FrancophonIA/ELRC3.0 huggingface dataset:
English: In a randomized open-label study, adult RA patients treated with RoActemra and MTX were able to mount an effective response to both the 23-valent pneumococcal polysaccharide and tetanus toxoid vaccines which was comparable to the response seen in patients on MTX only.
Danish: I et randomiseret, åbent studie responderede voksne RA-patienter, som var i behandling med RoActemra og MTX, effektivt på både 23-valent pneumokokpolysaccharidog tetanustoxoid-vaccine; responset var sammenligneligt med responset hos patienter, som kun var i behandling med MTX.
English: Check with your healthcare provider for instructions about the right way to throw away used syringes.
Danish: Spørg sundhedspersonalet om vejledning i hvordan du kommer af med brugte injektionssprøjter.
English: At the start, your doctor or nurse may inject RoActemra.
Danish: I starten vil lægen eller sygeplejersken måske give indsprøjtningen med RoActemra.
English: Treatment with RoActemra, particularly when administered concomitantly with MTX, may be associated with elevations in hepatic transaminases, therefore, caution should be exercised when considering treatment of patients with active hepatic disease or hepatic impairment (see sections 4.2 and 4.8).
Danish: Behandling med RoActemra kan, særligt hvis det administreres samtidigt med MTX, være forbundet med stigninger i leveraminotransferase, og der bør derfor udvises forsigtighed når det overvejes at behandle patienter med aktiv leversygdom eller nedsat leverfunktion (se pkt.
English: Study IV evaluated 1,220 patients who had an inadequate response to their existing rheumatologic therapy, including one or more DMARDs.
Danish: Studie IV undersøgte 1.220 patienter, som havde responderet klinisk utilstrækkeligt på deres hidtidige reumatologiske behandling, herunder en eller flere DMARDs.
English: A patient or parent/guardian can self-inject RoActemra only if the physician determines that it is appropriate and the patient or parent/guardian agrees to medical follow-up as necessary and has been trained in proper injection technique.
Danish: En patient eller forældre/værge kan foretage selvadministration i de tilfælde, hvor lægen finder det hensigtsmæssigt og hvor patienten eller forældre/værge forinden er trænet i korrekt injektionsteknik efter behov samt har givet samtykke til medicinsk opfølgning.
English: Total Sharp-Genant score Erosion score JSN score
Danish: Erosions-score JSN-score
English: In the 12 week controlled phase, 16% of patients in the tocilizumab group and 5.4% of patients in the placebo group experienced an event within 24 hours of infusion.
Danish: I den kontrollerede 12 ugers fase oplevede 16 % af patienterne i tocilizumab-gruppen og 5,4 % af patienterne i placebogruppen en bivirkning inden for 24 timer efter infusionen.
English: At week 24, a significant reduction in DAS28 from baseline of 3.1 was observed on subcutaneous and 1.7 on placebo arm, and for DAS28 < 2.6, 32.0% was observed on subcutaneous and 4.0% on placebo arm.
Danish: Ved uge 24 var der observeret signifikant reduktion i DAS28 fra baseline på 3,1 observeret i den subkutane arm og 1,7 i placebo armen og for DAS28<2,6 blev der observeret en reduktion på 32,0% i den subkutane arm og en reduktion på 4,0% i placebo armen.
English: After week 52, all patients could receive open-label treatment with RoActemra 8 mg/kg.
Danish: Efter uge 52 kunne alle patienterne få åben behandling med RoActemra 8 mg/kg.
English: Fifty out of seventy five (67%) tocilizumab treated patients had a haemoglobin < LLN at baseline.
Danish: 50 ud af 75 (67 %) patienter behandlet med tocilizumab havde hæmoglobin < nedre normalgrænse ved baseline.
English: Symptoms would include abdominal pain and unexplained changes in bowel habits with a fever.
Danish: Symptomerne kan være mavesmerter og uforklarlige ændringer i afføringsmønster med feber.
English: The total content (0.9 mL) of the pre-filled pen should be administered as a subcutaneous injection.
Danish: Alt indholdet (0,9 ml) i den fyldte pen skal administreres som subkutan injektion.
English: RoActemra is not recommended for use with other biological agents.
Danish: RoActemra bør ikke anvendes sammen med andre biologiske midler.
English: Reporting suspected adverse reactions after authorization of the medicinal product is important.
Danish: Når lægemidlet er godkendt, er indberetning af formodede bivirkninger vigtig.
English: If you miss a dose of RoActemra
Danish: Hvis du glemmer en dosis RoActemra
English: RoActemra monotherapy should not be used for the treatment of acute relapses as efficacy in this setting has not been established.
Danish: RoActemra monoterapi skal ikke anvendes til behandling af akutte tilbagefald, da effekten i denne kliniske sutuation ikke er blevet klarlagt.
English: Prepare the Injection Site
Danish: Gør indsprøjtningsstedet klar
English: There are no adequate data from the use of tocilizumab in pregnant women.
Danish: De foreliggende data for anvendelse af tocilizumab til gravide er utilstrækkelige.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet.
English: A higher incidence of infections and infestations was reported in the RoActemra arm (48% vs. 42%), with no difference in the incidence of serious infections (3.1%).
Danish: En højere forekomst af infektioner og parasitære sygdomme blev rapporteret i RoActemra-armen (48 % vs. 42 %), men uden forskel i forekomsten af alvorlige infektioner (3, 1 %).
English: If an anaphylactic reaction or other serious hypersensitivity / serious infusion related reaction occurs, administration of RoActemra should be stopped immediately and RoActemra should be permanently discontinued.
Danish: Hvis en anafylaktisk reaktion eller anden alvorlig overfølsomhedsreaktion/alvorlig infusionsreaktion indtræffer, skal administrationen af RoActemra stoppes øjeblikkeligt og RoActemra bør seponeres permanent.
English: Age, gender and ethnicity: Population pharmacokinetic analyses in RA and GCA patients, showed that age, gender and ethnic origin did not affect the pharmacokinetics of RoActemra.
Danish: Alder, køn og etnicitet: Populationsfarmakokinetiske analyser af patienter med RA og GCA viste, at alder, køn og race ikke påvirkede RoActemras farmakokinetik.
English: In the long-term exposure population, the overall rate of serious infections (bacterial, viral and fungal) was 4.7 events per 100 patient years.
Danish: I populationen, som blev eksponeret i lang tid, var den samlede hyppighed af alvorlige infektioner (bakterie-, virus-, svampe-) 4,7 hændelser pr. 100 patientår.
English: The recommended injection sites (abdomen, thigh and upper arm) should be rotated and injections should never be given into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.
Danish: De anbefalede injektionssteder (mave, lår og overarm) skal anvendes på skift, og injektionen må aldrig gives i skønhedspletter, ar, blå mærker eller områder, hvor huden er øm, rød, hård eller, hvor huden ikke er intakt.
English: Patients randomized to tocilizumab had fewer ACR30 flares and higher overall ACR responses than patients receiving placebo regardless of a history of prior biologic use.
Danish: Patienter, der var randomiseret til tocilizumab, havde færre ACR30-flare-episoder og et højere samlet ACR-respons end patienter, som fik placebo.
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 dilution has taken place in controlled and validated aseptic conditions.
Danish: Det bør normalt ikke være længere end 24 timer ved 2 - 8 °C, medmindre fortyndingen fandt sted under kontrollerede og validerede aseptiske betingelser.
English: INFORMATION IN BRAILLE roactemra 162 mg pen
Danish: INFORMATION I BRAILLESKRIFT roactemra 162 mg pen
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Danish: INFORMATION I BRAILLESKRIFT Fritaget for krav om blindskrift
English: The syringe is closed by a rigid needle shield (elastomer seal with a polypropylene shell) and a plunger stopper (butyl rubber with a fluororesin coating).
Danish: Injektionssprøjten er lukket med et hårdt beskyttelseshylster (elastomerforsegling med polypropylskal) og stempel (fluororesindbelagt butylgummi).
English: The recommended posology is 8 mg/kg body weight, given once every four weeks.
Danish: Den anbefalede dosis er 8 mg/kg legemsvægt administreret én gang hver 4. uge.
English: All patients treated with RoActemra should be given the Patient Alert Card.
Danish: Alle patienter, der behandles med RoActemra, skal have udleveret et patientkort.
English: • The needle-shield may not have locked.
Danish: • nåleskjoldet ikke er kommet ud.
English: INFORMATION IN BRAILLE roactemra 162 mg
Danish: INFORMATION I BRAILLESKRIFT roactemra 162 mg
English: In pJIA patients, infusion related reactions are defined as all events occurring during or within 24 hours of an infusion.
Danish: Infusionsreaktioner hos pJIA-patienter defineres som alle bivirkninger, der indtræffer under eller inden for 24 timer efter en infusion.
English: In vitro studies with cultured human hepatocytes demonstrated that IL-6 caused a reduction in CYP1A2, CYP2C9, CYP2C19 and CYP3A4 enzyme expression.
Danish: In vitro-studier med dyrkede humane hepatocytter har vist, at IL-6 forårsager et fald i CYP1A2, CYP2C9, CYP2C19 og CYP3A4 enzym-ekspression.
English: No injection site reaction was reported as a serious adverse event or required treatment discontinuation.
Danish: Ingen reaktion ved injektionsstedet blev rapporteret som en alvorlig bivirkning eller, som krævede seponering af behandlingen.
English: calcium channel blockers, theophylline, warfarin, phenprocoumon, phenytoin, ciclosporin, or benzodiazepines) should be monitored as doses may need to be increased to maintain therapeutic effect.
Danish: atorvastatin, calciumantagonister, theophyllin, warfarin, phenprocoumon, phenytoin, ciclosporin eller benzodiazepiner) kontrolleres, da dosis måske skal justeres for at bevare den terapeutiske virkning.
English: These results are consistent with those observed in patients treated with intravenous RoActemra.
Danish: Disse resultater er i overensstemmelse med det, der ses hos patienter behandlet med intravenøs RoActemra.
English: Laboratory Abnormalities
Danish: Laboratorie abnormiteter
English: JIA ACR response rates at week 12 (% patients)
Danish: JIA ACR-responsrater ved uge 12 (% patienter)
English: The safety profile of tocilizumab in the pediatric population is summarized in the sections on pJIA and sJIA below.
Danish: Tocilizumabs sikkerhedsprofil i den pædiatriske population med pJIA- og sJIA er beskrevet i nedenstående sektioner.
English: These reactions were generally observed during the second to fifth infusions of RoActemra (see section 4.4).
Danish: Reaktionerne blev generelt observeret under den anden til femte infusion af RoActemra (se pkt.
English: • abdominal pain/tenderness and/or change in bowel function
Danish: • mavesmerter/-ømhed og/eller ændret afføringsmønster
English: In the 12 week double-blind, controlled phase, 75 patients received treatment with tocilizumab (8 mg/kg or 12 mg/kg based upon body weight).
Danish: I den dobbeltblindede kontrollerede 12 ugers fase fik 75 patienter tocilizumab (8 mg/kg eller 12 mg/kg afhængigt af legemsvægt).
English: Primary Endpoint - Mean Change from baseline at Week 24 DAS28 (adjusted mean) Difference in adjusted mean (95% CI) Secondary Endpoints - Percentage of Responders at Week 24
Danish: Primært endepunkt - gennemsnitlig ændring fra baseline til uge 24 DAS28 (justeret gennemsnit) Forskel i justeret gennemsnit (95% konfidensinterval) Sekundære endepunkter - procent respondenter ved uge 24
English: • 1 Puncture-resistant container or sharps container for safe disposal of pre-filled pen cap and used pre-filled pen (see Step 4 “Dispose of the pre-filled pen”)
Danish: • 1 kanylebeholder til sikker bortskaffelse af brugte penne og hætter til penne (se Trin 4
English: No patients treated with SC RoActemra experienced a decrease in platelet count to ≤50 × 103 / μL.
Danish: Ingen af patienterne behandlet med subkutan RoActemra oplevede et fald i trombocytter til ≤ 50 × 103/μl.
English: A median of 1 dose of tocilizumab (range, 1-4 doses) was administered.
Danish: En median på 1 dosis (i et spænd på 1-4 doser) af tocilizumab blev givet.
English: RoActemra AUC, Cmin and Cmax increased with increase of body weight.
Danish: AUC, Cmin og Cmax for RoActemra steg med øget legemsvægt.
English: The overall safety profile observed in the RoActemra treatment groups was consistent with the known safety profile of RoActemra (see Table 1).
Danish: Den overordnede sikkerhedsprofil observeret i RoActemra behandlingsgrupperne var i overensstemmelse med den allerede kendte sikkerhedsprofil for RoActemra (se tabel 1).
English: RoActemra, in combination with methotrexate (MTX), is indicated for
Danish: RoActemra er, i kombination med methotrexat (MTX), indiceret til
English: Very rare side effects: These may affect up to 1 in every 10,000 patients
Danish: Meget sjældne bivirkninger: Forekommer hos op til 1 ud af 10.000 patienter
English: The adjusted mean change in the pain VAS after 12 weeks of tocilizumab treatment was a reduction of 41 points on a scale of 0 - 100 compared to a reduction of 1 for placebo patients (p<0.0001).
Danish: Den justerede gennemsnitlige ændring på den visuelle analog skala (VAS) for smerte efter 12 ugers tocilizumab-behandling var en reduktion på 41 point på en skala fra 0 til 100 sammenlignet med en reduktion på 1 for placebo-patienter (p < 0,0001).
English: In study SC-II, at week 24 there was ACR20 of 60.9%, ACR50 of 39.8% and ACR70 of 19.7% for patients treated with RoActemra subcutaneous every other week versus placebo ACR20 of 31.5%, ACR50 of 12.3% and ACR70 of 5.0%.
Danish: I SC-II-studiet var ACR20 på 60,9%, ACR50 på 39,8% og ACR70 på 19,7% ved uge 24 hos patienter, som var behandlet med subkutan RoActemra hver anden uge, sammenlignet med placebo, hvor ACR20 var på 31,5%, ACR50 på 12,3% og ACR70 på 5,0%.
English: RoActemra is usually given in combination with methotrexate.
Danish: RoActemra gives normalt sammen med methotrexat.
English: The all control population includes all patients from the double-blind phases of each core study from randomization until either the first change in the treatment regimen, or two years is reached.
Danish: Populationen, alle kontroller, omfatter alle patienter fra den dobbeltblindede fase af hvert studie fra randomeisering til enten første ændring i behandlingsregimet eller til en behandlingsvarighed på 2 år er nået.
English: There are no adequate data from the use of RoActemra in pregnant women.
Danish: De foreliggende data for anvendelse af RoActemra til gravide er utilstrækkelige.
English: L-Histidine, L-Histidine monohydrochloride monohydrate, L-Arginine, L-Arginine hydrochloride, LMethionine, Polysorbate 80, Water for injections.
Danish: L-histidin, L-histidinmonohydrochloridmonohydrat, L-arginin, L-argininhydrochlorid, Lmethionin, polysorbat 80, vand til injektionsvæsker.
English: In the 12 week controlled phase, 4% of patients from the tocilizumab group experienced events occurring during infusion.
Danish: I den kontrollerede 12 ugers fase oplevede 4 % af patienterne i tocilizumab-gruppen bivirkninger under infusion.
English: Tocilizumab is a recombinant humanized, anti-human monoclonal antibody of the immunoglobulin G1 (IgG1) sub-class directed against soluble and membrane-bound interleukin 6 receptors.
Danish: Tocilizumab er et rekombinant humaniseret, anti-humant monoklonalt antistof af immunglobulin G1 (IgG1) sub-klassen rettet mod opløselige og membranbundne interleukin 6-receptorer.
English: Do not fan or blow on the clean area.
Danish: Du må ikke vifte eller puste på det rensede område tørt.
English: Five patients (0.8%) developed positive anti-RoActemra antibodies; of these, all developed neutralizing anti-RoActemra antibodies.
Danish: Fem patienter (0,8%) udviklede positive anti-RoActemra-antistoffer; af disse udviklede alle neutraliserende anti-RoActemraantistoffer.
English: Mild renal impairment (estimated creatinine clearance based on Cockcroft-Gault formula) did not impact the pharmacokinetics of RoActemra.
Danish: Let nedsat nyrefunktion (estimeret creatininclearance Baseret på Cockcroft-Gault formlen) påvirkede ikke RoActemras farmakokinetik.
English: At week 24, inhibition of structural damage was shown, with significantly less radiographic progression in patients receiving RoActemra subcutaneous compared to placebo (mean mTSS of 0.62 vs. 1.23, p=0.0149 (van Elteren).
Danish: Ved uge 24 sås hæmning af strukturel skade med signifikant mindre radiografisk progression blandt patienter behandlet med subkutan RoActemra sammenlignet med placebo (gennemsnitlig mTSS på 0,62 vs. 1,23; p=0,0149 (van Elteren)).
English: The concentrate is a clear to opalescent, colourless to pale yellow liquid.
Danish: Koncentratet er en klar til opaliserende, farveløs til lysegul væske.
English: The pre-filled pen should not be shaken.
Danish: Den fyldte pen må ikke rystes.
English: A higher incidence of infections and infestations was reported in the tocilizumab arm (48% vs. 42%), with no difference in the incidence of serious infections (3.1%).
Danish: En højere forekomst af infektioner og parasitære sygdomme blev rapporteret i tocilizumab-armen (48 % vs. 42 %), men uden forskel i forekomsten af alvorlige infektioner (3, 1 %).
English: As recommended for other biological treatments, all patients should be screened for latent tuberculosis (TB) infection prior to starting RoActemra therapy.
Danish: Som det er anbefalet for andre biologiske behandlinger, skal alle patienter undersøges for latent tuberkulose, før behandlingen med RoActemra påbegyndes.
English: 162 mg weekly
Danish: 162 mg ugentligt
English: The safety profile of subcutaneous RoActemra was evaluated in 51 paediatric patients (1 to 17 years of age) with sJIA.
Danish: Sikkerhedsprofilen for subkutan RoActemra er blevet undersøgt hos 51 pædiatriske patienter (1-17 år) med sJIA.
English: Drug-induced liver injury, Hepatitis, Jaundice,
Danish: Lægemiddelinduceret leverskade, hepatitis, gulsot.
English: This protein is involved in inflammatory processes of the body, and blocking it can reduce the inflammation in your body.
Danish: Ved at blokere disse processer, kan betændelsen (inflammationen) i kroppen nedsættes.
English: Hypertriglyceridae mia
Danish: Hypertriglycerid æmi
English: The safety profile of intravenous RoActemra in sJIA has been studied in 112 patients from 2 to 17 years of age.
Danish: Sikkerhedsprofilen af intravenøs RoActerma ved sJIA er blevet undersøgt hos 112 patienter i alderen 2 til 17 år.
English: RoActemra is usually given in combination with another medicine for RA called methotrexate.
Danish: RoActemra gives normalt sammen med et andet lægemiddel for leddegigt, som kaldes methotrexat.
English: Restart with weekly or every other week injection, as clinically appropriate.
Danish: Påbegynd behandlingen igen ugentligt eller hver anden uge efter et klinisk skøn
English: Following subcutaneous dosing in GCA patients, the absorption t½ was around 4 days.
Danish: Efter subkutan dosering hos GCA-patienter var halveringstiden t½ for absorptionen på omkring 4 dage.
English: The primary endpoint at week 24 was the proportion of patients who achieved an ACR 20 response.
Danish: Det primære endepunkt ved uge 24 var andelen af patienter, som opnåede et ACR 20-respons.
English: Do not use this medicine after the expiry date which is stated on the carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, som står på den ydre karton.
English: A total of 2,876 patients have been tested for anti-tocilizumab antibodies in the 6-month controlled clinical trials.
Danish: I alt 2.876 patienter er blevet testet for anti-tocilizumab-antistoffer i de 6-måneders kontrollerede kliniske studier.
English: No dose adjustment is required in patients with mild or moderate renal impairment.
Danish: Ingen dosisjustering er nødvendig hos patienter med let eller moderat nedsat nyrefunktion.
English: RA patients have an increased risk for cardiovascular disorders and should have risk factors (e.g. hypertension, hyperlipidaemia) managed as part of usual standard of care.
Danish: Patienter med reumatoid artrit har øget risiko for kardiovaskulære sygdomme, og risikofaktorer (f.eks. hypertension og hyperlipidæmi) skal behandles efter gældende standarder.
English: • Do not speed up the warming process in any way, such as using the microwave or placing the pre-filled pen in warm water.
Danish: • Du må ikke varme den fyldte pen hurtigere op, fx i mikroovn eller ved at lægge den i varmt vand.
English: Do not touch the needle-shield of the prefilled pen, because you may stick yourself with the needle.
Danish: Rør ikke ved nåleskjoldet på pennen, da du kan komme til at stikke dig selv.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION RoActemra 162 mg injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) RoActemra 162 mg injektion
English: Tocilizumab versus adalimumab in monotherapy
Danish: Tocilizumab versus adalimumab i monoterapi
English: However, your doctor may decide that you may inject RoActemra yourself.
Danish: Lægen kan dog vurdere, at du selv kan tage indsprøjtningen med RoActemra.
English: Concomitant administration of a single dose of 10 mg/kg RoActemra with 10-25 mg MTX once weekly had no clinically significant effect on MTX exposure.
Danish: Samtidig administration af en enkelt dosis af 10 mg/kg RoActemra og 10-25 mg MTX, én gang ugentligt, havde ingen klinisk signifikant effekt på MTX-eksponeringen
English: The clinical data are insufficient to assess the potential incidence of malignancy following exposure to tocilizumab.
Danish: De kliniske data er ikke tilstrækkelige til at vurdere den mulige incidens af malignitet efter eksponering af tocilizumab.
English: The number of active joints was significantly reduced compared to baseline in patients receiving tocilizumab compared to placebo (adjusted mean changes of -14.3 vs -11.4, p=0.0435).
Danish: Antallet af aktive led var signifikant reduceret i forhold til baseline hos patienter behandlet med tocilizumab sammenlignet med placebo (justerede gennemsnitlige ændringer på -14,3 versus -11,4; p=0,0435).
English: If an anaphylactic reaction or other serious hypersensitivity reaction occurs, administration of RoActemra should be stopped immediately, appropriate therapy initiated and tocilizumab should be permanently discontinued.
Danish: Hvis en anafylaktisk reaktion eller anden alvorlig overfølsomhedsreaktion indtræffer, skal administrationen af RoActemra stoppes øjeblikkeligt, relevant behandling initieres og tocilizumab bør seponeres permanent.
English: The frequency of ADRs in pJIA patients can be found in Table 2.
Danish: Frekvensen af bivirkninger for pJIA-patienter kan ses i tabel 2.
English: • allergic (hypersensitivity) reactions
Danish: • overfølsomhedsreaktioner (allergiske reaktioner)
English: RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX.
Danish: RoActemra er, i kombination med MTX, indiceret til behandling af polyartikulær juvenil idiopatisk artrit (pJIA) (reumafaktor-positiv eller -negativ og udvidet oligoartrit) hos patienter, som er 2 år og ældre, og som har haft utilstrækkelig respons på tidligere behandling med MTX.