FrancophonIA/ELRC3.0 huggingface dataset:
English: • Clean the chosen injection site area using the alcohol pad (See Fig. C), to reduce the risk of infection.
Danish: • Rengør området med en spritserviet (se Fig. C) for at mindske risikoen for infektion.
English: • Stevens-Johnson syndrome (skin rash, which may lead to severe blistering and peeling of the skin)
Danish: • Stevens-Johnsons syndrom (hududslæt, som kan medføre voldsomme blærer og afskalning af huden).
English: The most common events occurring during infusion were headache, nausea and hypotension and within 24 hours of infusion were dizziness and hypotension.
Danish: De hyppigste bivirkninger under en infusion var hovedpine, kvalme og hypotension, og inden for 24 timer efter en infusion svimmelhed og hypotension.
English: - to address the risk that patients using RoActemra may develop complications of diverticulitis which can become serious if not treated.
Danish: - til at gøre opmærksom på risikoen for at patienter, som får RoActemra, kan udvikle komplikationer til diverticulitis, og at disse komplikationer kan blive alvorlige, hvis de ikke behandles.
English: Keep the green button pressed in and continue holding the pre-filled pen pressed firmly against your skin (See Figure J).
Danish: Hold den grønne knap nede og bliv ved med at trykke pennen helt ind mod huden (se figur J).
English: • Open the box, and remove 1 single-use RoACTEMRA pre-filled pen from the box.
Danish: • Åbn æsken og tag 1 fyldt éngangspen med RoActemra ud af æsken.
English: • Take the box containing the syringe out of the refrigerator and open the box.
Danish: • Tag æsken med injektionssprøjten ud af køleskabet og åben æsken.
English: Leukopenia, Neutropenia, Hypofibrinogenae mia
Danish: Leukopeni, neutropeni, hypofibrinogenæ mi
English: • Check the expiration date on the pre-filled pen box.
Danish: • Check udløbsdatoen på æsken.
English: Patients should be advised to immediately seek medical help if they experience signs and symptoms of hepatic injury.
Danish: Patienterne skal rådes til straks at søge lægehjælp, hvis de oplever tegn og symptomer på leverskader.
English: Cough, Dyspnoea
Danish: Hoste, dyspnø
English: Seventeen (24%) tocilizumab treated patients versus 1 (3%) placebo patient were able to reduce their dose of corticosteroid by at least 20% without experiencing a subsequent JIA ACR30 flare or occurrence of systemic symptoms to week 12 (p=0.028).
Danish: 17 (24 %) tocilizumab-behandlede patienter versus 1 (3 %) placebo-patient var i stand til at reducere deres kortikosteroiddosis med mindst 20 % uden at opleve et efterfølgende flare i JIA ACR30 eller forekomst af systemiske symptomer op til uge 12 (p = 0,028).
English: • the medicine is cloudy
Danish: • medicinen er uklar
English: After the Injection
Danish: Efter indsprøjtningen
English: Pharmacotherapeutic group: Immunosuppressants, Interleukin inhibitors; ATC code: L04AC07.
Danish: Farmakoterapeutisk klassifikation: Immunsupprimerende midler, interleukinhæmmere, ATC-kode: L04AC07
English: The results from study SC-I is shown in Table 2.
Danish: Resultater fra SC-I-studiet vise i tabel 2.
English: Continued therapy should be carefully reconsidered in a patient exhibiting no improvement within this timeframe.
Danish: Fortsat behandling bør overvejes nøje hos patienter, der ikke udviser bedring inden for denne tidsramme.
English: Switching from 8 mg/kg intravenous once every 4 weeks to 162 mg subcutaneous once every week, will alter exposure in the patient.
Danish: Skift fra intravenøs indgift på 8 mg/kg hver 4 uge til subkutan indgift på 162 mg en gang ugentlig vil ændre eksponereringen hos patienten.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with RoActemra should be made taking into account the benefit of breast-feeding to the child and the benefit of RoActemra therapy to the woman.
Danish: Beslutningen om, hvorvidt amningen skal fortsætte eller stoppe, eller om behandlingen med RoActemra skal fortsætte eller stoppe, skal tages efter afvejning af barnets fordele ved amningen overfor kvindens fordele ved behandlingen med RoActemra .
English: • Do not remove the pre-filled pen cap until you are ready to inject RoACTEMRA.
Danish: • Tag ikke hætten af den fyldte pen, før du er klar til indsprøjtning af RoActemra.
English: Very rare: Hepatic failure
Danish: Meget sjælden: leversvigt
English: Patients with latent TB should be treated with standard anti-mycobacterial therapy before initiating RoActemra.
Danish: Patienter med latent tuberkulose skal sættes i standard-antimykobakteriel behandling, før behandlingen med RoActemra påbegyndes.
English: • Once the plunger is pushed all the way down, keep pressing down on the plunger to be sure all of the medicine is injected before taking the needle out of the skin.
Danish: • Når stemplet er skubbet helt i bund, skal du blive ved med at presse, for at sikre, at al medicinen er sprøjtet ind, inden kanylen trækkes ud af huden.
English: Supplies needed for an injection using your RoACTEMRA pre-filled pen (See Figure B):
Danish: Du skal bruge følgende til en indsprøjtning med en fyldt RoActemra-pen (se figur B):
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om RoActemra findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Study II, a two year study with planned analyses at week 24, week 52 and week 104, evaluated 1,196 patients who had an inadequate clinical response to MTX.
Danish: Studie II, som var et 2-års studie med planlagte analyser uge 24, uge 52 og uge 104, undersøgte 1.196 patienter, som havde et utilstrækkeligt klinisk respons på MTX.
English: Each of the RoActemra-treated groups and one of the placebo-treated groups followed a pre-specified prednisone-taper regimen over 26 weeks, while the second placebo-treated group followed a pre-specified prednisone-taper regimen over 52 weeks, designed to be more in keeping with standard practice.
Danish: Hver af de RoActemrabehandlede grupper og en af de placebo-behandlede grupper fulgte et forud specificeret nedtrapningsregime af prednison over 26 uger, mens den anden placebo-behandlede gruppe fulgte et forud specificeret nedtrapningsregime prednison over 52 uger, designet til at være mere i overensstemmelse med standard praksis.
English: Two subcutaneous doses of RoActemra (162 mg every week and 162 mg every other week) were compared to two different placebo control groups randomised 2:1:1:1.
Danish: To subkutane doser RoActemra (162 mg ugentligt og 162 mg hver anden uge) blev sammenlignet med to forskellige placebogrupper randomiseret 2: 1: 1: 1.
English: • You may hear a second “click” during the injection but you should continue to hold the pre filled pen firmly against your skin until the purple indicator stops moving.
Danish: • Du vil måske høre endnu et klik under indsprøjtningen, men du må ikke slippe pennen, der fortsat skal trykkes ned mod huden, indtil den lilla indikator holder op med at bevæge sig.
English: These decreases occurred without associated bleeding events.
Danish: Faldene forekom uden ledsagende blødningsepisoder.
English: What you need to know to use your RoActemra pre-filled pen (ACTPen) safely.
Danish: Vigtigt at vide for at du kan bruge den fyldte RoActemra-pen (ACTPen) sikkert.
English: The efficacy population for the tisagenlecleucel cohort included 28 males and 23 females (total 51 patients) of median age 17 years (range, 3-68 years).
Danish: Effektpopulationen for tisagenleclaucel kohorten inkluderede 28 mænd og 23 kvinder (i alt 51 patienter) med en medianalder på 17 år (i et spænd på 368 år).
English: • Check the Window area to see that it is filled with the purple indicator (See Figure L).
Danish: • Check at vinduet er fyldt af den lilla indikator (se figur L).
English: Population pharmacokinetic analysis for pJIA patients showed body size related impact on linear clearance so that body-weight based dosing should be taken into consideration (see Table 9).
Danish: Farmakokinetiske populationsanalyser hos pJIA patienter viste, at kropsstørrelsen har indflydelse på den lineære clearance og derfor bør kropsvægt tages i betragtning ved dosering (se tabel 9).
English: The safety profile comes from 4158 patients exposed to RoActemra in clinical trials; the majority of these patients were participating in RA studies (n=4009), while the remaining experience comes from GCA (n=149) studies.
Danish: Sikkerhedsprofilen er udarbejdet fra 4158 patienter eksponeret for RoActemra i kliniske studier; størstedelen af disse patienter deltog i reumatoid artrit-studier (n = 4009), mens de resterende erfaringer stammer fra GCA (n = 149) studier.
English: • Check the expiration date on the RoACTEMRA pre-filled pen (See Figure A).
Danish: • Check udløbsdatoen på den fyldte RoActemra-pen (se figur A).
English: The safety and efficacy of RoActemra subcutaneous formulation in children with conditions other than sJIA or pJIA have not been established.
Danish: Sikkerhed og virkning af RoActemra subkutan formulering hos børn med andre sygdomme end sJIA eller pJIA er ikke klarlagt.
English: Diarrhea pJIA, sJIA
Danish: Diarré pJIA, sJIA
English: Cumulative glucocorticoid dose
Danish: Kumulativ glukokortikoid dosis
English: Although IL-6 does not seem to be a critical cytokine for foetal growth or the immunological control of the maternal/foetal interface, a relation of this finding to tocilizumab cannot be excluded.
Danish: Selvom IL-6 ikke synes at være et kritisk cytokin over for føtal vækst eller immunologisk kontrol af den maternelle/føtale interface, kan en forbindelse mellem disse fund og tocilizumab ikke udelukkes.
English: Instructions for dilution prior to administration
Danish: Instrukser for fortynding før indgivelse
English: The total patient years duration in the RoActemra all exposure population was 138.5 patient years during the 12 month double blind, placebo controlled phase of the study.
Danish: I den RoActemra-eksponerede population var den samlede varighed 138,5 patientår i løbet af den 12 måneders dobbeltblindede, placebo-kontrollerede fase af studiet.
English: Infusion related reactions are defined as all events occurring during or within 24 hours of an infusion.
Danish: Infusionsreaktioner er defineret som alle bivirkninger, som indtræffer under eller inden for 24 timer efter en infusion.
English: These factors need to be monitored while receiving RoActemra.
Danish: Disse faktorer skal kontrolleres under behandlingen med RoActemra.
English: Following intravenous administration, RoActemra undergoes biphasic elimination from the circulation.
Danish: Efter intravenøs indgift undergår RoActemra en bifasisk elimination fra cirkulationen.
English: Two patients developed positive anti-tocilizumab antibodies with one of these patients having a hypersensitivity reaction leading to withdrawal.
Danish: To patienter udviklede positive anti-tocilizumab-antistoffer, og én af disse patienter havde en overfølsomhedsreaktion, som førte til afbrydelse af behandlingen.
English: Do not use RoActemra.
Danish: Brug ikke RoActemra.
English: Reported serious infections were similar to those seen in RA patients with the addition of varicella and otitis media.
Danish: De rapporterede alvorlige infektioner svarede til dem, som ses hos patienter med reumatoid artrit, samt varicella og otitis media.
English: • If you have moderate to severe kidney function problems, your doctor will monitor you.
Danish: • Hvis du har moderate eller svære problemer med din nyrefunktion vil din læge følge dig.
English: If appropriate, the dose of concomitant MTX and/or other medications should be modified or dosing stopped and tocilizumab dosing interrupted until the clinical situation has been evaluated.
Danish: Hvis det er hensigtsmæssigt, skal dosis af MTX og/eller andre lægemidler, der anvendes samtidig med tocilizumab, justeres eller dosering afbrydes, og tocilizumab-dosering afbrydes, indtil den kliniske situation er blevet evalueret.
English: Important: Keep your unused pre-filled pens in the original carton and keep in the refrigerator at 2˚C
Danish: Vigtigt: Opbevar ubrugte fyldte penne i den originale æske i køleskabet ved 2-8˚C.
English: Both study treatments induced the same pattern of changes in laboratory safety parameters (decreases in neutrophil and platelet counts, increases in ALT, AST and lipids), however, the magnitude of change and the frequency of marked abnormalities was higher with tocilizumab compared with adalimumab.
Danish: De 2 behandlinger i studiet udløste det samme mønster i ændringer i laboratoriesikkerheds-parametre (fald i neutrofiltal og trombocyttal, stigninger i ALAT, ASAT og lipider), dog var ændringen i og hyppigheden af de nævnte anormaliteter højere med tocilizumab end med adalimumab.
English: • Risk of gastrointestinal perforations especially in patients with history of diverticulitis or intestinal ulcerations
Danish: • Risiko for gastrointestinale perforationer, specielt hos patienter, der tidligere har oplevet diverticulitis eller blødninger i mave-tarmkanalen
English: Storage
Danish: Opbevaring
English: RoActemra contains sodium
Danish: RoActemra indeholder natrium
English: Patients must have a minimum body weight of 10 kg when receiving RoActemra subcutaneously.
Danish: Patienter skal have en kropsvægt på mindst 10 kg ved behandling med RoActemra subkutant.
English: In the RoActemra subcutaneous weekly group, a total of 6% (6/100) patients reported an adverse reaction occurring at the site of a subcutaneous injection.
Danish: I den RoActemra subkutane ugentlige patientgruppe, rapporterede i alt 6% (6/100) af patienterne en bivirkning ved stedet af en subkutan injektion.
English: • Hold the pre-filled pen comfortably in 1 hand by the upper part, so that you can see the Window area of the pre-filled pen (See Figure F).
Danish: • Hold om den øverste del af den fyldte pen med én hånd, så du kan se vinduet i den fyldte pen (se figur F).
English: RoActemra is for subcutaneous use.
Danish: RoActemra er til subkutan anvendelse.
English: In clinical studies with tocilizumab, patients who screened positive for hepatitis were excluded.
Danish: I kliniske studier med tocilizumab blev de patienter, som blev screenet positive for hepatitis, ekskluderet.
English: The usual dose of RoActemra depends on the patient's weight.
Danish: Den anbefalede dosis af RoActemra afhænger af patientens vægt.
English: The accumulation ratios for AUC, Cmin, and Cmax were 2.67, 6.02, and 2.12, respectively.
Danish: Akkumuleringsratio for AUC, Cmin og Cmax var henholdsvis 2,67; 6,02 og 2,12.
English: L-Arginine hydrochloride L-Methionine
Danish: L-Argininhydrochlorid L-Methionin
English: • If any patient has recently been vaccinated (either adult or child), or is planning a vaccination, tell your doctor.
Danish: • Hvis du eller dit barn er blevet vaccineret for nylig (både børn og voksne) eller planlægger at blive det, skal du fortælle det til lægen.
English: Do not attempt to administer an injection until you are sure that you understand how to use the RoActemra syringe.
Danish: Prøv ikke at give dig selv en indsprøjtning før du er helt sikker på hvordan RoActmra-injektionssprøjten.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden du begynder at få dette lægemiddel, da den indeholder vigtige oplysninger.
English: Part I consisted of a 16-week active tocilizumab treatment lead-in period (n=188) followed by Part II, a 24-week randomized double-blind placebo-controlled withdrawal period (n=163), followed by Part III, a 64-week open-label period.
Danish: Del I bestod af en 16-ugers opstartsperiode med aktiv tocilizumab-behandling (n=188), efterfulgt af del II, en 24-ugers, randomiseret, dobbeltblindet, placebo-kontrolleret periode, hvor patienterne kunne udtræde (n=163), efterfulgt af del III, 64 ugers åben behandling.
English: Women of childbearing potential must use effective contraception during and up to 3 months after treatment.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandling og indtil 3 måneder efter behandling.
English: Magyarország Roche (Magyarország) Kft. Tel: +36 - 23 446 800
Danish: Roche (Magyarország) Kft. Tel: +36 - 23 446 800
English: ADRs from clinical trials and/or post marketing experience with RoActemra based on spontaneous case reports, literature cases and cases from non-interventional study programs are listed in Table 1 and are presented by MedDRA system organ class.
Danish: Bivirkninger fra kliniske studier og/eller i perioden efter markedsføring af RoActemra, baseret på indberetninger af spontane rapportet, litteratur rapporter og rapporter fra ikke-interventionelle studier, er vist i tabel 1 og er opstillet efter MedDRA systemorganklasse.
English: The European Medicines Agency has waived the obligation to submit the results of studies with RoActemra in all subsets of the paediatric population in treatment of cytokine release syndrome associated with chimeric antigen receptor (CAR) T cell therapy.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med RoActemra i alle undergrupper af den pædiatriske population i behandling af cytokinfrigivelsessyndrom forbundet med CAR T-celle behandling.
English: Your healthcare provider should show you how to prepare and inject properly before you use the RoActemra syringe for the first time.
Danish: Lægen eller sygeplejersken skal vise dig hvordan du gør injektionssprøjten klar og hvordan du foretager indsprøjtningen korrekt inden du skal bruge RoActemra-injektionssprøjten første gang.
English: • If you have had tuberculosis, tell your doctor.
Danish: • Hvis du har haft tuberkulose, skal du fortælle det til din læge.
English: Manufacturer Roche Pharma AG Emil-Barell-Str. 1
Danish: Roche Pharma AG Emil-Barell-Str. 1
English: The expression of hepatic CYP450 enzymes is suppressed by cytokines, such as IL-6, that stimulate chronic inflammation.
Danish: Ekspression af hepatiske CYP450-enzymer supprimeres af cytokiner så som IL-6, som stimulerer kronisk inflammation.
English: This should be a final volume of 50 mL.
Danish: Det samlede volumen skal være 50 ml.
English: Patients transitioning from intravenous to subcutaneous formulation should administer their first subcutaneous dose instead of the next scheduled intravenous dose under the supervision of a qualified healthcare professional.
Danish: Patienter der skifter fra intravenøs til subkutan formulering bør tage første subkutane dosis på tidspunktet for næste planlagte intravenøse dosis og under supervision af kvalificeret sundhedspersonale.
English: Give the injection
Danish: Giv indsprøjtningen
English: It is unknown whether tocilizumab is excreted in human breast milk.
Danish: Det vides ikke, om tocilizumab udskilles i human mælk.
English: - Methotrexate
Danish: - Methotrexat
English: There have been postmarketing reports of interstitial lung disease (including pneumonitis and pulmonary fibrosis), some of which had fatal outcomes.
Danish: Efter markedsføring har der været rapporter om interstitiel lungesygdom (herunder pneumonitis og lungefibrose), som i nogle tilfælde var dødelige.
English: • Serious injection/infusion reaction and their management
Danish: • Alvorlige injektions/infusions-reaktioner og deres håndtering
English: Although IL-6 does not seem to be a critical cytokine for foetal growth or the immunological control of the maternal/foetal interface, a relation of this finding to RoActemra cannot be excluded.
Danish: Selvom IL-6 ikke synes at være et kritisk cytokin over for føtal vækst eller immunologisk kontrol af den maternelle/føtale interface, kan en forbindelse mellem disse fund og RoActemra ikke udelukkes.
English: Do not inject RoACTEMRA if the liquid is cloudy, discolored, or has lumps or particles in it because it may not be safe to use.
Danish: Du må ikke bruge RoActemra, hvis væsken er uklar eller misfarvet eller der er klumper eller partikler i væsken, fordi den ikke er sikker at bruge.
English: Do not use it if the expiration date has passed because it may not be safe to use.
Danish: Brug ikke pennen, hvis udløbsdatoen er overskredet, fordi den ikke er sikker at bruge.
English: At steady-state following a dose of 8 mg/kg every 4 weeks, the effective t1/2 decreased with decreasing concentrations within a dosing interval from 18 days to 6 days.
Danish: Ved steady-state efter en dosis på 8 mg/kg hver 4. uge aftog den effektive t1/2 fra 18 dage til 6 dage ved faldende koncentrationer inden for et dosisinterval.
English: sJIA Patients
Danish: sJIA patienter
English: After 12 weeks or at the time of escape, due to disease worsening, patients were treated in the open label phase at weight appropriate dosing.
Danish: Efter 12 uger eller fra det tidspunkt, hvor patienten måtte udgå på grund af sygdomsforværring, blev patienterne behandlet i den igangværende åbne forlængelsesfase med dosering efter vægt.
English: A total of 5.8% of patients experienced an elevation of indirect bilirubin of > 1 to 2 x ULN and 0.4% had an elevation of > 2 x ULN.
Danish: Samlet oplevede 5,8 % af patienterne en stigning i indirekte bilirubin > 1-2 gange øvre normalgrænse, og 0,4 % havde en stigning på > 2 gange øvre normalgrænse.
English: Study I evaluated 673 patients who had not been treated with MTX within six months prior to randomisation and who had not discontinued previous MTX treatment as a result of clinically important toxic effects or lack of response.
Danish: I studie I undersøgte man 673 patienter, som ikke havde været behandlet med MTX i seks måneder før randomiseringen, og som ikke havde stoppet tidligere MTX-behandling på grund af klinisk signifikante toksiske virkninger eller mangel på respons.
English: • To unlock it, press the pre-filled pen firmly against your pinched skin until the needle-shield is completely pushed in (See Figure I).
Danish: • For at aktivere den, skal du trykke pennen helt ind mod hudfolden, indtil nåleskjoldet er helt skubbet ind (se figur I).
English: Do not attempt to use the upper arm area by yourself (See Figure D).
Danish: Brug ikke overarmen, hvis du selv giver indsprøjtningen (se figur D).
English: • low white blood cell counts shown by blood tests (neutropenia, leucopenia)
Danish: • lavt antal hvide blodlegemer i blodprøverne (neutropeni, leukopeni)
English: RoActemra is for single-use only.
Danish: RoActemra er kun til engangsbrug.
English: The majority was resolved without any treatment and none necessitated drug discontinuation.
Danish: De fleste forsvandt uden behandling og ingen krævede seponering af behandlingen.
English: Each patient continued in Part II of the study until Week 40 or until the patient satisfied JIA ACR30 flare criteria (relative to Week 16) and qualified for escape to tocilizumab therapy (same dose received in Part I).
Danish: Alle patienter fortsatte i del II indtil uge 40, eller indtil patienten opfyldte JIA-ACR30-kriterierne for flare (i forhold til uge 16) og kunne få tocilizumab som escape-behandling (samme dosis som i del I).
English: • Dispose of the full container as instructed by your healthcare provider or pharmacist.
Danish: • Fulde affaldsbeholdere skal bortskaffes i overensstemmelse med sundhedspersonalets eller apotekspersonalets anvisning.
English: Patients should be managed according to local clinical guidelines for management of hyperlipidaemia.
Danish: Patienterne skal behandles i henhold til de gældende retningslinjer for behandling af hyperlipidæmi.
English: The safety profile of subcutaneous RoActemra was also evaluated in 52 paediatric patients with pJIA.
Danish: Sikkerhedsprofilen for subkutan RoActemra er også blevet undersøgt hos 52 pædiatriske patienter med pJIA.
English: Keep track of your next dose.
Danish: Hold øje med hvornår du skal have næste dosis.
English: In healthy subjects administered tocilizumab in doses from 2 to 28 mg/kg, absolute neutrophil counts decreased to their lowest 3 to 5 days following administration.
Danish: Hos raske forsøgspersoner, som fik tocilizumab i doser fra 2 til 28 mg/kg, faldt det absolutte neutrofilocyttal til det laveste niveau 3-5 dage efter administrationen.