FrancophonIA/ELRC3.0 huggingface dataset:
English: A higher frequency of injection site reactions was observed in the subcutaneous arms compared with placebo subcutaneous injections in the intravenous arms.
Danish: Der blev observeret højere hyppighed af reaktioner ved injektionsstedet i den subkutane behandlingsarm sammenlignet med den intravenøse arm, hvor der blev givet subkutane placeboinjektioner.
English: Reducing the steroid dose can also lead to a flare-up of the GCA.
Danish: Reduktion af steroiddosis kan også føre til en pludselig opblussen af kæmpecellet arteritis.
English: These reactions were generally observed during the second to fifth infusions of tocilizumab (see section 4.4).
Danish: Reaktionerne blev generelt observeret under den anden til femte infusion af tocilizumab (se pkt.
English: Given its long elimination half-life (t1/2), the effect of tocilizumab on CYP450 enzyme activity may persist for several weeks after stopping therapy.
Danish: På grund af den lange eliminationshalveringstid (t1/2) kan virkningen af tocilizumab på enzymaktiviteten af CYP450 persistere i flere uger efter, at behandlingen er stoppet.
English: Patients would be monitored for liver function tests.
Danish: Patienterne skal monitoreres for leverfunktion.
English: • Never re-use the same syringe
Danish: • Brug aldrig den samme injektionssprøjte igen
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Bivirkningerne inden for hver frekvensgruppe er opstillet i rækkefølge efter aftagende alvorlighed.
English: The median time from start of CRS to first dose of tocilizumab was 3 days (range, 0-18 days).
Danish: Mediantiden fra start af cytokinfrigivelsessyndrom til første dosis med tocilizumab var 3 dage (i et spænd på 0-18 dage).
English: Table 2: List of ADRs occurring in clinical trial patients with sJIA or pJIA receiving tocilizumab as monotherapy or in combination with MTX.
Danish: Tabel 2: Liste over bivirkninger, som forekom i kliniske studier hos patienter med sJIA eller pJIA, der fik behandling med tocilizumab som monoterapi eller i kombination med MTX
English: List of ADRs occurring in patients treated with RoActemra MedDRA System Organ Class
Danish: Liste over bivirkninger, som forekom hos patienter behandlet med RoActemra MedDRA Systemorganklasse
English: • high blood fat (triglycerides)
Danish: • højt fedtindhold i blodet (triglycerider)
English: Slovenská republika Roche Slovensko, s.r.o.
Danish: Roche Slovensko, s.r.o.
English: • methylprednisolone, dexamethasone, used to reduce inflammation
Danish: • methylprednisolon eller dexamethason, som bruges til at nedsætte betændelse (inflammation)
English: Ask your healthcare provider or pharmacist for information about where you can get a "sharps" container or what other types of puncture-resistant containers you can use to safely dispose of your used syringes, if you do not have one.
Danish: Spørg sundhedspersonalet eller apotekspersonalet, hvordan du skaffer en affaldsbeholder til skarpe genstande eller anden type sikkerhedsbeholder, så du kan komme af med dine bruge injektionssprøjter på en sikker måde (se Fig. I).
English: One case of accidental overdose was reported in which a patient with multiple myeloma received a single dose of 40 mg/kg.
Danish: Der blev indberettet et tilfælde af utilsigtet overdosering, hvor en patient med multipelt myelom fik en enkeltdosis på 40 mg/kg.
English: • abnormal liver function tests (increased transaminases)
Danish: • unormale leverprøver (forhøjede aminotransferaser)
English: In clinical studies with RoActemra, patients who screened positive for hepatitis were excluded.
Danish: I kliniske studier med RoActemra blev de patienter, som blev screenet positive for hepatitis, ekskluderet.
English: the accumulation ratios for AUC and Cmax were small, 1.32 and 1.09, respectively.
Danish: Akkumulationsratioer for AUC og Cmax var små, hhv. 1,32 og 1,09.
English: Patients should seek immediate medical attention if developing symptoms of serious allergic reactions (see section 4.4).
Danish: Patienten bør straks søge lægehjælp, hvis der udvikles symptomer på alvorlig allergisk reaktion (se pkt.
English: Radiographic mean changes over 52 weeks in Study II PBO + MTX (+ TCZ from week 24) N = 393
Danish: Gennemsnitlige radiografiske ændringer efter 52 uger i studie II Placebo + MTX (+TCZ fra uge 24) N = 393
English: Events reported during the infusion were primarily episodes of hypertension; events reported within 24 hours of finishing an infusion were headache and skin reactions (rash, urticaria).
Danish: De hændelser, som forekom under infusionen, var fortrinsvis episoder af hypertension, medens de hændelser, som forekom inden for 24 timer efter infusionens afslutning, var hovedpine og hudreaktioner (udslæt og urticaria).
English: Parenteral medicinal products should be inspected visually for particulate matter or discoloration prior to administration.
Danish: Parenterale lægemidler bør inspiceres visuelt for partikler og misfarvning før anvendelse.
English: Both considerably lower than in the placebo plus 26 weeks and the placebo plus 52 weeks prednisone taper groups, 4023.5 mg and 5389.5 mg respectively.
Danish: Begge var betydeligt lavere end i grupperne, der fik placebo plus 26 ugers og placebo plus 52 ugers nedtrapningsregime af prednison, henholdsvis 4023,5 mg og 5389,5 mg.
English: Your doctor will check for signs and symptoms of tuberculosis before starting RoActemra.
Danish: Din læge vil undersøge dig for symptomer på tuberkulose, før du begynder behandlingen med RoActemra.
English: JIA ACR Response Rates at Week 40 Relative to baseline (Percentage of Patients)
Danish: JIA-ACR-respons ved uge 40 i forhold til baseline (procentdel af patienter)
English: PBO + DMARD
Danish: Placebo + DMARD
English: > 1 to 3 x Upper Limit of Normal (ULN)
Danish: > 1 til 3 gange øvre normalgrænse
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og reproduktions- og udviklingstoksicitet.
English: RoActemra is supplied in a vial (type I glass) with a stopper (butyl rubber) containing 4 mL, 10 mL or 20 mL concentrate.
Danish: RoActemra leveres i hætteglas (type I glas) med prop (butylgummi) indeholdende 4 ml, 10 ml eller 20 ml koncentrat.
English: In the SC Study (WA28118), 46 of the 51 (90.2%) patients tested for anti-tocilizumab antibodies at baseline had at least one post-baseline screening assay result.
Danish: I det subkutane studie (WA28118) havde 46 ud af 51 (90,2 %) patienter, som blev testet for antitocilizumab-antistoffer ved baseline, mindst ét screeningsanalyseresultat efter baseline.
English: The rate of infections in the tocilizumab all exposure population was 163.7 per 100 patient years.
Danish: Hyppigheden af infektioner blandt alle tocilizumab-eksponerede patienter var 163,7 per 100 patientår.
English: The double-blind controlled period was 6 months in four studies (studies I, III, IV and V) and was up to 2 years in one study (study II).
Danish: Den dobbeltblindede, kontrollerede periode var 6 måneder i fire studier (studierne I, III, IV og V) og op til 2 år i et studie (studie II).
English: Suitability of the patient or parent/guardian for subcutaneous home use should be assessed and patients or parent/guardian instructed to inform a healthcare professional before administering the next dose if they experience symptoms of an allergic reaction.
Danish: Patientens eller forældrenes/værgens egnethed til subkutan selvadministration bør vurderes og patienten eller forældrene/værgen bør instrueres i at kontakte sundhedspersonalet før administration af den næste dosis, hvis der opleves symptomer på allergisk reaktion.
English: After 2 years of treatment with RoActemra plus MTX, 14% of patients achieved a major clinical response (maintenance of an ACR70 response for 24 weeks or more).
Danish: Efter 2 års behandling med RoActemra plus MTX opnåede 14 % af patienterne et betydningsfuldt klinisk respons (opretholdelse af et ACR70-respons i 24 uger eller mere).
English: Clinical response
Danish: Klinisk respons
English: RoActemra is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.
Danish: RoActemra er indiceret til behandling af kimærisk antigenreceptor (CAR) T-celle-induceret svær eller livstruende cytokinfrigivelsessyndrom (CRS) hos voksne og pædiatriske patienter, som er 2 år og ældre.
English: Do not use the pre-filled pen if the box looks like it has already been opened.
Danish: Det er vigtigt at du ikke bruger de fyldte penne, hvis det ser ud som om æsken allerede har været åbnet.
English: This data does not suggest a relevant risk for cancer initiation and progression under tocilizumab treatment.
Danish: Disse data tyder ikke på en relevant risiko for initiering og progression af cancer under behandling med tocilizumab.
English: At one year in the open label extension phase the overall rate of serious infections remained stable at 11.3 per 100 patient years.
Danish: Efter 1 år i den åbne forlængelsesfase forblev hyppigheden af alvorlige infektioner stabil på 11,3 per 100 patientår.
English: The interval between live vaccinations and initiation of RoActemra therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
Danish: Tidsrummet mellem vaccination med levende vacciner og påbegyndelse af RoActemra-behandling skal være i henhold til de gældende retningslinjer vedrøreende vaccination og immunsuppressive lægemidler.
English: Study V evaluated 499 patients who had an inadequate clinical response or were intolerant to one or more TNF antagonist therapies.
Danish: Studie V undersøgte 499 patienter, som havde responderet utilstrækkeligt, eller som ikke tolererede behandling med en eller flere TNF-antagonister.
English: RoActemra subcutaneous formulation is not intended to be given to children with sJIA weighing less than 10 kg.
Danish: RoActemra subkutan formulering er ikke beregnet til børn med sJIA, der vejer mindre end 10 kg.
English: Patients who completed Part I of the study and achieved at least a JIA ACR30 response at week 16 compared to baseline were eligible to enter the blinded withdrawal period (Part II) of the study.
Danish: Patienter, som fuldførte del I af studiet og mindst opnåede JIAACR30-respons ved uge 16 sammenlignet med baseline, var kvalificerede til at fortsætte i den blindede periode (del II).
English: However, a slight increase in abortion/embryonal-foetal death was observed with high systemic exposure (> 100 x human exposure) in the 50 mg/kg/day high-dose group compared to placebo and other low-dose groups.
Danish: Der blev dog set en mindre stigning i antallet af aborter/embryonal-føtal død efter høj systemisk eksponering i højdosisgruppen (> 100 gange human eksponering), som fik 50 mg/kg/dag, sammenlignet med placebo og andre lavdosisgrupper.
English: The t1/2 of RoActemra was concentration-dependent.
Danish: RoActemras halveringstid (t1/2) var koncentrationsafhængig.
English: Reported serious infections, some with fatal outcome, included pneumonia, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis, bacterial arthritis.
Danish: De indberettede alvorlige infektioner, nogle med dødeligt udfald, omfattede pneumoni, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis og bakteriel arthritis.
English: List of ADRs occurring in patients with RA receiving tocilizumab as monotherapy or in combination with MTX or other DMARDs in the double-blind controlled period or during postmarketing experience
Danish: Liste over bivirkninger, som forekom hos patienter med reumatoid artrit, der fik behandling med tocilizumab som monoterapi eller i kombination med MTX eller andre DMARDs i den dobbeltblindede, kontrollerede periode eller i perioden efter markedsføring
English: One case of accidental overdose was reported in which a patient with multiple myeloma received a single dose of 40 mg/kg administered intravenously.
Danish: Der blev indberettet et tilfælde af utilsigtet overdosering, hvor en patient med multipelt myelom fik en enkeltdosis på 40 mg/kg administreret intravenøst.
English: Action
Danish: Handling
English: This data does not suggest a relevant risk for cancer initiation and progression under RoActemra treatment.
Danish: Disse data tyder ikke på en relevant risiko for initiering og progression af cancer under behandling med RoActemra.
English: The most common events observed were nasopharyngitis and upper respiratory tract infections.
Danish: De hyppigste bivirkninger var nasopharyngitis og øvre luftvejsinfektioner.
English: The total patient exposure to RoActemra in the pJIA all exposure population was 184.4 patient years for IV and 50.4 patient years for SC tocilizumab.
Danish: Den samlede RoActemra-eksponering hos pJIA populationen var 184,4 patientår for intravenøs tocilizumab og 50,4 patientår for subkutan tocilizumab.
English: At the conclusion of Part I, JIA ACR 30/50/70/90 responses were 89.4%, 83.0%, 62.2%, and 26.1%, respectively.
Danish: Ved afslutningen af del I var JIA-ACR30-, ACR50-, ACR70- og ACR90-respons henholdsvis 89,4%, 83,0%, 62,2% og 26,1%.
English: Neutrophils
Danish: Neutrofilocytter
English: After 2 years of treatment with tocilizumab plus MTX, 14% of patients achieved a major clinical response (maintenance of an ACR70 response for 24 weeks or more).
Danish: Efter 2 års behandling med tocilizumab plus MTX opnåede 14 % af patienterne et betydningsfuldt klinisk respons (opretholdelse af et ACR70-respons i 24 uger eller mere).
English: In the 12 week controlled phase, the rate of serious infections in the intravenous RoActemra group was 11.5 per 100 patient years.
Danish: I den kontrollerede 12 ugers fase var hyppigheden af alvorlige infektioner i intravenøs RoActemragruppen 11,5 per 100 patientår.
English: At week 12, the proportion of tocilizumab treated patients showing a minimally clinically important improvement in the Childhood Health Assessment Questionnaire - Disability Index (defined as an individual total score decrease of ≥ 0.13) was significantly higher than in placebo treated patients, 77% versus 19% (p<0.0001).
Danish: Ved uge 12 var andelen af patienter,som viste en minimal klinisk vigtig forbedring i Childhood Health Assessment Questionnaire Disability Index (defineret som et individuelt total fald i total-score på ≥ 0,13) signifikant højere hos tocilizumabbehandlede patienter og end hos placebobehandlede patienter; 77 % versus 19 % (p<0,0001).
English: Primary Endpoint ****Sustained remission (Tocilizumab groups vs Placebo+26) Responders at Week 52, n (%)
Danish: Primært endepunkt ****Vedvarende remission (Tocilizumab grupper vs Placebo+26) Respondenter ved uge 52, n (%)
English: The median values of Tmax were 3 days after the RoActemra weekly dose and 4.5 days after the tocilizumab every other week dose.
Danish: Medianværdierne for Tmax var 3 dage efter ugentlig dosis RoActemra og 4,5 dage efter RoActemra dosis administreret hver anden uge.
English: • Continue to keep the needle-shield pushed in.
Danish: • Fortsæt med at trykke nåleskjoldet helt ind.
English: ADRs in the pJIA and sJIA patients treated with tocilizumab are listed in the Table 2 and presented by MedDRA system organ class.
Danish: Bivirkninger for pJIA- og sJIA-patienter behandlet med tocilizumab er vist i tabel 2, inddelt efter MedDRA systemorganklasse.
English: Diluted product: After dilution, the prepared solution for infusion is physically and chemically stable in sodium chloride 9 mg/mL (0.9%) solution for injection at 30ºC for 24 hours.
Danish: Fortyndet produkt: Efter fortynding er den tilberedte infusionvæske, opløsning fysisk og kemisk stabil i natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning i 24 timer ved 30 ºC.
English: Immunoglobulin G
Danish: Immunglobulin G
English: Patients with severe or life-threatening CRS frequently have cytopenias or elevated ALT or AST due to the underlying malignancy, preceding lymphodepleting chemotherapy or the CRS.
Danish: Patienter med svær eller livstruende cytokinfrigivelsessyndrom har ofte cytopenier eller forhøjede værdier af ALAT og ASAT på grund af den underliggende malignitet, forudgående lymfodepleterende kemoterapi eller pga. selve cytokinfrigivelsessyndromet.
English: • Do not use the syringe if it appears to be damaged
Danish: • Brug ikke den fyldte injektionssprøjte, hvis den ser ud til at være beskadiget
English: In GCA patients, at steady state, the effective t ½ of RoActemra varied between 18.3 and 18.9 days for 162 mg weekly regimen, and between 4.2 and 7.9 days for 162 mg every other weekly regimen.
Danish: Ved steady-state hos GCA-patienter varierede den effektive t ½ for RoActemra mellem 18,3 og 18,9 dage for 162 mg ugentlig regime og mellem 4,2 og 7,9 dage for 162 mg administreret hver anden uge regimet.
English: This should be a final volume of 100 mL.
Danish: Det totale volumen skal være 100 ml.
English: The Marketing Authorisation Holder (MAH) shall provide an educational pack covering the therapeutic indications RA, sJIA, pJIA and GCA, targeting all physicians who are expected to prescribe/use RoActemra containing the following:
Danish: • Yderligere risikominimeringsforanstaltninger Indehaveren af markedsføringstilladelsen (MAH) skal udlevere en undervisningspakke, som dækker de terapeutiske indikationer RA, sJIA,pJIA og kæmpecellet arteritis, til alle læger, som forventes at skulle udskrive/anvende RoActemra.
English: Following intravenous administration, tocilizumab undergoes biphasic elimination from the circulation.
Danish: Efter intravenøs indgift undergår tocilizumab en bifasisk elimination fra cirkulationen.
English: • redness, heat, unusual swelling of skin or joint
Danish: • rødme, hedeture, usædvanlige hævelser i hud eller led
English: • Use your other hand to gently pinch the area of skin you cleaned, to prepare a firm injection site (See Figure G).
Danish: • Klem forsigtigt med den anden hånd om det område du har renset, så du får en fast hudfold du kan give indsprøjtningen i (se figur G).
English: At steady-state, predicted AUC and Cmin were 3.2 and 30 fold higher at 8 mg/kg as compared to 4 mg/kg, respectively.
Danish: Ved steady-state var de forventede værdier for AUC og Cmin hhv. 3,2 og 30 gange højere efter 8 mg/kg, sammenlignet med 4 mg/kg.
English: SF-36 (mean change in mental and physical component scores) was significantly greater with RoActemra subcutaneous group (6.5 and 5.3) versus placebo (3.8 and 2.9).
Danish: SF-36 (gennemsnitlig ændring i de score for mentale og fysiske komponenter) var signifikant højere i den subkutane RoActemra arm (6,5 og 5,3) sammenlignet med placebo (3,8 og 2,9).
English: • To be sure the needle can be inserted correctly under the skin, pinch a fold of loose skin at the clean injection site with your free hand.
Danish: • For at sikre, at kanylen går rigtigt ind under huden, skal du klemme en fold hud mellem 2 fingre med din frie hånd.
English: The most commonly reported ADRs (occurring in ≥ 5% of patients treated with tocilizumab monotherapy or in combination with DMARDs) were upper respiratory tract infections, nasopharyngitis, headache, hypertension and increased ALT.
Danish: De hyppigst indberettede bivirkninger (som forekom hos ≥ 5 % af patienterne, der fik tocilizumab monoterapi eller kombinationsbehandling med DMARDs) var øvre luftvejsinfektioner, nasopharyngitis, hovedpine, hypertension og forhøjet ALAT.
English: The clinical data are insufficient to assess the potential incidence of malignancy following exposure to RoActemra.
Danish: De kliniske data er ikke tilstrækkelige til at vurdere den mulige incidens af malignitet efter eksponering for RoActemra.
English: RoActemra versus adalimumab in monotherapy
Danish: RoActemra versus adalimumab i monoterapi
English: The safety profile comes from 4510 patients exposed to RoActemra in clinical trials; the majority of these patients were participating in adult RA studies (n=4009), while the remaining experience comes from GCA (n=149), pJIA (n=240) and sJIA (n=112) studies.
Danish: Sikkerhedsprofilen er udarbejdet fra 4510 patienter eksponeret for RoActemra i kliniske studier; størstedelen af disse patienter deltog i reumatoid artrit-studier (n = 4009) med voksne patienter, mens de resterende erfaringer stammer fra GCA (n = 149), pJIA (n = 240) samt sJIA (n = 112) studier.
English: • Preparation of injection/infusion
Danish: • Fremstilling af injektionen/infusionen
English: Patients had mean DAS28 at baseline of 6.7 on subcutaneous and 6.6 on placebo arms.
Danish: Patienterne havde gennemsnitlig DAS28 ved baseline på 6,7 i den subkutane arm og 6,6 i placebo armen.
English: Reported serious infections, some with fatal outcome, included active tuberculosis, which may present with intrapulmonary or extrapulmonary disease, invasive pulmonary infections, including candidiasis, aspergillosis, coccidioidomycosis and pneumocystis jirovecii, pneumonia, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis and bacterial arthritis.
Danish: De indberettede alvorlige infektioner, nogle med dødeligt udfald, omfattede aktiv tuberkulose, som kan vise sig ved intrapulmonal eller ekstrapulmonal sygdom, invasive pulmonale infektioner, inklusive candidiasis, aspergillose, kokcidioidomykose og pneumocystis jirovecii, pneumoni, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis og bakteriel arthritis.
English: • Take the box containing the pre-filled pen out of the refrigerator.
Danish: • Tag æsken med fyldte penne ud af køleskabet.
English: Most of the patients in the population pharmacokinetic analysis had normal renal function or mild renal impairment.
Danish: De fleste patienter i den populationsfarmakokinetiske analyse havde normal eller let nedsat nyrefunktion.
English: • Do not remove the needle-cap on your syringe until Step 5.
Danish: • Fjern ikke kanylens hætte før Trin 5.
English: Forty eight percent (48.1%, 39/81) of the patients treated with placebo flared compared with 25.6% (21/82) of tocilizumab treated patients.
Danish: 48,1% (39/81) af de placebobehandlede patienter oplevede flare sammenlignet med 25,6% (21/82) af de tocilizumab-behandlede patienter.
English: The efficacy of RoActemra for the treatment of CRS was assessed in a retrospective analysis of data from clinical trials of CAR T-cell therapies (tisagenlecleucel and axicabtagene ciloleucel) for hematological malignancies.
Danish: Virkningen af RoActemra til behandling af cytokinfrigivelsessyndrom blev undersøgt i en retrospektiv analyse af data fra kliniske forsøg med CAR T-celle behandling (tisagenlecleucel og axicabtagen ciloleucel) anvendt ved hæmatologiske maligniteter.
English: All patients treated with RoActemra should be given the Patient Alert Card. Suitability of the patient for subcutaneous home use should be assessed and patients should be instructed to inform a healthcare professional if they experience symptoms of an allergic reaction before administering the next dose.
Danish: Alle patienter, der behandles med RoActemra, skal have udleveret et patientkort.Patientens egnethed til subkutan selvadministration bør vurderes og patienten bør instrueres i at kontakte sundhedspersonalet, hvis der opleves symptomer på allergisk reaktion.
English: Table 6: Efficacy Results for Study VII (WA19926) on MTX-naïve, early RA patients
Danish: Effektresultater for studie VII (WA19926) hos MTX-naive patienter med tidlig reumatoid artrit
English: • Put your used RoACTEMRA pre-filled pen and green cap in a sharps disposal container right away after use (See Figure M).
Danish: • Læg den brugte RoActemra-pen og den grønne hætte i kanylebeholderen straks efter brug (se figur M).
English: The pen should not be shaken.
Danish: Pennen må ikke rystes.
English: The usual dose of RoActemra is 8 mg for every kg of body weight if you weigh 30 kg or more.
Danish: Den normale dosis RoActemra er 8 mg pr. kg kropsvægt, hvis du vejer 30 kg eller mere.