FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients < 30 kg were randomized 1:1 to receive either tocilizumab 8 mg/kg or 10 mg/kg IV every 4 weeks for 4 doses.
Danish: Patienter <30 kg blev randomiseret 1:1 til enten tocilizumab 8 mg/kg eller 10 mg/kg som infusion hver 4. uge, i alt 4 doser.
English: • Do not throw away (dispose of) the pre-filled pen and the green cap in your household trash and do not recycle them.
Danish: • Smid aldrig den brugte pen eller den grønne hætte i skraldespanden eller til genbrug.
English: The usual dose of RoActemra depends on your weight.
Danish: Den normale dosis RoActemra afhænger af din/barnets vægt.
English: In the long-term exposure population, the overall rate of infections with RoActemra was 108 events per 100 patient years exposure.
Danish: I populationen, som blev eksponeret i lang tid, var den samlede infektionshyppighed for RoActemra 108 hændelser pr. 100 patientår.
English: 0.9 mL solution in a pre-filled syringe (type I glass) with a staked-in needle containing 162 mg RoActemra assembled into a pre-filled pen.
Danish: 0,9 ml opløsning i en fyldt injektionssprøjte (type I-glas) med indbygget kanyle indeholdende 162 mg RoActemra, samlet i en fyldt pen.
English: Do not throw away used syringes or the puncture resistant container in household trash and do not recycle them.
Danish: Smid aldrig brugte injektionssprøjter eller affaldsbeholdere til skarpe genstande i husholdningsaffaldet eller til genbrug
English: In SCII, 656 patients were randomized 2:1 to RoActemra subcutaneous 162 mg every other week or placebo, in combination with non-biologic DMARD(s).
Danish: I SC-II-studiet blev 656 patienter randomiseret 2:1 til RoActemra SC 162 mg hver anden uge eller placebo, i kombination med non-biologiske DMARDs.
English: During the 6-month controlled period, in SC-I, the frequency of injection site reactions was 10.1% (64/631) and 2.4% (15/631) for the subcutaneous RoActemra and the subcutaneous placebo (intravenous group) weekly injections, respectively.
Danish: I den 6-måneders kontrollerede periode i SC-I-studiet var hyppigheden af reaktioner ved injektionsstedet 10,1% (64/631) og 2,4% (15/631) for ugentlige injektioner med henholdsvis subkutan RoActemra og subkutan placebo (den intravenøse arm).
English: • cough, shortness of breath
Danish: • hoste, åndenød
English: In Study I, RoActemra was administered intravenously every four weeks as monotherapy.
Danish: I studie I blev RoActemra givet intravenøst hver 4. uge som monoterapi.
English: Clinically significant hypersensitivity reactions associated with tocilizumab and requiring treatment discontinuation, were reported in 1 out of 112 patients (< 1%) treated with tocilizumab during the controlled and up to and including the open label clinical trial.
Danish: Klinisk signifikante overfølsomhedsreaktioner, der blev associeret med tocilizumab, og som krævede afbrydelse af behandlingen, blev rapporteret hos 1 ud af 112 patienter (< 1 %) behandlet med tocilizumab, under den kontrollerede del af det kliniske studie samt under den åbne del af studiet.
English: Steady-state was reached following the first administration for Cmax and after 8 and 20 weeks for AUC and Cmin, respectively.
Danish: Steady-state for Cmax blev nået efter første indgift, mens steady-state for AUC og Cmin blev nået efter hhv. 8 og 20 uger.
English: • Always keep the puncture-resistant container out of the sight and reach of children.
Danish: • Opbevar altid affaldsbeholdere til skarpe genstande utilgængeligt for børn.
English: • The other ingredients are sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injections.
Danish: • Øvrige indholdsstoffer: saccharose, polysorbat 80, dinatriumphosphatdodecahydrat, natriumdihydrogenphosphatdihydrat og vand til injektionsvæsker.
English: In the open label extension phase, elevation in ALT or AST ≥ 3 x ULN occurred in 12% and 4% of patients, respectively, in the tocilizumab group.
Danish: I den åbne forlængelsesfase forekom der stigning i ALAT eller ASAT til ≥ 3 gange øvre normalgrænse hos henholdsvis 12 % og 4 % af patienterne i tocilizumab-gruppen.
English: What RoActemra looks like and contents of the pack RoActemra is a solution for injection.
Danish: Udseende og pakningsstørrelser RoActemra er en opløsning til injektion.
English: • If you have liver disease, tell your doctor.
Danish: • Hvis du har en leversygdom, skal du fortælle det til lægen.
English: • the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.
Danish: • behandling af svær, aktiv og progressiv reumatoid artrit (RA) hos voksne patienter, som ikke tidligere er blevet behandlet med MTX.
English: Peripheral oedema, Hypersensitivity reactions
Danish: Perifert ødem, overfølsomhedsreaktioner
English: • RoActemra is used to treat adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough.
Danish: • RoActemra anvendes til at behandle voksne patienter med moderat til svær aktiv leddegigt (en autoimmun sygdom), hos hvem tidligere behandling ikke har virket godt nok.
English: The proportion of patients achieving a clinically relevant improvement in HAQ-DI at week 24 (change from baseline of ≥ 0.3 units) was also comparable on the subcutaneous (65.2%) versus intravenous (67.4%) arms, with a weighted difference in proportions of - 2.3% (95% CI - 8.1, 3.4).
Danish: Også andelen af patienter, der opnåede klinisk relevant forbedring i HAQ-DI ved uge 24 (ændring fra baseline på ≥ 0,3 enheder) var sammenlignelig for den subkutane (65,2%) og den intravenøse (67,4%) behandlingsarm, med en vægtet forskel på -2,3% (95% konfidensinterval -8,1; 3,4).
English: The concentrationdependent non-linear clearance plays a major role at low tocilizumab concentrations.
Danish: Den koncentrationsafhængige non-lineære clearance spiller en væsentlig rolle ved lave koncentrationer af tocilizumab.
English: There is no experience with the use of RoActemra with TNF antagonists or other biological treatments for RA patients.
Danish: Der er ingen erfaring med anvendelse af RoActemra sammen med TNF-antagonister eller andre biologiske behandlinger hos patienter med reumatoid artrit.
English: • Keep pressing down on the plunger while you take the needle out of the skin at the same angle as inserted.
Danish: • Bliv ved med at presse stemplet ned, mens du tager kanylen ud af uden i samme vinkel, som du satte den ind (se Fig. G).
English: A total of 2,876 patients have been tested for anti-RoActemra antibodies in the 6-month controlled clinical trials.
Danish: I alt 2.876 patienter er blevet testet for anti- RoActemra-antistoffer i de 6-måneders kontrollerede kliniske studier.
English: The proportion of patients with serious adverse events was balanced between the treatment groups (RoActemra 11.7% vs. adalimumab 9.9%).
Danish: Andelen af patienter med alvorlige bivirkninger balancerede mellem de 2 behandlingsgrupper (RoActemra 11,7% mod adalimumab 9,9%).
English: Polysorbate 80, sucrose, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injections.
Danish: Polysorbat 80, saccharose, dinatriumphosphatdodecahydrat, natriumdihydrogenphosphatdihydrat og vand til injektionsvæsker.
English: If you stop using RoActemra
Danish: Hvis du holder op med at få RoActemra
English: Of the patients who completed the study who were originally randomised to placebo + MTX, 86% received open-label tocilizumab 8 mg/kg in year 2.
Danish: 86 % af de patienter, som fuldførte studiet, og som oprindeligt var randomiseret til placebo + MTX, fik åben behandling med tocilizumab 8 mg/kg i år 2.
English: Frequency category with preferred term
Danish: Hyppighed kategoriseret efter foretrukken terminologi Meget almindelig
English: • Details on how to report serious adverse drug reactions
Danish: • Detaljer om rapportering af alvorlige bivirkninger
English: Consistent with the effect on acute phase reactants, treatment with RoActemra was associated with reduction in platelet count within the normal range.
Danish: I overensstemmelse med virkningen på akut fase reaktanter var behandlingen med RoActemra ledsaget af et fald i trombocyttallet inden for referenceintervallet.
English: The rate of serious infections was numerically higher in patients weighing <30 kg treated with 10 mg/kg tocilizumab (12.2 per 100 patient years) compared to patients weighing ≥30 kg, treated with 8 mg/kg tocilizumab (4.0 per 100 patient years).
Danish: Forekomsten af alvorlige infektioner var numerisk højere hos patienter, der vejede <30 kg og fik 10 mg/kg tocilizumab (12,2 per 100 patientår), sammenlignet med patienter, der vejede ≥30 kg og fik 8 mg/kg tocilizumab (4,0 per 100 patientår).
English: Of the 46 patients (1.6%) who developed anti-RoActemra antibodies, 6 had an associated medically significant hypersensitivity reaction, of which 5 led to permanent discontinuation of treatment.
Danish: Af de 46 patienter (1,6 %), som udviklede anti- RoActemra-antistoffer, havde 6 en ledsagende, klinisk signifikant overfølsomhedsreaktion, som hos 5 medførte permanent seponering af behandlingen.
English: RoActemra is supplied in a single use pre-filled pen.
Danish: RoActemra leveres i fyldt pen til éngangsbrug.
English: In all patients, assessment of lipid parameters should be performed 4 to 8 weeks following initiation of RoActemra therapy.
Danish: Hos alle patienter bør lipidparametrene vurderes 4 til 8 uger efter, at behandlingen med RoActemra er påbegyndt.
English: The excretion of tocilizumab in milk has not been studied in animals.
Danish: Udskillelsen af tocilizumab i mælk er ikke undersøgt i dyreforsøg.
English: The dose-response curve for RoActemra flattens at higher exposure, resulting in smaller efficacy gains for each incremental increase in RoActemra concentration such that clinically meaningful increases in efficacy were not demonstrated in patients treated with > 800 mg of RoActemra.
Danish: Dosis-responskurven for RoActemra flader ud ved højere eksponering, hvilket resulterer i mindre effektgevinst for hver trinvis forøgelse af RoActemra -koncentrationen, således at klinisk relevante stigninger i effekt ikke blev vist hos patienter, som blev behandlet med > 800 mg tocilizumab.
English: The safety and efficacy of RoActemra subcutaneous formulation in children from birth to less than 1 year have not been established.
Danish: Sikkerhed og virkning af RoActemra i den subkutane formulering er ikke klarlagt hos børn fra fødslen og op til 1 år.
English: In study SC-II, mean decrease in HAQ-DI from baseline to week 24 was significantly greater for patients treated with RoActemra subcutaneous every other week (0.4) versus placebo (0.3).
Danish: I SC-II-studiet var den gennemsnitlige reduktion i HAQ-DI fra baseline ved uge 24 signifikant større hos patienter, som var behandlet med subkutan RoActemra hver anden uge, (0,4) sammenlignet med placebo (0,3).
English: Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R).
Danish: Tocilizumab bindes specifikt til både opløselige og membranbundne IL-6 receptorer (sIL-6R og mIL6R).
English: pJIA Patients:
Danish: pJIA-patienter:
English: Each mL concentrate contains 20 mg tocilizumab*.
Danish: Hver ml koncentrat indeholder 20 mg tocilizumab*.
English: In the long-term exposure population the overall rate of gastrointestinal perforation was 0.28 events per 100 patient years.
Danish: I populationen, som blev eksponeret i lang tid, var den samlede hyppighed af gastrointestinal perforation 0,28 hændelser per 100 patientår.
English: The Patient Information Pack should contain the following key elements:
Danish: Informationsmaterialet til patienten skal indeholde følgende nøgleelementer:
English: Each 200 mg vial contains 0.20 mmol (4.43 mg) sodium.
Danish: Hvert 200 mg hætteglas indeholder 0,20 mmol (4,43 mg) natrium.
English: • any part of the syringe appears to be damaged
Danish: • en eller flere dele af injektionssprøjten virker beskadiget
English: The mean change in HAQ-DI was maintained at Week 104 in the RoActemra 8 mg/kg plus MTX group (-0.61).
Danish: Den gennemsnitlige ændring i HAQ-DI var opretholdt ved uge 104 i RoActemra 8 mg/kg plus MTX gruppen (-0,61).
English: In the open label extension phase, decreases in platelet counts below 100 x 103/µl, occurred in 3% of patients in the tocilizumab group, without associated bleeding events.
Danish: I den åbne forlængelsesfase forekom der fald i trombocyttal til under 100 x 103/µl hos 3 % af patienterne i tocilizumab-gruppen uden ledsagende blødningsepisoder.
English: In all studies, patients treated with RoActemra 8 mg/kg had statistically significant higher ACR 20, 50, 70 response rates at 6 months compared to control (Table 5).
Danish: I alle studier havde de patienter, som fik behandling med RoActemra 8 mg/kg, statistisk signifikant højere ACR20-, ACR50- og ACR70-responsrater efter 6 måneder, sammenlignet med kontrolgrupperne (tabel 5).
English: Study VI (WA19924), a 24 week double-blinded study that compared RoActemra monotherapy with adalimumab monotherapy, evaluated 326 patients with RA who were intolerant of MTX or where continued treatment with MTX was considered inappropriate (including MTX inadequate responders).
Danish: Studie VI (WA19924), et 24-ugers dobbeltblindet studie, som sammenlignede RoActemra-monoterapi med adalimumab-monoterapi, undersøgte 326 patienter med reumatoid artrit, som var intolerante overfor methotrexat, eller hvor fortsat behandling med methotrexat blev betragtet som uhensigsmæssigt (inklusive patienter, som responderede utilstrækkeligt på methotrexat).
English: Week TCZ 8 mg/kg
Danish: Uge TCZ 8 mg/kg
English: A decrease in platelet count below 100 × 103 / μL was not observed in either of the placebo plus prednisone taper groups.
Danish: Et fald i trombocytter under 100 × 103/μL blev ikke observeret i nogen af grupperne, der fik placebo plus nedtrappende prednison-dosis.
English: The corresponding frequency category for each
Danish: Den korresponderende hyppighed i henhold til følgende kategorier:
English: Study VI (WA19924), a 24 week double-blinded study that compared tocilizumab monotherapy with adalimumab monotherapy, evaluated 326 patients with RA who were intolerant of MTX or where continued treatment with MTX was considered inappropriate (including MTX inadequate responders).
Danish: Studie VI (WA19924), et 24-ugers dobbeltblindet studie, som sammenlignede tocilizumab-monoterapi med adalimumab-monoterapi, undersøgte 326 patienter med reumatoid artrit, som var intolerante overfor methotrexat, eller hvor fortsat behandling med methotrexat blev betragtet som uhensigsmæssigt (inklusive patienter, som responderede utilstrækkeligt på methotrexat).
English: • 1 Sterile cotton ball or gauze
Danish: • 1 stykke sterilt vat eller gaze
English: RoActemra is supplied as vials containing 4 mL, 10 mL and 20 mL concentrate for solution for infusion.
Danish: RoActemra leveres i hætteglas indeholdende 4 ml, 10 ml og 20 ml koncentrat til infusionsvæske, opløsning.
English: For individuals whose body weight is more than 100 kg, doses exceeding 800 mg per infusion are not recommended (see section 5.2).
Danish: For personer med legemsvægt på over 100 kg anbefales det, at dosis ikke overstiger 800 mg pr. infusion (se pkt.
English: In all studies, patients treated with tocilizumab 8 mg/kg had statistically significant higher ACR 20, 50, 70 response rates at 6 months compared to control (Table 3).
Danish: I alle studier havde de patienter, som fik behandling med tocilizumab 8 mg/kg, statistisk signifikant højere ACR20-, ACR50- og ACR70-responsrater efter 6 måneder, sammenlignet med kontrolgrupperne (tabel 3).
English: • If you have cancer, tell your doctor.
Danish: • Fortæl det til din læge, hvis du har kræft.
English: Week 24 ACR20, n (%) ACR50, n (%) 165 (56.9)** 139 (47.6) ACR70, n (%) 112 (38.6)** Week 52 ACR20, n (%) ACR50, n (%) 162 (55.9)** 144 (49.3) ACR70, n (%) 125 (43.1)** 105 (36.0) HAQ-DI (adjusted mean change from baseline) Week 52
Danish: ACR20, n (%) ACR50, n (%) 162 (55,9)** 144 (49,3) ACR70, n (%) 125 (43,1)** 105 (36,0) HAQ-DI (justeret gennemsnitsændring fra baseline)
English: The proportion of patients with serious adverse events was balanced between the treatment groups (tocilizumab 11.7% vs. adalimumab 9.9%).
Danish: Andelen af patitenter med alvorlige bivirkninger balancerede mellem de 2 behandlingsgrupper (tocilizumab 11,7% mod adalimumab 9,9%).
English: The primary endpoint for each of the five studies was the proportion of patients who achieved an ACR 20 response at week 24.
Danish: Det primære endepunkt i alle fem studier var antallet af patienter, som opnåede et ACR20-respons ved uge 24.
English: Change in EQ5D scores from baseline to week 52 were RoActemra weekly plus 26 weeks 0.10 [0.198], RoActemra every other weekly plus 26 weeks 0.05 [0.215], placebo plus 26 weeks 0.07 [0.293], and placebo plus 52 weeks -0.02 [0.159].
Danish: Ændring i EQ5D scorer fra baseline til uge 52 var ugentlig RoActemra plus 26 uger 0,10 [0,198], RoActemra hver anden uge plus 26 uger 0,05 [0,215], placebo plus 26 uger 0,07 [0,293] og placebo plus 52 uger -0,02 [0,159 ].
English: Other Secondary Endpoints Time to first GCA flare¹ (Tocilizumab groups vs Placebo+26)
Danish: Andre sekundære endepunkter Tid til første GCA flare¹ (Tocilizumab grupper vs Placebo+26)
English: Keep the RoActemra syringe and all medicines out of the sight and reach of children.
Danish: Opbevar den fyldte RoActemra-injektionssprøjte og al medicin utilgængeligt for børn.
English: RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.
Danish: RoActemra kan gives som monoterapi (i tilfælde af intolerans over for MTX, eller hvis behandling med MTX er uhensigtsmæssig) eller i kombination med MTX.
English: Do not use this medicine after the expiry date which is stated on the pre-filled pen label and carton (EXP).
Danish: Brug ikke lægemidlet efter den udløbsdato, som står på etiketten på den fyldte pen og den ydre karton.
English: The efficacy of subcutaneous administered RoActemra in alleviating the signs and symptoms of RA and radiographic response, was assessed in two randomised, double-blind, controlled, multi-center studies.
Danish: Effekt af subkutant administreret RoActemra med hensyn til lindring af symptomer på RA og radiografisk respons, blev undersøgt i to randomiserede, dobbeltblindede, kontrollerede multicenterstudier.
English: If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever) or any other infection appear during or after therapy tell your doctor immediately.
Danish: Hvis du får symptomer på tuberkulose (vedvarende hoste, vægttab, sløvhed, let feber) eller nogen anden infektion under eller efter behandlingen, skal du omgående fortælle det til din læge.
English: • If you have cardiovascular risk factors such as raised blood pressure and raised cholesterol levels, tell your doctor.
Danish: • Fortæl det til din læge, hvis du har risikofaktorer for at udvikle hjerte-karsygdomme, som f.eks. forhøjet blodtryk eller forhøjet kolesterol.
English: In study I, superiority of RoActemra 8 mg/kg was demonstrated against the active comparator MTX.
Danish: I studie I var RoActemra 8 mg/kg bedre end den aktive komparator MTX.
English: • Once the needle is removed completely from the skin, you can release the plunger, allowing the needle-shield to protect the needle.
Danish: • Når kanylen er helt ude af huden, kan du slippe stemplet og lade beskyttelseshylsteret glide på plads henover kanylen (se Fig. H).
English: Tocilizumab-treated patients reported an improvement in all patient-reported outcomes (Health Assessment Questionnaire Disability Index - HAQ-DI), Short Form-36 and Functional Assessment of Chronic Illness Therapy questionnaires.
Danish: De patienter, som blev behandlet med tocilizumab, berettede om forbedring i alle patientrapporterede resultater (Health Assessment Questionnaire Disability Index - HAQ-DI, den korte version af SF-36 og Functional Assessment of Chronic Illness Therapy Questionnaires).
English: Available data suggest that clinical improvement is observed within 6 weeks of initiation of treatment with RoActemra.
Danish: Tilgængelig data indikerer, at klinisk bedring observeres inden for 6 uger efter påbegyndelse af behandling med RoActemra.
English: Patients (which includes younger children with sJIA or pJIA who may be less able to communicate their symptoms) and parents/guardians of sJIA or pJIA patients, should be instructed to contact their healthcare professional immediately when any symptoms suggesting infection appear, in order to assure rapid evaluation and appropriate treatment.
Danish: For at sikre hurtig undersøgelse og passende behandling skal patienter (herunder yngre børn med sJIA eller pJIA, som kan have svært ved at kommunikere deres symptomer), og forældre/værger for sJIA- og pJIA-patienter informeres om omgående at kontakte sundhedspersonalet, hvis de får symptomer, som tyder på en infektion.
English: Platelets During routine laboratory monitoring in the 12 week controlled phase, 3% of patients in the placebo group and 1% in the tocilizumab group had a decrease in platelet count to ≤ 100 x 103/µl.
Danish: Under rutinemæssig laboratoriekontrol i den kontrollerede 12 ugers fase havde 3 % af patienterne i placebogruppen og 1 % i tocilizumab-gruppen et fald i trombocyttal til ≤ 100 x 103/µl.
English: Upper Respiratory Tract Infections pJIA, sJIA
Danish: Infektioner og parasitære sygdomme Øvre luftvejsinfektioner pJIA, sJIA
English: RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids.
Danish: RoActemra er indiceret til behandling af aktiv systemisk juvenil idiopatisk artrit (sJIA) hos patienter, som er 1 år og ældre, og som har haft utilstrækkelig respons på tidligere behandling med NSAID'er og systemiske kortikosteroider.
English: • You may see a drop of liquid at the end of the needle.
Danish: • Der kan være en dråbe væske på kanylens spids.
English: • Liver enzyme abnormalities Laboratory Value
Danish: • Abnorme leverenzymværdier Laboratorieværdi
English: It is not known whether RoActemra is passed into breast milk.
Danish: Det vides ikke, om RoActemra udskilles i mælken.
English: Abdominal pain, Mouth ulceration, Gastritis
Danish: Mavesmerter, sår i munden, gastritis
English: Injection into muscle could cause the injection to feel uncomfortable.
Danish: Hvis indsprøjtningen gives i muskelvæv, kan den føles ubehagelig.
English: RoActemra PK Parameter
Danish: RoActemra farmakokinetisk parameter
English: • If a caregiver is giving the injection, the outer area of the upper arms may also be used.
Danish: • Hvis indsprøjtningen gives af en hjælper, kan den yderste del af overarmen også anvendes (se Fig. B)
English: In SC-I, 1262 patients were randomized 1:1 to receive RoActemra subcutaneous 162 mg every week or RoActemra intravenous 8 mg/kg every four weeks in combination with non-biologic DMARD(s).
Danish: I SC-I-studiet blev 1262 patienter randomiseret 1:1 til subkutan RoActemra, 162 mg ugentligt eller intravenøs RoActemra, 8 mg/kg hver 4. uge i kombination med non-biologisk(e) DMARDs.
English: Adults will be given RoActemra once every 4 weeks through a drip in the vein (intravenous infusion) over one hour.
Danish: Voksne vil få RoActemra én gang hver 4. uge gennem et drop i en vene (intravenøs infusion).
English: Step 5.
Danish: Trin 5.
English: Reports of gastrointestinal perforation on RoActemra were primarily reported as complications of diverticulitis including generalised purulent peritonitis, lower gastrointestinal perforation, fistulae and abscess.
Danish: Rapporter om gastrointestinal perforation ved RoActemra-behandling blev primært rapporteret som komplikationer til diverticulitis, herunder generaliseret purulent peritonitis, nedre gastrointestinal perforation, fistel og absces.