FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects reported with Xeljanz are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Xeljanz vurderes omhyggeligt, og der tages om nødvendigt forholdsregler for at beskytte patienterne.
English: By blocking the enzymes' action, tofacitinib helps reduce the inflammation and other symptoms of these diseases.
Danish: Ved at blokere enzymerne mindsker tofacitinib inflammationen og andre symptomer ved disse sygdomme.
English: The fact that Xeljanz is taken by mouth may be an advantage compared with existing medicines taken as an injection under the skin.
Danish: Xeljanz tages gennem munden, og det kan være en fordel sammenholdt med eksisterende lægemidler, der injiceres under huden.
English: Xeljanz must not be used in patients with active tuberculosis, serious infections or any opportunistic infection.
Danish: Xeljanz må ikke anvendes hos patienter med aktiv tuberkulose, alvorlige infektioner eller opportunistisk infektion.
English: An overview of Xeljanz and why it is authorised in the EU
Danish: En oversigt over Xeljanz, og hvorfor det er godkendt i EU
English: The dose may also be lowered in some patients with reduced kidney or liver function.
Danish: Dosen kan sænkes hos patienter med nedsat nyre- eller leverfunktion.
English: For the treatment of ulcerative colitis, the recommended dose is 10 mg twice a day for the first 8 weeks and then 5 mg twice a day.
Danish: Til behandling af colitis ulcerosa er den anbefalede dosis 10 mg to gange dagligt i de første 8 uger og derefter 5 mg to gange dagligt.
English: Why is Xeljanz authorised in the EU?
Danish: Hvorfor blev Xeljanz godkendt i EU?
English: Additionally, more patients treated with Xeljanz were able to reduce their use of corticosteroid medicines.
Danish: Desuden var der flere Xeljanz-behandlede patienter, der kunne reducere deres forbrug af kortikosteroider.
English: What is Xeljanz and what is it used for?
Danish: Hvad er Xeljanz, og hvad anvendes det til?
English: Xeljanz can only be obtained with a prescription, and treatment should be started and supervised by a specialist doctor experienced in treating the relevant condition.
Danish: Xeljanz udleveres kun efter recept, og behandlingen skal iværksættes og overvåges af en speciallæge med erfaring i behandling af den pågældende sygdom.
English: The active substance in Xeljanz, tofacitinib, works by blocking the action of enzymes known as Janus kinases.
Danish: Det aktive stof i Xeljanz, tofacitinib, virker ved at blokere virkningen af nogle enzymer, der kaldes Janus-kinaser.
English: Xeljanz must also not be used in patients with severely reduced liver function or in pregnant and breastfeeding women.
Danish: Xeljanz må heller ikke anvendes hos patienter med svært nedsat leverfunktion eller hos gravide eller ammende kvinder.
English: These enzymes play an important role in the process of inflammation that occur in rheumatoid and psoriatic arthritis, and ulcerative colitis.
Danish: Disse enzymer spiller en vigtig rolle i den inflammationsproces, der finder sted ved leddegigt, psoriasisgigt og colitis ulcerosa.
English: Xeljanz is used together with methotrexate after treatment with one or more medicines known as disease-modifying anti-rheumatic drugs (DMARDs) has not worked well enough or has led to troublesome side effects.
Danish: Xeljanz anvendes sammen med metotrexat, når behandling med et eller flere lægemidler, der kaldes sygdomsmodificerende antireumatiske lægemidler (DMARD'er), ikke har virket tilstrækkeligt eller har medført uacceptable bivirkninger.
English: For the treatment of rheumatoid arthritis and psoriatic arthritis, the recommended dose is 5 mg taken twice a day.
Danish: Til behandling af leddegigt og psoriasisgigt er den anbefalede dosis 5 mg to gange dagligt.
English: The first study compared Xeljanz with adalimumab (an injected medicine for psoriatic arthritis) and placebo in 422 patients.
Danish: Det første studie sammenlignede Xeljanz med adalimumab (et lægemiddel mod psoriasisgigt, der indgives som injektion) og placebo hos 422 patienter.
English: What are the risks associated with Xeljanz?
Danish: Hvilke risici er der forbundet med Xeljanz?
English: Several studies have shown that Xeljanz is effective at treating rheumatoid arthritis, psoriatic arthritis and ulcerative colitis in patients who had previously tried other treatments.
Danish: Flere studier har vist, at Xeljanz er effektivt til behandling af leddegigt, psoriasisgigt og colitis ulcerosa hos patienter, der tidligere har prøvet andre lægemidler.
English: The most common serious side effects seen with Xeljanz are serious infections such as pneumonia (infection of the lungs), cellulitis (infection of the deep skin tissue), herpes zoster (shingles), urinary tract infection, diverticulitis (infection affecting the intestines) and appendicitis (infection of the appendix) as well as opportunistic infections that can occur in patients with weakened immune systems.
Danish: De hyppigste alvorlige bivirkninger ved Xeljanz er alvorlige infektioner som f.eks. lungebetændelse, cellulitis (bindevævsbetændelse), herpes zoster (helvedesild), urinvejsinfektion, diverticulitis (betændelse i tarmene) og blindtarmsbetændelse samt opportunistiske infektioner, der kan forekomme hos patienter med et svækket immunforsvar.
English: Rheumatoid arthritis
Danish: Leddegigt (reumatoid artritis)
English: The most common side effects with Xeljanz (seen in between 1 and 10 patients in 100) are headache, infection and inflammation of the nose and throat, diarrhoea, nausea (feeling sick), joint pain and hypertension (high blood pressure).
Danish: De hyppigste bivirkninger ved Xeljanz (der kan forekomme hos mellem 1 og 10 ud af 100 patienter) er hovedpine, infektion og betændelse i næse og svælg, diarré, kvalme, ledsmerter og forhøjet blodtryk.
English: Similarly, in the second study Xeljanz was more effective than placebo at improving symptoms (50% of Xeljanz-treated patients versus 24% of those given placebo) and ability to perform everyday activities.
Danish: Tilsvarende sås i det andet studie, at Xeljanz var mere effektivt end placebo til at afhjælpe symptomerne (der sås bedring hos 50 % af de patienter, der fik Xeljanz, sammenholdt med 24 % af de patienter, der fik placebo) og til at bedre evnen til at klare hverdagens gøremål.
English: In patients with rheumatoid arthritis, Xeljanz can also be taken alone by patients who cannot take or are intolerant to methotrexate.
Danish: Xeljanz kan også tages alene af patienter med leddegigt, der ikke kan tåle metotrexat.
English: Xeljanz is a medicine for treating adults with moderate to severe rheumatoid arthritis, a disease that causes inflammation of the joints, and psoriatic arthritis (red, scaly patches on the skin with inflammation of the joints).
Danish: Xeljanz er et lægemiddel til behandling af voksne med moderat til svær leddegigt (inflammation i leddene) og voksne med psoriasisgigt (røde, skællende pletter på huden og inflammation i leddene).
English: Xeljanz is also used to treat adults with moderate to severe ulcerative colitis, a disease causing inflammation and ulcers in the lining of the gut, after treatment with other medicines has not worked well, has stopped working or has led to troublesome side effects.
Danish: Xeljanz anvendes også til behandling af voksne med moderat til svær colitis ulcerosa (inflammation og sår i tarmslimhinden), når behandling med andre lægemidler har haft utilstrækkelig effekt, er holdt op med at virke eller har givet uacceptable bivirkninger.
English: In one of the studies, where Xeljanz was taken alone, Xeljanz was more effective than methotrexate at slowing down joint damage and reducing symptoms.
Danish: I et af studierne, hvor Xeljanz blev taget alene, var Xeljanz mere effektivt end metotrexat til at forsinke ledbeskadigelse og reducere symptomerne.
English: Six studies in over 4,200 patients with rheumatoid arthritis have shown that Xeljanz is effective at reducing joint pain and swelling, improving joint movement and slowing down joint damage.
Danish: Det er i 6 studier med over 4.200 patienter med leddegigt påvist, at Xeljanz reducerer smerter og hævelser i leddene, forbedrer leddenes bevægelighed og forsinker ledbeskadigelse.
English: In another study, Xeljanz taken alone was more effective than placebo (a dummy treatment) at reducing symptoms, such as pain and swelling.
Danish: I et andet studie var Xeljanz taget alene mere effektivt end placebo (ikke-aktivt stof) til at reducere symptomer som f.eks. smerter og hævelse.
English: How is Xeljanz used?
Danish: Hvordan anvendes Xeljanz?
English: In the first study in 614 patients with ulcerative colitis, 18% of patients treated with Xeljanz 10 mg twice a day had mild or no symptoms after 8 weeks of treatment compared with 8% of patients who received placebo.
Danish: I det første studie, der omfattede 614 patienter med colitis ulcerosa, havde 18 % af de patienter, der fik Xeljanz 10 mg to gange dagligt, milde eller ingen symptomer efter 8 ugers behandling, sammenholdt med 8 % af de patienter, der fik placebo.
English: In a third study with 593 patients, 34% of patients treated with Xeljanz 5 mg twice a day had mild or no symptoms after a year of treatment compared with 11% of patients receiving placebo.
Danish: I det tredje studie, der omfattede 593 patienter, havde 34 % af de patienter, der fik Xeljanz 5 mg to gange dagligt, milde eller ingen symptomer efter et års behandling, sammenholdt med 11 % af de patienter, der fik placebo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xeljanz have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Xeljanz.
English: What benefits of Xeljanz have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Xeljanz?
English: Xeljanz was more effective than placebo at reducing the symptoms of ulcerative colitis in three main studies.
Danish: I 3 hovedstudier var Xeljanz mere effektivt end placebo til at reducere symptomerne ved colitis ulcerosa.
English: How does Xeljanz work?
Danish: Hvordan virker Xeljanz?
English: Similarly, in a second study with 547 patients, after 8 weeks of treatment 17% of patients treated with Xeljanz had mild or no symptoms compared with 4% of placebo-treated patients.
Danish: Tilsvarende sås i det andet studie, der omfattede 547 patienter, at 17 % af de patienter, der fik Xeljanz, havde milde eller ingen symptomer efter 8 ugers behandling, sammenholdt med 4 % af de patienter, der fik placebo.
English: In the first study symptoms improved substantially in 50 and 52% respectively of patients taking Xeljanz and adalimumab for 3 months, compared with 33% of those receiving placebo; patients given Xeljanz or adalimumab also showed a greater improvement in their ability to perform everyday activities.
Danish: I det første studie bedredes symptomerne markant hos hhv. 50 % og 52 % af de patienter, der fik Xeljanz og adalimumab i 3 måneder; til sammenligning sås en bedring hos 33 % af de patienter, der fik placebo.
English: Xeljanz, in combination with methotrexate, was shown to be effective at improving symptoms of psoriatic arthritis in 3 main studies.
Danish: Det blev i 3 hovedstudier påvist, at Xeljanz i kombination med metotrexat er effektivt til at afhjælpe symptomerne på psoriasisgigt.
English: It is not known whether they respond differently from younger subjects.
Danish: Det vides ikke, om de reagerer anderledes end yngre personer
English: Date of first authorisation: 11 May 2016
Danish: Dato for første markedsføringstilladelse: 11 maj 2016
English: Please contact your doctor immediately:
Danish: Kontakt straks lægen:
English: (initial level)
Danish: (startniveau)
English: The required dose is determined using the following formulae:
Danish: Den nødvendige dosis bestemmes ved hjælp af følgende formel:
English: This can be done either by leaving the vials at room temperature for about an hour, or by holding them in your hands for a few minutes.
Danish: Dette kan enten gøres ved at lade hætteglassene stå i stuetemperatur i en times tid eller ved at holde dem i hænderne i nogle få minutter.
English: 50 - 80 (initial level)
Danish: 50-80 (startniveau)
English: Let blood flow back to the end of the tube.
Danish: Lad blod flyde tilbage til enden af røret.
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af shock skal standardbehandling af shock iværksættes.
English: In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
Danish: I visse tilfælde, især hos yngre patienter, kan kortere doseringsinterval eller højere doser være nødvendigt.
English: IDELVION can be used for all age groups.
Danish: IDELVION kan bruges til alle aldersgrupper.
English: In each of these situations, the benefit of treatment with IDELVION should be weighed against the risk of these complications.
Danish: I hvert enkelt tilfælde skal fordelen ved behandling med IDELVION vejes op imod risikoen for disse komplikationer.
English: • Do not use this medicine after the expiry date, which is stated on the label and carton.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og kartonen.
English: Your doctor will calculate the dose of IDELVION you need.
Danish: Din læge vil beregne, hvilken dosis af IDELVION du har brug for.
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Danish: ABR er ikke sammenlignelig mellem forskellige faktorkoncentrater og mellem forskellige kliniske studier.
English: The product contains traces of hamster proteins (see also “Do not use IDELVION”).
Danish: Præparatet indeholder spor af hamsterproteiner (se også afsnittet "Brug ikke IDELVION").
English: Therefore, factor IX should be used during pregnancy and lactation only if clearly indicated.
Danish: Faktor IX bør derfor kun anvendes under graviditet og amning, hvis det er klart indiceret.
English: After reconstitution the chemical and physical in-use stability has been demonstrated for 8 hours at 2-25 °C).
Danish: Efter rekonstitution er der påvist kemisk og fysisk i-brug-stabilitet på 8 timer ved 2-25 °C.
English: All 85 bleeding episodes were successfully treated with 1 or 2 doses of IDELVION.
Danish: Alle 85 blødningsepisoder blev behandlet med succes med 1 eller 2 doser IDELVION.
English: • if you notice that the medicine stops working properly
Danish: • hvis du opdager, at lægemidlet er holdt op med at virke korrekt
English: Your doctor should inform you of the early signs of hypersensitivity reactions.
Danish: Din læge vil oplyse dig om de tidlige tegn på overfølsomhedsreaktioner.
English: ATC code: B02BD04
Danish: ATC-kode B02BD04
English: Patients ≥ 12 years of age
Danish: Patienter ≥ 12 år
English: Osmolality:
Danish: Osmolalitet:
English: • if you notice symptoms of allergic reactions (see below)
Danish: • hvis du får symptomer på en allergisk reaktion (se nedenfor)
English: The safety and efficacy in the perioperative setting was evaluated in two pivotal Phase 3 studies (Study 3001 and 3002) and the on-going Phase 3 safety extension study (Study 3003).
Danish: Sikkerheden og virkningen ved perioperativ brug er blevet evalueret i to pivotale fase 3-studier (studie 3001 og 3002) og i det igangværende sikkerhedsrelaterede fase 3-forlængelsesstudie (studie 3003).
English: Elimination t1/2 (h)
Danish: Elimination t1/2 (t)
English: Frequencies have been evaluated according to the following convention: 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: Hyppigheden er vurderet i henhold til følgende konvention: meget almindelig (≥1/10), almindelig (≥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: • IDELVION must not be mixed with other medicines or solvents except those mentioned in section 6.
Danish: • IDELVION må ikke blandes med andre lægemidler eller opløsningsmidler end dem, der er nævnt i punkt 6.
English: Single dose should be sufficient for majority of bleeds.
Danish: En enkelt dosis bør være tilstrækkelig ved de fleste blødninger.
English: Albumin is a natural, inert carrier protein in plasma with a half-life of approximately 20 days.
Danish: Albumin er et naturligt, inert transportprotein i plasma med en halveringstid på cirka 20 dage.
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Der skal tages højde for dette hos patienter på natriumkontrolleret diæt.
English: Frequency of doses (hours) / Duration of therapy (days)
Danish: Doseringsfrekvens (timer)/ behandlingsvarighed (dage)
English: There is no information on the effects of factor IX on fertility.
Danish: Der findes ingen data om virkningen af faktor IX på fertilitet.
English: The amount of IDELVION you need to take and the duration of treatment depend on:
Danish: Hvor meget IDELVION, du skal have, samt behandlingens varighed afhænger af:
English: Clinical studies of IDELVION did not include subjects aged 65 and over.
Danish: Kliniske studier med IDELVION har ikke inkluderet personer på 65 år og derover.
English: No investigations on carcinogenicity and reproductive toxicology have been conducted.
Danish: Der er ikke udført studier af karcinogenicitet og reproduktionstoksikologi.
English: Currently available information support extension of treatment intervals for some patients though potentially associated with an increased risk for bleeding compared to a once weekly regimen.
Danish: De nuværende tilgængelige oplysninger understøtter forlængelse af behandlingsintervallerne for visse patienter, selvom det potentielt kan være forbundet med en øget risiko for blødning sammenlignet med behandling én gang om ugen.
English: • The reconstituted product should preferably be used immediately.
Danish: • Den fremstillede injektionsvæske skal helst anvendes med det samme.
English: Type of surgical procedure
Danish: type af kirurgisk procedure
English: Repeat PK assessment for up to 30 weeks demonstrated a stable pharmacokinetic profile and incremental recovery was consistent over time.
Danish: Ved gentagen farmakokinetisk vurdering i op til 30 uger blev der påvist en stabil farmakokinetisk profil, og den inkrementelle genfinding var konsistent over tid.
English: Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Danish: Alle patienter, der oplever allergiske reaktioner, bør derfor undersøges for tilstedeværelsen af inhibitorer.
English: Haemostasis was maintained throughout the study duration.
Danish: Hæmostase blev opretholdt i hele studiets varighed.
English: General Instructions
Danish: Generel vejledning
English: If you have any side effects that might be related to the administration of IDELVION, the injection should be stopped (see also sections 2 and 4).
Danish: Hvis du får bivirkninger, der kan skyldes indgivelse af IDELVION, skal du stoppe injektionen (se også afsnit 2 og 4).
English: DO NOT expose the vials to direct heat.
Danish: Udsæt IKKE hætteglassene for direkte varme.
English: Of the 106 bleeding episodes, the majority (94; 88.7%) was treated with single injection, 103; 97.2% were treated with 1-2 injections.
Danish: Størstedelen af de 106 blødningsepisoder (94; 88,7 %) blev behandlet med enkelt injektion, 103 (97,2 %) blev behandlet med 1-2 injektioner.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Danish: Tabellen nedenfor er opstillet efter MedDRAs klassifikation (systemorganklasse og foretrukken term).
English: Single dose may be sufficient for a majority of minor surgeries.
Danish: En enkelt dosis kan være tilstrækkelig ved de fleste mindre kirurgiske indgreb.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Danish: Ved dosering baseret på kropsvægt kan justering være nødvendig hos under- og overvægtige patienter.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using IDELVION.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger IDELVION.
English: • Side effects in children and adolescents Side effects in children are expected to be the same as in adults.
Danish: Bivirkninger hos børn og unge Bivirkninger hos børn forventes at være de samme som hos voksne.
English: • The formation of inhibitors (neutralising antibodies) is a known complication that has been reported during treatment with IDELVION, which stops the treatment from working properly.
Danish: • Dannelse af inhibitorer (neutraliserende antistoffer) er en kendt komplikation, der er rapporteret under behandling med IDELVION, og det bevirker, at behandlingen ikke længere virker.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Danish: Den dosis, der skal administreres, og administrationshyppigheden skal altid indrettes efter den kliniske effekt i det enkelte tilfælde.
English: If not used immediately, in-use storage times and conditions prior to use are in the responsibility of the user.
Danish: Hvis det ikke anvendes straks, er opbevaringstider og -forhold inden brug brugerens ansvar.
English: You should be monitored carefully for the development of inhibitors.
Danish: Du vil blive fulgt tæt for udvikling af inhibitorer.
English: Patients < 12 years of age
Danish: Patienter < 12 år
English: Patients with haemophilia B have a lack of this factor which means that their blood does not clot as quickly as it should so there is an increased tendency to bleed.
Danish: Patienter med hæmofili B mangler denne faktor, hvilket betyder, at deres blod ikke koagulerer så hurtigt, som det bør, hvorved tendensen til blødninger øges.
English: Haemostatic efficacy at resolution of a bleed was rated excellent or good in 96% of all treated bleeding episodes.
Danish: Den hæmostatiske virkning til at stoppe blødning blev vurderet som fremragende eller god ved 96 % af alle behandlede blødningsepisoder.
English: • If you are allergic to hamster proteins.
Danish: • hvis du er allergisk over for hamsterproteiner.
English: The reconstituted solution should be administered by slow intravenous injection.
Danish: Den rekonstituerede injektionsvæske skal administreres som langsom intravenøs injektion.
English: Clinical studies investigating safety and efficacy of longer treatment intervals than once weekly are ongoing.
Danish: Der er igangværende kliniske studier til undersøgelse af sikkerheden og virkningen ved behandlingsintervaller, der er længere end en uge.
English: - Reconstitution and withdrawal must be carried out under aseptic conditions.
Danish: - Rekonstitution og fyldning af sprøjte skal ske under aseptiske forhold.
English: Care should be taken that no blood enters the syringe filled with product, as there is a risk that the blood could coagulate in the syringe and fibrin clots could therefore be administered to the patient.
Danish: Sørg omhyggeligt for, at der ikke kommer blod i den fyldte sprøjte, da der er en risiko for, at blodet kan koagulere i sprøjten, så der administreres fibrinkoagler til patienten.
English: Inhibitor development was reported in an ongoing clinical study with previously untreated patients.
Danish: Der blev rapporteret udvikling af inhibitorer i et igangværende klinisk studie med tidligere ubehandlede patienter.
English: IDELVION (50 (IU/kg)) (N=22)
Danish: IDELVION (50 (IE/kg)) (N=22)
English: • Inhibitors: the medicine stops working properly (continuous bleeding).
Danish: • Neutraliserende antistoffer (inhibitorer): Medicinen holder op med at virke korrekt (blødning varer ved).