måneder efter fødslen (se pkt.
English: • Signs of low blood counts such as persistent fever, bleeding or bruising more easily, small red or purple spots caused by bleeding under the skin, or looking pale.
Danish: • Tegn på lave blodtal såsom vedvarende feber, blødningstendens, tendens til lettere at få blå mærker, små røde eller lilla pletter, der skyldes blødning under huden, eller bleghed.
English: In psoriasis patients treated with infliximab as a maintenance regimen in the absence of concomitant immunomodulators, approximately 28% developed antibodies to infliximab (see section 4.4: “Infusion reactions and hypersensitivity”).
Danish: Hos psoriasis patienter behandlet med infliximab som vedligeholdelsesbehandling uden samtidige immunmodulerende midler udviklede 28 % antistoffer mod infliximab (se pkt.
English: Some of the cases have resulted in a fatal outcome.
Danish: Nogle tilfælde har resulteret i et dødsfald.
English: After infliximab treatment, patients exhibited decreased levels of serum interleukin 6 (IL-6) and C-reactive protein (CRP), and increased haemoglobin levels in rheumatoid arthritis patients with reduced haemoglobin levels, compared with baseline.
Danish: Efter infliximabbehandling udviste patienter nedsat niveau af serum interleukin 6 (IL-6) og C-reaktiv protein (CRP).
English: • Blood problems such as anaemia or low white blood cell count
Danish: • Blodproblemer såsom blodmangel eller lavt antal hvide blodlegemer
English: • Maintenance: Additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or
Danish: • Vedligeholdelsesbehandling: Yderligere infusionsdosis på 5 mg/kg 6 uger efter den første dosis, efterfulgt af infusionsdoser hver 8. uge eller
English: If a patient shows no response after 14 weeks (i.e. after 4 doses), no additional treatment with infliximab should be given.
Danish: Hvis en patient ikke viser respons efter 14 uger (det vil sige efter 4 doser), bør der ikke gives yderligere behandling med infliximab.
English: Signs include persistent fever, bleeding or bruising more easily, small red or purple spots caused by bleeding under the skin, or looking pale.
Danish: Tegn omfatter vedvarende feber, større tendens til blødning eller blå mærker, små røde eller lilla pletter, der skyldes blødning under huden, eller bleghed.
English: Signs include persistent cough, weight loss, feeling tired, fever, night sweats.
Danish: Tegn inkluderer vedvarende hoste, vægttab, træthedsfølelse, feber eller natlig svedtendens.
English: At week 8, 45 patients were randomised and received 5 mg/kg infliximab at either q8 weeks or q12 weeks as a maintenance treatment regimen.
Danish: Ved uge 8 blev 45 patienter randomiseret og fik 5 mg/kg infliximab enten hver 8. eller hver 12. uge som et vedligholdelsesregime.
English: What Remicade looks like and contents of the pack Remicade is supplied as a glass vial containing a powder for concentrate for solution for infusion.
Danish: Remicade leveres som et hætteglas (glasflaske) indeholdende et pulver til koncentrat til infusionsvæske, opløsning.
English: • The medicine will be given as an infusion (drip) (over 2 hours) into one of your veins, usually in your arm. After the third treatment, your doctor may decide to give your dose of Remicade over 1 hour.
Danish: • Medicinen vil blive givet som en infusion (drop) (over 2 timer) i en af dine blodårer (vener),
English: The safety and efficacy of Remicade have not been studied in children with ulcerative colitis below the age of 6 years.
Danish: Remicades sikkerhed og virkning hos børn under 6 år med colitis ulcerosa er ikke klarlagt.
English: • Signs of a heart problem such as chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea (feeling sick), vomiting, fluttering or pounding in your chest, a fast or a slow heartbeat, and swelling of your feet.
Danish: • Tegn på hjerteproblemer såsom ubehag i brystkassen eller brystsmerter, armsmerter, mavesmerter, åndenød, angst, ørhed, svimmelhed, besvimelse, svedtendens, kvalme (utilpashed), opkastning, skælven eller banken i brystet, hurtigt eller langsomt hjerteslag og hævede fødder.
English: Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study (SONIC) of 508 adult patients with moderate to severe Crohn's disease (CDAI ≥ 220 ≤ 450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Danish: Infliximab med eller uden AZA blev vurderet i et randomiseret, dobbeltblind studie med aktiv komparator (SONIC) hos 508 voksne patienter med moderat til svær Crohns sygdom (CDAI ≥ 220 ≤ 450).
English: Thirty two (32) evaluable paediatric patients crossed over (9 subjects in the q8 weeks and 23 subjects in the q12 weeks maintenance groups).
Danish: Hos32 evaluérbare patienter blev doseringen ændret (9 personer i 8. ugers gruppen og 23 i 12. ugers gruppen).
English: Cases of transient visual loss occurring during or within 2 hours of Remicade infusion have been reported.
Danish: Der er set tilfælde af kortvarigt synstab under infusion eller inden for 2 timer efter infusion af Remicade.
English: In group 2, starting with the week 36 infusion, patients who had a BASDAI ≥ 3 at 2 consecutive visits, received 7.5 mg/kg infliximab every 6 weeks thereafter through week 96.
Danish: Patienter i gruppe 2, som havde en BASDAI ≥ 3 ved 2 på hinanden følgende konsultationer, fik 7,5 mg/kg infliximab hver 6. uge startende med uge 36 og frem til uge 96.
English: Caution should be exercised in considering treatment of patients with increased risk for malignancy due to heavy smoking.
Danish: Forsigtighed bør udvises hos patienter med øget risiko for maligne sygdomme på grund af kraftig rygning, når TNF-blokerende behandling overvejes.
English: Uncommon: Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia.
Danish: Ikke almindelig: Hjerteinsufficiens (debuterende eller forværret), arytmi, besvimelse, bradykardi.
English: Remicade and Kineret should not be used together.
Danish: Du må ikke få Remicade og Kineret samtidig.
English: Common: Vertigo, dizziness, hypoaesthesia, paraesthesia.
Danish: Almindelig: Vertigo, svimmelhed, hypæstesi, paræstesi.
English: If you have ankylosing spondylitis you will first be given other medicines.
Danish: Hvis du lider af ankyloserende spondylitis, vil du først få andre lægemidler.
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions.
Danish: Hvis infusionsvæsken ikke anvendes straks, er opbevaringstider og -forhold efter anbrud indtil anvendelse brugerens ansvar, og de vil normalt ikke overskride 24 timer ved 2 °C - 8 °C, medmindre rekonstitution/fortynding har fundet sted under kontrollerede og validerede aseptiske forhold.
English: Remicade may be stored at temperatures up to a maximum of 25 °C for a single period of up to 6 months, but not exceeding the original expiry date.
Danish: Remicade kan opbevares ved temperaturer på op til højst 25°C i en enkelt periode på op til 6 måneder, men den oprindelige udløbsdato må ikke overskrides.
English: Infliximab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment at the week 24 primary endpoint as measured by change from baseline in total modified vdH-S score (mean ± SD score was 0.82 ± 2.62 in the placebo group compared with -0.70 ± 2.53 in the infliximab group; p < 0.001).
Danish: Endepunkt blev målt ved ændring fra baseline i samlet modificeret vdH-S score (middel ± SD score var 0,82 ± 2,62 i placebogruppen sammenlignet med -0,70 ± 2,53 i infliximab-gruppen; p < 0,001).
English: Carriers of HBV who require treatment with Remicade should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Danish: Hos patienter med positiv test for HBV-infektion, anbefales det at rådføre sig med en læge med erfaring i behandling af hepatitis B. Bærere af HBV, hvor behandling med Remicade er nødvendig, skal følges nøje under behandlingen og i adskillige måneder efter afslutning af behandlingen for at registere tegn og symptomer på aktiv HBV-infektion.
English: Infliximab Monotherapy
Danish: Infliximab Monoterapi
English: • Signs of a lung problem such as coughing, breathing difficulties or tightness in the chest.
Danish: • Tegn på lungeproblemer såsom hoste, åndedrætsbesvær eller trykken for brystet.
English: No rebound was observed.
Danish: Ingen rebound sås.
English: • Re-administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur (see
Danish: • Fornyet indgift: Doser på 5 mg/kg, hvis sygdomstegn og symptomer på sygdommen kommer igen (se ‘Fornyet indgift' nedenfor samt pkt.
English: During the 24-week double-blind phase, patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6, 14, and 22 (100 patients in each group).
Danish: Under den 24 uger dobbeltblinde fase modtog patienterne enten 5 mg/kg infliximab eller placebo i ugerne 0, 2, 6, 14 og 22 (100 patienter i hver gruppe).
English: Excipients: sucrose, polysorbate 80, monobasic sodium phosphate and dibasic sodium phosphate.
Danish: Hjælpestoffer: Saccharose, polysorbat 80, natriumdihydrogenphosphat og dinatriumphosphatdihydrat.
English: Paediatric patients on infliximab may receive concurrent vaccinations, except for live vaccines (see sections 4.5 and 4.6).
Danish: Pædiatriske patienter, der får infliximab, kan få vaccinationer samtidigt, med undtagelse af levende vacciner (se pkt.
English: The proportion of subjects achieving clinical remission at week 10 was 58.9% (66/112).
Danish: Andelen af personer med klinisk respons i uge 10 var 88,4 % (99/112), og andelen af personer, som opnåede klinisk remission i uge 10, var 58,9 % (66/112).
English: Continued therapy with a shortened interval should be carefully considered in those patients who show no evidence of additional therapeutic benefit after a change in dosing interval.
Danish: Fortsat behandling med forkortet interval bør overvejes grundigt hos patienter, som ikke viser tegn på øget terapeutisk fordel efter ændring af doseringsintervallet.
English: Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit after dose adjustment.
Danish: Fortsat behandling bør nøje genovervejes hos patienter, der ikke viser tegn på terapeutisk fordel efter dosisjustering.
English: • adult patients with active disease when the response to disease-modifying antirheumatic drugs
Danish: • voksne patienter med aktiv sygdom, når responset til sygdomsmodulerende antireumatiske lægemidler (DMARDs), inklusive methotrexat, har været utilstrækkeligt.
English: Do not use if opaque particles, discolouration, or other foreign particles are present.
Danish: Koncentratet må ikke anvendes, hvis det indeholder uigennemsigtige partikler, er misfarvet eller indeholder andre fremmedlegemer.
English: For more information about the safety of Remicade in elderly patients (see sections 4.4 and 4.8).
Danish: 4.4 og 4.8 for mere information omkring sikkerhed ved brug af Remicade hos ældre patienter.
English: Common: Lower respiratory tract infection (e.g. bronchitis, pneumonia), dyspnoea, epistaxis.
Danish: Almindelig: Nedre luftvejsinfektion (fx bronchitis, pneumoni), dyspnø, næseblod.
English: • Swelling of small blood vessels (vasculitis)
Danish: • Hævelse af små blodkar (blodkarbetændelse)
English: • Kidney infections
Danish: • Nyreinfektioner
English: Remicade 100 mg powder for concentrate for solution for infusion infliximab
Danish: Remicade 100 mg pulver til koncentrat til infusionsvæske, opløsning infliximab
English: • Fungal infections such as yeast infection or fungal infection of the nails
Danish: • Svampeinfektioner såsom gærsvampeinfektion eller svampeinfektion i neglene
English: Psoriatic arthritis
Danish: Psoriasis arthritis
English: Uncommon: Peripheral ischaemia, thrombophlebitis, haematoma.
Danish: Ikke almindelig: Perifer iskæmi, tromboflebitis, hæmatom.
English: During the 16-week double-blind phase, patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6, and 14 (52 patients in each group).
Danish: Under den 16 uger lange dobbeltblinde fase fik patienterne enten 5 mg/kg infliximab eller placebo i uge 0, 2, 6 og 14 (52 patienter i hver gruppe).
English: • Rheumatoid arthritis
Danish: • Reumatoid arthritis
English: It is recommended that live vaccines not be given concurrently with Remicade.
Danish: Levende vacciner bør ikke gives samtidig med Remicade.
English: Adult psoriasis
Danish: Psoriasis hos voksne
English: In clinical studies, delayed hypersensitivity reactions have been uncommon and have occurred after Remicade-free intervals of less than 1 year (see sections 4.4 and 4.8).
Danish: I kliniske studier har forsinkede overfølsomhedsreaktioner været usædvanlige og er forekommet efter Remicade-fri perioder på mindre end 1 år (se pkt.
English: Patients received either 3 or 5 mg/kg infliximab or placebo infusions at weeks 0, 2 and 6.
Danish: Patienterne fik enten 3 eller, 5 mg/kg infliximab eller placeboinfusioner i uge 0, 2 og 6.
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions, (see section 6.3 above).
Danish: Hvis infusionsvæsken ikke anvendes straks, er opbevaringstider og -forhold efter anbrud indtil anvendelse brugerens ansvar, og de vil normalt ikke overskride 24 timer ved 2°C til 8°C, medmindre rekonstitution/fortynding har fundet sted under kontrollerede og validerede aseptiske forhold (se pkt.
English: • Upper respiratory infections such as sinusitis
Danish: • Øvre luftvejsinfektioner såsom bihulebetændelse
English: If a patient does not respond after 3 doses, no additional treatment with infliximab should be given.
Danish: Hvis en patient ikke responderer efter 3 doser, bør der ikke gives yderligere behandling med infliximab.
English: What Remicade contains
Danish: Remicade indeholder
English: Patients randomised 52
Danish: Randomiserede patienter
English: Remicade 100 mg powder for concentrate for solution for infusion.
Danish: Remicade 100 mg pulver til koncentrat til infusionsvæske, opløsning.
English: If you have ulcerative colitis you will first be given other medicines.
Danish: Hvis du lider af colitis ulcerosa, vil du først få andre lægemidler.
English: All patients received an induction regimen of 5 mg/kg infliximab at weeks 0, 2, and 6.
Danish: Alle patienter fik induktionsbehandling med 5 mg/kg infliximab i uge 0, 2, og 6.
English: Adult Crohn's disease
Danish: Crohns sygdom, voksne
English: Signs include a fever, feeling tired, (persistent) cough, shortness of breath, weight loss, night sweats, diarrhea, wounds, dental problems, burning when urinating or ‘flu-like' signs.
Danish: Tegn inkluderer feber, træthedsfølelse, (vedvarende) hoste, åndenød, vægttab, natlig svedtendens, diarré, sår, tandproblemer, en brændende smerte, når du lader vandet, eller influenzalignende symptomer.
English: Patients on infliximab may receive concurrent vaccinations, except for live vaccines (see sections 4.5 and 4.6).
Danish: Patienter, der får infliximab, kan få vaccinationer samtidigt, med undtagelse af levende vacciner (se pkt.
English: Uncommon: Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis.
Danish: Ikke almindelig: Tarmperforation, tarmstenose, diverticulitis, pancreatitis, keilitis.
English: Uncommon: Impaired healing.
Danish: Ikke almindelig: Forringet heling.
English: Fistulising Crohn's disease
Danish: Fistulerende Crohns sygdom
English: Juvenile rheumatoid arthritis
Danish: Juvenil reumatoid arthritis
English: How to store Remicade
Danish: Sådan får du Remicade
English: • Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease,
Danish: • Alvorlige lidelser i nervesystemet såsom transversal myelitis, multipel sklerose-lignende sygdom, optisk neuritis og Guillain-Barrés syndrom
English: In patients who develop HBV reactivation, Remicade should be stopped and effective antiviral therapy with appropriate supportive treatment should be initiated.
Danish: Der er ikke tilgængelige data om antiviral behandling profylaktisk mod HBV-reaktivering i forbindelse med TNF-antagonist-behandling hos patienter, som er bærere af HBV. Remicade bør seponeres hos patienter, hvor HBV reaktiveres, og effektiv antiviral behandling med passende understøttende behandling bør igangsættes.
English: Immune system disorder
Danish: Sygdomme i immunsystemet
English: Can be stored at room temperature (up to 25 °C) for a single period up to 6 months, but not exceeding the original expiry date.
Danish: Kan opbevares ved temperaturer på op til højst 25 °C i en enkelt periode på op til 6 måneder, men den oprindelige udløbsdato må ikke overskrides.
English: If you have active psoriatic arthritis you will first be given other medicines.
Danish: Hvis du har aktiv psoriasisarthritis, vil du først få andre lægemidler.
English: • Fast heart beat (tachycardia) or palpitations
Danish: • Galoperende hjerte (hurtig puls) eller hjertebanken
English: Administration of live vaccines (e.g. BCG vaccine) to infants exposed to infliximab in utero is not recommended for at least 6 months after birth (see sections 4.4 and 4.5).
Danish: Det anbefales ikke at give levende vacciner (fx BCG-vaccine) til spædbørn, eksponeret for infliximab i uterus, i mindst 6 måneder efter fødslen (se pkt.
English: If a patient does not respond by 6 weeks (i.e. after 2 doses), no additional treatment with infliximab should be given.
Danish: Hvis en patient ikke responderer ved uge 6 (det vil sige efter 2 doser), bør der ikke gives yderligere behandling med infliximab.
English: Dizziness may occur following administration of Remicade (see section 4.8).
Danish: Der kan opstå svimmelhed under behandling med Remicade (se pkt.
English: 5 mg/kg given as an intravenous infusion followed by an additional 5 mg/kg infusion 2 weeks after the first infusion.
Danish: 5 mg/kg indgivet som en intravenøs infusion efterfulgt af en yderligere 5 mg/kg infusion 2 uger efter den første infusion.
English: Rheumatoid arthritis
Danish: Reumatoid arthritis
English: Common: Neutropenia, leucopenia, anaemia, lymphadenopathy.
Danish: Almindelig: Neutropeni, leukopeni, anæmi, lymfadenopati.
English: Nervous system disorders Very common: Headache.
Danish: Meget almindelig: Hovedpine.
English: Infliximab (week 16)
Danish: Infliximab (uge 16)
English: CDAI < 150 at both week 30 and 54 and not receiving corticosteroids in the 3 months prior to week 54 among patients who were receiving corticosteroids at baseline.
Danish: De patienter, der fik kortikosteroider ved baseline, fik ikke kortikosteroider i de 3 måneder forud for uge 54.
English: Tell your doctor straight away if you get signs of TB during treatment with Remicade.
Danish: Fortæl straks din læge, hvis du får tegn på TB under behandlingen med Remicade.
English: Tell your doctor straight away if you get symptoms of low blood counts during treatment with Remicade.
Danish: Fortæl det straks til lægen, hvis du får symptomer på lave blodtal under behandlingen med Remicade.
English: Juvenile rheumatoid arthritis patients
Danish: Patienter med juvenil reumatoid arthritis
English: Tell your doctor straight away if you get signs of infection during treatment with Remicade.
Danish: Fortæl straks din læge, hvis du får tegn på infektion under behandling med Remicade.
English: Infliximab (week 98)
Danish: Infliximab (uge 98)
English: (n = 110)
Danish: Placebovedligeholdelse (n = 110)
English: Psoriatic arthritis Plaque psoriasis
Danish: Psoriasis arthritis Psoriasis
English: Infliximab (week 54)
Danish: Infliximab (uge 54)
English: Other medicines and Remicade
Danish: Brug af anden medicin sammen med Remicade
English: Infliximab (week 24)
Danish: Infliximab (uge 24)
English: Overall, 8 (13.3%) of 60 treated patients experienced one or more infusion reactions, with 4 of 22 (18.2%) in the q8 week and 3 of 23 (13.0%) in the q12 week treatment maintenance group.
Danish: Det drejede sig om 4 ud af 22 (18,2 %) i 8-ugers vedligeholdelsesbehandlingsgruppen og 3 ud af 23 (13,0 %) i 12ugers vedligeholdelsesbehandlingsgruppen.
English: Tell your doctor if you are using or have recently used any other medicines, including any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis or medicines obtained without a prescription, such as vitamins and herbal medicines.
Danish: Dette gælder også medicin til behandling af Crohns sygdom, colitis ulcerosa, reumatoid arthritis, ankyloserende spondylitis, psoriasisarthritis eller psoriasis eller medicin, som ikke er købt på recept, fx naturlægemidler og vitaminer og mineraler.
English: Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Remicade.
Danish: Fortæl straks din læge, hvis du får symptomer på en nervesygdom under behandlingen med Remicade.
English: Cases of malignancies, including lymphoma, have also been reported in the post-marketing setting (see section 4.4).
Danish: Efter markedsføring er der også set tilfælde af maligne sygdomme, herunder lymfomer (se pkt.
English: Patients treated with Remicade should be given the patient reminder card.
Danish: Patientinformationskortet skal udleveres til patienter, som er i behandling med Remicade.
English: After reconstitution each ml contains 10 mg of infliximab.
Danish: Efter rekonstitution indeholder hver ml 10 mg infliximab.
English: Ulcerative colitis Paediatric Ulcerative colitis
Danish: Colitis ulcerosa Colitis ulcerosa (børn)
English: The safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established (see sections 4.4 and 4.8).
Danish: Fornyet indgift ved ankyloserende spondylitis Sikkerhed og effekt ved fornyet indgift, udover hver 6. til 8. uge, er ikke vist (se pkt.
English: Adult psoriatic arthritis
Danish: Psoriasis arthritis hos voksne